€¦ · 2014-12-11 · 1 minutes for 246th meeting of registration board held on 10-11th...

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Minutes for 246th

Meeting of Registration Board held on

10-11th

December, 2014.

Item No. Detail of Item

Item No.I Confirmation of minutes of 245th

meeting Registration Board

Item No.II Agenda points referred by Members, Registration Board

Item No.III Cases for conduction of Clinical Trials – Pharmacy Services Division

Item No.IV Matters referred for deliberation by Registration Board

Item No.V Registration of drugs - Pharmaceutical Evaluation Cell

Item No.VI Miscellaneous cases - Pharmaceutical Evaluation & Registration Division

Item No.VII Registration of Biological Drugs – Biological Evaluation & Research

Division

Item No.VIII Quality Control Cases – Quality Assurance & Lab Testing Division

Item No.IX Registration of Medical Devices – Medical Devices Division

Item No.X Local Manufacturing of Biological Drugs.

Item No.XI Applications for transfer of registrations

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246th

meeting of Registration Board was held on 10-11th

December, 2014 in the

Committee Room, M/o National Health Regulation Services and Coordination, Islamabad. The

meeting was chaired by Mr. Ghulam Rasool Dutani, Director, Pharmaceutical Evaluation &

Registration Division. The meeting started with the recitation of Holy Verses. The meeting was

attended by the following:-

1. Lt General (R) Karamat Ahmed Karamat.

Member

2. Prof.Dr.Rafi uz Zaman Saeedul Haq

Assocaite Dean, Faculty of Pharmacy, University of

Lahore, Islamabad

Member

3. Brig (R). Dr. Muzammil Hasan Najmi,

Associate Dean, Basic Sciences Division,

Foundation Medical University, Rawalpindi.

awalpindi.

Member

4. Brig.Dr.Aslam Khan,

Professor of Medicine, Military Hospital Rawalpindi.

Member

5. Dr. Muhammad Arshad,

President, Pakistan Veterinary Medical Council

Member

6. Abdul Razak

Director Drugs Testing Laboratory

Government of Sind, Karachi.

Member

7. Dr.Muhammad Khalid Khan


Government of Khyber Pakhtunkhwa, Peshawar.

Member

8. Dr.Amanullah Khan


Government of Baluchistan, Quetta.

Member

9. Shaikh Ansar Ahmad

Director Biological Drugs, DRAP

Member

10. Dr.Noor Muhammad Shah

Director MD&MC, DRAP

Member

11. A.Q.Javed Iqbal

Director QA &LT, DRAP

Member

12. Dr. Obaidullah, Deputy Director General (Reg.I). Secretary/Member

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Dr. Muhammad Arshad did not attend the meeting on 10.12.2014 and Dr. Muhammad

Khalid Khan did not attend the meeting on 11.12.2014. Both days, meeting started at 09:30 AM

and continued till 08:00 PM.

Dr.Masud ur Rehman DDG (Biological), Dr. Abdur Rasheed DDG (Pharmacovigilance),

Dr. Tariq Siddique (DDG R.II), Muhammad Arif (DDC R.I), Muhammad Amin (DDC R.V),

Babar Khan (Incharge, PEC), Muneeb Ahmad Cheema ADC (PEC), Ammad Zaka ADC (PEC),

Atiq ul Bari ADC (PEC), Tehreem Sara (DDC MD&MC), Asif Jalil (ADC MD&MC) and

Khalid Mehmood (DDC QC) assisted relevant Directors and Secretary of the Board with agenda.

Mr.Shamim Ahmad and Abuzar Faizy, Mr.Nadeem Alamgeer and Muhammad Farooq

Memon attended the meeting as observer on behalf of PPMA, Pharma Beauru and PCDA

respectively.

In addition to routine agenda, the Board discussed and decided various other matters, as

follows:

1. In future agenda will be circulated about 07 days before the meeting.

2. Registration Board deliberated on agenda point referred by Director DTL, Quetta

regarding attending the meeting by observers (PPMA, Pharma Bureau and PCDA). The

Board decided that respective observer will leave the meeting by ownself, when agenda

related to its company will be discussed. All observers also consented to the decision

3. Registration Board authorized its Chairman for grant of registration for export purpose on

contract manufacturing basis excluding controlled drugs and new drug as per contract

manufacting policy.

4. Dr.Aslam Khan Director Malaria Control Program and Dr.Qutub-ud-Din Kakar, WHO

National Professional Officer briefed the Board about irrational use of antimalarial drugs

in the country particularly injectable anti-malarial therapy and development of emerging

artemisinin resistance. Keeping in view briefing by experts, Registration Board decided

that Malaria Control Program will hold a consultative meeting of all the stakeholders

including DRAP, prescribers, provincial governments, pharmaceutical manufacturers etc

for framing recommendations on the matter.

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5. Registration Board discuused comments of its members, stakeholders and international

practices and agreed that for all topical preparations viz. eye / ear preparations, external

preparations (cream / ointment / gel / lotion / spary) and aerosols, steroid manufacturing

may be permitted on campaign manufacturing basis in general manufacturing areas for

these dosage forms provided that manufacturer has segregated dispensing booths,

validation and controls studies for processes and adequate system to minimize any

potential risk of cross contamination. Registration Board decided to forward above

recommendation to Licensing Division for ultimate decision by Central Licensing Board.

6. Registration Board deliberated on the storage requirement for Misoprostol and keeping in

view EMA’s assessment report decided that Misoprostol 1% HMPC dispersion

(processed material) will be permitted for use in tablet dosage form with storage

condition of 5+3 °C.

7. Registration Board discussed matter regarding non-availability of finished drugs in

country of origin and advised stake holders (PPMA, Pharma Bureau and PCDA) to

forward their comments till 15.01.2015 to already constituted committee for framing its

recommendations for considerartion by Registration Board.

8. Registration Board advised stake holders (PPMA, Pharma Bureau and PCDA) to forward

their comments on case of re-registration of drugs till 15.01.2015 for considerartion by

Registration Board.

9. While discussing case for grant of registration for export purpose, Mr.A Q Javed Iqbal,

Director QA &LT opined that for export purpose only those formulations should be

registered, which are already registered in Pakistan. For new fornulations (which are not

registered in Pakistan), manufacturers should first conduct stability studies and then

registration for export purpose be granted. Prof. Muzammil H Najmi also endorsed it.

Registration Board after deliberation decided that inorder to facilitate export of quality

drugs (non-me too drugs), export registration will be granted and manufacturer will

comply following conditions before export of drug:

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Manufacturer will export the product after complying all the conditions as required under

Drug Act, 1976 including No objection certificate from concerned DRAP office.

Moreover, Federal Inspector of drugs will take sample from each consignemnet for

analysis from CDL, Karachi.

Manufacturer will also furnish export documents endorsed from custom authorities in

order to ensure the export of the product.

These conditions will also be applicable to products approved for exports

(Sofosbuvir) by Chairman, registration Board.

10. Chairman again advised all members, PPMA and Pharma Bureau to forward their

scientific comments and relevant references on manufacturing requirements till

15.01.2015 for following classes of drugs:

a. Immunosuppresants.

b. Clomiphene and letrozole

c. Prostaglandins and its analogues.

d. Vancomycin

11. On the direction of the Honorable Ombudsman, the case for local manufacturing of

biological drugs was re-examined by Registration Board. Representatives of local

manufacturers (Hilton, Getz, Nextar and Macter) were also heard and the Board then

decided the matter in light of directions of Ombudsman.

12. Registration Board discussed the matter regarding issuance of registration letter of

products for which product specific inspections have been conducted and recommended

by the panel of inspectors or cases where product specific inspections are not required /

exempted as per Import Policy for Finished Drugs. The Board authorized its Chairman

for issuance of registration letter in both aforementioned cases. In cases where there is

any ambiguity in inspection reports or products not recommended by panel of inspectors

then such cases will be placed before Regisrtration Board for decision.

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Item No I: Confirmation of minutes of 245th

meeting Registration Board.

245th

meeting of Registration Board was held on 28-29th

September, 2014 and minutes

were circulated to all members through e-mail. Two members forwarded following comments, as

follows:

Dr. Amanullah Khan (Director, DTL, Quetta):

Agenda Item No II:

The following comments may be added as discussed in the 245th Registration Board Meeting regarding

Registration of Sofosbuvier which is very important drug and very badly required for the country man.

“The stability study shall be conducted by the manufacturer and accordingly stability data must be

submitted to the Registration Board before the launch of their product into the market, my point is this

that registration may be granted to the firms with the undertaking that they will provide stability study

before the launch of their product into the market as per previous practice.”

Case No. 50. Cases deferred by Registration Board.

M/s Ideal Pharma, Lahore- Product Specific Inspection-

There is typographic error and needs correction for record purpose, the inspection for product specific

inspection was carried out by two members only that is Director DTL, Quetta and area FID.

Mr.A.Q.Javed Iqbal, Director QA & LT, DRAP.

g. Import of raw materials for experimental purpose and stability studies etc.

Director QA stated that any such Import for trial batch is not discouraged subject to meet all

codal formalities required for the production of commercial batch as per defined policy

Item No.VII: Miscellenous cases. Case No.15. Change in company name from M/s.

Bayer Schering Pharma AG to M/s. Bayer Pharma AG.

Company also informed that German authorities have confirmed the GMP of manufacturer of this

product & product is available in Switzerland and UK which is part of EMA/ SRA.

Minutes were approved after incorporation of above points.

Registration Board in 245th meeting discussed and approved following case but erroneously

decision was not recorded in minutes. However, later on Chairman, Registration Board approved

correction in minutes as decided by the Board.

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Case No.30 Registration of Drugs for export purpose-Not me too Drugs.

Following firms have requested for registration of following drugs for export purpose

only which are not me-too. Details are as under:-

S.

No.

Name of

Company

Name of product(s) Date of application,

Diary No. & Form

1. M/s

PharmEvo

Karachi

Procoxam Forte 1500mg

Tablet

Each tablet contains:-

Glucosamine HCl ....1500mg

13-05-2014

688

Rs.20,000/-

2. -do- Procoxam 625mg Tablet


Glucosamine HCl …..625mg

13-05-2014

686

Rs.20,000/-

3. M/s

Medisure

Labs,

Karachi

Calvita Syrup

Each 5ml contains:-

Calcium lacatate

Gluconate…………..40mg

Vitamin A ………….1200IU

Vitamin D3 ………….100IU

Vitamin B1 HCl …….1mg

Vitamin B2 5-sodium

phosphate …….. …….1mg

Vitamin B5 HCl.. …0.5mg

Nicotinamide ………..5mg

Dexpanthenol ……….2mg

Vitamin C…….. …….50mg

Vitamin E acetate ……1mg

15-04-2014

668

Rs.20,000/-

4. M/s

Kaizen

Pharma,

Karachi

Vitacal Syrup

Calcium lacatate

Gluconate…………..40mg

Vitamin A ………….1200IU

Vitamin D3 ………….100IU

Vitamin B1 HCl …….1mg

Vitamin B2 5-sodium

phosphate …….. …….1mg

Vitamin B5 HCl.. …0.5mg

Nicotinamide ………..5mg

Dexpanthenol ……….2mg

Vitamin C…….. …….50mg

Vitamin E acetate ……1mg

26-06-2014

701

Rs.20,000/-

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5. M/s

Genix

Pharma,

Karachi

Apitonic Syrup

Each 5ml contains:-

Cyproheptadine HCl

(anhydrous) BP ……..2mg

Thiamine HCl (B-1) ...2mg

Riboflavin BP (as 5-

phosphate sodium)…2mg

Pyridoxine HCl ….0.75mg

D-Panthenol BP ….2.5mg

Nicotinamide BP ….22.5mg

27-08-2014

719

Rs.20,000/-

6. -do- Calceg Injection 100mg/ml

Each ml contains:-

Calcium gluconate

(10%)……. …….10mg

27-08-2014

720

Rs.20,000/-

7. -do- Tyca Tablet 90


Ticagrelor ………90mg

27-08-2014

726

Rs.20,000/-

Decision: Registration Board approved minutes of 245th

meeting with above correction

/ amendment in already approved minutes.

Item No II: Agenda points referred by Members, Registration Board.

Dr. Amanullah Khan, Director DTL, Quetta:

a. PPMA Representation from North zone.

Reference to the above , it is submitted that for the last few DRB Meetings it is observed

that PPMA from North Zone/Region nominates that member for to attend the DRB Meetings

whose case is part of the agenda and in my opinion its a matter of conflict of interest. Therefore

it is requested that in the forthcoming meeting of DRB , this matter may be placed as agenda

item before the DRB and take decision whether such conflict of interest nomination may be

allowed or otherwise. Furthermore it is expected that PPMA from both the regions may

nominate(s) a member for DRB for a specified period.

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Decision: Registration Board deliberated on the point and it was decided that

respective observer will leave the meeting by ownself, when agenda related to its company

will be discussed. All observers also consented to the decision.

b. Registration of drugs under Drugs Act, 1976.

Reference DRAP letter No. F.1-20/2000-Reg-I(Pt) dated 23rd April 2014 on the subject cited

above, in this regard it is submitted that DRAP has constituted a panel to carryout inspection

abroad at Argentina, the panel comprised of the following officials,

(I) Dr. Amanullah Khan, Director Drugs Testing Laboratory Government of

Balochistan, Quetta/ Member Drug Registration Board DRAP.

(II) Ms Sara Naeem, Assistant Drugs Controller, DRAP Lahore.

As per said letter there were four (04) importers / firms who have requested for the

import of their products from Argentina and accordingly on the request of the importers/firms the

panel was constituted to carry out inspections of their Principals abroad for the purpose of

registration of drugs under Drugs Act, 1976. The following is the list of firms/importers who had

requested for registration of drugs under the Drugs Act 1976.

i. M/s Pine International Lahore.

ii. M/s Atco Pharma International (Pvt) Ltd Karachi.

iii. M/s Oncogene Pharmaceuticals Karachi.

iv. M/s Nawab Sons, Karachi.

As per procedure of the DRAP the letter for inspection is issued only when all the

prerequisite documents/information for the Registration of the Drugs is completed and

accordingly the said letter is also issued on the same grounds by the competent authority,

however regret to mention that M/s Pine International Lahore has declined to carryout

inspection of their Principal abroad so there is need that the Firm has to clear their position and

explain their position for refusing inspection abroad and why action may not be taken against

them in wasting the time of the officials/inspectors and by enlarge of the DRAP.

Regret to mention that M/s Oncogene Pharmaceuticals Karachi as per DRAP, changed

their principal without approval from the DRAP which is not accepted ethically and officially.

They kept the inspection in grey and at any stage never accepted their mistake of change of

Principal and ultimately on 16th October 2014 the coordinator of the inspection team from Atco

Pharma has forwarded an e-mail from Mr Zubair Khalil owner of M/s Oncogene

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Pharmaceuticals Karachi, and explained that DRAP has refused our request for change of

Principal and further added that i will be obliged if Atco Pharma etc takes my case to DRAP for

not carryout inspection abroad. As a Member Drug Registration Board i am not comfortable with

such offensive statement issued from M/s Oncogene Pharmaceuticals Karachi and there is need

to ask them explain their position on such offended statement.

M/s Atco Pharma International (Pvt) Ltd Karachi and M/s Nawab Sons, Karachi also

declined to carry out their inspection abroad by giving no reason.

Keeping in view an exercise of more than six months wherein the Inspectors from time to

time has to reschedule their official activities for the purpose to carryout inspection abroad

smoothly , but regret to say that the inspectors have been kept in dark by the firms/importers and

there was nobody who could come up with truth that we are not in position to carryout

inspection , as from the beginning it was apparent that the importers/firms were not interested to

carryout inspection abroad and it was also apparent that among the firms/importers blame game

has started which was not a good sign for inspection.

I would like that the case may be kept as Agenda Point in the forthcoming meeting of

DRB and a decision may be taken against the firm/importers who are responsible for this Act.

The cases may be dealt as per Drug Act and as per Policy of DRAP to stop such practices in

future and the offenders may be treated as per policy/Drug Act and I also request for the

cancellation of their requested products.

Decision: Registration Board advised pharmaceutical Evaluation & Registration

Division to present update status of these cases in its forthcoming meeting.

Mr.A.Q.Javed Iqbal, Director QA & LT, DRAP.

c. This point should be brought into discussion of next meeting that Board should define

uniform guidelines to scrutinize variations if it is related to API / quality of Drug substance in

light of ICH guidelines (Q 8, Q9 & Q10) for all originators and for generic products as well.

Moreover the all respective change should be assessed under the scope of applied variations.

Decision: Registration Board discussed the matter and it was decided that QA & LT

Division will develop guidelines for this purpose in consultation with PPMA and Pharma

Bureau.

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Item No.III Cases for conduction of Clinical Trials – Pharmacy Services Division

Case No.01. Polio End-game strategies-Poliovirus Type 2 challenge study. A Five Arm

Community Based Randomized Trial, Karachi. Pakistan.

Aga Khan University has applied for the clinical trial to be conducted in collaboration

with WHO in assistance with EPI Programme.

The key feature of the trial is as under:

Title Polio End-game strategies-Poliovirus Type 2 challenge study. A Five Arm

Community Based Randomized Trial, Karachi. Pakistan.

Phase III

Background Polio disease is present in only three countries including Pakistan. Since the

injectable polio vaccine has better results, WHO “Polio Endgame Strategy ”

is to slowly withdraw the current vaccines replace all oral polio vaccine with

injectable polio vaccine.

Objective The over all purpose of this study is to compare the suggested five different

polio vaccine strategies to see which produces the best immunity for Pakistani

Children and prevents the spread of polio.

Participating

Country/Sites.

Pakistan

Outreach Primary clinics in Karachi at Rehri Goth, Ali Akber Shah Goth,

Ibrahim Hyderi and Bhains Colony.

Number of

participants

1000 children each study group (arm) will have 200 children.

Duration of

Trial.

One year (June 2014-15)

Study

Interventions. Oral Bivalent vaccine – Available from EPI

Oral Trivalent Vaccine – Available from EPI

Inactivated Polio Vaccine (IPV) – To be imported

Inactivated Polio Vaccine2 (IPV2) – To be imported

Oral Monovalent Vaccine2 (mOPV2) – To be imported at a later stage

in the study. An amendment and request will be sent to DRA at that

time.

Study

Outcomes To determine which vaccine best protects the children from polio

Quantity of

Drug to be

Imported.

IPV= 1510 Doses

IPV= 230 Doses

Other vaccines are already registered and standard of care. These will

be purchased from EPI.

Registration

Status of drugs

in Pakistan.

Oral Bivalent, trivalent polio vaccine is provided to EPI by WHO.

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Monitor of the

Trial. Dr. Maha Mohamed Saadeldine Salama

Head Clinical Research Sector/VACSERA, Cairo Egypt.

Sponsor World Health Organization (Geneva)

Bilthoven Biologicals BV (BBIO) has been a manufacturer of IPV and monovalent bulk

components since 1994. The company has now developed an investigational monovalent high

dose inactivated poliovirus vaccine (m-IPV2 HD) in alignment with the Global Polio Eradication

Initiative (GPEI) and World Health Organization (WHO)’s strategic advisory group of experts

(SAGE) recommendation for the eradication of polio. The m-IPV2 HD vaccine contains 32 D-

antigen (D-Ag) units of inactivated type 2 poliovirus, which is four times the current dose of type

2 polioviirus in the trivalent inactivated poliovirus vaccine (t-IPV). This high dose of antigen

should permit the one step immunization of children against type 2 polioviirus while avoiding

the safety issues associated with the attenuated type 2 poliovirus used in the oral poliovirus

vaccine (OPV).

Bulk virus was initially produced in monkey kidney cells and is now produced in Vero

cell line. Full nonclinical toxicology testing was performed on the trivalent polio vaccine.

Manufactured using bulk viruses produced in monkey kidney cells. Extensive clinical data were

also obtained for this formulation. When production of IPV was switched from sub cultured

monkey kidney cells to Vero cells, a limited number of preclinical and clinical studies were

conducted to compare the safety and the efficacy of IPV produced in Vero cells (IPV-Vero) to

the safety and the efficacy of IPV produced in subculture monkey kidney cells (IPV-MK). A

nonclinical toxicology study in rats showed no unexpected toxicological findings.

There are currently no clinical data with the m-IPV-HD. However, clinical studies

showed that t-IPV-Vero is a safe, well-tolerated vaccine that induces as effective immune

response similar to that of IPV-MK. The safety and effectiveness of IPV-Vero is further

supported by post-marketing surveillance bases on a 15-year follow-up of more than 90 million

IPV-Vero vaccine doses distributed worldwide in close to 60 countries.

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As per procedure in vogue the submitted trial was referred to three experts for expert

opinion to facilitate the decision making process by the Registration Board. The same is

summarized as under:

S.No. Expert Name Opinion

1. Syed Sohail Zahoor

Zaidi, Chief Scientist

(Virology) Head of

Department of Virology

It is hereby informed that the subject study is well planned to

determine the improved effect of vaccination with combined

formulations i.e bivalent OPV + IPV vaccines to fill-in the

gaps in immunity type 2 polioviruses among Pakistani

Children.

The study will be conducted with the financial and technical

support of WHO Head Quarters, Geneva and does not pose

any apparent burden on the GoP/National or international stake

holders providing assistance for the Polio Eradication program

in the country.

I hope that the findings and outcomes of this interventional

study will improve our understanding and help to devise

progressive recommendations for vaccination to achieve the

goal of Polio eradication.

2. Mr.Mazharullah

Memon, Principal

Scientific

Officer/Manager

Quality Control

Laboratory.

The five arms plan for End Game Polio Virus, the pattern of

dosing as described are suitable for the subject study and the

subject clinical trial is suggested in my opinion and there is no

financial burden on the Government of Pakistan.

3. Dr. Haider Sherazi,

Neonatology, PIMS,

Islamabad.

Comments are still awaited in spite of reminders

The institution has also requested for import of the following trial material to supplied by the WHO

through EPI:

Drug Name Quantity required

Inj IPV 1510 Doses

Inj IPV2 230 Doses

Decision: Registration Board discussed trial for its all prons and cons keeping in view

the prevalence of polio in the country. Dr.Abdur Rasheed, DDG (Pharmacovigilance)

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informed that Dr. Haider Sherazi has also given his expert views in favor of the trial.

However, after thorough deliberation the Board deferred the case for presentation by

Principal Investigator of the trial.

Case No.02. Phase III (b) Clinical Trial for use of Buprenorphine for treatment and

detoxification of injectable drug users in Pakistan.

Pakistan is signatory to the Millennium Development Goals (MDGs). Goal 6 state that

Pakistan will halt and begin to reverse the spread of HIV/AIDs Globally the most

recommendation intervention to halt the spread of HIV/AIDs infections among the group of

injectable drug users is Buprenorphine which is being used by the drug users for Detoxification,

treatment or at lease substitute the other injectable drugs with oral dosage form.

National AIDs Control Programme, Ministry of National Health Services, Regulation &

Coordination Islamabad has submitted a project proposal to the subject cited above. It is

hypothesized that Buprenorphine has challenges of misuse considering the non regulated

environment if produced and made available in higher doses.. Safety, as reflected by Adverse

Events (AEs) and severe Adverse Events (SAEs), withdrawal severity, stabilization dose and

treatment retention during the study will also be explored.

This is an open-label study, 1,000 (One Thousand) IDU’s seeking treatment for opiate

dependence will be enrolled in 5 centers across Pakistan. Participants are expected to be

predominantly males and non-pregnant and non-lactating females who are at least 18 years-of-

age at the time of enrollment. Following screening, there will be a 28 day stabilization period on

Buprenorphine. All participants will be inducted onto the drug over a period of 3 days with doses

not to exceed 8mg on the first day, 12 mg on the second day and 16mg of third day. Until the end

of the third week doses may be adjusted in 4 or 8mg increments to a total dose of 8, 16, 24mg

based on clinical need, as judged by the treating physician/investigator. The duration of study

participation for each participant will be a maximum of approximately 6 months, including

screening, stabilization, tapering, post-tapering and follow-up, results from this study will add to

the knowledge bases of the clinical use of Buprenorphine in Pakistani population and provide

clinicians/regulatory bodies with data to guide the process of Buprenorphine treatment.

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Principal investigator has submitted ethical approval issued by the National Bioethics

Committee (NBC Pakistan) on 5.11.2014. The trial material is proposed to be arranged from two

following sources if approved by the Registration Board:-

S.No Name of Firms 2mg tablets 8mg tablets

1. M/s. Valor Pharmaceutical, Islamabad 1,80,000 tabs 1,80,000 tabs

2. M/s. Wilshire Labs, Lahore 1,80,000 tabs 1,80,000 tabs

Decision: Dr.Basir Achakzai, Director National AIDS Control Programme and his

team presented in detail background of the case with special refrenece to Pakistan scenario.

The Board also discussed that internationally such therapies are available in combination

with Naloxone for patients admitted in hospital. After detailed deliberation, registration

Board deferred the case dor following:

National AIDs Control Programme will revise its protocol in line With International

Best Practices recommended / adopted for this purpose.

Pharmacy Services Division, DRAP will forward revised protocols to Narcotic

Control Division anf following expert for their views:

o Prof.Dr.Rizwan Taj, PIMS, Islamabad.

o Maj.Gen.Saleem Jehangeer, AFIMH, Pawalpindi.

o Prof.Dr.Ghulam Rasool, Quetta.

Item No.IV Matters referred for deliberation by Registration Board

a. Comments of Director Malaria Control, Islamabad regarding injectable anti-

malarial therapy.

Registration Board in 245th

meeting discussed following comments of Director Malaria

Control, Islamabad.

“The matter has been discussed with the National Professional Officer, MCE, WHO Pakisan

and technical team of this Directorate. Due to emerging Artemisinin resistance in the South East

Asia, which also threatened Pakistan, because of uncontrolled / irrational use of parental

Artemisinin Monotherapy derivatives including Artemether in uncomplicated P. Falciparium

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case and also in clinical Malaria cases by the unregulated Private Sector. During the recent 6th

Inter Country Meeting of National Malaria Control Managers held at Cairo, Egypt on 13th

– 14th

August, 2014 WHO EMRO Region showed their serious concern on production of Artemisinin

monotherapy and injectable chloroquine in Pakistan. According to the approved National Anti-

Malaria Drug Policy only Injection Artesunate is recommended for confirmed severe

Falciparium Malaria cases in hospital settings and as pre-referral treatment in RHCs /BHUs.

Directorate of Malaria Control intends to convene a meeting with Drug Regulatory Authority of

Pakistan along-with other stake holders to share the views on emerging artemisinin resistance

and irrational use of antimalarial drugs in the country. It is also requested to halt further

registration Antimalarial Drugs”.


meeting deferred all injectable anti-malarial drugs and invited

Director Malaria Control, Islamabad in forthcoming meeting for detailed discussion.

Discussion: Dr.Aslam Khan Director Malaria Control Program and Dr.Qutub-ud-Din Kakar,

WHO National Professional Officer briefed the Board about irrational use of antimalarial drugs

in the country particularly injectable anti-malarial therapy and development of emerging

artemisinin resistance. Crux of the briefing is as follows:

a. Resistance to antimalarial drugs is the biggest challenge to malaria control in the country

resulting from “increased drug pressure” due to irrational use of antimalarial drugs

particularly the “monotherapies”.

b. Malaria is re-emerging due to “failure” of control interventions particularly the low coverage

of “effective treatment” and vector control.

c. Effective treatment is the “Foundation stone” of malaria control today which is dependent on

correct lab diagnosis and effective medicines. Effective treatment is the most effective tool to

reduce transmission potential due to reduction in parasite reservoir in human hosts.

d. Malaria Control programmes have been left with limited choices of treatment for confirmed

cases and there has been no development made in the development of new effective and safe

drugs in near future. This calls for rational and restricted use of available regimens where the

mainstay of treatment is Artemesinin Combination Therapies.

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e. In Pakistan the positivity rate in suspected cases has been lower than 5% in highly endemic

areas and <1% in low endemic province of Punjab, treatment of malaria cases on clinical

grounds is mostly wrong in 98% of suspected cases, which is the major reason of misuse of

these drugs. No antimalarial drug should be dispensed in Pakistan without confirmatory test,

is the national policy and promotion of produced “anti-malarial” molecules by the industry

has led to the indiscriminate prescriptions by the untrained physicians, paramedics and

kwakes.

f. As per policy injectable quinine and Artesunate only can be sued in the treatment of

complicated and severe malaria cases, which are only seen in a fraction malaria cases due to

falciparum species only. The total estimated number of confirmed cased due to falciparum

malaria in the country are not >200,000 cases and the number of true severe malaria cases

will not be more than 20,000 warranting treatment with injectable quinine and Artesunate.

g. Treatment of severe cases of malaria is a medical emergency requiring intravenous

medication with above mentioned drugs and can only be dealt in at Secondary or tertiary care

hospitals only.

h. Huge quantities of Artesunate injections have been provided by the Global Fund from WHO

Pre-Qualified manufacturer (Guillin Pharma) sufficient to cover all the country needs of

dealing with severe cases.

i. Resistance is rapidly developing against artemisinin group and within short time the care

delivery system will be unable to treat the complicated cases at hospitals.

Decision: Registration Board appreciated the concern raised during the briefing. It

was then decided that Malaria Control Program will hold a consultative meeting of all the

stakeholders including DRAP, prescribers, provincial governments, pharmaceutical

manufacturers etc for framing recommendations on the matter.

18

b. Transfer of registered drugs.

Under Rule 27 of Drugs (Licensing, Registering & Advertisement) Rules 1976, a

certificate for registration is issued for a period of five years unless earlier suspended or

cancelled. As per practice in vogue, if a firm applies for transfer of registration, such cases are

transferred according to the following provisions incorporated in schedule F vide SRO

877(I)/2000 dated 09th

December, 2000:-

An application for:-

(i) transfer of registration from one importer or manufacturer to another,

(ii) transfer from import to local manufacture,

(iii) import in bulk and repacking locally, and

(iv) change of name of registered drug, shall be considered as for grant of a new

registration and shall be made as per rule 26(1).

Registration Board in its 240th

meeting also approved the following SOPs to stream line

the transfer of registrations and delegated its powers to the Chairman Registration Board to

approve such cases:-

Transfer of registration:

i) With change in manufacturing site:

a. Application with Form-5 and required fee as per relevant SRO.

b. Copy of registration letter and renewal status.

c. NOC for CRF clearance.

d. Copy of approved section by Central Licensing Board.

e. Copy of last inspection report.

f. NOC from existing manufacturer / registration holder permitting for transfer of

product.

g. Statement / undertaking that applicant do not have registration of same products.

If so, it has to apply for cancellation of product.

h. Accelerated stability studies of 6 months with to conduct real time stability

studies up to assigned shelf life & report if any result falls outside shelf life

specifications with proposed action).

i. Validated method of analysis, master formula and product development data

ii) Change in name / title of manufacturer (site of manufacturing remains the same)

a. Application on Form-5 with required fee as per relevant SRO.



d. Approval of new name / title from CLB.

19

e. Undertaking that the formulation, API source & Specifications, manufacturing

process, analytical test methods, release & shelf life specifications have not

changed.

However, schedule F was amended as per SRO 1117(I)/2012 dated 10th

September, 2012

and above provisions defined for transfer of registration vide SRO 877(I)/2000 dated 09th

December, 2000 have been omitted now.

In view of above, directions /guidance of Registration Board is solicited to process cases

of transfer of registration of drugs.

Decision: Registration Board deliberated on the matter and it was decided that

following procedure will be adopted for these cases.

Registration will be cancelled from name of existing registration holder. The

applicant will comply all requiremenrs for grant of registration and then

registration Board will decide the case for grant of registration keeping in view

safety, efficacy and quality parameters.

For imported drugs, Import Policy for Finished Drugs will be followed.

A reference will be sent to Cost & Pricing Division whether such cases for grant of

registration shall be considered at existing MRP or otherwise.

Cases will be divided into any of following category and requisite documents will be

as follows:

o Registration of drug for local manufacturing.

a. Application with Form-5 and required fee as per relevant SRO.



d. Copy of approved section by Central Licensing Board.

e. Copy of last inspection report.

f. NOC from existing manufacturer / registration holder permitting for cancellation

of product from its name and grant to new registration holder / manufacturer.

g. Statement / undertaking that applicant do not have registration of same products.

If so, it has to apply for cancellation of product.

20

o Registration of drug for import (Change of authorized agent in Pakistan only).

a. Application on Form 5A with required fee as per relevant SRO.

b. Copy of registration letter and last renewal status.

c. Notorized termination letter (original) from manufacturer for previous importer.

d. Notorized authority letter/sole agent letter (original) from manufacturer.

e. NOC from existing importer / registration holder permitting for cancellation of

product from its name and grant to new importer / registration holder.

o Registration of drug when title of firm has been changed by firm and approved

by Central Licensing Board (manufacturing site remains the same).

Registration Board discussed that in this case registration will not be cancelled from

previous name as there is no change in manufacturing site and only title of registration

holder has been changed. Thus case will be processed for change of title of the firm and

firm will submit following documents.

a. Application on Form-5 with required fee as per relevant SRO.



d. Approval of new name / title from CLB.

e. Undertaking that the formulation, API source & Specifications, manufacturing

process, analytical test methods, release & shelf life specifications have not been

changed.

c. Re-registration of drugs.

Under Rule 27 of Drug (Licensing Registration and Advertising) rule, 1976, a certificate

of registration, shall unless earlier suspended or cancelled, be in force for a period of five

years from the date of registration of the drug and may thereafter be renewed for periods not

exceeding five years. Provided that an application for the renewal of registration shall not be

entertained unless it has been made within sixty days after the expiry of the registration and

when and application has been made as aforesaid the registration shall subject to the orders

passed on the application for renewal continue in force for the next period of five years.

Previously, in case a firm applies for re-registration of drug i.e after expiry of renewal

of registration of a drug, such cases were processed for re-registration on payment of full

registration fee and submission of form-5. Chairman Registration Board was authorized to

approve such cases on file.

21

Decision: Registration Board advised stake holders (PPMA, Pharma Bureau and

PCDA) to forward their comments till 15.01.2015 for considerartion by Registration Board.

d. Registration of 10 Products per section for New Drug Manufacturing Licence/

Additional Section.


meeting constituted following committee to review policy of

registration of 10 products per section to new manufacturers/ additional sections.

- Prof. Muzamil Hassan Najmi, Member Registration Board

- Mr. A Q Javed, Director QA, DRAP.

- Mr. Arif Chowdhry, DDC Reg-I

The Committee forwarded following recommendations:

To achieve the standards as laid down in GMP, the present practice of granting

registrations of ten products in a section to the new licensees may be continued.

The operational status of the manufacturer may be assessed by a panel inspection after 60

days of commencement of manufacturing activity.

Subject to compliance of GMP, as determined by the inspection panel, another ten

products per section may be granted to the new licensees on priority.

Decision: Registration Board was informed that DRAP’s Policy Board has also

discussed and deferred instant matter for further deliberation. The Board decided that

above points will be forwarded to DRAP’s Policy Board as recommendation from

Registration Board.

e. Non-Availability of finished drugs in country of origin.


meeting discussed that in some cases, finished drug of a

manufacturing site is neither available / authorized for sale in country of origin / manufacture

nor approved by any of regulatory authority of USFDA, Australian TGA, Japan or EMA, but

applicant intend to import finished product from that site. The Board constituted following

committee to look into the matter keeping in view international practices in such cases and

frame its recommendations.

- Prof. Muzamil Hassan Najmi, Member Registration Board.

- Mr. A Q Javed, Director QA & LT

22

- Mrs. Sara Mahreen ADC, PEC

Mrs. Sara Mahreen could not join the committee due to her posting in DRAP, Lahore and

Mr.Ammad Zaka, ADC was assigned the task.

The Committee forwarded following recommendations:

If any such drug which is not available in country of origin and not approved by reference

regulatory authorities i.e., USFDA, Australian TGA, Japan or EMA, it may be considered

for registration or approval of post registration variation, provided:

o Its registration has not been cancelled / withdrawn by any ICH member countries,

which are considered SRA, for safetyreasons.

o There is no new toxicity data reported about the drug requiring re-evaluation of its

status.

o It is available in atleast threeSRAcountries as notified by International Conference

onHarmonization of Technical Requirements for Registration of Pharmaceuticals

for Human use (ICH) on www.ich.org.

Decision: Registration Board advised stake holders (PPMA, Pharma Bureau and

PCDA) to forward their comments till 15.01.2015 to already constituted committee for

framing its recommendations for considerartion by Registration Board.

f. Export of drugs with same brand name of different manufacturers

M/s Ambrosia Pharmaceuticals, Islamabad has informed that they have exported

following drug:-

Name of product Regn No. for M/s

Ambrosia in

Pakistan

Regn No. for M/s

Ambrosia in Kingdom

of Combodia

Util Capsule 40mg

(Esomeprazole)

046889 CAM 0279-10

Firm has submitted that they were surprise and shock that M/s Medisure Labs, Karachi

exporting their same molecule “Esomeprazole” with same brand name “Util” to Kingdom of

Combodia with printed same registration number granted to them in Cambodia. This kind of act

is not only hurting their marketing and market share and image in Kingdom of Combodia as their

http://www.ich.org/

23

product are more effective and superior quality but more importantly damaging the image of

DRAP. At this time their distributor in Combodia has refused to place any further orders or

accept shipments of above products till such time they receive letter from DRAP stating that

DRAP will cancel these EX registrations of M/s Medisure and also confirmed that this brand

name will not be issued to any other manufacturers / companies in Pakistan by DRAP for export

purposes in the future.

Decision: Registration Board was informed that M/s Ambrosia Pharmaceuticals,

Islamabad has also submitted similar type of complaint against M/s English Pharma,

Lahore. Thus the Board decided to call these three manufacturers in forthcoming

Registration Board meeting with relevant record for presentation of their case.

g. Registration of generic Nilotinib

Advocate Mr. Kazim Hasan, Barrister-at-Law of M/s Novartis Pharma Limited has informed

that they have been instructed by Novartis to advise the Drug Registration Board of the DRAP

that the intellectual property rights to Nilotinib vests in Novartis globally. Nilotinib is a

breakthrough treatment of Lukemia and it has been developed by Novartis. M/s Novartis has

come to know that M/s Genix Pharma has applied for generic registration of Nilotinib under the

trade name Lukopenil. Being intellectual property rights to Nilotinib vests in Novartis globally a

generic Nilotinib would be a violation intellectual property rights.

Advocate Mr. Kazim Hasan has further submitted that such registration would also constitute

a sovereign breach, as Pakistan is a signatory to international treaties which guarantee protection

of intellectual property rights. He requested that application filed by Genix Pharma for generic

registration of a Novartis product may be rejected and Drug Registration Board should not even

entertain any application for generic registration Nilotinib under any trade name.

Decision: Registration Board decided to forward instant letter to IPO, Pakistan for its

comments for consideration by the Board.

e. Recommendation of Review committee.


meeting considered following recommendations of review

committee and advised PPMA and Pharma Bureau to forward their comments for consideration

24

of Registration Board. Now both stake holders forwarded their comments on these

recommendations, as follows:

PPMA:

A. Trimethyl Phologlucinol 80mg+Phloroglucinol 80mg.

i. Products Containing Phloroglucinol are available in many countries of the world, including Italy,

France, Switzerland, Luxemburg, Belgium, China and South Korea where more than 42

Companies including Multinationals have market since many years.

ii. In Italian health system, inclusion of Phloroglucinol as a fully reimbursed product is a further

guarantee of its efficacy and safety. In June , 2011 the transparency Committee of the Prestigious

HAS, France as recommended continued inclusion on the list of medicines refundable by national

health insurance and on the list of medicines approved for hospital uses in the indication of

“Symptomatic Treatment of Pain Related to Functional Disorder of the Gastrointestinal tract

including IBS and dosages given in the marketing authorization”.

iii. The product containing this molecule in France has been in the market since very long and is one

of the highest used specialties in gynaecology. Today about 15 French and multinational

companies have marketed their brands in France only.

iv. Also in Pakistan where this is the most used specialty for renal colic, biliary colic, abdominal

colics, IBS andfor the facilitation of labor, since almost 20 years with excellent safety and

efficacy.

v. All the leading medical specialists of Pakistan in related fields confirm its usefulness and are

completely satisfied.

vi. The clinical trials conducted within Pakistan have been included in International Literatures.

Volumes of data speak about its safety and efficacy.

vii. Phloroglucinol is well documented in well reputed medical reference books including Extra

pharmacopeia Martindale and Merck Index.

viii. The molecule Phloroglucinol is not under any review by EMA (European Medicine Agency) and

FDA (Food and Drug Authority of America).

ix. Only authentic documents about the safety of a product in Europe are PSUR (Periodic Safety

Update Report), which confirms the safety of the product.

B. Omeprazole + Sodium Bicarbonate 20mg, 40mg.

i. The product is safe for use to cure GERD. Authentic clinical trials/study attached to your

reference to use product for short term only (4 to 8 weeks) depending upon the patient health

severity. Minor side effects like hypokalemia, alkalosis and problem with acids base balance only

related with long term use. Companies already not recommended product for long term use.

25

ii. Product is approved in USFDA and on under prescription.

C. Citicoline.

i. Availability in Multiple Countries:

Citicoline is available in multiple European, North America and Asia Pacific Countries. It

highlights the wide spread usage of Citicoline as Nootropic and Neurotonic agent with

established efficacy and safety.

ii. Evidence of Citicoline’s Mode of Action as Neuroprotective:

A study of International Society for Neurochemistry in Journal of Neurochemistry has established

Citicoline as an intermediate in the biosynthesis of phosphahatidylcholine which has beneficial

effects in number of CNS injury models and patholological conditions of brain.

iii. Reference of Citicoline in Authentic & Reputable Journals:

a. British Medical Journal has highlighted Citicoline as more effective if given within 24 hours of

stroke than placebo while referring the study of clinical trial “Stroke Management” by Elizabeth

Warburton; Josef A Alawneh; Philip L Clatworthy; Rhiannon S Morris”.

b. Journal of the American Heart Association has highlighted beneficial therapeutic effect of the

long term treatment of Citicoline in acute cerebral infarction.

c. According to Clinical Interventions in Aging, a world renowned journal, Citicoline is effective

and well tolerated in patients with mild vascular cognitive impairment.

iv. Citicoline Granted Novel Food Ingredient Status in EU

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition

and Allergies (NDA) delivered a scientific opinion on Citicoline as a novel food ingredient (NFI),

which concluded on October 2013 that Citicoline is safe under the proposed use and use levels.

The Commission Implementing Decision 2014/423/EU on July 1, 2014 authorized Kyowa Hakko,

New York, NY, to market and manufacture Citicoline as a NFI under Regulation (EC) No 258/97 of

the European Parliament and of the Council.

v. Huge prescription base in Pakistan

According to the latest “Sales” data, around 700,000 injections of 250mg whereas 1,000,000 tablets

have been selling in a year in Pakistan. It reflects strong confidence of leading neurologists and

neuro-surgeons in efficacy and safety of the product which leads to such a massive prescription base.

D. Diacerein.

i. The molecule is registered with the European Medicines Agency.

ii. The product is very effective for the treatment of Osteoarthritis Specially in advanced age

26

iii. The product is available and authorized to be used in the European Union Including France.

E. Calcium Dobesilate.

i. The molecule is included in the European Pharmacopoeia.

ii. Molecule is registered and available in Switzerland (COPP available)

iii. Molecule is registered in more than sixty countries of the world and marketed in more than fifty

countries.

iv. The molecule has been registered and marketed since 1972 and available in European Union

since 1975.

F. Smectite.

i. The molecule is available in France, Greek and USA.

ii. The molecule is extremely useful in the treatment of Acute Diarrhea.

iii. It is a time tested and important product for treatment of Dierrhea specially in children.

iv. The molecule is available in the European Union including Switzerland, Germany, Austria, Italy,

Spain and countries of Eastern Europe as well as South America and South Anastasia.

v. It is an important molecule to prevent Hepatotoxicity.

G. Saccharomyces Boulardi.

i. Clinical efficacy has been established for chronic disease like Crohn disease, Ulcerative Colitis,

Irritable Bowel Syndrome, Parasitic infection & Human Immunodeficiency virus related

Diarrhea. An overdose of saccharomyces boulardii and long term use ae not likely to cause life-

threatening symptoms.

ii. USFDA are withdrawing a notice of eligibility and recommendation of safety data for

consideration as OTC product and recommended product monograph for antidiarrheal drug..

iii. Product is already approved and recommended by TGA.

iv. In many of countries like in Vietnam, Product registered as drug and in Pakistan this product is

under price control and if product transfers to OTC division then market price might be change

and ultimately effect on patient.

H. Piracetam.

i. Availability in Multiple Countries:

Piracetam is available as “Central Stimulant” and “Nootropic Agent” in large number of countries

including multiple European, South America and Asia Pacific Countries. Among them the most

significant are Germany, France, Belgium, India, Malaysia, Turkey, Singapore etc.

ii. Authentic References:

- Assay method given in “British Pharmacopoeia” highlighting the authenticity of the product.

27

- Piracetam has been mentioned in “Martindale - The extra Pharmacopoeia” 36th Edit on with

mode of action and its therapeutic uses.

iii. Mode of Action:

Mode of Action of Piracetam is well-explained which highlights its beneficial influence on

neuronal and vascular functions. Further Piracetam also improves the function of neurotransmitter

acetylcholine.

iv. Wide-spread Usage of Piracetam by leading Neurologists & Neuro-Surgeons in Pakistan:

There are significant number of Piracetam users all around the Pakistan who are very much

satisfy with therapeutic results as Nootropic and Neurotonic Agent.

v. Huge Prescription Base in Pakistan:

According to the latest “Sales” data, around 400,000 syrups have been selling in a year in

Pakistan. It reflects strong confidence of leading neurologists and Neuro-surgeons in efficacy and

safety of the product which leads to such a massive prescription base.

I. Thiocolchicoside.

i. Committee for Medicinal Products for Human use (CHMP) of the European medicines agency in

its assessment report no. EMA/40340/2014 dated 17th January, 2014 as made the following

conclusion.

a. Having considered all available data from pre-clinical studies, Pharmacoepidemiological studies,

published literature, post-marketing experience on the safety of thiocolchicoside containing

medicinal products for systemic use with regards to its genotoxicity, the Committee considered

that thiocolchicoside containing medicinal products for systemic use remain an effective adjuvant

treatment of painful muscle contractures in acute spinal pathology.

b. However, having considered the risks, thiocolchicoside containing medicinal products for

systemic use should only be administered to patients over 16 years of age in acute conditions.

With treatment duration limited to 7 (oral) and 5 (IM) consecutive days. In that respect, the

CHMP was of the view that the indication in “Parkinson’s disease and drug-induced

Parkinsonism with special consideration to neurodyslectic syndrome” should be removed as this

is a chronic condition which requires longer treatment duration. The package size should be

adapted to new recommended treatment-days.

c. The committee considered also that thiocolchicoside containing medicinal products for systemic

use should be contraindicated during the entire pregnancy period. These products should also be

contraindicated in women of childbearing potential not using contraception and during lactation.

The CHMP also recommended further changes to the product information including information

on fertility.

28

d. The Committee as consequence concluded that the benefit-risk balance of thiocolchicoside

containing medicinal products for systemic use as adjuvant treatment of painful muscle

contractures acute spinal pathology in adults and adolescents from 16 years onwards remains

favorable, subject to the restrictions, warnings, other changes to the products information,

additional pharmacovigilance activities and risk minimization measures agreed.

ii. The molecule is available in France, Greece, Italy, Portugal, Malta, Spain, Hungary, Czech

Republic, India and many countries of the Fareast.

iii. The molecule has been in use in Europe since last more than 30 years.

J. Dry Powder Suspension of Famotidine.

Famotidine has many advantages in the Dry Powder form (reconstitute before use) as compared

to liquid suspension due to the following reasons.

i. International Availability of Dry Powder Suspension by the Innovator: Please see the

attached Annexure, I, which clearly shows that in USA, the research company Merck & Co is

manufacturing Famotidine in Dry Powder Suspension. We have attached Product information

available freely on internet for your perusal and record.

ii. Proof of availability of this formulation i.e. Dry Powder Suspension is attached as Annexure II –

IV, which shows that renowned companies such as Zydus Pharmaceutical USA, Paddock

Laboratories Inc., Minneapolis and Lupin Pharmaceuticals Inc., USA are manufacturing and

marketing their products in USA which is approved by USA FDA. We have attached the product

details downloaded from Internet.

iii. Pharmacopeial Monograph: For your kind record, please note that Dry Powder Suspension is

mentioned in the Monograph of Famotidine in USP (Please see Annexure - V ). It is mentioned in

the monograph that total impurities in the Oral suspension should not be more than 2.0%. it is

very unlikely that Famotidine that is not stable in water could meet criteria of impurities of 2% if

provided in the form of liquid suspension.

iv. Comments on Stability: Famotidine stability in aqueous solution is temperature dependent,

therefore storage condition for Famotidine injection is recommended at 2-8oC(See Annexure VI).

Various studies are available in the literature which supports termal degradation of Famotidine in

Aqeouse Solution at room temperature (See Annesure VII), hence liquid suspension degrade at

room temperature.

v. Based on the above authentic references, it may be noted that Dry Powder Suspension is more

stable and is used within 30 days after reconstitution (USA product brief). Therefore this

formulation is the benchmark as marked by its researcher. Therefore liquid suspension at room

temperature is not stable and should be look into for patient safety.

K. Silymarin

29

Silymarin is mentioned in more than one standards books like:

1) Martindale: The complete drug Reference, which is a comprehensive & reliable reference

source on drug & medicines used throughout the world.

2) U.S.P 34: Silymarin is prescribed in more than 50 countries of the world, we are enclosing

herewith reference of substantial internationally available brands.

S.No Brand name Manufacturing/Availability

1 Lagalon

Austria,Bahrain,Balgaria,China,Colombia,Georgia

Germany, Italy,Hungary,Mexico,Philippine, Poland,

Portugal,Romania, South Africa, Spain,

Switzeland,Slovakia,Thailand, Venezuela.

2 Simepar Switzerland

3 Cefasilymarin Germany

4 Samarin 140 Thailand

5 Doindi Vietnam

6 Silymarin Forte Romania

7 Silymarin Duo Macedonia

8 Hepasil Bangladesh

9 Esimerin Plus India

10 Good Liver India

11 Heptosil 200ml India

12 Livoriv-B India

13 Livosil-B India

14 Silyvit India

15 Tezaliv India

It is an important molecule used in various liver disorders. Various studies regarding

usage of Silymarin are available in different medical Journals.

30

Various manufacturers have also forwarded their comments on various formulations.

Recommendations of review committee considered by Registration Board in 245th

meeting

are as follows:

S.

No

Drug Name

Generic (Brands)

Approv

al by

Internat

ional

Regulat

ory

Bodies

Status in

Authentic

Textbooks

(Pharmacol

ogical basis

of

therapeutic

s-Goodman

& Gilman,

Basic &

Clinical

pharmacolo

gy-B G

Katzung,

Current

Medical

Diagnosis &

Treatment

– 2013)

Research

published in

Reputed/

Authentic

Journals

Concluding

Remarks &

Recommendation

1. Keto Injection

Each vial contains:-

Ketamine HCl

Ketamine 500 mg

(General Anesthetics)

Yes

FDA

EMA &

others

Recommend

ed for use in

general

anesthesia.

Numerous Ketamine is

chemically related to

phencyclidine and

therefore has a

potential for abuse.

The drug is included in

the controlled list and

is placed in Schedule

III in USA.

In view of its useful

role in anesthesia,

Ketamine is

recommended to be

retained as a

registered drug.

However, it should be

dealt with narcotics

and appropriate

restrictions may be

applied to prevent its

abuse.

31

Recommended for

registration.

2. Fluoxetine + Olenzapine

Citrate

Each capsule contains:-

Fluoxetine HCl 25 mg

Olenzapine Citrate

Olenzapine 12 mg

(Antidepressant)

FDA

only

The

individual

drugs are

recommende

d but the

combination

has not been

mentioned.

Available Fluoxetine is an

SSRI and can

interact with MOAIs

to cause serotonin–

syndrome. Since it is

converted into a very

long acting

metabolite, the

interaction can occur

during 4 weeks after

cessation of

Fluoxetine. The risk

of QT prolongation

and causing Torsade

de pointes also

exists.

The Fixed-Dose

combination may

be allowed with

relevant warning

and to be dispensed

on prescription by

qualified

psychiatrist only.

Recommended for

registration.

3. Each capsule contains:-

Omeprazole 20 mg

Sodium Bicarbonate 1100

mg

(Proton Pump Inhibiter)

Tentativ

e

approval

by FDA

only.

Not

approve

d by

EMA,

PMDA,

TGA

The

individual

drugs are

recommende

d but the

combination

has not been

mentioned.

No independent

scientifically

designed studies

available to

support the

combination of

these two drugs.

Omeprazole, a PPI,

is a prodrug which

requires acidic

environment for

conversion into

active form. It blocks

the H/K ATPase

irreversibly and

reduces the gastric

acid secretion to very

low levels (most

potent among all

anti- secretory

drugs).

Sodium bicarbonate

is a rapidly acting

32

systemic antacid. It

absorbs into blood

and long-term use

may cause systemic

alkalosis, besides

other toxicity.

It is irrational to

combine the two

drugs as the antacid

may impair

activation of

Omeprazole. Further,

in the face of strong

acid-inhibiting effect

of Omeprazole, it is

superfluous to

administer an antacid

on regular basis.

The combination

adds to the cost and

increases adverse

effects.

Not Recommended

for registration.


Omeprazole 40 mg


mg


Tentativ

e

approval

by FDA

only.

Not

approve

d by

EMA,

PMDA,

TGA

The

individual

drugs are

recommende

d but the

combination

has not been

mentioned.

No independent

scientifically

designed studies

available to

support the

combination of

these two drugs.

Omeprazole, a PPI,

is a prodrug which

requires acidic

environment for

conversion into


the H/K ATPase

irreversibly and

reduces the gastric


low levels (most

potent among all

anti- secretory

drugs).

Sodium bicarbonate

is a rapidly acting


absorbs into blood

and long-term use

may cause systemic

alkalosis, besides

33

other toxicity.

It is irrational to

combine the two


may impair

activation of





superfluous to


on regular basis.

The combination


increases adverse

effects.

Not Recommended

for registration.

5. U-Fit 10 mg Dry Suspension

Each 5ml contains:-

Famotidine 10 mg

(Antiulcer)

Famotidi

ne in dry

suspensi

on form

is not

approve

d by any

reputed

internati

onal

agency

NA NA Famotidine is widely

available in Tablet,

Capsule, Suspension,

Chewable &

Dispersible tablet

forms. Dry

suspension does not

seem to offer any

advantage over the

existing formulations

and is not supported

by international

market scenario.

Not Recommended

for registartion.

6. Sacopan Sachets

Each sachet contains:-

Saccharomyces

Boulardii 250mg

(anti Diarrhoeal)

Not

approve

d by

FDA,

EMA,

PMDA

Approve

d by

TGA

only

Some studies

about the role of

probiotics in

IBS and CD

infection have

been published

but their role

requires more

elucidation.

The probiotics are in

evaluation stage and

their benefits in IBS,

Crohn’s disease, C.

difficle infection etc.

have not been

established. In

immune-compromised

patients these may

cause life-threatening

infection. In most of

the countries these are

34

available as food-

supplements or OTCs.

Some of these are

already available as

additives in milk

formulas for infants.

May be de-registered

as drug and allowed

as food supplements.

7. Ritocin-B Dry Suspension

200 mg

Each 5ml contains:-

Erythromycin Ethyl

Succinate.

Erythromycin 200mg

Bromhexine HCl 4mg

(Macrolide)

Not

approve

d by

FDA,

EMA,

TGA &

PMDA.

Erythromyci

n as single

drug is

recommende

d by books

for

infections by

susceptible

organisms.

Bromhexine

is not even

mentioned.

Studies have

been published

showing in vitro

effect of

bromhexine as

mucolytic.

There is no

evidence for

such action in

vivo after oral

administration.

Mucolytics are

useful in

management of

COPD after

administration by

inhalation. Evidence

is lacking for any

benefit after oral

administration.

All oral

formulations

containing

bromhexine as

single drug or in

combination with

other drugs, are

recommended to be

de-registered.

8. Spardix Tablets 100mg


Sparfloxacin 100 mg

(Anti-infective,

Fluoroquinolone)

Not

approve

d by

FDA,

EMA,

TGA &

PMDA.

Mentioned

as member

of

fluoroquinol

one group.

Studies have

been published

showing activity

of sparfloxacin

against Gram

positive

bacteria.

Reports are

published

describing

potassium

channel

blocking

activity causing

QT prolongation

and life-

threatening

Several of the

Fluoroquinolones

have been reported

to cause QT

prolongation and

cardiac arrhythmias.

The potential is

highest for

Sparfloxacin.

In view of the

unfavorable

risk/benefit ratio,

the drug is not

recommended for

registration.

35

torsade de

pointes

arrhythmias.

9. ES ZIN 20mg Tablets Each

tablet contains:-

Esomeprazole 20mg

Magnesium 700mg

Sodium Bicarbonate 20mg

Not

approve

d by

FDA,

EMA,

TGA &

PMDA.

The

individual

drugs are

recommende

d but the

combination

has not been

mentioned.

No independent

scientifically

designed studies

available to

support the

combination of

these drugs.

The comments given

above at No.3 also

hold good for this

preparation.

All dosage

strengths

recommended for

de-registration.

10. ES ZIN 40mg Tablets Each

tablet contains:-

Esomeprazole 40 mg

Magnesium 700 mg

Sodium Bicarbonate 40mg

Not

approve

d by

FDA,

EMA,

TGA &

PMDA.

The

individual

drugs are

recommende

d but the

combination

has not been

mentioned.

No independent

scientifically

designed studies

available to

support the

combination of

these drugs.

The comments given

above at No.3 also

hold good for this

preparation.

All dosage

strengths

recommended for

de-registration.

11. Calzob-500 Capsules


Calcium dobesilate 500mg

(Vasotherapeutics,

Coagulants, Haemostatics)

Not

approve

d by

FDA,

EMA,

TGA &

PMDA.

Not

mentioned

in any

standard

textbook.

The published

clinical trials

have shown that

calcium

dobesilate does

not reduce the

occurrence of

diabetic

retinopathy in

patients.

Calcium dobesilate

was developed for

prevention of

diabetic retinopathy.

Theoretically its

mechanism of action

(inhibition of aldose

reductase and

reduction of capillary

permeability)

supports its use for

this purpose.

However, in

evidence-based

medicine, benefits of

this drug could not

be established.

Recommended for

de-registration.

12. Ciprozan Tablets 1gm

Each film coated SR-tablet

contains:-

Ciprofloxacin ……… 1 gm

(Quinolone Antibiotic)

One Gm

SR

dosage

form not

approve

One Gm

extended-

release

tablet

mentioned

The strength is

within the

therapeutic

range of dose

described in

The slow release

tablet of 1 Gm is not

in vogue but has

been described by

the standard

36

d by

FDA,

EMA,

TGA &

PMDA.

by B G

Katzung

published

studies.

textbook and lies

within the

therapeutic range of

dose. The applicant

may be asked to

provide full

justification for the

formulation, quoting

examples of

countries where

similar forms are

available.

Final decision may

be pended till point

of view of the

applicant is

evaluated.

13. Diacin 50mg

Capsules Each capsule

contains:-

Diacerein 50mg

( Anti-Rheumatic )

Not

approved

by FDA,

TGA &

PMDA.

Approved

by EMA

for use in

epidermo

lysis

bullosa

only

Not

mentioned

in any

standard

textbook

Some in vitro

studies on

chondrocytes

have been

published.

Clinical trials

have reported

slight but

statistically

significant

superiority over

placebo.

Diacerein is an anti-

inflammatory drug

acting by inhibition

of Interleukin-1beta.

It has been used in

osteoarthritis where

it may produce slight

improvement. In

limited number of

countries where it is

available, it is being

reviewed and

withdrawn due to

hepatotoxicity.

In view of the

limited usefulness

and concerns of

toxicity, diacerein is

not recommended

for registration.

14. Swanliag 5 mg Tablet


Cyclobenzaprine 5mg

(Skeletal Muscle Relaxant)

Not

approved

by EMA,

TGA &

PMDA.

5 mg

dosage-

form

discontin

Mentioned

by BG

Katzung

Studies have

been published

in which

cyclobenzaprine

was found to be

superior to

placebo and

equivalent to

Although 5 mg dosage

form has been

discontinued by FDA,

but other dosage forms

contain higher doses

which may be

associated with more

side effects. By virtue

of its non-addictive

37

ued by

FDA. other

spasmolytics.

nature It may be

superior to

benzodiazepines.

In view of the

scientific evidence for

efficacy of the drug,

Cyclobenzaprine may

be retained as a

registered drug.

15. Mepridone 20mg Capsules


Esomeprazole Magnesium

Trihydrate Pellets eq. to

Esomeprazole 20 mg

Domperidone 30mg

(Proton Pump Inhibitor /

Anti-Dopaminergic)

Not

approve

d by

FDA,

EMA,

TGA &

PMDA

The

individual

drugs are

recommende

d but the

combination

has not been

mentioned.

Studies on

individual drugs

are available but

not on this

combination.

Besides the

combination,

Domperidone as an

individual drug is not

approved by FDA. It

has been associated

with cardiac

arrhythmias. The

combination is

irrational and carries

the risk of toxicity.

Recommended to

be de-registered.

16. Each Sachet contains:-

Omeprazole 20 mg


mg


Tentativ

e

approval

by FDA

only.

Not

approve

d by

EMA,

PMDA,

TGA

The

individual

drugs are

recommende

d but the

combination

has not been

mentioned.

No independent

scientifically

designed studies

available to

support the

combination of

these two drugs.

Omeprazole, a PPI,

is a prodrug which

requires acidic

environment for

conversion into


the H/K ATPase

irreversibly and

reduces the gastric


low levels (most

potent among all

anti- secretory

drugs).

Sodium bicarbonate

is a rapidly acting


absorbs into blood

and long-term use

may cause systemic

alkalosis, besides

other toxicity.

It is irrational to

38

combine the two


may impair

activation of





superfluous to


on regular basis.

The combination


increases adverse

effects.

Not Recommended

for registration.

17. Floronol Tablets


Phloroglucinol hydrate 80

mg Trimethyl

Phloroglucinol 80 mg (Anti

Spasmodic)

Not

approve

d by

FDA,

EMA,

TGA &

PMDA

Not

mentioned

by any

standard

textbook

No scientifically

designed

clinical studies

are available. In

vitro and

toxicological

studies have

been published.

Phloroglucinol is a

synthetic phenol

having

antispasmodic

properties. However

its use in medicine

has remained

restricted due to

toxicity concerns. It

is mainly used in

explosive industry.

The adverse effects

reported by FDA

include neutropenia,

hepatotoxicity, renal

failure, metabolic

acidosis,

hyperkalemia and

allergic reactions.

In view of severely

unfavorable

benefit/risk ratio all

preparations

containing

phloroglucinol are

recommended to be

de-registered.

39

18. EsmoDome 20 Tablets



Esomeprazole 20 mg

Domperidone Maleate

Domperidone 30 mg

(Antiemetics &

Antinauseants)

Not

approve

d by

FDA,

EMA,

TGA &

PMDA

The

individual

drugs are

recommende

d but the

combination

has not been

mentioned.

Studies on

individual drugs

are available but

not on this

combination.

Besides the

combination,

Domperidone as an


approved by FDA. It

has been associated

with cardiac

arrhythmias. The

combination is



Recommended to

be de-registered.

19. EsmoDome 40 Tablets Each

tablet contains:-

Esomeprazole as

Magnesium……..40mg

Domperidone Maleate

Domperidone 30 mg

(Antiemetics &

Antinauseants)

Not

approve

d by

FDA,

EMA,

TGA &

PMDA

The

individual

drugs are

recommende

d but the

combination

has not been

mentioned.

Studies on

individual drugs

are available but

not on this

combination.

Besides the

combination,

Domperidone as an


approved by FDA. It

has been associated

with cardiac

arrhythmias. The

combination is



Recommended to

be de-registered.

20. Piram 1 gm Syrup

Each 5 ml contains:-

Piracetam 1g

(Psychostimulants,

Nootropic, Neurotonic)

Not

approve

d by

FDA,

EMA,

TGA &

PMDA

Not

mentioned

by any

standard

textbook

Scientifically

conducted

clinical studies

have not shown

any benefit of

piracetam.

Piracetam is used in

treatment of

cognitive disorders

and myoclonus but

scientific evidence

for efficacy is

lacking. Side effects

including anxiety,

insomnia, irritability,

headache, agitation,

nervousness, tremor,

and hyperkinesia,

have been reported

with its use.

Not Recommended

for registration.

40

21. Wincoline 250 mg Injection

Each 2ml ampoule

contains:- Citicoline

Sodium

Citicholine 250 mg

(Nootropics & Neurotonic)

Not

approve

d by

FDA,

EMA,

TGA &

PMDA

Not

mentioned

by any

standard

textbook.

Efficacy has not

been established

in scientifically

conducted

clinical trials.

Citicoline is cytidine

diphosphate choline

which is said to

increase

dopaminergic

receptor density in

brain. It has been

used in cognitive and

some other disorders

on this basis but

evidence for efficacy

is lacking.

Not recommended

for registration.

22. Each film coated tablet

contains:- Citicoline

Sodium

Citicholine 500 mg

(Nootropics and

Vasotherapeutic)

Not

approve

d by

FDA,

EMA,

TGA &

PMDA

Not

mentioned

by any

standard

textbook.

Efficacy has not

been established

in scientifically

conducted

clinical trials.

Citicoline is cytidine

diphosphate choline

which is said to

increase

dopaminergic

receptor density in

brain. It has been

used in cognitive and

some other disorders

on this basis but

evidence for efficacy

is lacking.

Not recommended

for registration.

23. Esso Forte Tablets Each

tablet contains:-

Naproxen USP 500 mg


Trihydrate

Esomeprazole 20mg

( NSAID + PPI )

Delayed

release

tablets

are

approve

d by

FDA

and

TGA.

Not

approve

d by

EMA &

PMDA.

This

particular

combination

is not

mentioned

but

combining

NSAIDs

with PPIs

and H2

blockers is

recommende

d in general

for

prevention

of

gastropathy.

Studies on this

particular

combination are

not found.

It is rational to

combine NSAIDs

with PPIs for

prevention of

gastropathy. Both the

drugs individually

are well established

in their respective

categories.

Recommended for

registration.

41

24. Valex Talets

Each film coated tablet

contains:- Phloroglucinol

hydrate 80 mg Trimethyl

Phloroglucinol 80 mg

(Gastrointestinal/Antispasm

odics)

Not

approve

d by

FDA,

EMA,

TGA &

PMDA

Not

mentioned

by any

standard

textbook

No scientifically

designed

clinical studies

are available. In

vitro and

toxicological

studies have

been published.

Phloroglucinol is a

synthetic phenol

having

antispasmodic

properties. However

its use in medicine

has remained

restricted due to

toxicity concerns. It

is mainly used in

explosive industry.

The adverse effects

reported by FDA

include neutropenia,

hepatotoxicity, renal

failure, metabolic

acidosis,

hyperkalemia and

allergic reactions.

In view of severely

unfavorable

benefit/risk ratio all

preparations

containing

phloroglucinol are

Recommended to

be de-registered.

25. S.OM-D 30mg Capsules


Esomeprazole Enteric

Coated Pellets eq.

Esomeprazole 40 mg

Domperidone 30mg

(Proton Pump Inhibitor /

antiemetic)

Not

approve

d by

FDA,

EMA,

TGA &

PMDA

The

individual

drugs are

recommende

d but the

combination

has not been

mentioned.

Studies on

individual drugs

are available but

not on this

combination.

Besides the

combination,

Domperidone as an


approved by FDA. It

has been associated

with cardiac

arrhythmias. The

combination is



Recommended to

be de-registered.

42

26. Thicol 4mg Capsules


Thiocolchicoside……..4 mg

(Muscle Relaxant)

Not

approve

d by

FDA,

EMA &

TGA

Not

mentioned

by any

standard

textbook.

No reference

found in

authentic

journals

Thiocolchicosideis a

muscle relaxant with

anti-inflammatory and

analgesic effects. It

acts as a competitive

GABAA receptor

antagonist and also

glycine receptor

antagonist. A variety

of adverse effects have

been reported with this

drug. Particularly of

concern are its ability

to cause seizures and

potential to cause

tratogenecity and male

infertility.

Not recommended for

registration.

27. Darcin ER 15mg Tablets

Each extended release tablet

contains:-

Darifenacin 15 mg

(Anti-Cholinergic)

Approve

d by

EMA &

TGA.

Tentativ

e

approval

granted

by FDA.

Recommend

ed for use in

genito-

urinary

disorders.

Available. Darifenacin is a M 3

selective

antimuscarinic drug

used for control of

urinary incontinence

in adults. A

congener, solifenacin

is already registered.

Recommended for

registration.

28. Darcin ER 7.5mg Tablets

Each extended release tablet

contains:-

Darifenacin ………. 7.5mg

(Anti-Cholinergic)

Approve

d by

EMA &

TGA.

Tentativ

e

approval

granted

by FDA.

Recommend

ed for use in

genito-

urinary

disorders.

Available. Darifenacin is a M 3

selective

antimuscarinic drug

used for control of

urinary incontinence

in adults. A

congener, solifenacin

is already registered.

Recommended for

registration.

29. CarionJect 500mg Injection

Each 10 ml injection

contains:- Iron Ferric

Carboxymaltose

Iron Element 500mg

(Haematinic)

Approved

by FDA

(750mg/1

5 ml) &

TGA

(500mg/1

0ml)

This

particular

preparation

not

mentioned.

Few but

available.

It is a new parenteral

form of iron.

Comparable to the

existing formulations

in efficacy and safety

profiles.

Recommended for

43

registration.

30. C-Zyme Tablet


Metoclopramide HCl 6mg

Sodium dehydrocholate 20

mg Bromelain 35000 PU

Pancreatin 210 FIPPU

Simethicone 50 mg

Not

approve

d by

FDA,

EMA,

TGA &

PMDA.

Not

mentioned

by any

standard

textbook.

No reference

found in

authentic

journals.

A completely

irrational

combination

containing drugs

whose efficacy is not

established.

Not recommended

for registration.

31. Carolate Injection

Each 1ml ampoule

contains:- Glycopyrrolate

0.5 mg Neostigmine

methylsulphate 2.5mg

Not

approve

d by

FDA,

EMA,

TGA &

PMDA.

This

particular

combination

is not

mentioned

but use of

atropine-like

drugs to

counter the

muscarinic

effects of

anticholinest

erases is

recommende

d.

Available Neostigmine is

generally used to

reverse muscle

paralysis induced by

curare-like drugs

during anesthesia.

This action is exerted

on nicotinic

receptors but is

accompanied with

unwanted muscarinic

stimulation. This is

countered by

administration of

antimuscarinic drugs

like glycopyrrolate.

Recommended for

registration.

32. Isotretinoin Cap/

Isotretinoin Tablet

Recdommen

ded for

severe acne

and certain

malignant

disorders.

Available Isotretinoin is 13-cis

retinoic acid. It is used

in treatment of cystic

acne, squamous cell

carcinoma of skin and

certain other

malignancies. In view

of its established

efficacy, the drug is

recommended to be

retained.

Any issues related to

dosage

form/formulation

may be resolved after

obtaining view point

of manufacturers.

33. Amoxicillin + Sulbactum The general

principal for

It is rational to

combine penicillin

44

combining

penicillins

with beta

lacatmase

inhibitors is

described.

with beta lactamase

inhibitors but

Amoxicillin is

generally combined

with clavulanate.

The manufacturers

may be asked to

provide reasons for

using sulbactam

along with references

in the favor of this

combination.

May be deferred for

the time being.

34. Silymarin Not

approve

d by

FDA,

EMA,

TGA &

PMDA.

Not

mentioned

by any

standard

textbook.

No scientifically

designed studies

available in

authentic

journals.

Silymarin is a dried

extract obtained from

Milk thistle plant.

Efficacy in hepatic

disorders has not

been proved in

authentic clinical

trials. Adverse

effects have been

reported in patients

using milk thistle

capsules.

Not recommended

for registration.

35. Aescin Not

approve

d by

FDA,

EMA,

TGA &

PMDA.

Not

mentioned

by any

standard

textbook.

No scientifically

designed studies

available in

authentic

journals.

Aescin is a mixture

of saponins present

in horse chestnut

plant. It is claimed to

have anti

inflammatory and

vasoprotective

effects but this has

not been proved in

scientifically

designed clinical

studies

Not recommended

for registration.

36. Solcoseryl Not

approve

Not

mentioned

No scientifically

designed studies

Solcoseryl is

deproteinated blood

45

d by

FDA,

EMA,

TGA &

PMDA.

by any

standard

textbook.

available in

authentic

journals.

of calves. It has been

used in a variety of

formulations for

various purposes but

scientific evidence

for efficacy is

lacking. Not

recommended for

registration.

37. Serratiopeptidase Not

approve

d by

FDA,

EMA,

TGA &

PMDA.

Not

mentioned

by any

standard

textbook.

No scientifically

designed studies

available in

authentic

journals.

Serratiopeptidase is a

proteolytic enzyme

present in silkworm

gut which helps it to

dissolve the cocoon.

It has been used as

an anti-inflammatory

agent without any

scientific evidence of

efficacy.Takeda

Pharmaceuticals, the

brand leader

Japanese company,

had agreed for

voluntary withdrawal

from market in 2011.

Not recommended

for registration.

38. Smectite Not

mentioned

by any

standard

textbook.

No clinical

studies available

to support

efficacy.

Smectite is mineral

clay having

adsorbent properties.

It is similar to kaolin

in its medicinal

value.

Not recommended

for registration.

Decision: Keeping in view recommendations of Review Committee and comments of

stake holders, Registration Board decided as follows:

Following formulations will be considered for registration by Registration Board

and thus the Board advised P E & R Division to place all deferred cases in agenda of

the meeting.

46

i. Ampoule (1ml) containing Glycopyrrolate 0.5 mg Neostigmine + methylsulphate 2.5mg

ii. Injection (10 ml) containing Iron Ferric Carboxymaltose Iron Element 500mg.

iii. Extended release tablet containing Darifenacin 7.5mg, 15mg.

iv. Tablet containing Naproxen USP 500 mg + Esomeprazole Magnesium Trihydrate

Esomeprazole 20mg.

v. Tablet containing Cyclobenzaprine 5mg.

vi. Capsule containing Fluoxetine HCl 25 mg + Olenzapine Citrate Olenzapine 12 mg.

vii. Injection containing Ketamine HCl Ketamine 500 mg

Registration Board discussed comments of stakeholders for following formulations

and decided that Review Committee will review these comments for framing its final

recommendation. The Board also advised the committee to take assistance of any

expert (if required) and can also call any stakeholder for their views. These

formulations are as follows:

viii. Trimethyl Phologlucinol 80mg+Phloroglucinol 80mg.

ix. Omeprazole + Sodium Bicarbonate 20mg+1100mg, 40mg+1100mg.

x. Citicoline.

xi. Diacerein.

xii. Calcium Dobesilate.

xiii. Smectite.

xiv. Saccharomyces Boulardi.

xv. Piracetam.

xvi. Thiocolchicoside.

xvii. Dry Powder Suspension of Famotidine.

xviii. Silymarin

Keeping in view recommendations of Review Committee, Registration Board

decided to proceed further for cancellation of registration as per procedure laid

down in Drugs (L R & A) Rules, 1976 of following items.

xix. Suspension containing Erythromycin Ethyl Succinate Erythromycin 200mg +

Bromhexine HCl 4mg

xx. Sparfloxacin 100mg

xxi. Tablets containing Esomeprazole 20mg + Magnesium 700mg + Sodium Bicarbonate 20mg

xxii. Tablets containing Esomeprazole 40mg + Magnesium 700mg + Sodium Bicarbonate 20mg

xxiii. Capsule and tablet containing Esomeprazole 20mg, 40mg + Domperidone 30mg

xxiv. Serratiopeptidase.

xxv. Solcoseryl

xxvi. Aescin

xxvii. Tablet containing Metoclopramide HCl 6mg + Sodium dehydrocholate 20 mg + Bromelain

35000 PU + Pancreatin 210 FIPPU + Simethicone 50 mg.

47

Registration Board advised Review Committee to finalize recommendation for

following formulations. The Board also advised the committee to take assistance of

any expert (if required) and can also call any stakeholder for their views. These

formulations are as follows:

xxviii. Amoxicillin + Sulbactum

xxix. Isotretinoin Capsule/ Tablet

xxx. Film coated Sustained release containing 1 gm Ciprofloxacin

f. Manufacturing requirement for various classes of drugs.


meeting discussed manufacturing requirements for various

classes of drugs, and Chairman advised all members, PPMA and Pharma Bureau to forward their

scientific comments and relevant references on manufacturing requirements for following classes

of drugs:

- Steroids.

- Immunosuppresants.

- Clomiphene and letrozole

- Prostaglandins and its analogues.

- Storage requirement of Misoprostol

- Vancomycin

Two members and PPMA has forwarded their comments on manufacturing requirements for

steroids, as follows:

Dr. Amanullah Khan (Director, DTL, Quetta).

For all steroidal preparations except topical preparations must have separate

manufacturing area, so it may be added that topical preparations may be manufactured in the

same approved area and exempted from separate area.

Lt General (R) Karamat Ahmed Karamat.

Reference to the Board meeting proceedings, all non-inflammatory steroids like

prednisolone, Dexamethasone are manufactured in the same general area on campaign basis.

Topical steroids like eye preparations/drops, otic drops, creams and ointments are manufactured

through wet process and should be allowed to manufacture across the board as everywhere in the

world. However, sensitive steroids which fall under category A like penicillin, cytotoxic

substances, Beta lactam and sex hormones may be considered to be manufactured in the

dedicated area.

48

PPMA.

Requirement by international regulatory agencies / cGMP

Internationally the dedicated facility is recommended for certain hormones, as evident from the

following:

Medicinal Control Agency U.K Requirements:

The Orange book published by Medicine Control Agency (MCA) of U.K in chapter 3 dealing

with premises and equipment, of guide to Good Manufacturing Practices for Medicinal Products,

under section 3.6 states requirements which are very close to section 5.2 of Pakistan drug rules.

“In order to minimize the risk of serious medical hazard due to cross contamination, dedicated

and self contained facilities must be available for the production of particular medicinal products,

such as highly sensitizing materials {e.g Penicillin} or biological preparations {e.g from live

microorganism}. The production of certain additional products, such as certain antibiotics,

Certain hormones, certain cytotoxics, certain highly active drugs and non medicinal products

should not be conducted in the same facilities. For those products, in exceptional cases, the

principle of campaign working in the same facilities can be accepted provided that specific

precautions are taken and the necessary validation made. The manufacture of technical poisons,

such as pesticides and herbicides, should not be allowed in premises used for the manufacture of

medicinal products.

As can be observed that requirement is for certain hormones.

Canadian GMP:

11. Prevention of cross-contamination druring manufacturing is the responsibility of the

fabricator and packager. They must demonstrate that the premises are designed in such a manner

that the risk of cross-contamination between products is minimized.

11.1 In order to minimize the risk of a serious health hazard due to cross-contamination,

additional controls, including the need for self-contaiment, should be considered for particular

drugs such as:

-Certain hormones (e.q. estrogen)

-Certain cytotoxic drugs

-other highly active drugs

Factors to consider are the manufacturing process, use of closed systems, dedication of product

contact equipment parts, HVAC controls, engineering controls such as fail safe systems, coupled

with validation and ongoing monitoring using highly sensitive analytical methods.

49

11.2 Campaign production can be accepted where, on a product by product by basis,

proper justification is provided, validation conducted and rigorous, validated controls and

monitoring are in place and demonstrate the minimization of any risk of cross

contamination.

As can be observed tht requirment is for certain hormones, Specifically Canadian cGMP

refers to Estrogens, Further Canadian GMP allows campaign production provided validation

conducted.

Indian cGMP

Schedule M describing GMP & requirements of Premises Plant & equipment for pharmaceuitcal

product, under section 8.2 states as under:

The licensee shall ensure processing or sensitive drugs like Beta-Lactum antibiotics, Sex

hormones and cycotoxic substances in segregated areas or isoliated production areas within the

building with independent air-handling unit and proper pressure differentials. The effective

segregation of these areas shall be demonstrated with adequate records of maintenance and

services.

As can be observed tht requirment is for certain hormones which are sex hormones.

Technical perspective

In order to exercise better control on Steroids, the PPMA Technial Committee members

observed that there should be clarity between the definition of “Anabolic Steroids” and

“Corticosteroids”.

References reveal that in human body, adrenal glands produce an anti-inflammatory steroid

similar to cortisone {corticosteroids}. Simulating human body secretion, synthetic Cortisone are

developed and prescribed to treat asthma, rashes, and various kinds of swelling or inflammation.

Whereas, another kind of steroids are calles anabolic steroids. The term anabolic means building

up of a bodily substance. Anabolic steroids are related to the major sex hormones, which are

produced in both men and women and their synthetic substitutes are uese as supporitve therapy.

Ref. Hormone Abuse Overview, http://www.hormone.org/Abuse/overview.com

Above references cleary state that all Steroids doesn’t fall under the category of “Highly

sensitizing materials”. Furhter, that the Steroids are classified as Corticosteroids (Anti-

http://www.hormone.org/Abuse/overview.com

50

Inflammatory hormones) and Anabolic Steroids (Sex hormones) and later are requirmed to be

manufactured under special controlled conditions.

Based on above submissions, our recommendations are;

1. That all Steroids do not fall in the category of “Highly sensitizing materials”

2. Anabolic/Sex hormones e.q. Progesterone., Testosteron and Contraceptive hormone

needs special conditions for manufacturing.

3. Corticosteroids, Dexamethasone, Prednisolone and others are used as anti-inflammatory

drugs which are not included in the category of “highly sensitizing materials” as such

should be allowed tomanufacture in general purpose are exercising standard controls to

avoid cross contamination.

4. Since several companies have been granted license to manufracture sex hormones in their

existing facility, campaign manufacturing may be allowed if necessary precautions have

been taken and that future plans for seprate facility are in place.

M/s Sante Pharmaceuticals, Karachi.

1. Drugs (Licensing, Registration & Advertisement) Rules 1976. Schedule B- 5.2.

Dedicated Facility for production states that:

Dedicated and self -contained facilities for the production of particular drugs shell be provided in

addition to general facilities such as highly sensitizing materials ( e.g. penicillin) or biological

preparation (e.g. live microorganism) or cytotoxic substances or veterinary immunological preparations

or sterile products or for that matter such other highly active pharmaceutical products, antibiotics,

hormones as may be identified by the Central Licensing Board at any stage in order to minimize the risk

of serious medical hazard due to cross- contamination. In exceptional cases of emergency, the principal of

campaign working in the same facilities may be allowed by the Central Licensing Board provided that

specific precautions are taken and necessary validations are made.

2. In 195th

Meeting of Central Licensing & Registration Board held on 24th

Nov. 2005 a

presentation was made by PPMA and Pharma Bureau

Item No.3.

Dedicated /Segregated Facilities for Particular Drugs : Detailed history of dedicated facilities was

discussed.

A team of Pharma Bureau and PPMA members presented their view about the matter of segregated

facilities for “Quinolones / Antibiotics (except Beta lactam antibiotics) and psychotropic / Narcotic drugs.

They explained that the dedicated facilities are required for highly sensitizing drugs e.g. Penicillin,

Cephalosporin, and Biological which fall under category A drugs.

51

Decision of Registration Board:

It was decided that the permission to manufacture the Quinolone products will be allowed on the

basis of campaign manufacturing, subject to compliance to the GMP and cGMP regulation.

HVAC system and cleaning validation is mandatory.

3. EU guideline for GMP for Medicinal Products and Veterinary Use Part I Chapter

5:Production

Section 3.6: Production Area states that:

Dedicated facilities are required for manufacturing when a medicinal product present a risk;

a) Which cannot be adequately controlled by operational and/ technical measures.

b) Scientific data does not support threshold values ( e.g. allergic potential from highly sensitizing

materials such as beta lactam) or

c) Threshold values derived from toxicological evaluation are below the level of detection

4. GMP and requirements of Premises, Plant and Equipments of PHARMACEUTICAL

PRODUCTS

PART II-SECTION 3, SUB-SECTION (i)] - Ministry of Health -New Delhi- INDIA

SCHEDULE M. Production area.—

In order to avoid the risk of cross-contamination, separate dedicated and self contained facilities

shall be made available for the production of sensitive pharmaceutical products like penicillin or

biological preparations with live micro-organisms. Separate dedicated facilities shall be provided

for the manufacture of contamination causing and potent products such as Beta lactam, Sex

Hormones and Cytotoxic substances.

5. ICH guideline

“Self-contained facilities shall be made available for the production of highly

sensitive pharmaceutical products like penicillin or biological preparations with live micro-

organisms. Separate dedicated facilities shall be provided for the manufacture of

contamination causing and potent products such as Beta lactam, Sex Hormones and

Cytotoxic substances.”

6. Based on the current guidelines by EU Orange Guide, ICH, WHO, Indian GMP guidelines, Saudi

FDA and others;

“Dedicated facility is required for highly sensitive products like Beta lactam, Sex

Hormones, Cephalosporin and Cytotoxic products”

DEFINITION OF HORMONES

1. Different types of steroid hormones, a class of hormones chemically similar to each other, have

different functions. For example, the adrenal glands produce an anti-inflammatory steroid similar

52

to cortisone. Cortisone may be prescribed to treat asthma, rashes, and various kinds of swelling or

inflammation.

2. The term anabolic means building up of a bodily substance. Anabolic steroids are related to the

major male hormone testosterone, which is produced in the testes in men and in the adrenal

glands in both men and women. These chemicals are recognized for their effects on building up

muscle.

3. Anabolic steroids should not be confused with corticosteroids, which are used routinely as anti-

inflammatory medications to help treat illnesses in which inflammation is part of the disease

process.

4. Steroids include the dietary fat cholesterol, the sex hormones estradiol and testosterone, and the

anti-inflammatory drug Dexamethasone.

5. Steroid: One of a large group of chemical substances classified by a specific carbon structure.

Steroids include drugs used to relieve swelling and inflammation, such as Prednisone and

Cortisone.

IMPACT OF CROSS CONTAMINATION

There are certain categories of hormones

1. Sex Hormones

Sex hormones comes under category A. In category A, Sex hormones like progesterone (female

sex hormone), testosterone (male sex hormone) contraceptive hormones (estrogens). They fall

under “Highly sensitizing materials” where cross contamination in very less quantity (microgram)

can cause risk of serious health hazard. The cross contamination of male sex hormone with in a

manufacturing process can produce changes in the secondary behavior in female like extra hair

growth, voice change etc. and vice versa female sex hormone cross contamination during

manufacturing operation can cause serious health hazard like diminishing of sexual desire,

enlargement of mammary glands etc. therefore in order to minimize the risk of serious health

hazard due to cross contamination addition control during manufacturing operation, used of

closed system, dedicated product contact equipment parts, HVAC control are necessary.

2. Anabolic Steroids

They also fall in category A and are those used for muscle building weight gain and weak

anabolic activities. Same principal followed during the manufacturing operation for cross

contamination.

3. Corticosteroids (Dexamethasone, Prednisolone & Hydrocortisone)

Corticosteroids should not be confused with sex hormones as they do not fall in category A of

highly sensitive materials and used in topical preparations as anti inflammatory drugs in Eye

preparation, Otic preparation and Eye / Skin Ointments. The cross contamination of

corticosteroids during the manufacturing operation can not impact the same health hazards as sex

hormones even in micro grams quantities hence no dedicated self contained facility is suggested

53

by international guideline agencies like Eur. ICH, and orange guide where they recommend use

of same facility with following instructions on campaign bases and cleaning validation.

RISK ASSESSMENT / ANALYSIS OF CROSS CONTAMINATION DURING

MANUFACTURING OPERATION

What is the risk involved in case a cross contamination of corticosteroids occur during the manufacturing

operation in spite of observing instructions and guidelines provided by the international agencies due to

certain negligence and improper supervision? The quantities of API (Active Pharmaceutical Ingredients

i.e. Dexamethasone, Prednisolone, Mometasone, Betamethasone, and Triamcenolone) is very minute i.e.

in 0.1%, 0.2% up to 0.5%. The entire manufacturing process is wet process, after the dispensing of API it

is transferred to glass jar under Laminar Air Flow hood in a diluent system comprising of HPMC / water

dispersion, then these glass jars with glass beads are placed on Ball Mill to get the desired particle size

finally blend was transferred to main bulk container in liquid form there is no less chances of dust

generation during the process. During the product change over a cleaning validation procedure is

followed by QC who only allows next batch processing after their approval.

There are two strong arguments in favor of using the same facility for steroid and non-steroid

preparations.

1. If there is any risk of health hazard involved due to cross contamination of corticosteroids during

the manufacturing operation the international agencies like European Union (Orange Guide),

WHO and ICH will never recommend the same facility on campaign basis following the cleaning

validation method as in case of sex hormones because corticosteroids are not classified under the

highly sensitizing materials even the cross contamination of corticosteroids cannot impact any

bad health hazard.

2. Currently topical steroid containing preparations are produced in same facility (Non Steroids)

under toll manufacturing agreement for international brands like Allergan, Alcon, Bausch &

Lomb etc. and there audit for facility will also conducted by their corporate office under

international GMP guidelines, who allows them to manufacture steroids and non steroids in the

same facility. So far no adverse drug reaction was reported internationally and nationally which is

due to cross contamination.

CONCLUSION

1. All Steroids do not fall in the category of “Highly sensitizing materials”.

2. Sex hormones e.g. Progesterone, Testosterone and Contraceptive hormone may be classified in

category A.

3. Anabolic Steroids are those used for muscles building and used by weightlifters, wrestlers and

sportsmen may be classified in category A

4. Corticosteroids (Dexamethasone, Prednisolone, Mometasone, Betamethasone, and

Triamcenolone) are used as anti-inflammatory drug and are not potent and highly sensitizing

materials.

54

Corticosteroids do not fall in the category of highly sensitive materials and the companies

like Alcon, Allergan, Bausch & Lomb and many Local Companies are manufacturing eye

drops, ointments, creams etc. containing steroids like Dexamethasone, Prednisolone,

Mometasone, Betamethasone and Triamcenolone in the same facility with following the

instructions on campaign basis.

MANUFACTURING OF EYE DROPS, OINTMENT & CREAMS

In eye drops the entire manufacturing method is wet process except dispensing of materials.

The concentration of steroids in Topical and Tropical preparations

Ophthalmic Preparation is 0.1 to 0.2 %

Otic Preparations (Drops and Ointments) is 0.1 to 0.2%

The steroids are dispensed in dispensing booth with laminar flow having strong extraction

system.

These steroids are immediately transferred under laminar flow, into glass jars containing a

mixture of water and HPMC

Tightly close Jars are placed on ball mill to reduce the particle size of steroids.

Then ready slurry is transferred into bulk under laminar flow.

Eye Drops, Eye Ointments, Otic Drops and Creams are being manufactured by local manufacturers

having Dexamethasone, Prednisolone, Hydrocortisone in the same manufacturing facility for the last

many years.

Decision: Registration Board discuused comments of its members, stakeholders and

international practices and agreed that for all topical preparations viz. eye / ear preparations,

external preparations (cream / ointment / gel / lotion / spary) and aerosols, steroid

manufacturing may be permitted on campaign manufacturing basis in general manufacturing

areas for these dosage forms provided that manufacturer has segregated dispensing booths,

validation and controls studies for processes and adequate system to minimize any potential

risk of cross contamination. Registration Board decided to forward above recommendation to

Licensing Division for ultimate decision by Central Licensing Board.

Storage requirement of Misoprostol.

- M/s Pfizer Pakistan, Karachi.

There is an obligation to maintain a temperature of -200C and has to kept in an air tight

container.

55

- M/s Rasco Pharma, Lahore.

The firm has provided assessment report (EMA) of misoprostol API which is reproduced as

under:-

Misoprostol, as described in the Ph.Eur., is an only liquid which is very unstable and

difficult to be process into a drug product in liquid form. The stability of misoprostol is

significantly enhanced when it is dispersed in hypromellose. Hence, misoprostol

dispersed in hypromellose is used as an intermediate in the manufacture of misoprostol

tablet. The dispersion consists of a powder that can be stored at 5+3 °C, whereas the

actual active substance is an oily liquid that needs to be stored at -20 °C.

The certificate of analysis of the misoprostol API of the firm shows that the product is

Misoprostol 1% HMPC dispersion (White to off-white powder) and it is to be stored at 2-

8 °C.

Decision: Registration Board deliberated on the matter indetail and keeping in view

EMA’s assessment report decided that as per EMA,s report, Misoprostol 1% HMPC

(processed material) dispersion will be permitted for use in tablet dosage form with

storage condition of 5+3 °C.

Chairman again advised all members, PPMA and Pharma Bureau to forward their

scientific comments and relevant references till 15.01.2015 on manufacturing requirements

for following classes of drugs:

a. Immunosuppresants.

b. Clomiphene and letrozole

c. Prostaglandins and its analogues.

d. Vancomycin

56

Item No. V Registration of drugs – Pharmaceutical Evaluation Cell.

Case No.01. Correction in minutes M-245

S/N Name and

address of

manufacturer /

Applicant

1. Brand Name

2. Dosage Form

3. Composition

4. Pharmacological

group

1. Type of Form

2. Type of

application

3. Demanded

Price / Pack size

4. Initial date,

diary. 5. Date on

which fee

becomes

complete

according to type

of application /or

Form

1.Finished

Product

Specification

2. Facility where

drug has to be

manufactured

with status

whether approved

by CLB or not

3. Last GMP

inspection report

with date &

status.

Decision in

245th

meeting of

the

Registratio

n Board

Correction

required by the

applicant

Decision

1. M/s. Ali Gohar &

Company (Pvt)

Limited, Karachi.

Manufacturer

M/s. Boehringer

Ingelheim Pharma

GmbH & Co. KG,

Located in Binger

Strasse 173,

55216 Ingelheim

am Rhein,

Germany.

Jentadueto

2.5mg/850mg

Tablets

Each Film Coated

Tablets contains:-

Linagliptin…..2.5

mg

Metformin

Hydrochloride…….

850mg

(Drugs used in

Diabetes,

combination of oral

blood glucose

lowering drugs).

Form 5 A

01-07-2013

Rs.50000/-

Rs. 7130/

Per packs of 60

Tablets.

International:

Jantadueto 2.5/850

(FDA)

Local: Me too (M

243)

Approved. The firm

applied for

packs of 10’s &

30’s as under

just before

meeting of

Registration

Board that’s

why it was

missed in

agenda &

minutes.

Rs. 0.9 x 10

USD for 10’s

Rs. 0.9 x 30

USD for 30’s &

Rs. 7130/

Per packs of 60

Tablets.

(Word CIF as

appeared in

firm’s request

was

inadvertantly

missed for 10’s

& 30’s pack

sizes).

The Board

acceded to the

request of the

firm with

approval of

following

price & pack

sizes.

1. Rs. 7130/

Per packs of

60 Tablets.

2. CIF price

for 10’s pack

size:

0.9 x 10 USD

for 10’s

3. CIF price

for 30’s pack

size:

0.9 x 30 USD

for 30’s

57

2. M/s. Ali Gohar &

Company (Pvt)

Limited, Karachi.

Manufacturer

M/s. Boehringer

Ingelheim Pharma

GmbH & Co. KG,

Located in Binger

Strasse 173,

55216 Ingelheim

am Rhein,

Germany.

Jentadueto

2.5mg/1000mg

Tablets

Each Film Coated

Tablets contains:-

Linagliptin…..2.5

mg

Metformin

Hydrochloride…….

1000mg

(Drugs used in

Diabetes,

combination of oral

blood glucose

lowering drugs).

Form 5 A

01-07-2013

Rs.50000/-

Rs.7130/

Per packs of 60

Tablets

International: Jantadueto

2.5/1000 (FDA)

Local: Me too (M

243)

Approved. The firm

applied for

packs of 10’s &

30’s as under

just before

meeting of

Registration

Board that’s

why it was

missed in

agenda &

minutes.

Rs. 0.9 x 10

USD for 10’s

Rs. 0.9 x 30

USD for 30’s &

Rs. 7130/

Per packs of 60

Tablets.

(Word CIF as

appeared in

firm’s request

was

inadvertantly

missed for 10’s

& 30’s pack

sizes).

The Board

acceded to the

request of the

firm with

approval of

following

price & pack

sizes.

1. Rs. 7130/

Per packs of

60 Tablets.

2. CIF price

for 10’s pack

size:

0.9 x 10 USD

for 10’s

3. CIF price

for 30’s pack

size:

0.9 x 30 USD

for 30’s

58

S/N Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary

name + Dosage

Form +

Strength)

Composition

Pharmacological

Group

Finished

product

Specification

Type of Form

Initial date,

diary

Fee including

differential

fee

Demanded

Price / Pack

size

Decision of

Previous

Meeting

Remarks on the

formulation (if any)

including

International status

in stringent drug

regulatory agencies /

authorities.

Decision

3. M/s. Medisearch

Pharmacal (Pvt)

ltd, 5-Km,

Raiwind Manga

Road, Lahore.

Molus

Dry Suspension

When

reconstituted

Each 5ml

contains:-

Montelukast

Sodium…..5mg

(anti-asthmatic)

(Manufacturer’s

Spec.s)

Form-5

20-12-

2013(1308)

Rs.20,000/-

As per

SRO/60ml

Approved.

Letter will be

issued after

rectification

of

shortcomings.

(M-243)

The Formulation

was erroneously

approved by the

Drug Registration

Board. This

Formulation is

under review by the

Review Committee.

Deferred till

review of

formulation by

Review

Committee.

4. M/s Allmed Pvt.

Ltd.

(Formerly,

EverGreen

Pharmaceuticals,

Pvt. Ltd.

Plot.No.590,

Sundar Industrial

Estate Lahore.

Reevo Tablets

Each tablet

contains:

Levocarnitin……

………….250mg

(Aminoacid

derivative/suppli

ment)

Form5

06-08-2010

Rs.8000/-

11-10-2012

Rs.12,000/-

Rs.350/10’s

Deferred for

confirmation of

pharmacologic

al group as

applied by

firm.

(M-244)

Initially the Firm

had applied for Levocarnitine………

……250mg per

Tablet formulation on

Form 5. Before the

formation of

Pharmaceutical

Evaluation Cell some

Registration

applications were

sent to various DRAP

officers for

evaluation including

this one. Agenda of

these applications

was prepared for M-

Deferred for the

following:

1) Fee for

application on

Form 5D for 330

mg Tablet

strength.

2) Evaluation of

Form 5D.

3) Confirmation of

pharmacological

group as applied

by the firm.

59

242 but could not be

discussed. Later on

the Firm submitted

Form 5-D for this

formulation and

changed the

formulation to

Levocarnitine…330m

g mg per Tablet. The

left over agenda of

M-244 was discussed

in M-244 but the

change was not

incorporated. The

Registration Board

considered the

formulation as

Levocarnitine…250m

g per Tablet and

deffered it merely for

confirmation of

pharmacological

group as applied by

firm. Registration

Board may ask the

firm to submit the

firm to submit

differential fee

required for

application on Form

5-D and evaluate the

application

accordingly.

60

Evaluator – III

Case No.02. Registration of a Patent Drug – Iodine Complex

M/s MTI Medical (Pvt) Limited Lahore has informed that they have developed Iodine complex

molecule in their Research & Development Laboratories and the said molecule has been awarded patent in

Pakistan. The firm submitted that they have conducted preclinical studies in UVAS (University of Veterinary

& Animal sciences, Lahore) and human studies in different teaching hospitals in Pakistan. Results of these

studies have been published in international and national journals which show that addition of iodine complex

with standard therapy of Hepatitis gives significant results.

S/N

Brand Name

(Proprietary name +

Dosage Form +

Strength)

Composition

Pharmacological Group (as

submitted by the firm)

Finished product Specification

Type of Form

Initial date, diary

Fee including differential fee

Demanded Price / Pack size

1. IODIRIN Tablets

200mcg

Each tablet contains:

Iodine complex equivalent to

elemental Iodine…….200mcg

Iodine deficiency disorder/

Antithyroid

Manufacturer

Form-5E

23-10-14 Dy. No: 1271

50,000/-

Not provided

2. IDOMARINE Capsules

50mg

Each capsule contains:


elemental Iodine…….50mg

Iodine deficiency disorder/

Antithyroid/ Immunomodulator

Manufacturer

Form-5E

23-10-14 Dy. No: 1271

50,000/-

Not provided

3. RENESSANS Capsule

200mg




Antiviral/ Hepatic Preps/


Form-5E

23-10-14 Dy. No: 1271

50,000/-

Not provided

61

The firm has also claimed that the above mentioned molecule is a major breakthrough avoiding and

treating some deadly diseases and diseases due to iodine deficiency, therefore requested to register the drug on

fast track basis in public interest. In this regard, they have submitted registration applications on Form-5 E in

different dosage forms. Details of which are tabulated below.

2. The request of the firm has been evaluated / assessed by the cell. Prima facie the following

observations have been noticed:

a. The applicant has been granted patent for the said molecule named as “Iodine Complex” for cure

against Hepatitis C. Here, the question arises that whether patent is valid for purpose of getting

the registration for a patent drug or not.

b. The application has been filed on Form 5-E for the purpose of registration of a patent drug and

currently the Pharmaceutical Evaluation Cell has no approved check list for the said form. There

are many clauses of the said form wherein the applicant is unable to answer properly. Evaluation

reports clearly depicts the same.

c. The Safety & Efficacy aspects of the drug are important to be evaluated in the instant case (being

new molecule not else- where approved in the world). At present, the Cell for the said purpose

(especially in cases of new drug molecule), relies on the approvals by the Stringent or Reference

Drug Regulatory Agencies of the world like USFDA, EMA, TGA, Health Canada & PMDA

Japan etc. While the drug under discussion has no such approval from any of the drug regulatory

agency in the world.

5. In the light of the above observations, the case was handed over to Pharmacy Services Division, who has

taken up the case. The said Division has forwarded the submitted clinical trial data / research publication

of the applicant to the Executive Director of PMRC for the validity of the trials / research conducted.

Their reply is awaited. The case is therefore, placed for consideration before Registration Board.

Decision: Dr. Muhammad Ajmal and his team appeared and presented before the Board

about development of above formulations and results of clinical trials conducted on the above

formulations. Registration Board then directed the applicant to provide all the documents

Manufacturer

4. RENESSANS

Suspension 15mg/ 5ml

Each 5ml contains:



Antiviral/ Hepatic Preps/


Manufacturer

Form-5E

23-10-14 Dy. No: 1271

50,000/-

Not provided

62

related to development of formulations and their clinical studies for confirmation of safety and

efficacy Prof. Dr. Muzammil H.Najmi, Member Registration Board for further evaluation.

Recommendations / views the expert will be considered by the Board for further processing of

case.

Case No.03. Grant of registrations of newly approved DMLs (Drug Manufacturing Licenses).

Evaluator – II

S/N Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary name +

Dosage Form +

Strength)

Composition

Pharmacological

Group

Finished product

Specification

Type of Form

Initial date, diary

Fee including

differential fee

Demanded Price /

Pack size

Remarks on the


including


in stringent drug


authorities

Me-too status

GMP status as

depicted in latest

inspection report

(with date) by the

Evaluator

Decision

1. M/s Sigma

Pharma

International Pvt.

Limited E-50,

N.W.I.Z., Port

Qasim Karachi

(Tablet General:

No. F.6-6/2014-

Lic (M-237 dated

17-10-2014)

Klar 250mg Tablet

Each film coated Tablet

contains:-

Clarithromycin(USP)…

250mg

(Macrolide Antibiotic)

(USP Spec,s)

Form 5

17-11-2014 (232)

Rs. 20,000/-

As Per SRO/

Pack 10’s

BNF: Klaricid

(Abbott Healthcare)

Claritek 250mg Tablet

Getz Pharma Pvt. Ltd.

Karachi

New Licensee

Approved

2. -do- Klar 500mg Tablet


contains:-

Clarithromycin(USP)…

500mg

Form 5

17-11-2014(228)

Rs. 20,000/-

As Per SRO/

BNF: Klaricid

(Abbott Healthcare)

Claritek 250mg Tablet

Getz Pharma Pvt. Ltd.

Karachi

Approved

63


(USP Spec,s)

Pack 10’s

New Licensee

3. -do- Monti 10mg Tablet


contains:-

Montelukast Sodium as

Montelukast…10mg

(Bronchodilators &

Anti-asthma

(Leukotriene

antagonist))

(Manufacturer’s Spec.s)

Form 5

17-11-2014(229)

Rs. 20,000/-

As Per SRO/

Pack 14’s

Singulair 10mg

Tablet of Merck & Co.

Inc. USA

Myteka 10mg Tablet

Hilton Pharma Pvt.

Ltd. Karachi

New Licensee

Approved

4. -do- Cip 250mg Tablet


contains:-Ciprofloxacin

as Ciprofloxacin

HCl…250mg

(Quinolones Antibiotic)

(B.P Spec,s)

Form 5

17-11-2014(235)

Rs. 20,000/-

As Per SRO/

Pack 10’s

CIPROXIN 250mg

Tablet Bayer Australia

Limited

GETCIPRO 250mg

Tablet Getz Pharma

(Pvt.) Ltd. Karachi

New Licensee

Approved

5. -do- Cip 500mg Tablet


contains:-Ciprofloxacin

as Ciprofloxacin

HCl…500mg


(B.P Spec,s)

Form 5

17-11-2014

Rs. 20,000/-

As Per SRO/

Pack 10’s

CIPROXIN 500mg

Tablet Bayer Australia

Limited

GETCIPRO 500mg

Tablet Getz Pharma

(Pvt.) Ltd. Karachi

New Licensee

Approved

6. -do- Levof 250mg Tablet


contains:-

Levofloxacin (as

hemihydrate)…250mg


(USP Spec,s)

Form 5

17-11-2014(234)

Rs. 20,000/-

As Per SRO/

Pack 10’s

LEVAQUIN 250mg

Tablet Janssen Pharma

USA

LEFLOX 250mg

Tablet Getz Pharma

(Pvt.) Ltd Karachi

New Licensee

Approved

7. -do- Levof DS 500mg Tablet


contains:-

Levofloxacin (as

hemihydrate)…500mg

Form 5

17-11-2014(233)

Rs. 20,000/-

As Per SRO/

Pack 10’s

LEVAQUIN 500mg

Tablet Janssen Pharma

USA

LEFLOX 500mg

Approved

64


(USP Spec,s)

Tablet Getz Pharma

(Pvt.) Ltd Karachi

New Licensee

8. -do- Moxif 400mg Tablet


contains:-

Moxifloxacin (as

Moxifloxacin

HCl)…400mg



Form 5

17-11-2014(237)

Rs. 20,000/-

As Per SRO/

Pack 5’s

VIGAMOX 400mg

Tablet Alcon Lab,

USA

MOXIGET 400mg

Tablet Getz Pharma

(Pvt.) Ltd.

New Licensee

Approved

9. -do- Mecob 500mcg Tablet

Each sugar coated

Tablet contains:-

Mecobalamin

(JP)…500mcg

(Co-enzyme Vitamin

B12)


Form 5

17-11-2014(230)

Rs. 20,000/-

As Per SRO/

Pack 20’s

50’s & 100’s

METHYCOBAL

500mcg Tablet Eisai

Co Ltd. JAPAN

METHYCOBAL

500mcg Tablet Hilton

Pharma (Pvt.) Ltd

Karachi

New Licensee

Approved

10. -do- Trump 37.5/325mg

Tablet


contains:-

Tramadol HCl…37.5mg

Paracetamol…325mg

(Opiate

analogue/analgesic )

(USP Spec,s)

Form 5

17-11-2014(231)

Rs. 20,000/-

As Per SRO/

Pack 10’s

BNF: Tramacet

(Gru¨nenthal)

TONOFLEX Tablet

Sami Pharmaceuticals

Karachi

New Licensee

Approved

11. M/s Sigma

Pharma

International Pvt.

Limited E-50,

N.W.I.Z., Port

Qasim Karachi

(Capsule General:

No. F.6-6/2014-

Lic (M-237 dated

17-10-2014)

Coxib 200mg Capsule

Each Capsule Contains:-

Celecoxib…200mg

(Cox-2 Inhibitor)


Form 5

17-11-2014 (196)

Rs. 20,000/-

As Per SRO/

Pack 20’s

CELEBREX 200mg

Capsule of Pfizer

Laboratories USA

CELBEX 200mg

Capsule Getz Pharma

Pvt. Ltd. Karachi

New Licensee

Approved

65

12. -do- Coxib 100mg Capsule


Celecoxib…100mg

(Cox-2 Inhibitor)


Form 5

18-11-2014(Nil)

Rs. 20,000/-

As Per SRO/

Pack 20’s

CELEBREX 100mg

Capsule of Pfizer

Laboratories USA

CELBEX 100mg

Capsule Getz Pharma

Pvt. Ltd. Karachi

New Licensee

Approved

13. -do- Profile 20mg Capsule


Omeprazole enteric

coated Pellets 8.5%

equivalent to

Omeprazole…20mg

(Source of Pellets:

M/s Titan Laboratories

Private Limited Plot No.

E27/1, E27/2, MIDC,

Mahad Village Jite

District, Raigad,

Maharashtra, India) (Proton pump inhibitor)


Form 5

17-11-2014 (192)

Rs. 100,000/-

As Per SRO/

Pack 14’s

BNF: Losec

(AstraZeneca)

RISEK 20mg Capsule

Getz Pharma (Pvt.)

Ltd

New Licensee

1. Original Legalized

Copy of Valid

GMP certificate of

manufacturer of

Pellets is required.

Approved. Firm will

provide legalized

GMP of the

manufacturer of

pellets and then

registration letter will

be issued after

approval of Chairman,

RB.

14. -do- Profile 40mg Capsule


Omeprazole enteric

coated Pellets 8.5%

equivalent to

Omeprazole…40mg

(Source of Pellets:



E27/1, E27/2, MIDC,

Mahad Village Jite

District, Raigad,

Maharashtra, India) (Proton pump inhibitor)


Form 5

17-11-2014(193)

Rs. 100,000/-

As Per SRO/

Pack 14’s

BNF: Losec

(AstraZeneca)

RISEK 40mg Capsule

Getz Pharma (Pvt.)

Ltd

New Licensee


Copy of Valid

GMP certificate of

manufacturer of


Approved. Firm will

provide legalized

GMP of the

manufacturer of

pellets and then


be issued after


RB.

66

15. -do- Somep 40mg Capsule


Esomeprazole enteric

coated Pellets 22.50%

equivalent to

Esomeprazole…40mg

(Source of Pellets:



E27/1, E27/2, MIDC,

Mahad Village Jite

District, Raigad,

Maharashtra, India)

(Proton pump inhibitor)


Form 5

17-11-2014(191)

Rs. 100,000/-

As Per SRO/

Pack 14’s

NEXIUM 40mg

Capsule AstraZeneca

E-CAP 40mg

Capsule Brookes

Pharmaceutical

Laboratories

New Licensee


Copy of Valid

GMP certificate of

manufacturer of


Approved. Firm will

provide legalized

GMP of the

manufacturer of

pellets and then


be issued after


RB.

16. -do- Somep 20mg Capsule


Esomeprazole enteric

coated Pellets 22.50%

equivalent to

Esomeprazole…20mg

(Source of Pellets:



E27/1, E27/2, MIDC,

Mahad Village Jite

District, Raigad,

Maharashtra, India)



Form 5

17-11-2014(190)

Rs. 100,000/-

As Per SRO/

Pack 14’s

NEXIUM 40mg

Capsule AstraZeneca

E-CAP 40mg

Capsule Brookes

Pharmaceutical

Laboratories

New Licensee


Copy of Valid

GMP certificate of

manufacturer of


Approved. Firm will

provide legalized

GMP of the

manufacturer of

pellets and then


be issued after


RB.

17. -do- Zith 250mg Capsule

Each Capsule contains:-

Azithromycin (as

Dihydrate)…250mg


(USP Spec,s)

Form 5

17-11-2014(194)

Rs. 20,000/-

As Per SRO/

Pack 6's & 10's

ZITHROMAX 250mg

Capsule Pfizer

Laboratories

ZETRO 250mg

Capsule Getz Pharma

(Pvt.) Ltd.

New Licensee

Approved

67

18. -do- Malrid Capsule


Dihydroartemisinin…

40mg

Piperaquine

Phosphate… 320mg

(Anti-Malarial)


Form 5

17-11-2014(195)

Rs. 20,000/-

As Per SRO/

Pack 8's

Not confirmed

DIPIP 40/320mg

Capsule Hilton

Pharma (Pvt.) Ltd

New Licensee

1. Availability in

SRA’s not

confirmed. Firm

has provided

international

availability in

Italy.

Deferred for views of

recommendations of

WHO.

19. -do- Tranex 500mg Capsule


Tranexamic

Acid…500mg

(Haemostatic/

Fibrinolytic)


Form 5

17-11-2014(197)

Rs. 20,000/-

As Per SRO/

Pack 20's & 100's

Not confirmed

XED 500mg Capsule

Indus Pharma

New Licensee

1. Availability in

SRA’s not

confirmed. Firm

has provided

international

availability in

Bangladesh.

Deferred for

confirmation of

formulation / strength

whether approved in

reference Stringent

Regulatory Agencies

or not.

20. -do- Flucap 150mg Capsule


Fluconazole …150mg

(Antifungal)


Form 5

17-11-2014(198)

Rs. 20,000/-

As Per SRO/

Pack 1's

CANESTEN 150mg

Capsule Bayer

Healthcare

FLUDERM 150mg

Capsule Nabiqasim

Industries (Pvt.) Ltd

New Licensee

Approved.

68

21. M/s Sigma

Pharma

International Pvt.

Limited E-50,

N.W.I.Z., Port

Qasim Karachi

(Sachet General:

No. F.6-6/2014-

Lic (M-237 dated

17-10-2014)

Onitum 2gm Sachet

Each Sachet contains:-

Strontium Ranelate… 2g

(Anti-osteoporotic)


Form 5

17-11-2014(204)

Rs. 20,000/-

As Per SRO/

Pack 7’s

PROTELOS Sachet

Les Laboratoires

Servier Industrie

ONITA Sachet

PharmEVO

New Licensee

Approved.

22. -do- Monti 4mg Sachet


Montelukast Sodium

equivalent to

Montelukast 4mg

(Bronchodilators &

Anti-asthma

(Leukotriene antagonist)


Form 5

17-11-2014(218)

Rs. 20,000/-

As Per SRO/

Pack 14’s

Singulair (MSD

MONTIKA 4mg

Sachet Sami

Pharmaceutical (Pvt.)

Ltd

New Licensee

Approved.

23. -do- Malrid 15/120mg Sachet


Dihydroartemisinin…

15mg

Piperaquine Phosphate

…120mg

(Anti-Malarial)


Form 5

17-11-2014(206)

Rs. 20,000/-

As Per SRO/

Pack 16’s

Not confirmed

ARMIQIN Sachet

PharmEVO

New Licensee

1. Availability in

SRA’s not

confirmed. Firm

has provided

international

availability in

Taiwan

Deferred for views of

recommendations of

WHO.

24. -do- Citrosalt 4mg Sachet


Sodium Bicarbonate…

1.716gm Sodium Citrate

Anhydrous… 0.613gm

Citric Acid

Anhydrous…0.702gm

Tartaric Acid…

0.856gm

(Antacids, Anti-

flatulents)

Form 5

17-11-2014(217)

Rs. 20,000/-

As Per SRO/

Pack 20’s & 100’s

Not confirmed

CITRO SODA Sachet

Abbott Laboratories,

Pakistan

New Licensee

1. Availability in

SRA’s not

Deferred for

confirmation of

approval in reference

Stringent Regulatory

Agencies.

69

(Manufacturer’s Spec.s) confirmed. Firm

has provided

international

availability in

India.

25. -do- Profile 20mg Sachet


Omeprazole… 20mg


1680mg

(Proton pump

inhibitor/antacid)


Form 5

17-11-2014(206)

Rs. 20,000/-

As Per SRO/

Pack 10’s

FDA: Zegerid

RISEK INSTA

Powder 20mg Sachet

Getz Pharma (Pvt.)

Ltd

New Licensee

1. Formulation is

under review by

the Review

Committee of

DRB.

Deferred till review of

formulation by

Review Committee.

26. -do- Profile 40mg Sachet


Omeprazole… 40mg

Sodium Bicarbonate

…1680mg

(Proton pump

inhibitor/antacid)


Form 5

17-11-2014(212)

Rs. 20,000/-

As Per SRO/

Pack 10’s

FDA: Zegerid

RISEK INSTA

Powder 40mg Sachet

Getz Pharma (Pvt.)

Ltd

New Licensee

1. Formulation is

under review by

the Review

Committee of

DRB.


formulation by

Review Committee.

27. -do- ORES Sachet


Sodium Chloride… 2.6g

Sodium Citrate…2.9g

Potassium Chloride…

1.50g

Glucose Anhydrous…

13.50g

(Electrolytes)

Form 5

17-11-2014(213)

Rs. 20,000/-

As Per SRO/

Pack 20's

BNF: Oral

Rehydration Salts

(Non-proprietary)

WHO Formulation

OEM Sachet Indus

Pharma Pvt. Ltd.

New Licensee

Approved.

70

(BP Spec,s)

28. -do- Cysteine Sachet


Acetylcysteine …200mg

(Mucolytic Agent)


Form 5

17-11-2014 (210)

Rs. 20,000/-

As Per SRO/

Pack 30’s

Not confirmed (ACC

Sandoz Switzerland by

Firm)

MUCOLATOR

200mg Sachet Abbott

Laboratories

(Pakistan) Ltd

New Licensee

1. Availability in

SRA’s not

confirmed. Firm

has provided

international

availability in

Switzerland.

Deferred for

confirmation of



Agencies.

29. -do- Laxit Sachet


Polyethylene Glycol

3350… 13.125g

Sodium Chloride…

0.3507g


0.1785g

Potassium chloride…

0.0466g

(Laxatives)

(Manufacturer’s Spec’s)

Form 5

17-11-2014 (211)

Rs. 20,000/-

As Per SRO/

Pack 10’s

Not confirmed

MOVCOL Sachet

Genix Pharma Private

Limited

New Licensee

1. Availability in

SRA’s not

confirmed in same

strength.

Approved as it is BNF

approved formulation

30. -do- Gastolyte Sachet


Rice Powder …6g

Sodium Citrate

…0.580g Sodium

Chloride …0.350g

Potassium Chloride…

0.3g

(Electrolytes)


Form 5

17-11-2014(216)

Rs. 20,000/-

As Per SRO/

Pack

1 x 10’s

BNF: Dioralyte Relief

(Sanofi-Aventis)

GASTROLYTE

Sachet Sanofi-Aventis

Pakistan Limited

New Licensee

Approved.

71

31. M/s Sigma

Pharma

International Pvt.

Limited E-50,

N.W.I.Z., Port

Qasim Karachi

(Oral Dry Powder

Suspension

General: No. F.6-

6/2014-Lic (M-

237 dated 17-10-

2014)

Klar 125mg/5ml Dry

Suspnsion

Each 5ml contains:-

Clarithromycin…125mg


(USP Spec.s)

{Source of

Clarithromycin taste

masked Granules:

M/s Surge Lab10th KM

Faisalabad road

Sheikhupura}

Form 5

17-11-2014(222)

Rs. 20,000/-

As Per SRO/

Pack 30ml & 60ml

BNF . Klaricid

(Abbott)

(Klaricid (Abbott))

New Licensee

Approved

32. -do- Klar 250mg/5ml Dry

Suspnsion

Each 5ml contains:-

Clarithromycin…250mg


(USP Spec.s)

{Source of

Clarithromycin taste

masked Granules:

M/s Surge Lab10th KM

Faisalabad road

Sheikhupura}

Form 5

17-11-2014(223)

Rs. 20,000/-

As Per SRO/

Pack 60ml

BNF . Klaricid

(Abbott)

(Klaricid (Abbott))

New Licensee

Stability studies of

zone IV-A of

granules

Valid GMP

certificate.

Approved

33. -do- Fantin 15mg/90mg/5ml

Dry Suspnsion

Each 5ml contains:-

Artemether… 15mg

Lumefantrine… 90mg

(Antimalarial )


Form 5

17-11-2014(225)

Rs. 20,000/-

As Per SRO/

Pack 15ml

30ml & 60ml

ATRENAM

15/90mg/5ml Dry

Suspension Areneco

Pharma Belgium

ARTHEGET

15/90mg/5ml Dry

Suspension Getz

Pharma (Pvt.) Ltd.

Karachi

New Licensee

Approved.

34. -do- Fantin DS

30mg/180mg/5ml

Dry Suspnsion

Each 5ml contains:-

Artemether… 30mg

Form 5

17-11-2014(221)

Rs. 20,000/-

As Per SRO/

ATRENAM

30/180mg/5ml Dry

Suspension Areneco

Pharma

Approved.

72

Lumefantrine… 180mg

(Antimalarial )


Pack 30ml & 60ml Belgium ARTHEGET

30/180mg/5ml Dry

Suspension Getz

Pharma (Pvt.) Ltd.

Karachi

New Licensee

35. -do- Cip 250mg/5ml

Dry Suspnsion

Each 5ml contains:-

Ciprofloxacin (as

Ciprofloxacin HCl

Monohydrate) 250mg

( Quinolones Antibiotic

)


Form 5

17-11-2014(220)

Rs. 20,000/-

As Per SRO/

Pack 60ml

CIPROXIN Bayer

(Formulation is

different)

HIFLOX Hilton

Pharma (Pvt.) Ltd

Karachi

New Licensee

1. Formualtion is

under review by

the Review

Committee of

DRB.


formulation by

Review Committee

36. -do- Zith 200mg/5ml

Dry Suspnsion

Each 5ml contains:-

Azithromycin (as

Azithromycin

Dihydrate)…200mg

(Macrolide Antibiotic )

(USP Spec.s)

Form 5

17-11-2014(224)

Rs. 20,000/-

As Per SRO/

Pack 15ml, 22.5ml,

25ml, 30ml, &

60ml

BNF: Zithromax

(Pfizer)

ZETRO Getz Pharma

(Pvt.) Ltd Karachi.

New Licensee

Approved.

37. -do- Eryt 200mg/5ml

Dry Suspnsion

Each 5ml contains:-

Erythromycin Ethyl

succinate Monohydrate

equivalent to

Erythromycin… 200mg

( Macrolide Antibiotic

)

(USP Spec.s)

Form 5

17-11-2014(225)

Rs. 20,000/-

As Per SRO/

Pack 60ml

Not confirmed

ERYTHROCIN Indus

Pharma Karachi.

New Licensee

1. Availability in

same strength in

SRA’s not

confirmed. Firm

has provided

international

availability in

Deferred for

confirmation of

formulation approval

in reference Stringent

Regulatory Agencies

73

Jordan.

38. -do- Fosil 250mg/5ml

Dry Suspnsion

Each 5ml contains:-

Fosfomycin (as

Fosfomycin

Calcium)…250mg

(Anti Bacterial Agent )


Form 5

17-11-2014 (219)

Rs. 20,000/-

As Per SRO/

Pack 60ml

FOSFOCINA

Laboratories ERN,

Spain

MIFOS 250mg/5ml

Dry Suspension

Remington Pharma

Lahore

New Licensee

1. Availability in

same strength in

SRA’s not

confirmed. Firm

has provided

international

availability in

Spain.

Deferred for

confirmation of

formulation approval


Regulatory Agencies

39. -do- Flucap 50mg/5ml

Dry Suspnsion

Each 5ml contains:-

Fluconazole…50mg

(Antifungal)

(USP Spec.s)

Form 5

17-11-2014(227)

Rs. 20,000/-

As Per SRO/

Pack 35ml

BNF: Diflucan

(Pfizer)

FLUCANOL

50mg/5ml Dry

Suspension Rock

Pharma Nawshehra

New Licensee

Approved.

40. -do- Linz 100mg/5ml

Dry Suspnsion

Each 5ml contains:-

Linezolid 100mg

(Antibacterial )


Form 5

20-11-2014(Nil)

Rs. 20,000/-

As Per SRO/

Pack 60ml

BNF:

Zyvox(Pharmacia)

NEZOCIN

100mg/5ml Dry

Suspension Brookes

Pharma (Private)

Limited

New Licensee

Approved.

74

Evaluator – III

S/N Name and

address of

manufacturer

/ Applicant

Brand Name

(Proprietary name +

Dosage Form + Strength)

Composition

Pharmacological Group

Finished product

Specification

Type of Form

Initial date,

diary

Fee including

differential fee

Demanded Price

/ Pack size

Remarks on the


including


in stringent drug


authorities

Me-too status

GMP status as

depicted in latest

inspection report

(with date) by the

Evaluator

Recommendations

by the Evaluator

41. M/s MTI

Medical (Pvt)

Limited, 586-

587 Sunder

Industrial

Estate,

Raiwind Road

Lahore.

(Tablet

General)

LOFAMIN Tablet 250mg


contains:

Levofloxacin as

hemihydarte…..250mg

Fluoroquinolone

Manufacture

Form-5

Dy No: 1258

dated 20-10-2014

20,000/-

As per SRO/

Pack of 10’s

Levaquin Tablet of

Janssen Pharms

(USFDA)

Leflox of Getz

Karachi.

The CLB in its 236th

meeting approved the

grant of DML by the

way of formulation

with sections namely:

a. Oral Liquid

General

b. Tablet General

c. Capsule General

d. Oral Dry Powder

suspension

General

Approved.

42. -do- LOFAMIN Tablet 500mg


contains:

Levofloxacin as


Fluoroquinolone

Manufacture

Form-5

Dy No: 1262

dated 20-10-2014

20,000/-

As per SRO/

Pack of 10’s

Levaquin Tablet of

Janssen Pharms

(USFDA)

Leflox of Getz

Karachi.

Approved.

75

43. -do- TEMURIN Tablet 100mg

Each chewable tablet

contains:

Iron III Hydroxide

Polymatose Complex

equivalent to elemental

Iron…..100mg

Anti- Anemic

Manufacturer

(Word film coated has been

replaced with chewable as

firm applied as chewable)

Form-5

Dy No: 1018

dated 26-09-2014

20,000/-

As per SRO/

Pack of 1x10’s,

2x10’s

International

availability requires

confirmation.

Rubifer Chewable

Tablets of AGP (Pvt)

Limited, Karachi.

Approved.

44. -do- TEMURIN-F Tablet 100mg


contains:

Iron III Hydroxide

Polymaltose Complex


Iron…..100mg

Folic acid……0.35mg

Anti- Anemic

Manufacturer


replaced with chewable as

firm applied as chewable)

Form-5

Dy No: 1261

dated 20-10-2014

20,000/-

As per SRO

Pack of 1x10’s,

2x10’s

International

availability requires

confirmation.

Rubifer-F Chewable

Tablet of AGP (Pvt)

Limited Karachi.

Deferred for product

specific inspection by

panel comprising of

Director DTL &

Area FID

45. -do- CYTO Tablet 250mg


contains:-

Ciprofloxacin as

hydrochloride….250mg

Fluoroquinolone

BP

Form-5

Dy No: 1019

dated 26-09-2014

20,000/-

As per SRO

1x10’s

Cipro of Bayer Health

Care


Care Karachi

Approved.

76

46. -do- CYTO Tablet 500mg


contains:-

Ciprofloxacin as

hydrochloride….500mg

Fluoroquinolone

BP

Form-5

Dy No: 1017

dated 26-09-2014

20,000/-

As per SRO/

Pack of 1x10’s


Care


Care Karachi

Approved.

47. -do- PRIZO Tablets 100mg


contains:-

Flurbiprofen…..100mg

Cyclo-oxygenase Inhibitor,

Analgesic, Anti-

inflammatory

BP

Form-5

Dy No: 1054

dated 26-09-2014

20,000/-

As per SRO/

Pack of 3x10’s

Ansaid of Pharmacia

(USFDA)

Ansaid of Pfizer

Karachi

Approved.

48. -do- OSTIM Tablets 50mg


contains:

Clomiphene Citrate…..50mg

Antioestrogen

USP

Form-5

Dy No: 1020

dated 26-09-2014

20,000/-

As per SRO/

Pack of 1x10’s,

2x10’s and

3x10’s

Serophene of EMD

Serno (USFDA)

Cerophene of Hilton

Pharma Karachi.

Deferred till decision

on the manufacturing

requirement for this

product.

49. -do- MOZEX Tablet 400mg


contains:

Moxifloxacin as

HCL….400mg

Fluoroquinolone

Manufacturer


omitted in the agenda so has

been added in the minutes)

Form-5

Dy No: 1046

dated 26-09-2014

20,000/-

As per SRO/

Pack of 5’s

Avelox Tablet of

Bayer Health Care

Avelox of Bayer

Health Care Karachi

Approved.

77

50. -do-

(Capsule

General)

ESTO Capsules 20mg

Each capsules contains:-


Trihydrate enteric coated

pellets (22.5%) equivalent to

Esomeprazole……20mg

PPI

Manufacturer

Source: M/s Vision

Pharmaceuticals, Islamabad.

Form-5

Dy No: 1047

dated 26-09-2014

20,000/-

As per SRO/

1x10’s & 1x7’s

Nexium of

AstraZeneca USFDA

Esso Capsules of

Shaigan

Pharmaceuticals,

Islamabad.

Approved.

51. -do- ESTO Capsules 40mg

Each capsules contains:-


Trihydrate enteric coated


Esomeprazole………40mg

PPI

Manufacturer

Source: M/s Vision


Form-5

Dy No: 1048

dated 26-09-2014

20,000/-

As per SRO/

1x10’s & 1x14’s

Nexium of

AstraZeneca USFDA

Esso Capsules of

Shaigan

Pharmaceuticals,

Islamabad.

Approved.

52. -do- AZOl Capsules 250mg


Azithromycin as

dihydrate…..250mg

Macrolide

USP

Form-5

Dy No: 1050

dated 26-09-2014

20,000/-

As per SRO/

1x6’s & 1x10’s

Zithromax of Pfizer

(USFDA).

Zithromax of Pfizer

Karachi.

Approved.

53. -do- GRIBOL Capsules 150mg


Fluconazole…..150mg

Antifungal

Manufacturer

Form-5

Dy No: 1260

dated 20-10-2014

20,000/-

As per SRO/

1x4’s

Diflucan of Pfizer

(USFDA)

Diflucan Of Pfizer

Karachi.

Approved.

54. -do- GOTEC Capsules 40mg

Form-5

Prilosec of

AstraZeneca

Approved.

78


Omeprazole enteric coated


Omeprazole ……40mg

PPI

BP

Source: M/s Vision


Dy No: 1055

dated 26-09-2014

20,000/-

As per SRO/

1x10’s, 1x14’s

(USFDA)

Risek of Getz Karachi

55. -do- GOTEC Capsules 20mg


Omeprazole enteric coated


Omeprazole ……20mg

PPI

BP

Source: M/s Vision


Form-5

Dy No: 1044

dated 26-09-2014

20,000/-

As per SRO/

1x10’s, 1x14’s

Prilosec of

AstraZeneca

(USFDA)

Risek of Getz Karachi

Approved.

56. -do-

Oral liquid

(General)

APRIN Syrup

Each ml contains:

Cetirizine

dihydrochloride ………1mg

Antihistamine

Manufacturer

Form-5

Dy No: 1051

dated 26-09-2014

20,000/-

As per SRO

Pack of 30ml

and 60ml bottle

Benadryl Allergy Oral

Syrup of McNeil

Products UK

Baydal of Bayer

Health Care Karachi.

Approved.

57. -do- APHOLAC Suspension

Each 5ml contains:

Lactulose…..3.35gm

Laxative

BP

Form-5

Dy No: 1052

dated 26-09-2014

20,000/-

As per SRO/

Pack of 120ml &

240ml bottle

Duphalac of Solvay

(USFDA)

Duphalac of Abbot

Pharma, Karachi

Firm has submitted

invoice of purchase of

Refractive Index

detector.

Deferred for:

1. confirmation of

dosage form &

verification of HPLC

equipped with RI

detector by area FID.

2. Fee for import.

3. Legalized GMP of

source.

4. Stability studies.

58. TEMURIN Syrup

Each 5ml contains:

Iron III Hydroxide

Polymatose Complex

Form-5

Dy No: 1053

dated 26-09-2014

Availability in SRA’s

need confirmation

Engfer Syrup of

English Pharma Lahore

Approved.

79


Iron…….50mg

Anti-anemic

Manufacturer

20,000/-

As per SRO/

Pack of 60ml &

120ml bottle

59. -do-

(Oral Dry

Powder

Suspension

General)

AZOL Suspension

Each 5ml contains:

Azithromycin dihydrate

equivalent to Azithromycin

…..200mg

Macrolide

USP

Form-5

Dy No: 1257

dated 20-10-2014

20,000/-

As per SRO/

Pack of 15ml

bottle

Zithromax of Pfizer

(USFDA)

Zithromax of Pfizer

Karachi

Approved.

60. -do- CYTO Suspension

Each 5ml contains:

Ciprofloxacin as HCL taste

masked pellets 25%

equivalent to

Ciprofloxacin..…..250mg

Fluoroquinolone

Manufacturer

Form-5

Dy No: 1259

dated 20-10-2014

20,000/-

As per SRO/

60ml bottle

Not available in

SRA’s

Novidat of Sami

Pharma Karachi


formulation by

Review Committee.

Evaluator – III (Veterinary New DML)

S/N Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary name +

Dosage Form +

Strength)

Composition

Pharmacological

Group

Finished product

Specification

Type of Form

Initial date,

diary

Fee including

differential fee

Demanded Price

/ Pack size

Remarks on the


including


in stringent drug


authorities

Me-too status

GMP status as

depicted in latest

inspection report

(with date) by the

Evaluator

Recommendations

by the Evaluators

61. M/s Izfaar

Pharmaceutical

TRIOZIN Injection

Form-5

Trisolizin of Star Labs

Lahore.

Deferred for

confirmation of TOC

80

Industries,

Lahore

Veterinary Liquid

Injection

(General

Antibiotic)

Each ml contains:

Sulphadiazine…..400mg

Trimethoprim……80mg

Antibiotic

Manufacturer

10-07-14 Dy. No:

64

20,000/-

Decontrolled/

50ml vial

The CLB in its 236th

meeting of

Registration Board

approved the grant of

DML with following

sections namely:

a. Veterinary Liquid

Injection (General

Antibiotic)

b. Veterinary Liquid

Injection (General)

analyzer & Liquid

Particle Counter.

62. -do- TYLOGEN Injection

Each ml contains:

Tylosin Tartrate….10mg

Gentamicin as

sulphate…..50mg

Antibiotic

Manufacturer

Form-5

03-07-14 Dy. No:

15

20,000/-

Decontrolled/

50ml vial

Tygent Injection of

Selmore

Pharmaceuticals

Lahore

Deferred for

confirmation of TOC

analyzer & Liquid

Particle Counter.

63. -do- OXY FAR LA Injection

Each ml contains:

Oxytetracycline as

Hydrochloride…….200

mg

Antibiotic

Manufacturer

Form-5

10-07-14 Dy. No:

63

20,000/-

Decontrolled/

100ml vial

Oxy-LA injection of

Selmore

Pharmaceuticals,

Lahore

Deferred for

confirmation of TOC

analyzer & Liquid

Particle Counter.

64. -do- OXY FAR Injection

Each ml contains:

Oxytetracycline as

Hydrochloride…….50m

g

Antibiotic

Manufacturer

Form-5

10-07-14 Dy. No:

63

20,000/-

Decontrolled/

50ml Vial

Oxy-5 injection of

Selmore

Pharmaceuticals,

Lahore

Deferred for

confirmation of TOC

analyzer & Liquid

Particle Counter.

65. -do- ENRO-100 Injection

Each ml contains:

Enrofloxacin….100mg

Fluoroqunolone

Form-5

03-07-14 Dy. No:

17

20,000/-

Enroxsel of Selmore

Pharmaceuticals

Lahore

Deferred for

confirmation of TOC

analyzer & Liquid

Particle Counter.

81

Antibacterial

Decontrolled/

50ml vial

66. -do- FLOXIN Injection

Each ml contains:

Oxytetracycline as

HCL…..300mg

Flunixin as

Meglumine……20mg

Antibiotic/ Analgesic,

Anti-inflammatory

Manufacturer

Form-5

03-07-14 Dy. No:

19

20,000/-

Decontrolled/

50ml vial

I-Fom of International

Pharma Labs Lahore

Deferred for

confirmation of TOC

analyzer & Liquid

Particle Counter.

67. -do- TYLOFAR Injection

Each ml contains:

Tylosin

Tartrate……200mg

Antibiotic

Form-5

03-07-14 Dy. No:

15

20,000/-

Decontrolled/

50ml vial

Tylosel of Selmore

Pharmaceuticals,

Lahore

Deferred for

confirmation of TOC

analyzer & Liquid

Particle Counter.

68. -do- Ketoxay LA

Each ml contains:

Oxytetracycline as

HCL…….200mg

Ketoprofen….30mg

Antibiotic/ Analgesic

Manufacturer

Form-5

03-07-14 Dy. No:

19

20,000/-

Decontrolled/

50ml vial

Oxyfen-LA of

Selmore

Pharmaceuticals,

Lahore

Deferred for

confirmation of TOC

analyzer & Liquid

Particle Counter.

69. -do- TYLOPRIM Injection

Each ml contains:

Sulphamethoxypyridazin

e……150mg

Trimethoprim……30mg

Tylosin tartrate…..50mg

Antibiotic

Manufacturer

Form-5

03-07-14 Dy. No:

15

20,000/-

Decontrolled/

50ml vial

Tylotrim of Selmore

Pharmaceuticals

Lahore

Deferred for

confirmation of TOC

analyzer & Liquid

Particle Counter.

70. -do- DICOTYL Injection

Each ml contains:

Form-5

03-07-14 Dy. No:

Bacticom of Selmore

Pharmaceuticals

Lahore

Deferred for

confirmation of TOC

analyzer & Liquid

82

Tylosin tartrate….50mg

Colistin

sulphate…..10mg

Dimetridazole…..100mg

Antibiotic/ Anti-

Protozoal

Manufacturer

17

20,000/-

Decontrolled/,

50ml vial

Particle Counter.

71. -do- IVERIN Injection

Each ml contains:

Ivermectin….10mg

Anthelmintic

BP

Form-5

03-07-14 Dy. No:

14

20,000/-

Decontrolled/

50ml vial

Actimec Injection of

Selmore

Pharmaceuticals

Lahore

Deferred for

confirmation of

Liquid Particle

Counter.

72. -do- PARACTIN Injection

Each ml contains:

Ivermectin….20mg

Anthelmintic

BP

Form-5

03-07-14 Dy. No:

14

20,000/-

Decontrolled/

50ml vial

Elvomec D/S of Elko

Karachi

Deferred for

confirmation of

Liquid Particle

Counter.

73. -do- MELOXAM Injection

Each ml contains:

Meloxicam…….7.5mg

Analgesic/ Anti-

inflammatory

BP

Form-5

03-07-14 Dy. No:

14

20,000/-

Decontrolled/ 50

ml vial

Calimox of Selmore

Pharma

Deferred for

confirmation of TOC

analyzer & Liquid

Particle Counter.

74. -do- B-Vita Injection

Each ml contains:

Cyanocobalamin…..125

mcg

Vitamin

USP

Form-5

03-07-14 Dy. No:

15

20,000/-

Decontrolled/

Pack of 50 ml

vial

B-Vita of Kakasian

Pharma Lahore

Deferred for

confirmation of TOC

analyzer & Liquid

Particle Counter.

75. -do- ADE-FAR Injection

Form-5

Nawan Laboratories

Karachi

Deferred for

confirmation of TOC

83

Each ml contains:

Vitamin

A…….100,000IU

Vitamin

D3……40,000IU

Vitamin E…….40mg

Vitamin and Growth

promoters

Manufacturer

03-07-14 Dy. No:

17

20,000/-

Decontrolled/

50ml vial

analyzer & Liquid

Particle Counter.

76. -do- VITOBION Injection

Each ml contains:

Thiamine HCL……5mg

Riboflavin……2.5mg

Pyridoxine

HCL……2.5mg

Nicotinamide……37.5m

g

Vitamin

Manufacturer

Form-5

03-07-14 Dy. No:

15

20,000/-

Decontrolled/ 50

ml vial

Thiaprin Injection of

Star Labs Karachi

Deferred for

confirmation of TOC

analyzer & Liquid

Particle Counter.

77. -do- HEPAFAR Injection

Each ml contains:

Phenoxy-2-methyl-2-

propionic acid…..100mg

Hepatoprotectant/ Liver

Tonic

Manufacturer

Form-5

03-07-14 Dy. No:

15

20,000/-

Decontrolled/

50ml vial

Hepaguard of Star

Labs Lahore

Deferred for

confirmation of TOC

analyzer & Liquid

Particle Counter.

78. -do- IMIDO-FAR Injection

Each ml contains:

Imidocarb

dipropionate……120mg

Antiprotozoal

Form-5

03-07-14 Dy. No:

15

20,000/-

Decontrolled/

50ml vial

IMIPRO of Selmore

Pharmaceuticals,

Lahore

Deferred for

confirmation of TOC

analyzer & Liquid

Particle Counter.

79. -do- AAVIL Injection

Each ml contains:

Pheniramine

maleate…..11.35mg

Form-5

03-07-14 Dy. No:

15

20,000/-

Anril Injection of

Syman Pharma Lahore

Deferred for

confirmation of TOC

analyzer & Liquid

Particle Counter.

84

Antihistamine

Manufacturer

Decontrolled/

50ml vial

80. -do- ATRO Injection

Each ml contain:

Atropine

Sulphate…..1mg

Anti-muscarinic

BP

Form-5

03-07-14 Dy. No:

15

20,000/-

Decontrolled/

Pack of 50ml vial

Atrovet Injection of

Selmore

Pharmaceuticals

Lahore

Deferred for

confirmation of TOC

analyzer & Liquid

Particle Counter.

85

Case No.04. Grant of registrationsfor additional sectionsof already licensed manufacturers.

Evaluator – II

S/N Name and address of

manufacturer /

Applicant

Brand Name

(Proprietary

name + Dosage

Form +

Strength)

Composition

Pharmacological

Group

Finished

product

Specification

Type of Form

Initial date,

diary

Fee including

differential fee

Demanded

Price / Pack

size

Remarks on the

formulation (if

any) including

International

status in stringent

drug regulatory

agencies /

authorities

Me-too status

GMP status as

depicted in latest

inspection report

(with date) by the

Evaluator

Decision

81. M/s Pharmatec

Pakistan (Pvt.) Limited,

D-86/A, S.I.T.E.,

Karachi-75700.

(Cream/Oint General:

No. F.6-6/2014-Lic

(M-237 dated 14-10-

2014)

Adagel Gel

Contains:-

Adapalene

(B.P)…0.1%w/w

Benzoyl Peroxide

(B.P)…2.5%w/w

(Anti-acne

Preperation)

(Manufacturer’s

Spec.s)

Form 5

13-10-2014

(31)

Rs. 20,000/-

As Per

SRO/15gm,

30gm

BNF: Epiduo

(Galderma)

ADAPLUS

(BIOGEN

PHARMA,Islamab

ad)

Grant of additional

section

Cream/Ointment

(General)

recommended.(24-

07-2014)

Approved.

86

82. -do- Pamulin

Ointment

Contains:-

Retapamulin…1.

0%w/w

(Antibiotic and

chemotherapeutic

for

dermatological

use)

(Manufacturer’s

Spec.s)

Form 5

13-10-2014

(34)

Rs. 50,000/-

As Per

SRO/5gm,15g

m

BNF: Altargo

(GSK)

Altapam

Ointment of M/s

Atco Lab, Regn

No 061764

Grant of additional

section

Cream/Ointment

(General)

recommended.(24-

07-2014)

1. Me-too status

has been given as

Altapam Ointment

of M/s Atco Lab

(Reg. No 061764)

that needs

confirmation.

Pricing of

formulation has

been done in 9th

PAC.

Approved

83. M/s Sami

Pharmaceuticlas (Pvt.)

Limited, F-95, S.I.T.E.

Karachi-Pakistan

Tablet (Psychotropic)

Section (No. F.6-

5/2014-Lic (M-236)

dated 8th Sep, 2014.

Pralzo 0.25mg

Tablets

Each tablet

contains:-

Alprazolam

(USP)…0.25mg

(Benzodiazepine)

(USP Spec.s)

Form 5

09-09-2014

(240)

Rs. 20,000/-

Rs.157.47/30’s

BNF: Alprazolam

(Non-proprietary)

XANAX (PFIZER

LABORATORIES

LTD.,Karachi)

Very good, Panel

recommends all the

additional sections

as per approved

layout plan. (24-06-

14)

1. Alprazolam is a

controlled drug

substance.

Approved.

84. -do- Pralzo 0.5mg

Tablets

Form 5

09-09-2014

BNF: Alprazolam

(Non-proprietary)

Approved.

87

Each tablet

contains:-

Alprazolam

(USP)…0.5mg

(Benzodiazepine)

(USP Spec.s)

(239)

Rs. 20,000/-

Rs.157.47/30’s

XANAX (PFIZER

LABORATORIES

LTD.,Karachi)

Very good, Panel

recommends all the

additional sections

as per approved


14)

1. Alprazolam is a

controlled drug

substance.

85. -do-

Tablet (General)

Section (No. F.6-

5/2014-Lic (M-236)


Gasicol

Chewable Tablets

Each Chewable

tablet contains:-

Sodium

Alginate(BP)…5

00mg

Potassium

Bicarbonate

(BP)…100mg

(Antacid)

(Manufacturer’s

Spec.s)

Form 5

03-04-2014

(201)

Rs. 20,000/-

Rs. 5 per

Tablet, Rs.

80/16’s

BNF: Gaviscon

Advance

Not confirmed

Very good, Panel

recommends all the

additional sections

as per approved


14)

1. Verification of

photocopy of

fee receipt is

required.

2. Me-too status

needs

confirmation.

Deferred for application on

Form -5D alongwith

requisite fee & other codal

formalities.

86. -do- Solfy 5mg

Tablets

Each film coated

tablet contains:-

Solifenacin

Succinate…5mg

(Muscarinic

antagonist)

(Manufacturer’s

Spec.s)

Form 5

21-10-2014

(72)

Rs. 20,000/-

As per PRC

BNF: Vesicare

(Astellas)

Fenaso (Highnoon)

Very good, Panel

recommends all the

additional sections

as per approved


14)

Approved.

88

87. -do- Urigo 80mg

Tablets

Each film coated

tablet contains:-

Febuxostat……

……….…80mg

(Xanthine

Oxidase

Inhibitor)

(Manufacturer’s

Spec.s)

Form 5

21-10-2014

(73)

Rs. 20,000/-

As per PRC

FDA: Uloric

Zurig (Getz)

Very good, Panel

recommends all the

additional sections

as per approved


14)

Approved.

88. -do- Urigo 40mg

Tablets

Each film coated

tablet contains:-

Febuxostat…40m

g

(Xanthine

Oxidase

Inhibitor)

(Manufacturer’s

Spec.s)

Form 5

21-10-2014

(71)

Rs. 20,000/-

As per PRC

FDA: Uloric

Zurig (Getz)

Very good, Panel

recommends all the

additional sections

as per approved


14)

Approved.

89. -do-

Capsule (General)

Section (No. F.6-

5/2014-Lic (M-236)


Beritex 150mg

Capsules

Each capsule

contains:-

Polysaccharide

Iron Complex

equivalent to

Elemental

Iron…150mg

(Iron compound)

(Manufacturer’s

Spec.s)

Form 5

09-09-2014

(241)

Rs. 20,000/-

As per PRC

Not confirmed

Ferricure (S. J. &

G)

Very good, Panel

recommends all the

additional sections

as per approved


14)

1. Availability in

SRA’s not

confirmed.

Firm has

provided

international

availability of

un approved

products in

USA, Canada,

Approved.

89

Evaluator – III

S/N Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary name +

Dosage Form +

Strength)

Composition

Pharmacological

Group

Finished product

Specification

Type of

Form

Initial

date, diary

Fee

including

differential

fee

Demanded

Price /

Pack size

Remarks on

the

formulation

(if any)

including

International

status in

stringent

drug

regulatory

agencies /

authorities

Me-too status

GMP status

as depicted in

latest

inspection

report (with

date) by the

Evaluator

Recommendations

by the Evaluator

Decision

90. M/s Rasco

Pharma, 5.5

Km Raiwind

Road, Lahore

Liquid Injection

General (Small

Volume Vial)

PARA-RAS Infusion

Each 100ml vial

contains;

Paracetamol

(BP)…..1000mg

Antipyretic/ Analgesic

Manufacturer

Form-5

Dy No: 659

dated 22-

09-2014

20,000/-

As per

SRO

1x 100ml

PERFALGAN

10 mg/ml,

solution for

infusion (100

ml vial

contains 1000

mg

paracetamol)

of BMS UK

Provas of

Firm has submitted

the invoices of

purchase of Liquid

Particle counter and

TOC analyzer.

Approved. Area FID

will confirm

instalation &

operational

qualifications of TOC

& Liquid Particle

Counter and then


be issued after

approval of

Chairman, RB.

UK.

90

Sami Karachi

The

inspection of

firm was

carried out on

03-06-2014

by the panel

of inspectors

and

recommended

the renewal of

DML and

additional

section

namely Liquid

Injection

General

(Small

Volume Vial)

91. -do- LEVOFLOXA Infusion

Each 100ml vial

contains:

Levofloxacin

hemihydarte equivalent

to Levofloxacin

USP…..500mg

Quinolone

Manufacturer

Form-5

Dy No: 660

dated 22-

09-2014

20,000/-

As per

SRO

1x 100ml

Tevanic of

Sanofi

Aventis

(BNF)

Levocil of

CCL Pharma

Lahore.

Approved. Area FID

will confirm

instalation &

operational


& Liquid Particle

Counter and then


be issued after

approval of

Chairman, RB.

92. -do- LEVOFLOXA Infusion

Each 100ml vial

contains:

Levofloxacin

hemihydarte equivalent

to Levofloxacin

USP…..250mg

Quinolone

Manufacturer

Form-5

Dy No: 665

dated 22-

09-2014

20,000/-

As per

SRO

1x 100ml

250mg

levofloxacin

(as

hemihydarte)

in 50ml

solution

(Tavanic of

sanofi)

Levocil of

CCL Pharma

Lahore

Deferred for

confirmation of

approval by the

reference Stringent

Regulatory Agencies

for this strength /

volume.

91

93. -do- CIP-RX Infusion

Each 100ml vial

contains:

Ciprofloxacin lactate

equivalent to

Ciprofloxacin

USP….400mg

Quinolone

USP

Form-5

Dy No: 656

dated 22-

09-2014

20,000/-

As per

SRO

1x 100ml

Ciprofloxacin

2 mg/ml

Solution for

Infusion

400mg/200ml

vial of

Hospira UK

Limited

Novidat of

Sami Karachi

Deferred for

confirmation of

approval of

formaulation in


Agencies in the

same strength.

94. -do- CIP-RX Infusion

Each 100ml vial

contains:


equivalent to

Ciprofloxacin

USP….200mg

Quinolone

USP

Form-5

Dy No: 660

dated 22-

09-2014

20,000/-

As per

SRO

1x 100ml

Ciprofloxacin

2 mg/ml

Solution for

Infusion

200mg/100ml

vial of

Hospira UK

Limited

Novidat of

Sami Karachi

Approved. Area FID

will confirm

instalation &

operational


& Liquid Particle

Counter and then


be issued after

approval of

Chairman, RB.

95. -do- LINZO Infusion

Each 100ml contains:

Linezolid….200mg

Oxazolidinone

Manufacturer

Form-5

Dy No: 654

dated 22-

09-2014

20,000/-

As per

SRO

1x 100ml

Zyvox of

Pfizer USA

Nezocin of

Brookes

Pharma

Approved. Area FID

will confirm

instalation &

operational


& Liquid Particle

Counter and then


be issued after

approval of

Chairman, RB.

96. -do- RESGYL Infusion


Metronidazole…500mg

Antiprotozoal

Manufacturer

Form-5

Dy No: 657

dated 22-

09-2014

20,000/-

As per

SRO

1x 100ml

Flagyl of

Sanofi

(USFDA)

Metrozine of

Searle Karachi

Approved. Area FID

will confirm

instalation &

operational


& Liquid Particle

Counter and then


be issued after

approval of

Chairman, RB.

92

97. -do- RE-VED Infusion


Ofloxacin HCL

equivalent to

Ofloxacin……200mg

Quinolone

Manufacturer

Form-5

Dy No: 658

dated 22-

09-2014

20,000/-

As per

SRO

1x 100ml

Teravid of

Sanofi USA

Loxat of Siza

Lahore

Approved. Area FID

will confirm

instalation &

operational


& Liquid Particle

Counter and then


be issued after

approval of

Chairman, RB.

98. -do- MOXILINE Infusion

Each 250ml vial

contains:

Moxifloxacin HCL

equivalent to

Moxifloxacin……400mg

Quinolone Antibiotic

Manufacturer

Form-5

Dy No: 662

dated 22-

09-2014

20,000/-

As per

SRO

1x 250ml

Avelox of

Bayer Health

Care USA

Moxiget of

Getz Karachi

Applied volume is

250ml however the

approval of section

is for Liquid

Injection General

(Small Volume

Vial)

Approved. Area FID

will confirm

instalation &

operational


& Liquid Particle

Counter and then


be issued after

approval of

Chairman, RB.

99. M/s Arsons

Pharmaceuticals

Industries (Pvt)

Limited, Lahore

(Tablet

Psychotropic)

RELAXIM Tablet 3mg


Bromazepam…….3mg

Benzodiazepine

Manufacturer

Form-5

23-09-14

Dy. No:

793

20,000/-

As per

SRO

3x10’s

Lexotan

Tablets of

Roche (TGA

Approved)

Tensium

Tablets of

Werrick

Pharma

Islamabad.

The

inspection of

the firm was

conducted on

08-05-2014

by the panel

of inspectors

and

recommended

the renewal of

DML and

grant of

additional

section of

tablets

Approved with

change in applied

brand name.

93

psychotropic.

100. -do- ARVOTRIL Tablets

0.5mg


Clonazepam……0.5mg

Benzodiazepine

BP

Form-5

Dy No: 788

dated 23-

09-2014

20,000/-

As per

SRO

5x10’s

Clonazepam

Tablet of Teva

(USFDA)

Clonzil of

English

Pharma

Lahore

Approved with

change in applied

brand name.

101. -do- ARVOTRIL Tablets

2mg


Clonazepam……2mg

Benzodiazepine

BP

Form-5

Dy No: 790

dated 23-

09-2014

20,000/-

As per

SRO

3x10’s

Clonazepam

Tablet of Teva

(USFDA)

Clonzil of

English

Pharma

Lahore

Approved with

change in applied

brand name.

102. -do- ARTIVAN Tablets 1mg


Lorazepam……1mg

Benzodiazepine

BP

Form-5

Dy No: 792

dated 23-

09-2014

20,000/-

As per

SRO

10x10’s

Ativan of

Pfizer

(USFDA)

Ativan of

Pfizer Karachi

Approved with

change in applied

brand name.

94

103. -do- ARTIVAN Tablets 2mg


Lorazepam……2mg

Benzodiazepine

BP

Form-5

Dy No: 791

dated 23-

09-2014

20,000/-

As per

SRO

10x10’s

Ativan of

Pfizer

(USFDA)

Ativan of

Pfizer Karachi

Approved with

change in applied

brand name.

104. -do- XALLIUM Tablets 5mg


Diazepam………5mg

Benzodiazepine

BP

Form-5

Dy No: 794

dated 23-

09-2014

20,000/-

As per

SRO

3x10’s

Diazeoam of

Wockhardt

UK

Valium of

Martin Dow

Karachi

Approved with

change in applied

brand name.

105. -do- ARMICUM Tablet

7.5mg


Midazolam as

meleate……7.5mg

Benzodiazepine

Manufacturer

Form-5

Dy No: 794

dated 23-

09-2014

20,000/-

As per

SRO

3x10’s

Hypnovel

tablets of

Roche New

Zealand

Dormicum of

Martin Dow

Karachi

Approved with

change in applied

brand name.

5. Left-over agenda (245)

a) Remaining application of previously approved new sections

Evaluator - II

95

S/N Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary name +

Dosage Form +

Strength)

Composition

Pharmacological

Group

Finished product

Specification

Type of Form

Initial date, diary

Fee including

differential fee

Demanded Price

/ Pack size

Remarks on the


including


in stringent drug


authorities

Me-too status

GMP status as

depicted in latest

inspection report

(with date) by the

Evaluator

Decision

106. M/s Herbion

Pakistan (Pvt)

Ltd., Kahuta

Road, industrial

Triangle, Humak,

Rawalpindi-

Islamabad.

EsNovex/AciNovex/

GastriNovex

Capsules 20mg

Each capsule

contains:-Enteric

coated pellets of

Esomeprazole

Magnesium

Trihydrate

eq. to

Esomeprazole…20m

g

( Antipeptic

Ulcerants / Proton

Pump Inhibitor)

(Manufacturer’s

Spec.s)

{Source of Pellets:

M/s Glukem

Pharmaceuticals (P)

Ltd Plot # 205/2A, 1st

Floor , IDA, Phase-II,

Cherlapally,

Hyderabad-Andhra

Pradesh, India}

Form 5

02-05-2014

Dy.No.2076

Rs.20,000/=+Rs.

80,000/- (05-09-

2014)

Rs.200.00/

2x7’s

Nexium of

AstraZeneca

Esso of Shaigan

Pharmaceuticals

Islamabad.

Grant of DML

recommended (23-24th

January 2014)

1. Valid and

legalized GMP

Certificate of

Source, COA and

stability studies

according to zone

IV-a of pellets are

required.

The stability & COA

have been provided

by the applicant

before the meeting of

the Board.

Approved. Firm will

provide legalized GMP of

the manufacturer of pellets

and then registration letter

will be issued after

approval of Chairman, RB.

107. -do- EsNovex/AciNovex/

GastriNovex

Capsules 40mg

Each capsule

contains:-Enteric

coated pellets of

Esomeprazole

Form 5

02-05-2014

Dy.No.2077

Rs.20,000/- +

Rs. 80,000/- (05-

09-2014)

Nexium of

AstraZeneca

Esso of Shaigan

Pharmaceuticals

Islamabad.

Approved. Firm will

provide legalized GMP of

the manufacturer of pellets

and then registration letter

will be issued after

approval of Chairman, RB.

96

Magnesium

Trihydrate

eq. to

Esomeprazole …40

mg

( Antipeptic

Ulcerants / Proton

Pump Inhibitor)

(Manufacturer’s

Spec.s)

{Source of Pellets:

M/s Glukem

Pharmaceuticals (P)

Ltd Plot # 205/2A,

1st Floor , IDA,

Phase-II,

Cherlapally,

Hyderabad-Andhra

Pradesh, India}

Rs.371.00/2x7’s

Grant of DML


January 2014)

1. Valid and

legalized GMP

Certificate of

Source, COA and

stability studies

according to zone

IV-a of pellets are

required.

The stability & COA

have been provided

by the applicant

before the meeting of

the Board.

108. -do- OmeNovex /

SecNovex /

PeptiNovex

Capsules 20mg

Each capsule

contains:-

Omeprazole enteric

coated Pellets eq. to

Omeprazole

…20mg

( Antipeptic

Ulcerants / Proton

Pump Inhibitor)

(Manufacturer’s

Spec.s)

{Source of Pellets:

M/s Vision

Pharmaceuticals, Plot No.224, Street

No.1, I-10/3,

Industrial Area,

Islamabad.}

Form 5

02-05-2014

Dy.No.2078

Rs.20,000/=

Rs.290.00/

2x7’s

Losec (Astrazeneca)

Omega(Ferozsons)

Grant of DML


January 2014)

Approved.

97

109. -do- OmeNovex /

SecNovex /

PeptiNovex

40mg Capsules

Each capsule

contains:-

Omeprazole enteric

coated Pellets

eq. to

Omeprazole…

40mg

( Antipeptic

Ulcerants / Proton

Pump Inhibitor)

(Manufacturer’s

Spec.s)

{Source ofPellets:

M/s Vision

Pharmaceuticals, Plot

No.224, Street No.1,

I-10/3, Industrial

Area, Islamabad.}

Form 5

02-05-2014

Dy.No.2079

Rs.20,000/=

Rs.354.00/

2x7’s

Losec (Astrazeneca)

Omega(Ferozsons)

Grant of DML


January 2014)

Approved.

110. -do- FluNovex / CF-

Novex / TheraNovex

Extra Tablets

Each film coated

tablet contains:-

Paracetamol BP

….…..650mg

Chlorphenirmine

Maleate

BP………………..…

…..4mg

Phenylephrine HCl

BP…10mg

(Analgesic +

Decongestant

Combination)

(Manufacturer’s

Spec.s)

Form 5-D

24-02-2014

Dy.No.194

Rs.20,000+Rs.

30,000/- (07-05-

14)

Rs.230.00/

10x10’s

Not confirmed

Form 5-D

Grant of DML


January 2014)

1. The firm had

applied on Form 5

, after evaluation

the Firm applied

on Form 5-D and

submitted

additional fee of

Rs. 30,000/-

2. International

availability not

confirmed in

stringent DRS’s.

Deferred for confirmation

of approval in reference


Agencies. It will be

followed by assessment of

stability studies and expert

opinions by Brig Aslam,

Dr.Rehana Kauser and

Dr.Shazli Manzoor.

111. -do- VitaNovex /

CilaNovex /

BonNovex

Form 5

26-02-2014

Dy.No.211

Not confirmed

Not confirmed

Deferred for approval in

reference Stringent

Regulatory Agencies &

98

Suspension

Each 5ml contains:-

Ossein Mineral

Complex …250mg

Vitamin D … 400 i.u

(Calcium-Phosphorus

Supplements)

(Manufacturer’s

Spec.s)

Rs.20,000

Rs.144.00/

60ml

Grant of DML


January 2014)

1. International

availability not

confirmed in

stringent DRA’s.

2. Me-too status not

confirmed.

3. Firm has claimed

that they possess

Atomic Absorption

(PerkinElmer- A

Analyst 300)

spectrophometer

and has submitted

that it can be

verified by area

FID.

me-too status alongwith

installational &

operational qualification

of atomic absorption

spectrophotometer by area

FID.

99

Evaluator – I

S/N Name and

address of

Manufacturer /

Applicant

Brand Name

(Proprietary

name + Dosage

form + Strength)

Composition

Pharmacological

Group

Finished product

specification

Type of Form

Initial date,

diary.

Fee including

differential fee

Demanded

Price / Pack

size

Internationa

l status in

stringent

regulatory

agencies

Me-too

status

GMP status

as depicted

in inspection

report

(dated)

Remarks /

Observations

Decision

112. M/s Hiranis

Pharmaceuticals

(Pvt) Ltd., Plot

No. E-145 – E-

149, North

Western

Industrial Zone,

Port Qasim,

Karachi.

Acen Effervescent

Tablet 200mg

Each effervescent

tablet contains:

N-acetylcysteine

…………..200mg

(Manufacturer’s

Specs)

Mucolytic agent

Form-5D

New License

28-05-2014

804 R&I

Rs. 800 / per

10’s

Rs. 50,000/-

ACC™ 200

effervescent

tablets

N-

acetylcystein

e 200mg

South Africa

References and

data of various

international

clinical studies

have been provided

along with 06

months accelerated

and real time

stability summary.

Deferred for

approval in

reference

Stringent

Regulatory

Agencies to

establish safety &

efficacy of

product.

113. M/s Hiranis

Pharmaceuticals

(Pvt) Ltd., Plot

No. E-145 – E-

149, North

Western

Industrial Zone,

Port Qasim,

Karachi.

Glucort S.R. Tablet

5mg Each enteric

coated tablet

contains:-

Beclomethasone

Dipropionate ...

5mg

(Manufacturer’s

Specs)

Corticosteroid

Form-5D

New License

28-05-2014

808 R&I

Rs. 1,000 / per

10’s

Rs. 50,000/-

CLIPPER

Gastro-

resistant

prolonged

release tablet

5mg

MHRA

References and

data of various

international

clinical studies has

been provided

along with 06

months accelerated

and real time

stability summary.

Firm has also

submitted

undertaking to

submit comparative

dissolution profile

with established

brand before

marketing the

product.

Deferred for

expert opinions by

Brig Aslam,

Dr.Rehana Kauser

and Dr.Shazli

Manzoor and

evaluation of

stability studies by

Incharge, PEC.

100

114. M/s Hiranis

Pharmaceuticals

(Pvt) Ltd., Plot

No. E-145 – E-

149, North

Western

Industrial Zone,

Port Qasim,

Karachi.

Lafelax Liquid

Sachet

Each 15ml sachet

contains:-

Lactulose………6

7% w/v

(USP

Specification)

Laxative

Source: M/s

Fresenius Kabi,

Austria

Form-5D

New License

28-05-2014

811 R&I

Rs. 250 / per

10’s

Rs. 50,000/-

28/05/2014

Rs. 50,000/-

24/09/2014

Total fee: Rs.

100,000/-

LAEVOLAC

10g/15ml

Sachet

MHRA

References and

data of various

international

clinical studies /

literature have been

provided along

with 06 months

accelerated and real

time stability

summary.

GMP certificate of

the source of

Lactulose dated 13-

02/2012 with the

statement that this

certificate reflects

the status of

manufacturer at the

time of inspection

(31-01-2012) and

should not be relied

upon to reflect the

compliance status if

more than three

years have elapsed

since the date of

that inspection.

Deferred for

confirmation of

same strength

internationally,

evaluation of

stability studies,

confirmation of

HPLC equipped

with RI detector &

legalized GMP of

source.

115. M/s Hiranis

Pharmaceuticals

(Pvt) Ltd., Plot

No. E-145 – E-

149, North

Western

Industrial Zone,

Port Qasim,

Karachi.

Diolyte Rice

Sachet

Each sachet

contains:-

Rice Powder…6g

Sodium

Citrate……. 0.58g

Sodium Chloride

………….. 0.35g

Potassium Chloride

…………… 0.3g

(Manufacturer’s

Specs)

Form 5

New License

05-05-2014

662 R&I

As per PRC

10’s

Rs. 20,000/-

DIAROLYT

E

GASTROLY

TE

Sanofi

Approved with

change in brand

name.

101

ORS

116. M/S Pharma

Lord (Pvt) Ltd.,

12 Km, Lahore

Road, Layyah.

Tablet (General)

Capsule

(General)

Oral Dry Powder

Suspension

(General)

CPRO 125mg/5ml

Suspension

Dry Suspension

Each reconstituted

5ml contains:

Ciprofloxacin

………..... 125mg

(Anti-infective /

Quinolone)

Reference

formulation:

CIPRO Oral

Suspension (M/s

Bayer HealthCare

Pharmaceuticals

Inc.)

Ciprofloxacin Oral

Suspension is

available in 5% (5

g ciprofloxacin in

100 mL) and 10%

(10 g ciprofloxacin

in 100 mL)

strengths.

Ciprofloxacin Oral

Suspension is a

white to slightly

yellowish

suspension with

strawberry flavor

which may contain

yellow-orange

droplets. It is

composed of

ciprofloxacin

microcapsules and

diluent which are

Form 5

Rs. 125/- per

60ml

R&I diary No.

and date not

available

Rs.20,000

(Duplicate)

NOVIDAT

125mg/5ml

Sami

Panel

inspection

report for

grant of

DML dated

14th

December,

2012

attached.

1. Under

international

availability Cipro

of M/s Bayer, Italy

has been

mentioned.

2. Role of

ingredients has not

been provided.

3. Ciprofloxacin

25% granules had

been proposed

earlier. However,

now firm has

proposed dry

powder suspension

containing

Ciprofloxacin

(base) with water

as diluent which is

different from the

reference

international

brand*.

4. Copy of latest

GMP report

required.

Deferred for

review of

formulation.

102

mixed prior to

dispensing. The

components of the

suspension have

the following

compositions:

Microcapsules–

ciprofloxacin,

povidone,

methacrylic acid

copolymer,

hypromellose,

magnesium

stearate, and

Polysorbate 20.

Diluent–medium-

chain triglycerides,

sucrose, lecithin,

water, and

strawberry flavor.

103

Evaluator – III

S/N Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary name +

Dosage Form +

Strength)

Composition

Pharmacological

Group

Finished product

Specification

Type of Form

Initial date, diary

Fee including

differential fee

Demanded Price /

Pack size

Remarks on the


including


in stringent drug


authorities

Me-too status

GMP status as

depicted in latest

inspection report

(with date) by the

Evaluator

Decision

117. M/s Faas

Pharmaceuticals

(Pvt) Limited, F-

748/ L S.I.T.E.

Karachi

(Tablet General)

Ciploxin Tablet

250mg


contains:

Ciprofloxacin as

HCL…..250mg

Anti-Infective

USP

Form-5

Dy No:977 dated

12-06-2014

20,000/-

As per SRO

Cipro of Byaer Health

Care

Cipro of Bayer

Healthcare Karachi

Inspection of the firm

was conducted on 18-

03-2014 by the area

FID and GMP

compliance was found

satisfactory.

Approved.

118. -do- Ciploxin Tablet

500mg


contains:

Ciprofloxacin as

HCL…..500mg

Anti-Infective

USP

Form-5

Dy No:975 dated

12-06-2014

20,000/-

As per SRO

Cipro of Byaer Health

Care

Cipro of Bayer

Healthcare Karachi

Approved.

119. -do- Levoquin Tablet

250mg


contains:

Levofloxacin as


Form-5

Dy No:976 dated

12-06-2014

20,000/-

As per SRO

Levaquin Approved

USFDA

Leflox of Getz Pharma

Karachi

Approved.

104

Anti-Infective

Manufacturer

120. -do- Levoquin Tablet

500mg


contains:

Levofloxacin as


Anti-Infective

Manufacturer

Form-5

Dy No:974 dated

12-06-2014

20,000/-

As per SRO

Levaquin Approved

USFDA

Leflox of Getz Pharma

Karachi

Approved.

121. -do-

Capsule (General)

Omezole-D Capsule

Each capsule

contains:-

Blended pellets of

Omeprazole 20mg

EC….20mg

Domperidone IR

….10mg

Anti-Ulcer and Anti-

Emetic

Manufacturer

Source: M/s Glukem


No. 205/2A, IDA,

Phase II, Chedapally,

Hyderabad, India

Form-5

Dy No:974 dated

12-06-2014

100,000/-

As per SRO

Not available in

stringent SRA,s

Me too status is not

submitted by the firm.

a. Evidence of

approval of same

dosage form and

strength in FDA,

TGA, EMA,

MHLW, and

Health Canada is

required.

b. GMP certificate

of the source

(which shall be

legalized) and

stability studies

as per ZONE-IV

A needs to be

submitted.


formulation.

122. M/s Martin Dow

Limited, Plot No.

37, Sector 19,

Korangi Industrial

Area, Karachi

Sparta Sachet

Each sachet conatins:-

L-Ornithine –L-

Aspartate……3gm

Cholagogues and

Hepatic Protectors\

Manufacturer

Form-5

Dy No. 1067 dated :

30-06-2014

As per brand leader

price/ Pack of 5,10

& 30’s

Hepa-MerzMerz

Pharmaceuticals

Germany

Hepa-Merz of Brookes

Pharma, Karachi.




Agencies & me too status.

105

123. -do- Olyte Sachet


Precooked Rice

Powder ……6gm

Sodium

citrate…..0.58gm

Sodium

chloride…..0.35gm

Potassium

chloride……0.30gm

Form-5

Dy No. 1069 dated :

30-06-2014

As per brand leader

price/ Pack of 6,10

& 20’s

Doalyte Relief Black

current sachet of

Aventis Pharma UK

Diarolyte of Sanofi

Avnetis Karachi

Approved.

124. -do- Evrease Sachet

Each sachet contains:

Mebeverine as

Hydrochloride:

135mg

Physillium

Husk…..3.5gm

Antispasmodic and

Laxative

Manufacturer

Form-5

Dy No. 1070 dated :

30-06-2014

Rs.155.52 per pack

of 10’s

Rs. 310.50 per pack

of 20’s

Rs.465.75 per pack

of 30’s

Fybogel Mebeverine

of Reckitt Benkiser

UK

Ispamer Sachet of

Getz, Karachi

Approved.

125. M/s Elite Pharma

(Pvt) Limited, 9.5

Km Sheikhupura

Road Lahore

Flucolite Infusion

50ml

Each ml contains:-

Fluconazole……2mg

Antifungal

Manufacturer

Form-5

Dy No. 885 dated :

25-11-2013

20,000/-

Price not submitted

/Pack of 100ml of

1’s

Diflucan of Pfizer.

Diflucan of Pfizer

Labs Karachi

Evidence of

availability of TOC is

required as BP

specifications are

claimed.

Panel inspection of the

firm was conducted on

28-01-13 and the

panel recommended

the liquid injectable

infusion (100ml)


of installation and

performance qualification

of TOC analyser & Liquid

Particle Counter by Area

FID.

106

126. -do- Percemol Infusion

1gm/100ml

Each 100ml conatins:-

Paracetamol……1gm

Analgesic

Manufacturer

Form-5

Dy No. 883 dated :

25-11-2013

20,000/-

Price not submitted

/Pack of 100ml of

1’s

Perfalgan of BMS, UK

Provas of SAMI

Pharmaceuticals

Karachi

Evidence of


required as BP

specifications are

claimed.


of installation and




FID.

127. -do- Capronic Infusion

50mg/ml

Each ml contains:-

Aminocaproic

acid…..50mg

Hemostatis

Form-5

Dy No. 883 dated :

25-11-2013

20,000/-

Price not submitted

/Pack of 100ml of

1’s

Not available in

SRA,s.

Me too is not provided

by the company.

Evidence of


required as BP

specifications are

claimed.


of following:

1. Installation and




FID.

2. Me too status & approval

by referenece Stringent

Regulatory Agencies.

128. -do- Elite Reserbelakta

Each ml contains:-

Sorbitol…..200mg

Sodium

Lactate…..1.9mg

So+dium

chloride…..6mg

Calcium

chloride…..0.1mg

Potassium

Chloride……0.3mg

Magnesium

Chloride…..0.2mg

Hyperosmoler

complex and infusion

solution

Manufacturer

Form-5

Dy No. 884 dated :

25-11-2013

20,000/-

Price not submitted

/Pack of 400ml of

1’s

Not available in

stringent SRA’s. Firm

has submitted the

applied product is

available in Ukraine

(Saorbilactum infusion

of Yuria Pharma)

which also needs

verification.

Firm submitted that

product is not

available locally.

Evidence of


required as BP

specifications are

claimed.


of folowing:

1. Installation and




FID.




129. -do- Elite Reserbelakta

Each ml contains:-

Sorbitol…..200mg

Sodium

Lactate…..1.9mg

Sodium

Form-5

Dy No. 888 dated :

25-11-2013

20,000/-

Not available in

stringent SRA’s. Firm

has submitted the

applied product is

available in Ukraine

(Saorbilactum infusion

of Yuria Pharma)


of folowing:

1. Installation and




FID.

107

chloride…..6mg

Calcium

chloride…..0.1mg

Potassium

Chloride……0.3mg

Magnesium

Chloride…..0.2mg

Hyperosmoler

complex and infusion

solution

Manufacturer

Price not submitted

/Pack of 200ml of

1’s

which also needs

verification.

Firm submitted that

product is not

available locally.

Evidence of


required as BP

specifications are

claimed.




b) Routine applications

Evaluator – II

S/N Name and address of

manufacturer /

Applicant

Brand Name

(Proprietary name +

Dosage Form +

Strength)

Composition

Pharmacological

Group

Finished product

Specification

Type of Form

Initial date, diary

Fee including

differential fee

Demanded Price /

Pack size

Remarks on the


including


in stringent drug


authorities

Me-too status

GMP status as

depicted in latest

inspection report

(with date) by the

Evaluator

Decision

130. M/s Maple

Pharmaceuticals (Pvt.)

Ltd., 147/23, Korangi

Industrial Area,

Karachi.

Faxim-E 200mg

Tablet

Each film coated

Tablet contains:-

Rifaximin

(B.P)…200mg

(Antibacterial)

(Manufacturer’s

Spec.s)

Form-5

15-07-2010

(N/A)

Rs.8,000/-+Rs. 12,000

(14-05-2013)

As per PAC

BNF: Xifaxanta

(Norgine)

Nimixa (Getz Pharma)

Overall cGMP

measures are followed

in the Firm (31-03-

2014)

1. Verification of

Approved. Reference

will be sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan. If confirmed,

then Chairman, RB

will permit issuance of

registration letter.

108

photocopies of fee

challan is

required.

131. -do- Faxim 550mg Tablet

Each Tablet

contains:-Rifaximin

(B.P)…550mg

(Antibacterial)

(Manufacturer’s

Spec.s)

Form-5

15-07-2010

(N/A)

Rs.8,000/-+Rs. 12,000

(25-07-2013)

As per PAC

BNF: Xifaxanta

(Norgine)

Nimixa (Getz Pharma)

Overall cGMP


in the Firm (31-03-

2014)

1. Verification of

photocopies of fee

challan is

required.

Approved. Reference


Division, DRAP for

verification of

photocopy of fee


then Chairman, RB



132. M/s Sami

Pharmaceuticlas (Pvt.)

Limited, F-95, S.I.T.E.

Karachi-Pakistan

Neege 20mg Tablets

Each delayed release

Tablet contains:-

Pantoprazole Sodium

Sesuiquihydrate

equivalent to

Pantoprazole

(USP)…20mg

(Proton Pump

Inhibitor) USP

Spec.s)

Form 5

06-07-2010

Rs.8,000/ (69)

+Rs. 12000 (10-05-

2013)

As Per PRC

BNF. Pantoprazole

(Non-proprietary)

Zentro (Bosch)

Good (28-11-2013)

Very good (24-06-

2014) Grant of

Additional sections

Satisfactory (07-11-

2013) Routine

1. Verification of

photocopy of fee

of Rs. 12000/- is

required.

Approved. Reference


Division, DRAP for

verification of

photocopy of fee


then Chairman, RB



109

1. The Routine applications checked by the Field Officers before establishment of Cell

Evaluator - II

S/N Name and

address of

manufacturer/

Applicant

1. Brand

Name

2. Dosage

Form

3.

Composition

4.

Pharmacologi

cal

group

1.Type of

Form

2. Type of

application

3.

Demanded

Price / Pack

size

4. Initial

date, diary.

5. Date on

which fee

becomes

complete

according to

type of

application

/or Form

(total Fee)

1. Finished

Product

Specification

2. Me-too status

Comments /

observation on

the product (if

any)

Decision

Registration-II

133. M/s Barrett

Hodgson

Pakistan Pvt.

Ltd. F/423,

SITE, Karachi

1.DutaBar

2.Capsule

3.Each

Capsule

contain:

Dutasteride…

……….0.5mg

4.Alpha-

Reductase

Inhibitors

1.Form5

2.Routine

3. Rs.

1200/20’s

4.28/09/2010

Dy. No. 1738

Form 5

Rs. 8000/-

(Original)

21-5-2013

Rs.12,000/-

(Photo copy)

Me too confirmed

Advodart of GSK

FDA : Avodart

(GSK)

Deferred for

confirmation of

formualtion in soft

gelatin capsule form.

Reference will be

sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan. If

confirmed, then

Chairman, RB will

permit issuance of


134. -do- 1.MindSet

2.Capsules

3.Each

Capsule

contains:

Ziprasidone

……….20mg

4.Atypical

1.Form5

2.Routine

3. Rs.

900/14’s

4.28/09/2010

Dy. No. 1742

Form 5

Rs. 8000/-

Me too status

confirmed.

FDA : Geodon

(Pfizer)

Approved with

change in applied

brand name.

Reference will be

sent to B & A

Division, DRAP for

verification of

photocopy of fee

110

Anti-

Psychotropic

Agent

(Original)

21-5-2013

Rs.12,000/-

(Photo copy)

challan. If

confirmed, then

Chairman, RB will

permit issuance of


135. -do-

1.MindSet

2.Capsules

3.Each

Capsule

contains:

Ziprasidone…

…….40mg

4.Atypical

Anti-

Psychotropic

Agent

1.Form5

2.Routine

3. Rs.

1500/14’s

4.28/09/2010

Dy. No. 1741

Rs. 8000/-

(Original)

21-5-2013

Rs.12,000/-

(Photo copy)

Me too status

confirmed.

FDA : Geodon

(Pfizer)

Approved with

change in applied

brand name.

Reference will be

sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan. If

confirmed, then

Chairman, RB will

permit issuance of


136. -do-

1.MindSet

2.Capsules

3.Each

Capsule

contains:

Ziprasidone

……….60mg

4.Atypical

Anti-

Psychotropic

Agent

1.Form5

2.Routine

3. Rs.

2100/14’s

4.28/09/2010

Dy. No. 1740

Rs. 8000/-

(Original)

21-5-2013

Rs.12,000/-

(Photo copy)

Ziprox of Nabi

qasim

FDA : Geodon

(Pfizer)

Approved with

change in applied

brand name.

Reference will be

sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan. If

confirmed, then

Chairman, RB will

permit issuance of


137. -do-

1.MindSet

2.Capsules

3.Each

Capsule

contains:

Ziprasidone…

…….80mg

4.Atypical

Anti-

Psychotropic

Agent

1.Form5

2.Routine

3. Rs.

2800/14’s

4.28/09/2010

Dy. No. 1739

Rs. 8000/-

(Original)

21-5-2013

Rs.12,000/-

(Photo copy)

Me too status

confirmed

FDA : Geodon

(Pfizer)

Approved with

change in applied

brand name.

Reference will be

sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan. If

confirmed, then

Chairman, RB will

permit issuance of


111

138. M/s Macter

International Ltd.

F-216, SITE,

Karachi

1.Amlotel

2.Tablet

3.Each tablet

contains:

Telmisartan…

…………….4

0mg

Amlodipine…

…………..….

5mg

4.antihyperten

sive

1.Form5

2.Routine

3.14’s / As

per PRC

4.22/09/2010

Dy. No. 1709

Rs. 8000/-

(Original)

22-5-2013

Rs.12,000/-

(Not

attached)

Me too confirmed FDA: Generic

(TORRENT

PHARMS LTD)

Approved.

Reference will be

sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan. If

confirmed, then

Chairman, RB will

permit issuance of


139. -do- 1.Amlotel

2.Tablet

3.Each tablet

contains:

Telmisartan…

…………….8

0mg

Amlodipine…

…………..….

5mg

4.antihyperten

sive

1.Form5

2.Routine

3.14’s / As

per PRC

4.22/09/2010

Dy. No. 1708

Rs. 8000/-

(Original)

22-5-2013

Rs.12,000/-

(Not

attached)


(TORRENT

PHARMS LTD)

Approved.

Reference will be

sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan. If

confirmed, then

Chairman, RB will

permit issuance of


140. -do- 1.Amlotel

2.Tablet

3.Each tablet

contains:

Telmisartan…

…….40mg

Amlodipine…

………10mg

4.antihyperten

sive

1.Form5

2.Routine

3.14’s / As

per PRC

4.22/09/2010

Dy. No. 1710

Rs. 8000/-

(Original)

22-5-2013

Rs.12,000/-

(Not

attached)


(TORRENT

PHARMS LTD)

Approved.

Reference will be

sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan. If

confirmed, then

Chairman, RB will

permit issuance of


141. -do- 1.Amlotel

2.Tablet

3.Each tablet

contains:

Telmisartan…

…………….8

0mg

Amlodipine…

…………..….

10mg

4.antihyperten

sive

1.Form5

2.Routine

3.14’s / As

per PRC

4.22/09/2010

Dy. No. 1707

Rs. 8000/-

(Original)

22-5-2013

Rs.12,000/-

(Not

attached)

Me too status

confirmed

FDA: Generic

(TORRENT

PHARMS LTD)

Approved.

Reference will be

sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan. If

confirmed, then

Chairman, RB will

permit issuance of


112

142. -do- 1.Prophed

2.Suspension

3.Each 5ml

contains:

Ibuprofen.100

mg

Pseudoephedri

ne

HCI……15mg

4.Pain reliever

/fever reducer

nasal

decongestant)

1.Form5

2.Routine

3. 60ml/As

per PRC

4.22/09/2010

Dy. No. 1711

Rs. 8000/-

(Original)

22-5-2013

Rs.12,000/-

(Not

attached)

Rovinac of Rock

pharmaceutical

Int. avail not

confirmed in Str

DRAs.

Psychotropic

precursor

(For

Psychotropic

Precursors,

there is no

requirement

for dedicated /

separate

manufacturing

facility)

Deferred for

confirmation of



Agencies.

Reference will be

sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan.

143. M/s Nabiqasim

Industries Pvt

Ltd. 17/24,

Korangi

industrial Area,

Karachi.

1.Qutex

2.Tablet

3.Each film

coated tablet

contains:

Quetiapine

fumarate eq to

quetiapine.100

mg

4.anti

psychotic,

dibenzothiaze

pine)

Specs:

NabiQasim

1.Form5

2.Routine

3. 10’s, 30’s/

As per PRC

4.16/09/2010

Dy. No. 1699

Rs. 8000/-

(Original)

14-5-2013

Rs.12,000/-

(Photo copy)

Me too status

confirmed

FDA: Generic

(DR. REDDYS

LABS LTD)

Approved.

Reference will be

sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan. If

confirmed, then

Chairman, RB will

permit issuance of


144. -do- 1.Bepcor

2.Tablet

3.Each film

coated tablet

contains:

Bosentan (as

monohydrate)

…………...12

5mg

4.Pulmonary

arterial

hypertension)

(PAH),

systemic

sclerosis with

ongoing

digital ulcer

disease

1.Form5D

2.Routine

3. Rs.

30,000/10’s

4.16/09/2010

Dy. No. 1690

Rs. 15000/-

(Original)

14-5-2013

Rs.5000/-

(Photo copy)

1. It is a me too

2. At the time of

filing application,

the drug was new.

The firm submitted

Form 5-D with fee

Rs. 15,000/-. Now

the drug has

become registered.

The firm has

submitted the from

5.

FDA: Tracleer Approved.

Reference will be

sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan. If

confirmed, then

Chairman, RB will

permit issuance of


113

Specs:

NabiQasim

145. -do- 1.Qrist

2.Tablets

3.Each

extended

release tablet

contains:

Desvenlafaxin

e succinate eq

to

desvenlafaxine

……….50mg

4.Antidepressa

nt

Specs:

NabiQasim

1. Form 5

2.Routine

3. 10’s, 14’s,

/

As per PRC

4.16/09/2010

Dy. No. 1689

Rs. 8000/-

(Original)

14-5-2013

Rs.12,000/-

(Photo copy)

1.Me too status

confirmed

Denla XR

50mg&100mg of

M/s Semos

Pharma,

(Reg.No.070433&0

70434)

2.The firm has

submitted the

undertaking

regarding

submission of

comparative

dissolution profile

before marketing of

the product

FDA : Khedezla Approved.

Reference will be

sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan. If

confirmed, then

Chairman, RB will

permit issuance of


146. -do- 1.Qrist

2.Tablets

3.Each

extended

release tablet

contains:

Desvenlafaxin

e succinate eq

to

desvenlafaxine

………..….10

0mg

4.antidepressa

nt

Specs:

NabiQasim

1. Form 5

2.Routine

3.

10’s,14’s/As

per PRC

4.16/09/2010

Dy. No. 1693

Rs. 8000/-

(Original)

14-5-2013

Rs.12,000/-

(Photo copy)

1.Me too status

confirmed

Denla XR

50mg&100mg of

M/s Semos

Pharma,

(Reg.No.070433&0

70434)

2.The firm has

submitted the

undertaking

regarding

submission of

comparative

dissolution profile

before marketing of

the product

FDA: Kheedezla Approved.

Reference will be

sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan. If

confirmed, then

Chairman, RB will

permit issuance of


147. -do- 1.Qutex

2.Tablet

3.Each film

coated tablet

contains:

Quetiapine

fumarate eq to

quetiapine..25

mg

4.anti

psychotic,

dibenzothiaze

1. Form 5

2.Routine

3.

10’s,30’s/As

per PRC

4.16/09/2010

Dy. No. 1698

Rs. 8000/-

(Original)

14-5-2013

Rs.12,000/-

(Photo copy)

Me too status

confirmed

FDA: Seroquel Approved.

Reference will be

sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan. If

confirmed, then

Chairman, RB will

permit issuance of


114

pine

Specs:

NabiQasim

148. -do-

1.Qutex

2.Tablet

3.Each film

coated tablet

contains:

Quetiapine

fumarate eq to

quetiapine.200

mg

4.anti

psychotic,

dibenzothiaze

pine

Specs:

NabiQasim

1. Form 5

2.Routine

3. 10’s, 30’s /

As per PRC

4.16/09/2010

Dy. No. 1695

Rs. 8000/-

(Original)

14-5-2013

Rs.12,000/-

(Photo copy)

Me too status

confirmed

FDA: Seroquel Approved.

Reference will be

sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan. If

confirmed, then

Chairman, RB will

permit issuance of


149. -do- 1.Bepcor

2.Tablet

3.Each film

coated tablet

contains:

Bosentan (as

monohydrate)

……..62.5mg

4.Pulmonary

arterial

hypertension

(PAH)

Specs:

NabiQasim

1. Form 5

2.Routine

3. Rs.

19000/10’s

4.16/09/2010

Dy. No. 1696

Rs. 15000/-

(Original)

14-5-2013

Rs.5000/-

(Photo copy)

1. It is a me too.

2. The firm has

now submitted

form 5.

FDA: Tracleer Approved.

Reference will be

sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan. If

confirmed, then

Chairman, RB will

permit issuance of


Registration-V

115

150. M/s Care

Pharmaceuticals,

8Km, Thokor

Raiwind Road,

Lahore

1.Sinocare

2.Cream

3.Each gm

contains:

Fluocinolone

acetonide..2.5

mg

4.Corticosteroi

d

1.Form5

2.Routine

3.Rs.50/15g

m,

Rs.90/30gm

4.30-09-2010

Dy.No.4032

Rs.8000/-

Rs.12,000/-

13-5-2013

Reply has been

received.

FDA: Generic

(Taro)

Deferred for

confirmation of

steroidal section.

151. -do- 1.Fusidcare

2.Cream

3.Each gm

contains:

Fusidic Acid

(2%)…….20

mg

4.Antibacterial

1.Form5

2.Routine

3.Rs.65/5gn,

Rs.165/15gm

4.30-09-2010

Dy.No.4033

Rs.8000/-

15-05-2013

Rs.12,000/-

Reply is still

awaited.

The firm was

communicated

twice. They have

stated that they are

no more interested

in the product

registration.

BNF: Fucidin

(Leo)

Last reminder will be

issued to the firm for

rectification opf

shortcomings.

152. -do- 1.Clomezole

2.Cream

3.Each gm

contains:

Clotrimazole

………….10

mg

4.Antifungal

1.Form5

2.Routine

3.

Rs.41/10gn,

Rs.70/20gm

4.30-09-2010

Dy.No.4029

Rs.8000/-

15-05-2013

Rs.12,000/-

Reply is still

awaited.

The firm was

communicated

twice. They have

stated that they are

no more interested

in the product

registration.

FDA: Generic

(Taro)

Last reminder will be

issued to the firm for

rectification opf

shortcomings.

153. M/s CCL

Pharmaceuticals,

Pvt. Ltd.

62-Industrial

Estate, Kot

Lakhpat, Lahore

1.Cip

2.Suspension

3.Each 5ml

contains:

Ciprofloxacin

hydrochloride

eq. to

ciprofloxacin

…..................1

25mg

4.Antibiotic.

1.Form5

2.Routine

3.60ml/ Price

not

mentioned

4.06-09-2010

Rs.8000/-

(Photo copy)

20-05-2013

20-05-2013

Rs.12,000/-

(Original)

FDA: Cipro

(Different

formulation)

The originator’s

(M/s Bayer)

formulation

contains

ciprofloxacin in

base form,

however the

firm has

submitted that a

number of

products in

Pakistan are

registered in

which

ciprofloxacin is

Deferred for review

of formulation by

Review Committee.

116

present in HCl

form. The firm

has also

provided

labeling and

outer packaging

of Novidate

(product of Sami

pharmaceuticals,

Karachi) which

confirms the

stance of the

firm.

154. M/s Schazoo

Pharmaceuticals

Laboraories Pvt.

Ltd. Kaolawala

Stop, 20, KM

Jaranwala Road,

District

Shehikhupura.

1.Cavrex

2.Tablet

3.Each film

coated tablet

contains:

Entecavir as

monohydrate

(M.S)……1

mg

4.Anti viral.

1.Form5

2.Routine

3.Rs.15,000/

30’s

4.24-09-2010

Rs.8000/-

(Original)

28-05-2013

Rs.12,000/-

(Original)

Tacavair of M/s

Consolidated

chemical Lab.

FDA: Baraclude

Me too status

confirmed

Approved.

155. -do- 1.Ceretek

2.Injection

3.Each 1ml

contains:

Haloperidol as

lactate…5mg

4.Anti

Psychotic

1.Form5

2.Routine

3.Rs.300/(2x

5) 1ml

Ampoule

4.24-09-2010

Rs.8000/-

(Original)

28-05-2013

Rs.12,000/-

(Original)

FDA: Generic

(Sagent Pharms)

Me too status

confirmed

Deferred for

confirmation of

installation and

operational

qualification of TOC

analyser & Liquid

Particle Counter by

area FID.

156. -do- 1.Ceretek

2.Tablet

3.Each tablet

contains:

Haloperidol

Usp……….20

mg

4. Anti

Psychotic

1.Form5D

2.Routine

3.Rs.300/3x1

0’s

4.24-09-2010

Rs.8000/-

(Original)

28-05-2013

Rs.12,000/-

(Original)

1. It is new drug.

2. Differential fee

of Rs. 30,000/- is

required to be

deposited by the

applicant.

FDA: Generic

(Sandoz)

The firm has

been asked for

submission of

fee. Her

responses still

awaited.

Deferred for

submission of

differential fee,

assessment of

stability studies &

opinion by the

experts.

Registration – II

117

157. M/s Genix

Pharma (Pvt.)

Ltd;

44, 45-B,

Korangi Creek

Road,

Karachi

Diphos Dry

Suspension

Each 5ml

contains:

Dihydroartemi

sinin………15

mg

Piperaquine

Phosphate…

…...…120mg

1.Form5

2.Routine

3. 30 ml Rs.

250/-

60 ml Rs.

500/-

80 ml Rs.

667/-

4.14-09-2010

5.Dy. No.72

Rs.8,000/-

Rs.12,000/-

21-05-2013

Me too confirmed Int. avail not

confirmed in

Stringent DRAs.

The firm has

submitted

reference of Me

too as Poart

susp. of Neutro

pharma (62770)

Deferred for views

of recommendations

of WHO.

158. -do- Diphos DS

Sachet

30/240mg

Each Sachet

contains:

Dihydroartemi

sinin

(Ph.I)….30mg

Piperaquine

Phosphate

Anhydrous…

….….. 240mg

1.Form5

2. Routine

3. per sachet

Rs. 45/-

10’s Rs.450/-

16’s Rs.

720/-

4.14-09-2010

5.Dy. No.64

Rs.8,000/-

Rs.12,000/-

(21-5-2013)

1. Me too status

needs confirmation

Int. avail not

confirmed in Str

DRAs.

Deferred for views

of recommendations

of WHO.

159. -do- 1.Diphos

2. Syrup

3.Each 5ml

contains:

Dihydroartemi

sinin……..15

mg

Piperaquin

Phosphate

………120mg

4.Anti

Malarial

1.Form5-D

2. Routine

3. 30 ml Rs.

250/-

60 ml Rs.

500/-

80 ml Rs.

667/-

4.14-09-2010

Dy. No.73

Rs.8,000/-

Rs.12,000/-

(21-5-2013)

1. Me too status

needs confirmation

Int. avail not

confirmed in Str

DRAs.

Deferred for views

of recommendations

of WHO.

118

160. -do- 1.Diapil

2.Tabs

3.Each film

coated tablet

contains:

Saxagliptin

HCl e.q to

Saxagliptin…

…….…5mg

4.Anti Diabetc

1.Form5D

2.Routine

3. Rs.

4500/10’s

Rs. 9000/20’s

Rs.

13500/30’s

4.14/09/2010

Dy. No. 1684

Rs. 15000/-

Rs.12,000/-

21-5-2013

Gliplyza 5mg

Tablet, Regn

no.076316, M/s

Macter int, Karachi

FDA: Onglyza Approved

161. -do- 1.Diapil

2.Tablet

3.Each film

coated tablet

contains:

Saxagliptin

HCl e.q to

Saxagliptin…

……..……2.5

mg

4. Anti

Diabetc

1.Form5D

2.Routine

3. Rs.

2500/10’s

Rs. 5000/20’s

Rs. 7500/30’s

4.14/09/2010

Dy. No. 1681

Rs. 15000/-

Rs.12,000/-

21-5-2013

Gliplyza 2.5mg

Tablet, Regn

no.076316, M/s

Macter int,

Karachi.

FDA: Onglyza Approved

162. -do- 1.Diphos DS

2.Tablet

3.Each Tablet

contains:

Dihydroartemi

sinin

(Ph.I)…….80

mg

Piperaquine

Phosphate

(M.S) 640mg

4.Anti

Malarial

1.Form-5 D

2.Routine

3. Rs.800/8’s

4.14/09/2010

Dy. No. 67

(Moh)

Rs. 8000/-

Rs.12,000/-

21-5-2013

Me too status needs

confirmation.

Int. avail not

confirmed in Str

DRAs.

Deferred for views

of recommendations

of WHO.

163. -do- 1.Diphos DS

2.Suspension

3.Each 5ml

contains:

Dihydroartemi

sinin

1.Form-5

2.Routine

3. Rs.

450/10’s

Rs. 720/16’s

4.16/09/2010

Me too status needs

confirmation.

Int. avail not

confirmed in Str

DRAs.

Deferred for views

of recommendations

of WHO.

119

(PhI)….30mg

Piperaquine

Phosphate

Anhydrous…

……..…240m

g

4.Anti

Malarial

Dy. No. 69

(Moh)

Rs. 8000/-

Rs.12,000/-

21-5-2013

164. M/s Noa Hemis

Pharmaceuticals,

Plot No. 154,

Sector-23, Korangi

Industrial Area,

Karachi-74900

Loxicam 4mg

Tablet

Each film coated

tablet contains:

Lornoxicam

…………4 mg

(NSAID)

(Manufacturer’s

Spec.s)

Form-5

30-7-2010

Dy.No.1507

Rs.8000/-+Rs.

12000/- (10-05-

13)

Rs.1200/-/10’s

The formulation

found to be EMA

approved but

appeared as not

confirmed in the

agenda erroneously.

Xefast (Pharmevo)

Good (09-06-2014)

2. Verification of

photocopy of fee

of Rs. 8000/- is

required.

3. International

availability in

stringent DRA,s

not confirmed.

Approved (as found

approved by EMA).

Reference will be sent

to B & A Division,

DRAP for verification

of photocopy of fee


then Chairman, RB



165. -do- Loxicam-DS 8mg

Tablet

Each film coated

tablet contains:

Lornoxicam

…………8 mg

(NSAID)

(Manufacturer’s

Spec.s)

Form-5

30-7-2010

Dy.No.1505

Rs.8000/-

+Rs. 12000/-

(10-05-13)

Rs.2300/-/10’s

The formulation

found to be EMA

approved but

appeared as not

confirmed in the

agenda erroneously.

Xefast (Pharmevo)

Good (09-06-2014)

1. Verification of

photocopy of fee

of Rs. 8000/- is

required.

2. International

Approved (as found

approved by EMA).

Reference will be sent

to B & A Division,

DRAP for verification

of photocopy of fee


then Chairman, RB



120

availability in

stringent DRA,s

not confirmed.

166. -do- Resipa 1mg Tablet

Each film coated

tablet contains:

Risperidone …1

mg

(Antipsychotic)

(Manufacturer’s

Spec.s)

Form-5

30-7-2010

Dy.No.1500

Rs.8000/-+Rs.

12000/- (14-05-

13)

As per PRC

BNF : Risperdal

(Janssen)

Risperdal

(Janssen)

Good (09-06-2014)

1. Verification of

photocopy of fee

of Rs. 8000/- is

required.

Approved. Reference


Division, DRAP for

verification of

photocopy of fee


then Chairman, RB




Each film coated

tablet contains:

Risperidone…2 mg

(Antipsychotic)

(Manufacturer’s

Spec.s)

Form-5

30-7-2010

Dy.No.1509

Rs.8000/-+Rs.

12000/- (14-05-

13)

As per PRC

BNF : Risperdal

(Janssen)

Risperdal

(Janssen)

Good (09-06-2014)

1. Verification of

photocopy of fee

of Rs. 8000/- is

required.

Approved Reference


Division, DRAP for

verification of

photocopy of fee


then Chairman, RB




Each film coated

tablet contains:

Risperidone ...3 mg

(Antipsychotic)

(Manufacturer’s

Spec.s)

Form-5

30-7-2010

Dy.No.1503

Rs.8000/-+Rs.

12000/- (14-05-

13)

As per PRC

BNF : Risperdal

(Janssen)

Risperdal

(Janssen)

Good (09-06-2014)

1. Verification of

photocopy of fee

of Rs. 8000/- is

required.

Approved Reference


Division, DRAP for

verification of

photocopy of fee


then Chairman, RB



121

169. -do- Gasiton 50mg

Tablet

Each tablet

contains:

Itopride

Hydrochloride……

…….50 mg

(Gastroprokinetic)

(Manufacturer’s

Spec.s)

Form-5

30-7-2010

Dy.No.1508

Rs.8000/-+Rs.

12000/- (10-05-

13)

As per PRC

Not confirmed

GANATON

(ABBOTT)

Good (09-06-2014)

1. Verification of

photocopy of fee

of Rs. 8000/- is

required.

2. International

availability in

stringent DRA,s

not confirmed.

3. Formulation is

under review by

the review

committee.

Deferred for review

of formulation by

Review Committee.

170. -do- Etecav 0.5 mg

Tablet

Each film coated

tablet contains:

Entecavir (as

monohydrate)……

……...0.5 mg

(Anti Viral)

(Manufacturer’s

Spec.s)

Form-5

30-7-2010

Dy.No.1506

Rs.8000/-+Rs.

12000/- (10-05-

13)

As per PRC

BNF : Baraclude

(Bristol-Myers

Squibb)

Centauru S

(Ferozsons)

Good (09-06-2014)

1. Verification of

photocopy of fee

of Rs. 8000/- is

required.

2. Amount of active

drug is very less

(500mcg), may be

considered for

Product specific

inspection.

Deferred for product


panel comprising of

Director DTL Karachi,

DDG (E & M) & area

FID.

171. -do- Proxat 20mg Tablet

Each film coated

tablet contains:

Paroxetine (as

Form-5

30-7-2010

Dy.No.1504

Rs.8000/-+Rs.

BNF : Seroxat (GSK)

Seroxat (GSK)

Good (09-06-2014)

Approved. Reference


Division, DRAP for

verification of

photocopy of fee


122

HCl)…..…20 mg

(Antidepressant,

selective serotonin

reuptake inhibitor)

(B.P Spec.s)

12000/- (10-05-

13)

As per PRC

1. Verification of

photocopy of fee

of Rs. 8000/- is

required.

then Chairman, RB



172. -do- Muscolex 4mg

Capsule

Each capsule

contains:

Thiocolchicoside…

…..4 mg

(Muscle relaxant)

(Manufacturer’s

Spec.s)

Form-5

30-7-2010

Dy.No.1502

Rs.8000/-+Rs.

12000/- (10-05-

13)

As per PRC

Not confirmed

Muscoril (Searle)

Good (09-06-2014)

1. Verification of

photocopy of fee

of Rs. 8000/- is

required.

2. International

availability in

stringent DRA,s

not confirmed.

3. Formulation is

under review by

the review

committee.

Deferred for review of

formulation by

Review Committee.

173. -do- Gabagyl 200mg

Capsule

Each capsule

contains:

Gabapentin………

……...200 mg

(Anticonvulsant)

(Manufacturer’s

Spec.s)

Form-5

30-7-2010

Dy.No.1510

Rs.8000/-+Rs.

12000/- (10-05-

13)

As per PRC

Gebapentin in 200mg

strength Not found in

FDA & UK

Gabin of PharmEvo

Good (09-06-2014)

1. Verification of

photocopy of fee

of Rs. 8000/- is

required.

2. International

availability in

stringent DRA,s

not confirmed.

Deferred for

confirmation of


Stringeny Regulatory

Agencies.

174. -do- Zofen 0.25mg/5ml Form-5 BNF : Sanomigran Rejected on the

grounds that the

123

Syrup

Each 5ml contains:

Pizotifen( as

Hydrogen

Maleate)…………

………………..0.2

5 mg

(Appetite

stimulant)

(Manufacturer’s

Spec.s)

30-7-2010

Dy.No.1501

Rs.8000/-+Rs.

12000/- (10-05-

13)

As per PRC

(Novartis)

Not confirmed

Good (09-06-2014)

1. Verification of

photocopy of fee

of Rs. 8000/- is

required.

2. The firm has

applied the

formulation as

appetite stimulant

which is not

rational.

applicant applied the

formulation for wrong

pharmacological

indication.

124

2. Veterinary applications

S/N Name of

Applicant

Name of Drug(s) /

Composition

Price/Pack

Size

Shelf Life Date of

application

receiving.

Decision

175. M/s. Nawan

Laboratories

(Pvt) Ltd.,

Karachi.

Pameron Injection

Each ml contains:-

Methampyrone…

…………100mg

Chlorpheniramine

Maleate…..1mg

Caffeine……10mg

(Antipyretic and

Analgesic).

Decontrolled

10ml

50ml

100ml

2 years 24-12-2010

Rs.8000 + Rs.

12000 =

Rs.20,000/-


of installation and

operational qualification of

TOC analyser and Liquid

Particla Counter, Me-too

status & GMP status of the

firm.

176. M/s. Mallard

Pharmaceutic

als (Pvt) Ltd.,

Multan.

Shina Gold Drench

Each ml contains:-

Oxyclozanide……

….…..62.50mg

Oxfendazole……

…….…25mg

Cobalt

Sulphate…..2mg

Sodium

Selenite……0.5mg

(Anthelmentic).

Decontrolled

100ml

250ml

500ml

1000ml

2.5 Liter

2 years 15-12-2010

Rs.8000 + Rs.

12000 =

Rs.20,000/-

Deferred for name change,

Me-too & GMP status of

the firm.

177. M/s. Mallard

Pharmaceutic

als (Pvt) Ltd.,

Multan.

Shinazan Plus

Drench

Each ml contains:-

Oxyclozanide……

……...30mg

Levamisole

Decontrolled

100ml

150ml

250ml

500ml

2 years 15-12-2010

Rs.8000 + Rs.

12000 =

Rs.20,000/-



the firm.

125

HCI………...15mg

Cobalt

Sulphate………....

0.75mg

Sodium

Selenite……..…..0

.35mg

Vitamin

K……………....3

mg

(Anthelmentic).

1000ml

2.5 Liter

178. M/s. Mallard

Pharmaceutic

als (Pvt) Ltd.,

Multan.

Shina Fax Liquid

Each ml contains:-

Oxfendazole……

…..22.65mg

Zinc

Sulphate………2.6

mg

(Anthelmentic).

Decontrolled

100ml

250ml

450ml

500ml

1000ml

2.5 Liter

2 years 15-12-2010

Rs.8000 + Rs.

12000 =

Rs.20,000/-



the firm.

179. M/s. Mallard

Pharmaceutic

als (Pvt) Ltd.,

Multan.

Shina Zole 12.5%

SC Liquid

Each ml contains:-

Albendazole……

………..125mg

Sodium Selenite

………..1.67mg

Cobalt

Sulphate…………

0.50mg

(Anthelmentic).

Decontrolled

30ml

100ml

250ml

500ml

1000ml

2.5 Liter

2 years 15-12-2010

Rs.8000 + Rs.

12000 =

Rs.20,000/-



the firm.

126

180. M/s. Sanna

Laboratories,

Faisalabad.

Sanoxicam

Injection

Each ml contains:-

Meloxicam...7.5mg

(Analgesic).

Decontrolled

10ml

30ml

50ml

100ml

2 years 30-12-2010

Rs.8000 + Rs.

12000 =

Rs.20,000/-

Deferred for Me-too &

GMP status of the firm.

181. M/s. Sanna

Laboratories,

Faisalabad.

SCS-Forte

Injection

Each ml contains:-

Colistin

Sulphate……...1

MIU

(Polymyxin

Antibiotic).

Decontrolled

50ml

100ml

2 years 30-12-2010

Rs.8000 + Rs.

12000 =

Rs.20,000/-



182. M/s. Sanna

Laboratories,

Faisalabad.

Sanacol-50 Water

Soluble Powder

Each gram

contains:-

Colistin

Sulphate…….50,0

0,000 IU

(Polymyxin

Antibiotic).

Decontrolled

100gm

300gm

500gm

1 Kg

2 years 30-12-2010

Rs.8000 + Rs.

12000 =

Rs.20,000/-



183. M/s. Sanna

Laboratories,

Faisalabad.

ECS-150 Oral

Liquid

Each 100ml

contains:-

Enrofloxacin

…………10gm

Colistin

Sulphate…50,000,

000 IU

(Antibiotic).

Decontrolled

100ml

500ml

1 Liter

2 years 30-12-2010

Rs.8000 + Rs.

12000 =

Rs.20,000/-



127

Evaluator – I

S. N Name and

address of

Manufacturer /

Applicant

Brand Name

(Proprietary

name + Dosage

form + Strength)

Composition

Pharmacological

Group

Finished product

specification

Type of Form

Initial date,

diary.

Fee including

differential fee

Demanded

Price / Pack

size

International

status in

stringent

regulatory

agencies

Me-too status

GMP status as

depicted in

inspection

report (dated)

Remarks /

Observations

Decision

184. M/s Ray Pharma

(Pvt.) Ltd, S-58,

S.I.T.E.

Extension

Hawksbay

Road, Karachi

Raylox Tablet

Film Coated

Tablet

Each Film Coated

Tablet Contains.

Levofloxacin as

Hemihydrate

..........750mg

(Quinolone group

Antibacterial)

Manufacturers

Specifications

Form 5

10’s /Rs.299/-

Dy. No. Not

mentioned

(Duplicate

Dossier)

Dossier dated

29-06-2010

Rs.8000/- (17-

05-2010)

Dy. No. Not

mentioned

Rs.12,000/-

dated 26-09-

2013 (Fee

challans are

duplicate)

Total

Rs.20,000/-

LEVAQUIN

750mg Film

coated tablet

US FDA

LEFLOX

750mg

Getz

Inspection report

dated 06/05/2014

good level of

GMP compliance

reported.

Approved.

185. M/s Ray Pharma

(Pvt.) Ltd, S-58,

S.I.T.E.

Extension

Hawksbay

Road, Karachi

Rayart DS Tablet

Tablet

Each Tablet

Contains.

Artemether

Form 5

8’s /Rs.264/-

Dy. No. Not

mentioned

(Duplicate

ARTHEGET

40/240mg tablet

Getz

Inspection report

dated 06/05/2014

good level of

Approved

128

……….40mg

Lumefantrine……

.240mg

(Anti Malarial)

Manufacturers

Specifications

Dossier)

Dossier dated

29-06-2010

Rs.8000/- (17-

05-2010)

Dy. No. Not

mentioned

Rs.12,000/-

dated 26-09-

2013 (Fee

challans are

duplicate)

Total

Rs.20,000/-

GMP compliance

reported.

186. M/s Ray Pharma

(Pvt.) Ltd, S-58,

S.I.T.E.

Extension

Hawksbay

Road, Karachi

Rayart Tablet

Tablet

Each Tablet

Contains.

Artemether

……….80mg

Lumefantrine……

.480mg

(Anti Malarial)

Manufacturers

Specifications

Form 5

4’s /Rs.220/-

Dy. No. Not

mentioned

(Duplicate

Dossier)

Dossier dated

19-07-2010

Rs.8000/- (17-

05-2010)

Dy. No. Not

mentioned

Rs.12,000/-

dated 26-09-

2013 (Fee

challans are

duplicate)

Total

Rs.20,000/-

ARTHEGET

80/480mg tablet

Getz

Inspection report

dated 06/05/2014

good level of

GMP compliance

reported.

Approved.

187. M/s Ray Pharma

(Pvt.) Ltd, S-58,

S.I.T.E.

Extension

Rayaz Tablet

Tablet

Form 5

3’s /Rs.160/-

Dy. No. Not

ZITHROMAX

500mg tablets

US FDA

Approved.

129

Hawksbay

Road, Karachi

Each Film Coated

Tablet Contains.

Azithromycin as

dihydrate

………………….

500mg

(Macrolide

Antibiotic)

Manufacturers

Specifications

mentioned

(Duplicate

Dossier)

Dossier dated

29-06-2010

Rs.8000/- (17-

05-2010)

Dy. No. Not

mentioned

Rs.12,000/-

dated 26-09-

2013 (Fee

challans are

duplicate)

Total

Rs.20,000/-

AZOMAX

500mg tablet

Novartis

Inspection report

dated 06/05/2014

good level of

GMP compliance

reported.

188. M/s Macter

International

(Pvt.) Ltd. F-

216, S.I.T.E.,

Karachi

Micam

Tablet

Each film coated

tablet Contains:-

Lornoxicam

…..4mg

(Analgesic and

anti-

inflammatory)

Form 5

5’s and 10’s/As

Per PRC

Dy No 255 R&I

dated 23-07-

2010 Rs.8000/-

Rs.12,000/-

22-05-2013

VICTRA

4mg tablet

Scitech

Lornoxicam

4mg f/c tablet

EMA

Inspection report

dated 10-04-2014

considered to be

operating at

satisfactory level

of GMP.

Capsule section

mentioned in

inspection report.

Approved.

189. M/s Bosch

Pharmaceutical,

221, Bosch

House, Sector

23, Korangi

Industrial Area,

Karachi.

Falgan

500mg/50ml

Infusion

Each Vial

Contains.

Paracetamol

….(B.P)

500mg/50ml

Form 5-D

1,s /Rs.60/-

Dy

No.1386/R&I

dated 22-07-

2010/

Rs.15,000/-

PERFALGAN

10mg/ml (50ml

Vial)

MHRA

Injectable Liquid

section granted

vide letter No. F.

2-4/91-Lic (Vol-

II) (M-196).

Routine GMP

1. Copy of

cashiers’ cheque

amounting to

168,000/- (Rs.

12,000/- each for

14 products,

including Falgan

500mg/50ml).

However, the

cheque or the

covering is not

endorsed by STO

Deferred for

rectification of

following

shortcomings in the

dossier:

1. Copy of

cashiers’ cheque

amounting to

168,000/- (Rs.

12,000/- each for

14 products,

including Falgan

500mg/50ml). The

130

(Analgesics and

Antipyretics)

(Manufacturer’s

Specs)

Copy of cashiers

cheque

amounting to

168,000/- (Rs.

12,000/- each

for 14 products,

including Falgan

500mg/50ml).

However, the

cheque or the

covering is not

endorsed by

STO and is also

not the

prescribed fee

for Form-5D

applications.

inspection report

dated 12-08-2014

cGMP level rated

as good.

and is also not the

prescribed fee for

Form-5D

applications.

2. Pyrogen free

distilled water has

been mentioned in

the master

formulation

whereas, the

reference brand

contains WFI for

which evidence of

TOC analyzer and

liquid particle

counter is required.

However, firm has

provided copies of

operator’s manual

of particle counter

only, as evidence.

3. Stability

summary at 30 C

and 65% RH for

only one batch of

3,000/- vials

submitted.

cheque or the

covering is not

endorsed by STO

and is also not the

prescribed fee for

Form-5D

applications.

2. Pyrogen free

distilled water has

been mentioned in

the master

formulation

whereas, the

reference brand

contains WFI for

which evidence of

TOC analyzer and

liquid particle

counter is

required.

However, firm has

provided copies of

operator’s manual

of particle counter

only, as evidence.

Confirmation from

FID is required for

the Installational

& Operation

Qualification of

liquid particle

counter & TOC

analyzer.

3. Stability

summary at 30 C

and 65% RH for

only one batch of

3,000/- vials

submitted. Which

is required to be as

per WHO

guidelines.

190. M/s Pakistan

Pharmaceutical

Products (Pvt)

Ltd. D-122,

Sindh Industrial

Trading Estate,

Karachi

Pioglit 15mg +

2mg Tablet

Tablet

Each Tablet

Form 5

Dy. No. Not

mentioned / R&I

date not

mentioned

(Covering letter

Glibetic

15/2mg

ICI

Inspection report

dated 13-02-2013

Evidence of

approval of same

formulation by

stringent regulatory

authority e.g.,

FDA, TGA,

MHLW, EMA and

Deferred for

confirmation of

approval in

reference

Stringent

Regulatory

Agencies.

131

Contains.

Pioglitazone..

…..…. 15mg

Glimepiride..

…….. 2mg

(Anti-

Hyperglycemic)

dated

07/07/2010)

Rs.8000/-

(19/07/2010)

Rs.12,000/-

(15/05/2013) fee

challans are

duplicate

Total

Rs.20,000/-

14’s / Rs. 10 per

tablet

and 03-06-2014

considered to be

operating at

satisfactory level

of GMP.

Health Canada

required.

191. M/s Pakistan

Pharmaceutical

Products (Pvt)

Ltd. D-122,

Sindh Industrial

Trading Estate,

Karachi

Glitter 4mg Tablet

Tablet

Each Tablet

Contains.

Glimepiride ……..

4mg

(Anti-

Hyperglycemic)

Form 5

Dy. No Not

mentioned / R&I

dated not

mentioned

(Covering letter

dated

20/07/2010)

Rs.8000/-

(22/07/2010)

Rs.12,000/-

(15/05/2013)

fee challans are

duplicate

Total

Rs.20,000/-

20’s As per PRC

Amaryl

MHRA

Amaryl

Sanofi-Aventis

Inspection report

dated 13-02-2013

and 03-06-2014

considered to be

operating at

satisfactory level

of GMP.

Approved.

192. M/s Pakistan

Pharmaceutical

Products (Pvt)

Ltd. D-122,

Sindh Industrial

Trading Estate,

Karachi

Glitter 3mg Tablet

Tablet

Each Tablet

Contains.


Form 5

Dy. No. Not

mentioned / R&I

dated not

mentioned

(Dossier dated

20/07/2010)

Amaryl

MHRA

Amaryl

Sanofi-Aventis

Inspection report

Approved.

132

3mg

(Anti-

Hyperglycemic)

Rs.8000/-

(22/07/2010)

Rs.12,000/-

(15/05/2013)

fee challans are

duplicate

Total

Rs.20,000/-

20’s / As per

PRC

dated 13-02-2013

and 03-06-2014

considered to be

operating at

satisfactory level

of GMP.

193. M/s Pakistan

Pharmaceutical

Products (Pvt)

Ltd. D-122,

Sindh Industrial

Trading Estate,

Karachi

Glitter 2mg Tablet

Tablet

Each Tablet

Contains.


2mg

(Anti-

Hyperglycemic)

Form 5

Dy. No. Not

mentioned / R&I

dated not

mentioned

(Dossier dated

20/07/2010)

Rs.8000/-

(22/07/2010)

Rs.12,000/-

(15/05/2013)

fee challans are

duplicate

Total

Rs.20,000/-

20’s / As per

PRC

Amaryl

MHRA

Amaryl

Sanofi-Aventis

Inspection report

dated 13-02-2013

and 03-06-2014

considered to be

operating at

satisfactory level

of GMP.

Approved.

194. M/s Pakistan

Pharmaceutical

Products (Pvt)

Ltd. D-122,

Sindh Industrial

Trading Estate,

Karachi

Glitter 1mg Tablet

Tablet

Each Tablet

Contains.


1mg

(Anti-

Form 5

Dy. No. Not

mentioned / R&I

dated not

mentioned

(Dossier dated

20/07/2010)

Rs.8000/-

(22/07/2010)

Amaryl

MHRA

Amaryl

Sanofi-Aventis

Inspection report

dated 13-02-2013

and 03-06-2014

considered to be

operating at

satisfactory level

Approved.

133

Hyperglycemic) Rs.12,000/-

(15/05/2013)

fee challans are

duplicate

Total

Rs.20,000/-

20’s / As per

PRC

of GMP.

6. Routine drug registration applications

Evaluator – II

S.No Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary name +


Composition


Finished product

Specification

Type of Form

Initial date, diary

Fee including

differential fee

Demanded Price /

Pack size

Remarks on the


including

International status in

stringent drug


authorities

Me-too status

GMP status as

depicted in latest

inspection report

(with date) by the

Evaluator

Decision

195. M/s Macter

International

(Pvt) Ltd. F-216,

S.I.T.E, Karachi.

Affient 5mg Tablet Each film coated tablet

contains: Prasugrel HCl eq. to Prasugrel…………….5

mg (Inhibitor of platelet activation and

aggregation)


Form 5

05‐7‐2010(54)

Rs.15000/‐ 22‐5‐2013

Rs.5,000/‐

Rs. 8.42/Tab

Rs. 118/14’s

Rs.236/28’s

BNF: Efient(Lilly)

Prasu (Amson)

Satisfactory level of

GMP compliance. (10-

04-14)

1. Verification of

photocopy of

differential fee (Rs.

5000/-) paid is

required.

2. The Firm had

applied on Form 5-

D initially but has

Approved.

Reference will be

sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan. If

confirmed, then

Chairman, RB will

permit issuance of


134

now submitted

Form 5.

3. Approval of section

/ manufacturing

facility of applied

drug from licensing

section is required.

The Firm has

submitted GMP

insp. Report dated

10-04-14 which

mentions Tablet

(General) Section.

196. -do- Affient 10mg Tablet Each film coated tablet

contains: Prasugrel HCl eq. to Prasugrel…………….10

mg (Inhibitor of platelet activation and

aggregation)


Form 5

05‐7‐2010(46)

Rs.15000/‐ 22‐5‐2013

Rs.5,000/‐

Rs. 14/Tab

Rs. 96/14’s

Rs.392/28’s

BNF: Efient(Lilly)

Prasu (Amson)



04-14)

1. Verification of

photocopy of

differential fee (Rs.

5000/-) paid is

required.

2. The Firm had

applied on Form 5-

D initially but has

now submitted

Form 5.

Approved.

Reference will be

sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan. If

confirmed, then

Chairman, RB will

permit issuance of


197. -do- Tamsyl Tablets Each Tablet contains: Etamsylate (B.P)….250mg (Antifibrinolytic, synthetic antihaemorrhagic and angioprotective) (Manufacturer’s Spec.s)

Form 5

05‐7‐2010(N/A)

Rs.15000/‐ 22‐5‐2013

Rs.5,000/‐

Rs. 7.5/Tab

Rs. 75/10’s

Rs.150/20’s

Not confirmed

Not confirmed



04-14)

1. Verification of

photocopies of fee

(Rs. 15000/- + Rs.

5000/-) paid is

required.

2. The Firm had

applied on Form 5-

Deferred for

confirmation of me

too status &



Agencies.

Reference will be

sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan.

135

D initially but has

now submitted

Form 5.

3. International

availability not

confirmed in same

strength.

4. Me-too status given

as Dicynone of

French

Pharmaceuticals

Group (Reg. No.

004229) needs

confirmation.

198. -do- Tamsyl Tablets Each Tablet contains: Etamsylate (B.P)….500mg (Antifibrinolytic, synthetic antihaemorrhagic and angioprotective) (Manufacturer’s Spec.s)

Form 5

05‐7‐2010(N/A)

Rs.15000/‐ 22‐5‐2013

Rs.5,000/‐

Rs. 15/Tab

Rs. 150/10’s

Rs.300/20’s

BNF: Dicynene

(Sanofi-Aventis)

Cytoplex of M/s AGP

Reg. No. 061420

(Me too status appeared

in agenda as not

confirmed erroneously)



04-14)

1. Verification of

photocopies of fee

(Rs. 15000/- + Rs.

5000/-) paid is

required.

2. The Firm had

applied on Form 5-

D initially but has

now submitted

Form 5.

Deferred for

confirmation of me

too status. Reference

will be sent to B &

A Division, DRAP

for verification of

photocopy of fee

challan.

199. -do- Valsitan Tablets Each film coated tablet

contains: Amlodipine (as besilate)…5mg Valsartan….160mg (Calcium Antagonist) (Manufacturer’s Spec.s)

Form 5

06‐7‐2010(N/A)

Rs.8000/‐ 22‐5‐2013 Rs.12,000/‐

AS per PRC

BNF: Exforge

(Novartis)

Exforge

(Novartis)



04-14)

Approved.

Reference will be

sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan. If

confirmed, then

Chairman, RB will

136

1. Verification of

photocopies of fee

(Rs. 8000/- + Rs.

12000/-) paid is

required.

permit issuance of


200. -do- Valsitan Plus Tablets Each tablet contains: Amlodipine (as besilate)…10mg Valsartan….160mg (Calcium Antagonist) (Manufacturer’s Spec.s)

Form 5

06‐7‐2010(N/A)

Rs.8000/‐ 22‐5‐2013 Rs.12,000/‐

AS per PRC

BNF: Exforge

(Novartis)

Exforge

(Novartis)



04-14)

1. Verification of

photocopies of fee

(Rs. 8000/- + Rs.

12000/-) paid is

required.

Approved with

change in brand

name. Reference wil

be sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan. If

confirmed, then

Chairman, RB will

permit issuance of


201. -do- Alozin Tablets Each film coated extended release tablet contains: Ranolazine…1000mg

(anti‐ischemic And

antianginal) (Manufacturer’s Spec.s)

Form 5

06‐7‐2010(N/A)

Rs.8000/‐ 22‐5‐2013 Rs.12,000/‐

AS per PRC

FDA: Ranexa (Gilead)

Ranola (Highnoon)



04-14)

1. Verification of

photocopies of fee

(Rs. 8000/- + Rs.

12000/-) paid is

required.

Approved.

Reference will be

sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan. If

confirmed, then

Chairman, RB will

permit issuance of


202. -do- Tamsyl 2ml Injection Each 2ml ampoule

contains: Etamsylate……….250 mg (Antifibrinolytic synthetic antihaemorrhagic and angioprotective) (Manufacturer’s Spec.s)

Form 5-D

06‐7‐2010(N/A)

Rs.15,000/‐ 22‐5‐2013 Rs.5,000/‐

AS per PRC/4’s,

100’s

Not confirmed

Cytoplex of M/s AGP

Reg. No. 061419

(Me too status appeared

in agenda as not

confirmed at that time)



04-14)

1. Verification of

Deferred for

confirmation of

followings:

1. Installation and

performance

qualifications of

TOC analyser &

Liquid Particle

Counter by area FID.

2. Approval in

reference Stringent

Regulatory

Agencies.

137

photocopies of fee

(Rs. 15000/- + Rs.

5000/-) paid is

required.

2. The Firm had

applied on Form 5-

D initially but has

now submitted

Form 5.


/ manufacturing

facility of applied

drug from licensing


The Firm has

submitted GMP

insp. Report dated

10-04-14 which

mentions Sterile

Products (Liquid

injections,

Opthalmic/Otic

drops).

4. International

availability not

confirmed.

5. Verification of

Total Organic

Testing Facility is

required.

Reference will be

sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan.

203. M/s. WelMark

Pharmaceuticals

Plot # 122,

Block-B, Phase-

V Industrial

Estate Hattar.

Rismek 3mg Tablets


contains:-

Risperidone(USP)….3mg

(Antipsychotic)

(USP Spec.s)

Form 5

12-07-2010 (17)

Rs.8,000/

+Rs. 12000 (09-

05-2013)

As Per PRC

BNF. Risperdal

(Janssen)

Benzisox (Highnoon)

No conclusion of

inspection report,

recommendations of

some corrections (24-

05-14 routine GMP

inspection)

The Board considered

the above inspection

Approved.

138

report & satisfied with

the same.

204. -do- Welfam 40mg Tablets


Famotidine (USP)…40mg

(H2 receptor Blocker,

Antipeptic ulcerate)

(USP Spec.s)

Form 5

12-07-2010 (16)

Rs.8,000/

+Rs. 12000 (09-

05-2013)

As Per PRC/10’s

BNF: Famotidine (Non-

proprietary)

Acicon (Barrett

Hodgson)

No conclusion of

inspection report,

recommendations of

some corrections (24-

05-14 routine GMP

inspection)




the same.

1. BNF describes the

product as uncoated

while the Firm has

applied for the film

coated formulation.

Approved in

uncoated Tablets.

205. M/s Atco

Laboratories

Limited B-18,

S.I.T.E, Karachi.

Combinol-D Sugar Free

Syrup

Each 5ml contains:-

Dextromethorphan

Hydrobromide

(B.P)…10mg

Ephedrine Hydrochloride

(B.P)…7.5mg

Chlorphenamine Maleate

(B.P)…4mg

Terpin Hydrate (USP)…

3.5 mg

Ammonium Chloride

(B.P)…90mg

(Bronchodilator)


Form 5

06-07-2010

Rs.8,000/ (N/A)

+Rs. 12000 (22-

05-2013)

Rs. 38/- Per 120ml

bottle

Not confirmed

Combinol-D Syrup

(Atco Laboratories)

Good level of GMP

(18-06-2014)

1. Verification of

photocopies of fee

(Rs. 8000/- + Rs.

12000/-) paid is

required.


/ manufacturing

facility of applied

drug from licensing

section was asked.

The Firm has

submitted GMP

Deferred for review

of formulation by

Review Committee.

139

insp. Report dated

18-06-14 which

mentions Oral

Liquid

(Syrup/Suspension)

section Non

Antibiotic.

3. International

availability of

formulation in

SRA’s not

confirmed.

4. Formulation

contains Ephedrine

Hydrochloride, a

controlled drug

substance.

206. M/s Nenza

Pharmaceuticals,

33 A Industrial

Estate

Hayatabad

Peshawar

NenKast 5mg Tablets

Each Chewable Tablet

contains:-

Montulekast Sodium

Equivalent to

Montelukast(B.P)…5mg

(Antiasthmatic)


Form 5

16-07-2010

Rs.8,000/ (80)

+Rs. 12000 (23-

05-2013)

As Per SRO/- 14’s

BNF: Singulair (MSD)

Montiget (Getz)

No conclusion

regarding GMP of the

Firm, some minor

observations at which

the management was

agreed to rectify.

(routine GMP 10-04-

2014)




the same.

Approved.

207. -do- Nenmether DS Tablets

Each Tablet contains:-

Artemether…40mg

Lumefantrine…240mg

(Antimalarial)

(USP Salmous Spec.s)

Form 5

16-07-2010

Rs.8,000/ (79)

+Rs. 12000 (23-

05-2013)

As Per SRO/- 8’s

WHO approved

formulation

A-Fantrine 40/240 by

M/s Atco

No conclusion


Firm, some minor


the management was

agreed to rectify.

Approved.

140

(routine GMP 10-04-

2014)




the same.

208. M/s PharmEvo

(Private Limited

Plot #A-29,

North West

Industrial Zone,

Port Qasim,

Karachi-75020

Evorox 1.5g Injection

(Powder for reconstitution)

Each Vial contains:-

Cefuroxime Sodium

equivalent to Cefuroxime

(USP) …1.5g

(Antibiotic)

(USP Spec.s)

Form 5

06-07-2010, Rs.

8000/- + Rs.

12,000 (22-05-

2013)

As per PRC

BNF: Zinacef (GSK)

Zecef (Bosch)

Good, GMP compliance

(01-04-14) Provincial

Drug Inspector.

The firm later on

submitted inspection

report dated 20.03.2013

conducted by DRAP.




the same.

1. Verification of

copies of fee

challans is required.

2. Evidence of

approval of

technical staff from

licensing section is

required.

(The firm

provided the

technical staff

approval but

missed

erroneously in

agenda).

3. Firm has submitted

inspection report of

provincial drug

inspector and has

informed that they

will submitt latest


FID when

Approved.

Reference will be

sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan. If

confirmed, then

Chairman, RB will

permit issuance of


141

inspection report

would be received.

209. M/s Maple

Pharmaceuticals

(Pvt.) Ltd.,

147/23, Korangi

Industrial Area,

Karachi.

Defrinac Plus Tablets


contains:-

Dexibuprofen

(M.S)…300mg

Pseudoephidrine

Hydrochloride(B.P)…60mg

(NSAID+Decongestant)


Form 5-D

01-07-

2010(11)Rs.8,000/-

+Rs. 12,000 (25-

07-2013)+Rs.

30,000/- (01-12-

2014)

Rs. As per PRC

/3×10’s

Form 5-D

Overall cGMP


in the Firm (31-03-

2014)

1. The Firm had

applied on Form 5,

but after evaluation

the Firm has

deposited

differential fee for

application on Form

5-D. Form 5-D is

incorrect.

2. Verification of fee

of Rs. 12000/- is

required.

3. Formulation

contains controlled

drug substance.

Deferred for last

reminder for

correction in form 5-

D alongwith stability

studies. Reference

will be sent to B &

A Division, DRAP

for verification of

photocopy of fee

challan.

210. -do- Fastofen Tablets


contains:-

Ibuprofen lysinate…342mg

(NSAID)


Form-5

05-07-

2010(44)Rs.8,000/-

+Rs. 12,000 (14-

05-2013) Rs.

30,000/- (01-12-

2014)

Rs. As per PAC

/30’s

Form 5-D

Overall cGMP


in the Firm (31-03-

2014)

1. The Firm had

applied on Form 5,

but after evaluation

the Firm has

deposited

differential fee for

application on Form

5-D. Form 5-D is

incorrect.

2. Verification of fee

of Rs. 12000/- is

required.

Deferred for last

reminder for

correction in form 5-

D alongwith stability

studies. Reference

will be sent to B &

A Division, DRAP

for verification of

photocopy of fee

challan.

211. M/s Nabiqasim Misocot 50 mg Tablets Form 5 BNF: Arthrotec Deferred for Product

142

Industries (Pvt)

Ltd. 17/24,

Korangi

Industrial Area,

Karachi.


Diclofenac Sodium

(B.P)…50mg

Misoprostol…200mcg

(NSAIDs)


01/07/10(Nil)

Rs.8000/-

+Rs.12000/-

(14/05/13)

As per PRC

/10’s,20’s

(Pharmacia)

Arthrotec (Pfizer)

Good GMP compliance

(18-12-13)

1. Verification of

photocopies of fee

submitted is

required.

2. Other strength of

the product Misocot

75 mg Tablets has

already been

deferred for Product

specific inspection

by panel

comprising of

Director DTL,

DDG (E&M) and

area FID


panel comprising of

Director DTL,

Karachi, DDG

(E&M) and area FID.

Reference will be

sent to B & A

Division, DRAP

for verification of

photocopy of fee

challan.

Evaluator – II

Applications checked by Evaluator IV (human)

S.No Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary name +


Composition


Finished product

Specification

Type of Form

Initial date, diary

Fee including

differential fee

Demanded Price /

Pack size

Remarks on the


including


in stringent drug


authorities

Me-too status

GMP status as

depicted in latest

inspection report

(with date) by the

Evaluator

Decision

212. M/s Pfizer

Pakistan Limited.

Zetamax Tablet


Form 5

23-07-2010

International: BNF:

Azithromycin (Non-

Approved.

143

B-2, S.I.T.E.,

Karachi

contains

Azithromycin Dihydrate eq

to Azithromycin USP

……….500mg

Antibiotic

Finished product

specifications are USP

Dy. No. 264

Rs. 8000 + 12000

Rs 340/ 6’s

proprietary)

Local: Azitor of Macter Int

Pvt Limited Karachi

According to

inspection report

dated 16-05-2012,

factory premises and

manufacturing

operations were found

in line and good with

GMP compliance

standards at time of

inspection.

Latest inspection

report is required. The

firm later on


report dated

09.09.2014 conducted

by DRAP.



report & satisfied

with the same.

According to BNF

Azithromycin has

been approved in UK

as Azithromycin

monohydrate hemi-

ethanolate in Tablet

dosage form.

213. -do- Zetamax Tablet


contains

Azithromycin Dihydrate eq

to Azithromycin USP

……….250mg

Antibiotic

Finished product


Form 5

05-07-2010

Dy. No. 37

Rs. 8000 + 12000

Rs 240/ 6’s

International: BNF:

Azithromycin (Non-

proprietary)

Local: Azitor of Macter Int

Pvt Limited Karachi

According to

inspection report

dated 16-05-2012,

factory premises and

manufacturing

operations were found

in line and good with

GMP compliance

standards at time of

Approved.

144

inspection.

Latest inspection

report is required. The

firm later on


report dated

09.09.2014 conducted

by DRAP. The Board

considered the above

inspection report &

satisfied with the

same.

According to BNF

Azithromycin has

been approved in UK

as Azithromycin

monohydrate hemi-

ethanolate in Tablet

dosage form.

214. M/s Genome

Pharmaceuticals

(Pvt) Limited.,

Plot No. 16/I-

Phase IV,

Industrial Estate,

Hattar

Ovulin Tablet

Each tablet contains

Clomiphene Citrate USP

…… 50mg

Anti estrogen

Finished product


Form 5

17-08-2010

Rs 20,000/-

As per PRC

BNF: Clomid

(Sanofi-Aventis)

Ovi-F (Merck)

Grant of GMP for

Export recommended

(27-12-13)

Deferred till decision

on the manufacturing

requirement for this

product.

215. M/s Rotexmedica

Pakistan (Pvt)

Ltd.,

Plot no 206 & 207,

Industrial triangle,

Kahuta Road,

Islamabad

Texpami Capsule

Each capsule contains

Pamidronate as disodium

USP ………..100 mg

(bone Resorption Inhibitor)

Finished product

specifications are

Manufacturer

Form 5

19-05-2010

Rs 8000 + 12000

10’s as per SRO

Not confirmed

Aminomux Cap

100mg by M/s

Seignior

A compliance report

was asked to be

submitted for follow

up inspection. (13-02-

14)

Firm has not given

international

availability. It is

required as it is part

of Form 5. Firm has

replied reference of

Deferred for

confirmation of



Agencies & latest

GMP report.

145

argentina.

Latest satisfactory

GMP inspection

report is required. A

compliance report

was asked to be

submitted for follow

up inspection. (13-02-

14)

216. M/s Macter

International (Pvt.)

Limited. F-216,

S.I.T.E., Karachi.

Zincasa Syrup 10 mg/ 5 ml

Each 5 ml contains

Zinc Sulphate Monohydrate

USP eq to elemental

Zinc……10 mg

Antidiarrheal

Finished Product

Specifications are

Manufacturer

Form 5

20-08-2010

Dy. No. 151

Rs. 8000 + 12000

As per PRC

Me too Zegen Syrup

10 mg/5ml by Genera

International

available in India,

China, Bangladesh

According to

inspection report

dated 10-04-2014,

firm was considered

to be operating at

satisfactory level of

compliance with

GMP guidelines.

International

availability in SRA’s

not confirmed. USP

mentions the

formulation as Oral

Solution with pH of

2.5to 4.5 while

Manuf. Spec.s for this

formulation has pH of

5 to 6.

Approved with USP

specification (as

formulation is WHO

recommended).

217. M/s Macter


Limited. F-216,

S.I.T.E., Karachi.

Mclevo Infusion 250mg

Each 100 ml contains

Levofloxacin USP 250 mg

Broad Spectrum

Antibacterial Agent

Finished Product

Specifications are

Manufacturer

Form 5

21-07-2010

Dy. No. 1371

Rs. 8000 + 12000

Rs 500

FDA has not

approved strength of

2.5mg/ml. FDA

approved 5ml/ml with

Dextrose5%.

Firm has not

submitted undertaking

(The firm had

submitted the above

undertaking but was

Deferred for approval


Regulatory Agencies

in same strength &

volume along with

confirmation of

installation and

operational


analyser & Liquid

Particle Counter by

146

erroneously missed

in the agenda)

According to

inspection report

dated 10-04-2014,

firm was considered

to be operating at


compliance with

GMP guidelines.

International: FDA

has not approved 2.5

mg/ml

Local: Bexus Inf

250mg/100ml by M/s

Shaigan

area FID.

218. M/s Macter


Limited. F-216,

S.I.T.E., Karachi.


Each 50 ml contains

Levofloxacin 250 mg

Broad Spectrum

Antibacterial Agent

Finished Product

Specifications are

Manufacturer

Form 5

21-07-2010

Dy. No. 1371

Rs. 8000 + 12000

Rs 400/ 50 ml

Firm has not


(The firm had

submitted the above

undertaking but was

erroneously missed

in the agenda)

According to

inspection report

dated 10-04-2014,

firm was considered

to be operating at


compliance with

GMP guidelines.

International:

Levaquine 250mg/50

ml (FDA)

Local: Xeflox Inf

250mg/50ml by M/s

Helix

Deferred for

confirmation of

installation and

operational


analyser & Liquid

Particle Counter by

area FID.

147

219. M/s Macter


Limited. F-216,

S.I.T.E., Karachi.


Each 100 ml contains

Levofloxacin 750 mg

Broad Spectrum

Antibacterial Agent

Finished Product

Specifications are

Manufacturer

Form 5

21-07-2010

Dy. No. 1371

Rs. 8000 + 12000

Rs 800/ 100 ml

Firm has not


(The firm had

submitted the above

undertaking but was

erroneously missed

in the agenda)

According to

inspection report

dated 10-04-2014,

firm was considered

to be operating at


compliance with

GMP guidelines.

International: FDA

has not approved 7.5

mg/ml

Local: Bexus Inf

750mg/100ml by M/s

Shaigan

Deferred for approval


Regulatory Agencies

in same strength &

volume along with

confirmation of

installation and

operational


analyser & Liquid

Particle Counter by

area FID.

220. M/s Macter


Limited. F-216,

S.I.T.E., Karachi.


Each 20 ml contains

Levofloxacin 500 mg

Broad Spectrum

Antibacterial Agent

Finished Product

Specifications are

Manufacturer

Form 5

21-07-2010

Dy. No. 1373

Rs. 8000 + 12000

Rs 500/ 20 ml

Firm has not


(The firm had

submitted the above

undertaking but was

erroneously missed

in the agenda)

According to

inspection report

dated 10-04-2014,

firm was considered

to be operating at


compliance with

GMP guidelines.

International:

Deferred for

verification of me too

status along with

confirmation of

installation and

operational


analyser & Liquid

Particle Counter by

area FID.

148

Levaquine 500mg/20

ml (FDA)

Local: Me too status

needs confirmation

221. M/s Macter


Limited.

F-216, S.I.T.E.,

Karachi.

Kirin Tablet


contains

Aliskirin hemifumarate

MS……150 mg

Hydrochlorothiazide USP

…..12.5 mg

Non peptide, direct rennin

inhibitor

Finished Product

Specifications are

Manufacturer

Form 5

30-08-2010

Dy. No. 191

Rs. 8000

As per PRC

1 × 14’s

Me too Co-Kiren

Tablet by Tabros

Pharma

International

Tekturna HCT tablet

(USA)

According to

inspection report

dated 10-04-2014,

firm was considered

to be operating at


compliance with

GMP guidelines.

Firm has not

submitted

undertaking.

(The firm had

submitted the above

undertaking but was

erroneously missed in

the agenda)

Approved.

222. M/s Macter


Limited.

F-216, S.I.T.E.,

Karachi.

Mimin Tablet 200 mg


contains

Rifaximin……..200 mg

Non systemic Antibiotic

Finished Product

Specifications are

Manufacturer

Form 5

30-08-2010

Dy. No. 196

Rs. 8000

As per PRC

1 × 10’s

Me too Xerifax

Tablet 200 mg

International

Xifaxan Tablet 200

mg (FDA)

According to

inspection report

dated 10-04-2014,

firm was considered

to be operating at


Approved.

149

compliance with

GMP guidelines.

Firm has not

submitted

undertaking.

(The firm had

submitted the above

undertaking but was

erroneously missed

in the agenda)

223. M/s Macter


Limited.

F-216, S.I.T.E.,

Karachi.

Mirin Capsule 50 mg


Diacerein MS …..50 mg

Antirheumatics/ Pain

Management

Finished Product

Specifications are

Manufacturer

Form 5

30-08-2010

Dy. No. 198

Rs. 8000 + 12000

As per PRC

Me too Diora Capsule

50 mg by Getz

International

Diacerein Capsule 50

mg available in India.

EMA approved

Diacerein for rare

disease

(epidermolysis

bullosa).

According to

inspection report

dated 10-04-2014,

firm was considered

to be operating at


compliance with

GMP guidelines.

Firm has not

submitted

undertaking.

(The firm had

submitted the above

undertaking but was

erroneously missed in

the agenda)

Firm has given assay

Deferred for review

of formulation by

Review Committee.

150

limit for finished

product as 288-368

mg/capsule.

Firm has given assay

for tablets while

applied product is

capsule.

The firm has

submitted the correct

assay method with

correct limits.

224. M/s Macter


Limited.

F-216, S.I.T.E.,

Karachi.

Micam Injection 8 mg

Each vial contains

Lornoxicam…….8 mg

Analgesic & Anti

inflammatory

Finished Product

Specifications are

Form 5

30-08-2010

Dy. No. 200

Rs. 8000 + 12000

As per PRC

Firm has not provided

reference of

specifications of

finished product.

The firm submitted

Finished Product

Specification as

Manufacturer’s

specifications

Firm has written

Glenmark as

reference to

specifications of

active raw material

for description,

identification,

solubility and Aydin/

Turkey for assay of

active raw material.

QC tests for injections

have not been

provided.

Me too Xefast tablet

8 mg by PharmEvo

International Xefo

powder for injection 8

Deferred for

confirmation of

installation and

operational


analyser & Liquid

Particle Counter by

area FID.

151

mg (EMA)

225. -do- Zincasa DS Syrup 20 mg/ 5

ml

Each 5 ml contains


USP eq to elemental

Zinc……20 mg

Antidiarrheal

Finished Product

Specifications are

Manufacturer

Form 5

20-08-2010

Dy. No. 151

Rs. 8000 + 12000

As per PRC

Me too Zegen Syrup

10 mg/5ml by Genera

International

available in India,

China, Bangladesh

According to

inspection report

dated 10-04-2014,

firm was considered

to be operating at


compliance with

GMP guidelines.

International


not confirmed. USP

mentions the

formulation as Oral

Solution with pH of

2.5to 4.5 while

Manuf. Spec.s for this

formulation has pH of

5 to 6.

Approved with USP

specification as

formulation is WHO

recommended.

226. M/s Pharmatec

Pakistan (Pvt.)

Ltd.

D- 86/A., S.I.T.E.,

Karachi.

Alptec 0.25mg Tablet


Alprazolam USP

….0.25mg

Anxiolytic

Finished product


Form 5

31-05-2013

Rs 60,000/-

3 × 10

International:

Alprazolam 0.25mg

(FDA)

Me too: Alloram 0.25

mg by M/s Global

According to

inspection report

dated 23-10- 2013,

firm was considered

to be operating at

good level of

compliance with

GMP guidelines.

Deferred for

confirmation of

segregated

manufacturing facility

for Narcotic Drugs

and Psychotropic

substances.

227. M/s Benson

Pharmaceuticals. Plot No 119, street

No 8, I-10/3,

Industrial area

Islamabad.

Moxi Tablet


contains

Moxifloxacin (as

hydrochloride)

(USP...400mg

Form 5

09-06-2010

Rs 8000 + 12000

5’s as per SRO

BNF: Avelox (Bayer)

Local: Morax tab

400mg by M/s Global

Firm is operating at

Deferred for

provision of assay

method of Finished

Product.

152

(Fluroquinolone)



GMP compliance (15-

04-14)

Assay method had not

been given in

Finished Product

specifications.

228. -do-

Piclo Tablet


contains

Piroxicam (as beta

cyclodextrin)……………20

mg

(NSAID)


Form 5

09-06-2010

Rs 8000 + 12000

5’s as per SRO

BNF:

Brexidol(Chiesi)

Local: Brexidol cap

20mg by M/s Genome

Firm is operating at


GMP compliance (15-

04-14)

Originator’s

formulation is

uncoated while the

Firm has applied Film

coated formulation.

Firm has not given

active raw material

specifications.

Finished product

specifications are

incomplete and

without reference.

Assay, identification,

dissolution methods

have not been

provided.

Deferred for

correction in coating

& speficication of

active material &

finished product.

229. M/s WnsFeild

Pharmaceuticals

Plot no. 122, Block

B, Phase V,

Industrial Estate,

Hattar

Venlax tablet 37.5 mg

Each extended release film

coated tablet contains

Venlafaxine (as HCl)

……..37.5 mg

(Anti depressant)

(B.P Spec.s)

Form 5

04-08-2010

Rs 20,000/-

Pack of 20’s

As fixed by Govt

BNF: Venlafaxine

(Non-proprietary)

Local: Zaxine (Araf

Pharma)

Grant of GMP

Certificate for Export

recommended (04-09-

14)

Approved with

change in brand

name.

230. -do- Venlax tablet 75mg Form 5 BNF: Venlafaxine Approved with

153

Each extended release film

coated tablet contains


……..75 mg

(Anti depressant)

(B.P Spec.s)

04-08-2010

Rs 20,000/-

Pack of 2 × 7’s

As fixed by Govt

(Non-proprietary)

Local: Zaxine (Araf

Pharma)

Grant of GMP


recommended (04-09-

14)

change in brand

name.

231. -do- Venlax tablet


contains


(USP)……..50 mg

(Anti depressant)

(BP Spec.s)

Form 5

04-08-2010

Rs 20,000/-

Pack of 20’s

As fixed by Govt

FDA: Venlafaxine (as

HCl) by Teva

Amfax (Amson)

Grant of GMP


recommended (04-09-

14)

Approved with

change in brand

name.

232. -do- Artidoxin DS co-blister

Tablet

(i) 3Tablets of which Each

coblister tablet contains

Sulphadoxin USP ……..

500mg

Pyrimethamine USP

……..25mg

(USP Spec.s)

(ii) 6Tablets of which Each

tablet contains

Artisunate……100mg

(Antimalarial)

Finished product

specifications are


Form 5

04-08-2010

Rs 20,000/-

2 × 10’s tab

As fixed by Govt

International: Not

confirmed.

(Formulation is

found WHO

approved)

Local:Fansi Plus

(Wilshire)

Grant of GMP


recommended (04-09-

14)

International


not confirmed. Firm

has provided

reference from China.

For verification of

Facility (Co-blister

Machine etc) Firm

has submitted that

they possesses the

Chinese made blister

machine which has

the capability of

blistering different

size of tablets

together I to one

Deferred for

confirmation of co-

blister facility by area

FID.

154

blister. The machie is

convertible from Alu

Alu to Alu PVC and

vice versa. The have

given undertaking

that they will procure

the specific dye for

the purpose if the

product is registered.

233. -do- Artidoxin co-blister Tablet

(i) 3Tablets of which Each

coblister tablet contains

Sulphadoxin USP ……..

500mg

Pyrimethamine USP

……..25mg

(USP Spec.s)

(ii) 6Tablets of which Each

tablet contains

Artisunate……50mg

(Antimalarial)

Finished product

specifications

are(Manufacturer’s Spec.s)

Form 5

04-08-2010

Rs 20,000/-

2 × 10’s tab

As fixed by Govt

International: Not

confirmed.

Local: Arteka of

Hemis

Grant of GMP


recommended (04-09-

14)

International


not confirmed. Firm

has provided

reference from China.

Me-too status needs

confirmation. (Arteka

of Hemis), Pricing of

formulation has been

fixed in 19th PRC.

For verification of

Facility (Co-blister

Machine etc) Firm

has submitted that

they possesses the

Chinese made blister

machine which has

the capability of

blistering different

size of tablets

together I to one

blister. The machie is

convertible from Alu

Alu to Alu PVC and

vice versa. The have

given undertaking

that they will procure

the specific dye for

the purpose if the

product is registered.

Deferred for

confirmation WHO

recommended

formulation / Pack &

verification of co-

blister facility by area

FID.

155

234. -do- Winprid Tablet


contains:-

Itopride HCl…..50mg

Gastroprokinetic


Form 5

04-08-2010

Rs 20,000/-

1 × 10’s tab

As fixed by Govt

International:

Ganaton

Local:Ganaton

(Abbot)

Grant of GMP


recommended (04-09-

14)

Formulation is under

review by the review

committee.

Deferred for review

of formulation by

Review Committee.

235. M/s Qintar

Pharmaceuticals,

14-A P.S.I.E.,

Lahore road,

Sargodha

HEMA Chewable (Sugar

Free) Tablets


contains

Mecobalamin (J.P)…500

mcg

(Co enzyme type vitamin

B12)


Form 5

27-03-2010

Rs 8000 + 12000

Rs 178 for 20’s

Rs 267 for 30’s

Rs 890 for 100’s

International: Not

confirmed

Local: Hicobal

500mcg by M/s

Himont

Renewal of DML

recommended (08-10-

12)

International

availability not

confirmed in SRAs.

Firm has given

reference of

international

availability from

India.

Formulation given is

not of chewable

Tablets

Latest inspection

report is required.

Deferred for

confirmation of

approval of same

dosage form in

reference Stringent

Regulatory Agencies

and clarification of

formulation as not

given for applied

chewable dosage

form and submission

of latest GMP

inspection report.

236. -do-

Gexin Tablets


contains:-

Gemifloxacin as

mesylate………… 320 mg

(Fluroquinolone)


Form 5

27-03-2010

Rs 8000 + 12000

Rs 625 for 7’s

International: FDA

Factive

Local: Actigem tab

320mg by M/s

Ferozsons

Renewal of DML

recommended (08-10-

12)

Latest inspection

report is required.

Deferred for

submission of latest

GMP inspection

report.

237. -do- Smart XR Tablets Form 5 International:ALLEGRA-

D 12 HOUR ALLERGY AND

Deferred for

156

Each film coated XR tablet

contains

Fexofenadine HCL (USP)

as immediate Layer…..60

mg

Pseudoephedrine HCL

(USP) as extended

release….. 120 mg

(Histamine H1 receptor

antagonist & adrenergic

vasoconstrictor)

Finished product


27-03-2010

Rs 8000 + 12000

Rs 120 for 10’s

CONGESTION (Sanofi)

Local: Fexet D by

M/s Getz

Renewal of DML

recommended (08-10-

12)

Formulations is

specialized dosage

form, Product specific

inspection may be

carried out for the

product for

verification of facility

etc.

Confirmation of


Latest inspection

report is required.


GMP inspection

report & product


panel comprising of

DDG, Lahore and

area FID for

verification of

manufacturing &

testing facilities of the

applied formulation.

238. -do-

Rovax Tablet


contains

Rosuvastatin Calcium eq to

Rosuvastatin….. ……..5mg

(Hypolipidaemics)


Form 5

27-03-2010

Rs 8000 + 12000

Rs 100 for 10’s

BNF: Crestor

(AstraZeneca)

Local: Rast 5mg by

M/s Tabros

Renewal of DML

recommended (08-10-

12)

Latest inspection

report is required.

Deferred for


GMP inspection

report.

239. -do-

Rovax Tablet


contains

Rosuvastatin Calcium eq to

Rosuvastatin…..

……..10mg

(Hypolipidaemics)


Form 5

27-03-2010

Rs 8000 + 12000

Rs 180 for 10’s

BNF: Crestor

(AstraZeneca)

Local: Rast 5mg by

M/s Tabros

Renewal of DML

recommended (08-10-

12)

Latest inspection

report is required.

Deferred for


GMP inspection

report.

240. M/s Nenza

Pharmaceuticals,

Plot No. 33 A,

Flotin Tablet 20 mg


Fluoxetin HCl USP eq to

Form 5

15-07-2010

8000 + 12000

Me too Floxac tablet

20 mg by Schazo

Approved.

157

Phase- V,

Industrial Estate,

Hayatabad,

Peshawar.

Fluoxetin….

20 mg

(Antidepressant)

Finished product


As fixed by govt

1 × 10 pack International Selfemra tablet 20 mg

(FDA)

No conclusion


Firm, some minor


the management was

agreed to rectify.

(Routine GMP 10-04-

2014).

The Board

considered the above

inspection report &

satisfied with the

same.

241. M/s Genix Pharma

(Pvt.) Ltd.

44, 45- B, Korangi

Creek Road,

Karachi.

Triptan Tablet


contains

Frovatriptan (as Succinate

monohydrate)….. …2.5 mg

Anti migraine

Finished product

specifications are

Manufacturer.

Form 5 D

10-08-2010(52)

Rs 15000/-+ Rs.

12000/- (21-05-

13)+Rs. 23000/- 21-

11-2014

Rs. 200 per tablet

Pack of 10’s for Rs

2000/-

International:Frova

Tablet 2.5 mg (FDA)

Local: Form 5-D

Good GMP (30-04-

2014)

Verification of copy

of Rs.12000/- fee

challan is required.

No authentic

reference to clinical

use & doses given in

clinical part of dossier

Stability studies

conducted under Zone

IV A conditions as

per ICH/ WHO

guidelines, Clinical

data/ clinical trials are

required.

Reference of

specifications/testing

methods of finished

product is required.

Deferred for

rectification of

following

observations in the

dossier:

1. Reference will be

sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan.

2. No authentic




3. Stability studies


IV A conditions as

per ICH/ WHO



required.

4. Reference of


methods of finished



(Pvt.) Ltd.

44, 45- B, Korangi

Eltram Tablet


contains

Form 5-D

10-08-2010

Rs 15000/-+ Rs.

International:

Promacta Tablet 50

mg (FDA)

Deferred for

rectification of

following observation

158

Creek Road,

Karachi.

Eltrambopag (as

olamine)….. …50 mg

Haematopoietic

Finished product

specifications are

Manufacturer.

12000/- (21-05-13)

Rs. 200 per tablet


2000/-


4000/-

Local: Not

confirmed.

Good GMP (30-04-

2014)


of Rs.12000/- fee


Firm has requested to

change Form 5-D to

Form 5 as at the time

of initial application,

the product was new

but now it has

become me-too.

Form 5 is required.

Evidence of Me-too

status is required.

in the dossier:


sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan.

2. Form 5 is required.

3. Evidence of Me-

too status is required.


(Pvt.) Ltd.

44, 45- B, Korangi

Creek Road,

Karachi.

Eltram Tablet


contains

Eltrambopag (as

olamine)….. …25 mg

Haematopoietic

Finished product

specifications are

Manufacturer.

Form 5 D

10-08-2010

Rs 15000/-/-+ Rs.

12000/- (21-05-13)

Rs. 150 per tablet


1500/-


3000/-

International:

Promacta Tablet 50

mg (FDA)

Local:

Good GMP (30-04-

2014)


of Rs.12000/- fee


Firm has requested to

change Form 5-D to

Form 5 as at the time

of initial application,

the product was new

but now it has

become me-too.

Form 5 is required.

Evidence of Me-too

status is required.

Deferred for

rectification of


in the dossier:


sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan

2. Form 5 is required.

3. Evidence of Me-

too status is required.


(Pvt.) Ltd.

44, 45- B, Korangi

Creek Road,

Art-M Tablet


Artesunate …….60 mg

Pyronaridine Phosphate eq

Form 5 D

10-08-2010(52)

Rs 15000/-+ Rs.

12000/- (21-05-

International:

Local: Form 5-D

Deferred for

rectification of


in the dossier:

159

Karachi. to Pyronaridine…180 mg

Anti malarial

Finished product

specifications are

Manufacturer.

13)+Rs. 23000/- 21-

11-2014

Rs. 300 per tablet


3000/-


6000/-


9000/-

Good GMP (30-04-

2014)


of Rs.12000/- fee


No authentic




Stability studies


IV A conditions as

per ICH/ WHO



required.

Reference of


methods of finished


Evidence of

Availability in

Stringent SRA’s is

required.


sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan.

2. No authentic




3. Stability studies


IV A conditions as

per ICH/ WHO



required.

4. Reference of


methods of finished


5. Evidence of

Availability in

Stringent SRA’s is

required.

245. M/s Helix Pharma

(Pvt) Ltd.,

Hakimsons House,

A/ 56, S.I.T.E.,

Karachi

Primavera/ Omni Plus/

Ristor/ Omnita Omitag/

OSB Capsule


Omeprazole…..20mg

Sodium Bicarbonate

…….1100mg

(Strength has been

corrected as 1100 mg which

was typed as 110mg in the

agenda copy)

Proton Pump Inhibitor &

Antacid


Form 5

30-08-2010

Dy No 203

Rs 8000+Rs.

12000/- (22-07-13)

MRP of 10 capsules

as per PRC

International: Zegerid (FDA)

Local: Rapid (global)

Satisfactory GMP

compliance (11-08-

14)


of Rs.12000/- fee


Deferred for review

of formulation by

Review Committee.

246. M/s AGP (Private)

Limited.

B-23, S.I.T.E.,

Karachi

Maxna Injection

Each ml contains

Tranexamic acid BP

……….100mg

Anti Fibrinolytic Agent

Form 5

30-08-2010

Rs. 8000 + 12000

As fixed by DPC

5 × 10 ml ampoules

International:

Local:

Satisfactory GMP

compliance (26-11-

13)

Deferred for

rectification of

following

observations in the

dossier:

160

Finished product

specifications are BP


of fee challans is

required.

Verification of TOC

analyzer & liquid

particle counter is

required.

Confirmation of Me

too status in 1g/10ml

is required.

Letter of approval of

injection section is

required. Inspection

report dated 26-09-

2012 mentions

Injectable (Antibiotic,

Analgesic,

Spasmolytics etc)

Section.


sent to B & A

Division, DRAP for

verification of

photocopy of fee

challan.

2. confirmation of

installation and

operational

qualification for TOC

analyzer & liquid

particle counter by

area FID.

3. Confirmation of

Me too status in

1g/10ml is required.

4. Letter of approval

of injection section is

required.

247. M/s Bloom

pharmaceuticals

(Pvt) Ltd. Phase I

& II Industrial

Estate, Hattar

Surfen Plus Tablet


Contains:

Hyoscine N

Butylbromide BP…………

10 mg

Paracetamol BP……

500mg

Anticholinergic &

Analgesic

(B.P Spec.s)

Form 5

05-08-2010

Rs 20,000/-

10 × 10’s tab

As per SRO

International:

Local: Buscopan

Plus Tablets

NO conclusion ,

routine GMP

inspection ,

Shortcomings have

been improved (25-

07-14)

International

availability has not

been written. It is


of Form 5.

Reference to finished

product specifications

has been given as B.P

while the formulation

is not included in B.P.

Undertaking on

desired format has not

been submitted.

Deferred for

rectification of

following

observations in the

dossier:

1. International

availability (in


Agencies) required as

part of Form 5.

2. Reference to

finished product

specifications has

been given as B.P

while the formulation

is not included in B.P.

3. Undertaking on


been submitted.

248. M/s Bloom Amalar Suspension Form 5 International: Deferred for

161

Pharmaceuticals

(Pvt) Ltd. Phase

I & II Industrial

Estate, Hattar

Each 5 ml contains

Artemether…..15mg

Lumefantrine…..90mg

Antimalarial

Finished product

specifications are

Manufacturer.

05-08-2010

Rs 20,000/-

As per SRO

30 ml & 60 ml

Local: Buscopan

Plus Tablets

NO conclusion ,

routine GMP

inspection ,

Shortcomings have

been improved (25-

07-14)

Firm has written that

“we will surrender

our already registered

product Benol

Capsule Reg No.

022525 in case of fast

track registration of

our this product

Amalar Suspension.”

No clarification has

been given in reply.

International


been written. It is


of Form 5.

Active raw material

specifications have

been given as B.P

while these are not

included in B.P.

Undertaking on


been submitted.

rectification of

following

observations in the

dossier:

1. International


been submitted.

2. Active raw material

specifications have

been given as B.P

while these are not

included in B.P.

3. Undertaking on


been submitted.

249. Rogen

Pharmaceuticals.

Plot No. 30, St No.

S-4

National Industrial

Zone (RCCI),

Rawat, Islamabad.

Olirag 10 mg Tablet


contains:

Olanzapine 10 mg

(Tranquilizers, Sedative,

Hypnotics)

USP Specifications

Form 5

19-07-2010

20,000

As per SRO for 10’s

International:

Olanzapine 52 mg

(FDA)

Me too: Amprex

tablet 5 mg by

Amarant

The firm has rectified

the short-comings

conveyed to him.

Approved.

250. Rogen Olirag 5 mg Tablet Form 5 International: Approved.

162

Pharmaceuticals.

Plot No. 30, St No.

S-4

National Industrial

Zone (RCCI),

Rawat, Islamabad.


Olanzapine 5 mg

(Tranquilizers, Sedative,

Hypnotics)

USP Specifications

19-07-2010

20,000


Olanzapine 5 mg

(FDA)

Me too: Amprex

tablet 5 mg by

Amarant

251. Rogen

Pharmaceuticals.

Plot No. 30, St No.

S-4

National Industrial

Zone (RCCI),

Rawat, Islamabad.

Rocep 250 mg Capsule


Ciprofloxacin HCL USP

250 mg

(Quinolone)

Finished product

specifications are

Manufacturer

Form 5

19-07-2010

20,000


International: Not

approved by reference

DRAs

Local: Ciprocin cap

250mg by M/s

Miracle

Deferred for review

of formualation by

Review Committee.

252. Rogen

Pharmaceuticals.

Plot No. 30, St No.

S-4

National Industrial

Zone (RCCI),

Rawat, Islamabad.

Rocep 500 mg Capsule


Ciprofloxacin HCL 500

mg

(Quinolone)

Finished product

specifications are

Manufacturer

Form 5

19-07-2010

20,000


International: Not


DRAs

Local: Ciprocin cap

250mg by M/s

Miracle

Deferred for review

of formualation by

Review Committee.

253. Rogen

Pharmaceuticals.

Plot No. 30, St No.

S-4

National Industrial

Zone (RCCI),

Rawat, Islamabad.

Sulrog Tablet 25 mg


Levosulpride 25 mg

(Antidepressant/

Gastroprokinetic)

Finished product

specifications are

Manufacturer

Form 5

19-07-2010

20,000


International: Not


DRAs

Local: levopraid

tablet 25mg by M/s

Pacific

Deferred for review

of formualation by

Review Committee.

163

254. Rogen

Pharmaceuticals.

Plot No. 30, St No.

S-4

National Industrial

Zone (RCCI),

Rawat, Islamabad.

Sulrog Tablet 50 mg


Levosulpride 50 mg

(Antidepressant/

Gastroprokinetic)

Finished product

specifications are

Manufacturer.

Form 5

19-07-2010

20,000


International: Not


DRAs

Local: levopraid

tablet 50mg by M/s

Pacific

Deferred for review

of formualation by

Review Committee.

255. Rogen

Pharmaceuticals.

Plot No. 30, St No.

S-4

National Industrial

Zone (RCCI),

Rawat, Islamabad.

Sulrog Tablet 100 mg


Levosulpride 100 mg

(Antidepressant/

Gastroprokinetic)

Finished product

specifications are

Manufacturer

Form 5

19-07-2010

20,000


International: Not


DRAs

Local: levopraid

tablet 100mg by M/s

Pacific

Deferred for review

of formualation by

Review Committee.

256. Rogen

Pharmaceuticals.

Plot No. 30, St No.

S-4

National Industrial

Zone (RCCI),

Rawat, Islamabad.

Mecrogen 500 mcg Tablet


contains

Macobalamin……..500

mcg

Vitamin B12

Finished product

specifications are

Manufacturer

Form 5

19-07-2010

20,000


International:

Methycobal tablet

(Japan)

Local: levopraid

tablet 100mg by M/s

Pacific

Approved with sugar

coating.

164

Evaluator – II

Applications of impot checked by Evaluator – IV

S.No Name and address of

manufacturer /

Applicant

Brand Name

(Proprietary name +


Composition


Finished product

Specification

Type of Form

Initial date,

diary

Fee including

differential

fee

Demanded

Price / Pack

size

Remarks on the


including

International status in

stringent drug


authorities

Me-too status

GMP status as

depicted in latest

inspection report (with

date) by the Evaluator

Decision

257. M/s. Novartis Pharma

(Pvt) Ltd, Karachi. /

Product License

Holder:-

M/s. Novartis Pharma

Schweiz Ltd

Monbijoustrasse Bern,

Switzerland.

Manufacturing Site:-

M/s. Novartis Pharma

SAS, rue la Chapelle,

Huningue, France.

Sebivo Oral Solution

20mg/ml

Each ml of oral solution

contains: -

Telbivudine…………20mg

(Hepatitis B)

Form 5-A

11-11-2009

Diary No. 659

Rs.15000/-

12-02-2014

Rs.35000/-

Total

Rs.50,000/-

Demanded

Price/Pack

Size

Rs.3915/300ml

FDA: Tyzeka (Novartis)

New Application

N/A

Following objections

were raised on the

applications:

1. Firm has not provided

Studies like process

validation,

pharmaceutical

development studies,

validation of analytical

methods.

2.Firm has not provided

chromatographs for

sample and reference of

active ingredient,

benzoic acid,

degradation products in

analytical procedures

and stability studies.

3.Clinical trial data/

clinical data

Firm had objected on

these observations and

regarding limited time

period provided for

Approved

`(The firm submitted

the relevant portion

of CTD showing the

Process validation,

validation of

analytical method &

chromatograms of

sample and standard

of :

(i) API

(ii) Benzoic acid

(iii) Degradation

products.

The referred CTD

mentions same the

manufacturing site

as applied).

165

reply of these objections

but now has submitted

the reply of these

observations.

Assessment of reply

reveals that the Firm has

not submitted the

validation reports

regarding process and

analytical methods in a

prescribed manner viz.

without contents like

specificity, linearity,

precision, accuracy,

limit of detection, Range

, Robustness etc.

Further, the Firm has

also not submitted the

chromatograms of

sample and standard of :

(i) API

(ii) Benzoic Acid

(iii) Degradation

products.

258. Applicant:

M/s. Mehran Dental,

Karachi.

M No. Al Noor

Centre Randle Road,

ADJ-

ANKLESeriaHospital,

Karachi

Manufacturer:

M/s. Laboratorios

Zeyco S.A. DE C.V.

CAMINO A SANTA

ANA TEPETITLAN

NO. 2230 COLONIA

SANTA ANA

TEPETITLAN 45230

ZAPOPAN

JALISCO, Mexico.

FD Injection IV

Each 1.8ml ampoule

contains: -

Lidocaine HCl…36.0mg

Epinephrine…0.018mg

Local Anesthetic

/Adrenergic agonist

Finished product


Form 5-A

17-02-2009

Diary No.153

Rs.15000/-

18-06-2013

Rs.85000/-

Rs.1200 /

1 x 10

cartridge in

each blister

Total 5 blister

in packet

Total 50 Pieces

of cartridges in

Packet

International:

Local:

Sole agency agreement

has been expired.

GMP certificate of

manufacturer has been

expired.


original & legalized

Certificate of

Pharmaceutical Product

with english translation.


long term stability

studies under zone IV A

conditions are ICH/

WHO guidelines.

Chromatograms in

analytical methods &

stability studies have not

been provided along

with data.

Firm gave reference of

USP for finished

product specifications

Deferred for

rectification of

following

observations in the

dossier:

1. Sole agency

agreement has been

expired.

2. GMP certificate

of manufacturer has

been expired.

3. Firm has not

provided original &

legalized Certificate

of Pharmaceutical

Product with english

translation.

4. Firm has not

provided long term

stability studies

under zone IV A

conditions are ICH/

WHO guidelines.

5. Chromatograms in

analytical methods

166

while given assay

method is not as same as

given in USP 35.


active raw material

specifications.


specifications of

primary packaging

material (glass vial).

Undertaking on desired

format has not been

submitted.

& stability studies

have not been

provided along with

data.

6. Firm gave

reference of USP for

finished product

specifications while

given assay method

is not as same as

given in USP 35.

7. Firm has not

provided active raw

material

specifications.

8. Firm has not

provided

specifications of

primary packaging

material (glass vial).

9. Undertaking on

desired format has

not been submitted.

259. Applicant:

M/s. Haroon Brothers,

1/ A,

KarimjeeBuilding,

Opposite HBL Napier

Rd Branch, Near

Denso Hall,

Karachi.

Manufacturer:

M/s. Pharma Stulln

GmbH Werksstrasse

3, D-92551 Stulln,

Germany.

Mydriaticum Stulln UD

Eye Drops

Each ml contains: -

Tropicamide Ph. Eur.

….…5mg

Ophthalmic Preparation /

Mydriatic & Cycloplegic

Finished product

specifications are

Form 5-A

30-04-2009

Rs.15000 +

Rs.85000 =

Rs.100000/

Rs.30/ Per Vial

(0.4ml),

depending on

pack size

Reply of the Firm needs

further evaluation.

Deferred for

evaluation of replies

submitted by the

firm.

260. Applicant:

M/s. Haroon Brothers,

1/ A,

KarimjeeBuilding,

Opposite HBL Napier

Rd Branch, Near

Denso Hall,

Karachi.

Manufacturer:

M/s. Penta

Arzneimittel GmbH

Blupan UD Eye Drops

Each ml contains: -

Sodium

Hyaluronate Ph. Eur.

…1.5057mg

Dexpanthenol (Vitamin

B5) USP….20.0000 mg

Ophthalmic Preparation

Finished product

Form 5-A

30-04-2009

Rs.15000 +

Rs.85000 =

Rs.100000/

Rs.36/ per vial

(0.5ml)

Reply of the Firm needs

further evaluation.

Deferred for

evaluation of replies

submitted by the

firm.

167

Werksstrasse 3,

Germany.

specifications are

Evaluator – III

S/N Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary name

+ Dosage Form +

Strength)

Composition


Finished product

Specification

Type of Form

Initial date,

diary

Fee including

differential

fee

Demanded

Price / Pack

size

Remarks on

the

formulation (if

any) including

International

status in

stringent drug

regulatory

agencies /

authorities

Me-too status

GMP status as

depicted in

latest

inspection

report (with

date) by the

Evaluator

Recommendations

by the Evaluator

Decision

261. M/s Atco

Laboratories

(Pvt) Limited

Karachi.

ADVOCORT Fatty

Ointment 0.1%

Each gram contains:

Methylprednisolone

aceponate…….1mg

Synthetic corticosteroid

Manufacturer

Form-5

Dy. No: 126

dated 14th

October 2010

8,000/-

Rs. 95/- per

5gm tube

Rs. 176/- per

10gm tube

Rs. 250/- per

15gm tube

Advantan Fatty

Ointment of

CSL Limited

(TGA

Approved)

Advantan of

Bayer Pakistan

Karachi.

Inspection of

the firm was

conducted on

18-06-14 by the

area FID and

GMP

Compliance was

found good.

Firm has submitted

that they are in

process of

establishing the

steroidal section

facility. The firm

has also submitted

letter regarding

approval of

proposed layout

plan for Ointment

(Steroid) and Oral

Liquid Section

(General).

Deferred for

confirmation of

manufacturing

facility for

steroids.

168

262. -do- ADVOCORT Ointment

0.1%

Each gram contains:

Methylprednisolone

aceponate…….1mg


Manufacturer

Form-5

Dy. No: 125

dated 14th

October 2010

8,000/-

Rs. 95/- per

5gm tube

Rs. 176/- per

10gm tube

Rs. 250/- per

15gm tube

Advantan

Ointment of

CSL Limited

(TGA

Approved)

Advantan of

Bayer Pakistan

Karachi

Deferred for

confirmation of

manufacturing

facility for

steroids.

263. -do- ADVOCORT Lotion 0.1%

Each ml contains:

Methylprednisolone

aceponate…….1mg


Manufacturer

Form-5D

Dy. No: 127

dated 14th

October 2010

15,000/- dated

14-10-10

35000/- dated

05-12-13

Rs. 225/- 30ml

Rs. 330/- per

60ml

Advantan

Lotion of CSL

Limited (TGA

Approved)

Inspection of

the firm was

conducted on

18-06-14 by the

area FID and

GMP

Compliance was

found good.

a. Stability studies

needs to be

submitted as per

ICH/ WHO

guidelines.

b. Clinical trial

data is required

along with

clinical

justification.

Deferred for

followings:

1. Confirmation

of

manufacturing

facility for

steroids.

2. Stability

studies as per

ICH/ WHO

guidelines.

3. Clinical trial

data along with

clinical

justification.

264. M/s Linear

Pharma, Rawat

Islamabad.

PYRETIC Effervescent

Tablets 500mg


Paracetamol….500mg

Analgesic/ Antipyretic

Manufacturer

Form-5

06-10-2010

Dy. No.9220

8,000/-

28-02-2014

Dy. No.595

12000/-

As per SRO/

Pack of 100’s

Paracetamol

effervescent

tablet of Accord

Health Care

UK.

Acetosol of

Shigan Pharma

Islamabad.

Inspection of

the firm was

conducted by

the area FID on

13-11-14 and

the was

complying the

GMP

Approved.

169

265. -do- MEFQUINE Tablets 250mg


Mefloquine

Hydrochloride…..250mg

Antimalarial

Manufacturer

Form-5

06-10-2010

Dy. No.9226

8,000/-

28-02-2014

Dy. No.594

12000/-

As per SRO/

Pack of 25’s

Lariam Tablet

of Roche UK

Meflogen of

Genome

Pharmaceuticals

Approved.

266. -do- PENTO Capsule 40mg


Pantoprazole sodium 22.5

% pellets equivalent to

Pantoprazole…..40mg

PPI

Manufacturer

Source: Vision

Pharmaceuticals Islamabad.

Form-5

06-10-2010

Dy. No.9226

8,000/-

28-02-2014

Dy. No.596

12000/-

As per SRO/

Pack of 14’s

Not available in

SRA’s

Pentoloc of

Aeries Pharma

Deferred for

review of

formulation.

267. M/s Innvotek

Pharmaceuticals

Islamabad.

LETRO Tablets


contains:

Letrozole……2.5mg

Non steroidal aromatase

Inhibitor

USP

Form-5

Dy. No: 1037/

20-10-10

20,000/-

As per PRC/

Pack of 10’s

Femara of

Novartis

Femara of

Novartis

Karachi

Inspection of

the firm was

conducted on

04-07-14 by the

area FID and

GMP

compliance was

found

satisfactory.

Deferred till

decision on the

manufacturing

requirement for

this product.

170

268. -do- MILTEFO Capsules


Miltefosine…..50mg

Antiprotozoal

Manufacturer

Form-5

Dy. No: 1036/

20-10-10

20,000/-

As per PRC/

Pack of 8x7’s

Impavido of

Knight Theraps

(USFDA)

Fosin Capsules

of Nimral Labs

Approved.

269. M/s Fedro

Pharmaceutical

Labs. Peshawar

RANIDOL Tablets 150mg


contains:

Ranitidine as

hydrochloride……150mg

H2 Blocker

BP

Form-5

20-09-2010

Dy. No. 1148

20,000/-

As per SRO

1x10’s

Ranitidine

tablets of

Aurobindo

Pharma.

Zantac of GSK

a. Evidence of

approval of

section from

Drug Licensing

division is not

submitted.

b. Inspection of the

Firm was

conducted by

the area FID on

23-07-14 and

certain

shortcomings

were found,

which are

discussed with

the management

of which they

agreed to

rectify.

(“drainage line

found not

cleaned properly

in tablet section,

three blistering

and one

stripping

machines found

kept in one

room without

segregation and

advised to

provided

partition and AC

facilities to

control

temperature and

Deferred till

rectifications of

shortcomings as

mentioned in

GMP inspection

report dated

23.07.2014.

171

humidity.”)

270. -do- RANIDOL Tablets 300mg


contains:

Ranitidine as

hydrochloride……300mg

H2 Blocker

BP

Form-5

20-09-2010

Dy. No. 1137

20,000/-

As per SRO

1x10’s

Ranitidine

tablets of

Aurobindo

Pharma.

Zantac of GSK

Deferred till

rectifications of

shortcomings as

mentioned in

GMP inspection

report dated

23.07.2014.

271. -do- FEKAST Tablets 4mg


contains:

Montelukast as

sodium……4mg

Leukotriene Receptor

Antagonist

Manufacturer

Form-5

20-09-2010

Dy. No. 1138

20,000/-

As per SRO

2x7’s

Not found in

SRA’s, (applied

strength is

approved as

chewable

tablet.)

Me too status

needs

confirmation

Deferred till

rectifications of

shortcomings as

mentioned in

GMP inspection

report dated

23.07.2014.



contains:

Montelukast as

sodium……5mg


Antagonist

Manufacturer

Form-5

20-09-2010

Dy. No. 1146

20,000/-

As per SRO

2x7’s

Not found in

SRA’s, applied

strength is

approved as

chewable tablet.

Me too status

needs

confirmation

Deferred till

rectifications of

shortcomings as

mentioned in

GMP inspection

report dated

23.07.2014.



contains:

Montelukast as

sodium……10mg


Antagonist

Manufacturer

Form-5

20-09-2010

Dy. No. 1143

20,000/-

As per SRO

2x7’s

Motelukast of

Accord

Healthcare

Aerokast of

Barrett &

Hodgson (Pvt)

Limited Karachi

Deferred till

rectifications of

shortcomings as

mentioned in

GMP inspection

report dated

23.07.2014.

172

274. -do- FINFLEX-S Tablets 50mg

Each enteric coated tablet

contains:

Diclofenac Sodium

BP…….50mg

Antirehumatic

BP

Form-5

20-09-2010

Dy. No. 1147

20,000/-

As per SRO

2x10’s

Voltral of

Novartis

Fastaid of

Platinum

Pharma Karachi

Master formulation

submitted is of film

coated tablets

however applied

product is enteric

coated.

Deferred till

rectifications of

shortcomings as

mentioned in

GMP inspection

report dated

23.07.2014 &

rectification of

following

observation:

Master

formulation is of

film coated

tablets while

applied product

should be

enteric coated.

275. -do- FINFLEX-S Tablets 75mg

Each enteric coated tablet

contains:

Diclofenac Sodium

BP…….75mg

Antirehumatic

BP

Form-5

20-09-2010

Dy. No. 1142

20,000/-

As per SRO

2x10’s

Diclofenac

sodium of

Sandoz

(USFDA)

Fastaid of

Platinum

Pharma Karachi

Master formulation

submitted is of film

coated tablets

however applied

product is enteric

coated.

Deferred till

rectifications of

shortcomings as

mentioned in

GMP inspection

report dated

23.07.2014 &

rectification of

following

observation:

Master

formulation is of

film coated

tablets while

applied product

should be

enteric coated.

276. -do- FEDRACAM-BCD Tablets

20mg


Piroxicam as Beta

Cyclodextrin……20mg

NSAID

Manufacturer

Form-5

20-09-2010

Dy. No. 1140

20,000/-

As per SRO

2x10’s

Brexidol of

Chesi (BNF)

Brexin of Chiesi

Karachi.

Master formulation

needs rectification

regarding quantity

of API.

Deferred till

rectifications of

shortcomings as

mentioned in

GMP inspection

report dated

23.07.2014 &

rectification of

following

observation:

Master

formulation

needs

rectification

regarding

173

quantity of API.

277. -do- CERIGEX-L Tablet 5mg


contains:

Levocetirizine as

dihydrochloride…..5mg

Antihistamine

Manufacturer

Form-5

20-09-2010

Dy. No. 1139

20,000/-

As per SRO

Pack of 10’s

Levocetirizine

of Actavis UK

Alergocit of

Global Pharma

Islamabad.

Deferred till

rectifications of

shortcomings as

mentioned in

GMP inspection

report dated

23.07.2014

278. -do- DI- METHER Tablets


Artemether ……40mg

Lumefantrine….240mg

Antimalarial

USP (Salmus)

Form-5

20-09-2010

Dy. No. 1145

20,000/-

As per SRO

Pack of 10’s

WHO

recommended

Formulation

Artem DS of

Hilton

Deferred till

rectifications of

shortcomings as

mentioned in

GMP inspection

report dated

23.07.2014

279. M/s Asian

Continental

(Pvt) Limited,

Karachi

FEVEREN 6 Plus

Suspension

Each 5ml contains:

Paracetamol……..250mg

Analgesic and Antipyretic

USP

Form-5

Dated: 08-10-

2010

8,000/-

Dated: 31-07-

2013

12000/-

As per SRO/

Pack of 1’s

90ml bottle

Calpol 6 Plus

(BNF)

Calpol 6 Plus

GSK Karachi

Inspection of

the firm was

conducted on

09-09-14 by the

area FID and

concluded that

the firm is

working at

acceptable level

of GMP

compliance.

Approved.

280. -do- ATIZA Syrup 2.5mg/ 5ml

Each 5ml contains

Levocetirizine

dihydrochloride……..2.5mg

Antihistamine

Manufacturer

Form-5

Dated: 12-10-

2010

8,000/-

Dated: 31-07-

2013

12000/-

As per SRO/

Pack of 1’s

90ml bottle

Xyzal Oral

Solution

(USFDA)

T-Day of

Novartis

Karachi

Approved.

174

281. -do- FEVEREN Tablet 500mg


Pracetamol……500mg

Analgesic

Manufacturer

Form-5

Dy. No: 1916/

29-10-10

8,000/-

As per PRC

Panadol GSK

USA

Panadol GSK

Karachi

Approved.

282. -do- FEVEREN Extra Tablet

500mg


Pracetamol……500mg

Caffiene…….65mg

Analgesic

Form-5

Dy. No: Not

provided

8,000/- dated

27-10-10

As per PRC

Panadol Extra

GSK USA

Panadol Extra

GSK Karachi.

Approved.

283. M/s Linear

Pharma, Rawat

Islamabad

FACAL Tablet


Alfacalcidol….0.25mg

Elemental

Calcium…..50mg

Vitamin D supplement

Manufacturer

Form-5

Dy. No: 9229

dated 06-10-10

20,000/-

As per SRO/

Pack of 10’s

Not available in

SRA’s

Me too status

needs

confirmation.

Inspection of

the firm was

conducted by

the area FID on

13-11-14 and

the was

complying the

GMP

Deferred for

confirmation of

approval in

reference

Stringent

Regulatory

Agencies & me

too status.

284. -do- ALEND Tablets


Alendronate as

sodium…..10mg

Biphosphonates

Manufacturer

Form-5

Dy. No: 1139

dated 03-11-10

20,000/-

As per SRO/

Pack of 10’s

Alendronic acid

of Accord

HealthCare UK

Alendrate of

Global Pharma

Approved.

285. -do- DOMELATE-C Tablet


Domperidone as

meleate….15mg

Form-5

Dy. No: 1148

dated 03-11-10

Not available in

SRA’s

Me too status

needs

Deferred for

review of

formulation by

Review

Committee.

175

Cinnarizine……25mg

Antidopaminergic/

Antihistamine

Manufacturer

20,000/-

As per SRO/

Pack of 2x10’s

confirmation

286. -do- DIVAL Tablets

Each delayed release tablet

contains:

Divalproex

sodium…….500mg

Antiepileptic

USP

Form-5

Dy. No: 1147

dated 03-11-10

20,000/-

As per SRO/

Pack of

10x10’s

Depakote of

Abbive

Divarex of

Medera Pharma

Approved.

287. -do- DIVAL Tablets

Each delayed release tablet

contains:

Divalproex

sodium…….250mg

Antiepileptic

USP

Form-5

Dy. No: 1146

dated 03-11-10

20,000/-

As per SRO/

Pack of

10x10’s

Depakote of

Abbive

Divarex of

Medera Pharma

Approved.

288. -do- LINQUE Tablets


contains:

Quetiapine Fumarate

equivalent to

Quetiapine….200mg

Hypnotic

Form-5

Dy. No: 1151

dated 03-11-10

20,000/-

As per SRO/

Pack of 3x10’s

Seroquel of

AstraZeneca

(USFDA)

Dequit of

Shaheen

Pharma

Approved.

289. -do- LINQUE Tablets


contains:

Quetiapine Fumarate

equivalent to

Quetiapine….400mg

Hypnotic

Manufacturer

Form-5

Dy. No: 1150

dated 03-11-10

20,000/-

As per SRO/

Pack of 10’s

Seroquel of

AstraZeneca

(USFDA)

Dequit of

Shaheen

Pharma

Approved.

176

290. -do- ALMOVAL Tablets


contains:

Amlodipine as

besylate……5mg

Valsartan….80mg

Antihypertensive

Manufacturer

Form-5

Dy. No: 1142

dated 03-11-10

20,000/-

As per SRO/

Pack of 14’s

Exforge of

Novartis

(USFDA)

Exforge of

Novartis

Karachi

Approved.

291. -do- AMEASAID Tablets

Each sugar coated tablet

contains:

Flurbiprofen….100mg

Antirheumatic

Manufacturer

Form-5

Dy. No: 1152

dated 03-11-10

20,000/-

As per SRO/

Pack of 30’s

Froben Tablet

of Abbot

HealthCare UK

Ansaid of Pfizer

Karachi

Approved (As

sugar coated

approved in

UK).

292. -do- ALDONATE Tablet


contains:

Methyldopa….250mg

Antihypertensive

Manufacturer

Form-5

Dy. No: 1155

dated 03-11-10

20,000/-

As per SRO/

Pack of 100’s

Aldomet of

Aspen UK

Aldomet of

MSD

Approved.

293. -do- LINESTIN Tablet


contains:

Ebastine……10mg

Antihistamine

Form-5

Dy. No: 1149

dated 03-11-10

20,000/-

As per SRO/

Pack of 10’s

Aerius of

Dermagen

Pharma

Islamabad

Approved.

294. -do- L-FENAC Capsule


Acitretin…..10mg

Vitamin A Derivative

Form-5

Dy. No: 1136

dated 03-11-10

20,000/-

As per SRO/

Pack of 3x10’s

Acitretin

Capsules of

Genus

Pharmaceuticals

UK

Neotigason of

Roche Karachi

Approved.

177

295. -do- TOLFERID Tablet


contains:

Tolterodine tartrate…..2mg

Urinary antispasmodic

Manufacturer

Form-5

Dy. No: 1153

dated 03-11-10

20,000/-

As per SRO/

Pack of 28’s

Detrusitol

Tablet of Pfizer

UK

Detrusitol

Tablet of Pfizer

Karachi

Approved.

296. -do- OFLOX Tablet


contains:

Ofloxacin……200mg

Fluoroquinolone

Manufacturer

Form-5

Dy. No: 9221

dated 06-10-10

20,000/-

As per SRO/

Pack of 10’s

Terivid of

Sanofi UK

Treivid of

Sanofi Karachi

Approved.

297. -do- CITAL Tablet


contains:

Escitalopram as

oxalate……10mg

Antidepressant

Manufacturer

Form-5

Dy. No: 9228

dated 06-10-10

20,000/-

As per SRO/

Pack of 10’s

Not available in

SRA’s

Me too status

needs

confirmation

Deferred for

approval in

reference

Stringent

Regulatory

Agencies & me

too status.

298. -do- LEVRINE Tablets


contains:

Alverine Citrate…..60mg

Simethicone….300mg

Antispasmodic

Manufacturer

Form-5

Dy. No: 1140

dated 03-11-10

20,000/-

As per SRO/

Pack of 2x10’s

Not available in

SRA’s

Me too status

needs

confirmation.

Deferred for

approval in

reference

Stringent

Regulatory

Agencies & me

too status.

299. -do- TAMSIN Capsule


Tamsulosin HCL as

modified release pellets

(0.2%) equivalent to

Tamsulosin……0.4mg

Alpha-1 Blocker

Manufacturer

Form-5

Dy. No: 1154

dated 03-11-10

20,000/-

As per SRO/

Pack of 10’s

Flomax MR

Capsules of

Boehringer

Inghelheim UK

Tamsolin of

Getz Karachi

Approved.

178

Source: Vision

Pharmaceuticals Islamabad

300. -do- LINAKSAT Tablets


contains:

Montelukast as

sodium……10mg

Antihistamine

Manufacturer

Form-5

Dy. No: 9222

dated 06-10-10

20,000/-

As per SRO/

Pack of 30’s

Singulair of

MSD

Montiget of

Getz Karachi

Approved.

301. -do- GEMNILOX Tablets


contains:

Gemifloxacin as

mesylate…..320mg

Quinolone

Manufacturer

Form-5

Dy. No: 1157

dated 03-11-10

20,000/-

As per SRO/

Pack of 7’s

Factive of LG

Life Sciences

(USFDA)

Factiflox of

Envoy Pharma

Approved.

302. -do- LINPRIDE Tablets


Amisulpride…..50mg

Antipsycotic

Manufacturer

Form-5

Dy. No: 1141

dated 03-11-10

20,000/-

As per SRO/

Pack of 2x10’s

Solian Tablet

Solian Tablet of

Sanofi Karachi

Approved.

303. -do- DOB-C Capsules


Calcium

dobisilate….500mg

Vasotherapeutic

Form-5

Dy. No: 1138

dated 03-11-10

20,000/-

As per SRO/

Pack of 2x10’s

Not available in

SRA’s

Doxium of AGP

Karachi

Deferred for

review of

formulation by

the Review

Committee.

304. M/s Caraway

Pharmaceuticals,

Islamabad.

ONDENLES Injection 8mg

Each ml contains:

Ondansetron hydrochloride

dihydrate equivalent to

Ondansetron……2mg

5HT-3 Antagonist

Form-5

Dy. No: 9773

dated 18th

October 2010

20,000/-

Zofran of GSK

Zofran of GSK,

Karachi

The inspection

of the firm was

conducted on

a. Evidence of

availability of

TOC and liquid

particle counter

is not provided

by the firm.

b. Latest

inspection

Deferred for the

followings:

1. Confirmation

of installation

and operational

qualifications of

TOC analyser

and liquid

179

USP

As per SRO 24-09-12 by the

panel of

inspectors and

they concluded

that the firm is

operating at

good level of

GMP

compliance.

report is

required.

particle counter

by FID.

2. Latest

inspection report

is required.

305. -do- ONDENLES Tablet 8mg


contains:

Ondansetron hydrochloride

dihydrate equivalent to

Ondansetron……8mg

5HT-3 Antagonist

USP

Form-5

Dy. No: 9774

dated 18th

October 2010

20,000/-

As per SRO

Zofran of GSK

Zofran of GSK,

Karachi

Latest inspection

report is required.

Deferred for

latest GMP

status of the

firm.

306. M/s Genix

Pharma (Pvt)

Limited,

Karachi.

GRANI Tablet


contains:

Granisetron HCL equivalent

to Granisetron…….1mg

Antiemetic

Manufacturer

Form-5

Dy. No: 1899

dated 29-10-10

8,000/-

Rs. 3250/-

Pack of 10’s

Rs. 6500/-

Pack of 20’s

Kytril Tablet of

Roche

Kytril Tablets

of Roche

Karachi

Inspection of

the firm was

conducted on

30-04-14 by the

area FID and

GMP

compliance is

rated as GOOD

Approved.

307. -do- GRANI Syrup

Each 5ml contains:

Granisetron HCL equivalent

to Granisetron…….1mg

Antiemetic

Manufacturer

Form-5

Dy. No: 1907

dated 29-10-10

8,000/-

Rs. 210/- Pack

of 30ml

Rs. 420/- Pack

of 60ml

Kytril Syrup of

Roche

Graniset Syrup

of SJ & G Fazul

Elahi Karachi

Approved.

180

Evaluator – III (Veterinary Cases)

S/N Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary name

+ Dosage Form +

Strength)

Composition

Pharmacological

Group

Finished product

Specification

Type of Form

Initial date,

diary

Fee including

differential fee

Demanded

Price / Pack

size

Remarks on the

formulation (if

any) including

International

status in

stringent drug

regulatory

agencies /

authorities

Me-too status

GMP status as

depicted in latest

inspection report

(with date) by the

Evaluator

Recommendat

ions by the

Evaluators

Decision

308. M/s Noble

Pharma, Mirpur

Azad Kashmir

NOBI-LINCOL

Powder

Each 1gm contains:

Lincomycin

Sulphate…..100mg

Colistin

Sulphate……8,00,0

00IU

Antibacterial

Manufacturer

Form-5

Dy. No: 05

dated 02-10-10

20,000/-

Decontrolled/

100gm, 500gm

and 1kg

Vety Lincon

Powder of Leads

Pharma Karachi.

Approved.

309. -do- TRIDOX-TD Oral

Powder

Each 1000gm

contains:

Doxycycline

HCL……200gm

Tylosin

Tartrate…..100gm

Bromohexine

HCL…..5ogm

Colistin

sulphate…..48MIU

Form-5

Dy. No: 85

dated 08th

November 2010

20,000/-

Decontrolled/

100gm, 500gm,

and 1Kg

Pulmotin Water

Soluble Powder of

Attabak Pharma

Islmabad.

Approved.

181

Evaluator – III (Import applications)

S/N Name and

address of

manufacturer

/ Applicant

Brand Name

(Proprietary name

+ Dosage Form +

Strength)

Composition

Pharmacological

Group

Finished product

Specification

Type of Form

Initial date,

diary

Fee including

differential fee

Demanded

Price / Pack

size

Remarks on

the

formulation

(if any)

including

International

status in

stringent

drug

regulatory

agencies /

authorities

Me-too status

GMP status

as depicted in

latest

inspection

report (with

date) by the

Evaluator

Recommendation

s by the

Evaluators

Decision

310. Applicant

M/s Bajwa

Sons, 129

Circular Road,

Lohari Lahore

Manufacturer

Shanghai

Transfusion

Technology

Co. Ltd.

Add: No.500

You Dong

Road,

Minhang,

Shanghai,

201100, P.R of

China

Famous Brand

Single Blood Bags

Each 100ml of

CPDA (Citrate

Phosphate Dextrose

Adenine Solution,

Anticoagulant)

contains:

Citric acid

monohydrate……0

.299g

Sodium citrate

dihydrate…………

2.63g

Sodium

biphosphate

monohydrate……0

.222g

Dextrose

monohydrate……..

3.19g

Adenine……….0.0

275g

Form-5A

Dy No: Not

provided

15000/- dated

08-10-10

Rs 150/ Blood

Bag of 250ml

Rs 150/ Blood

Bag of 450ml

Rs 160/ Blood

Bag of 500ml

a. Evidence of

Balance fee is

not submitted.

b. Stability studies

as per Zone-IV-

A conditions as

per ICH/ WHO

guidelines need

to be submitted.

c. Original

Legalized and

valid COPP as

per WHO format

or original and

legalized GMP

certificate along

with Free sale

certificate from

regulatory body

of country of

origin, needs to

be submitted.

d. Clinical trial

data is not

submitted.

Deferred for the

followings:

1. Evidence of

Balance fee is not

submitted.

2. Stability studies as

per Zone-IV-A

conditions as per

ICH/ WHO

guidelines need to be

submitted.


and valid COPP as

per WHO format or

original and legalized

GMP certificate along

with Free sale

certificate from

regulatory body of

country of origin,

needs to be

submitted.

4. Clinical trial data is

not submitted.

5. Packaging material

182

Water for

Injection….Qs

Disposable

e. Packaging

material

specification are

not provided

specification has not

been provided

311. Applicant

M/s Bajwa

Sons, 129

Circular Road,

Lohari Lahore

Manufacturer

Shanghai

Transfusion

Technology

Co. Ltd.

Add: No.500

You Dong

Road,

Minhang,

Shanghai,

201100, P.R of

China

Famous Brand

Double Blood Bags

Each 100ml of

CPDA (Citrate

Phosphate Dextrose

Adenine Solution,

Anticoagulant)

contains:

Citric acid

monohydrate……0

.299g

Sodium citrate


2.63g

Sodium

biphosphate

monohydrate……0

.222g

Dextrose

monohydrate……..

3.19g

Adenine……….0.0

275g

Water for

Injection….Qs

Disposable

Form-5A

Dy No: 29 dated

08-10-10

15000/- dated

08-10-10

Rs 300/ Blood

Bag of 450ml

Rs 315/ Blood

Bag of 500ml

a. Evidence of

Balance fee is

not submitted.


as per Zone-IV-

A conditions as

per ICH/ WHO

guidelines need

to be submitted.

c. Original

Legalized and

valid COPP as

per WHO format

or original and

legalized GMP

certificate along

with Free sale

certificate from

regulatory body

of country of

origin, needs to

be submitted.

d. Clinical trial

data is not

submitted.

e. Packaging

material

specification are

not provided

Deferred for the

followings:

1. Evidence of

Balance fee is not

submitted.


per Zone-IV-A

conditions as per

ICH/ WHO


submitted.


and valid COPP as

per WHO format or



with Free sale

certificate from

regulatory body of

country of origin,

needs to be

submitted.


not submitted.



been provided

312. Applicant

M/s Bajwa

Sons, 129

Circular Road,

Lohari Lahore

Manufacturer

Shanghai

Transfusion

Technology

Co. Ltd.

Add: No.500

You Dong

Road,

Minhang,

Famous Brand

triple Blood Bags

Each 100ml of

CPD (Citrate

Phosphate Dextrose

Solution,

Anticoagulant)

contains:

Citric acid

monohydrate……0

.299g

Sodium citrate


2.63g

Form-5A

Dy No: Not

provided

15000/- dated

08-10-10

Rs 510/ Blood

Bag of 450ml

Rs 525/ Blood

Bag of 500ml

a. Evidence of

Balance fee is

not submitted.


as per Zone-IV-

A conditions as

per ICH/ WHO

guidelines need

to be submitted.

c. Original

Legalized and

valid COPP as

per WHO

format or

original and

Deferred for the

followings:

1. Evidence of

Balance fee is not

submitted.


per Zone-IV-A

conditions as per

ICH/ WHO


submitted.


and valid COPP as

per WHO format or


183

Shanghai,

201100, P.R of

China

Sodium

biphosphate

monohydrate……0

.222g

Dextrose

monohydrate……..

3.19g

Water for

Injection….Qs to

100ml

Each 100ml of

SAGM (Saline

Adenine Glucose

Mannitol, Red

Blood Cell

Preservative)

contains:

Dextrose

monohydrate…..0.

900g

Sodium

chloride…..0.877g

Adenine…….0.016

9g

D-

Mannitol…….0.52

5g

Water for

Injection….qs to

100ml

Disposable

legalized GMP

certificate

along with Free

sale certificate

from regulatory

body of country

of origin, needs

to be submitted.

d. Clinical trial

data is not

submitted.

e. Packaging

material

specification

are not

provided


with Free sale

certificate from

regulatory body of

country of origin,

needs to be

submitted.


not submitted.



been provided

313. Applicant

M/s Bajwa

Sons, 129

Circular Road,

Lohari Lahore

Manufacturer

Shanghai

Transfusion

Technology

Co. Ltd.

Add: No.500

You Dong

Road,

Minhang,

Shanghai,

Famous Brand

Quadruple Double

Blood Bags

Each 100ml of

CPD (Citrate

Phosphate Dextrose

Solution,

Anticoagulant)

contains:

Citric acid

monohydrate……0

.299g

Sodium citrate


2.63g

Form-5A

Dy No: Not

provided

15000/- dated

08-10-10

Rs 440/ Blood

Bag of 450ml

Rs 445/ Blood

Bag of 500ml

a. Evidence of

Balance fee is

not submitted.


as per Zone-IV-

A conditions as

per ICH/ WHO

guidelines need

to be submitted.

c. Original

Legalized and

valid COPP as

per WHO

format or

original and

legalized GMP

Deferred for the

followings:

1. Evidence of

Balance fee is not

submitted.


per Zone-IV-A

conditions as per

ICH/ WHO


submitted.


and valid COPP as

per WHO format or



184

201100, P.R of

China

Sodium

biphosphate

monohydrate……0

.222g

Dextrose

monohydrate……..

3.19g

Water for

Injection….Qs to

100ml

Each 100ml of

SAGM (Saline

Adenine Glucose

Mannitol, Red

Blood Cell

Preservative)

contains:

Dextrose

monohydrate…..0.

900g

Sodium

chloride…..0.877g

Adenine…….0.016

9g

D-

Mannitol…….0.52

5g

Water for

Injection….qs to

100ml

Disposable

certificate

along with Free

sale certificate

from regulatory

body of country

of origin, needs

to be submitted.

d. Clinical trial

data is not

submitted.

e. Packaging

material

specification

are not

provided

with Free sale

certificate from

regulatory body of

country of origin,

needs to be

submitted.


not submitted.



been provided

185

Case No.07. Remaining drug registration applications of previously approved new sections

Evaluator – I

M/s Stallion Pharmaceuticals (Pvt) Ltd, Lahore have informed that their 04 products were deferred in

244th meeting of Registration Board held on 8

th and 9

th May, 2014 due to confirmation of manufacturing

facility and that they are now under process of developing a dedicated Carbapenem facility and that the

04 deferred products may be considered of their approved manufacturing facility. The firm has requested

consideration of the following 04 products on priority basis (according to 10 products per section policy).

S.

N

Name and address

of Manufacturer /

Applicant

Brand Name

(Proprietary

name + Dosage

form + Strength)

Composition

Pharmacological

Group

Finished product

specification

Type of Form

Initial date,

diary.

Fee including

differential fee

Demanded Price

/ Pack size

International

status in

stringent

regulatory

agencies

Me-too status

GMP status as

depicted in

inspection

report (dated)

Remarks /

Observations

Decision

314. M/s. Stallion

Pharmaceuticals

(Pvt) Ltd, 581-

Sunder Industrial

Estate, Lahore

New License

1.Capsule.(Penicillin

)

2.Dry Powder

Suspension

(Penicillin)

3.Dry Powder

Injection (Penicillin)

Vide letter No. F. 1-

33/2009 – Lic dated

6th February, 2014

Fluclox Injection

500mg

Dry Powder

Injection

Each vial

contains:-

Flucloxacillin

Sodium (B.P) eq.

to Flucloxacillin

………………..

500mg

(Penicillin)

BP Specifications

Form-5

27-10-2014

1336 R&I

Rs. 20,000/-

Pack of one Rs.

90/-

Pack of 5 Rs.

450/-

Pack of 10 Rs.

900/-

FLOXAPEN

Injection 500mg

MHRA UK

A-FLOX

500mg Injection

Laderly

N/A (New

License)

Approved.

315. -do- Staclox Injection

Dry Powder

Injection

Form-5

27-10-2014

1337 R&I

AMPICLOX

250/250mg

Injection

MHRA

Approved.

186

Each vial

contains:-

Ampicillin

Sodium (B.P) eq.

to Ampicillin

………………..

250mg

Cloxacillin

Sodium (B.P) eq.

to Cloxacillin

250mg

(Penicillin)

Manufacturers

Specifications

Rs. 20,000/-

Pack of one Rs.

70/-

Pack of 5 Rs.

350/-

Pack of 10 Rs.

700/-

AMPICLOX

500mg Injection

Gsk

N/A (New

License)

316. -do- Flustal Injection

Dry Powder

Injection

Each vial

contains:-

Amoxicillin

Sodium (B.P) eq.

to

Amoxicillin……..

….. 250mg

Flucloxacillin

Sodium (B.P) eq.

to Flucloxacillin

…………………

250mg

(Penicillin)

Manufacturers

Specifications

Form-5

27-10-2014

1338 R&I

Rs. 20,000/-

Pack of one Rs.

144/-

Pack of 5 Rs.

720/-

Pack of 10 Rs.

1440/-

FLUMOX

250/250mg Inj

EIPICO, Egypt

Biflocin

500mg Inj

Zam Zam Corp

N/A (New

License)

1) Evidence of

approval of

same

formulation in

Egypt has been

provided

instead of

stringent

regulatory

authority e.g.,

FDA, TGA,

MHLW, EMA

and Health

Canada.

Deferred for

confirmation of

approval in

reference

Stringent

Reulatory

Agencies.

317. -do- Amoxi Injection

500mg (BP)

Dry Powder

Injection

Each Vial

Contains:

Amoxicillin

Sodium ( BP) eq.

Form-5

25-10-2013

643 R&I

Rs. 20,000/-

Rs. 90.0 / 1’s,

Amoxil 500 mg

Vial

MHRA

Amoxil 500 mg

GSK, Pakistan

N/A (New

Approved.

187

to

Amoxicillin ……

500mg

(Penicillin)

BP Specifications

Rs. 900.0 / 10’s

License)

Evaluator – II

The Registration Board has been granting 10 products per section to newly approved sections. Following

are the remaining products of the applicants as per above policy.

S/

N

Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary name +

Dosage Form +

Strength)

Composition

Pharmacological

Group

Finished product

Specification

Type of Form

Initial date, diary

Fee including

differential fee

Demanded Price /

Pack size

Remarks on the


including International

status in stringent drug


authorities

Me-too status

GMP status as depicted

in latest inspection

report (with date) by

the Evaluator

Decision

318. M/s Rogen

Pharmaceuticals

Plot No. 30 Street

No. # S-4 National

Industrial Zone

Rawat Islamabad.

Semi Solid

(Cream/Ointment)

General Section

(No. F. 1-27/2009-

Lic Dated 19-07-10

)

Efrog 13.9%Cream

Each gram contains:-

Eflornithine (as

eflornithine

Hydrochloride

…139mg

(Enzyme Inhibitor)

(Manufacturer’s

Spec.s)

Form 5

26/11/2014 Dy. No.

1907 Rs. 20000/-

As per SRO

BNF: Vaniqa (Almirall),

but in 11.5% strength

Vanika (Crystollite) 13.9

% , Depilus Cream (Atco)

in 11.5% strength but no

pricing

The company may be

issued cGMP Certificate

for export purpose. (09-

06-2014)

1. The product is

available in 11.5 %

Approved in 11.5 %

strength.

188

strength as per BNF.

In Pakistan product is

available in both

13.9% and 11.5 %

strengths but pricing

of 11.5 % strength

could not be traced.

The Firm has

submitted master

formulation of both

strength after

evaluation of initial

dossier and has

requested to grant

them registration of

any one strength.

319. M/s Faas

Pharmaceuticals

(Pvt.) Limited F-

784/L S.I.T.E.

Karachi

Sachet Section:

F. 2-2/2009-Lic

dated 15-02-2013

Antisec Sachet

Each Sachet

contains:-

Racecadotril

(B.P)…10mg

(Anti-Diarrheal)

(Manufacturer’s

Spec.s)

Form 5

29/10/2014 Dy. No.

117 Rs. 20000/-

As per SRO/1×10’s

BNF: Hidrasec (Abbott

Healthcare)

Not confirmed

Satisfactory level of GMP

compliance(18-03-14)

1. Me-too status needs

confirmation.


of me too status

otherwise the firm shall

apply on form 5-D with

fee & other codal

formalities.

320. -do- Antisec Sachet

Each Sachet

contains:-

Racecadotril

(B.P)…15mg

(Anti-Diarrheal)

(Manufacturer’s

Spec.s)

Form 5

29/10/2014 Dy. No.

116 Rs. 20000/-


Not confirmed

Not confirmed



1. International

availability of

formulation in SRA’s

not confirmed.


confirmation.




Agencies & me too

status.

189

321. -do- Antisec Sachet

Each Sachet

contains:-

Racecadotril

(B.P)…30mg

(Anti-Diarrheal)

(Manufacturer’s

Spec.s)

Form 5

29/10/2014 Dy. No.

115 Rs. 20000/-


BNF: Hidrasec (Abbott

Healthcare)

Not confirmed




confirmation.


of me too status



fee & other codal

formalities.

322. -do- Uronol Sachet 3G

Each Sachet

contains:-

Fosfomycin (as

Tromethamine

…3gm

(Anti-bacterial)

(Manufacturer’s

Spec.s)

Form 5

29/10/2014 Dy. No.

114 Rs. 20000/-


Health Canada: Monurol

(Triton Pharma Inc.)

Not confirmed


compliance (18-03-14)


confirmation.


of me too status



fee & other codal

formalities.

323. -do- Ostrolife Sachet

Each Sachet

contains:-

Cholecalciferol

(USP)…60,000IU

(Vitamin)

(Manufacturer’s

Spec.s)

Form 5

29/10/2014 Dy. No.

276 Rs. 20000/-


Not confirmed

Not confirmed



1. International

availability of


not confirmed.


confirmation.




Agencies & me too

status.

324. -do- Oraltral Sachet

(Orange Flavor)

Each Sachet

contains:-

Sodium

Chloride…3.5g

Sodium Citrate

Dihydrate…2.9g

Potassium

Chloride…1.5

Glucose

Anhydrous…20g

(Electrolytes)

(Manufacturer’s

Spec.s)

Form 5

29/10/2014 Dy. No.

271 Rs. 20000/-


Not confirmed

Peditral (Searle)



1. International

availability of


not confirmed. WHO

formulation is sodium

chloride 2.6 g,

potassium chloride

Approved as the

formulation is WHO

approved.

190

1.5 g, sodium citrate

2.9 g, anhydrous

glucose 13.5 g

325. -do- Oraltral Sachet

(Lemon and Lime

Flavor)

Each Sachet

contains:-

Sodium

Chloride…3.5g

Sodium Citrate

Dihydrate…2.9g

Potassium

Chloride…1.5

Glucose

Anhydrous…20g

(Anti-Malarial)

(B.P Spec.s)

Form 5

17/09/2014 Dy. No.

274 Rs. 20000/-


Not confirmed

Peditral (Searle)



1. International

availability of


not confirmed. WHO

formulation is sodium

chloride 2.6 g,

potassium chloride

1.5 g, sodium citrate

2.9 g, anhydrous

glucose 13.5 g.

Approved as the

formulation is WHO

approved.

326. -do- Neomecta Sachet

Each Sachet

contains:-

Dioctahedral

Smectite…3000mg

(Anti-diarrhioeals)

(Manufacturer’s

Spec.s)

Form 5

17/09/2014 Dy. No.

275 Rs. 20000/-


Not confirmed

Smecta (Atco)



1. International

availability of


not confirmed.


formulation by Review

Committee.

327. -do-

Capsule Section:

F. 2-2/2009-Lic

dated 15-02-2013

Itometic Capsule

Each capsule

contains:

Itopride

hydrochloride…150

mg

(as sustained release

pellets)

(Gastoprokinetic /

antiemetic)

(Manufacturer’s

Spec.s)

(Source of Pellets:

Form 5

17/09/2014 Dy. No.

270 Rs. 20000/-


Not confirmed

Ganaton OD (Abbott)



1. Formulation is under

review by the Review

Committee.

2. Fee for import of

pellets, Legalized

Copy of Valid GMP

certificate of


formulation alongwith the

rectification of following

observations:

1. Fee for import of

pellets, Legalized Copy

of Valid GMP certificate

of manufacturer of

Pellets;

2. stability studies

according to zone of

Pakistan of Pellets are

required.

.

191

M/s Titan

Laboratories Private

Limited Plot No.

E27/1, E27/2, MIDC,

Mahad Village Jite

District, Raigad,

Maharashtra, India)

manufacturer of

Pellets; stability

studies according to

zone of Pakistan of

Pellets are required.

328. -do- Azobact Capsule

250mg

Each capsule

contains:

Azithromycine (As

dihydrate)

(USP)..250mg

(Anti-Infective)

(USP Spec.s)

Form 5

17/09/2014 Dy. No.

266 Rs. 20000/-


BNF : Zithromax

(Pfizer)

Azomax (Novartis)



Approved.

329. -do- Pirotrin 20mg

Capsule

Each capsule

contains:

Piroxicam beta

cyclodextrin eq. to

Piroxicam……..20

mg

(Analgesic / anti-

rheumatic/ anti

pyretic)

(Manufacturer’s

Spec.s)

Form 5

17/09/2014 Dy. No.

267 Rs. 20000/-


BNF : Feldene (Pfizer)

Pirobet (Highnoon)



Approved.

330. -do- Tamsol 0.4mg

Capsule

Each capsule

contains:-

Tamsulosin

hydrochloride(as

modified release

pellets)…….0.4 mg

(Anti BPH)

(USP Spec.s)

{Source: M/s Vision


No 224, Street No.

Form 5

17/09/2014 Dy. No.

268 Rs. 20000/-


BNF: Tamsulosin

hydrochloride (Non-

proprietary)

Tamsolin (Getz)


compliance (18-03-14)

1. Certificate of

Analysis, stability

studies according to

zone of Pakistan of

Pellets are required.

Approved. Firm will

provide Certificate of

Analysis and stability

studies of pellets

according to zone IV A

and Chairman, RB will

permit issuance of


192

Evaluator – III

S/N Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary name +

Dosage Form +

Strength)

Composition

Pharmacological

Group

Finished product

Specification

Type of

Form

Initial date,

diary

Fee

including

differential

fee

Demanded

Price / Pack

size

Remarks on

the

formulation (if

any) including

International

status in

stringent drug

regulatory

agencies /

authorities

Me-too status

GMP status as

depicted in

latest

inspection

report (with

date) by the

Evaluator

Recommendations

by the Evaluator

Decision

331. M/s Wenovo

Pharmaceuticals,

Taxila

(Dry Powder Vial

Injectable)

CLARITHREM

Injection

Each vial contains:

Clarithromycin

….….500mg

Macrolide

BP

Form-5

Dy No: 864

dated 24-09-

2014

20,000/-

As fixed by

Govt.

Pack of 1’s

Klaricid of

Abbott UK

(Lyophilized

Powder)

Clariset of

Mediate

Pharma

Approved.

332. -do- LANSOP Injection

30mg

Each vial contains:

Lansoprazole……30mg

PPI

Manufacturer

Form-5

Dy No: 863

dated 24-09-

2014

20,000/-

As fixed by

Govt.

Pack of 1’s

Prevacid of

Takeds Pharm

(USFDA)

Lyophilized

Powder

Lansit of SJ &

G Fazul Elhahi

Karachi

Approved.

01, I-10/3 , Industrial

area, Islamabad}

193

333. -do- PANTOWEN Injection

Each vial contains:

Pantoprazole as

sodium…..40mg

PPI

Manufacturer

Form-5

Dy No: 862

dated 24-09-

2014

20,000/-

As fixed by

Govt.

Pack of 1’s

Protonix of

Wyeth

(USFDA)

Lyophilized

powder

Lesprot of

Nabiqasim

Karachi

Approved.

334. -do- AZINOV Injection

Each vial contains:

Azithromycin….500mg

Macrolide

Manufacturer

Form-5

Dy No: 862

dated 24-09-

2014

20,000/-

As fixed by

Govt.

Pack of 1’s

Zithromax of

Pfizer

(USFDA)

Lyophilized

Powder

Azimycin of

Medicina

Pharma Lahore

Approved.

335. -do-

(Capsule General)

WENOLOX Capsule


Duloxetine as HCL

enteric coated pellets

(17%) eq. to

Duloxetine…..30mg

Antidepressant

Manufacturer

Source: Vision Pharma

Islamabad

Form-5

Dy No: 1277

dated 24-10-

2014

20,000/-

As per policy

of MOH

1x10’s

Cymbalta of

EliLilly

Netherlands

Duxafit of

Wnsfield Hattar

Approved.

336. -do-

WENOLOX Capsule


Duloxetine as HCL


(17%) eq. to

Duloxetine…..60mg

Antidepressant

Manufacturer

Form-5

Dy No: 1276

dated 24-10-

2014

20,000/-

As per policy

of MOH

1x10’s

Cymbalta of Eli

Lilly

Netherlands

Duxafit of

Wnsfield Hattar

Approved.

194

337. -do- GABANOV Capsules


Gabapentin…..300mg

Anticonvulsant

USP

Form-5

Dy No: 1274

dated 24-10-

2014

20,000/-

As per policy

of MOH

1x10’s

Gabapentin

Capsules of

Sandoz UK

Nerogabin of

Merck

Approved.

338. -do- GABANOV Capsules


Gabapentin…..400mg

Anticonvulsant

USP

Form-5

Dy No: 1275

dated 24-10-

2014

20,000/-

As per policy

of MOH

1x10’s

Gabapentin

Arrow 400mg

Hard Capsules

of Actavis UK

Nerogabin of

Merck

Approved

339. -do-

(Liquid Ampoule

SVP)

TRAMANOV Injection

Each 2ml ampoule

contains:

Tramadol

HCL……100mg

Synthetic opiate

analogue

Manufacturer

Form-5

Dy No: 1273

dated 23-10-

2014

20,000/-

As per policy

of MOH

Pack of 5’s &

10’s

Tramdol

Injection of

Beacon Pharma

UK

Lamadol of

Brooks Karachi

Evidence of

availability of TOC

analyzer and liquid

particle counter is

required.

Deferred for

confirmation of

installation and

operational

qualifications of

TOC analyser &

liquid Particle

Counter by Area

FID.

340. -do- WENOFEN Injection

Each 2ml of amber

glass ampoule contains:

Diclofenac

Sodium…..75mg

Lidocaine

HCl…..20mg

Analgesic, Local

anesthetic

Manufacturer

Form-5

Dy No: 1272

dated 23-10-

2014

20,000/-

As per policy

of MOH

Pack of 5’s &

10’s

Availability in

SRA’s needs

confirmation

Dinopen of

Global Pharma,

Islamabad.

Evidence of

availability of TOC

analyzer and liquid

particle counter is

required.

Deferred for

confirmation of

installation and

operational

qualifications of

TOC analyser &

liquid Particle

Counter by Area

FID.

195

Evaluator – III (Veterinary applications)

S/N Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary name +

Dosage Form +

Strength)

Composition

Pharmacological

Group

Finished product

Specification

Type of Form

Initial date,

diary

Fee including

differential

fee

Demanded

Price / Pack

size

Remarks on the

formulation (if

any) including

International

status in

stringent drug

regulatory

agencies /

authorities

Me-too status

GMP status as

depicted in

latest

inspection

report (with

date) by the

Evaluator

Remarks by the

Evaluator

Decision

341. M/s Noble

Pharma, Mirpur

Azad Kashmir

Liquid Injection

Section

(Veterinary)

Approved vide

letter No. F.5-

2/207 Lic dated:

18-02-13

Nobivec Injection 2%

Each ml contains:

Ivermectin……..20mg

Antiparasitic

BP

Form-5

Dy. No: 65

dated 20-07-14

20,000/-

Decontrolled/

Pack of 50ml

Elvomec D/S of

Elko Karachi

Inspection of the

firm was

conducted by

the area FID and

firm was found

GMP compliant.

Deferred for

confirmation of

installation and

operational

qualifications of

liquid Particle

Counter by Area

FID.

342. -do- Nobivec Injection 1%

Each ml contains:

Ivermectin……..10mg

Antiparasitic

BP

Form-5

Dy. No: 66

dated 20-07-14

20,000/-

Decontrolled/

Pack of 50ml

Actimec

Injection of

Selmore

Pharmaceuticals

Lahore.

Deferred for

confirmation of

installation and

operational

qualifications of

liquid Particle

Counter by Area

FID.

196

Case No.08. Registration applications of Pregabalin deferred in previous meetings of

Registration Board

Evaluator - I

Sr.

No.

Name and address

of Manufacturer /

Applicant

Brand Name

(Proprietary name

+ Dosage form +

Strength)

Composition

Pharmacological

Group

Finished product

specification

Type of Form

Initial date,

diary.

Fee including

differential fee

Demanded

Price / Pack

size

International

status in

stringent

regulatory

agencies

Me-too status

GMP status as

depicted in

inspection

report (dated)

Remarks /

Observations

Decision

343. M/S CCL

Pharmaceutical

(Pvt.) Ltd. 62-

Industrial Estate ,

Kot Lakhpat,

Lahore.

Achlin Capsule

25mg

Capsule

Each Capsule

Contains:

Pregabalin……25

mg

(Antiepileptics,

other antiepileptics)

Manufacturers

specifications

Form 5

14-11-2005

Rs.8000/-

Dy. No. Not

mentioned

14-02-2014

Dy. No.596

Rs.12000/-

14’s/ As Per

Brand Leader

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

ZEEGAP

Capsules (25, 50,

75, 100 and

150mg)

Hilton

Panel inspection

for the grant of

GMP certificate

conducted on

06/11/2013,

12/12/2013 &

18/12/2013.

Capsule

(General) section

mentioned in

Issuance of /

Revalidation of

DML vide letter

No. F. 1-8/84-Lic

(Vol. II)

Approved.

344. M/S CCL

Pharmaceutical

Achlin Capsule

50mg

Form 5

LYRICA

Capsules (25, 50,

Approved.

197

(Pvt.) Ltd. 62-

Industrial Estate ,

Kot Lakhpat,

Lahore.

Capsule

Each Capsule

Contains:

Pregabalin……50

mg

(Antiepileptics,


Manufacturers

specifications

14-11-2005

Rs.8000/-

Dy. No. Not

mentioned

14-02-2014

Dy. No.596

Rs.12000/-

14’s/ As Per

Brand Leader

75, 100,

150,200, 225 and

300mg)

US FDA

ZEEGAP

Capsules (25, 50,

75, 100 and

150mg)

Hilton

Panel inspection

for the grant of

GMP certificate

conducted on

06/11/2013,

12/12/2013 &

18/12/2013.

Capsule

(General) section

mentioned in

Issuance of /

Revalidation of

DML vide letter

No. F. 1-8/84-Lic

(Vol. II)

345. M/S CCL

Pharmaceutical

(Pvt.) Ltd. 62-

Industrial Estate ,

Kot Lakhpat,

Lahore.

Achlin Capsule

100mg

Capsule

Each Capsule

Contains:

Pregabalin……100

mg

(Antiepileptics,


Manufacturers

specifications

Form 5

14-11-2005

Rs.8000/-

Dy. No. Not

mentioned

14-02-2014

Dy. No.596

Rs.12000/-

14’s/ As Per

Brand Leader

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

ZEEGAP

Capsules (25, 50,

75, 100 and

150mg)

Hilton

Panel inspection

for the grant of

GMP certificate

conducted on

06/11/2013,

12/12/2013 &

18/12/2013.

Capsule

Approved.

198

(General) section

mentioned in

Issuance of /

Revalidation of

DML vide letter

No. F. 1-8/84-Lic

(Vol. II)

346. M/S NabiQasim

(Pvt) Ltd. 17/24,

Korangi Industrial

Area, Karachi-

Pakistan.

Preka Capsule

150mg

Capsule

Each Capsule

Contains:

Pregabalin……150

mg

(Anticonvulsant)

Manufacturers

Specifications

Form 5

24-04-2008

Rs.8000/-

Dy. No. Not

mentioned

09-09-2013

Rs.12000/-

Dy. No. not

mentioned

duplicate dossier

/

10’s, / Rs. 288/-

20’s / Rs. 547/-

30’s / 799/-

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

ZEEGAP

Capsules (25, 50,

75, 100 and

150mg)

Hilton

Inspection report

dated 18-12-

2013. Capsule

section

mentioned in

report and cGMP

certificate.

Approved.

347. M/S NabiQasim

(Pvt) Ltd. 17/24,

Korangi Industrial

Area, Karachi-

Pakistan.

Preka Capsule

75mg

Capsule

Each Capsule

Contains:

Pregabalin……75

mg

(Anticonvulsant)

Manufacturers

Specifications

Form 5

24-04-2008

Rs.8000/-

Dy. No. Not

mentioned

09-09-2013

Rs.12000/-

Dy. No. not

mentioned

duplicate dossier

/

10’s / Rs.160/-

20’s / Rs. 304/-

30’s / Rs. 444/-

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

ZEEGAP

Capsules (25, 50,

75, 100 and

150mg)

Hilton

Inspection report

dated 18-12-

2013. Capsule

section

mentioned in

report and cGMP

Approved.

199

certificate.

348. M/S NabiQasim

(Pvt) Ltd. 17/24,

Korangi Industrial

Area, Karachi-

Pakistan.

Preka Capsule

50mg

Capsule

Each Capsule

Contains:

Pregabalin……50

mg

(Anticonvulsant)

Manufacturers

Specifications

Form 5

24-04-2008

Rs.8000/-

Dy. No. Not

mentioned

09-09-2013

Rs.12000/-

Dy. No. not

mentioned

duplicate dossier

/

10’s / Rs.144/-

20’s / Rs. 273/-

30’s / Rs. 400/-

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

ZEEGAP

Capsules (25, 50,

75, 100 and

150mg)

Hilton

Inspection report

dated 18-12-

2013. Capsule

section

mentioned in

report and cGMP

certificate.

Approved.

349. M/S NabiQasim

(Pvt) Ltd. 17/24,

Korangi Industrial

Area, Karachi-

Pakistan.

Preka Capsule

100mg

Capsule

Each Capsule

Contains:

Pregabalin……100

mg

(Anticonvulsant)

Manufacturers

Specifications

Form 5

24-04-2008

Rs.8000/-

Dy. No. Not

mentioned

09-09-2013

Rs.12000/-

Dy. No. not

mentioned

duplicate dossier

/

10’s / Rs.201/-

20’s / Rs. 382/-

30’s / Rs. 558/-

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

ZEEGAP

Capsules (25, 50,

75, 100 and

150mg)

Hilton

Inspection report

dated 18-12-

2013. Capsule

section

mentioned in

report and cGMP

certificate.

Approved.

350. M/S Linz

Pharmaceuticals

(Pvt) Ltd., 31-G/H,

Sector 15 Korangi

Industrial Area,

Karachi-Pakistan.

Pegab 300mg

Capsule

Capsule

Each Capsule

Contains:

Pregabalin……300

mg

Form 5

Covering letter

not attached.

Rs.8000/- Jul,

2008

Dy. No. Not

mentioned

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Approved.

200

(Anticonvulsant

Agent)

Manufacturers

specifications

28-05-2014

Rs.12000/-

Dy. No. 802

duplicate dossier

/

14’s/ Rs.390/-

Capsules (50, 75,

100, 150 and

300mg)

Getz

Panel inspection

dated 27-05-

2014. Capsule

section

mentioned. Panel

recommended

grant of renewal.

351. M/S Linz

Pharmaceuticals

(Pvt) Ltd., 31-G/H,

Sector 15 Korangi

Industrial Area,

Karachi-Pakistan.

Pegab 100mg

Capsule

Capsule

Each Capsule

Contains:

Pregabalin……100

mg

(Anticonvulsant

Agent)

Manufacturers

specifications

Form 5

Covering letter

not attached.

Rs.8000/- Jul,

2008

Dy. No. Not

mentioned

28-05-2014

Rs.12000/-

Dy. No. Not

mentioned

14’s/ Rs.291/-

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Panel inspection

dated 27-05-

2014. Capsule

section

mentioned. Panel

recommended

grant of renewal.

Approved.

352. M/S Linz

Pharmaceuticals

(Pvt) Ltd., 31-G/H,

Sector 15 Korangi

Industrial Area,

Karachi-Pakistan.

Pegab 75mg

Capsule

Capsule

Each Capsule

Contains:

Pregabalin……75

mg

(Anticonvulsant

Agent)

Manufacturers

specifications

Form 5

Covering letter

not attached.

Rs.8000/- Jul,

2008

Dy. No. Not

mentioned

28-05-2014

Rs.12000/-

Dy. No. Not

mentioned

14’s/ Rs.237/-

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Panel inspection

dated 27-05-

2014. Capsule

Approved.

201

section

mentioned. Panel

recommended

grant of renewal.

353. M/S Bosch 221,

Bosch House ,

Sector 23, Korangi

Industrial

Area,Karachi.

Gablin 100mg

Capsule

Capsule

Each Capsule

Contains:

Pregabalin……100

mg

(Anticonvulsant

Agent)

Manufacturers

specifications

Form 5

Covering letter

not attached.

June, 2008

Rs.8000/-

Dy. No. Not

mentioned

28-05-2014

Rs.12000/-

803 R&I

14’s / Rs.291/-

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

ZEEGAP

Capsules (25, 50,

75, 100 and

150mg)

Hilton

Inspection report

dated 12-08-

2014. Capsule

section approved

Approved.

354. M/S Bosch 221,

Bosch House ,

Sector 23, Korangi

Industrial

Area,Karachi.

Gablin 75mg

Capsule

Capsule

Each Capsule

Contains:

Pregabalin……75

mg

(Anticonvulsant

Agent)

Manufacturers

specifications

Form 5

Covering letter

not attached.

June, 2008

Rs.8000/-

Dy. No. Not

mentioned

28-05-2014

Rs.12000/-

803 R&I

14’s/ Rs.237/-

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

ZEEGAP

Capsules (25, 50,

75, 100 and

150mg)

Hilton

Inspection report

dated 12-08-

2014. Capsule

section approved

Approved.

355. M/S Bosch 221,

Bosch House ,

Sector 23, Korangi

Industrial

Area,Karachi.

Gablin 300mg

Capsule

Capsule

Each Capsule

Contains:

Pregabalin……300

mg

Form 5

Covering letter

not attached.

June, 2008

Rs.8000/-

Dy. No. 803

28-05-2014

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

ZEEGAP

Capsules (25, 50,

Approved.

202

(Anticonvulsant

Agent)

Manufacturers

specifications

Rs.12000/-

803 R&I

14’s/ Rs.390/-

75, 100 and

150mg)

Hilton

Inspection report

dated 12-08-

2014. Capsule

section approved

356. M/S Sami

Pharmaceutical

Pvt., Limited F-95,

S.I.T.E. Karachi.

Pregy 50mg

Capsule

Capsule

Each Capsule

Contains:

Pregabalin……50

mg

(Anticonvulsant)

Manufacturer

Specifications

Form 5

Rs.8000/-

22-12-2009

Dy. No. not

mentioned

Rs.12000/- fee

challan is

missing

As per PRC

duplicate dossier

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Panel inspection

report dated 24-

06-2014. Panel

recommended

grant of

additional

sections. Capsule

section

mentioned.

Approved.

357. M/S Sami

Pharmaceutical

Pvt., Limited F-95,

S.I.T.E. Karachi.

Pregy 75mg

Capsule

Capsule

Each Capsule

Contains:

Pregabalin……75

mg

(Anticonvulsant)

Manufacturer

Specifications

Form 5

Rs.8000/-

22-12-2009

Dy. No. not

mentioned

Rs.12000/-

29-07-2013

Dy. No. Not

mentioned

As per PRC

duplicate dossier

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Panel inspection

report dated 24-

06-2014. Panel

recommended

grant of

additional

Approved.

203

sections. Capsule

section

mentioned.

358. M/S Sami

Pharmaceutical

Pvt., Limited F-95,

S.I.T.E. Karachi.

Pregy 100mg

Capsule

Capsule

Each Capsule

Contains:

Pregabalin……100

mg

(Anticonvulsant)

Manufacturers

specifications

Form 5

Rs.8000/-

22-12-2009

Dy. No. not

mentioned

Rs.12000/-

29-07-2013

Dy. No. Not

mentioned

As per PRC

Duplicate

dossier

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Panel inspection

report dated 24-

06-2014. Panel

recommended

grant of

additional

sections. Capsule

section

mentioned.

Approved.

359. M/S Sami

Pharmaceutical

Pvt., Limited F-95,

S.I.T.E. Karachi.

Pregy 150mg

Capsule

Capsule

Each Capsule

Contains:

Pregabalin……150

mg

(Anticonvulsant)

Manufacturers

specifications

Form 5

Rs.8000/-

22-12-2009

Dy. No. not

mentioned

Rs.12000/-

29-07-2013

Dy. No. Not

mentioned

As per PRC

Duplicate

dossier

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Panel inspection

report dated 24-

06-2014. Panel

recommended

grant of

additional

sections. Capsule

section

mentioned.

Approved.

360. M/S AGP (Private)

Limited, B-23,

Hi-Gab Capsules

75mg

Form 5

LYRICA

Capsules (25, 50,

Approved.

204

S.I.T.E., Karachi Capsule

Each Capsule

Contains:

Pregabalin……75

mg

(Anti-Epileptic)

Manufacturers

specifications

Rs.8000/-

17-07-2009

Dy. No. not

mentioned

Rs.12000/-

19-03-2014

Dy. No. Not

mentioned

14’s / Rs.565/-

Duplicate

dossier

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Inspection report

dated

26/11/2013.

Capsule section

mentioned in FID

report.


Limited, B-23,

S.I.T.E., Karachi

Hi-Gab Capsules

50mg

Capsule

Each Capsule

Contains:

Pregabalin……50

mg

(Anti-Epileptic)

Manufacturers

specifications

Form 5

Rs.8000/-

17-07-2009

Dy. No. not

mentioned

Rs.12000/-

19-03-2014

Dy. No. Not

mentioned

14’s / Rs.450/-

duplicate dossier

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Inspection report

dated

26/11/2013.

Capsule section

mentioned in FID

report.

Approved.


Limited, B-23,

S.I.T.E., Karachi

Hi-Gab Capsules

200mg

Capsule

Each Capsule

Contains:

Pregabalin……200

mg

(Anti-Epileptic)

Manufacturers

Form 5

Rs.8000/-

17-07-2009

Dy. No. not

mentioned

Rs.12000/-

19-03-2014

Dy. No. Not

mentioned

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

SYNGAB

Capsules 200mg

Atco

Inspection report

Approved.

205

specifications 14’s / Rs.1225/-

duplicate dossier

dated

26/11/2013.

Capsule section

mentioned in FID

report.


Limited, B-23,

S.I.T.E., Karachi

Hi-Gab Capsules

225mg

Capsule

Each Capsule

Contains:

Pregabalin……225

mg

(Anti-Epileptic)

Manufacturers

specifications

Form 5

Rs.8000/-

17-07-2009

Dy. No. not

mentioned

Rs.12000/-

19-03-2014

Dy. No. Not

mentioned

14’s / Rs.1370/-

duplicate dossier

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

Evidence of Me

too status

required

Inspection report

dated

26/11/2013.

Capsule section

mentioned in FID

report.

1) Evidence

of me too

status

required.

Deferred for

confirmation of

me too status.


Limited, B-23,

S.I.T.E., Karachi

Hi-Gab Capsules

300mg

Capsule

Each Capsule

Contains:

Pregabalin ……

300mg

(Anti-Epileptic)

Manufacturers

specifications

Form 5

Rs.8000/-

17-07-2009

Dy. No. not

mentioned

Rs.12000/-

19-03-2014

Dy. No. Not

mentioned

14’s/Rs.1560/-

duplicate dossier

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Inspection report

dated

26/11/2013.

Capsule section

mentioned in FID

report.

Approved.


Limited, B-23,

S.I.T.E., Karachi

Hi-Gab Capsules

100mg

Capsule

Each Capsule

Contains:

Pregabalin……100

mg

Form 5

Rs.8000/-

17-07-2009

Dy. No. not

mentioned

Rs.12000/-

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Approved.

206

(Anti-Epileptic)

Manufacturers

specifications

19-03-2014

Dy. No. Not

mentioned

14’s/Rs.735/-

duplicate dossier

Capsules (50, 75,

100, 150 and

300mg)

Getz

Inspection report

dated

26/11/2013.

Capsule section

mentioned in FID

report.


Limited, B-23,

S.I.T.E., Karachi

Hi-Gab Capsules

25mg

Capsule

Each Capsule

Contains:

Pregabalin……25

mg

(Anti-Epileptic)

Manufacturers

specifications

Form 5

Rs.8000/-

17-07-2009

Dy. No. not

mentioned

Rs.12000/-

19-03-2014

Dy. No. Not

mentioned

14’s / Rs.270/-

duplicate dossier

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

ZEEGAP

Capsules (25, 50,

75, 100 and

150mg)

Hilton

Inspection report

dated

26/11/2013.

Capsule section

mentioned in FID

report.

Approved.


Limited, B-23,

S.I.T.E., Karachi

Hi-Gab Capsules

150mg

Capsule

Each Capsule

Contains:

Pregabalin……150

mg

(Anti-Epileptic)

Manufacturers

specifications

Form 5

Rs.8000/-

17-07-2009

Dy. No. not

mentioned

Rs.12000/-

19-03-2014

Dy. No. Not

mentioned

14’s/Rs.940/-

duplicate dossier

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Inspection report

dated

26/11/2013.

Capsule section

mentioned in FID

report.

Approved.

207

368. M/s Neutro Pharma

(Pvt) Ltd., 9.5 Km,

Sheikhupura Road,

Lahore

Gabin Capsules

300mg

Capsule

Each Capsule

Contains:

Pregabalin……300

mg

(GABA Analogue)

Manufacturers

Specifications

Form 5

Rs.8000/-

17-08-2009

Dy. No. not

mentioned

Rs.12000/-

07-07-2014

Dy. No. 66

As per PRC

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Panel inspection

to check GMP

compliance

conducted on

6th& 7

th January,

2014.

Approved.

369. M/s Atco

Laboratories

Limited, B-18,

S.I.T.E., Karachi

Syngab

Capsules75mg

Capsule

Each Capsule

Contains:

Pregabalin……75

mg

(Anti Epileptic)

Manufacturers

Specifications

Form 5

Rs.8000/-

29-04-2008

Dy. No. not

mentioned

Rs.12000/-

08-04-2014

Dy. No. not

mentioned

As per leader

price per 14’s

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Inspection report

dated 18-06-2014

Approved.

370. M/s Atco

Laboratories

Limited, B-18,

S.I.T.E., Karachi

Syngab Capsules

150mg

Capsule

Each Capsule

Contains:

Pregabalin……150

mg

(Anti Epileptic)

Manufacturers

Specifications

Form 5

Rs.8000/-

29-04-2008

Dy. No. not

mentioned

Rs.12000/-

08-04-2014

Dy. No. not

mentioned

As per leader

price per 14’s

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Inspection report

dated 18-06-2014

Approved.

208

371. M/s Atco

Laboratories

Limited, B-18,

S.I.T.E., Karachi

Syngab Capsules

300mg

Capsule

Each Capsule

Contains:

Pregabalin……300

mg

(Anti Epileptic)

Manufacturers

Specifications

Form 5

Rs.8000/-

22-04-2008

Dy. No. not

mentioned

Rs.12000/-

08-04-2014

Dy. No. not

mentioned

As per leader

price per 14’s

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Inspection report

dated 18-06-2014

Approved.

372. M/S Tabros

Pharma

L-20/B, F.B.

Industrial Area,

Karachi.

Grelin Capsule

75mg

Capsule

Each Capsule

Contains:

Pregabalin……75

mg

(Anti-Epileptic.)

Manufacturers

specifications

Form 5

Rs.8000/-

30-06-2008

Dy. No. Not

mentioned

Rs.12000/-

Dated 20-03-

2014

Dy. No. not

mentioned

14’s / Rs.1100/-

(Rs. 78.57 per

capsule)

(duplicate

dossier)

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Inspection report

dated

11/03/2014.

Overall

conditions noted

improved as

compared to last

visit.

Approved.

373. M/S Tabros

Pharma

L-20/B, F.B.

Industrial Area,

Karachi.

Grelin Capsule

100mg

Capsule

Each Capsule

Contains:

Pregabalin……100

mg

(Anti-Epileptic.)

Manufacturers

specifications

Form 5

Rs.8000/-

30-06-2008

Dy. No. Not

mentioned

Rs.12000/-

Dated.20-03-

2014

Dy. No. not

mentioned

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Approved.

209

14’s/Rs.1300/-

(duplicate

dossier)

Inspection report

dated

11/03/2014.

Overall

conditions noted

improved as

compared to last

visit.

374. M/S Tabros

Pharma

L-20/B, F.B.

Industrial Area,

Karachi.

Grelin Capsule

150mg

Capsule

Each Capsule

Contains:

Pregabalin……150

mg

(Anti-Epileptic.)

Manufacturers

specifications

Form 5

Rs.8000/-

30-06-2008

Dy. No. Not

mentioned

Rs.12000/-

Dated.20-03-

2014

Dy. No. not

mentioned

14’s/Rs.1600/-

(duplicate

dossier)

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Inspection report

dated

11/03/2014.

Overall

conditions noted

improved as

compared to last

visit.

Approved.

375. M/S Tabros

Pharma

L-20/B, F.B.

Industrial Area,

Karachi.

Grelin Capsule

300mg

Capsule

Each Capsule

Contains:

Pregabalin……300

mg

(Anti-Epileptic.)

Manufacturers

specifications

Form 5

Rs.8000/-

30-06-2008

Dy. No. Not

mentioned

Rs.12000/-

Dated.20-03-

2014

Dy. No. not

mentioned

14’s/Rs.2600/-

(duplicate

dossier)

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Inspection report

dated

11/03/2014.

Overall

conditions noted

improved as

compared to last

Approved.

210

visit.

376. M/S Scotmann

Pharmaceuticals, 5-

D, I-10/3, Industrial

Area Islamabad.

Foxril Capsule

75mg

Capsule

Each Capsule

Contains:

Pregabalin……75

mg

(Anticonvulsant.)

Manufacturers

specifications

Form 5

Rs.8000/-

15-07-2008

Dy. No. 186

Rs.12000/-

Dated.08-07-

2014

Dy. No. 1244

14’s / Rs. 16.95

/ Capsule

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Inspection report

dated 12-04-

2013. Good

compliance.

Capsule section

mentioned in

panel inspection

report dated 02-

12-2008.

Approved.

377. M/S Scotmann

Pharmaceuticals, 5-


Area Islamabad.

Foxril Capsule

100mg

Capsule

Each Capsule

Contains:

Pregabalin……100

mg

(Anticonvulsant.)

Manufacturers

specifications

Form 5

Rs.8000/-

15-07-2008

Dy. No.176

Rs.12000/-

Dated.08-07-

2014

Dy. No. 1244

14’s/Rs.20.85/C

apsule

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Inspection report

dated 12-04-

2013. Good

compliance.

Capsule section

mentioned in

panel inspection

report dated 02-

12-2008.

Approved.

378. M/S Scotmann

Pharmaceuticals, 5-


Foxril Capsule

150mg

Capsule

Form 5

Rs.8000/-

LYRICA

Capsules (25, 50,

75, 100,

Approved.

211

Area Islamabad.

Each Capsule

Contains:

Pregabalin……150

mg

(Anticonvulsant.)

Manufacturers

specifications

15-07-2008

Dy No.181

Rs.12000/-

Dated.08-07-

2014

Dy. No. 1244

Rs.33.90/Capsul

e

14’s

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Inspection report

dated 12-04-

2013. Good

compliance.

Capsule section

mentioned in

panel inspection

report dated 02-

12-2008.

379. M/S OBS Pakistan

(Pvt.) Ltd. C-14,

S.I.T.E.,

Manghopir Road

Karachi-75700

Pregalin Capsule

Capsule

Each Capsule

Contains:

Pregabalin……150

mg

(Antiepileptics)

Manufacturers

specifications

Form 5

Rs.8000/-

18-10-2008

Not mentioned

Rs.12000/-

Dated.29-07-

2013 duplicate

dossier

Dy. No. not

mentioned

14’s/Rs.1300/-

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Inspection report

dated 06-03-

2014. GMP

satisfactory and

capsule section

mentioned in

report.

Approved.


(Pvt.) Ltd. C-14,

S.I.T.E.,

Manghopir Road

Karachi-75700

Pregalin Capsule

Capsule

Each Capsule

Contains:

Pregabalin……300

mg

(Antiepileptics)

Form 5

Rs.8000/-

18-10-2008

Not mentioned

Rs.12000/-

Dated.29-07-

2013 duplicate

dossier

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

Approved.

212

Manufacturers

specifications

Dy. No. not

mentioned

14’s/Rs.2200/-

300mg)

Getz

Inspection report

dated 06-03-

2014. GMP

satisfactory and

capsule section

mentioned in

report.


(Pvt.) Ltd. C-14,

S.I.T.E.,

Manghopir Road

Karachi-75700

Pregalin Capsule

Capsule

Each Capsule

Contains:

Pregabalin……75

mg

(Antiepileptics)

Manufacturers

specifications

Form 5

Rs.8000/-

18-10-2008

Not mentioned

Rs.12000/-

Dated.29-07-

2013 duplicate

dossier

Dy. No. not

mentioned

14’s/Rs.900/-

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Inspection report

dated 06-03-

2014. GMP

satisfactory and

capsule section

mentioned in

report.

Approved.

382. M/S Glitz Pharma

(Pvt.) Ltd; 265-

Industrial Triangle,

Kahuta Road

Islamabad.

P-Gab 75

Tablet

Each film coated

tablet Contains:

Pregabalin……75

mg

(Antiepileptics)

Manufacturers

specifications

Form 5

Rs.8000/-

31-12-2008

Dy. No.561

Rs.12000/-

Dated.08-07-

2014

Dy. No. 1239

10x2=20’s /As

Per SRO

Inspection report

dated 18-03-

2013.

Satisfactory GMP

and tablet section

mentioned.

1) Firm had

initially

applied on

Form 5 for

registration of

Pregabalin

75mg tablet.

Since the

product is not

me too, firm

was asked to

provide me

too reference

or application

on Form 5D.

Now, firm

has requested

to change the

particulars of

The request of the

firm has not been

acceded to by the

Board & the

Board rejected the

application of P-

Gab 75 Tablet

213

the file to

Pregabalin

Oral Solution

20mg/ml.

Firm has also

submitted that

additional fee

if any, will be

deposited.


(Pvt.) Ltd; 265-


Kahuta Road

Islamabad.

P-Gab 100

Tablet

Each tablet

Contains:

Pregabalin……100

mg

(Antiepileptics)

Manufacturers

specifications

Form 5

Rs.8000/-

31-12-2008

Dy. No.562

Rs.12000/-

Dated.08-07-

2014

Dy. No. 1235

10x2=20’s &

14’s /As Per

SRO

Inspection report

dated 18-03-

2013.

Satisfactory GMP

and tablet and

capsule section

mentioned.

1) Firm had

initially

applied on

Form 5 for

registration of

Pregabalin

100mg tablet.

Since the

product is not

me too, firm

was asked to

provide me

too reference

or application

on Form 5D.

Now, firm

has requested

to change the

particulars of

the file to

Pregabalin

300mg

capsules.

Firm has also

submitted that

additional fee

if any, will be

deposited.

The request of the

firm has not been

acceded to by the

Board & the

Board rejected the

application P-Gab

100, Tablet


(Pvt.) Ltd; 265-


Kahuta Road

Islamabad.

P-Gab 50

Tablet

Each tablet

Contains:

Pregabalin……50

mg

(Antiepileptics)

Form 5

Rs.8000/-

31-12-2008

Dy. No. 560

Rs.12000/-

Dated.08-07-

2014

Dy. No. 1233

Inspection report

dated 18-03-

2013.

Satisfactory GMP

and tablet section

mentioned.

1) Firm had

initially

applied on

Form 5 for

registration of

Pregabalin

100mg tablet.

Since the

product is not

me too, firm

The request of the

firm has not been

acceded to by the

Board & the

Board rejected the

application of P-

Gab 50, Tablet

214

Manufacturers

specifications

10x2=20’s /As

Per SRO

was asked to

provide me

too reference

or application

on Form 5D.

Now, firm

has requested

to change the

particulars of

the file to

Pregabalin

200mg

capsules.

Firm has also

submitted that

additional fee

if any, will be

deposited.


(Pvt.) Ltd; 265-


Kahuta Road

Islamabad.

P-Gab 150mg

Tablet

Each film coated

tablet Contains:

Pregabalin……150

mg

(Antiepileptics)

Manufacturers

specifications

Form 5

Rs.8000/-

31-12-2008

Dy. No.563

Rs.12000/-

Dated.08-07-

2014

Dy. No. 1234

10x2=20’s/As

Per SRO

Inspection report

dated 18-03-

2013.

Satisfactory GMP

and tablet section

mentioned.

1) Firm had

initially

applied on

Form 5 for

registration of

Pregabalin

100mg tablet.

Since the

product is not

me too, firm

was asked to

provide me

too reference

or application

on Form 5D.

Now, firm

has requested

to change the

particulars of

the file to

Pregabalin

150mg

capsules.

Firm has also

submitted that

additional fee

if any, will be

deposited.

The request of the

firm has not been

acceded to by the

Board & the

Board rejected the

application of P-

Gab 150mg

Tablet

386. M/S Glitz Pharma P-Gab 100 Form 5 LYRICA Approved.

215

(Pvt.) Ltd; 265-


Kahuta Road

Islamabad.

Capsule

Each capsule

Contains:

Pregabalin……100

mg

(Antiepileptics)

Manufacturers

specifications

Rs.8000/-

31-12-2008

Dy. No.559

Rs.12000/-

Dated.08-07-

2014

Dy. No. 1236

10x2=20’s &

14’s /As Per

SRO and Rs.

625/- per 20’s

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Inspection report

dated 18-03-

2013.

Satisfactory GMP

and tablet section

mentioned.


(Pvt.) Ltd; 265-


Kahuta Road

Islamabad.

P-Gab 75

Capsule

Each capsule

Contains:

Pregabalin……75

mg

(Antiepileptics)

Manufacturers

specifications

Form 5

Rs.8000/-

31-12-2008

Dy. No.557

Rs.12000/-

Dated.08-07-

2014

Dy. No. 1238

10x2=20’s &

14’s/As Per

SRO and Rs.

345/- per 20’s

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Inspection report

dated 18-03-

2013.

Satisfactory GMP

and tablet section

mentioned.

Approved.


(Pvt.) Ltd; 265-


Kahuta Road

Islamabad.

P-Gab 50

Capsule

Each capsule

Contains:

Pregabalin……50

mg

(Antiepileptics)

Manufacturers

Form 5

Rs.8000/-

31-12-2008

Dy. No.556

Rs.12000/-

Dated.08-07-

2014

Dy. No. 1237

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Approved.

216

specifications 10x2=20’s &

14’s/As Per

SRO

Getz

Inspection report

dated 18-03-

2013.

Satisfactory GMP

and tablet section

mentioned.

389. M/S Global

Pharmaceuticals

(Pvt.) Ltd., Plot No.

204-205, Industrial

Triangle, Kahuta

Road, Islamabad.

Pert 50 mg

Capsules

Capsule

Each capsule

Contains:

Pregabalin……50

mg

(Anticonvulsant)

Manufacturers

Specifications

Form 5

Rs.8000/- fee

challan not

attached

Rs.12000/-

Dated.05-06-

2014

Dy. No. 566

R&I

14’s As Per

SRO

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

cGMP certificate

dated 21-11-

2014.

Capsule section

mentioned in

inspection report

and GMP

certificate dated

31-05-2012 and

21-11-2014.

1) Rs. 8,000/-

fee challan

(duly

endorsed by

Statistical

Officer) has

not been

provided.

However,

copy of

extracts from

214th meeting

of

Registration

Board as

evidence of

fee

submission.

Approved.

Reference will be

sent to B & A

Division for

verification of fee

challan. In acse of

non-confirmation,

firm will deposit

the fee (Rs.8000/-

) and Chairman,

RB will permit for

issuance of


390. M/S Global

Pharmaceuticals

(Pvt.) Ltd., Plot No.

204-205, Industrial

Triangle, Kahuta

Road, Islamabad.

Pert 75 mg

Capsules

Capsule

Each capsule

Contains:

Pregabalin……75

mg

(Anticonvulsant)

Manufacturers

Specifications

Form 5

Rs.8000/- fee

challan not

attached

Rs.12000/-

Dated.05-06-

2014

Dy. No. 565

R&I

14’s As Per

SRO

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

cGMP certificate

dated 21-11-

2014.

Capsule section

mentioned in

1) Rs. 8,000/-

fee challan

(duly

endorsed by

Statistical

Officer) has

not been

provided.

However,

copy of

extracts from

214th meeting

of

Registration

Board as

evidence of

fee

submission.

Approved.

Reference will be

sent to B & A

Division for

verification of fee

challan. In acse of

non-confirmation,

firm will deposit

the fee (Rs.8000/-

) and Chairman,

RB will permit for

issuance of


217

inspection report

and GMP

certificate dated

31-05-2012 and

21-11-2014.

391. M/S Genome

Pharmaceutical

Private Limted,

Factory 16/1-Phase

IV, Industrial

Estate, Hattar.

Pregabanome-150

Capsule

Capsule

Each Capsule

Contains:

Pregabalin……150

mg

(Gaba Analogue)

Manufacturers

specifications

Form 5

Rs.8000/-

09-08-2008

Dy. No.287

Rs.12000/-

16-06-2014

Dy. No. 258

As Per SRO

2x7’s (14)

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

ZEEGAP

Capsules (25, 50,

75, 100 and

150mg)

Hilton

Panel inspection

for grant of GMP

dated 27-12-

2013.

Capsule General /

Antibiotic

mentioned.

Approved.

392. M/S Genome

Pharmaceutical

Private Limted,

Factory 16/1-Phase

IV, Industrial

Estate, Hattar.

Pregabanome-75

Capsule

Capsule

Each Capsule

Contains:

Pregabalin……75

mg

(Gaba Analogue)

Manufacturers

specifications

Form 5

Rs.8000/-

09-08-2008

Dy. No.288

Rs.12000/-

16-06-2014

Dy. No. 258

As Per SRO

2x7’s (14)

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

ZEEGAP

Capsules (25, 50,

75, 100 and

150mg)

Hilton

Panel inspection

for grant of GMP

dated 27-12-

2013.

Capsule General /

Antibiotic

mentioned.

Approved.

393. M/S Genome

Pharmaceutical

Private Limted,

Pregabanome-50

Capsule

Capsule

Form 5

Rs.8000/-

LYRICA

Capsules (25, 50,

75, 100,

Approved.

218

Factory 16/1-Phase

IV, Industrial

Estate, Hattar.

Each Capsule

Contains:

Pregabalin……50

mg

(Gaba Analogue)

Manufacturers

specifications

09-08-2008

Dy. No. 289

Rs. 12000/-

16-06-2014

Dy. No. 258

As Per SRO

2x7’s (14)

150,200, 225 and

300mg)

US FDA

ZEEGAP

Capsules (25, 50,

75, 100 and

150mg)

Hilton

Panel inspection

for grant of GMP

dated 27-12-

2013.

Capsule General /

Antibiotic

mentioned.

394. M/S Genome

Pharmaceutical

Private Limted,

Factory 16/1-Phase

IV, Industrial

Estate, Hattar.

Pregabanome-

100Capsule

Capsule

Each Capsule

Contains:

Pregabalin……100

mg

(Gaba Analogue)

Manufacturers

specifications

Form 5

Rs.8000/-

09-08-2008

Dy. No.286

Rs.12000/-

16-06-2014

Dy. No. 258

As Per SRO

2x7’s (14)

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

ZEEGAP

Capsules (25, 50,

75, 100 and

150mg)

Hilton

Panel inspection

for grant of GMP

dated 27-12-

2013.

Capsule General /

Antibiotic

mentioned.

Approved.

395. M/s Noa Hemis

Pharmaceuticals

Plot No.154,

Sector-23, Korangi

Industrial

Area,Karachi

Gabatil-75mg

Capsule

Each Capsule

Contains:

Pregabalin

……75mg

(Anti epileptic)

Manufacturers

specifications

Form 5

Rs.8000/-

22-07-2008

Dy. No. not

mentioned

Rs.12000/-

19-06-2014

1609 R&I

10’s, 14’s/15%

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Approved.

219

less then brand

leader

DDG and FID

inspection report

dated 09-06-2014

GMP compliance

considered good.

Capsule section

mentioned in

GMP inspection

reports.

396. M/s Noa Hemis

Pharmaceuticals

Plot No.154,

Sector-23, Korangi

Industrial

Area,Karachi

Gabatil-150mg

Capsule

Each Capsule

Contains:

Pregabalin

……150mg

(Anti epileptic)

Manufacturers

specifications

Form 5

Rs.8000/-

22-07-2008

Dy. No. not

mentioned

Rs.12000/-

19-06-2014

1609 R&I

10’s, 14’s / 15%

less then brand

leader

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

DDG and FID

inspection report

dated 09-06-2014

GMP compliance

considered good.

Capsule section

mentioned in

GMP inspection

reports.

Approved.

397. M/s Noa Hemis

Pharmaceuticals

Plot No.154,

Sector-23, Korangi

Industrial

Area,Karachi

Gabatil-300mg

Capsule

Each Capsule

Contains:

Pregabalin

……300mg

(Anti epileptic)

Manufacturers

specifications

Form 5

Rs.8000/-

22-07-2008

Dy. No. not

mentioned

Rs.12000/-

19-06-2014

1609 R&I

10’s, 14’s / 15%

less then brand

leader

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

DDG and FID

inspection report

dated 09-06-2014

Approved.

220

GMP compliance

considered good.

Capsule section

mentioned in

GMP inspection

reports.

398. M/S Sharooq

Pharmaceuticals

(Pvt) Ltd. 21-KM

Ferozepur Road,

Lahore.

Gabmor Capsule

Capsule

Each Capsule

Contains:

Pregabalin……300

mg

(Antiepileptic)

Manufacturers

specifications

Form 5

Rs.8000/-

19-01-2009

Not mentioned

Rs.12000/-

Dated.19-06-

2014 duplicate

dossier

Dy. No. 1286

14’s/As per PRC

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Panel inspection

after non-

compliance

report and grant

of GMP

certificate dated

28-03-2014.

GMP issued and

capsule section

mentioned.

Approved.

399. M/S Sharooq

Pharmaceuticals

(Pvt) Ltd. 21-KM

Ferozepur Road,

Lahore.

Gabmor Capsule

Capsule

Each Capsule

Contains:

Pregabalin……75

mg

(Antiepileptic)

Manufacturers

specifications

Form 5

Rs.8000/-

19-01-2009

Not mentioned

Rs.12000/-

Dated.19-06-

2014 duplicate

dossier

Dy. No. 1281

14’s,10’s/As per

PRC

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Panel inspection

after non-

compliance

report and grant

of GMP

certificate dated

28-03-2014.

Approved.

221

GMP issued and

capsule section

mentioned.

400. M/S Sharooq

Pharmaceuticals

(Pvt) Ltd. 21-KM

Ferozepur Road,

Lahore.

Gabmor Capsule

Capsule

Each Capsule

Contains:

Pregabalin………

………..…150mg

(Antiepileptic)

Manufacturers

specifications

Form 5

Rs.8000/-

19-01-2009

Not mentioned

Rs.12000/-

Dated.19-06-

2014 duplicate

dossier

Dy. No. 1282

14’s, 10’s/As

per PRC

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Panel inspection

after non-

compliance

report and grant

of GMP

certificate dated

28-03-2014.

GMP issued and

capsule section

mentioned.

Approved.

401. M/s Rasco Pharma,

5.5Km Raiwind

Road Lahore.

Pregab Capsule

300mg

Capsule

Each Capsule

Contains:

Pregabalin

….……300mg

(Anticonvulsant)

Manufacturers

specifications

Form 5

Rs.8000/-

25-07-2009

Dy. No. Not

mentioned

Rs.12000/-

20-06-2014

Dy. No. 1296

Rs.630/-, 1x14

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Panel inspection

dated 03-06-2014

where panel

recommended

grant of renewal

of DML. Capsule

section

mentioned in said

report.

Approved.

222


5.5Km Raiwind

Road Lahore.

Pregab Capsule

150mg

Capsule

Each Capsule

Contains:

Pregabalin

……150mg

(Anticonvulsant)

Manufacturers

specifications

Form 5

Rs.8000/-

25-07-2009

Dy. No. Not

mentioned

Rs.12000/-

20-06-2014

Dy. No. 1295

Rs.350/-, 1x14

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Panel inspection

dated 03-06-2014

where panel

recommended

grant of renewal

of DML. Capsule

section

mentioned in said

report.

Approved.


5.5Km Raiwind

Road Lahore.

Pregab Capsule

50mg

Capsule

Each Capsule

Contains:

Pregabalin

……50mg

(Anticonvulsant)

Manufacturers

specifications

Form 5

Rs.8000/-

25-07-2009

Dy. No. Not

mentioned

Rs.12000/-

20-06-2014

Dy. No. 1294

Rs.175/-, 1x14

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Panel inspection

dated 03-06-2014

where panel

recommended

grant of renewal

of DML. Capsule

section

mentioned in said

report.

Approved.

404. M/s WnsFeild

Pharmaceuticals,

Plot#122, Block-A,

Phase-V, Industrial

Lyricowin 75

Capsule

Each capsule

Form 5

Rs.8000/-

19-04-2009

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

Approved.

Reference will be

sent to B & A

Division for

223

Estate, Hattar Contains:

Pregabalin

……75mg

(Anticonvulsants)

Manufacturer’s

specifications

In agenda,

erroneously

dosage form with

brand name

written as Tablet

instead of

Capsule. The firm

actually

mentioned dosage

form as capsule in

form 5.

Dy. No. Not

mentioned

Rs.12000/-

19-06-2014

Dy. No. 259

As per SRO

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Panel report

dated 04-09-

2014. Panel

recommends

grant of GMP

and capsule

section

mentioned.

verification of fee

challan for

capsule dosage

form. If

confirmed, then

Chairman, RB

will permit for

issuance of


Otherwise case

will be placed

before the Board

for decision.

405. M/s Pakistan

Pharmaceuticals

Products (Pvt) Ltd.

D-122, Sindh

Industrial Trading

Estate, Karachi.

Gablin 150mg

Capsule

Capsule

Each capsule

Contains:

Pregabalin

……150mg

(Anticonvulsants)

Form 5

Rs.8000/-

17-06-2009

(Challan

submission date)

Dy. No. Not

mentioned

Rs.12000/-

26-07-2013

Dy. No. not

mentioned

Covering letter

is not attached

Rs.25/Capsule

/not mentioned

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Inspection report

dated 13-02-2013

and 03-06-2014

considered to be

operating at

satisfactory level

of GMP.

Approved.

406. M/s Pakistan

Pharmaceuticals

Products (Pvt) Ltd.

D-122, Sindh

Industrial Trading

Estate, Karachi.

Gablin 75mg

Capsule

Capsule

Each capsule

Contains:

Pregabalin

……75mg

Form 5

Rs.8000/-

17-06-2009

Dy. No. Not

mentioned

Rs.12000/-

26-07-2013

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

Approved.

224

(Anticonvulsants)

Dy. No. not

mentioned

Covering letter

is not

attached

Rs.25/Capsule

/not mentioned

100, 150 and

300mg)

Getz

Inspection report

dated 13-02-2013

and 03-06-2014

considered to be

operating at

satisfactory level

of GMP.

407. M/s Pakistan

Pharmaceuticals

Products (Pvt) Ltd.

D-122, Sindh

Industrial Trading

Estate, Karachi.

Gablin 300mg

Capsule

Capsule

Each capsule

Contains:

Pregabalin

……300mg

(Anticonvulsants)

Form 5

Rs.8000/-

17-06-2009

Dy. No. Not

mentioned

Rs.12000/-

26-07-2013

Dy. No. not

mentioned

Covering letter

is not attached

Rs.25/Capsule

/not mentioned

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Inspection report

dated 13-02-2013

and 03-06-2014

considered to be

operating at

satisfactory level

of GMP.

Approved.

408. M/s Danas

Pharmaceuticals

(Private) Limited,

Islamabad.

Gabfast

Capsule300mg

Capsule

Each capsule

Contains:

Pregabalin

……300mg

(Gaba analogue)

Form 5

Rs.8000/-

08-12-2009

Dy. No. 57

Rs.12000/-

05-06-2014

Dy. No. 555

10’s/As Per

SRO

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

cGMP certificate

dated 28-01-

2014. Capsule

section

mentioned.

Approved.

225

409. M/s Danas

Pharmaceuticals

(Private) Limited,

Islamabad.

Gabfast

Capsule75mg

Capsule

Each capsule

Contains:

Pregabalin

……75mg

(Gaba analogue)

Form 5

Rs.8000/-

08-12-2009

Dy. No. 55

Rs.12000/-

05-06-2014

Dy. No. 555

10’s/As Per

SRO

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

cGMP certificate

dated 28-01-

2014. Capsule

section

mentioned.

Approved.

410. M/s Danas

Pharmaceuticals

(Private) Limited,

Islamabad.

Gabfast

Capsule150mg

Capsule

Each capsule

Contains:

Pregabalin

……150mg

(Gaba analogue)

Form 5

Rs.8000/-

08-12-2009

Dy. No. 56

Rs.12000/-

05-06-2014

Dy. No. 555

10’s/As Per

SRO

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

cGMP certificate

dated 28-01-

2014. Capsule

section

mentioned.

Approved.

411. M/S Sami

Pharmaceutical

Pvt., Limited F-95,

S.I.T.E. Karachi.

Pregy 25mg

Capsule

Capsule

Each Capsule

Contains:

Pregabalin……25

mg

(Anticonvulsant)

Manufacturer

Specifications

Form 5

Rs.8000/-

07-09-2010

Dy. No. not

mentioned

Rs.12000/-

10-05-2013

duplicate dossier

Dy. No. Not

mentioned

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

ZEEGAP

Capsules (25, 50,

75, 100 and

150mg)

Hilton

Approved.

226

As per PRC Panel inspection

report dated 24-

06-2014. Panel

recommended

grant of

additional

sections. Capsule

section

mentioned.

412. M/S Weather Folds

Pharmaceuticals,

Plot No.69/2,

Phase-II, Industrial

Area, Hattar, KPK

Gabalin 50mg Cap

Capsule

Each Capsule

Contains:

Pregabalin……50

mg

(Analgesic /

Anticonvulsant

Activity)

Manufacturers

specifications

Form 5

Rs.8000/-

29-12-2010

Dy. No. Not

mentioned

Rs.12000/-

Dated.11-07-

2014

Dy. No. 323

As per SRO

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

ZEEGAP

Capsules (25, 50,

75, 100 and

150mg)

Hilton

Panel inspection

report dated 04-

09-2014. Panel

recommended

grant of GMP

certificate.

Capsule section

approved.

Approved.

413. M/S Weather Folds

Pharmaceuticals,

Plot No.69/2,

Phase-II, Industrial

Area, Hattar, KPK

Gabalin 100mg

Cap

Capsule

Each Capsule

Contains:

Pregabalin……100

mg

(Analgesic /

Anticonvulsant

Activity)

Manufacturers

specifications

Form 5

Rs.8000/-

29-12-2010

Dy. No. Not

mentioned

Rs.12000/-

Dated.11-07-

2014

Dy. No. not

mentioned

As per SRO

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

ZEEGAP

Capsules (25, 50,

75, 100 and

150mg)

Hilton

Panel inspection

report dated 04-

09-2014. Panel

recommended

grant of GMP

Approved.

227

certificate.

Capsule section

approved.

414. M/S Lowitt Pharma

(pvt.) Ltd. 24-

Hayatabad

Industrial Estate

Peshawar.

P-Gablin

150Capsule

Oral Capsule

Each Capsule

Contains:

Pregabalin……150

mg

(Gaba Analogue,

Anticonvulsant.An

algasic)

Manufacturers

specifications

Form 5

Rs.8000/-

22-03-2010

(Endorsement

date)

Dy. No. Not

mentioned

Rs.12000/- (for

tablet)

Dated 22-05-

2014

Dy. No. Not

mentioned

Both pack size

and price as Per

SRO

Duplicate

Dossier

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

ZEEGAP

Capsules (25, 50,

75, 100 and

150mg)

Hilton

Inspection report

dated 21-08-

2014. Overall

firm in good

working

condition.

Capsule section

mentioned in

inspection report

and revised

layout plan

approval dated

13-12-2013.

1) Balance

fee Rs.

12,000/- has

been

submitted for

tablet dosage

form.

Approved.

Reference will be

sent to B & A

Division for

verification of fee

challan for

capsule dosage

form. In acse of

non-confirmation,

firm will deposit

the fee

(Rs.12000/-) and

Chairman, RB

will permit for

issuance of



(pvt.) Ltd. 24-

Hayatabad

Industrial Estate

Peshawar.

P-Gablin

50Capsule

Oral Capsule

Each Capsule

Contains:

Pregabalin……50

mg

(Gaba Analogue,

Anticonvulsant.An

algasic)

Manufacturers

specifications

Form 5

Rs.8000/-

22-03-2010

(Endorsement

date)

Dy. No. Not

mentioned

Rs.12000/-

Dated. 22-05-

2014

Dy. No. Not

mentioned

Both pack size

and price as Per

SRO

Duplicate

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

ZEEGAP

Capsules (25, 50,

75, 100 and

150mg)

Hilton

Inspection report

dated 21-08-

2014. Overall

firm in good

working

condition.

Approved.

228

Dossier Capsule section

mentioned in

inspection report

and revised

layout plan

approval dated

13-12-2013.


(pvt.) Ltd. 24-

Hayatabad

Industrial Estate

Peshawar.

P-Gablin

100Capsule

Oral Capsule

Each Capsule

Contains:

Pregabalin……100

mg

(Gaba Analogue,

Anticonvulsant.An

algasic)

Manufacturers

specifications

Form 5

Rs.8000/-

22-03-2010

(Endorsement

date)

Dy. No. Not

mentioned

Rs.12000/-

Dated.21-05-

2014

Dy. No. Not

mentioned

Both pack size

and price as Per

SRO

Duplicate

Dossier

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

ZEEGAP

Capsules (25, 50,

75, 100 and

150mg)

Hilton

Inspection report

dated 21-08-

2014. Overall

firm in good

working

condition.

Capsule section

mentioned in

inspection report

and revised

layout plan

approval dated

13-12-2013.

Approved.

417. M/s Rogen

Pharmaceuticals

Plot#30, S-4,

National Industrial

Zone, Rawat,

Islamabad.

P-Roglin 75mg

Capsule

Capsule

Each capsule

Contains:

Pregabalin

……75mg

(Anti-epileptic)

Manufacturers

specifications

Form 5

Rs.8000/-

02-06-2010

Dy. No. 4754

Rs. 12000/-

16-06-2014

Dy. No.735

10’s/As Per

SRO

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Panel inspection

report dated 09-

06-2014. Tablet /

Approved.

229

capsule section

mentioned.

General Capsule

section

mentioned on the

report.

418. M/s Focus & Rulz

Pharmaceuticals

(Pvt) Ltd. Plot

No.4, Industrial

Triangle, Kahuta

Road, Islamabad.

Pregab 75mg

Capsule

Capsule

Each capsule

Contains:

Pregabalin

……75mg

(Analgesic and

Anticonvulsant)

Manufacturers

specifications

Form 5

Rs.8000/-

61 R&I

28-06-2010

Fee Rs.12000/-

challans form is

missing

14’s/As Per

SRO

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Panel inspection

report dated 27-

03-2014. Capsule

section approved.

Approved. Firm

will provide

verified challan of

Rs.12000/- and

Chairman will

authorize issuance

of registration

letter.

419. M/s Focus & Rulz

Pharmaceuticals

(Pvt) Ltd. Plot

No.4, Industrial

Triangle, Kahuta

Road, Islamabad.

Pregab 50mg

Capsule

Capsule

Each capsule

Contains:

Pregabalin

……50mg

(Analgesic and

Anticonvulsant)

Manufacturers

specifications

Form 5

Rs.8000/-

62 R&I

28-06-2010

Fee Rs.12000/-

challans form is

missing

14’s/As Per

SRO

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Panel inspection

report dated 27-

03-2014. Capsule

section approved.

Approved. Firm

will provide

verified challan of

Rs.12000/- and

Chairman will

authorize issuance

of registration

letter.

420. M/s Amarant

Pharmaceuticals

(Pvt) LTD 158-D,

Toro Gadap Road,

Super highway,

Karachi.

Gabalin Capsule

50mg

Capsule

Each filled Capsule

Contains:

Pregabalin……50

mg

Form 5

Rs.8000/-

22-11-2010

Dy. No. not

mentioned

Rs.52,000/-

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Approved.

230

(Anticonvulsant)

Manufacturers

specifications

(fast track)

19-11-2012

Dy. No. Not

mentioned

Rs.36/- capsule

duplicate dossier

Capsules (50, 75,

100, 150 and

300mg)

Getz

Inspection report

dated 08-08-2014

observed that

management is

taking serious

measures to

rearrange and

upgrade their

whole

manufacturing,

quality control

and storage

facilities as per

approved layout

plan.

421. M/s Amarant

Pharmaceuticals

(Pvt) LTD 158-D,

Toro Gadap Road,

Super highway,

Karachi.

Gabalin Capsule

75mg

Capsule

Each filled Capsule

Contains:

Pregabalin……75

mg

(Anticonvulsant)

Manufacturers

specifications

Form 5

Rs.8000/-

22-11-2010

Dy. No. not

mentioned

Rs.52,000/-

(fast track)

19-11-2012

Dy. No. Not

mentioned

Rs.71/- capsule

duplicate dossier

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Inspection report

dated 08-08-2014

observed that

management is

taking serious

measures to

rearrange and

upgrade their

whole

manufacturing,

quality control

and storage

facilities as per

approved layout

plan.

Approved.

422. M/s Amarant Gabalin Capsule Form 5 LYRICA Approved.

231

Pharmaceuticals

(Pvt) LTD 158-D,

Toro Gadap Road,

Super highway,

Karachi.

100mg

Capsule

Each filled Capsule

Contains:

Pregabalin……100

mg

(Anticonvulsant)

Manufacturers

specifications

Rs.8000/-

22-11-2010

Dy. No. not

mentioned

Rs.52,000/-

(fast track)

18-11-2012

Dy. No. Not

mentioned

Rs.89/- capsule

duplicate dossier

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Inspection report

dated 08-08-2014

observed that

management is

taking serious

measures to

rearrange and

upgrade their

whole

manufacturing,

quality control

and storage

facilities as per

approved layout

plan.

423. M/s Amarant

Pharmaceuticals

(Pvt) LTD 158-D,

Toro Gadap Road,

Super highway,

Karachi.

Gabalin Capsule

150mg

Capsule

Each filled Capsule

Contains:

Pregabalin……150

mg

(Anticonvulsant)

Manufacturers

specifications

Form 5

Rs.8000/-

22-11-2010

Dy. No. not

mentioned

Rs.52,000/-

(fast track)

19-11-2012

Dy. No. Not

mentioned

Rs.107/- capsule

duplicate dossier

LYRICA

Capsules (25, 50,

75, 100,

150,200, 225 and

300mg)

US FDA

GABICA

Capsules (50, 75,

100, 150 and

300mg)

Getz

Inspection report

dated 08-08-2014

observed that

management is

taking serious

measures to

rearrange and

upgrade their

whole

Approved.

232

manufacturing,

quality control

and storage

facilities as per

approved layout

plan.

9. Contract manufacturing applications

Evaluator – II (Application checked by Evaluator - IV)

S.No Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary

name + Dosage

Form + Strength)

Composition

Pharmacological

Group

Finished product

Specification

Type of Form

Initial date,

diary

Fee including

differential

fee

Demanded

Price / Pack

size

Remarks on the

formulation (if

any) including

International

status in stringent

drug regulatory

agencies /

authorities

Me-too status

GMP status as

depicted in latest

inspection report

(with date) by the

Evaluator

Decision

424. M/s Safe

Pharmaceuticals

(Pvt.) Ltd.

Plot No. C-1-20,

Sector 6-B,

North Karachi

Industrial Area,

Karachi

For

M/s Amarant

Pharmaceuticals

(Pvt.) Ltd.

158, D. Tore,

Gadap Road,

Super Highway,

Karachi.

Impulse Injection

500 mcg/ml

Each 1 ml

ampoule contains

Mecobalamin

(J.P)…..500 mcg

(Co-enzyme type

Vitamin B12)

(Manufacturer’s

Spec.s)

Form 5

Not mentioned

Rs 150,000

1 ml × 10’s

International:

Methycobal Inj by

M/s Eisai Co., Ltd.

Tokyo

Me too:Elgin Inj by

M/s Novartis

According to

inspection report

dated 20-08-2014 of

M/s Safe

Pharmaceuticals;

GMP compliance

level of firm is rated

as good.

Only Form 5 of the

application has been

evaluated. Rest of

Deferred for rectification of

following observation in the

dossier:

1. Reference will be sent to B &

A Division for verification of

challan.

2. Confirmation of installation

and operational qualifications

for TOC analyzer and liquid

particle counter by the area FID.

233

the conditions of

policy matters have

not been evaluated .

Verification fee


Evidence of TOC

analyzer and liquid

particle counter is

required. Firm has

replied that these are

under the process of

procurement.

425. -do- Moxina Infusion

400 mg/ 250 ml

Each vial (250 ml)

contains

Moxifloxacin (as

HCl) (USP)….

400 mg

Quinolone

(Manufacturer’s

Spec.s)

Form 5

Not mentioned

Rs 150,000

As per PAC

International:

Avelox Inf (FDA)

Me too: Moxiget

Inf 400mg/250ml

According to

inspection report

dated 20-08-2014 of

M/s Safe

Pharmaceuticals;

GMP compliance


as good.

Only Form 5 of the


evaluated. Rest of

the conditions of

policy matters have


Verification fee


Evidence of TOC

analyzer and liquid

particle counter is

required. Firm has



procurement.



dossier:



challan.





426. -do-

Quvoxin Injection

500 mg/ 100 ml

Each vial (100ml)

contains

Levofloxacin

(USP)…. 500 mg

Quinolone

Form 5

Not mentioned

Rs 150,000

As per PAC

International:

Levaquine

500mg/100ml

(FDA)

Me too: Raylox Inf

500mg/100ml by

M/s Ray



dossier:



challan.

234

(Manufacturer’s

Spec.s)

According to

inspection report

dated 20-08-2014 of

M/s Safe

Pharmaceuticals;

GMP compliance


as good.

Only Form 5 of the


evaluated. Rest of

the conditions of

policy matters have


Verification fee


Evidence of TOC

analyzer and liquid

particle counter is

required. Firm has



procurement.





427. -do-

Amadrol Injection

100 mg/ 2 ml

Each 2 ml

contains

Tramadol HCl

(B.P) …..100 mg

Non Narcotic

analgesic

(Manufacturer’s

Spec.s)

Form 5

Not mentioned

Rs 150,000

2 ml × 5’s

As per PAC

International:

Zamadol Inj

50mg/ml (100mg

ampoule) in UK

Me too: Tramadol

Inj 50mg/ml by M/s

Highnoon

Latest GMP


contract giver is

required.

According to

inspection report

dated 20-08-2014 of

M/s Safe

Pharmaceuticals;

GMP compliance


as good.

Only Form 5 of the


evaluated. Rest of

the conditions of

policy matters have



dossier:



challan.





235


Verification fee


Evidence of TOC

analyzer and liquid

particle counter is

required. Firm has



procurement.

428. -do-

Amblum Injection

Each ml ampoule

contains

Artemether……80

mg

(Anti malarial)

(Manufacturer’s

Spec.s)

Form 5

Not mentioned

Rs 150,000

1 × 5 ampoule

As per PAC

International:

Artem Inj in China

Me too: Artem Inj

by M/s Hilton

According to

inspection report

dated 20-08-2014 of

M/s Safe

Pharmaceuticals;

GMP compliance


as good.

Only Form 5 of the


evaluated. Rest of

the conditions of

policy matters have


Verification fee


Formulation was

Deferred in the light

of recommendations

by Malaria Control

Programme in M-

245 of DRB.

Deferred in the light of

recommendation of National

Malaaria Control programme &

for rectification of following

observation in the dossier:



challan.





429. M/s Caraway

Pharmaceuticals

Plot No. 12,

street # N-3,

National

Industrial Zone,

Rawat,

Islamabad.

For

M/s Amarant

Pharmaceuticals

(Pvt.) Ltd.

158, D. Tore,

Amant- D

Injection

Each ml contains

Cholecalciferol

BP …..5 mg

Vitamin

Finished product

specifications are

B.P

Form 5

Not mentioned

Rs 150,000

As per PAC

International:

Required

Me too: Calciferol

Inj by M/s Global

Good level of GMP

compliance (24-09-

2012)

Only Form 5 of the


evaluated. Rest of

the conditions of

policy matters have




dossier:



challan.





236

Gadap Road,

Super Highway,

Karachi.

Verification fee


International

availability not

confirmed in SRA’s.



required. Inspection

report dated 24-09-

12 mentions

Ampoule and Vial

sections.

Labeling

information has

been given for

malaria.

3. Evidence of approval in

reference Stringent Regulatory

Agencies.

4. Approval of manufacturing

facility by Licensing section.

5. Correction in labeling as

submitted label mentions the

use of formulation in malaria.

430. -do-

Amta- Rose

Injection

Each ampoule

(5ml) contains

Iron Sucrose 420

mg eq to

elemental Iron …..

100mg

Haematinic

Finished product

specifications are

USP

Form 5

Not mentioned

Rs 150,000

As per PAC

International:

Venofer Inj (FDA)

Me too: Merofer

JInj by M/s Bosch

Good level of GMP

compliance (24-09-

2012)

Only Form 5 of the


evaluated. Rest of

the conditions of

policy matters have


Verification fee


Initially on Form 5,

firm mentioned

quantity of active as

420 mg/ ampoule, in

reply firm

mentioned it as

1873 mg/ ampoule.

Clarification is

required. No

clarification is

provided in second

reply.



required. Not

provided in second

reply. Inspection



dossier:



challan.





3. Initially on Form 5, firm

mentioned quantity of active as

420 mg/ ampoule, in reply firm

mentioned it as 1873 mg/

ampoule. Clarification is

required. No clarification is

provided in second reply.

4. Letter of approval of

injection section is required.

Not provided in second reply.

Inspection report dated 24-09-

12 mentions Ampoule and Vial

sections.

237

report dated 24-09-

12 mentions

Ampoule and Vial

sections.

Evidence of TOC

analyzer and liquid

particle counter is

required. Not

provided in replies.

Evaluator – III

S/N Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary name +

Dosage Form +

Strength)

Composition


Finished product

Specification

Type of Form

Initial date,

diary

Fee including

differential fee

Demanded

Price / Pack

size

Remarks on the

formulation (if

any) including

International

status in stringent

drug regulatory

agencies /

authorities

Me-too status

GMP status as

depicted in latest

inspection report

(with date) by the

Evaluator

Recommendations

by the Evaluator

Decision

431. Contract Giver

M/s Dyson

Research Labs,

Lahore.

Contract

Acceptor

M/s McOlson

Research

Laboratories,

Sheikhupura.

OD-CEF Injection 500mg

Each vial contains:

Ceftriaxone sodium

equivalent to

Ceftriaxone…..500mg

Cephalosporin

USP

Form-5

Dy No: 2437

dated: 15-04-

2013

1,42,000/- dated

15-04-13

8,000/- dated

18-05-09

As per SRO

Pack of 1’s

Inspection of M/s

McColson

Research Labs

conducted on 26-

08-14 and 11-09-

14 by the panel of

inspectors and

recommends the

grant of renewal of

DML to the firm

The applications

have been

evaluated as per

Form-5. However

the formalities as

per contract

manufacturing

policy may be

fulfilled by the

concerned section

before issuance of


Approved.

Firm will

provide

undertakings &

agreement as

per approved

contract policy

and Chairman

will permit

issuance of

registration

letter.

Permission will

be valid till

30.06.2015).

238

432. Contract Giver

M/s McOlson

Research

Laboratories,

Sheikhupura.

Contract

Acceptor

M/s Dyson

Research Labs,

Lahore.

AZIBAC Suspension

200mg

Each 5ml after

reconstitution contains:


equivalent to

Azithromycin

USP…..200mg

Macrolide Antibiotic

USP

Form-5

Dy No: 2430

dated: 15-04-

2013

50,000/- dated

15-04-13

1,00,000/- dated

14-05-13

As per SRO

Inspection of the

M/s Dyson

Research Labs

Sheikhupura was

conducted on 26-

09-14 by the area

FID and overall

hygiene and

condition is found

good.

Approved.

Firm will

provide

undertakings &

agreement as

per approved

contract policy

and Chairman

will permit

issuance of

registration

letter.

Permission will

be valid till

30.06.2015).

433. Contract Giver

M/s Masfa

Industries (Pvt)

Limited, Lahore

Contract

Acceptor

M/s McOlson

Research

Laboratories,

Sheikhupura.

M-XIME Suspension

100mg/5ml

Each 5ml contains:

Cefixime trihydraye

equivalent to

Cefixime…..100mg

Cephalosporin

USP

Form-5

Dy No: 2430

dated: 15-04-

2013

1,50,000/-

As per SRO

Inspection of M/s

McColson

Research Labs

conducted on 26-

08-14 and 11-09-

14 by the panel of

inspectors and

recommends the

grant of renewal of

DML to the firm

Approved.

Firm will

provide

undertakings &

agreement as

per approved

contract policy

and Chairman

will permit

issuance of

registration

letter.

Permission will

be valid till

30.06.2015).

434. Contract Giver

M/s Masfa

Industries (Pvt)

Limited, Lahore

Contract

Acceptor

M/s McOlson

Research

Laboratories,

Sheikhupura.

M-XIME Capsule 400mg


Cefixime as

Trihydrate…..400mg

Cephalosporin

USP

Form-5

Dy No: 2405

dated: 15-04-

2013

1,50,000/-

As per SRO

Pack of 5’s

Inspection of M/s

McColson

Research Labs

conducted on 26-

08-14 and 11-09-

14 by the panel of

inspectors and

recommends the

grant of renewal of

DML to the firm

Approved.

Firm will

provide

undertakings &

agreement as

per approved

contract policy

and Chairman

will permit

issuance of

registration

letter.

Permission will

be valid till

30.06.2015).

239

435. Contract Giver

M/s Arsons

Pharmaceutical

Industries,

Lahore.

Contract

Acceptor

M/s Friends

Pharma (Pvt)

Limited, Lahore

for

MECOFOL Injection

Each1ml ampoule

contains:

Mecobalamin……500mcg

Co-Enzyme Vitamin B-12

IP

Form-5

Dy No: 2383

dated 12-04-13

1,50,000/-

As per SRO

Pack of 1’s

Inspection of M/s

Friends Pharma

Lahore was

conducted by the

panel of inspectors

on 21-05-14

concluded the firm

GMP compliant.

Liquid Injection

(general) section

approval vided

letter No. F.1-18/

93-Lic (Vol-II)

(M-227) dated 17-

06-11.

Evidence of

availability of

TOC and liquid

particle counter

is not provided.

Deferred for

confirmation

of installation

and

operational

qualifications

for TOC

analyser &

Liquid

Particle

Counter by

Area FID.

436. Contract Giver

M/s M/s Unison

Chemical

Works Lahore.

Contract

Acceptor

M/s English

Pharmaceuticals

Lahore

ESUN Injection 40mg

Each vial contains:

Sterilized Esomeprazole

Sodium lyophilized

equivalent to

Esomeprazole…..40mg

PPI

Manufacturer

Form-5

Dy No: 3160

dated 17-05-13

1,50,000/-

As per SRO

Nexium of

AstraZeneca

Nexium of BMS

The inspection M/s

English

Pharmaceuticals

Lahore was

conducted on 14-

11-2012 and 15-

11-2012 by the

area FID and found

GMP complaint

a. Quantity of API

in master

formulation

needs

rectification.

b. Latest GMP

Inspection

report of M/s

English Pharma

is required.

Deferred for

rectification of

following

observations:

1. Quantity of

API in master

formulation

needs

rectification.

2. Latest

GMP

Inspection

report of M/s

English

Pharma is

required.

437. Contract Giver

M/s M/s Unison

Chemical

Works Lahore.

Contract

Acceptor

M/s English

Pharmaceuticals

Lahore

U-MIP Injection 40mg

Each vial contains:

Sterilized Omeprazole

Sodium lyophilized

equivalent to

Omeprazole…..40mg

PPI

Manufacturer

Form-5

Dy No: 3161

dated 17-05-13

1,50,000/-

As per SRO

Losec Infusion of

AstraZeneca

Risek of Getz

Pharma

The inspection M/s

English

Pharmaceuticals

Lahore was

conducted on 14-

11-2012 and 15-

11-2012 by the

area FID and found

GMP complaint

a. Quantity of

API in master

formulation

needs

rectification

b. Latest GMP

Inspection

report of M/s

English

Pharma is

required.

Deferred for

rectification of

following

observations:

1. Quantity of

API in master

formulation

needs

rectification.

2. Latest

GMP

Inspection

report of M/s

English

Pharma is

required.

240

438. Contract Giver

M/s Dyson

Research Labs,

Lahore.

Contract

Acceptor

M/s English

Pharmaceuticals

Lahore

BEMOX Infusion


Moxifloxacin as

hydrochloride…….400mg

Fluoroquinolone

Manufacturer

Form-5

Dy No: 2417

dated: 15-04-

2013

1,50,000/-

As per SRO

Avelox of Bayer

HealthCare Inc

Molox Infusion of

CCL Pharma

a. Specifications

of API needs to

be submitted. b. Under finished

product

specifications

assay method

needs to be

submitted. c. Evidence of

facility of TOC

analyzer and

particle counter

needs to be

submitted.

d. Latest GMP

Inspection

report of M/s

English Pharma

is required.

Deferred for

rectification of

following

observations:

1.

Specifications

of API needs to

be submitted. 2. Under

finished

product

specifications

assay method

needs to be

submitted. 3.

Confirmation

of installation

and operational

qualifications

for TOC

analyzer and

particle

counter. 4. Latest

GMP

Inspection

report of M/s

English

Pharma is

required.

439. Contract Giver

M/s Dyson

Research Labs,

Lahore.

Contract

Acceptor

M/s English

Pharmaceuticals

Lahore

DYPENEM Injection

500mg

Each vial contains:

Meropenem trihydrate

equivalent to

Meropenem……500mg

Penicillin Antibiotic

Manufacturer

Form-5

Dy No: 2411

dated: 15-04-

2013

50,000/-dated

15-04-13

100,000 dated

14-05-13

As per SRO

Meronem of

AstraZeneca

Demonem of

Rotex Medica

a. Evidence of

approval of

manufacturing

facility for

applied product

needs to be

submitted

b. Latest GMP

Inspection

report of M/s

English Pharma

is required.

Deferred for

rectification of

following

observations:

1. Evidence of

approval of

manufacturing

facility for

applied product

needs to be

submitted 2. Latest GMP

Inspection

report of M/s

English

Pharma is

required.

241

440. Contract Giver

M/s Dyson

Research Labs,

Lahore.

Contract

Acceptor

M/s English

Pharmaceuticals

Lahore

DYPENEM Injection 1g

Each vial contains:

Meropenem trihydrate

equivalent to

Meropenem……1g

Penicillin Antibiotic

Manufacturer

Form-5

Dy No: 2412

dated: 15-04-

2013

50,000/-dated

15-04 -13

100,000 dated

14-05-13

As per SRO

Meronem of

AstraZeneca

Demonem of

Rotex Medica

a. Evidence of

approval of

manufacturing

facility for

applied product

needs to be

submitted

b. Latest GMP

Inspection

report of M/s

English Pharma

is required.

Deferred for

rectification of

following

observations:

1. Evidence of

approval of

manufacturing

facility for

applied product

needs to be

submitted 2. Latest GMP

Inspection

report of M/s

English

Pharma is

required.

Case No.10. Replies of deferred applications

Evaluator – I

Case No. a: -

The following two products, namely Effiflox 125mg/5ml and Effiflox 250mg/5ml, of M/s

Sami Pharmaceuticals (Pvt) Ltd., Karachi were deferred in the 242nd

meeting of the Registration

Board held on 24th

– 25th

February, 2014 for confirmation of approved dosage form (dry powder

suspension or solution) by stringent regulatory bodies.

2. The firm has now submitted that they have prepared the drugs against LEVAQUIN of

M/s Janssen Pharma – USA as oral solution and in parallel conducted accelerated stability

studies. The firm has also submitted revised Form – 5 and requested the Board to grant

registration as oral solution.

3. It is pertinent to mention that evidence of approval of 250mg / 5ml strength by stringent

regulatory agencies was not submitted by the firm instead comments of some local prescribers in

favor of the same have been submitted.

S/N Name and

address of

manufacturer /

Applicant

1. Brand Name

2. Dosage Form

3. Composition

4.

Pharmacologic

al group

1.Type of

Form

2. Type of

application

3. Demanded

Price / Pack

size

4. Initial date,

1.Finished

Product

Specification

2. Facility where

drug has to be

manufactured

with status

whether

Decision in 242nd

Meeting of

Registration

Board

Decision

242

diary.

5. Date on

which fee

becomes

complete

according to

type of

application

/or Form

approved by

CLB or not

3. Last GMP

inspection

report with date

& status.

441.

M/s Sami

Pharmaceuticals

(Pvt) Ltd., F-95,

Off. Hub River

Road, S.I.T.E.,

Karachi.

1. EFFIFLOX

125 mg/5ml

2. Dry powder

suspension 3.

Each 5ml of

reconstituted

suspension

contains:

Levofloxacin

Hemihydrate

MS eq. to

Levofloxacin

……………..

125mg

4.

Fluroquinolone.

1. Form-5

2. Fast track

3. As per

PAC, 60ml.

4. 20/04/2011,

264 (R&I)

5. 24/04/2013

Rs.60,000/-

1. Manufacturers

specification.

2. Dry powder

suspension

General

Antibiotic

available as per

inspection report

dated 02/05.2013.

3. cGMP report

dated 02/05/2013

is provided

wherein good

level of GMP

compliance is

reported.

Deferred for

confirmation of

approved dosage

form (dry powder

suspension or

solution) by

stringent

regulatory bodies.

The Board did not

accede the request

of firm for change

in dosage form &

deferred the

instant application

for review of

formulation by

Incharge, PEC..

442. M/s Sami

Pharmaceuticals

(Pvt) Ltd., F-95,

Off. Hub River

Road, S.I.T.E.,

Karachi.

1. EFFIFLOX

250 mg/5ml

2. Dry powder

suspension

3. Each 5ml of

reconstituted

suspension

contains:

Levofloxacin

Hemihydrate

MS eq. to

Levofloxacin

……………..

250mg

4.

Fluroquinolone.

1. Form-5

2. Fast track

3. As per

PAC, 60ml. 4.

20/04/2011,

263 (R&I)

5. 24/04/2013

Rs.60,000/-

1. Manufacturers

specification.

2. Dry powder

suspension

General

Antibiotic

available as per

inspection report

dated 02/05.2013.

3. cGMP report

dated 02/05/2013

is provided

wherein good

level of GMP

compliance is

reported.

Deferred for

confirmation of

approved dosage

form (dry powder

suspension or

solution) by

stringent

regulatory bodies.

The Board did not

acceed the request

of firm for change

in dosage form &

deferred the

instant application

for review of

formulation by

Incharge, PEC.

243

Case No. b:

Following registration application of M/s Arson Pharmaceutical Industries (Pvt) Ltd., Lahore was

deferred in the 243rd

meeting of the Registration Board for status of license in light of inspection report

dated 15-04-2013.

2. The firm has now submitted copy of panel inspection report dated 08/05/2014 for renewal of

Drug Manufacturing License and Grant of additional section (Tablet Psychotropic). The panel in its

aforesaid report reached on the following recommendations:

a. Recommend the renewal of Drug Manufacturing License of the firm M/s Arson

Pharmaceutical Industries (Pvt) Ltd., Multan Road Lahore.

b. Recommend the grant of license to the additional tablet Psychotropic Section.

3. The firm has also submitted a copy of certificate of current Good Manufacturing Practices dated

19-08-2014 wherein it is reported that firm is found complying with cGMP in terms of process control,

maintenance of equipment and area, documentation etc. as per provisions of Drugs Act, 1976 and rules

framed there under.

443. M/s Arsons

Pharmaceutical

Industries (Pvt) Ltd.

22 Km Multan

Road off 4 Km

Defence Road,

Lahore

Anomaly Case:

Capsule (General

Antibiotic)

Vide letter No. F. 1-

14/95 – Lic (Vol I)

(M – 227) dated

13th June, 2011

DOXICYCLINE

100mg Capsules

Capsule

Each Capsule

contains:-

Doxycycline as

Hyclate…..100 mg

Tetracycline

As Per

SRO 10 x

10’s

Form-5

28-09-2012

2280 R&I

Rs.20,000/-

Vibramycin

100mg

Capsules

US FDA

DOTUR

100mg

Capsule

Novartis

Deferred for

status of lisence

in light of

inspection report

dated 15-04-2013

Decision: The Board approved the registration of application.

244

Case No. c: -

Following registration application of M/s A’raf (Pvt) Ltd., Lahore was deferred in the 242nd

meeting of the Registration Board for expert opinion of Dr.Rizwan Taj, PIMS and Brig Jehangeer

Saleem. Now, the firm has informed that same product is already registered in the 214th meeting of the

Registration Board having registration No. 062765 to the firm M/s Schazoo Zaka.

2. In light of above, firm has requested for registration of their product and to change it to XR.

444.

M/s A’RAF (Pvt)

Ltd. (Former M/s

Remedy

Pharmaceutical Pvt

Limited), 23 Km

Raiwind Road

Lahore.

1. Zaxine SR

150mg tablets 2.

Sustained release

film coated tablet

3. Each tablet

contains:

Venlafaxine as

Hydrochloride

……. 150mg

4. Serotonin and

Noradrenaline

Reuptake

Inhibitors.

1. Form-5 D

2. Fast track

3. Rs. 1100/-

per 14’s 4.

30/07/2013,

9209 (R&I)

5. Rs.60,000/-

Rs. 90,000/-

1. B.P. specifications.

2. General Tablet

section available as

per inspection report

dated 19/01/2012.

3. GMP report dated

19/01/2012 attached.

The formulation is

found available in

UK

Deferred for expert

opinion of

Dr.Rizwan Taj,

PIMS; Brig

Jehangeer Saleem

Decision: The Board approved the registration of the product & acceded to the request of

the firm for change in nomenclature from SR to XR.

245

Evaluator - I

S/

N

Name and address

of manufacturer /

Applicant

Brand Name

(Proprietary

name + Dosage

Form + Strength)

Composition

Pharmacological

Group

Finished product

Specification

Type of Form

Initial date,

diary

Fee including

differential fee

Demanded

Price / Pack

size

Decision of

Previous

Meeting

Remarks on the

formulation (if

any) including

International

status in

stringent drug

regulatory

agencies /

authorities

Me-too status

GMP status as

depicted in

latest inspection

report (with

date) by the

Evaluator

Decision

445. M/s. P.D.H.

Pharmaceuticals,

Lahore

Pyrox-B Tablets

Each tablet

contains:-

Piroxicam Beta

Cyclodextrin

equivalent to

Piroxicam ….

20mg

(NSAID)

Manufacturers

specifications

Form-5

Fast Track

28/8/2013 9991

R&I

28/8/2013

(Rs. 60,000/-)

Rs.265.22 per

2x10’s

Deferred for

final reminder

for completion

of Form 5

1. An

undertaking /

commitment

regarding the

submission of

following, as

per decision of

the

Registration

Board, may be

submitted:

a) Label claim

and prescribing

information

being same as

approved by

reference drug

agencies e.g.,

FDA, TGA,

MHLW, EMA

Brexidol, Cheisi,

BNF

Brexin 20mg,

Cheisi

Inspection report

dated 30/09/2014

provided. Firm

showed

improvement

regarding

previous

shortcomings /

observations.

Approved.

246

and Health

Canada.

2. Several

observations

have been

made by the

area FID in the

inspection

report dated

05/03/2014

regarding

validation of

HVAC,

frequency of In

Process testing,

differential

pressure

maintenance,

old machinery

like fluid bed

dryer, mixer,

granulator to

be replaced

with latest

version etc.

446. M/s. P.D.H

Pharmaceuticals

(Pvt) Ltd., 19 Km,

Ferozpur Road,

Lahore.

Giostatin 10mg

Tablets

Each film coated

tablet contains:-

Rosuvastatin

Calcium

equivalent to

Rosuvastatin

……………..

10mg

Statins

Manufacturers

specifications

Form 5

Fast Track

12/4/2013 798

R&I

13/11/2013

(Rs. 60,000/-)

Rs.250/10’s

Deferred for

final reminder

for completion

of Form 5

1. An

undertaking /

commitment

regarding the

submission of

following, as

per decision of

the

Registration

Board, may be

submitted:

a) Label claim

and prescribing

information

being same as

approved by

reference drug

agencies e.g.,

FDA, TGA,

MHLW, EMA

and Health

Canada.

2. Several

Crestor 10mg,

FDA

Rosutrol 10mg,

Pfizer

Inspection report

dated 30/09/2014

provided. Firm

showed

improvement

regarding

previous

shortcomings /

observations.

Approved.

247

observations

have been

made by the

area FID in the

inspection

report dated

05/03/2014

regarding

validation of HVAC,

frequency of In

Process testing,

differential

pressure

maintenance,

old machinery

like fluid bed

dryer, mixer,

granulator to

be replaced

with latest

version etc.

447. M/s. P.D.H

Pharmaceuticals

(Pvt) Ltd., 19 Km,

Ferozpur Road,

Lahore.

Esogerd 20mg

Capsule

Enteric coated

pellets

Each capsule

contains:-

Esomeprazole

Magnesium

trihydrate enteric

coated pellets

equivalent to

Esomeprazole

…………..…

20mg

Anti-ulcer

Manufacturers

specifications

Source: M/s

Vision

Pharmaceuticals,

Islamabad

Form 5

Fast Track

12/11/2013 788

R&I

12/11/2013

(Rs. 60,000/-)

Rs.231/ 2x7’s

Deferred for

final reminder

for completion

of Form 5

1. An

undertaking /

commitment

regarding the

submission of

following, as

per decision of

the

Registration

Board, may be

submitted:

a) Label claim

and

prescribing

information

being same as

approved by

reference drug

agencies e.g.,

FDA, TGA,

MHLW, EMA

and Health

Canada.

2. Several

observations

Nexium 20mg

Capsules, FDA

Nexum 20mg,

Capsules

Inspection report

dated 30/09/2014

provided. Firm

showed

improvement

regarding

previous

shortcomings /

observations.

FID mentioned

that automatic

capsule filling

machine should

be provided in

capsule filling

area.

Approved.

248

have been

made by the

area FID in

the inspection

report dated

05/03/2014

regarding

validation of

HVAC,

frequency of

In Process

testing,

differential

pressuremaint

enance, old

machinery like

fluid bed

dryer, mixer,

granulator to

be replaced

with latest

version etc.

448. M/s. P.D.H

Pharmaceuticals

(Pvt) Ltd., 19 Km,

Ferozpur Road,

Lahore.

Esogerd 40mg

Capsule

Enteric coated

pellets

Each capsule

contains:-

Esomeprazole

Magnesium

trihydrate enteric

coated pellets

equivalent to

Esomeprazole

………………

40mg

Anti-ulcer

Manufacturers

specifications

Source: M/s

Vision

Pharmaceuticals,

Islamabad

Form 5

Fast Track

12/11/2013 788

R&I

12/11/2013

(Rs. 60,000/-)

Rs.360/ 2x7’s

Deferred for

final reminder

for completion

of Form 5

1. An

undertaking /

commitment

regarding the

submission of

following, as

per decision of

the

Registration

Board, may be

submitted:

a) Label claim

and prescribing

information

being same as

approved by

reference drug

agencies e.g.,

FDA, TGA,

MHLW, EMA

and Health

Canada.

2. Several

Nexium 40mg

Capsules, FDA

Nexum 40mg,

Capsules

Inspection report

dated 30/09/2014

provided. Firm

showed

improvement

regarding

previous

shortcomings /

observations.

FID mentioned

that automatic

capsule filling

machine should

be provided in

capsule filling

area.

Approved.

249

observations

have been

made by the

area FID in the

inspection

report dated

05/03/2014

regarding

validation of

HVAC,

frequency of In

Process testing,

differential

pressure

maintenance,

old machinery

like fluid bed

dryer, mixer,

granulator to

be replaced

with latest

version etc. 449. M/s Zanctok

Pharmaceutical

Laboratories, F/5

S.I.T.E Area,

Hyderabad

Genelor

Syrup

Each 5ml

Contains:

Desloratadine……

………….2.5mg

Antihistamine

Manufacturers

specifications

Form5

Routine

23/07/2010

Dy. No. 1411

Rs. 8000/-

13-05-2013

Rs. 12000/-

60ml,120ml/As

per PRC

Deferred for

confirmation

of me too

status

Firm has

informed that due

to typographic

error the strength

was typed as

5mg/10ml and

that they have

corrected the

strength to

2.5mg/5ml. A

revised Form-5

has been

submitted by the

firm.

Clarinex

0.5mg/ml, Syrup,

FDA

Desora 0.5mg/ml

Syrup,

Continental

Pharma

Approved.

250

450. M/s Hiranis

Pharmaceuticals

(Pvt) Ltd., Plot No.

E-145 – E-149,

North Western

Industrial Zone,

Port Qasim,

Karachi.

Relevo Sachet

20mg

Each sachet

contains:

Piroxicam beta-

cyclodextrin 191.2

mg eq. to

Piroxicam

………… 20mg

(Manufacturer’s

Specs)

NSAIDs

Form-5D

New License

28-05-2014

810 R&I

Rs. 150 / per

10’s

Rs. 50,000/-

Deferred for

evidence of

approval of

same

formulation by

reference drug

agencies e.g.,

FDA, TGA,

MHLW, EMA

and Health

Canada.

BREXIN

PULVER

20mg powder

Torrex-Chiesi

Pharma,Austria

BREXIN

20mg granules

for oral solution

(Sachet)

Promedica, Italy

Deferred for

evaluation of

stability data &

expert opinion by

the following:

1. Dr.Abid

Farooki, PIMS

2.Brig.Mushtaq,

MH

3.Dr.fareedullah

Zimri, NIRM

451. M/s Hiranis

Pharmaceuticals

(Pvt) Ltd., Plot No.

E-145 – E-149,

North Western

Industrial Zone,

Port Qasim,

Karachi.

Gastocon Liquid

Sachet

Each 10ml sachet

contains:

Sodium alginate

(BP) 500 mg

Sodium bicarbonate

(BP) 267mg

Calcium carbonate

(BP)…. 160 mg

(BP Specifications)

Reflux suppressant

/ Antacid

Form-5D

New License

28-05-2014

809 R&I

Rs. 100 / per

10’s

Rs. 50,000/-

Deferred for:

1) Evidence of

approval of

same

formulation by

reference drug

agencies e.g.,

FDA, TGA,

MHLW, EMA

and Health

Canada.

2) Stability

data.

Now following

reference in

terms of evidence

of international

availability has

been submitted:

GAVISCON

Liquid Sachet

MHRA

Deferred for

evaluation of

stability data &

expert opinion by

the following:

1.Brig.Amjad

Salamat

2.Dr.Najam,

Shifa

3.Prof.Umer,

RMC

452. M/s

GlaxoSmithKline

Pakistan limted, F-

268 S.I.T.E.,

Karachi

Panadol Sinus

Caplets

Caplets

Each Caplet

Contains:

Paracetamol…500

mg

Phenylephrine

Hcl. 5.00mg

Form 5-D (Fast

Track)

Rs.8,000/-

09-12-2010

Dy. No. not

mentioned

Rs.60,000/-

20-03-2013

Dy. No. not

Registration

Board referred

Panadol sinus

Caplets to

Pharmaceutica

l Evaluation

Cell for

scrutinization

in light of

check list

approved by

BENYLIN

COLD & SINUS

500/5mg

Health Canada

Inspection dated

07-01-2014, 21-

01-2014 & 19-

02-2014. Well

maintained /

retained unit

Deferred for

evaluation of

stability data

which should be

performed at the

applicant’s site &

expert opinion by

the following:

1.Brig.Aslam

2.Dr.Shazli

Manzor

251

mentioned

Rs.82,000/-

19-11-2013

Dy. No. not

mentioned

Rs.300/-100’s

Registration

Board.

reported. Tablet

section

mentioned in

report.

1. In terms of

Prescribing

information (PI),

Patient

Information

Leaflet (PIL) and

Summary of

product

characteristics

(SmPC) as

approved by

Drug regulatory

agencies or

authorities of

country of origin

or FDA, EMA,

TGA, etc., firm

has submitted

international data

sheet for the

product.

2. Data of

stability studies

conducted on

three pilot

batches at

25C/60%RH,

30C/60%RH,

30C/75%RH and

40C/75%RH.

However, it is

pertinent to

mention that the

batches were

manufactured in

Sydney, Australia

as the raw

material and

pharmaceutical

development was

carried out in

firms R&D

center in

Australia.

3.Dr.Rehana

Kauser, PIMS

252

Evaluator – II

S/

N

Name and address

of manufacturer /

Applicant

Brand Name

(Proprietary

name + Dosage

Form +

Strength)

Composition

Pharmacologic

al Group

Finished

product

Specification

Type of Form

Initial date,

diary

Fee including

differential fee

Demanded

Price / Pack

size

Decision of

Previous

Meeting

Remarks on the

formulation (if

any) including

International

status in

stringent drug

regulatory

agencies /

authorities

Me-too status

GMP status as

depicted in

latest

inspection

report (with

date) by the

Evaluator

Decision

453. M/s Herbion Pakistan

(Pvt) Ltd., Kahuta

Road, industrial

Triangle, Humak,

Rawalpindi-

Islamabad.

LacNovex /

LaxNovex /

ConstiNovex

3.35g Syrup

Each 5ml

contains:-

Lactulose

(BP)………3.35

g

(Laxative)

(B.P Spec.s)

{Source of

Lactulose: M/s

Fresenius Kabi

Austria GmbH

EstermannstraB

e 17 4020 Linz}

Form 5

26-02-2014

Dy.No.208

Rs.20,000+

Rs.80,000/-(05-

09-2014)

Rs.170.00/

120ml

Deferred for

confirmation of

1. Source &

Fee.

2. Testing

facility by DDG

DRAP and FID

(M-243)

BNF 61

(Lactulose

(Non-

proprietary)

DUPHALAC(H

IGHNOON

LABORATORI

ES LTD.)

Grant of DML

recommended

(23-24th January

2014)

1. The firm has

Approved. Firm will

provide legalized

GMP of source of

lactulose and

Chairman, RB will

permit issuance of


253

deposited fee

of Rs.

80,000/- and

requested for

fixation of

source i.e.

M/s Fresenius

Kabi Austria

GmbH

Estermannstr

aBe 17 4020

Linz.

2. Valid and

legalized

GMP

Certificate of

Source, COA

and stability

studies

according to

zone IV-a of

lactulose are

required.

(The firm has

submitted

COA &

Stability

studies)

3. Confirmation

of testing

facility by

DDG DRAP

and FID.

(The

inspection

report by

area FID &

DDG dated

02.12.2014

confirms the

testing

facility).

254

454. -do- MonteNovex /

AzmaNovex /

LeukoNovex

5mg Chewable

Tablets

Each chewable

tablet contains:-

Montelukast

Sodium BP eq.

to

Montelukast…5

mg

(Antiasthmatic

Agent

(Leukotriene

Receptor

antagonist)

(Manufacturer’s

Spec.s)

Form 5

24-02-2014

Dy.No.201

Rs.20,000

Rs.400.00/

14’s

Deferred for

correction in

master

formulation.

BNF 61:

(Singulair

(MSD)

Aerokast

(Barrett

Hodgson)

Grant of DML

recommended

(23-24th January

2014)

1. The firm has

corrected

master

formulation.

Approved.

455. -do-

MonteNovex /

AzmaNovex /

LeukoNovex

10mg Chewable

Tablets

Each chewable

tablet contains:-

Montelukast

Sodium BP eq.

to

Montelukast…

…….10mg

(Antiasthmatic

Agent

(Leukotriene

Receptor

antagonist)

(Manufacturer’s

Spec.s)

Form 5

24-02-2014

Dy.No.197

Rs.20,000

Rs.460.00/

14’s

Deferred for

correction in

master

formulation and

confirmation of

international

availability

Not confirmed

Aerokast

(Barrett

hodgson) not in

chewable

dosage form

Grant of DML

recommended

(23-24th January

2014)

1. The firm has

corrected

master

formulation.

2. Reference of

International

availability

has been

given from

India and

Bangladesh.

3. Reference of

5mg

Rejected on the

grounds that the

efficacy & safety of

the said formulation

has not been

established in

chewable dosage

form.

255

chewable

tablets has

been given

from Health

Canada.

Formulation

is in film

coated

dosage form

in Health

Canada.

456. -do- Neemplast

Plaster

Contains:-

Acrinol………

…10.4%

(Disinfectant

and Antiseptic)

(Manufacturer’s

)

Form 5

17-03-2014

Dy.No.251

Rs.20,000

Rs. 25/

19×72mm (10

strips)

Rs.

35/19×72mm

(20 strips)

Rs.

160/19×72mm

(100 strips)

Rs.

720/19×72mm

(500 strips)

Deferred for

confirmation of

me too status

and international

availability.

Not confirmed

Saniplast

(Uniferoz

Karachi)

Grant of DML

recommended

(23-24th January

2014)

1. The firm has

provided

reference of

Saniplast of

Uniferoz for

both

international

availability

and me-too

status.

2. International

availability

not

confirmed in

stringent

DRS’s.

3. Discussion

is requested

from

honorable

Drug

Deferred for

verification that the

said formulation is

registered in which

category in the

reference Stringent

Regulatory Agencies

whether as an OTC

or Pharmaceutical.

256

Registration

Board about

the status of

formulation

that whether

it is a drug

or HOTC

product.

S/

N

Name and address

of manufacturer /

Applicant

Brand Name

(Proprietary

name + Dosage

Form +

Strength)

Composition

Pharmacologic

al Group

Finished

product

Specification

Type of Form

Initial date,

diary

Fee including

differential fee

Demanded

Price / Pack

size

Decision of

Previous

Meeting

Remarks on the

formulation (if

any) including

International

status in

stringent drug

regulatory

agencies /

authorities

Me-too status

GMP status as

depicted in

latest inspection

report (with

date) by the

Evaluator

Decision

457. M/s. Simz

Pharmaceuticals (Pvt)

Ltd, 574-575 Sundar

Industrial Estate,

Raiwind Road

Lahore.

Ibusim DS

200mg

Liquid

Suspension

Each 5ml

contains:-

Ibuprofen

(B.P)…..200mg

(Antirheumatic,

anti-

inflammatory)

(B.P Spec.s)

Form-5

Rs.20,000/-10-

2-2014

Rs.60.00/90ml

Deferred for

confirmation

of

international

availability.

(M-244)

Health Canada:

Advil Pediatric

Drops

Brufen DS

(Abbot)

GMP compliant

(22-11-2013)

1. The product

was deferred

because the Firm

had not provided

the International

Approved.

257

availability

especially in

FDA, EMA,

Health Canada,

TGA & MHLW

for same generic,

dosage form &

strength with

reference is

required. Firm

had provided

Dolan Fp Forte

from Phillipine.

Later on same

formulation was

approved in M-

245 for M/s

Titles Pharma

Karachi because

international

availability was

confirmed. The

Firm has

requested to

consider their

application for

registration.

458. M/s. Cibex (Private)

Ltd. F-405, SITE,

Karachi

Batema-F Syrup

Each 15ml

contains:

Iron Protein

Succinylate

800mg

equivalent to

elemental

iron…40mg

Folic

Acid…5mg

(Anti-Anaemic)

(Manufacturer’s

Spec.s)

Form-5

30-04-2014

(611)

Rs.20,000/-

As per

SRO/60ml,

120ml

Deferred for

confirmation

of Me-Too &

International

(especially in

Stringent

Regulatory

Agencies)

registration

Status.

(M-245)

Not confirmed

Sucrofer-F

Syrup

(Nexpharm)

Grant of DML

recommended

(22-10-2013)

1. The Firm has

submitted

that the

product is

already

available

locally

manufactured

by CCL

under the

Approved

258

license of

Nexpharm

and the

product is

although not

available in

SRA,s but

DRAP has

granted

registration

to several

companies.

The Firm has

requested for

product

registration.

459. -do- Cimora 20mg

Capsule

Each Capsule

contains:

Esomeprazole

Magnesium

Trihydrate

enteric coated

pellets equivalent

to

Esomeprazole…

20mg

(Anti-Ulcerant)

(Manufacturer’s

Spec.s)

Form-5

30-04-2014

(625)

Rs.20,000/-

As per

SRO/14

Capsules

Deferred for

rectification

of following

observation:

1. Fee for

import.

2. Legalized

and Valid

GMP

3. Certificate

of Analysis

4. Stability

Studies

according to

zone assigned

to Pakistan.

(M-245)

BNF: Nexium

(AstraZeneca)

C-ESO (Crown

Pharmaceuticals

)

Grant of DML

recommended

(22-10-2013)

1. The Firm has

submitted

documents

for source of

pellets, M/s

Surge Lab

(Pvt. ) Ltd.

10th K.M

Faisalabad

Road ,

Sheikhupura.

2. cGMP

certificate

has been

issued to M/s

Surge for

Enteric

coated

Approved

259

Evaluator – III

Cases deferred in M-245 meeting

S/N Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary name

+ Dosage Form +

Strength)

Composition

Pharmacological

Group

Finished product

Specification

Type of Form

Initial date, diary

Fee including

differential fee

Demanded Price

/ Pack size

Decision in

245th

of

Registration

Board.

Remarks on

the

formulation (if

any) including

International

status in

stringent drug

regulatory

agencies /

authorities

Me-too status

GMP status as

depicted in

latest

inspection

report (with

date) by the

Evaluator

Decision

Pellets/Granu

les and Taste

Masked

Granules/

Pellets.

3. Approval by

CLB for

manufacturin

g of

Esomeprazol

e enteric

coated pellets

by M/s Surge

submitted.

260

460. M/s Cibex (Pvt)

Limited Karachi.

KATAFEN Rapid

Gel 1%


Diclofenac

diethylamine….10mg

Anti-Rheumatic

Manufacturer

Form-5

Dated 30/04/14

Dy No: 602

20,000/-

Pack of 1’s, 20gm

& 50gm/ As per

PRC

Deferred for

submission of

finished

product

specifications

The firm has

submitted the

finished

product

specifications

of applied

product.

Approved.

461. -do- MYBINA Plus

Ointment


Polymyxin B

sulphate….5000IU

Bacitracin…500IU

Neomycin…3.5mg

Lidocaine….40mg

Antibacterial

Manufacturer

Form-5

Dated 30/04/14

Dy No: 605

20,000/-

Pack of 1’s, 20gm

tube/ As per PRC

Deferred for

rectification of

following

observations:

Under finished

product

specifications

assay method

is not

submitted.

The firm has

submitted the

assay method

under finished

product

specifications

of applied

product.

Approved.

462. M/s.Shawan

Pharmaceuticals,

Plot #37, Road:

NS-1, National

Industrial Zone,

Rawat Islamabad.

DEXPRO Tablet

300mg

Each film coated

Tablet contains:

Dexibuprofen …..

300mg

NSAID

Manufacturer

Form 5

Fast Track

Dy. No.5246

dated 16-08-2013

Rs.60,000/-

As per SRO

Pack of 10’s

Deferred for

review

committee for

review of

formulation

Seractil of

Genus (BNF-61)

Dexib of Tabros

Pharma Karachi

Inspection of the

firm was

conducted on 23

July 2013 and

GMP

compliance is

found GOOD

Approved.

Cases deferred in M-242 meeting

261

S/N Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary name

+ Dosage Form +

Strength)

Composition

Pharmacological

Group

Finished product

Specification

Type of Form

Initial date, diary

Fee including

differential fee

Demanded Price

/ Pack size

Decision in 242nd

of Registration

Board.

Remarks on the

formulation (if

any) including

International

status in

stringent drug

regulatory

agencies /

authorities

Me-too status

GMP status as

depicted in

latest inspection

report (with

date) by the

Evaluator

Decision

463. M/s Medwell

Pharmaceuticals,

Lawrencepur

BETADINE Scrub

Each 5ml contains:

Povidone-

Iodine…….7.5%

Disinfectant

BP

Form-5

Dy.No: 6382

dated: 07-10-2013

60,000/-

As per SRO/

50ml, 60ml and

450ml bottle

Deferred as the

firm has not

completed the

requisite

documentation per

Form-5

Pyodine of

Brookes Pharma

Karachi

The inspection of

firm was carried

out on 01-04-

2014 by the area

FID and GMP

compliance was

found good.

Approved.

262

Veterinary cases

S/N Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary name

+ Dosage Form +

Strength)

Composition

Pharmacological

Group

Finished product

Specification

Type of Form

Initial date,

diary

Fee including

differential

fee

Demanded

Price / Pack

size

Decision in 242nd

of Registration

Board.

Remarks on

the

formulation (if

any) including

International

status in

stringent drug

regulatory

agencies /

authorities

Me-too status

GMP status as

depicted in

latest

inspection

report (with

date) by the

Evaluator

Decision

464. M/s Jfrin

Pharmaceuticals,

Lasbella

Balochistan

JF COLAMINE

Oral Powder

Each 100gm

contains:

Tylosin

Tartrate…..100mg

Doxycycline

HCL…..200mg

Phenyl

Butazone….12gm

Bromohexine

HCL….05gm

Colistin

Sulphate…..500MIU

Antibiotic

Manufacturer

Form-5

Dy.No: 866

dated: 24-07-

2013

60,000/-

Decontrolled/

Jar of 100,

500, 1000gm

Deferred as the

firm has not

completed the

requisite

documentation

per Form-5

Broncofas of

Zakfas

Pharmaceuticals

Rejected as the

formulation

contains banned

drug that is Phenyl

Butazone.

263

Case No. 11. NEW APPLICATIONS IN LEIU OF REJECTED ONES

Evaluator - III

Two products of M/s Hiranis Pharmaceuticals are rejected in the 243rd

meeting of Registration Board as

the safety and efficacy has not been established in the stringent SRA’s. The firm has submitted new

applications in lieu of the rejected products. The detail is tabulated below:

Sr.

No.

Products Discussed in M-

243

Decision in M-243 New Products applied

1. Acebro Capsule

(Acebrophylline 100mg)

Rejected as safety and

efficacy of formulation has

not been established in


authorities.

Fungisaf Capsule

(Fluconazole 150mg)

2. Acebro syrup

(Acebrophylline 50mg/

5ml)

Rejected as safety and

efficacy of formulation has

not been established in


authorities.

Levopearl oral suspension

125mg/5ml (Levofloxacin)

264

The detail of new products is follows:

S/N Name and

address of

manufacturer /

Applicant

Brand Name

(Proprietary name +

Dosage Form +

Strength)

Composition

Pharmacological

Group

Finished product

Specification

Type of Form

Initial date,

diary

Fee including

differential fee

Demanded Price

/ Pack size

Remarks on the

formulation (if

any) including

International

status in

stringent drug

regulatory

agencies /

authorities

Me-too status

GMP status as

depicted in

latest inspection

report (with

date) by the

Evaluator

Recommendations

by the Evaluator

Decision

465. M/s Hiranis

Pharmaceuticals

Karachi

FUNGISAF Capsule

150mg


Fluconazole…..150mg

Triazole Antifungal

Manufacturer

Form-5

Dy No: 807 dated

28-07-14

20,000/-

As per PRC

Diflucan Pfizer

Inc

Diflucan of

Pfizer Karachi

Approved.

466. -do- LEVOPEARL Oral

Solution

Each 5ml contains:

Levofloxacin

(USP)….125mg/ 5ml

Quinolone

Manufacturer

Form-5

Dy. No: 2067

dated:16-12-2013

20,000/-

As per PRC

Levaquin Oral

Solution of

Janssen

(USFDA)

The product was

initially considered

as dry oral

suspension in 243rd

meeting of

Registration Board

and deferred with

following decision:

“Deferred for

confirmation of

formulation”

The firm then

revised the

formulation as Oral

Solution which was

product again

The Board did

not accede to the

request of firm

for change in

dosage form &

deferred the

instant

application for

review of

formulation by

Incharge, PEC.

265

considered in 244th

meeting of

Registration Board

and deferred with

decision:

“Deferred as the

Registration Board

has already granted

ten products in

liquid syrup section

(general)”

The firm has now

requested to

consider applied

formulation in lieu

of the rejected

product (Acebro

syrup

(Acebrophylline

50mg/ 5ml) in

243rd

meeting of

RB

266

Item No. VI Miscellaneous Cases - Pharmaceutical Evaluation & Registration Division.

Registration-I

Case No.01. Drugs deferred by Registration Board for expert opinion.

a. Strefen Lozenges - M/s. Reckitt Benckiser Healthcare International, Karachi.

Following drugs deferred for expert opinion. Accordingly product was referred to expert

for views. Comments are as under:-

S. No. Name of Indenter/

Manufacturer

Name of drug (s)/

Composition

& Therapeutic Group

Demanded

Price/Pack

Shelf Life Date of

application

receiving

& fee.

1. M/s. Reckitt Benckiser

Healthcare

International,

Karachi. /

M/s. Notting Site,

Nottingham,

Nottinghamshire,

United Kingdom.

Strefen Lozenge

Each one lozenge

contains:-

Flurbiprofen

BP……………..8.75mg

Price not

mentioned.

03 years 04-06-2012

Rs.15000 +

Rs.35000 =

Rs.50,000/-

Dr. M.Ehsan-ul-Haq,

MBBS, DTCD, FCPS,

(Physician (Medicine),

Federal Govt. Services

Hospital, Islamabad.

Prof. Dr. Ejaz Hussain

Malik,

Nishtar Medical Institution,

Multan.

Brig. (R) Prof. Dr.

Muzammil Hasan Najmi,

Chairman, Department of

Pharmacology/Associate

Dean, Basic Sciences

Division, Foundation

University, Medical College,

Rawalpindi. The drug Strefen Lozenge

containing flurbiprofen BP 8.75

can be useful addition to the list

of pharmaceutical available in

the country. Since the amount of

the active principle is quite small.

It is les likely to cause untoward

dose-related side effects. The

lozenge formulation of this

compound is already in use in the

world market. However the

therapeutic efficacy and the

I have gone through the literature

of Flurbiprofen. The only is good

and sample and recommended

for registration.

Awaited.

267

social acceptance in our

population can only be accessed

when it is used in our country.

The drug is intended for local use

and has small amount of the

active principle and thus is

expected to be cost effective.

Decision: Registration Board approved registration of Strefen Lozenge as per detail

mentioned in the case. The approval is subject to inspection of manufacturer abroad as per

import policy, verification of storage facilities and price fixation / calculation by the pricing

Division etc.

b. AminoFluid ® Infusion Solution 1000ml - M/s Otsuka Pakistan Ltd., Distt. Lasbella


meeting deferred following products for expert opinion.

Accordingly products were referred for views. Comments are as under:-

S.

No.

Name of

Indenter/

Manufacturer

Name of drug (s)/

Composition

& Therapeutic Group

Demanded

Price/Pack

Shelf

Life

Date of

application

receiving

& fee.

1. M/s Otsuka

Pakistan Ltd.,

Distt. Lasbella. /

M/s. PT. Otsuka

Indonesia,

Lawang, Malang.

Indonesia.

AminoFluid ® Infusion Solution

1000ml

Each 150ml contains:-

L-Leucine…...………………2.100g

L-Isoleucine……………...…1.200g

L-Valine..………………...…1.200g

L-Lysine hydrochloride…….1.965g

(L-Lysine Equivalent)….....(1.573g)

L-Threonine...........................0.855g

L-Tryptophen……………….0.300g

L-Methionine.………………0.585g

L-Cystoine………………….0.150g

L-Phenylalanine…………….1.050g

L-Tyrosine..………………...0.075g

L-Arginine………………….1.575g

L-Histidine………………….0.750g

L-Alanine…………………...1.200g

L-Proline….………………...0.750g

LSerine ……………………..0.450g

Gylcine……...........................0.885g

Rs.4201/Per

1000ml Soft

bags.

02

years

27-09-2012

Rs.50,000/-

268

L-Aspartic acid……………..0.150g

L-Glutamic acid….................0.150g

Dipostassium phosphate…....0.458g

Water for injection ad….........150ml

(Clinical Parrenteral Nutrition).

2. M/s Otsuka

Pakistan Ltd.,

Distt. Lasbella. /

M/s. PT. Otsuka

Indonesia,

Lawang, Malang.

Indonesia.

Kidmin ® Injection


L-Leucine………………….…14.0g

L-Isoleucine………………...…9.0g

L-Valine……………………...10.0g

L-Lysine acetate………………7.1g

(free base)…………………..(5.05g)

L-Threonine…...........................3.5g

L-Tryptophan……………….....2.5g

L-MEthionine…………………3.0g

L-Phenylalanine…………….....5.0g

L-Cysteine….…………………1.0g

L-Tyrosin……………………...0.5g

L-Arginine…..………………...4.5g

L-Histidine………………...…..3.5g

L-Alanine………………...……2.5g

L-Proline…………………...….3.0g

L-Serine……………………….3.0g

L-Aspartic acid..........................1.0g

L-Glutamic acid……………….1.0g

(Clinical Parentertal Nutrition).

Rs.1708/

Per 200ml

bag

02

years

18-10-2012

Rs.15000 +

Rs.35000 =

Rs.50,000/-

3. M/s Otsuka

Pakistan Ltd.,

Distt. Lasbella. /

M/s. PT. Otsuka

Indonesia,

Lawang, Malang.

Indonesia.

Amiparen ® Injection


L-Leucine…...………………..7.00g

L-Isoleucine……………….....4.00g

L-Valine……………………...4.00g

Lysine Acetate……………….7.40g

(L-Lysine equivalent)…....…(5.25g)

L-Threonine………………….2.85g

L-Tryptophan...........................1.00g

L-Methionine...........................1.95g

L-Phenylalanine……………...3.50g

L-Cysteine…………………...0.50g

Total free amino acids……50.00g

Essential amino acids (E)…..29.55g

Nonessential amino acids (N)20.45g

Total nitrogen………………..7.84g

L-Tyrosine…...........................0.25g

L-Arginine...…………………5.25g

L-Histidine…………………...2.50g

L-Alanine…………………….4.00g

L-Proline…..…………………2.50g

Rs.2512/

Per 500ml

Bag

02

years

24-09-2012

Rs.15000 +

Rs.35000 =

Rs.50,000/-

269

L-Serine…...…………………1.50g

Aminoacetic acid………….…2.95g

L-Aspartic Acid.......................0.50g

L-Glutamic acid.......................0.50g

Water for injection……ad 500mL

(Clinical Parenteral Nutrition).

In charge Intensive Care Unit

(ICU),

Pakistan Institute of Medical Sciences,

Islamabad.

In charge Intensive Care Unit

(ICU),

Military Hospital,

Rawalpindi.

I have evaluated the data provided by Otsuka Pakistan

Limited concerning AminoFluid ® 1000ml dual

chamber soft bags, Kidmin ® Injection 200ml soft bag

and Amiparen ® Injection 500ml soft bag. I have

found that the scientific data supports the therapeutic

efficacy and favorable safety profile. I recommended

that this drug be registered according to the drug

authority regulations.

Awaited

Decision: Brig. Aslam Khan, Member Registration Board / Incharge Intensive Care

Unit (ICU), Military Hospital, Rawalpindi also recommended the appled formulations.

Thus Registration Board approved registration of AminoFluid ® Infusion Solution 1000ml,

Kidmin ® Injection and Amiparen ® Injection as per detail mentioned in the case. The

approval is subject to inspection of manufacturer abroad as per import policy, verification

of storage facilities and price fixation / calculation by the pricing Division etc.

c. Propilen Surgical Suture with Needle - M/s. Nishat Surgical Hyderabad

Registration Board in its 243rd



S.

No.

Name of

Indenter/

Manufacturer

Name of drug (s)/

Composition

& Therapeutic Group

Demanded

Price/Pack

Shelf

Life

Date of

application

receiving &

fee.

1. M/s. Nishat

Surgical

Hyderabad Sindh

Pakistan

manufactured by

M/s. Dogsan

Propilen Surgical Suture with

Needle

As per PRC 05

years

26-03-2012

Rs.100,000/-

270

Tibbi Malzeme

Sanayi A.S.

Trabzon Turkey.

2. -do- Silk Non Absorbable Surgical

Sutures

As per PRC 05

years

26-03-2012

Rs.100,000/-

3. -do- Pegelak and Pegelak Rapid

Synthetic Absorbable

Surgical Sutures with Needle

As per PRC 05

years

26-03-2012

Rs.100,000/-

4. -do- Tektel Non Absorbable


As per PRC 05

years

26-03-2012

Rs.100,000/-

5. -do- Pedesente Synthetic

Absorbable Surgical Sutures

with Needle

As per PRC 05

years

26-03-2012

Rs.100,000/-

6. -do- Pegesorb and Pegesorb Rapid

Synthetic Absorbable


As per PRC 05

years

26-03-2012

Rs.100,000/-

Professor Tanwir Khaliq,

Professor of Surgery,

Department of General

Surgery, Pakistan Institute

of Medical Sciences,

Islamabad.

Dr. I.U Baig, FCPS FRCS,

Consultant Surgeon & HOD,

Federal Government

Polyclinic, Islamabad.

Lt. Col. Dr. Farhan Ahmad

Majeed, Surgeon, Combined

Military Hospital,

Rawalpindi

We have used the surgical

sutures in our procedures. The

tissue penetration, needle,

suture strength, pliability and

knotting quality have been

found satisfactory.

Samples of sutures supplied

by M/s. Nishat Surgical

Hyderabad Sindh Pakistan

manufactured by M/s. Dogsan

Tibbi Malzeme Sanayi A.S.

Trabzon Turkey were

used/tested by me and by my

surgeons at FGPC and our

observations regarding the

surgical sutures are :

1.Sterile packing is good.

2.Tensile strength of sutures

of their appropriate types and

sizes is good.

3.Needle anchorage is fine.

4.Needle quality is good.

5.Tissue reaction to sutures is

according to standard.

6.No allergic reaction to

Surgical sutures of M/s.

Nishat Surgical Hyderabad

Sindh Pakistan are of

unsatisfactory quality,

specially size of needle is

dispropertmat with thread size

(dia).

271

suture material.

7.No postoperative infections

nooted.

In light of above observations

I recommend sutures namely;

Propilen, Silk, Pegalak and

Pegalak Rapi, Tektel,

Pedesente and Pegesorb and

Pegesorb Rapid.

Decision: Registration Board deferred the case due to the comments of Lt. Col. Dr.

Farhan Ahmad Majeed, Surgeon, Combined Military Hospital, Rawalpindi as he

mentioned “unsatisfactory quality, specially size of needle is dispropertmat with thread size

(dia)”. The Board decided to send these observations of Lt. Col. Dr. Farhan Ahmad Majeed

to the following experts for further pratical evaluation:

Col. Dr.Bilal Umair, Surgeon, CMH.

Dr.Mamoon Rasheed, Surgeon, Shifa Int Hospital, Islamabad.

d. Azarga Eye Drop Suspension 5ml - M/s. Ali Gohar & Co. (Pvt) Ltd., Karachi




S.

No.

Name of

Indenter/

Manufacturer

Name of drug (s)/

Composition

& Therapeutic Group

Demanded

Price/Pack

Shelf

Life

Date of

application

receiving &

fee.

1. Applicant:

M/s. Ali Gohar &

Co. (Pvt) Ltd.,

Karachi. /

Manufacturer:

M/s. S.A. Alcon-

Couvreur N.V.

Rijksweg 14,

2870 Puurs,

Belgium.

Azarga Eye Drop Suspension

5ml

Each ml contains:-

Brinzolamide......10mg

Timolol...............4mg

(Beta Blocking agents).

Finished product

specifications are

Manufacturer.

Rs.1400/

5ml Eye

Drops packs

24

months

02-03-2010

Rs.50, 000/-

272

Prof. Dr. M. Daud Khan,

Principal & Dean,

Pak International Medical

College, Hayatabad,

Peshawar.

Prof.Dr. Ali Raza,

Head of Eye Department,

RMC and Allied Hospitals,

Rawalpindi.

Maj. Gen. Mazhar Ishaq,

Commandant,

Armed Forces Institute of

Opthalmology,

The Mall, Rawalpindi.

Alcon International is the

leading international

pharmaceutical company

dealing with Ophthalmic

drugs and devices. Alcon

drugs are known for quality,

safety and efficacy. Azarga

Eye Drops, which is a

combination of a beta blocker

and carbonic anhydrase

inhibitor. It is registered by

FDA and has many studies in

support of its safety, efficacy

and effectiveness. The price

seems to be reasonably

comparable to other anti-

glaucoma drugs. I therefore

recommend that the drug may

kindly be registered in

Pakistan.

I have reviewed the literature

& references relating to the

above mentioned product with

regard to its safety, efficacy &

cost effectiveness. Azarga

(Brinzolamide, Timolol) is

most comfortable Eye Drops

preferred by patient then

Dorzolomide/Timolol

combination. I have gone

through all references which

have been published in

renowned International

Medical Journals on regular

intervals. As you all know that

Glaucoma is a second leading

cause of irreversible blindness

worldwide & as well as in

Pakistan & patient has to use

lifelong. So it needs excellent

tolerability & efficacy both.

We need this product in

Pakistan for the preservation

of sight and prevention of

blindness with Glaucoma. I

always trust the quality of

innovative products & Brands.

I highly recommend this drug

for registration & made

available in Pakistan.

Azarga (Brinzolamide,

Timolol) is already being used

internationally for the

management of Glaucoma &

all references given by them

have been published in peer

reviewed international

Medical Journals on regular

basis. It has a very good

efficacy and is well tolerated

by the patients.

Therefore in the light of data

provided I recommend this

drug for registration in

Pakistan.

Decision: Registration Board approved registration of Azarga Eye Drop Suspension

5ml as per detail mentioned in the case. The approval is subject to inspection of

manufacturer abroad as per import policy, verification of storage facilities and price

fixation / calculation by the pricing Division etc.

273

e. Hidrasec 10mg, 30mg Sachet and and Hidrasec Capsule 100mg




S.

No.

Name of Indenter/

Manufacturer

Name of drug (s)/

Composition

& Therapeutic Group

Demanded

Price/Pack

Shelf

Life

Date of

application

receiving &

fee.

1. M/s. Abbott

Laboratories

(Pakistan) Limited,

Karachi. /

M/s. Laboratoires

SOPHARTEX 21

Rue du Pressoir

Vernouillet,

France.

Hidrasec 10mg Sachet


Racecadotril……10mg

(Anti-Diarrheal).

Rs.1046.30/Per

16 Sachets

24

months

29-04-2013

Rs.100,000/-

2. M/s. Abbott

Laboratories (Pakistan)

Limited,

Karachi. /

M/s. Laboratoires

SOPHARTEX 21 Rue

du Pressoir

Vernouillet, France.

Hidrasec 30mg Sachet


Racecadotril….30mg

(Anti-Diarrheal).

Rs.1046.30/Per

16 Sachets

24

months

29-04-2013

Rs.100,000/-

3. M/s. Abbott

Laboratories

(Pakistan) Limited,

Karachi. /

M/s. Laboratoires

SOPHARTEX 21

Rue du Pressoir

Vernouillet,

France.

Hidrasec 100mg

Capsules


Racecadotril….100mg

(Anti-Diarrheal).

Rs.654/

Per 10

Capsules

24

months

29-04-2013

Rs.100,000/-

Prof.Dr. Rauf Niazi,

Head of Unit-2

Pakistan Institute of Medical

Sciences,

Islamabad.

Prof.Dr. Syed Irfan Ahmed,

Professor of Medicine,

RMC & Allied Hospitals,

Benazir Bhutto Hospital,

Murree Road, Rawalpindi.

Brig.Amjad Salamat,

Military Hospital,

Rawalpindi.

I strongly recommend

registration of that Raceadotril

(acetorphan), Capsules and

Hidrasec is recommended for

registration for the treatment

of diarrhea in conjunction with

Awaited.

274

Sachets, however if the price

of the drug can be brought

down, keeping in mind the

economic status of our

population these drugs would

be very useful addition, to

present drugs, available to

treat acute secretory diarrhea

and reduce morbidity of this

common condition. I highly

recommend registration of the

drug, on fast track basis.

ORS. However it should not

be used to treat infections.

Even in Cholera, which

requires antibiotics and

intravenous saline, it should

be used with caution as severe

fluid depletion can be a “Pre-

renal” cause of renal failure.

Hidrasec has a renal mode

excretion. Also no studies

have been conducted

comparing its safety profile

with Zinc or probiotics. Hence

it can not be claimed superior

to these modes of treatment.

Decision: Registration Board deferred the case for evaluation of clinical data by the

following experts:

Brig.Amjad Salamat MH, Rawalpindi.

Prof.Syed Irfan, BBH.

Prof.Rauf Niazi, PIMS.

Case No. 02. Registration of solvents for Oncodex (Docetaxel) Injection - M/s. PharmEvo

(Pvt) Ltd, Karachi.

Drug Registration Board in 236th meeting held on 20th November, 2012 approved the

registration of following drugs in the name of M/s. PharmEvo (Pvt) Ltd, Karachi manufactured

by M/s. Jiangsu Aosaikang Pharmaceutical Co., Ltd., 699-Kejian Road, Jiangning Science Park,

Nanjing, China subject to inspection of manufacturer abroad:-

S. No. Name of drug (s) & composition.

1. Oncodex 20mg Injection.


Docetaxel……………20mg.


275






4. Oncotaxel 100mg Injection.


Paclitaxel……………100mg.

In compliance of Drug Registration Board’s decision, inspection of the manufacturer

M/s. Jiangsu Aosaikang Pharmaceutical Co., Ltd., 699-Kejian Road, Jiangning Science Park,

Nanjing, China has been carried out by the nominated panel comprising Dr. Obaidullah, Deputy

Director General (Registration) and Mr. Abdullah, Deputy Drugs Controller (RRR), Drug

Regulatory Authority of Pakistan. M/s. PharmEvo (Pvt) Ltd, Karachi was advised to submit

separate solvent application for each product. The panel of inspector has recommended the

registration of the above said products. The storage facility of the importer has already been

verified by the area FID.

In response to our latter M/s. PharmEvo (Pvt) Ltd, Karachi have informed that same

solvent with same composition is being used in all three strengths of docetaxel range with final

concentration of the diluted solution equivalent to 10mg/ml. Below is a self-explanatory chart

depicting the fill range, approximate extractable volume and final concentration of the product

i.e. 10mg/ml:-

PRODCUT

NAME

DILUENT 13%

(W/W)

ETHANOL IN

WATER FOR

INJECTION

FILL RANGE

(ML)

APPROXIMATE

EXTRACTABLE

VOLUME OF

DILUENT WHEN

ENTIRE

CONTENTS ARE

WITHDRAWN

(ML)

CONCENTRATION

OF THE INITIAL

DILUTED

SOLUTION

(MG/ML

DOCETAXEL)

DOCETAXEL

20MG INJECTION

3.88 – 3.08 ml 1.8 ml 10mg/ml

DOCETAXEL

40MG INJECTION

3.60 – 3.86 ml 3.66 ml 10mg/ml

DOCETAXEL

80MG INJECTION

6.96 – 7.70 ml 7.1 ml 10mg/ml

276

M/s. PharmEvo (Pvt) Ltd, Karachi was again advised to submit separate solvent

application for each strength. In response, M/s. PharmEvo (Pvt) Ltd, Karachi has submitted

separate solvent application for each three strengths.

Decision: Registration Board approved the request of the firm for registration of the

solvents for already registered Docetaxel range of products.

Case No.03. Drugs deferred by Registration Board for submission of documents.

a. Caflam 50mg Sachets - M/s. Novartis Pharma, Karachi.

Drug Registration Board deferred the following applications for registration of drugs in

its 243rd

meeting and decided as mentioned against each. Accordingly, firm was advised to

provide the same information and the firm has submitted the required information as follows:-

S.# Name of

Manufacturer /

Importer.

Name of Drug (s)

Composition &

Therapeutic

Group.

Demanded

Price &

Pack Size.

Shelf

Life

Decision Reply of

the firm.

1. M/s. Novartis Pharma

(Pakistan) Limited,

Karachi /

M/s. Mipharm S.p.A.,

Milan, Italy.

Caflam 50mg Sachets


Diclofenac

potassium……50mg

(Non-steroidal anti-

inflammatory drug

(NSAID) Analgesic.

Rs.198/

Per packs

of 9’s

Rs.22/Per

Sachet

02

years

Deferred for

submission

of COPP

from

regulatory

authority of

Italy

The firm has

provided

COPP of

Italy attested

by Pakistan

Embassy.

Decision: Registration Board approved registration of Caflam 50mg Sachets as per

detail mentioned in the case. The approval is subject to inspection of manufacturer abroad

as per import policy, verification of storage facilities and price fixation / calculation by the

pricing Division etc.

277

b. Fluimucil A 600mg Effervescent Tablets - M/s. Angelini Pharmaceuticals (Pvt) Ltd.,

Lahore.

Drug Registration Board in its 244th

meeting held on 22-23rd

July, 2014 considered and

deferred the application of “Fluimucil A 600mg Effervescent Tablets (Acetylcysteine

600mg)” applied by M/s. Angelini Pharmaceuticals (Pvt) Ltd., Lahore imported from M/s.

Zambon Switzerland Ltd., Cadempino, Switzerland for submission of safety and efficacy data of

the drug along with complete clinical trial data of the formulation.

Name of Importer /

Manufacturer.

Name of Drug (s)

Composition & Therapeutic

Group.

Demanded

Price & Pack Size.

Shelf Life

M/s. Angelini


Ltd., Lahore /

M/s. Zambon Switzerland

Ltd., Cadempino,

Switzerland.

Fluimucil A 600mg

Effervescent Tablets.

Each tablets contains:-

Acetylcysteine........600mg.

(Mucolytics).

Rs.561.41/Per

packs of 10

effervescent

tablets.

Rs.56.14/Per

effervescent

tablets.

03 years

Accordingly, M/s. Angelini Pharmaceuticals (Pvt) Ltd., Lahore was advised to provide

the same. The firm has submitted the documents safety and efficacy data, which needs

deliberation by the Board.

Decision: Registration Board deferred the case for evaluation of clinical data by the

following experts:

Brig. Aslam Khan, Member registration Board

Abdul Lateef Shaikh, Director Pharmacy, AKUH, Karachi.

Dr.Shazli Manzoor, Pulmonologist, Quaid-e-Azam Int Hospital, Islamabad.

278

Case No. 04. Registration of imported – Inspections of manufacturing units abroad

thereof.

a. Withdrawal of registration applications - M/s. Barrett Hodgson Pakistan (Private)

Limited, Karachi.


meeting held on 12th

- 13th

October, 2010 approved

the registration of following drugs in the name of M/s. Barrett Hodgson Pakistan (Private)

Limited, Karachi manufactured by M/s. Yangtze River Pharmaceutical (Group) Jiangsu, China,

subject to inspection of manufacturer abroad:-

S. No. Name of Drug (s) Composition.

1. PacliBar Injection 30mg.

Each 5ml vial contains:-

Paclitaxel………30mg USP Specs.

2. PacliBar Injection 100mg.

Each 16.7ml vial contains:-

Paclitaxel………100mg USP Specs.

Dr. Muhammad Khalid Khan, Director, DTL, KPK / Member Drug Registration Board

and Mrs. Rohi Obaid, DDC, DRAP, Karachi was nominated for inspection of M/s. Yangtze

River Pharmaceutical (Group) Jiangsu, China. Accordingly, M/s. Barrett Hodgson Pakistan

(Private) Limited, Karachi was informed for arranging the inspection.

In response, M/s. Barrett Hodgson Pakistan (Private) Limited, Karachi have informed

that their principal M/s. Yangtze River Pharmaceutical (Group) Jiangsu, China is no more

interested in getting these products registered in Pakistan due to much delay in the process.

Therefore, the firm has requested for withdrawing the cases for registration of the above

mentioned products.

Decision: Registration Board acceded to request of the firm about withdrawl of above

registration applications.

279

b. Registration of imported drugs – Comments of panel of inspectors.



November, 2012 approved the

registration of following drugs for import in the name of M/s. Sind Medical Stores, Karachi

manufactured by M/s. Boryung Pharmaceutical Co. Ltd., Singil-dong, Wonnam-dong, Chongro-

ku, Seoul, Korea, subject to inspection of manufacturer abroad:-

S. No. Name of Drug (s) &

Composition.

Fee

deposited.

Price approved by the Price

Advisory Committee.

1. A.D. Mycin Injection 10mg.


Doxorubicin HCI…….10mg.

Rs.100,000 Rs.430.00/Per vial.




Rs.100,000 Rs.1716.00/Per vial.

3. E.P. Mycin Injection 10mg.


Epirubicin HCI……10mg.

Rs.100,000 Rs.670.00Per vial.



Epirubicin HCI…....50mg.

Rs.100,000 Rs.2500.00/Per vial.

5. Neotabine Injection 1gm.


Gemcitabine HCI….1.14gm.

Rs.100,000 Rs.8330.00/Per vial.

6. Neotabine Injection 200mg.


Gemcitabine HCI….228mg.

Rs.100,000 Rs.1675.00/Per vial.

In compliance, inspection of the manufacturer abroad M/s. Boryung Pharmaceutical Co. Ltd.,

Singil-dong, Wonnam-dong, Chongro-ku, Seoul, Korea, has been carried out by the nominated

panel comprising Dr. Saifur-Rehman Khattak, Director, CDL, Karachi and Mr. Salateen Waseem

Philip, ADC (Licensing), Drug Regulatory Authority of Pakistan, Islamabad.

280

The panel of inspectors has recommended the registration of the above said products with the

remarks that registration of the applied products is recommended however import to Pakistan

should be allowed only after confirmation of successful execution of the desired improvement.

The storage facility of the importer has already been verified by the Area FID.

With reference to the inspection report Dr. Saifur-Rehman Khattak, Director, CDL, Karachi

and Mr. Salateen Waseem Philip, ADC (Licensing), Drug Regulatory Authority of Pakistan,

Islamabad were requested to inform about type of short coming pointed out whether these are

critical in nature affecting the quality of the product or suggestive / advisory nature for further

processing the case.

In response, Dr. Saifur-Rehman Khattak, Director, CDL, Karachi have informed that the firm

was thoroughly inspected for facilities regarding the production, quality control and storage of

their products (Anti-Cancer Injections) intended for registration in Pakistan. The risk based

assessment of the facilities of the firm identified a number of critical, major and minor

observations which can adversely affect the quality of the products intended for registration in

Pakistan. They has further clarified that the observation No.1,2,4,6 and 10 are the critical

observations which need be rectified in any stance along with the other stated observations

before importing these products in Pakistan.

The panel informed that the certain observations are very critical and can affect the quality of

the product which is very serious threat for the patients to whom use these products. It should be

the duty of the panel of experts should gave the clear recommendation in light of observation, in

light of these serious observations the panel also recommended these products in final

recommendation, which is not understandable.

Decision: Regiastration Board discussed the inspection report in detail and keeping in

view nature of the observations being critical rejected the following applications of M/s.

Sind Medical Stores, Karachi manufactured by M/s. Boryung Pharmaceutical Co. Ltd.,

Singil-dong, Wonnam-dong, Chongro-ku, Seoul, Korea;

S. No. Name of Drug (s) &

Composition.


281








Epirubicin HCI……10mg.



Epirubicin HCI…....50mg.

5. Neotabine Injection 1gm.


Gemcitabine HCI….1.14gm.

6. Neotabine Injection 200mg.


Gemcitabine HCI….228mg.

c. Registration of imported drug – Issuance of registration letter after inspection of

manufacturer abroad.

i. M/s. Laderly Bio-Tech Pharma, Karachi


meeting held on 22-23rd

July, 2014 approved the

registration of following drugs in the name of M/s. Laderly Bio-Tech Pharma, Karachi,

manufactured by M/s. CSPC Pharmaceutical Co., Ltd., No. 188 Gongnong Road, Shijiazhuang

City, P R China, subject to inspection of manufacturer abroad, verification of storage facilities

and price fixation / calculation etc as per policy:-

S.#

Name of drug (s)/Composition. Fee deposited. Prices approved by

the Price

Recommendatory

Committee

1. Meropeon Injection 0.5gm.

Each vial contains: -

Meropenem USP…… 0.5gm.

Rs.100000 Rs.600/Per vial

2. Meropeon Injection 1gm.


Meropenem USP …… 1gm.

Rs.100000 Rs.1100/Per vial.

Inspection of the manufacturer abroad M/s. CSPC Zhongnuo Pharmaceutical

282

(Shijiazhuang) Co., Ltd., 188 Gongnong Road, Shijiazhuang City, Hebei Province, China has

already been carried out by the nominated panel comprising Dr. Obaidullah, Deputy Director

General (Registration) and Mr. Abdullah, Deputy Drugs Controller (RRR), Drug Regulatory

Authority of Pakistan. The panel of inspectors has recommended the registration of the above

said products.

Decision: Registration Board considered the inspection report of the panel and

approved the registration of above products.

ii. M/s. Pak China International, Karachi.

Drug Registration Board in its 245th meeting held on 29-30th September, 2014 approved

the registration of following drug in the name of M/s. Pak China International, Karachi

manufacture by M/s. Zheijing Chimin Pharmaceutical Co. Ltd, 888 Beiyuan Road, Huangyan,

Zhejiang, P.R. China and exported by M/s. Ningbo Tisun Biochemi Company Ltd. Ningbo,

China subject to inspection of manufacturer abroad, verification of storage facilities and price

fixation / calculation etc as per policy:-

S.#

Name of drug (s)/Composition.

1. Sodium Ringer Lactate Injection.

Each 500ml bottle contains:-

Sodium Chloride….......................3.0gm.

Sodium Lactate, Anhydrous……1.55gm.

Potassium Chloride .....................0.15gm.

Calcium Chloride............................0.1gm.

Inspection of the manufacturer abroad M/s. Zheijing Chimin Pharmaceutical Co. Ltd, 888

Beiyuan Road, Huangyan, Zhejiang, P.R. China has already been carried out by the nominated

panel comprising Dr. Obaidullah, Deputy Director General (Registration) and Mr. Abdullah,

Deputy Drugs Controller (RRR), Drug Regulatory Authority of Pakistan. The panel of inspectors

has recommended the registration of the above said product.

Decision: Registration Board considered the inspection report of the panel and

approved the registration of above products.

283

Case No. 05. Change of manufacturing site of imported registered drug.

a. Duac Gel (Reg. No.043090) - M/s. GlaxoSmithKline Pakistan Limited, Karachi.

M/s. GlaxoSmithKline Pakistan Limited, Karachi have requested to approve the change

of source of manufacturing & supply of their registered imported drug “Duac Gel (Reg.

No.043090)” from M/s. Stiefel Laboratories, Ireland to M/s. Glaxo Operations UK Limited,

Barnard Castle, UK.

The firm has deposited fee Rs.50000/- and submitted following supporting documents:-

i) Original legalized CPP from new source.

ii) Supporting letter from endorsing source change.

iii) Copy of initial registration letter.

iv) Copy of transfer of registration letter in the name of M/s. GSK Pakistan Ltd.,

Karachi.

M/s. GlaxoSmithKline Pakistan Limited, Karachi was advised to submit the balance fee

as per revised “Schedule-F” for change of source of Duac Gel (Reg. No.043090) and status of

registration with EMA, US-FDA, Japan & Australia.

In response, M/s. GlaxoSmithKline Pakistan Limited, Karachi has submitted required fee

as per revised fee structure given in SRO 1117 (I) 2012.

The firm M/s. GlaxoSmithKline Pakistan Limited, Karachi has submitted legalized

Certificate of Pharmaceutical Product of “Duac Gel” issued by Australian Regulatory Authority.

The firm has submitted the all document and required fee as per approved policy of the

Drug Registration Board.

Decision: Registration Board approved request of M/s. GlaxoSmithKline Pakistan

Limited, Karachi for change in manufacturing site of Duac Gel (Reg. No.043090) from M/s.

Stiefel Laboratories, Ireland to M/s. Glaxo Operations UK Limited, Barnard Castle, UK.

Case No.06 Transfer of registered drugs.

a. M/s. Getz Pharma (Pvt) Limited, Karachi.

M/s. Getz Pharma (Pvt) Limited, Karachi have requested for transfer of registration of the

under-mentioned registered imported drugs from the name of previous importer M/s. Abbott

Laboratories (Pakistan) Limited, Karachi to their name as a result of agreement between M/s.

AbbVie Inc & M/s. Getz Pharma (Pvt) Limited, Karachi: -

284

S. No. Reg. No. Name of Drugs. Name of Manufacturer.

1. 015532 Survanta Suspension 8ml. M/s. Abbvie Inc., North Chicago, IL 60064,

USA.

2. 059025 Survanta Suspension 4ml. -do-

3. 011081 Forane Liquid for Inhalation

100ml. Manufactured by:-

M/s. Aescia Queenborough Limited, U.K.

Marketing Authorization Holder:-

M/s. Abbvie Limited, U.K.

4. 027374 Sevorane Volatile Liquid for

Inhalation 250ml.

-do-

M/s. Getz Pharma (Pvt) Limited, Karachi have deposited required fee

Rs.100000x4=400000/- and submitted the following documents:-

i) Legalized CoPP / GMP Certificate of Survanta Suspension 4ml.

ii) Legalized CoPP of Forane Liquid for Inhalation 100ml.

iii) Legalized GMP Certificate of Forane Liquid for Inhalation 100ml.

iv) Legalized CoPP of Sevorane Volatile Liquid for Inhalation 250ml.

v) Legalized GMP Certificate of Sevorane Volatile Liquid for Inhalation 250ml.

vi) Legalized Termination letter from M/s. AbbVie.

vii) Legalized Authorization letter from M/s. AbbVie

viii) No Objection Certificate from M/s. Abbott Laboratories (Pakistan) Limited,

Karachi.

ix) Registration applications on Form-5-A.

x) Copy of NOC for CRF.

Decision: Registration Board decided as follows:

Cancellation of above registrations from M/s. Abbott Laboratories (Pakistan)

Limited, Karachi.

Grant of above registrations in name of M/s. Getz Pharma (Pvt) Limited, Karachi.

Chairman, Registration Board will permit issuance of registration letter after

evaluation / completion of Form 5A as per check list approved by Registration

Board, comments of Cost & Pricing Division about MRP of the drug and

compliance of Import Policy for Finished Drugs.

285

b. Xenetix 350mg/ml Solution for Injection - M/s. A & Z Health Services, Rawalpindi

M/s. A & Z Health Services, Rawalpindi have requested for transfer of registration of a

registered drug “Xenetix 350mg/ml Solution for Injection (Reg. No.027353)” manufactured by

M/s. Guerbet France from the name of previous agent M/s. Digital Imaging Systems (Pvt) Ltd.,

Lahore to their name for finish import. They have deposited fee Rs.15000/- and submitted their

distribution agreement and previous agent dismissal notice. Since NOC of the former agent M/s.

Digital Imaging Systems (Pvt) Ltd., Lahore was not available. Therefore, as per practice in

vogue M/s. Digital Imaging Systems (Pvt) Ltd., Lahore were asked on 25th

May 2009 either to

submit their NOC in this regard or provide their fresh agency agreement (if any) with the

manufacturer abroad. Thereafter a reminder was issued on 01-07-2009 but they did not respond.

Then a show cause notice was issued to them on 29th

July 2009 to submit reply within 15 days

but they did not respond at all. Copy of this notice was also endorsed to DDG (E&M) Lahore to

ensure delivery to M/s. Digital Imaging Systems (Pvt) Ltd., Lahore. In response, Federal

Inspector of Drugs, Lahore, Mr. Asim Rauf has informed that despite personal visit of Drugs

Controller Officers to M/s. Digital Imaging Systems (Pvt) Ltd., Lahore on 03-03-2010 and

written reminder thereafter, the firm did not respond to the queries sought.

M/s. A & Z Health Services, Rawalpindi was advised to deposit balance fee as per

revised fee Schedule-F. In response, the firm have deposited the balance fee Rs.35000/-.

The firm has applied for the renewal neither on time nor after the expiry of the time till to

date. Therefore, the registration is not valid and cannot be transferred.

Decision: Registration Board did not accede to request of firm as registration of the

drug is not valid.

Case No. 07. Transfer of registrations and change of manufacturing site - M/s. Abbott

Laboratories (Pakistan) Limited, Karachi

M/s. Abbott Laboratories (Pakistan) Limited, Karachi have requested for transfer of

registration of the under-mentioned registered imported drugs from the name of previous

importer M/s. Highnoon Laboratories Ltd., Lahore to their name due to an International

Acquisition of the Pharmaceutical Section of Solvay with all associated companies has been

acquired by the Abbott group since February 15, 2010: -

286

S# Reg. No. Name of Drugs. Existing Name of

Manufacturer.

New Name of

Manufacturer.

1. 018552 Physiotens 0.2mg

Tablets.

M/s. Eli Lilly S.A.,

Spain.

Manufactured by:

M/s. Rottendrof Pharma

GmbH, Germany.

Packed by: -

M/s. Abbott Healthcare

SAS, France.


Tablets.

-do- -do-


Tablets.

-do- -do-

They have deposited required fee and following supporting documents: -

i) Original NOC of the previous importer M/s. Highnoon Laboratories Ltd., Lahore.

ii) Copy of the acknowledgement of last renewal of registration of the products

applied by the previous importer M/s. Highnoon Laboratories Ltd., Lahore.

iii) Copies of acknowledgement of receipt issued by the German National authority

BfArM & a notification submitted by the Solvay to the Germany authority for the

change in manufacturer name to M/s. Rottendrof Pharma GmbH, Germany.

iv) Copy of NOC for CRF.



September, 2013 approved the

transfer of registration of Physiotens Tablet from M/s. Highnoon to M/s. Abbott Laboratories

(Pakistan) Ltd. Karachi along-with the change in manufacturing site from M/s. Eli Lilly S.A.,

Spain to M/s. Rottendrof Pharma GmbH, Germany, while the packaging site of the finished

products will be M/s. Abbott Healthcare SAS, France. The Board advised to provide site master

file of both sites and panel will inspect the manufacturing sites as well to comply the provisions

of import policy. The Board authorized its chairman to accord approval for issuance of letter

after compliance of aforementioned provisions.

As per decision of the Drug Registration Board M/s. Abbott Laboratories (Pakistan)

Limited, Karachi have submitted site master files of both sites attested by an authorized person

of the company.

M/s. Abbott Laboratories (Pakistan) Limited, Karachi was again advised to submit the

Form-5 (A), legalized CoPP’s of both Germany and French sources.

287

In response, M/s. Abbott Laboratories (Pakistan) Limited, Karachi have submitted Form

5(A) and following documents for an intermediate International Change of Manufacturing from

M/s. Rottendrof Pharma GmbH, Germany to M/s. Abbott Healthcare SAS, France:-

i) CoPP of the M/s. Abbott Healthcare SAS, France legalized by Pakistan Embassy.

ii) GMP of the regulatory authority for the manufacturing site legalized by Pakistan

Embassy.

iii) Justification of Change.

M/s. Abbott Laboratories (Pakistan) Limited, Karachi have also submitted that both

manufacturing and release site will be M/s. Abbott Healthcare SAS, France.

This case was discussed in 239th

meeting of the Drug Registration Board for the change

of manufacturing site from M/s. Eli Lilly S.A., Spain to M/s. Rottendrof Pharma GmbH,

Germany & packaging at M/s. Abbott Healthcare SAS, France. Meanwhile the firm requested

that all the manufacturing and packaging steps will be carried out at “M/s. Abbott Healthcare

SAS, France” and for which they have submitted documents as per SOP. Under the Drugs Act,

1976 there is no provision for transfer of registration from one company to another.

Decision: Registration Board referred above formulations for c onsideration of Review

Committee.

Case No.08 Change in name of manufacturer.

a. Rocaltrol Capsules 0.25mcg and 0.5mcg - M/s. Martin Dow Limited, Karachi.

M/s. Martin Dow Limited, Karachi has requested to approve the change of

manufacturer name of their following registered imported drugs as follows:-

S# Reg. No. Name of Drug (s) Current Name of

Manufacturer.

New Proposed Name

of Manufacturer.

1. 015557 Rocaltrol Capsules

0.25mcg.

M/s. R.P Scherer GmbH,

Germany.

M/s. Catalent

Germany Eberbach

GmbH,

Gammelsbacher

Strasse 2

69412 Eberbach /

Baden, Germany.

288

2. 015556 Rocaltrol Capsules

0.5mcg.

-do- -do-

The firm have deposited required fee Rs.100000x2=200000/- and submitted following

supporting documents:-

i) Copy of registration letter.

ii) Copy of transfer of registration letter.

iii) Copy of change in manufacturing site.

iv) Copy of NOC for CRF clearance.

v) Original and legalized CoPP as per WHO format.

M/s. Martin Dow Limited, Karachi was advised to provide CoPP issued from German

authority as the above said products are being manufactured in Germany and Certificate of Swiss

Medica is irrelevant.

In response, M/s. Martin Dow Limited, Karachi have submitted that Rocaltrol Capsules

0.25mcg & 0.5mcg are imported in finished form from M/s. F. Hoffmann-La Roche Ltd.,

Switzerland, under contract manufacturing arrangement with M/s. R.P Scherer GmbH,

Germany. M/s. F. Hoffmann-La Roche Ltd., Switzerland holds marketing authorization for

Rocaltrol range and M/s. R.P Scherer GmbH, Germany is just a contract manufacturer of

Rocaltrol. M/s. R.P Scherer GmbH, Germany does not hold marketing authorization of Rocaltrol

in Germany as such German authorities cannot issue CoPP for the product not marketed by the

company in Germany.

The firm has further submitted that they have submitted CoPP of Rocaltrol Capsules

0.25mcg & 0.5mcg issued from Swiss authorities, as the finish product is supplied from

Switzerland which indicates M/s. R.P Scherer (new name Catalaent) as manufacturing site.

The firm has also informed that only the name of manufacturer of Rocaltrol Capsules is

changed from “R.P. Scherer GmbH & Co. KG” to “Catalent Germany Eberbach GmbH”. The

physical address of the facility, the manufacturing process and quality controls for the capsules

as well as the personnel producing & testing of the capsules remains unchanged.

The manufacturing site of the product “Rocaltrol Capsules” is located in Germany but the

firm has submitted CoPP of Swiss Medica and not of German Authorities. The same was asked

them but they have not provided the same. The CoPP of country of origin is mandatory for such

approval.

289

Decision: The Board deferred the case and advised the firm to submit the legalized

document issued by German regulatory authorities for following confirmations:

Above referred products are being contract manufactured at Catalent Germany

Eberbach GmbH.

It is only change of title / name of the firm and rest of facilities including address is

same as of previous manufacturer.

Case No.09 Exemption from the Drugs (Labeling & Packing) Rules, 1976.

a. Kytril (Granisetron) Ampoule 3mg/3ml, Reg. No.020691 - M/s. Roche Pakistan

Limited, Karachi.

M/s. Roche Pakistan Limited, Karachi have informed that “Kytril Ampoule 3mg/3ml

(Reg. No.020691)” was registered in the name of M/s. SmithKline & French Pakistan Limited,

Karachi on February 10, 1998 and the registration was subsequently transferred to M/s. Roche

Pakistan Limited, Karachi on July 25, 2001 after the global acquisition of this brand by their

principal M/s. F. Hoffmann La-Roche Basel, Switzerland. Due to the low volumes of the imports

/ sales, (approx 2000 packs / anum) M/s. Roche Pakistan Limited had applied for exemption

from the Drugs (Labeling & Packing) Rules 1986 and the exemption was granted on November

10, 2004. Furthermore, for necessary compliance to the Drugs (Labeling & Packing) Rules 1986,

i.e. (after imports of the consignment) the information, i.e. Pak Reg. No., Price and Urdu

instructions are being overprinted on the secondary carton using an ink-jet printer.

Recently M/s. Roche Pakistan Limited, Karachi have imported a consignment of “Kytril

Ampoules” in Islamabad, (1000 packs) and have been advised by the concerned ADC to paste

stickers for compliance to the Drugs (Labeling & Packing) Rules 1986 on the individual

ampoules of the 5’s pack. Following find few facts which would reveal that individual ampoule

sticker pasting would be detrimental to the 5’s pack and the product:-

i) It’s a Neo-top secondary carton, (5’s pack) with perforated seal, and if open once the

temper evident seal / integrity of the pack would be compromised.

ii) Pasting of stickers is not possible due to the limited space available on the 3ml

ampoule as the sticker would mask the primary label, hiding the critical information

on the primary label, (ampoule photo attached).

290

iii) There would be high risk of ampoule breakage during the excessive handling of the

pack after opening it and while carrying out the manual process of sticker pasting.

Considering the above mentioned facts M/s. Roche Pakistan Limited, Karachi have

requested for an exemption of overprinting of the primary label (ampoule), since the secondary

label (carton) is being duly complied with the requirement of the Drugs (Labeling & Packing)

Rules 1986 by ink-jet printing.

M/s. Roche Pakistan Limited, Karachi have deposited required fee Rs.5000/- and

submitted following supporting documents:-

i) Copy of transfer of registration letter.

ii) Copy of initial registration letter.

iii) Copy of letter exemption from Drugs (Labeling & Packing) Rules 1986.

iv) Copy of last renewal status.

v) Copy of labels.

Kytril Ampoules (Reg. No.020691) is an 5HT3-antagonist used as antienetic, available in

3ml ampoule, which cannot be allowed to sell without complying full requirement of the Drugs

(Labeling & Packing) Rules 1986.

Decision: The Board after detailed deliberations decided that M/s Roche Pakistan Ltd,

Karachi may be permitted for ink-ject printing of Urdu version only of the ampules of

Kytril Ampoules (Reg. No. 020691) in any licensed manufacturing unit having facility for

this purpose. The firm will provide NOC of any licensed manufacturing unit and case will

be processed for approval for issuance of letter. The firm will comply the rest of the

labeling requirements under the Drugs (Labeling & Packaging) Rules, 1986 before import.

Case No.10 Extension in shelf life of registered drugs.

a. Alimta 100mg Injection, Regn. No.066174 and Alimta 500mg Injection, Regn.

No.043068.

M/s. Eli-Lilly Pakistan (Private) Limited, Karachi have requested to approve the

extension of shelf life of their following registered imported drugs from 24 months to 36 months.

As the current stability studies conducted on this product confirms that the product is well stable

291

when tested at 36 months time interval:-

S. No. Reg. No. Name of Product.

1. 066174 Alimta 100mg Injection.

2. 043068 Alimta 500mg Injection.

The firm has deposited required fee Rs.5000x2=10,000/- and submitted following

supporting documents:-

i) Copy of registration letter of Alimta 100mg Injection.

ii) Original CoPP of Alimta 100mg Injection attested by Pakistan Embassy having

approved shelf life of 36 months.

iii) Copy of registration letter of Alimta 500mg Injection.

iv) Copy of the acknowledgement of last renewal of registration of Alimta 500mg

Injection.

v) Original CoPP of Alimta 500mg Injection attested by Pakistan Embassy having

approved shelf life of 36 months.

vi) Copies of Stability Studies.

M/s. Eli-Lilly Pakistan (Private) Limited, Karachi was advised to clarify whether

stability data conducted for Zone-IV is approved by US-FDA or otherwise. In response, M/s. Eli-

Lilly Pakistan (Private) Limited, Karachi have submitted that previously provided stability data

was conducted for Zone-IV and approved by FDA. They have further submitted that original

CPPs issued by the FDA mentioning 36 months shelf life. These CPPs issued by the FDA

specifically for Pakistan for Alimta 100mg & 500mg on the basis of submitted Zone-IV stability

data. Therefore, Zone IV stability data should be considered as approved by the FDA.

As per practice in vogue views of following experts regarding extension of shelf lives of

the products has been obtained:-

S. No. Name of Expert.

Opinion

1. Prof. Dr. Zafar Iqbal,

Chairman, Department of Pharmacy,

University of Peshawar,

Peshawar.

Recommended

2. Dr. Farzana Chowdhary,

Director, Department of Pharmacy,

University of Veterinary & Animal

Sciences, Lahore.

Extension in shelf-lives is recommended

on condition that they will be available

only in hospitals / institutions specialized

for the treatment of cancer.

292

3. Jamil Anwar,

Director,

Drugs Testing Laboratory,

Punjab, Lahore.

Recommended

M/s. Eli-Lilly Pakistan (Private) Limited, Karachi was advised to clarify as these

“Pemetrexed” containing products are meant for malignant pleural mesotheliona, which indicate

it is a specialized product for tertiary care institution. The one of the expert indicate these

products should be available only in hospitals / institutions specialized for the treatment of

cancer. Therefore, you are advice to inform this office about mode of sale whether it is selling to

institution / hospitals or also available in retail out lets as well.

In response, M/s. Eli-Lilly Pakistan (Private) Limited, Karachi have confirm that Alimta

(pemetrexed) is indicated for Nonsquamous Non-Small Cell Lung Cancer-NSCLC and

malignant Pleural Mesothelioma. Alimta 500mg and 100mg formulations are registered in

Pakistan since 2006 and 2010 respectively. They would like to inform that at the time of

registration, no restrictions were imposed on the availability of Alimta. They have authorized

their distributor to provide Alimta to hospitals / institutions specialized for the treatment of

Cancer based on tenders / orders and to the very selective licensed outlets in Pakistan.

Decision: Registration Board after deliberations approved the request of the firm for

increase in shelf life.

Case No.11. Resemblance of brand name – Personal hearing thereof.

M/s. NovaMed Pharmaceuticals (Pvt) Ltd., Lahore have informed about resemblance of

brand name of imported drug “OZOL-40 Infusion (Reg. No.044854)” imported by M/s. United

International, Karachi with the brand name of their already registered locally manufactured drug

“O-Zole Capsules 40mg (Reg. No.043642)”. M/s. NovaMed Pharmaceuticals (Pvt) Ltd., Lahore

submitted that they are facing problems in marketing the product, time and again, and it will be

even more aggravated if the situation continues. Therefore they have humbly requested to take a

check on the situation and to strictly instruct M/s. United International, Karachi to change their

brand name as early as possible, so that they could continue marketing their product smoothly

293

and without apprehensions.

Accordingly, M/s. United International, Karachi was advised to propose at least three

distinguished alternate names of their drug other than the existing name. Also, submit an

undertaking that the new proposed brands do not have resemblance with any already registered

drug.

In response, M/s. United International, Karachi have submitted that they had been

granted the registration of product “OZOL-40 Infusion (Reg. No.044854)” on 9th

February,

2007, i.e. more than seven years before and the said product is already being marketed by them

for more than seven years, therefore, their product is strongly recognized and accepted by their

prevailing customers in the market with the said name since they have incurred substantial

marketing expenditures to create awareness among the customers about the product with the said

brand name. They have therefore requested to consider the additional fact that the nature of the

products being traded by them and that by M/s. NovaMed Pharmaceuticals (Pvt) Ltd., Lahore is

different, meaning that the product traded by them is an Injection whereas the product traded by

M/s. NovaMed Pharmaceuticals (Pvt) Ltd., Lahore is a capsule. M/s. United International,

Karachi has requested to continue trading of the said product with the same brand name, keeping

in view the these facts.

Registration Board took serious note of firm for not complying the instructions for

change of brand name. The Board decided to suspend the import of “OZOL-40 Infusion (Reg.

No.044854)” imported by M/s. United International, Karachi immediately and call the firm’s

representative in next meeting for personal hearing.

Accordingly, the importer M/s. United International, Karachi has been advised to suspend

the import of “OZOL-40 Infusion (Reg. No.044854)” imported by them immediately, till the

change of name of the product and called for personal hearing in this meeting.

Decision: The representative of the firm did not appear before the Board and informed

that they are willing to change the name of their product in light of the directions of the

Board. The Board accepts the request of the firm and authorized its Chairman for decision

on the change of name request of the firm.

294

Case No.12. Veterinary drugs deferred by Registration Board for expert opinion.



-09th

May, 2014 referred all

veterinary applications to a committed comprises of Dr. Muhammad Arshad, Member

Registration Board, Dr. Muhammad Ashraf, UVAS, Lahore and Head of Pharmacology

Department Arid University Rawalpindi for expert opinion. The recommendations of expert are

as under:-

S. No. Name of Importer/

Manufacturer.

Name of Drug (s)/Composition. Recommendations

of Dr. Muhammad

Ashraf, UVAS,

Lahore

Recommendations

of Dr. Muhammad

Arshad, Member

R.B

Recommendatio

ns of Head of

Pharmacology

Department

Arid University

Rawalpindi

1. M/s. Ghazi Brothers,

Karachi-75350 /

Product License

Holder:-

M/s. Agrovet Market

S.A., San Luis, Lima,

Peru.

Manufacturer Under

Product License

Holder:-

M/s. Pharmadix Corp.

S.A.C. Urbanizacion La

Aurora-Ate Lima 3-

Peru.

Metri-CEF 3 Intrauterine

Suspension


Cephalexin monohydrate

(Base)……………….....600mg

Neomycin sulfate

(Base)…………………1.02gm

Cloxacillin

benzathine...1.50gm

Vitamin A……….....30.000 IU

Recommended He endorsed the

recommendations

of Dr. Muhammad

Ashraf.

Dr. Mazhar ul

Haq

Wrote to this

office “I am

unable to put

my opinion on

said drugs due

to certain

unavoidable

reasons.


Karachi-75350 /

Product License

Holder:-

M/s. Agrovet Market

S.A., San Luis, Lima,

Peru.

Catofos B9 + B12 Injectable

Solution

Each ml contains:-

Butaphosphan…………100mg

Vitamin B9 (Folic Acid)..15mg

Vitamin B12

(Cyanocobalamin)…….0.05mg

Recommended

295

Manufacturer Under

Product License

Holder:-

M/s. Pharmadix Corp.

S.A.C. Urbanizacion La

Aurora-Ate Lima 3-

Peru.

(Vitamin and Mineral).


Karachi. /

M/s. Vetanco S.A.

Buenos Aires,

Argentina.

Ketoxilen Injection


Oxytetracycline………...20gm

Ketoprofen………………3gm

(Antibiotic/Anti-

inflammatory).

Recommended


Karachi. /

M/s. Cheilbio Co. Ltd.,

Moknae-Dong, Ansan-

Si, Gyeonggi-Do,

Korea.

Geslong Injection

Each ml of solution contains:-

Metoclopramide HCI……5mg

(Antiemetic/ Gastroprokinetic).

Recommended


Karachi. /


Moknae-Dong, Ansan-

Si, Gyeonggi-Do,

Korea.

Cheil Tonocomp Injection


Toldimfos sodium……200mg

Recommended


Karachi. /


Moknae-Dong, Ansan-

Si, Gyeonggi-Do,

Korea.

Seletoco Injection


Vitamin E acetate……..100mg

Sodium Selenite…………1mg

(Nutritional additive).

Recommended


Karachi. /


Moknae-Dong, Ansan-

Si, Gyeonggi-Do,

Korea.

Procillin-LA Injection

Each ml contains:-

Pencillin G

Benzathine ………1,00,000 IU

Penicillin G

Procaine…………1,00,000 IU

Dihydrostreptomycin

sulfate…200mg

(Antibacterial).

Recommended


Karachi. /

M/s. Cheilbio Co.

Ltd.Gyeonggi-Do,

Korea.

Oxyneo Powder

Each 1 Kg contains:-

Oxytetracycline Quaternary

Ammonium Salts………110gm

Neomycin sulfate…...…110gm

(Antibiotic).

Potential of

misuse on feed

additive & drug

interaction.

9. M/s. Ghazi Brothers, Oxyone Powder Potential of

296

Karachi. /

M/s. Cheilbio Co.

Ltd.Gyeonggi-Do,

Korea.

Each 1 Kg contains:-

Oxytetracycline Quaternary

Ammonium Salts……….200g

(Antibiotic).

misuse on feed

additive & drug

interaction.


Karachi. /

M/s. Hebei Yuanzheng

Pharmaceutical Co.

Ltd., Shijiazhuang City,

Hebei Province, China.

Cefquin Suspension for

Injection

Each ml contains:-

Cefquinome (as sulfate)..25mg

(Antibiotic).

Recommended


Karachi. /


Pharmaceutical Co.



Isomedium Powder for

parental administration


Isometamedium chloride

hydrochloride…………..…1g

(Antiprotozoal).

Recommended


Karachi. /


Pharmaceutical Co.



Oxybiotic LA 30% Solution

for Injection

Each ml contains:-

Oxytetracycline (as

dihydrate)…………….300mg

(Antibiotic).

Recommended


Karachi. /


Pharmaceutical Co.



Bupaquone Solution for

Injection

Each ml contains:-

Buparvaqone…………...50mg

(Antiprotozoal).

Recommended

14. M/s. Orient Animal

Health (Pvt) Ltd.,

Karachi. /

M/s. Univet Ireland

Ltd. Tullyvin, Cootehill,

Co. Cavan, Ireland.

Unimox LA Injection

Each ml contains:-

Amoxicillin (as Amoxicillin

Trihydrate) Ph. Eur…...150mg

(Antibacterial).

Recommended -


Health (Pvt) Ltd.,

Karachi. /

M/s. Univet Ireland


Co. Cavan, Ireland.

Unicycline LA Injection

Each ml contains:-

Oxytetracycline (as

Oxytetracycline Dihydrate Ph.

Eur)…………………...200mg

(Antibacterial).

Recommended (Stability Study

of zone IV not

provided)


Health (Pvt) Ltd.,

Karachi. /

M/s. Univet Ireland


Co. Cavan, Ireland.

Multivit Injection


Vitamin B1…………….10mg

Vitamin B2………...……5mg

Vitamin B6…….………..3mg

Vitamin B12………....0.05mg

Nicotinamide………..…35mg

D-Panthenol…….……...25mg

Recommended COPP of

Ireland not

provided.

297

Vitamin A…………15,000 IU

Vitamin D3………....1,000 IU

Vitamin E…………........10mg

(Multivitamins).


Health (Pvt) Ltd.

Karachi. /

M/s. V.M.D. N.V,

Hoge Mauw, Arendonk-

Belgium.

Promycin-1000 Injectable

Solution

Each ml contains:-

Colistin

Sulphate………..1,000,000 IU

(Polypeptide Antibiotic).

Recommended (Mnf. In France

then packaging

in Belgium;

COPP of

France)


Health (Pvt) Ltd.,

Karachi. /

M/s. V.M.D. N.V,

Hoge Mauw, Arendonk-

Belgium.

Promycin-4800 Water Soluble

Powder


Colistin Sulphate…4,800,000

IU

(Polypeptide Antibiotic).

Recommended (Mnf. In France

then packaging

in Belgium;

COPP of

France)

19. M/s. Marush (Pvt) Ltd.,

Lahore. /

M/s. Univet Ltd.

Tullyvin, Cootehill, Co.

Cavan, Ireland.

Ubroloxin ® Intramammary

Suspension

Each 1 injector with 10g

(12ml) contains:-

Cefalexin

monohydrate...................200mg

Kanamycin

monosulfate……………133mg

(Corresponds to 100,000 I.U).

(Pharmaceuticals).

Recommended

20. M/s. U.M. Enterprises,

Karachi-74900/

M/s. Qilu Animal

Health Products Co.

Ltd., Jinan, Shandong,

China.

Flumeglu 5gm Injection


Flunixin Meglumine equivalent

to 5.0g of Flunixin.

(Non-steriod, Ant-

inflammatory drug).

Recommended


Karachi-74900/

M/s. Qilu Animal Health

Products Co. Ltd., Jinan,

Shandong, China.

Cefent 1gm Injection


Ceftiofur Sodium equivalent to

1.0g Ceftiofur.

(B.Lactum Antibiotics).

Recommended


Karachi-74900/

M/s. Qilu Animal

Health Products Co.


China.

Cefent 4gm Injection


Ceftiofur Sodium equivalent to

4.0g Ceftiofur.


Recommended


Karachi-74900/

Ceftihyde 5gm Injection


Recommended

298

M/s. Qilu Animal

Health Products Co.


China.

Ceftiofur Hydrochloride

equivalent to 5.0g Ceftiofur.


24. M/s. Siddiqui Pharma

(Pvt) Ltd., Multan. /

M/s. KBNP, INC,

Dugok-ri, Sinam,

Yesan, Chungnam,

Korea.

Ciroxin 10% Oral Solution

Each Liter contains:-

Ciprofloxacin…………100g

(Antibiotics).

Recommended



M/s. KBNP, INC,

Dugok-ri, Sinam,

Yesan, Chungnam,

Korea.

Kenoxin 10% Oral Solution


Enrofloxacin……100g

(Antibiotics).

Recommended



M/s. KBNP, INC,

Dugok-ri, Sinam,

Yesan, Chungnam,

Korea.

Noroxin 200 Oral Solution


Norfloxacin…………200g

(Antibiotics).

Recommended

27. M/s. Mustafa Brothers

Faisalabad. /

M/s. Laboratorio

Centrovet Santiago,

Chile.

Cefalexine Injectable

Suspension 15%

Each 10ml contains: -

Cefalexine ….150/ml

(Beta lactam Antibiotic)

Recommended

28. M/s. Mustafa Brothers

Faisalabad. /

M/s. Laboratorio

Centrovet Santiago,

Chile.

Ceftiofur Hydrochloride

Injectable Suspension 5%

Contains:

Ceftiofur

Hydrochloride…………...50mg

(Antibiotic)

Recommended


Karachi. /

M/s. CEVASA S.A.

Buenos Aires,

Argentina.

Sulfyvit Water Soluble Powder

Each 100gm contains:-

Sodium

sulfaquinoxaline………..15gm

Sodium

sulfamethazine………….14gm

Sodium

sulfadimethoxine………...2gm

Trimethoprim …………...6gm

More chances of

their misuse, drug

interaction and

development of

resistance. It is

better to have

separate products

for specific

purpose. Need

299

Prednisolone………...0.004gm

Vitamin A……....…300,000IU

Vitamin E……………..200 IU

Vitamin D3……..…..60.000IU

Vitamin C……………….2gm

Vitamin K3……………..1gm

Excipients……..…………..q.s

(Antibiotic, steroids Vitamin).

experimental

verification for

such combination,

30. M/s. Fartal

Pharmaceuticals,

Karachi. /

M/s. Laboratorios

Microsules Uruguay

S.A. Canelones,

Uruguay.

Ivermic M.O. Injectable

Suspension

Each ml contains:-

Ivermectin………..……1,000g

Zinc Sulphate 7H20…...0,043g

Magnesum Chloride

6H20…………………...0,650g

Copper Chloride

2H20…………………...0,004g

Magnesium Hypophosphite

6H20…………………..2,670g

Potassium Iodide……...0.030g

Vitamin B12…………..0,010g

Histidine HCI…………0,420g

Valine……….………..0,420g

Arginine HCI………….0,510g

Methionine……………0,420g

Threonine……………..0,500g

Sodium monobasic

glutamate……………....0,840g

(Endectocide, organic

More chances of

their misuse, drug

interaction and

development of

resistance. It is

better to have

separate products

for specific

purpose.

31. M/s. International

Chempharma (Pakistan)

Lahore. /

M/s. Biopharmachemie

Co Ltd TangNhon Phu

Vietnam.

CTC Plus Water Soluble

Powder

Contains:-

Chlortetracycline……5500mg

Vitamin A……………2400IU

Potassium Chloride…..760mg

Vitamin B12………...280mcg

Lysine…………………60mg

(Antibiotic)

More chances of

their misuse, drug

interaction and

development of

resistance. It is

better to have

separate products

for specific

purpose.

32. M/s. Better Traders

International,

Faisalabad. /

M/s. Kepro B.V.

Maagdenburgstraat,

Holland.

Thiacol 10% Oral Solution

Each ml contains:-

Thiamphenicol……….100mg

(Broad Spectrum

Antimicrobial Agent).

Recommended

33. M/s. Ani Cure

Veterinary Services,

Rawalpindi. /

Nemovit Water Soluble

Powder

Each gm contains: -

More chances of

their misuse, drug

interaction and

300

M/s. Interchemie

Werken ”De Adelaar”

B.V. Metaalweg, CG

Venray, Holland.

Neomycin

Sulpahte……………..…40mg

Oxytetracycline HCl…...60mg

Vitamin A……………7500IU

Vitamin D3,

Cholecalciferol………..1500IU

Vitamin E, a-tocopherol

acetate…………………....5mg

Vitamin B1….thiamine

hydrochloride……….....…1mg

Vitamin B2,

riboflavine………….….....2mg

Vitamin B6, pyridoxine

hydrochloride………….....2mg

Vitamin B12,

cyanocobalamin……….....7.5µ

Vitamin C, Ascorbic

acid..25mg

Ca-pantothenate……….7.5mg

Vitamin K3, menadione

sodium bisulfite………….5mg

Nicotinamide…………….5mg

Folic Acid…………..…300µg

DL-Methionine…………30mg

L-Lysine

hydrochloride…………...50mg

development of

resistance. It is

better to have

separate products

for specific

purpose.

34. M/s. Ani Cure

Veterinary Services,

Rawalpindi. /

M/s. Interchemie

Werken ”De Adelaar”

B.V. Metaalweg, CG

Venray, Holland.

Aliseryl Water Soluble Powder

Each gm contains: -

Erythromycin

thiocyanate…………..…35mg

Oxytetracycline HCl…...50mg

Streptomycin Sulphate…35mg

Colistin

Sulphate……….…..200,000IU

Vitamin A, retinol

acetate…………………3000IU

Vitamin D3,

cholecalciferol………1500IU

Vitamin E, a-tocopherol

acetate…….……………..2mg

Vitamin B1, thiamine

hydrochloride…………….2mg

Vitamin B2,

riboflavine…..4mg

Vitamin B6, pyridoxine

hydrochloride…………….2mg

Vitamin B12,

cyanocobalamin………..10µg

Vitamin C, Ascorbic

More chances of

their misuse, drug

interaction and

development of

resistance. It is

better to have

separate products

for specific

purpose.

301

Acid..20mg

Ca-

pantothenate…………10mg

Vitamin K3, menadione

sodium

bisulfite…………………..2mg

Nicotinamide……….…..20mg

Inositol……………….….1mg

35. M/s. Seignior Pharma

Karachi./

M/s. Instituto

Rosenbusch S.A. de

Biologia Experimental

Agropecuaria, San Jose

1469 (1136) Buenos

Aires, Argentina.

Ceftiofur LPU Injectable

Each 100ml vial contains: -

Ceftiofur HCL…………50mg

Excipients…………..…100ml

(Antibiotic)

Recommended

36. M/s. Seignior Pharma,

Karachi. /

M/s. Instituto

Rosenbusch S.A. de

Biologia Experimental

Agropecuaria, San Jose

1469 (1136) Buenos

Aires, Argentina.

Florfenicol 30% Rosenbusch

Injectable


Florfenicol………...…...30gm

Excipients q.s……....…100ml

(Antibiotic)

Recommended

37. M/s. Bio-Labs (Pvt)

Ltd., Islamabad.

Bio-Enrocol-A Liquid


Enrofloxacin………...…..10%

Colistin Sulphate………..3.5%

Amantadine…………….....4%

(Antibiotic, Anti-viral).

Contains

“Amantadine”

which is antiviral

drug for flu and

may have drug

interaction and

resistance problem

so should not be

used in these

combinations.

38. M/s. Bio-Labs (Pvt)

Ltd., Islamabad.

Coliflox 20% Liquid


Enrofloxacin……………20gm

Colistin Sulphate…50,000,000

i.u.

(Quinolones).

Recommended

39. M/s. Leads Pharma

(Pvt) Ltd., Islamabad.

Virex CRD Powder

Contains:-

Contains

“Amantadine”

302

Tylosin Tartrate……….....10%

Doxycycline HCI…….…..22%

Colistin Sulphate……….…4%

Amantadine HCI………….3%

(Antibiotic).

which is antiviral

drug for flu and

may have drug

interaction and

resistance

problem so should

not be used in

these

combinations.

40. M/s. Elko Organization

(Pvt) Ltd., Karachi.

Fe-Zole SC 5% Oral

Suspension

Each ml contains:-

Fenbendazole………..….50mg

Elemental Selenium…....1.6mg

Elemental Cobalt.............10mg

(Anthelmintic).

Recommended

41. Noble Pharma Mirpur

Azad Kashmir.

ENTRO-5 Powder


Tylosin Tartrate BP……..10%

Doxycycline Hyclate USP20%

Colistin Sulphate…...450 MIU

Bromhexine HCI………0.5%

Neomycin SO4…………3.6%

(Antibacterial).

Drug which are

“Me too” like

drugs with minor

modifications

which may or

may not be

considered.

42. M/s. Mallard


Ltd., Multan.

Centrum Liquid


Enrofloxacin HCI…...7500mg

Sulphamethoxypyridazine……

……………………7500mg

Sulphamethazine……5000mg

Trimethoprim………2500mg

(Antibiotic).

Drug which are

“Me too” like

drugs with minor

modifications

which may or

may not be

considered.

43. M/s. Intervac (Pvt) Ltd,

Sheikhupura Road,

Sheikhpura.

Tilmodox Liquid


Tilmicosin Phosphate….15gm

Doxycycline HCI………15gm

(Antibiotic).

Tissue resistance.

44. M/s. Intervac (Pvt)

Limited, Lahore.

Amprobit Liquid

Each liter contains:-

Amprolium HCI………250gm

Ethopabate……………..16gm

(Anticoccidial).

Recommended

303

45. M/s. Attabak

Pharmaceutical,

Islamabad.

Tylothrodox Powder


Doxycycline HCl……..…100g

Tylosin tartrate …………..50g

Amantadine HCl ………...40g

Erythromycin thiocyanate..60g

(Antibacterial, Antiviral).

Contains

“Amantadine”

which is antiviral

drug for flu and

may have drug

interaction and

resistance

problem so

should not be

used in these

combinations.

46. M/s. Attabak

Pharmaceutical,

Islamabad.

Spiralinc-B Powder

Each 100gm powder contains:-

Lincomycin HCI…………..5g

Spectinomycin HCI……..7.5g

Spiramycin adipate...........2.5g

Bromhexine HCI………...0.5g

(Antibacterials).

Recommended

47. M/s. D-Maarson

Pharmaceuticals,

Rawat, Islamabad.

CRD-555 Water Soluble

Powder

Each 1000g contains:-

Doxycycline HCl ............200g

Tylosin tartrate ………....100g

Colistin sulphate……500MIU

Amantadine HCl ………..40g

Drug which are

“Me too” like

drugs with minor

modifications

which may or

may not be

considered.

48. M/s. Symans


Ltd. Lahore.

SPZ-Plus Feed Additive Oral


Procaine Penicillin

B.P…1200mg

Streptomycine Sulphate

B.P……………………3600mg

Zinc Bacitracin B.P…5200mg

Colistin Sulphate B.P.500 MIU

(Antimicobial).

Recommended

49. M/s. Symans


Ltd. Lahore.

Cipro Plus Solution

Each Liter Contains:-

Ciprofloxacin…………200gm

Contains

“Amantadine”

which is antiviral

304

Colistin Sulphate……400MIU

Amantadine…………….40gm

(Antibiotics).

drug for flu and

may have drug

interaction and

resistance

problem so

should not be

used in these

combinations.

50. M/s. Jfrin

Pharmaceutical

Laboratories, Hub,

Balochistan.

Jfpidox Oral Powder

Each Kg contains:-

Tylosin Tartrate………100gm

Doxycycline Hcl……...200gm

Phyenylbutazone….……12gm

Bromhexine Hcl…...........5gm

Colistine Sulphate….500 MIU

(Antibacterial/Antibiotic).

Drug which are

“Me too” like

drugs with minor

modifications

which may or

may not be

considered.

51. M/s. Biogen Pharma.

8th Km Rawat Chak Beli

Road, Rawat.

Amcocin Liquid


Enrofloxacin………….…10%

Colistin Sulphate…………3%

Amantadine HCI…………4%

(Antibiotic)

Contains

“Amantadine”

which is antiviral

drug for flu and

may have drug

interaction and

resistance

problem so

should not be

used in these

combinations.

52. M/s. Biogen Pharma.

8th Km Rawat Chak Beli

Road, Rawat.

Doxytylodine Powder


Tylosin Tartrate BP…..200gm

Doxycycline HCI BP…100gm

Amantadine HCI……….40gm

Contains

“Amantadine”

which is antiviral

drug for flu and

may have drug

interaction and

resistance problem

so should not be

used in these

combinations.

53. M/s. Biogen Pharma,

Rawat.

Advantage Water Soluble

Powder


Tylosin Tartrate BP..…200gm

Doxycycline HCI BP….40gm

Amantadine HCI……...100gm

Colistin Sulphate…5000 MIU

(Antibiotic/

Antibacterial/Antiviral).

Contains

“Amantadine”

which is antiviral

drug for flu and

may have drug

interaction and

resistance

problem so should

not be used in

these

combinations.

305

54. M/s. Wimits

Pharmaceuticals,

Plot No.129, Sunder

Industrial Estate (P.I.E)

Raiwind Road, Lahore.

Wimtox Injection

Each ml of liquid injection

contains:-

Novaminsulfon………....40mg

Etilefrin B.P …………...0.2mg

Calcium Gluconate B.P.100mg

Magnesium Gluconate

B.P …………………….10mg

Sodium Salicylate B.P …7mg

Nicotinamide B.P …….0.3mg

Caffeine B.P ………..…10mg

Boric Acid B.P ……..…10mg

(Analgesic and Antipyretic)

Finished product specifications

are Manufacturer.

Recommended

55. M/s. Wimits

Pharmaceuticals,

Plot No.129, Sunder



Stop Spray

Each 100ml of aerosol

contains:-

Deltamethrin BP……...0.500g

(Insecticide)

Recommended

56. M/s. Wimits

Pharmaceuticals,

Plot No.129, Sunder



Defender Spray

Each 30g of aerosol contains:-

Neomycin Sulfate BP...150mg

Clostebol Acetate….....150 mg

(Antiseptic)

Recommended

57. M/s. Wimits

Pharmaceuticals,

Plot No.129, Sunder



Methra Spray

Each 100ml of aerosol

contains:-

Permethrin ……………..0.5 g

(Insecticide)

Recommended

58. M/s. D-Maarson

Pharmaceuticals,

Plot # 17, Street # SS-2,

National Industrial Zone

Rawat, Islamabad.

NOVA DM INJECTION

Liquid Injection


Novaminsulfon………..…..4g

Etilefrin………………...0.02g

Calcium Gluconate………10g

Magnesium Gluconate…...1.0g

Sodium salicylate……..0.700g

Nicotinamide…………....0.3g

Caffeine……………….…1.0g

Boric acid………………..1.0g

(Analgesic, Antipyretic)

Recommended

306

Decision: Registration Board deferred the case for the recommendations of Expert

Committee on Veterinary Drugs.

Case No.13. Directions from Drug Appellate Board regarding Nitrofurans.

Drugs Appellate Board in its 140th

Sitting held on 20-08-2013 in the appeal of M/s.

Selmore Pharmaceuticals (Pvt.) Ltd., Lahore regarding rejection of their product “URO-

Pessaries” decided as follows:-

i) That the said formulation shall be referred to two veterinary experts, by the

defendants, namely: (i) Vice Chancellor, University of Veterinary and Animal

Sciences, Lahore, and (ii) A veterinary expert from Army, to be named by Brig.

Akbar Waheed, Member, Drugs Appellate Board, for their expert opinion.

ii) The Chairman, Drugs Appellate Board was authorized to take decision on the

aforesaid Appeal in the light of the recommendations of the experts.

iii) That the fate of other drug(s) / brand(s) of the same formulation available in the

market shall also be decided by the Registration Board in the light of the

recommendations of the experts and the provisions of law / rules, under

intimation to the Drugs Appellate Board.

Accordingly, opinion of following experts regarding registration of product has been

obtained, which are as follows:-

S. No. Name of Expert. Recommendations.

1. Prof. Dr. Muhammad Ashraf,

Dean, Faculty of Bio-Sciences,

University of Veterinary &

Animal Sciences, Lahore

URO-Pessaries having combination of

Chlorotetracycline, Furazolidone and

Metronidazole is not recommended for approval in

animals.

2. Ltd. Col. Iftikhar Ahmad Anjum,

for DGRV&F, QMG Branch

RV&F Directorate, GHQ,

Rawalpindi.

In order to proceed further, following steps be

taken up before the product is registered:-

a) A fair trial on animals after cultural sensitivity

test, at least on 50 animals which can be provided

by Military Farms located at Lahore or Okara.

b) Deliberate and authentic recording of readings

and fair evaluation be ensured.

c) Post treatment cultural sensitively in an aseptic

environment.

307

The Drugs Appellate Board in its 142nd

Sitting held on 20-06-2014 keeping in view the

fact that Nitrofurans are recognized by FDA as mutagens / carcinogens, decided to dismiss the

appeal with the directions to the respondent Registration Board to decide the fact of similar

formulations accordingly. As per record, there is only one product “Utacare Pessary” (Reg.

No.035062) is registered in the name of M/s. Nawan Laboratories (Pvt) Ltd., Karachi.

Decision: In compliance to decision of Drugs Appellate Board, Registrstion Board

decided to issue the show cause notice to M/s. Nawan Laboratories (Pvt.) Karachi for

cancellation of registration of Utacare Pessary, (Reg. No.035062). Registration Board

authorized its Chairman for issuance of show cause notice for any other such me too drug.

Case No.14 Registration of imported veterinary drugs - Correction in minutes.

The Drug Registration Board in its 237th

meeting held on 26-02-2013 approved the

registration of following imported veterinary drugs in the name of M/s. Mustafa Brothers,

Faisalabad, manufactured by M/s. Veyx-Pharma B.V, Forellenwegm SJ Raamsdonksveer, The

Netherlands, subject to inspection of manufacturer abroad, verification of storage facilities as per

policy. The firm has deposited the required fee;

S# Name of Drug (s) /Composition. Decontrolled /

Pack Size.

Shelf Life

1. Masti Veyxym ® Suspension for

Intramammary.


All-rac-aTocopheryl acetate (Vitamin E

acetate)……120.00mg.

Vitamin A concentrate 100.000 IU.

Chymotrypsin………2400 FIP-U.

Trypsin……………..240 FIP-U.

Papain…………………6-FIP-U.

Tube of 10ml 02 years

2. Veyxyl ® LA 20% Solution.

Each 1ml contains:-

Amoxicillin trihydrate…229.60mg

(equivalent to 200.00mg Amoxicillin).

50ml

100ml

03 years

308

The applicant M/s. Mustafa Brothers, Faisalabad has requested for issuance of

registration letter of the above said drugs. M/s. Mustafa Brothers, Faisalabad was advised to

provide legalized (CoPP) of M/s. Vexy-Pharma B.V., Forellenweg 16, NL-4941 SJ

Raamsdonksveer, issued by Netherlands as the manufacturing site is located in Netherlands duly

endorsed by the Pakistan Embassy/Consulate office in the country of export.

In response, M/s. Mustafa Brothers, Faisalabad have informed that the production of

“Masti Veyxym ® Suspension for Intramammary & Veyxyl ® LA 20% Solution” is performed

in the Netherlands (as contract manufacturer) by M/s. Vexy-Pharma B.V, the Netherlands for

their principal company M/s. Vexy-Pharma GmbH, Germany. However, this production site only

produces bulk (unlabeled bottles / injections) that is shipped subsequently to their site in

Germany M/s. Vexy-Pharma GmbH for finalization the production. At the German site,

the secondary packaging takes place and final batch release is performed. The firm M/s. Vexy-

Pharma GmbH (Germany) is the marketing authorization holder and consequently responsible

for the overall quality, the safety and the efficacy of the products.

The firm has disclosed that the products referred above are being manufactured in bulk at

“M/s. Vexy-Pharma B.V, The Netherlands” then these will be labeled and packed at M/s. Vexy-

Pharma GmbH, Germany. Now it is clear the firm will import these drugs from Germany.

Therefore, it needs amendment in minutes i.e. name of manufacturer is mentioned from

Netherlands in the minutes of 237th

meeting of the Registration Board.

Decision: Registration Board approved correction in minutes of 237th

meeting for

name of manufacturer as M/s. Vexy-Pharma GmbH, Germany for the following products.

S# Name of Drug (s) /Composition. Decontrolled /

Pack Size.

Shelf Life

1. Masti Veyxym ® Suspension for

Intramammary.


All-rac-aTocopheryl acetate (Vitamin E

acetate)……120.00mg.

Vitamin A concentrate 100.000 IU.

Chymotrypsin………2400 FIP-U.

Tube of 10ml 02 years

309

Trypsin……………..240 FIP-U.

Papain…………………6-FIP-U.

2. Veyxyl ® LA 20% Solution.

Each 1ml contains:-

Amoxicillin trihydrate…229.60mg

(equivalent to 200.00mg Amoxicillin).

50ml

100ml

03 years

Case No.15 Registration of veterinary drug.



November, 2012 approved the

registration of following imported veterinary drugs in the name of M/s. Vet Line International,

Lahore manufactured by M/s. Bela-Pharm GmbH & Co.KG Lohner Strasse 19 49377 Vechta,

Germany, subject to inspection of manufacturer abroad, verification of storage facilities as per

policy. The firm has deposited the required fee.

# No. Name of Drug (s) /Composition. Decontrolled /

Pack Size.

Shelf Life.

1. Neomycinsulfat Powder.

Each gm powder contains:-

Neomycin Sulphate……..1000mg.

100gm.

500gm.

1kg.

5kg.

3 years

2. Belacol 100% Pulver

Each gm powder contains:-

Colistin Sulphate……….1000mg.

100gm.

250gm.

1kg. & 2.5kg

3 years

The storage facility of the importer has also already been verified by the Area FID. The

applicant M/s. Vet Line International, Lahore has requested for issuance of registration letter of

the above said drugs. During processing of case for issuance of registration letter, it was

observed that these products are 100% API and under the Drug Act 1976 the drugs which are

ready to use are registered under the Section 7 of the Act. Then it was deliberated to get opinion

of experts. Accordingly, views of the following experts regarding use of products above in pure

form “100 API” with special reference to efficacy, safety, toxicity and residual effects in food

producing animal has been obtained, which are as follows:-

310

S.# Name of Expert. Opinion

1. Dr. Muhammad Ovais Omer,

Chairman,

Department of Pharmacology &

Toxicology,

University of Veterinary and

Animal Sciences, Lahore.

i) Based on the pharmacological properties,

Neomycinsulfat is a recommended drug for

treatment of enteric infections in calves, pigs and

chickens.

ii) Based on the pharmacological properties,

Colistin Sulphate is a recommended drug for

treatment of Salmonella, E. coli, Campylobacter,

Pullorum, Paratyphoid infections, Colibacillosis

and Diarrhoea by E.coli in different animal

species.

2. Brig. Zahid Hussain Abid,

Director Rem & Vet.,

QMG Branch RV & F Dte,

General Headquarters,

Rawalpindi.

As regards efficacy, safety, toxicity and residual

effects in food producing animal, viz a viz both

the products are concerned, in puts of the experts

from University of Veterinary and Animal

Sciences, Lahore would be more valuable and

pertinent. However, it is suggested that a trial

may be conducted at least on 200 animals for

establishment of all above factors. In this regard

Army Veterinary School can be assigned this

task.

3. Dr. Farzana Chowdhary,

Director,

Department of Pharmacy,

University of Veterinary &

Animal Sciences,

Lahore.

1. Neomycinsulfat – this drug contains 100mg

Neomycin Sulphate in 1gm indicating that it is a

pure API and not a veterinary finished dosage

form. According to the Drugs Act, 1976 APIs do

not require registration and can only be imported

by manufacturers possessing a valid Drug

Manufacturing License (Formulation) and

registration of the finished drug of which it is an

ingredient.

2. Belacol 100% Pulver contains Colistin

Sulphate 1000mg per 1gm (1000mg) powder and

does not contain any adjuvant or excepient

which is indicative of the fact that it is a pure

API and not a finished dosage form for

veterinary use. Only finished dosage forms

require registration under the Drugs Act, 1976,

whereas, APIs can be imported only by those

who hold a valid DML (Formulation) and

registration of finished drug containing that API.

311


Committee on Veterinary Drugs and list of all such products registered earlier by the

DRAP.

Case No.16. Correction of composition of registered veterinary drug-Neurozoc Injection

Regn. No. 074072.

M/s. Hilton Pharma (Private) Limited, Karachi have requested for correction of

composition of their registered veterinary “Neurozoc Injection (Reg. No.074072)”. They have

informed that they want to apply below composition as “each 1ml contains, pack size of 100ml”

but by typographically mistake it was mentioned in application dossier as “each 100ml contains,

pack size 100ml”. The registration letter received for following composition “each 100ml

contains, pack size 250ml & 500ml”. They have therefore requested for correction of

composition from “each 100ml contains” to “each 1ml contains” and also change in pack size

from 250ml & 500ml to “100ml”:-

Approved composition Revised composition.

Neurozoc Injection.


Novaminsulfon …………….. .100mg.

Etilefrin……………………. 0.50mg.

Calcium gluconate …………250mg.

Magnesium gluconate ……… 25mg.

Sodium salicylate ………….17.5mg.

Nicotinamide ………………0.75mg.

Caffeine………………………. 25mg.

Boric acid………………………25mg.

Neurozoc Injection.

Each ml contains:-

Novaminsulfon …………….. .100mg.

Etilefrin……………………. 0.50mg.

Calcium gluconate …………250mg.

Magnesium gluconate ……… 25mg.

Sodium salicylate ………….17.5mg.

Nicotinamide ………………0.75mg.

Caffeine………………………. 25mg.

Boric acid………………………25mg.

M/s. Hilton Pharma (Private) Limited, Karachi have deposited required fee Rs.20000/-

and submitted following supporting documents:-

i) Copy of registration letter.

ii) Copy of old Form-5.

iii) New Stability data.

iv) Copy of new Form-5.


Committee on Veterinary Drugs.

312

Case No. 17. Cancellation of registration of drugs and stoppage of production.


meeting held on 07-11-2013 considered the

inspection report of M/s. Avicenna Laboratories (Pvt) Ltd.,14 Km, Sheikhupura, Faisalabad

Road, Bikhi, District Sheikhupura dated 04-03-2013 conducted by the area FID, wherein the FID

has reported that the firm has registration of following (10) injectable products including

(Penicillin and Steroids) but the Injectable Section is not approved as yet by Licensing Section

and the Registration Section has granted the registration of the same:-

S. No. Reg. No. Name of Drug (s) / composition.

1. 035001 Gentacen 100 Injectable Solution.

Each ml Contains: -

Gentamycin Sulphate (eq to 100mg

Gentamycin base).

2. 035002 Moxicol Injectable Suspension.

Each ml contains: -

Amoxycillin Trihydrate 100mg.

Colistin Sulphate 250,000 IU.

3. 035003 Avimox Injectable Suspension.

Each ml contains: -

Amoxycillin base (as trihydrate) 150mg.

4. 035004 Tylocen-200 Injectable Solution.

Each ml contains: -

Tylosin Sulphate 200mg.

5. 035005 Avoxy LA Injectable Suspension.

Each ml contains: -

Oxytetracycline HCl…200mg.

6. 035006 Dexon-5 Injectable Solution.

Each ml contains: -

Dexamethasone 5mg.

7. 035127 Oxytocen Injectable Solution.

Each ml contains: -

Oxytocin 10 I.U.

8. 043166 Predexon Injectable Suspension.

Each ml contains:-

Dexamethasone ……… 2.5mg.

Prednisolon ………….. 7.5mg.

9. 043167 Lincospec Injectable Solution.

Each ml contains:-

Spectinomycin Sulphate 100mg base.

Lincomycin Hydrochloride 50mg base.

313

10. 043168 Avigen-F20 Injectable Solution.

Each ml contains:-

Gentamycin Sulphate ……. 10mg.

Flumequine ……………… 20mg.

The Drug Registration Board decided that the production of the firm for above mentioned

products should immediately be stopped till the complete investigation of the matter and issue a

show cause notice to the firm for explanation of reasons in their defense. Then place the case

before the Board for further deliberations.

Accordingly, a show cause notice was issued to the firm.

In response to the show cause notice the firm has submitted following documents:-

i) Approval of layout plan.

ii) Copies of registration letters.

iii) Copy of layout plan.

M/s. Avicenna Laboratories (Pvt) Ltd., Sheikhupura was again advised to provide proof

of approval of the Injectable Section and also provide proof of renewal of registration of drugs

above said drugs. The firm have submitted copies of the acknowledgement of last renewal of

registration of above said products and also submitted that on April 15, 2014 the panel

constituted by the Director QA, inspected their Oral Powder, Liquid, Vaccine and Injectable

Sections. The report will be submitted in coming board meeting. The firm have further submitted

that they also want to shift all Penicillin products into toll manufacturing.

DDC (RRR) was also requested to confirm renewal status of the above products. DDC

(RRR) have confirmed the renewal of the drugs.

The Chairman, CLB also resumption of production to the firm only in veterinary oral

powder and veterinary oral liquid sections.

Decision: Registration Board after detailed deliberations canceled the registrations of

following products of M/s. Avicenna Laboratories (Pvt) Ltd., Sheikhupura as the firm do

not have the approved manufacturing facility for these products;

314

S. No. Reg. No. Name of Drug (s) / composition.

1. 035001 Gentacen 100 Injectable Solution.

Each ml Contains: -

Gentamycin Sulphate (eq to 100mg

Gentamycin base).

2. 035002 Moxicol Injectable Suspension.

Each ml contains: -

Amoxycillin Trihydrate 100mg.

Colistin Sulphate 250,000 IU.

3. 035003 Avimox Injectable Suspension.

Each ml contains: -

Amoxycillin base (as trihydrate) 150mg.

4. 035004 Tylocen-200 Injectable Solution.

Each ml contains: -

Tylosin Sulphate 200mg.

5. 035005 Avoxy LA Injectable Suspension.

Each ml contains: -

Oxytetracycline HCl…200mg.

6. 035006 Dexon-5 Injectable Solution.

Each ml contains: -

Dexamethasone 5mg.

7. 035127 Oxytocen Injectable Solution.

Each ml contains: -

Oxytocin 10 I.U.

8. 043166 Predexon Injectable Suspension.

Each ml contains:-

Dexamethasone ……… 2.5mg.

Prednisolon ………….. 7.5mg.

9. 043167 Lincospec Injectable Solution.

Each ml contains:-

Spectinomycin Sulphate 100mg base.

Lincomycin Hydrochloride 50mg base.

10. 043168 Avigen-F20 Injectable Solution.

Each ml contains:-

Gentamycin Sulphate ……. 10mg.

Flumequine ……………… 20mg.

Case No.18. Registration of Magnesium Sulphate 15% in veterinary products.

Drug Registration Board in its 243rd

meeting held on 08-09th

May, 2014 considered and

approved the registration of following drug for import in the name of M/s. BN Pharmaceuticals,

Lahore manufactured by M/s. Laboratories Chaix et Du Marais Lavoisier Head Quarter Paris

France subject to price fixation / calculation:-

315

Name of drug (s)/Composition. Demanded Price

/Pack.

Sulphate De Magnesium Lavoisier (1.5G/10ML) 15%

(I.V) Injectable.

Each ampoule contains: -

Magnesium as Sulphate. 1.5g/10ml (15%).

Rs.450/Per ampoule.

Rs.4500/Per 10 ampoules.

Meanwhile, the firm M/s. BN Pharmaceuticals, Lahore have submitted the references in

support of above mentioned product which is already under process of registration. The firm has

also submitted the list of countries-organizations in which this product is registered / sponsored

at this time along with the report of WHO Drug Information volume-21/2.2007 WHO Geneva.

The Magnesium Sulphate 15% is not approved by any of the reference authorities i.e.

EMA, USFDA, TGA or PDMC, except France.

Decision: Registration Board referred the case to Review Committee for formulation

review.

Registration-II

Case No.19 Registration of drugs deferred by Registration Board.

a. Cases deferred for expert opinions.

i. Lurisa Tablet 40mg and 80mg – M/S Helix Pharma, Karachi.

Registration Board in 242nd

meeting deferred following products for expert opinion. Accordingly

products were referred to expert for views. Comments are as under.

S.

No

Name of drug(s) & Composition Proposed

Pack size

Demanded

Price

1 Lurisa Tablets

Each film coated tablet contains:

Lurasidone HCl………..….40 mg

(Antipsychotic for Treatment of Schizophrenia)

10’s,

20’s,

30’s

As per PRC

2 Lurisa Oral Tablets


Lurasidone HCl…….80 mg

(Antipsychotic for Treatment of Schizophrenia)

10’s,

20’s,

30’s

As per PRC

316

Brig. Saleem Jehangeer


Mental Health,

Rawalpindi

Prof. Dr. Rizwan Taj

Psychiatrist,

Pakistan Institute of Medical

Sciences,

Islamabad

Dr. Nadeem Abbas

Fauji Foundation Medical

Centre,

Rawalpindi

Brig for Comdt (Farrukh Hayat

Khan) stated that Maj. Gen

Salim Jehangir, Commandant of


Mental Health is not avail due

to official commitments

I have study documents and fee

that this medication should be

available in Pakistan.

It is a new salt which has shown

promising result as compared to

other products in the market it

side effect profile is better also.

I am recommending its

availability in Pakistan

Although Lurasidone salt is not

available / introduced in Pakistan,

In the light of above mentioned

facts & data provided, the drugs

Lurasidone (Lurisa) 40mg &

Lurasidone (Lurisa) 80mg are

recommended for Registration

Board

Decision: Registration Board discussed and agreed to above expert opinions. However, the Board advised firm to provide data for stability studies conducted under zone IV-A conditions as per ICH / WHO guidelines for consideration of Registration Board.

ii. Roflumilast 500mcg Tablet.

Registration Board in its various meetings deferred registration of Roflumilast 500mcg Tablet of

various firms for expert opinion. Accordingly products were referred to expert for views. Comments are

as under.

S.

No

Name of firm(s) Name of drug(s), Composition &

Registration Board Meeting

Proposed

Pack size

Demanded

Price

1. M/s Macter

International

Karachi

Milast Tablet


Roflumilast …………… 500 mcg

(Phosphodiesterase 4 inhibitors)

( M-242 )

Per tab.

Rs.17.36/-

2. M/s Hiranis

Pharma, Karachi

Roflu Tablet


Roflumilast…………..500mcg

10’s

14’s

Rs.270/-

Rs.378/-

317

(Inhibitor of the enzyme PDE-4)

( M-243 )

3. M/s Helix

Pharma, Karachi

Raspro 500mcg Tablet


Roflumilast…………...500 mcg

(Anti-Inflammatory)

( M-243 )

10’s As per PRC

Brig. Dr. Aslam Khan,

Consultant Pulmonologist,

Military Hospital,

Rawalpindi

Dr. Rehana Kauser,

Consultant Pulmonologist,

Pakistan Institute of Mecial

Sciences, Islamabad

Dr. Shazli Manzoor

Quaid-e-Azam International

Hospital, Islamabad

Regarding expert opinion on

efficacy, safety, quality and

cost effectiveness of

Roflumilast in the

management of COPD

Roflumilast is a

Phosphodiesterase-4 Enzyme

Inhibitor. FDA and EMEA has

approved this drug as an

adjunct to bronchodilator

therapy in the maintenance

treatment of severe chronic

obstructive pulmonary disease

(COPD) associated with

chronic bronchitis given for the

purpose of preventing

exacerbations

Roflumilast significantly

improved prebronchodilator

FEV1 and decreased the rate of

moderate to severe

exacerbations in a 52 week,

randomized trial of 3091

patients with COPD .

Compared to placebo,

roflumilast decreased

exacerbations (17 percent [95%,

CI 8-25]).

The use of a once daily oral


efficacy, safety, quality and

cost effectiveness of

Roflumilast in the management

of COPD. FDA and EMEA

approved this drug for use in

COPD management in severe

and very severe COPD. This

drug reduce Exacerbations rate

in COPD also included in

GOLD guidelines

However certain studies

reported no much beneficial

role in the COPD patients.

Clinical Studies have also

demonstrated higher

pharmacological activity and

better tolerability of as

compared to earlier PDE-4

inhibitors. In my honest opinion

this drug may be helpful in the

management of COPD in

combination with other drugs

so it should be cost effective

and affordable to the patients.


efficacy, safety, quality and cost

effectiveness of Roflumilast. In

this connection I would

recommend that Roflumilast

(PDE4 inhibitor), is an FDA and

EMEA approved drug with

established role in the

management of COPD. This has

been proven to reduce COPD

exacerbations in various clinical

trials and also included in GOLD

guidelines 2014. Clinical Studies

have also demonstrated higher

pharmacological activity and

better tolerability of Roflumilast

as compared to earlier PDE-4

inhibitors. Therefore, Roflumilast

500mcg orally once a day if made

available in Pakistan especially

from Macter platform due to

quality and cost effectiveness

concern; it can held in reducing

suffering due to exacerbations of

COPD.

318

medication in COPD is

enticing; however, the

medication should be used as a

maintenance therapy to prevent

exacerbations rather than to

improve other COPD outcomes

It is a safe drug which is

contraindicated only in

moderate or severe hepatic

impairment (Child-Pugh class B

or C)

In view of the above I

recommend this drug for

registration at an affordable

price.

Decision: Registration Board discussed and agreed to above expert opinions. However,

the Board advised firm to provide data for stability studies conducted under zone IV-A

conditions as per ICH / WHO guidelines for consideration of Registration Board.

iii. Cocard Plus 75/75MG Tablet – M/S Helix Pharma, Karachi.


meeting approved following product of M/s Helix Pharma,

Karachi subject to reason mentioned in last column. Accordingly provided data was referred to

expert for views. Comments are as under.

S.

No


Pack size

Demand

ed Price

Decision

1 Cocard Plus 75/75mg Tablet


Clopidogrel bisulfate eq. to

clopidogrel……….75 mg

Aspirin as enteric coated

pellets………….…75 mg

(Anti coagulant anti platelet)

10’s As per

PRC

Approved subject to

confirmation of

Bilayered tablet

manufacturing facility

319

Dr. Amanullah Khan,

Director, Drug Testing

Laboratory,

Government of Baluchistan,

Quetta

Mr. Abdul Razzaq,


Laboratory,

Government of Sindh,

Karachi

Mr. Muhammad Jamil Anwar,


Laboratory,

Government of Punjab,

Lahore

COCARD PLUS 75/81MG

TABLET dissolution profile is

different from the originator

brand (OGREL PLUS 81

TABLET OF M/S BOSCH

PHARMA, Karachi) and

scientifically the dissolution

method applied is incorrect

because they use separate tablet

of Cocard for acid and buffer

stages rather replacing the

buffer medium from acid to

buffer stage, hence on scientific

grounds of dissolution profile

the product COCARD PLUS

75/81MG TABLET is not

recommended.

Tablet COCARD PLUS is a

bilayered film coated

(Antiplatelets) having 02

years shelf life is indicated in

different kind of CV diseases.

The comparative

dissolution profile of

M/s Helix Pharma

Products “ COCARD

PLUS Tablets” with

originator Brand “

OGREL PLUS 81

TABLETS” by M/s

Bosch Pharmaceuticals,

Karachi” was thoroughly

checked & evaluated.

The stability profile

shows that stability

studies was carried out,

and there was no

significant physical and

chemical changes when

product was kept at 40o

C + 2o

C /75% RH +

5%, provided proof of

climatic chamber, also

complies the other tests

performed such as

weight variation, Assay,

disintegration time,

dissolution and other

aspects that meets the

required quality

specifications.

The data provided

also reflects that

manufacturing method /

equipments / instruments

are properly validated

and calibrated.

The last panel

inspection was

COCARD PLUS 75/81MG

TABLET

It is observed that necessary

equipment, particularly Bilayered

Tableting Machine is available for

manufacturing of Cocard Plus 75mg

/81mg Tablet.

The accelerated stability studies for

the product has been carried out

with the concluded results of active

ingredient within the limits and also

shows that no significant physical

and chemical change occurred

during accelerated stability study

carried out for six months.

The Dissolution Profile of the

product Batch TF001 has been

studied in acidic and buffer stage

and observed satisfactory. The

comparative study with the other

brand “Ogrel Plus 81mg Tablets of

M/s Bosch Pharma, Karachi was

also carried out with the acceptable

results.

In the light of above and as per

data / information provide the

drug “Cocard Plus 75mg /81mg

(Clopidogrel 75mg + Aspirin

81mg) Tablet is recommended for

registration.

320

conducted on 28-06-

2013 & for verification

of bilayered tablets

manufacturing facilities

was conducted 06-12-

2013 wherein they stated

that the firm has good

facilities provided for

manufacturing and

quality control and GMP

Compliance was found

good / satisfactory.

The data provided is

sufficient regarding raw

material specification &

finished product

specification &

analytical procedures,

labeling, packing is also

available.

So In the light of

above mentioned facts

& data provided the

drug COCARD PLUS

Tablets is

recommended for

registration.

It is to mention here that following is correct formulation submitted by the firm and same has

been evaluated by experts. However, erroneously wrong formulation has been mentioned in

agenda and minutes of 245th

Registration Board meeting:-

Cocard Plus 75/81mg Tablet


Clopidogrel bisulfate eq. to clopidogrel…….75 mg

Aspirin as enteric coated pellets………….…81 mg

(Anti coagulant anti platelet)

Decision: Registration Board decided to forward comments of Director DTL, Quetta to

the manufacturer for clarification.

321

iv. Dexlansoprazole - M/s OBS Pakistan, Karachi


meeting deferred following products of M/s OBS Pakistan,

Karachi for reason mentioned in last column.

Name of Drug & Composition Pack Demanded

MRP

Decision

Kapdex 30mg Capsule


Dexlansoprazole ………..30mg

(Anti ulcerants)

14’s Rs.840.00 Deferred.

Not me- too

product.

May be referred to

expert committee

for new molecule

Kapdex 60mg Capsule


Dexlansoprazole ……...60mg

(Anti ulcerants)

14’s Rs.1260.00 Deferred.

Not me- too

product. May be

referred to expert

committee for new

molecule


meeting discussed same formulation and agreed to expert

opinions and advised the firms to provide data for stability studies conducted under zone IV-A

conditions as per ICH / WHO guidelines for consideration of Registration Board.

M/s OBS Pakistan, Karachi has deposited remaining fee (Rs.50000/-) and requested to consider

their above formulations.

Decision: Keeping in view decision of 245th

meeting of registration board regarding same

formulation, the advised firm to provide data for stability studies conducted under zone

IV-A conditions as per ICH / WHO guidelines for consideration of Registration Board.

b. Cases for registration of Tramadol.



November, 2012 had decided

that since Nalbuphine and Tramadol are not controlled drugs as per INCB regulation. So the

Board will not consider these cases in light of controlled drug guidelines. However to avoid

misuse potential, their procurement and manufacturing record shall be strictly maintained and

322

submitted in quadruplicate under Rule 30 (6) of Drugs (Licensing, Registering and Advertising)

Rules, 1976 to the E&M (Evaluation of Monitoring) Department of DRAP.

In light of above decision for registration of Tramadol containing product of

following firm was pending for decision. Firm has deposited the remaining fee @ Rs.12000/- as

per revised schedule for fees. Details are as under:-

S. No. Name of firm Name of Drug(s) Pack MRP Decision

1. M/s Safe

Pharmaceutic

als, Karachi

Magadol Drops

Each ml contains:-

Tramadol HCl ………2.5mg

(Non Narcotic Analgesic)

10ml As per PAC 225th

RB

Deferred for

confirmatio

n of facility

2. -do-

Magadol Capsule


Tramadol HCl ………50mg

(Non Narcotic Analgesic)

1x10’s As per PAC -do-

Decision: Registration Board deferred the case for evaluation of registration

application as per approved check list.

c. Registration of Agomelatine Tablet 25mg.


meetings deferred following products of M/s Nabiqasim

Industries, Karachi and M/s PharmaEvo, Karachi for confirmation of formulation, application on

Form 5D, fee Rs.15, 000.

M/s Nabiqasim Industries, Karachi


MRP

Modton Tablet 25mg

Each film coated tablet contains:-

Agomelatine ……25mg

10’s Rs.1500.00

323

(Antidepressant)

M/s PharmEvo, Karachi.


MRP

Agloda 25mg Tablet


Agomelatine ……..25mg

(Anti depressant)

10’s

14’s

28’s

Rs.2690/-

Rs.3750/-

Rs.7500/-

Later on scrutiny of registration data reveals that the above formulation is already approved by

the Registration Board in its 236th meeting in favour of M/s Servier Research and Pharmaceuticals

(Pakistan) Ltd, Lahore under the brand name “ Valdoxan 25mg Tablets”

M/s PharmEvo has deposited remaining fee @ Rs.5,000/- and M/s Nabiqasim Industries,

Karachi has also deposited fee @ Rs.15,000/- (dated 10-08-2010) + Rs.52,000/- (dated 24-

01-2013) + Rs.5,000/- (dated 06-05-2013)


applications as per approved check list.

d. Kaizen Pharmaceutical (Pvt.) Ltd , Karachi

i. Calcium citrate + Vitamin D.


meeting deferred following registration application of M/s

Kaizen Pharmaceuticals (Pvt.) Ltd, Karachi for reason mentioned in last column.


Pack size

Demanded

Price

Date of

application,

Diary No. &

Form

Decision

Calvit-D Sachet

Each sachet contains:

Calcium citrate

maleate…………..2500mg

Vitamin D……….400 IU

(Calcium and Vitamin

10’s

20’s

As per PRC 28-01-2013

Dy.No.60

Form-5

Rs.20,000/-

Deferred for

submission of

application on

form-5D with

balance fee

324

supplement/replacement preparation)

Now firm has stated that same formulation is already registered in favour of M/s Maple

Pharmaceuticals, Karachi with the brand name “Calcivit Sachet” Reg. No.076051 in 234th

meeting of Registration Board.



ii. Alfacalcidol + Calcium carbonate


meeting deferred following registration application of M/s

Kaizen Pharmaceuticals (Pvt.) Ltd, Karachi for reason mentioned in last column.


Pack size

Demanded

Price

Date of

application,

Diary No. &

Form

Decision

Alfakal Tablet


Alfacalcidol ………....0.5 mcg

Calcium carbonate….1000 mg

(Calcium and Vitamin Analogue)

10’s

20’s

30’s

As per PRC 28-01 -2013

65

Form-5

Rs.60,000/-

Deferred for

Clarification

regarding dosage

of calcium

Now firm has stated that same formulation is available / marketed by M/s SchazooZaka

(Pvt.) Ltd, Lahore with the brand name “Bone-Care C Tablet” vide Reg. No.062790.



e. Sodium Polystyrene– M/s PharmaEvo, Karachi.


meeting deferred following product of M/s PharmaEvo,

Karachi for expert opinion.

S.

No


Pack size

Demanded

Price

Date of

application,

Diary No. &

Decision

325

Form

1 Klenar Sachet


Sodium Polystyrene

Sulphonate …………..…15000mg

(Potassium removing resin)

15’s

30’s

Rs.3000.00

Rs.6000.00

02-11-2009

2229

Form-5

Rs.8000/-

Deferred for

expert

opinion

Now M/s PharmEvo have deposited remaining fee @ Rs.42,000/- being new formulation.


application as per approved check list. Moreover, the product will be referred to Prof. Dr.

Ghias Butt, PIMS, Islamabad; Syed Ather Hussain, Head of Nephrology, Agha Khan

University Hospital, Karachi and Uzma Bano, FFH, Rawalpindi for expert opinion.

f. Macter International, Karachi

Following products of M/s Macter International, Karachi was deferred by Registration

Board in 214th

meeting for confirmation of atomic absorption spectrophotometer.


MRP

Mactosin Suspension

Each 5ml contains:-

Ossien Mineral Complex (Hydroxy Apatite)

800mg equivalent to

Calcium …………. 130mg

Phosphorous …………… 68.8mg

Residual Mineral Salts ….57.5mg

Collagen …………………87.5mg

Other Proteins …………20mg

Trace elements F1,mg,Zn,Fe,Ni,Cu)

60ml Rs.100.00

Mactosin Tablets


Ossien Mineral Complex (Hydroxy Apatite)

250mg equivalent to

Calcium ….53.5mg

Phosphorous …….24.8mg



Other Proteins …………

Per tablet Rs.5.33

326

Trace elements F1,Mg,Zn,Fe,Ni,Cu)

Later on scrutiny of registration data reveals typographic error in above formulation.

Correct formulation as applied by the firm are as under:-

Correct Formulation

Mactosin Tablets


Ossien Mineral Complex (Hydroxy Apatite) 800mg

equivalent to

Calcium …………. 130mg

Phosphorous …………… 68.8mg



Other Proteins …………..…20mg

Trace elements F1,mg,Zn,Fe,Ni,Cu)

Mactosin Suspension

Each 5ml contains:-

Ossien Mineral Complex (Hydroxy Apatite) 250mg

equivalent to

Calcium ………….53.5mg

Phosphorous …….24.8mg



Other Proteins ………… 20mg

Trace elements F1,Mg,Zn,Fe,Ni,Cu)

Federal Inspector of Drug, Karachi in inspection dated 27.09.2012 confirmed atomic

absorption in the Quality Control Laboratory of the firm.

Decision: Registration Board approved correct formulation for registration.

327

g. M/s Bosch Pharmaceuticals, Karachi.


& 244th

meeting deferred following products of M/s Bosch

Pharmaceuticals, Karachi reason mentioned in last column.

S. No. Name of drug(s) & Composition Proposed

Pack size

Demanded

Price

Decision

1. Calamox Chewable Tablet 200mg

Each chewable tablet contains:-

Amoxycillin as Trihydrate ..200mg

Clavulanic Acid as

Potassium ……….….28.50mg

(Antibiotics)

Not

mentioned

Not

mentioned

Deferred for confirmation of

international availability &

expert opinion

2. Calamox Chewable Tablet 400mg



Clavulanic Acid as

Potassium ………………….57 mg

(Antibiotics)

Not

mentioned

Not

mentioned

-Do-

3. Calamox Dispersible Tablet 375mg

Each Dispersible tablet contains:-


Clavulanic Acid as

Potassium ………………...125mg

(Antibiotics)

Not

mentioned

Not

mentioned

-Do-

4. Calamox ES Oral Suspension

Each ml contains:

Amoxycillin as

Trihydrate……….600 mg

Clavulanic acid as potassium salt……

42.9 gm

(ntibiotic / antibacterial for microbial

diseases)

75ml

125ml

200ml

Rs.225.00

Rs.375.00

Rs.600.00


me too status

5. Calamox-XR Tablet

Each extended release tablet contains:

Amoxycillin as

trihydrate ……….…...1 gm

Clavulanic acid as

potassium…………… 62.5 mg

(Antibiotic / antibacterial for microbial

diseases)

6’s

14’s

28’s

Rs.180.00

Rs.420.00

Rs.840.00


me too status.

328

Now firm has stated as under:-

For products at S. No.1 – 3

Remaining fee @ Rs.35,000/- for each product

Application of Form-5-D

For products at S. No.4 – 5

Remaining fee @ Rs.23,000/- for each product

Application of Form-5-D

Decision: Registration Board advised firm to provide data for stability studies

conducted under zone IV-A conditions as per ICH / WHO guidelines for consideration of

Registration Board.

Case No.20 De-Registration of registered drugs.

M/s Tabros Pharma, Karachi have requested for de-registration of their registered drugs,

as per following details:-

S. No. Name of drug(s) Reg. No. Reason / Justification

1. Tabromide Capsule 2mg


Loperamide HCl …….2mg

014296 Due to some unavoidable

circumstances and unfeasibility in the

market

2. Evac 100mg Tablets

Each chewable coated tablet

contains:-

Alpha Tocopherol

Acetate J.P ……………100mg

021801 -do-



contains:-

Alpha Tocopherol


021802 -do-



contains:-

Alpha Tocopherol

021803 -do-

329




contains:-

Alpha Tocopherol


021804 -do-

6. Pyrazol 500mg Tablet


Pyrazolone Magnesium 500mg

014346 -do-

Decision: Registration Board deferred the case for presentation before the Board.

Case No.21 Grant of Registration – Mentioning of two MRPs for a formulation.

Registration Board in its 242nd

meeting approved following registration in favour of M/s

The Searle Company Ltd, Karachi and accordingly registration letter was issued as per following

details.

S. No Reg. No. Name of Drug(s) &

Composition

Packing MRP

1 076280 Peditral-R (Bubble Gum Flavor)

Powder

(Low Osmolar Formulation)


Pre-cooked Rice Powder…...6g

Sodium Chloride ……….0.35g

Potassium Chloride ……0.30g

Sodium Citrate ………..0.58g

(Manufacturer’s Specifications)

10’s Sachet Rs.100.00

2 076281 Peditral-R (Mango Flavor)

Powder









330

3 076282 Peditral-R (Orange Flavor)

Powder









Later on firm has stated that basically they have filed for pack size of 10’s in registration

dossier including Costing, pack proposed labeling & design but only in Form-5 pack size 20’s

were also mentioned by mistake. Being brand leader they have demanded the MRP Rs.200/- for

10 sachets. While minutes of meeting 242nd

of RB shows only pack size of 20’s instead of

10’s.Firm has also submitted that Drug Pricing Committee in its 15th

meeting dated 12-04-2011

has already fixed MRP Rs.140/- for pack size of 10’s for same formulation.

Case was referred to Evaluation Cell and they explained that firm has applied for both

packs / prices i.e Rs.200/20’s & Rs.200/10’s in the same dossier.

Decision: Registration Board referred to Cost & Pricing Division, DRAP for their

opinion on the case.

Case No.22 Transfer of registered drugs:

a. Transfer of registration from import to local manufacturing:

M/s The Searle Company Ltd, Karachi have requested for transfer of registration

of following drugs from import to local manufacturing at their own facility i.e M/s The Searle

Company Ltd, F-319, S.I.T.E, Karachi

S. No. Reg. No. Name of drug (s)

1 010172 Tramal – 100 Injection

(Tramadol)

2. 023317 Tramal SR100mg Tablet

(Tramadol)

331

As per SOP, supporting documents were sent for expert opinion to three (03) experts and

now two (02) experts out of three (03) has sent their opinion. Details of comments of experts are

as under:-

Prof. Nadeem Irfan Bukhari,

Faculty of Pharmacy,

University of the Punjab,

Lahore

Director,

Drug Testing

Laboratory,

Government of

Bluchistan,

Quetta

Director,

Drug Testing Laboratory,

Government of Punjab,

Lahore

The report sent for the above

subject shows the results of

ongoing real time stability

studies of Tramal SR Tablets

and Tramal 100mg/2ml

Injection. It is understood that

the case has been filed for the

transfer of registration from

import to local manufacturing

at their local facility. My

opinion / comments are as

follows:-

The data provided on tablet

formulation indicated that the

strength (assay) of tramadol

HCl , dissolution test and the

physical characteristics were

within the limits and

specifications after the real time

one year and accelerated

studies.

The data given on the injection

formulation showed that the

tramadol was stable in this

formulation during real time as

well as in the accelerated

stability study.

The data on real time and

accelerated study reflected

some variations which were

minor and within the acceptable

limits.

After thorough review of

the stability data and

validation of analytical

methods of the products of

Tramal SR Tablets 100mg

and Tramal Injection

100mg/2ml Injection is

recommended.

In this regard the

undersigned scientifically

and logically comments as

under:-

Stability Studies:

The stability studies of

both Tramal 100 Injection

as well as Tramal SR

100mg Tablets have been

carried out against ICH

guidelines.

The results of ongoing real

time stability studies

showing all physical

parameters and assay of

Tramadol HCl is well

within the specified limits.

Also, at accelerated

condition the stability data

is found satisfactory.

The data given on

Tramadol SR Tablets

Awaited

332

The HPLC method developed

for each formulations was

linear, precise and accurate,

through LOQ and LOD was not

provided. Meanwhile the drug

peaks were shown to be

resolved well without

interference. Furthermore, the

drug peaks seem to be

responsive to the changes in

concentrations of the tramadol

HCl in the samples.

Keeping the general reflection,

the data on the stability and

HPLC method of Tramal SR

Tablets 100mg and Tramal

Injection 100mg/2ml Injetion

seem to be appropriate.

specified that the

dissolution test, assay of

Tramadol and physical

characteristics of the

formulation is within the

limits in ongoing stability

studies (real time and

accelerated).

Validation data

The validation studies of

both products have been

evaluated the results are

found satisfactory.

Therefore keeping in view

the present data provided

by the firm for both their

products, the undersigned

is of the opinion to

recommend the

registration of Tramal -100

Injection (Tramadol)

100mg/2ml (Reg.

No.010172 and Tramal SR

100mg Tablets (Tramadol)

(Reg. No.023317) in

favour of the firm.

As per practice in vogue cases for transfer of registration from import to local

manufacturting are considered at same terms and condition including MRP. Cost & Pricing

Divison was also consulted, who confirmed to proceed as per previous practice. Form 5 has

already been evaluated by PEC as per check list approved by Registration Board.


Cancellation of registrations of Tramal – 100 Injection, Registration No. 010172 and

Tramal SR100mg Tablet, Registration No. 023317 from M/s Serale

Pharmaceuticals, Karcahi.

Grant of registrations of Tramal – 100 Injection, Registration No. 010172 and

Tramal SR100mg Tablet, Registration No. 023317 in name of M/s The Searle

Company Ltd, F-319, S.I.T.E, Karachi for local manufacturing.

333

b. Transfer of registrations from M/s Macter International, Karachi to M/s Ray

Pharma, Karachi.

M/s Ray Pharma, Karachi have requested for transfer of registration of following drugs

from M/s Macter International, Karachi to their name. Registration dossiers were evaluated by

Incharge PEC and DDC (R-II) as per check list approved by the Registration Board and firm has

also rectified shortcomings and following recommendations were framed.

S.

No.

Reg. No. Name of Drug(s) Recommendations

01 000482 Genticyn Ear / Eye

Drops

May be approved subject to confirmation

of renewal status

02 004298 Genticyn HC Ear /

Eye Drops

Referred to Review Committee or may be

discussed in Registration Board due to the

reason that these formulations have not

been found approved in SRA’s (reference

drug agencies)

03 000497 Genticyn Cream

0.1% w/w

May be approved subject to confirmation

of renewal status

04 000483 Genticyn HC Cream Referred to Review Committee or may be

discussed in Registration Board due to the

reason that these formulations have not

been found approved in SRA’s (reference

drug agencies)

05 010186 Genticyn B Cream -do-

06 007701 Multigesic Cream May be approved subject to confirmation

of renewal status

Renewal status of products are as follows:-

S.

No.

Reg. No. Name of Drug(s) Initial date Aplication

receiving

date

Renewal

status

01 000483 Genticyn HC Cream 06-09-2006 Application

received after

expiry date and

grace period

24-02-2012

Registraion

is not valid

02 010186 Genticyn B Cream -do- -do- -do-

334

03 007701 Multigesic Cream -do- -do- -do-

04 000482 Genticyn Ear / Eye Drops 24-08-1978

Trasnfer of

regn date

18-06-2007

07-06-2012 Registraion

is valid

upto

17-06-2017

05 004298 Genticyn HC Ear / Eye

Drops

-do- -do- -do-

0

06

000497 Genticyn Cream 0.1%

w/w

06-09-2006 Application

received after

expiry date

and grace

period

24-02-2012

Registraion

is not valid


Cancellation of registrations of Genticyn Ear / Eye Drops, Regn No. 010186 from

M/s. Macter International, Karachi.

Grant of registrations of Genticyn Ear / Eye Drops, Regn No. 010186 in name of

M/s. Ray Pharma, Karachi. Chairman, Registration Board will permit issuance of

registration letter after comments of Cost & Price Division.1

Genticyn HC Ear / Eye Drops, Registration No. 004298 referred to review

committee as it’s not found approved in SRA’s (reference drug agencies).

Registrations of Genticyn HC Cream, Genticyn B Cream, Multigesic Cream and

Genticyn Cream 0.1% w/w are not valid.

c. Transfer of registration from M/s Macter Pharmaceutical (Pvt.) Ltd, Karachi to

M/s Macter International (Pvt.) Ltd, Karachi.

M/s Macter International (Pvt.) Ltd, Karachi has requested for transfer of their following

registered drug from previous name i.e M/s Macter Pharmaceutical (Pvt.) Ltd, Karachi to new

name i.e M/s Macter International (Pvt.) Ltd, Karachi.

Sr.

No. Registration No.

Brand

Name(s)

Formulation/Generic

Name

Date of

Registration

Renewal

Status

1.

011206 Relaxin

Tablets 3mg Bromazepam

06-06-1990

Valid up to

05-06-2015

Central Licensing Board in its 238th

meeting held on 19-11-2014 approved Tablet

(Psychotropic) / Narcotic) Section as segregated section.

335

Decision: Registration Board approved registration of Relaxin Tablets 3mg in name of

M/s Macter International (Pvt.) Ltd, Karachi.

Case No.23 Change of Contract Manufacturer – M/s B. Braun Pakistan (Pvt.) Ltd, Karachi

M/s B. Braun Pakistan (Pvt.) Ltd, Karachi was granted approval for transfer of

registration from Import to Local manufacturing by contract manufacturing at M/s Mac & Rains

Pharmaceuticals (Pvt.) Ltd, Lahore. Now firm has requested for change of contract

manufacturing from M/s Mac & Rains Pharmaceuticals (Pvt.) Ltd, Lahore to M/s Frontier

Dextrose Ltd, Hattar as the M/s Mac & Rains were unable to manufacture their medicine due to

hiring of their plant by M/s Searle Pakistan.

Applicant Contract

manufacturer

Reg. No. Name of drug(s) & Composition Date of

application,

Diary No. &

Form

Category

1. M/s B.

Braun

Pakistan

(Pvt.) Ltd,

Karachi

M/s Frontier

Dextrose Ltd,

Haripur

053854 B. Braun-RL Infusion


Sodium Chloride …..0.600gm

Sodium Lactate …..…0.32gm

Potassium Chloride…0.040gm

Calcium

Chloride 2H2O …...0.027gm

03-06-2014

537

Form-5

Rs.50,000/-

Import to

local

contract

2. -do- -do- 053855 B. Braun-RLD Infusion



Sodium Lactate …..…0.32gm

Potassium Chloride…0.040gm

Calcium

Chloride 2H2O …...0.027gm

Dextrose Anhydrous for

Parenteral …………5.5gm

03-06-2014

538

Form-5

Rs.50,000/-

Import to

local

contract

3. -do- -do- 053848 B. Braun – Paeds Infusion




Parenteral use………5.0gm

03-06-2014

543

Form-5

Rs.50,000/-

Import to

local

contract

4. -do- -do- 053849 B. Braun – DS ½ Infusion 03-06-2014 Import to

336





536

Form-5

Rs.50,000/-

local

contract

5. -do- -do- 053850 B. Braun – DS Infusion





03-06-2014

541

Form-5

Rs.50,000/-

Import to

local

contract

6. -do- -do- 053851 B. Braun – G5 Infusion




03-06-2014

535

Form-5

Rs.50,000/-

Import to

local

contract

7. -do- -do- 053852 B. Braun – G10 Infusion




03-06-2014

539

Form-5

Rs.50,000/-

Import to

local

contract

8. -do- -do- 053856 B. Braun - Mannitol Infusion


Mannitol ………..17.5gm

Sorbitol for Parenteral

use…………….…2.5gm

03-06-2014

540

Form-5

Rs.50,000/-

Import to

local

contract

9. -do- -do- 053853 B. Braun - NS Infusion


Sodium Chloride ……0.90gm

03-06-2014

542

Form-5

Rs.50,000/-

Import to

local

contract

The above case was deferred in 245th meeting of Registration Board for confirmation of TOC

analyzer and particle counter in M/s Frontier Dextrose Ltd, Hattar. Federal Inspector of Drugs, DRAP,

Peshawar has reported that that he has checked physically the installation of TOC analyzer and particle

counter in the said firm’s laboratory on 17-11-2014.

Decision: Registration Board acceded to request of M/s B. Braun Pakistan (Pvt.) Ltd,

Karachi for change of contract manufacturer for above products to M/s Frontier Dextrose

Ltd, Hattar at same terms and conditions. This permission will be valid till 30.06.2015.

337

Case No: 24 Change of contract manufacturer-M/s Excell Health Care Laboratories

(Pvt.) Ltd, Karachi.

Following products of M/s Excell Health Care Laboratories (Pvt.) Ltd, Karachi

were registered for bulk import from M/s ACTAVIS UK Ltd, United Kingdom and local

repacking at M/s Elko Organization, Karachi.

S. No. Name of product(s) Reg. No.

1. Cyclogest Pessaries 200mg

(Progesterone Pessaries)

033181

2. Cyclogest Pessaries 400mg

(Progesterone Pessaries)

033182

Now the firm has requested for change of contract manufacturer for above mentioned

product (bulk import and local repacking) from M/s Elko Organization, Karachi to M/s Apex

Pharmaceuticals (Pvt.) Ltd, D-21-A1, S.I.T.E, Super Highway, Karachi. Firm has deposited fee

@ Rs.10, 0000/- for each product for the purpose.

Registration Board in 241st meeting discussed and decided as under:-

The Board deliberated that reapacking is the part of manufacturing and in this case final

quality control release will be granted by local manufacturer, which will be M/s Apex

Pharmaceuticals (Pvt.) Ltd, D-21-A1, S.I.T.E, Super Highway, Karachi. Thus Board

constituted a panel comprising of Director DTL, Peshawar, Director CDL Karachi and

area FID to inspect the premesis for confirmation of repacking and quality control

facilities of the firm. The Board also advised the panel to confirm that status of imported

products whether in pessaries, blister etc. Registration Board will decide the case in light

of report of the panel.

Accordingly panel inspected the premises of M/s Apex Pharmaceuticals, Karachi

and concluded as under:-

During inspection, it was observed that management has provided adequate facilities for

repacking of above named products and quality control that are being imported from M/s

Actavis, United Kingdom in form of strips and management is intended to repack 15

pessaries in one pack. A room with controlled temperature is also reserved for proper

placement of bulk and repacked products.

Based on the observations made, people met, record reviewed and repacking & QC

facilities provided by the management, panel recommends the transfer of the above name

338

products from M/s Elko Organization, Karachi to M/s Apex Pharmaceuticals (Pvt.) Ltd,

D-21-A1, S.I.T.E, Super Highway, Karachi

Decision: Registration Board acceded to request of M/s Excell Health Care

Laboratories (Pvt.) Ltd, Karachi for change of contract manufacturer for repacking and

quality control release of above products to M/s Apex Pharmaceuticals (Pvt.) Ltd, D-21-A1,

S.I.T.E, Super Highway, Karachi. However the firm will provide legalized COPP at WHO

format for both products and authorized its Chairman for issuance of letter. Permission is

at the same terms and conditions will be valid till 30.06.2015.

Case No.25 Issuance of duplicate registration letter.

M/s Johnson & Johnson, Karachi have requested for issuance of duplicate registration of

their following drugs:-

S. No. Reg. No. Name of Drug(s)

1. 009078 Daktarin Oral Gel

2. 009084 Daktacort Cream

3. 009083 Sibelium Capsule

4. 009082 Vermox Tablet 500mg

Firm has furnished following documents to support their request:-

a) Copy of entry in roznamcha from concerned policy station

b) Fee @ Rs.5000/- for each product for the purpose.

Decision: Registration Board deferred the case for confirmation of renewal status.

Case No.26 Grant of Registration for export purpose - Contract Manufacturing.

Following firm has requested for registration of drug for export purpose only,

on basis of contract manufacturing.

Contract giver Contract

manufacturer

Name of Drug(s) & Composition Date of

application,

Diary No. &

Form

M/s Medisure Labs,

Karachi

M/s Cirin Pharma,

Hattar

Rumaclav Tablet 625mg


Amoxicillin as Trihydrate ……500mg

Clavulanic Acid as Potassium…125mg

31-12 -2013

Form-5

Rs.50,000/-

339

Decision: Registration Board approved grant of above registration on contract

manufacturing basis for export purpose only. In order to boost export, The Board also

authorized Chairman for grant of registration for export purpose on contract

manufacturing basis excluding controlled drugs and new drug as per contract manufacting

policy.

Case No.27 Grant of Registration for export purpose – Controlled Drug.

M/s Pharmatec Pakistan (Pvt.) Ltd, Karachi has requested for registration of following

drug for export purpose only:-

S.

No.

Date of

application

Diary No.

& Form

Name of drug(s) &

Composition

Information required & reply of firm

30-09-2014

753

Form-5

Rs.20,000/-

Flu-Gone C&F

Tablet


Paracetamol ...600mg

Pseudoephedrine

HCl…………60mg

Chlorpheniramine

Maleate …….4mg

Application on Form 5 with required fee

as per relevant SRO

NOC for CRF clearance

Copy of approved section from CLB

Copy of last inspection report

An undertaking that applied registration

is exclusively for export purpose and

will not be sold in Pakistan.

If formulation / product is not registered

in Pakistan, then export order from

importing country (Registered in

Pakistan)

Above formulation is registered for local manufacturing as per following details:-

Applied formulations Registered in Pakistan Manufacturer

Flu-Gone C&F Tablet


Paracetamol …….....600mg

Pseudoephedrine HCl..60mg

Chlorpheniramine Maleate..4mg

Reltus C&F Tab(Reg. No.024908)

Epinol-CF Tab (Reg. No.023982)

M/s Pharmatec

M/s CCL, Lahore

Decision: Registration Board discussed that applied drug contains Pseudoephedrine,

which is a precursor chemical and segregated section is required only for Narcotic Drugs

and Psychotropic substances as per Central Licensing Board decision. Thus applied

formulation registered for export purpose only.

340

Case No.28 Change in flavour – Gastrolyte Rice (Reg.No.070436) –

M/s Sanofi Aventis Pakistan Ltd, Karachi.

M/s Sanofi Aventis Pakistan Ltd, Karachi has informed that their product

Gastrolyte Rice (Reg. No.070436) is registered in Apricot flavor. Now firm has requested for

change of flavor from Apricot to Raspberry.

Firm has submitted for information to support their request.

O6 months accelerated stability data

Undertaking

Specification & Control Method

Copy of Registration letter

Fee @ Rs.5,000/- for the purpose.

Decision: Registration Board approved the request. However, Incharge, PEC will

evaluate the stability data and Chairman, Registration Board will authorize issuance of

permission letter on the basis of these recommendations.

Case No.29 Change of manufacturing site from Contract to own facility.

Following products of M/s Medisure Labs (Pvt.) Ltd, Karachi were initially registered for

import as per following details and then permitted for local contract manufacturing from M/s

Indus Pharma, Karachi which are valid till 30.06.2015. Now M/s Medisure Labs (Pvt.) Ltd,

Karachi has informed that they have developed facility for Liquid Injectables (Ampoules &

Vials) at their own premises 17/24, Korangi Industrial Area Karachi and requested to permit

manufacturing of products at this facility.

S. No. Reg. No. Name of Drug(s) Date of Registration

1. 015566 Rosiden Injection

Each 1ml ampoule contains:-

Piroxicam …………….20mg

23-08-1994

2. 014084 Neurocoline 250mg/2ml Injection

Each 2ml contains:-

Citicoline …………….250mg

01-11-1993

341

Registration dossiers were evaluated by Incharge PEC and DDC (R-II) as per check list

approved by the Registration Board and firm has also rectified shortcomings. It is pertinent to

mention that citicoline is under consideration of Review Committee.

Decision: Registration Board approved request of M/s Medisure Labs (Pvt.) Ltd,

Karachi for manufacturing of Rosiden Injection, Registration No.015566 at its own

premesis. However, request of Neurocoline 250mg/2ml Injection, Registration No.014084

will be considered after recommendation of Review Committee and decision of the Board

on Citicoline.

Case No.30 Correction in Minutes:

a. M/s Amarant Pharma, Karachi


meeting approved following registration in favour

of M/s Amarant Pharma, Karachi. Registration letter could not be issued due to following

mistake in minutes. Existing and correct formulation are as under:-

Name of Drug(s) & Composition Correct Composition

Amprexa-F Tablet 12/25mg


Olanzapine ………..……12mg

Fluoxetine HCl …….……25mg

Amprexa-F Capsule 12/25mg


Olanzapine ……..………12mg

Fluoxetine HCl ………..…25mg

Decision: Registration Board approved the correction as Amprexa-F Capsule 12/25mg

instead of tablets.

Case No.31 Registration of Drugs for export purpose-Not me too Drugs.

Following firms have requested for registration of following drugs for export

purpose only which are not me-too. Details are as under:-

S.

No.

Name of

Company

Name of product(s) Date of application,

Diary No. & Form

Export Order

1. M/s

Genix

Pharma,

Sofos Tablet


contains:-

23-11-2014

769

Rs.20,000/-

Original Export

Order from

Afghanistan

342

Karachi Sofosbuvir MS ....400mg

2. -do- Sofopas Tablet


contains:-

Ledipasvir MS ……90mg

Sofosbuvir MS .......400mg

23-11-2014

770

Rs.20,000/-

Original Export

Order from

Afghanistan

3. M/s

Tabros

Pharma,

Karachi

Vibrenta 400mg Tablet


contains:-

Sofosbuvir MS ....400mg

19-11-2014

767

Rs.20,000/-

Copy of Export

Order from

Afghanistan

4. M/s Getz

Pharma,

Karachi

Azvira 400mg Tablet


contains:-

Sofosbuvir ....400mg

05-12-2014

771

Rs.20,000/-

Not provided

Decision: Mr.A Q Javed Iqbal, Director QA &LT opined that for export purpose only

those formulations should be registered, which are already registered in Pakistan. For new

formulations (which are not registered in Pakistan), manufacturers should first conduct

stability studies and then registration for export purpose be granted. Prof. Muzammil H

Najmi also endorsed it. Registration Board after deliberation decided that inorder to

facilitate export of quality drugs (non-me too drugs), export registration will be granted

and manufacturer will comply following conditions before export of drug:

Manufacturer will export the product after complying all the conditions as required

under Drug Act, 1976 including No objection certificate from concerned DRAP

office. Moreover, Federal Inspector of drugs will take sample from each

consignemnet for analysis from CDL, Karachi.

Manufacturer will also furnish export documents endorsed from custom authorities

in order to ensure the export of the product.

Registration Board approved above products for registration for export purpose only

with aforementioned conditions. These conditions will also be applicable to products

approved for exports (Sofosbuvir) by Chairman, registration Board

343

Registration-III

Case No.32

Registration Board in its 229th meeting approved the following product of M/s Global

Pharmaceutical, Islamabad.

S.No. Name and Composition of Product Pack size Demanded Price

1. Tamsol-D Tablets


Tamsulosin Hydrochloride 0.4 mg

(as modified – release tablets)

Dutasteride………………0.5 mg

10’s As Per SRO

Fee

Rs:8,000/=

The Registration Board reconsidered the decision of 229th meeting which is as follows:

“Decision: Registration Board after considering the technical opinion by its members

decided to ask the manufacturer to appear before Registration Board for presentation

of his opinion regarding efficacy of the above drug formulation. The Board further

ordered that till final decision, the registration of above product would remain

suspended under section 7(11) (ad) of Drug Act, 1976.”

Decision: Registration Board discussed the case and decided to issue show cause notice

to M/s Global Pharmaceutical, Islamabad for cancellation of registration.

Case No.33

M/s. Amgomed, Islamabad has requested to transfer of the following drug from being imported for

local manufacturing on contract basis by M/s. Bio-Lab (Pvt) Limited, Islamabad:-

S.No

.

Reg.

No.

Name and Composition of Product Pack size Demanded Price

1 053821 Amgozole Injection


Omeprazole Sodium

≡ Omeprazole……40 mg

(Proton Pump Inhibitor)

Per vial As Per SRO

The dossier has been submitted along with fee amounting Rs.50,000 and has been evaluated with the

collaboration of the Incharge Evaluation Cell as per check list.

344

Decision: Registration Board approved request of M/s. Amgomed, Islamabad for

contract manufacturing of Amgozole Injection, Registration No. 053821 from M/s. Bio-Lab

(Pvt) Limited, Islamabad. This permission will be valid till 30.06.2015.

Case No. 34.

M/s. Quaper (Pvt) Limited, Sargodha has requested to transfer the manufacturing site from M/s.

Fassgen Pharmaceuticals, Hattar to M/s. Mediate Pharmaceuticals, Karachi on contract basis:-

The dossiers have been submitted along with fee of Rs:50,000/each and have been evaluated with the

collaboration of the Incharge Evaluation Cell as per check list.

Decision: Registration Board approved the request of M/s. Quaper (Pvt) Ltd.,

Sargodha for change in contract manufacturer of above products from M/s.

1. From

Fassgen

Hattar

To

Mediate

Karachi

054069 Cefein 250 Injection IV


Ceftriaxone Sodium

≡ Ceftriaxone……..250 mg

(Cephalosporin)

2. Fassgen

Mediate 054077 Cefein 500 Injection IV


Ceftriaxone Sodium

≡ Ceftriaxone……..500 mg

(Cephalosporin)

3. Fassgen

Mediate 054073 Cefein 250 Injection IV


Ceftriaxone Sodium

≡ Ceftriaxone……..1g

(Cephalosporin)

4. Fassgen

Mediate 054067 Rayxime 400 mg Capsule


Cefixime Trihydrate

≡ Cefixime…………400 mg

(Cephalosporin)

5. Fassgen

Mediate 054065 Rayxime 100 mg Dry

Suspension

Each 5ml contains:-

Cefixime Trihydrate

≡ Cefixime…………100 mg

(Cephalosporin)

345

Fassgen Pharma to M/s. Mediate Pharma, Karachi. Permission is at already

approved terms and conditions.

Case No.35 Registration Board in 242nd

meeting approved the registration of following drug

of M/s. Olive Laboratories, Rawat.

S.N

o

Existing name with approved

Composition

Correct formulation/Nomenclature

1. 1. Hepatavir 300 mg Tablets

2.Tablets

3. Each film coated Tablet contains:

Tenofovir Disoproxil Fumarate ….30

mg

4. Anti-retroviral / Nucleoside and

Nucleotide Reverse Transcriptase

Inhibitors

1. Hepatavir 300 mg Tablets

2.Tablets

3. Each film coated Tablet contains:

Tenofovir Disoproxil Fumarate…300

mg 4. Anti-retroviral /

Nucleoside and Nucleotide Reverse

Transcriptase Inhibitors

The Evaluation Cell stated that the firm had correctly applied for Tenofovir Disoproxil Fumarate 300

mg film coated tablet but inadvertently incorporated as 30mg in agenda and minutes of 242nd

meeting.

The abovementioned inadvertent typographical error of the strength needs rectification as Tenofovir

Disoproxil Fumarate 300 mg.

Decision: Registration Board approved the correction as Tenofovir Disoproxil

Fumarate 300mg Tablet.

Case No.36

Registration Board in 244th meeting deferred the following registration applications of M/s. Welwink

Pharmaceutical, Gujranwala for manufacturing by M/s. Weather Fold Pharmaceuticals, Hattar on contract

basis in view of required GMP inspection as mentioned below:

M/s Welwink

Pharmaceuticals.

G.T Road,

Industrial Estate,

Gujranwala

Cantt.

Gujranwala

Manufacturing

on Contract basis

by

M/s Weather

Acticef 500 mg Powder for

reconstitution of IM

Injection


Ceftriaxone Sodium

≡ Ceftriaxone ……500 mg

(Cephalosporin Antibiotic)

(USP Specs)

Form 5

18-07-2012

Dy No 7333

21-05-2013

Rs. 150,000/-

As Per SRO

1‟s

vial

FDA. (Rocephin

(Roche)

SPORCEF(LOWITT

PHARMACEUTICALS

(PVT) LTD)

Advised for further

improvement in

different sections.

(22-03-2014)

Deferred for GMP

inspection of

contract

manufacturer by

panel comprising

of Dr. Muzammal

H. Najmi, Director

QA

& LT and Area

FID. Contract

giver will be

inspected by Area

346

Folds

Pharmaceuticals.

Plot 69/2, Phase-

2, Industrial

Estate, Hattar

FID as last

inspection report is

more than 01 year

old

-do- Acticef 250 mg Powder for

reconstitution of IM

Injection


Ceftriaxone Sodium

≡ Ceftriaxone…….250 mg


Form 5

18-07-2012

Dy No 7336

21-05-2013

Rs. 150,000/-

As Per

SRO/1‟s

vial

SPORCEF(LOWITT

PHARMACEUTICALS

(PVT) LTD)

Advised for further

improvement in

different sections. (22-

03-2014)

Deferred for GMP

inspection of

contract

manufacturer by

panel comprising

of Dr. Muzammal

H. Najmi, Director

QA

& LT and Area

FID. Contract

giver will be

inspected by Area

FID as last


more than 01 year

old

-do- Acticef 250mg Powder for

reconstitution of IV

Injection


Ceftriaxone Sodium

≡ Ceftriaxone ………250

mg


USP Specs

Form 5

18-07-2012

Dy No 7338

21-05-2013

Rs. 150,000/-

As Per SRO

1‟s

vial

BNF. (Rocephin

(Roche)

SPORCEF(LOWITT

PHARMACEUTICALS

(PVT) LTD)

Advised for further

improvement in

different sections. (22-

03-2014)

Deferred for GMP

inspection of

contract

manufacturer by

panel comprising

of Dr. Muzammal

H. Najmi, Director

QA

& LT and Area

FID. Contract

giver will be

inspected by Area

FID as last


more than 01 year

old

Weather Fold

Pharmaceuticals

Hattar

for

M/s Welwink

Pharmaceuticals,

Gujranwala

Acticef Injection 500mg

(IV)

Each vial contains:

Ceftriaxone sodium

≡ Ceftriaxone …500mg


USP Specs

Form 5

18-07-12 Dy

No 7341

Rs 8000/-

21-05-13 Dy

No 3283

1,42,000/-

As per SRO/

Pack of 1‟s

Rociphen of Gentech

USA

Rociphen of Roche

Karachi

Inspection of the M/s

Weather Folds

Pharmaceuticals, Hattar

was conducted by the

area FID on 22/03/14

and advised firm for

further improvements in

different sections

Deferred for GMP

inspection of

contract

manufacturer by

panel comprising

of Dr. Muzammal

H. Najmi, Director

QA

& LT and Area

FID. Contract

giver will be

inspected by Area

347

FID as last


more than 01 year

old

-do- Acticef Injection 1gm

(I.M.)

Each vial contains:

Ceftriaxone sodium

≡ Ceftriaxone …….1g

Cephalosporin Antibiotic

USP specs

Form 5

18-07-12 Dy

No 7334

Rs 8000/-

21-05-13 Dy

No 3283

1,42,000/-

As per SRO/

Pack of 1‟s

Rociphen of Gentech

USA

Rociphen of Roche

Karachi

Deferred for GMP

inspection of

contract

manufacturer by

panel comprising

of Dr. Muzammal

H. Najmi, Director

QA

& LT and Area

FID. Contract

giver will be

inspected by Area

FID as last


more than 01 year

old

-do- Acticef Injection 1gm( I.V)

Each vial contains

Ceftriaxone sodium

≡ Ceftriaxone …….1gm

Cephalosporin Antibiotic

USP Specs

Form 5

18-07-12 Dy

No 7339

Rs 8000/-

21-05-13 Dy

No 3283

Rs 1,42,000/-

As per SRO/

Pack of 1‟s

Rociphen of Gentech

USA

Rociphen of Roche

Karachi

Deferred for GMP

inspection of

contract

manufacturer by

panel comprising

of Dr. Muzammal

H. Najmi, Director

QA

& LT and Area

FID. Contract

giver will be

inspected by Area

FID as last


more than 01 year

old

M/s Weather

Folds

Pharmaceuticals.

Plot 69/2, Phase-

2, Industrial

Estate, Hattar

For

M/s Welwink

Pharmaceuticals.

G.T Road,

Maxoxim 200 mg/5ml

Dry powder suspension

Each 5 ml contains:

Cefixime Trihydrate USP

≡ Cefixime ……200 mg

(Cephalosporin antibiotics)

USP Specs

Form 5

18-07-2012

Dy No 7330

Rs. 150,000/-

As per SRO

International: Suprax

for suspension

200mg/5ml (FDA)

Local: Biozil Dry

Suspension 200 mg/5

ml by M/s BioLabs

According to report of

inspection dated 22-10-

2014 of M/s Weather f

old, firm is advised to

rectify shortcomings in

various sections.

Deferred for GMP

inspection of

contract

manufacturer by

panel comprising

of Dr. Muzammal

H. Najmi, Director

QA

& LT and Area

FID. Contract

giver will be

inspected by Area

348

Industrial Estate,

Gujranwala

Cantt.

Gujranwala

According to report of

inspection dated 13-06-

2013 of M/s Welwink,

inspection book was not

available at time of

inspection and firm was

once again directed to

submit their validation

data of areas and

processes before

starting of their

production.

FID as last


more than 01 year

old

-do- Maxoxim 100 mg/5ml

Dry Powder Suspension

Each 5 ml contains:

Cefixime Trihydrate USP

≡ Cefixime ………100 mg


USP Specs

1.Form 5

2.18-07-2012

Dy No 7335

3. 21-05-

2013

Rs. 150,000/-

-do- -do-

-do- Maxoxim 400 mg Capsule


Cefixime trihydrate

≡ Cefixime …….. 400 mg


Finished product

Manufacturing

specifications

1.Form 5

2.18-07-2012

Dy No 7335

3. 21-05-

2013

Rs. 150,000/-

-do- -do-

The panel of Central Licensing Board inspected Weather Fold Pharmaceuticals, on 18-11-2014 and

recommended the Renewal of DML. The Federal Inspector of Drugs Lahore also inspected the M/s.

Welwink Pharmaceutical Gujranwala and stated that the firm possesses the relevant facility of quality

control.

Decision: Registration Board approved the request of M/s. Welwink Pharmaceuticals

for contract manufacturing of above products by M/s. Weather Ford Pharmaceuticals,

Hattar. Permission will be valid till 30.06.2015.

Case No.37

Registration Board in 245th meeting considered the following new molecule of M/s. Global

Pharmaceutical, Islamabad

Dlanz 30mg Capsules


Dexlansoprazole …. 30 mg

30‘s

As Per

SRO

Registration Board discussed and

agreed to above expert opinions.

However, the Board advised firm to

349


provide data for stability studies

conducted under zone IV-A

conditions as per ICH / WHO

guidelines for consideration of

Registration Board.

Dlanz 60mg Capsules


Dexlansoprazole …. 60 mg


30‘s

As Per

SRO

-do-

Zaprin SR 15mg Capsules


Cyclobenzaprine HCl (USP)

≡ Cyclobenzaprine ……15 mg

(Skeletal Muscle Relaxant)

60‘s

As Per

SRO

-do-

Now the firm has submitted the stability report of quality control for period of 12, 9, 6, 3 (months)

and initial QC about Dexlansoprazole. Moreover, Cyclobenzaprine has been already approved in favour

of CCL, Lahore in 242nd

meeting of DRB. The firm has requested to grant of registration of above

mentioned drugs in view of the relevant explanation.

Decision: Registration Board approved the products. However, the Board advised

concerned P E & R Division and Incharge, PEC to evaluate submitted stability studies of

Zone IVA of Dexlansoprazole 30 & 60mg Capsule. Registration Board authorized its

Chairman for subsequent approval for issuance of registration letter.

Registration Board approved Cyclobenzaprine HCl 15mg Capsule, being me too

product.

Case No.38

Registration Board in 245th meeting deferred the following application of M/s. Global

Pharmaceuticals Islamabad for evaluation of dossier with the collaboration of Evaluation Cell as per

check list:-

Anarob Infusion


Metronidazole B.P…500

mg

026985

1x100

ml

M/s. Mac &

Rains

Pharmaceuticals,

M/s. Vision

Pharmaceuticals,

Ofloquin Infusion

Each 100 ml contains:

Ofloxacin HCl

≡ Ofloxacin….. 200 mg

026980

1x100

ml

-do- -do-

Nafcin Injection 026979 100 ml -do- -do-

350

Each 100 ml contains:

Ciprofloxacin Lactate

≡ Ciprofloxacin…..200 mg

The dossiers have been evaluated with the collaboration of Incharge Evaluation Cell as per check list.

Decision: Registration Board approved request of M/s Global Pharmaceuticals,

Islamabad for change of contract manufacturer of above products from the M/s. Mac &

Rains Pharmaceuticals to M/sVision Pharmaceuticals, Islamabad. Permission is at same

terms and conditions.

Case No.39

M/s. Vision Pharmaceutical, Kahuta Road, Islamabad has requested for transfer of registration of

following drugs from M/s. Vision Pharmaceutical, I-10/3, Islamabad. Previously, these products were

contract manufactured by m/s Mac & Rains Pharmaceuticals, Lahore:-

Levovis IV Infusion


Levofloxacin hemihydrate

≡ Levofloxacin……… 500ml

032160 1x100ml M/s. Mac & Rains

Pharmaceuticals,

M/s. Vision

Pharmaceuticals,

Medicip IV infusion



≡ Ciprofloxacin ......200 mg

030701 1x100ml -do- -do-

M/s. Vision Pharmaceutical, Kahuta Road, Islamabad has developed the relevant manufacturing

facilities and submitted complete dossier along with fee amounting Rs:50000/dossier. The dossiers have

been evaluated with the collaboration of Incharge of the Evaluation Cell as per check list.


Cancellation of above registrations from M/s. Vision Pharmaceuticals, I-10/3,

Islamabad.

Grant of above registrations in name of M/s. Vision Pharmaceutical, Kahuta Road,

Islamabad. Chairman, Registration Board will permit issuance of registration letter

after comments of Cost & Pricing Division about MRP of the drug.

351

Case No.40

M/s. Metro Pharmaceutical, Islamabad has requested for correction of nomenclature and label claim of

the following drugs as mentioned below:-

Existing /approved formulation Correct formulation/Nomenclature Reg No.

Myzinc Syrup

Each 5ml contains:-

Zinc Sulfate Monohydrate…. 20 mg

(USP Specs)

Myzinc Syrup

Each 5ml contains:-


≡ Zinc (element)……..…. 20 mg

(USP Specs)

075253

The management has deposited Fee of Rs:5000/- for this purpose. It is pointed out that the strength of the

API is calculated on the basis of content of zinc element.

Decision: Registration Board approved the correction as Zinc Sulphate Monohydrate

equivalent to Zinc (element) 20mg/5ml syrup.

Registration-IV

Case No.41

M/s. Genome Pharmaceutical, Hattar has requested for correction in formulation of following drugs.

Initially these drugs were registered on 2nd August, 2003 and 4th February, 2006 with M/s. Silver Oak

Corporation Hattar. The management was changed and the unit was renamed and registrations of the

products approved for Silver Oak Corporation Hattar were transferred in favour of M/s. Genome

Pharmaceuticals. It is pointed out that at the time of transfer of registration of the products, the brand

name was also changed but the strengths of active pharmaceutical ingredient in the below-mentioned

formulations were inadvertently typed as:

S.N

o

Previous name /

Formulation

Existing name / Incorrect

Formulation Reg No.

1.

Tick-Nil Tablets


Cetirizine 2HCl…..10 mg

Citgen Tablets


Cetirizine Dihydrate….10

mg

030815

2.

Solifen Tablets


Ketoprofen…………100

mg

Proket Tablets


Ketoprofen………30 mg

042511

352

It is pointed out that it was inadvertently written as Cetirizine Dihydrate 10 mg per tablet while

transferring the registration from M/s. Silver Oak to M/s. Genome. Similarly, the strength of Ketoprofen

was wrongly mentioned as 30mg/tablet. The correct formulation is mentioned below in the right column

of table.

S.N

o

Existing name with

Composition

Correct Formulation/

Nomenclature Reg

No.

1. Citgen Tablet


Cetirizine

Dihydrate…..…..10mg

Citgen Tablet


Cetirizine Dihydrochloride… 10

mg

030815

2. Proket Tablet


Ketoprofen……30mg

Proket Tablet


Ketoprofen……… 100 mg

042511

Decision: Registration Board approved the correction as Cetirizine Dihydrochloride

10mg film coated tablet and Ketoprofen 100mg film coated tablet of the above mentioned

products.

Case No.42

Registration Board approved the application of M/s. Genome Pharmaceuticals, Hattar for Tablets

containing combination of Domperidone Maleate and Cinnarizine in Drug Registration meeting 214th as

mentioned below:-

1. Approved formulations in

214th meeting

The formulation issued in

the Registration letter)

2. Domenome Tablets


Domperidone Maleate…19.48 mg

Cinnarizine………20.40mg

Zinom Tablets


Domperidone

Maleate......19.10 mg

Cinnarizine ...........25mg

(Genome’s Specs)

It is pointed out that Domperidone Maleate and Cinnarizine were inadvertently approved as 19.48 mg

and 20.4mg respectively. Moreover, the certificate of registration also contained typographical error

regarding Domperidone maleate 19.10mg and Cinnarizine 25mg. The firm provided the copy of the

dossier and requested to correct the Minutes of 214th meeting as well as the typographical error of the

respective formulation along with the correction in certificate of registration as mentioned below.

353

Reg No Correct formulation /Nomenclature

053580 Domenome Tablets


Domperidone Maleate……19.1mg

≡ Domperidone…………..15 mg

Cinnarizine………………..20 mg

(Approved formulations in 214th meeting )

Decision: Registration Board deferred and referred above formulations to Review

Committee.

Case No.43

Registration Board in 243rd

meeting approved the registration of following drug of M/s. Wnsfeild

Pharmaceutical Hattar.

S.N

o

Existing name with Composition Correct formulation/Nomenclature

1. 1. Alfa-Block

2. Capsule


Tamsulosin Hydrochloride SR

pellets……50mg

4. (Selective Alpha-a Adrenergic Blocking

Agents)

1. Alfa-Block Capsule


3.Tamsulosin Hydrochloride SR

pellets 0.2%w/w

≡ Tamsulosin HCl……….0.4mg

4. (USP Specification)

Now the firm has informed that the strength of Tamsulosin HCl pellets is incorrectly mentioned as 50

mg per capsule. Incharge Evaluation Cell stated that above mentioned error had been pointed to the firm

and it was rectified subsequently and prior to the 243-Meeting. But the agenda and minutes of 243rd

meeting could not be amended. The management has requested for the appropriate correction and

issuance of the certificate of registration accordingly.

Decision: Registration Board approved the correction as Tamsulosin Hydrochloride

SR pellets 0.2%w/w equivalent to Tamsulosin Hydrochloride 0.4mg/Capsule.

Case No.44

M/s. Wisdom Pharmaceuticals Industries, Peshawar requested for issuance of registration

letter of Zoramid (Domperidone) Suspension which was approved in 243rd meeting of

Registration Board with the following formulation:-

Zoramid Suspension

354

Each 5ml contains:-

Domperidone Maleate eq. to Domperidone….5mg

The registration letter was not issued due to inappropriate active pharmaceutical ingredient

and the ambiguous label claim. With reference to Motilium Suspension (brand leader Johnson &

Johnson) and BNF 66 it is evident that Suspension contains Domperidone 5mg/5ml instead of

Domperidone maleate equivalent to Domperidone 5mg/5ml.

The management was informed that the inappropriate description of active pharmaceuticals

ingredient and label claim needs verification by the Incharge Pharmaceutical Evaluation Cell

because the dossier was evaluated by the PEC and the management has to apply formally for this

rectification.

Mr. Tahir CEO M/s. Wisdom Pharmaceuticals, Peshawar verbally informed, “The

management corrected the formulation and claim of Zormid Suspension and submitted the same

to the PEC before the commencement of DRB meeting-243rd. The correction was neither

incorporated in agenda nor in the relevant minutes and the ambiguity prevailed the approved

minutes”. Instead of proceeding in the proper way, ironically, Mr. Tahir CEO wrote in the letter

No.WPI/DRAP/40/14 dated 11-11-2014, “but due to unknown reason registration letter of our

product has not been issued till to date it is requested to issue registration letter of our product as

soon as possible. If the registration letter is not issued up to 30-11-2014 the case will be sent to

the Honourable Wafaqi Mohtasib (Ombudsman) of Pakistan Islamabad.,” Moreover, the

management forwarded the copies to Honourable Wafaqi Mohtasib (Ombudsman) of Pakistan,

C.E.O DRAP and Director PE&R without waiting for the response of the department according

to the stipulated period of 30-11-2014.

Resultantly the Incharge Evaluation Cell was asked to verify the in appropriation in

formulation and the proclaimed rectifications of Wisdom Pharmaceuticals. The Evaluation Cell

confirmed from the record that stance of firm is true i.e.Wisdom Pharmaceuticals has corrected

the composition as per reference product but the same could not be reproduced into the agenda

and minutes of 243rd

meeting of DRB.

355

Decision: Registration Board deferred the formulation and referred the case to Review

Committee in conformity of decision of 244th

meeting.

Case No. 45

Registration Board in 227th meeting held on 26

th & 27

th August, 2010 deferred the following

registration application of M/s Cherwel Pharmaceuticals, Hattar for manufacturing on basis of contract till

the finalization of contract policy:-

1. M/s. Cherwel

Pharmaceutical

s, Hattar

Manufacturing

on Contract

basis by

M/s.Wise

Pharma,

Islamabad

Cherzone 250 mg Injection I.V


Ceftriaxone Sodium

≡ Ceftriaxone…….…….250 mg

(Cephalosporin)

Per

vial

As Per

SRO

3-10-2009 Deferred till

the finalization

of contract

policy

2. -do- Cherzone 500 mg Injection I.V


Ceftriaxone Sodium

≡ Ceftriaxone…….…….500 mg

(Cephalosporin)

Per

vial

As Per

SRO

-do- -do-

3. -do- Cherzone 1 g Injection


Ceftriaxone Sodium

≡ Ceftriaxone ………….1 g

(Cephalosporin)

Per

vial

As Per

SRO

-do- -do-

4. -do- Getxime 400 mg Capsules


Cefixime Trihydrate

≡ Cefixime………….….400 mg

(Cephalosporin)

5’s As Per

SRO

-do- -do-

5. -do- Getxime 100 mg Dry Suspension


Cefixime Trihydrate

≡ Cefixime …..…….….100mg

(Cephalosporin)

30ml As Per

SRO

-do- -do-

6. -do- Getxime200mg Dry Suspension


Cefixime Trihydrate

≡Cefixime …..…….….200 mg

(Cephalosporin)

30ml As Per

SRO

-do- -do-

356

7. -do- Welpime 500mg Injection


Cefepime HCl with L-Aginine

≡ Cefepime (anhydrous)

500mg

(Cephalosporin)

Per

vial

As Per

SRO

-do- -do-

8. -do- Welpime 1gm Injection


Cefepime HCl with L-Aginine

≡ Cefepime (anhydrous) 1 g

(Cephalosporin)

Per

vial

As Per

SRO

-do- -do-

9. -do- Biset 1 g Injection


Cefoperazone Sodium

≡ Cefoperazone.…… 500 mg

Sulbactam Sodium

≡ Sulbactam…………. 500 mg

(Cephalosporin)

Per

vial

As Per

SRO

-do- -do-

10. -do- Biset 2g Injection


Cefoperazone Sodium

≡ Cefoperazone……… 1g

Sulbactam Sodium

≡ Sulbactam…………… 1g

(Cephalosporin)

Per

vial

As Per

SRO

-do- -do-

Now contract manufacturing policy has been finalized and the management of the firm has deposited

the fee of Rs. 50,000/each and requested to change the manufacturer from M/s. Wise Pharmaceuticals

Rawat to M/s. Bloom Pharmaceuticals, Hattar and also to change the brand name of some product. The

Dossiers have been evaluated with the collaboration of Incharge Evaluation Cell as per check list.

Decision: Registration Board registered above products of M/s. Cherwell

Pharmaceuticals, Hattar on contract manufacturing basis from M/s. Bloom

Pharmaceuticals, Hattar. Permission will be valid till 30.06.2015

Case No.46

M/s. Maxi Care International, Lahore has requested for transfer of following drug from import for

local manufacturing on contract basis by M/s. Welwrd Pharmaceuticals Hattar:-

357

S.No

.

Reg.

No.

Name and Composition of Product Pack size Demanded Price

1 059263 PE-40 Lyophilized Injection


Pantoprazole Sodium

≡Pantoprazole……… 40 mg


Per vial Rs.250.00

They have submitted the complete dossier along with fee of Rs. 50,000/- for this purpose. The dossier

has been evaluated by the Incharge Evaluation Cell as per check list.

Decision: Registration Board approved request of Maxi Care International, Lahore for

contract manufacturing of above product from M/s. Welwrd Pharmaceuticals, Hattar.

Permission is at same terms and conditions except that firm will not claim the product as

lyophilized.

Case No.47

M/s. Aries Pharmaceuticals, Peshawar has requested for registration of following drugs for the

export only:-

S.No

.

Name and Composition of Product

1 Xanek Tablets


Alprazolam……….0.5 mg

(USP Spec)

2 Lexonil Tablets


Bromazepam…………3 mg

(Aries Specs)

The management of the firm provide the complete dossier, Fee of Rs,20000/- original export order and

requested for registration of drugs for export purpose only. The dossiers have been evaluated accordingly.

Decision: Registration Board approved grant of registration of above mentioned

products for the purpose of export only.

Case No. 48

Registration Board in 243rd

meeting deferred the following application of M/s. Genome

Pharmaceuticals, Hattar for opinion of experts but the panel of experts has not been proposed :-

358

1. M/s. Genome

Pharmaceutical,

Hattar.

Genozal Tablets


Balsalazide Disodium

Dihydrate………750 mg

(Genome Spec)

(Anti-inflammatory drug)

10’s As Per SRO Deferred for

expert opinion.

2. -do- Rebon-X Tablets


Strontium citrate………680 mg

(Bone stabilizer)

10’s As Per SRO Deferred due

to Methylene

Chloride.

Inspection

report nil

Form 5/ file

partially

signed.

Now the case is again included in the agenda for constitution of panel of expert for expert opinion.

The dossier has been evaluated and rectified by the Evaluation Cell as per check list.

Decision: Registration Board referred above products to following panel for expert

evaluation:

Genozal Tablets (Balsalazide Disodium Dihydrate………750 mg)

o Brig Dr. Aslam Khan, Member Registration Board.

o Dr. Rauf Niazi, PIMS, Islamabad.

o Dr.Irfan Ahmad, BBH, Rawalpindi

Rebon-X Tablets (Strontium citrate………680 mg)

o Mr. Abdul Latif Sheikh, AKUH.

o Prof Dr. Rafi-uz-Zaman, Member Registration Board.

o Prof. Dr. Zafar Iqbal, University of Peshawar

Case No. 49

M/s. Swat Pharmaceutical, Swat has requested to transfer the manufacturing site from M/s.

Medera Pharmaceuticals (toll manufacturer) to their own manufacturing unit in view of the existence of

the manufacturing facility:

1. Baxib 250mg Tablets


Ciprofloxacin HCl

≡ Ciprofloxacin……....250 mg

(Quinolone)

030449

2. Baxib 500mg Tablets


030450

359

Ciprofloxacin HCl


(Quinolone)

3. Baxib 750 mg Tablets


Ciprofloxacin HCl


(Quinolone)

030451

4. Sanlevo 250 mg Tablets


Levofloxacin Hemihydrate

≡ Levofloxacin…………….250 mg

(Quinolone)

029883

5. Sanlevo 500 mg Tablets



≡ Levofloxacin…………….500 mg

(Quinolone)

029884

The management of the firm has deposited the fee of Rs. 20,000/each and requested to transfer the

above mentioned drugs to their own manufacturing site M/s. Swat Pharmaceutical, Swat. The Dossiers

have been evaluated with the collaboration of incharge Evaluation Cell as per check list.

Decision: Registration Board approved request of M/s. Swat Pharmaceuticals, Swat for

manufacturing of the above products at its own facility. Permission is at same terms and

conditions.

Case No. 50

M/s. Usawa Pharmaceutical, Rislapur has requested to transfer the manufacturing site from M/s.

Caraway Pharmaceuticals (toll manufacturer) to their own manufacturing unit in view of the existence of

the manufacturing facility:

1. Afixim 400 mg Capsule


Cefixime Trihydrate

≡ Cefixime……………… 400 mg

060248

2. Durixil Capsule 500 mg


Cefadroxil Monohydrate

≡ Cefadroxil……………… 500 mg

060249

360

The management of the firm has deposited the fee of Rs. 20,000/each and requested to transfer the

above mentioned drugs to their own manufacturing site M/s. Usawa Pharmaceutical, Rislapurt. The

Dossiers have been evaluated with the collaboration of Incharge Evaluation Cell as per check list.

Decision: Registration Board approved request of M/s. Usawa Pharmaceuticals,

Risalpur for manufacturing of the above products at its own facility.

Permission is at same terms and conditions.

Case No. 51

Registration Board in 228th meeting and 238

th meeting deferred the following drugs of M/s.

Genome Pharmaceuticals, Hattar for the reasons mentioned below:

1. Perilone Tablets


Paliperidone……….1.5 mg

(Ant-psychotropic)(Genome Spec)

10’s As Per SRO Deferred for expert

opinion being a new

chemical entities.

(M-228

2. Lanso-SR Capsules

Each SR capsule contains:-

Dexlansoprazole enteric coated Pellets

≡ Dexlansoprazole….30 mg


14’s As Per SRO Deferred till

submission of

application on FORM

5-D along with

prerequisite fee

(M-238)

Now the firm has informed that the same formulations and same strength has been registered by the

Registration Board in favour of Pharmatec. The firm deposited the differential fee and dossiers have been

evaluated by the collaboration of Evaluation Cell as per check list.

Decision: Registration Board approved Lanso-SR Capsules. However, the Board

advised concerned P E & R Division and Incharge, PEC to evaluate submitted stability

studies of Zone IVA of Dexlansoprazole 60mg Capsule. Registration Board authorized its

Chairman for subsequent approval for issuance of registration letter.

Registration Board approved Tablets Paliperidone 1.5mg

361

Case No.52

The following anomaly cases drugs of M/s. Wnsfeild Pharmaceuticals, Hattar were deferred in 245th

meeting as mentioned below:-

1. Somac 40 mg Injection


Pantoprazole Sodium

Sesquihydrate

≡ Pantoprazole…..40 mg


Per

vial

As

per

SR

O

29-

1-13

As per SRO

29-1-13

Registration Board

deferred above products

for scrutinization of

registration application

as per check list.

2. Winomax 500 mg injection


Azithromycin monohydrate

≡ Azithromycin ………..40 mg

(Anti-infective)

Per

vial

As

per

SR

O

29-

1-13

As per SRO

29-1-13

-do-

3. Lantex 30 mg injection


Lansoprazole sodium

≡ Lansoprazole ……..30 mg


Per

vial

As

per

SR

O

29-

1-13

As per SRO

29-1-13

-do-

4. Kalwin 500 mg Injection


Clarithromycin

≡ Clarithromycin ……..500 mg


Per

vial

As

per

SR

O

29-

1-13

As per SRO

29-1-13

-do-

The dossiers have been evaluated by with the collaboration of Evaluation Cell as per check list and

the term lyophilized will not be claimed by the manufacturer.

Decision: Registration Board approved the registration of above mentioned products.

362

Case No.53

The following anomaly cases of M/s. Welmark Pharmaceuticals, Hattar were deferred in 237th meeting of

the Drug Registration Board as mentioned below:-

1. M/s. Welmark

Pharmaceuticals,

Hattar

New Section

Carimark 500 mg Injection


Clarithromycin

≡ Clarithromycin …500 mg

(Macrolide)

Per

vial

As

per

SRO

16-08-

11

Deferred for

clarification

weather

Lyophilization

procedure is

mandatory/required

for such

formulation or not.

2. -do- Ezi-mark 500 mg Injection

Each injection contains:-


≡ Azithromycin ….500 mg

(Macrolide)

Per

vial

As

Per

SRO

19-8-

2011

do

Now the firm has removed the word Lyophilized from the formulation and the dossiers have been

evaluated with the collaboration of Evaluation Cell as per check list.


Case No.54.

The following registration application of M/s. Navegal Pharmaceuticals, Hattar were considered in 225th

meeting and approved on the ground that the firm develop new separate Psychotropic Section. The

registration letter was not issued.

1. Zocin 25 mg Tablets


Pentazocine HCl

≡ Pentazocine base….. 25 mg

(Benzomarphan derivative)

10x10’s REs.2.50

per tablet

Approved

2. Fenotal 30mg Tablets


Phenobarbital………. 30 mg

(Barbiturate)

2x15’s Rs.2.70

per tablet

Approved

3. Buprex 0.2mg Tablets


Buprenorphine HCl

≡ Buprenorphine base0.2 mg

50’s Rs.0.68

per tablet

Approved

363

(Thebaine derivative)

4. Gytil 3 mg Tablets


Bromazepam……3 mg

(Benzodiazepine)

3x10’s Rs.3.50

per tablet

Approved

5. Gytil 6mg Tablets


Bromazepam……6 mg

(Benzodiazepine)

3x10’s Rs.7.50

per tablet

Approved

6. Xafil 0.25mg Tablets


Alprazolam………0.25 mg

(Benzodiazepine)

3x10’s Rs.4.00

per tablet

Approved

7. Xafil 0.5mg Tablets


Alprazolam……… 0.5 mg

(Benzodiazepine)

3x10’s Rs.10.00

per tablet

Approved

8. Xafil 1mg Tablets


Alprazolam………1 mg

(Benzodiazepine)

3x10’s Rs.10.00

per tablet

Approved

9. Xolpi 10mg Tablets


Zolpidem

Hemitartrate….10mg

(Imidazopyridine)

2x10’s Rs.16.00 Approved

10. Dilamid 1mg Tablets


Lormetazepam ………1mg

(Short Acting

Benzodiazepine)

100’s Rs.1.70

per tablet

Approved

Now the firm deposited the differential fee of Rs:12000/- each and complete the dossiers. The

dossiers have been evaluated with the collaboration of Evaluation Cell as per check list.


364

Registration-V

Case No.55: M/S. CCL Pharmaceuticals (Pvt.) Ltd, Lahore- Export Registrations.

M/s. CCL Pharmaceuticals (Pvt.) Ltd; Lahore has requested for registration of following

products for export purpose only:-

S. No Name of Products

1. Cef-OD Chewable Tablet 100mg


Cefixime trihydrate equivalent to

Cefixime ……………………….. 100mg

2. Bicarb Capsule 600mg


Sodium Bicarbonate ………………… 600mg

The above mentioned products are not available locally. However, product at Sr. No. 1 is

FDA approved and product at Sr. 2 is available in Sri-Lanka. The firm has submitted the

following documents:-

a. Fee of Rs. 20000/- for this purpose.

b. Form-5.

c. Under taking stamp paper.

d. Copy of GMP inspection.

e. CRF clearance certificate.

f. Export orders.

Decision: Registration Board approved the products with following conditions:

Manufacturer will export the product after complying all the conditions as required

under Drug Act, 1976 including No objection certificate from concerned DRAP

office. Moreover, Federal Inspector of drugs will take sample from each

consignemnet for analysis from CDL, Karachi.

Manufacturer will also furnish export documents endorsed from custom authorities

in order to ensure the export of the product.

Case No. 56: M/s. Wilshire Labs Lahore - Case deferred for expert opinion


deferred the following registration application of M/s.

Wilshire Laboratories, Lahore for expert opinion by Brig.(R).Prof. Dr. Muzammil Hasan Najmi,

member Registration Board and submission of differential fee. Initially the case was deferred for

365

expert opinion and two experts have already been given their opinions as follows. Now

Brig.(R).Prof. Dr. Muzammil Hasan Najmi has also give expert opinion:-

Name of Product Pack Size. MRP

Tripoli 400 mg & 800 mg


Metaxalone….400 mg & 800 mg

10’s

100’s

500’s

15% less

brand leader

S. No. Name of Expert Opinion

1. Prof. Dr.

Mohammad Hanif

Head Deptt. of

Medicine,

Rawalpindi

Medical College,

Rwp.

The mode of action of this drug has not been clearly identified,

absolute bioavailability is not known. Impact of age, gender,

hepatic and renal disease on the pharmacokinetics, carcinogenic

potential, safety in pregnancy, safety and effectiveness in

children under age of 12 has not determined. Leucopenia and

haemolytic anemia are among the side effects. The drug is not

cost-effective.

“Tripoli tablets cannot be recommended for registration for the

adjunctive treatment of acute, painful, musculo-skeletal

conditions”

2. Dr. Mughees

Sherani, Agha

khan Hospital

Karachi

“I have personal experience of writing this medication as this is

an FDA approved medication and is available in the United State

by the name of “Skelaxin”. Before moving to Pakistan in 2002, I

was practicing in Midland Texas, USA and use to prescribe this

medication”.

“It is used as an adjunctive treatment of acute, painful

musculoskeletal conditions and provides earlier relief.”

“It major side effects include drowsiness. It should be given with

caution in older patients and in patients with chronic disease,

especially in liver and kidney diseases.”

“I think this medication can be approved as this has long track

record without major complications or problems.”

3. Brig.(R).Prof. Dr.

Muzammil Hasan

Najmi

“Metaxalone is a skeletal muscle relaxant used in treatment of

painful muscle spasm/sprains. The exact mechanism of action of

the drug is not known but it produce generalized CNS

depression, which is also responsible for its side effects. It has

significant interactions with other centrally acting drugs like

benzodiazepines and antidepressants. It is considered to be

unsafe in elderly. Safety in pregnancy and location has bot been

determined. The drug is available in USA.

Metaxalone may be registered as a prescription drug to be

marketed with precautions as outlined above”.

366

The firm has also deposited remaining fee of Rs. 35,000/- for this purpose.

Decision: Registration Board discussed and agreed to above expert opinions.

However, the Board advised firm to provide data for stability studies conducted under zone


Case No.57 : M/s. Highnoon Labs, Lahore- Case deferred for submission of clinical data

The Registration Board in its 245th

meeting deferred the following product of M/s.

Highnoon Labs; Lahore for submission of safety and efficacy data of the drugs along with

complete clinical trial data of these formulations:-

Sr.No. Product Name with

composition

Pack size Demanded

price

Date of

submission

and fee

Remarks

1. Ebernet 1% Cream


Eberconazole (as

nitrate)….10mg

(anti fungal)

10gm Rs.320.00 21-06-2011

Rs. 8000/-

27-06-2011

Rs. 7000/-

10-7-2013

135000/-

(Total: Rs.

150000/-)

Form-5D

Not available

in FDA,

EMA,

Australia and

Japan.

In compliance to the decision of registration board, M/s. Highnoon Labs; Lahore has

submitted clinical trial data of the above mentioned product.

Decision: Board deferred above products for expert opinion of following experts on

submitted clinical studies data:

Dr.Fareed ur Rehman, FFH, Rawalpindi.

Dr.Afaq, PIMS, Islamabad.

Mr.Abdul Lateef Shaikh, AKUH

367

Case No.58 : Permission for Contract Manufacturing due to renovation.

M/s. Highnoon Laboratories Ltd; Lahore has applied for contract manufacturing of their

following products on toll manufacturing basis through M/s. Titlis Pharma, Lahore. Due to

continuous improvement and capacity enhancement program of their manufacturing plant, they

have planned for renovation/up gradation of their granulation-I area while granulation-II area

will remain operational. Therefore they have applied for contract manufacturing of the products

manufactured in granulation-I to avoid shortage of these products:-

S. No. Name of Drug(s) Reg. No.

1. Cyrocin Tablet 250mg

Ciprofloxacin

011406

2. Cyrocin Tablet 500mg

Ciprofloxacin

011407

3. Hilin Capsule 100mg

Pregabalin

048917


Pregabalin

048834


Pregabalin

048916


Pregabalin

047833

7. Oxaquin Tablet 400mg

Moxifloxacin

043660

8. Aria Tablet 1mg

Ketotfen (Fumarate)

014742

9. Inhibitol Capsule 30mg

Lansoprazole (pellets)

020613

10. Neupentin Capsule 100mg

Gabapentin

035763

11. Neupentin Capsule 300mg

Gabapentin

035764

12. Voxiquin Tablet 250mg


038991

13. Voxiquin Tablet 500mg


038992

14. Senegy-OD Tablet 10mg

Loratidine

017672

They have deposited fee of Rs. 50,000/- for each product and have furnished application

dossiers along with toll agreement.

368

It is submitted that in total there are 83 registered in tablet and capsule sections, however

firm has applied for 14 products only i.e. for products of granulation-I area. Orders are solicited,

whether such cases can be processed as per new toll policy.

Decision: Registration Board deferred the case and advised firm to provide complete

renovation plan with time frame for consideration of the Board. Form-5 will be checked as

per check list approved by Registration Board.

Case No. 59: M/s. Phamrawise Labs (pvt.) Ltd; Lahore - Transfer of registration due to

change of name of the firm without change in manufacturing site.

The name of M/s. Fakma Pharma, Lahore was changed from M/s. Fakma Pharma, Lahore

to M/s. Pharmawise Labs (Pvt.) Ltd; Lahore in 2000 on their request. The firm had requested that

either to change all letters regarding registrations with new name or issue a letter to reflect the

said change in each of the registration letter. However, they had not deposited any fee for this

purpose. The case was presented in Board meeting No. 164th on 30-07-2001 and the Registration

Board had decided as under:-

“The request of the firm was not acceded to and the firm was directed to deposit the

requisite fee of Rs. 8000/- for each product for transfer of registration in the new name”.

It is submitted that as per practice in vogue, in case a company changes their name / title apply

for transfer of registration from previous name to new name with full registration fee. However,

the owner of the firm has the view that there is no provision in law for transfer of registration on

same premises.

The case was also referred to Law Division for comments. Law Division in their reply

referred to the case of change of name of M/s. Breeze Pharma, Islamabad to M/s. ICI, Pakistan

Ltd; due to change in management. The issue was as to whether M/s. ICI Pakistan Ltd; require a

fresh license for manufacturing of drugs on leased premises or license of M/s. Breeze Pharma,

Islamabad would be a valid one for manufacturing of drugs.

In this regard, Law Division was of the opinion that license issued by competent

authority was issued to drug manufacturing facility/plant/premises and inspection was done for

369

drug manufacturing facility, plants, its premises and also of the qualifications of the management

under rule 15, 16 of Drug (Licensing Registering & Advertising) Rules 1976. It would therefore,

be wrong to state that license was issued to the premises and not the management. Law Division

has further referred to Section 196 of the Companies ordinance 1984 which states that business

of a company is run and managed by the Directors of a company. Therefore, lease agreement

between Breeze Pharma, & M/s. ICI amounts to transfer of license which is un-authorized under

the said rules.. It is also been suggested that referring Division (DRAP) shall suitable amend the

rules, so that such like complications due to silent position of rules can be averted in future.

Decision: Registration Board decided to seek opinion of Legal Affairs Division, DRAP in

the matter.

Case No. 60: M/s Servier Research & Pharmaceuticals (Pakistan) (Pvt.) Ltd; Lahore- Case

deferred for confirmation of registration in France


meeting deferred the following products of M/s. Servier

Research and Pharmaceuticals (Pakistan) Limited Lahore till confirmation of registration status

of Nartrilam 5 and 10 mg tablets in France:-

S.

No.

Name of Drug(s) with

formulation

Pack

size

Demande

d price

Fee & form

1 Natrilam 10mg Tablets


Indapamide SR…..1.5mg

AmlodapineBesilate…..10mg

(Antihypertensive diuretic +

Calcium antagonist)

30‘s Rs.72.52/

Tablet

20-6-2012

Rs.8000/-

30-04-13

Rs. 130,000/-

Total Fee Rs. 150,000/-

Form 5-D

2 Natrilam 5 mg Tablets


Indapamide SR…..1.5mg

Amlodapineas

Besilate…..5mg

(Antihypertensive diuretic +

Calcium antagonist)

30‘s Rs.36.26/

Tablet

05-04-2011 Rs.8000/-

30-04-13

Rs. 130,000/-

Total Fee Rs. 150,000/-

Form 5-D

The management of the firm has provided legalized free certificate of the products in

France and have requested to grant them registration of above mentioned products.

370

Decision: Board decided to defer the product for expert opinion of following experts on

clinical studies data:

Brig(R). Dr. Muzamil H. Najmi, Member Registration Board

Dr. Shahid Nawaz, PIMS, Islamabad.

Brig. Dr. Sohail Aziz, AFIC, Rawalpindi.

Case No. 61: M/s. English Pharma, Lahore- Case Deffred For Expert Opinion


meeting deferred the following product of M/s. English

Pharma, Lahore for expert opinion of Prof. Dr. Ghias Butt; Prof. Mumtaz Ahmad, Benazir

Bhutto hospital and Prof. Muzamil Tahir, Sh Zayed Hospital, Lahore:-

S. No. Name of Drug(s)

1. Ucholin 10mg Tablet


Bethanechol Chloride equivalent to Bethanechol ……………. 10mg

Two experts have provided their opinion as under:-

Name of expert Comments

Prof. Ghias-ud-Din Butt,

PIMS, Islamabad

Bethanechol chloride is indicated for the treatment of acute

postoperative and postpartum non obstructive (functional) urinary

retention and for neurogesic atony of the urinary bladder with

retention. It works by helping the bladder muscle to squeeze better,

thereby improving your ability to urinate.

Because of the selective action of bethanechol, nicotinic symptoms of

cholinergic stimulation are usually absent or minimal when orally or

subcutaneously administered in therapecutic doses, while muscarinic

effects are prominent.

Special care is required if this drug is given to patients receiving

ganglion blocking compounds because a critical fall in blood pressure

may occur. Usually, severe abdominal symptoms appear before there is

such a fall in the blood pressure. Safety and effectiveness in pediatric

patients have not been established.

Price is a matter of regulator authorities but considering the

effectiveness of Molecule or patients Bethanechol HCl availability

in Pakistan must be assured at affordable price. The maximum

price should not exceed Rs. 30 for 10mg tablet.

Prof. Dr. Mumtaz Ahmad

Benazir Bhutto Shaheed

Hospital, Rawalpindi

This medicine is used to treat certain bladder problems such as the

inability to urinate or empty the bladder completely due to certain

causes (e.g surgery, bladder muscle problems). It works by helping the

371

bladder muscle to squeeze better, thereby improving your ability to

urinate.

Synthetic choline ester with effects similar to those of acetylcholine

(ADh). Acts directly on postsynaptic receptor, and since it is not

hydrolyzed by cholinesterase, its actions are more prolonged than those

of Ach.

Dosage must be individualized, depending on the type and severity of

the condition to be treated. Preferably gives the drug when the stomach

is empty. If taken soon after eating, nausea and vomiting may occur.

Due to non availability of local brand price is at a high and

different prices are charged by patients in different areas. I

therefore recommended the immediate allocation of local

manufacturing of the drug so that the patients can also benefit from it.

There also have been incidents reported for high rates and over

charging of drug due the smuggled version of the drug.

Decision: Registration Board discussed and agreed to above expert opinions.

However, the Board advised firm to provide data for stability studies conducted under zone


Case No. 62: Case deferred for confirmation of storage facilities


meeting deferred the following product of M/s. Rasco

Pharma, Lahore for further deliberation on storage condition of the Misoprostol API. Chairman,

Registration Board advised members and stakeholders to forward their scientific comments on

storage condition of the Misoprostol API for consideration of Registration Board:-

Name of Drug(s) Form & demanded MRP. Competitor & specification

Aerotec-75 Tablet

(Inner core is enteric coated with outer

core as immediate release)


Diclofenac Sodium ….. 75mg

Misoprostol …….. 200mcg

NSAID + mucosal protective

1. Form 5

2. Fast Track

3. As per SRO/blister of 2×10

tablets

4. 29.06.2011/Rs.8000

5.21.05.2013/Rs.52000/4237

Arthrotec (Pfizer)

Manufacturers‘s Specs

The firm has now provided assessment report (EMA) of misoprostol API which is reproduced as

under:-

372

Misoprostol, as described in the Ph.Eur., is an only liquid which is very unstable and

difficult to be process into a drug product in liquid form. The stability of misoprostol is

significantly enhanced when it is dispersed in hypromellose. Hence, misoprostol dispersed in

hypromellose is used as an intermediate in the manufacture of misoprostol tablet. The

dispersion consists of a powder that can be stored at 5+3 °C, whereas the actual active

substance is an oily liquid that needs to be stored at -20 °C.

The certificate of analysis of the misoprostol API of the firm shows that the product is

Misoprostol 1% HMPC dispersion (White to off-white powder) and it is to be stored at 2-8 °C.

The panel of inspectors has already been recommended the storage facility of the firm for above

mentioned product. They have requested to grant them registration of above mentioned products.

A panel of inspectors comprising DDG (E & M), Lahore & area FID inspected the firm on

18-06-2014 for verification of manufacturing and storage facilities for misoprostol raw material.

The panel had recommended as under:-

“the management had provided cold cabinet to maintain temperature range from 2 to 8 C° at the

time of inspection. The panel member physically inspected the cabinet and found that the

conditions for storage were maintained. The overall sanitation and hygienic in this area was

satisfactory. SOPs for handling the raw material during sampling and dispensing were

available. The panel was satisfied with storage and production facilities at the time of inspection

to manufacture the Aerotec-75 Tablet”.

Decision: Keeping in view discussion regarding requirement of storage facility for

Misoprostol and inspection report of the firm, the Board approved the product

(Misoprostol with 1% dispersion HPMC) and with change in brand name.

373

RRR Section

Case No. 63: Applications for Re-Registration of drugs

Following firms have applied for registration of drug as they failed to apply for renewal of

registration in time:-

M/s. Ambrosia Pharmaceuticals, Islamabad

S.

No.

Reg.

No.

Name of Drugs with

composition

Date of

Initial Reg.

Renewal

Application

Due Date

Application

Receiving

Date for

Re-Reg.

Documents

Provided

by the firm

1. 035357 Ambrocillin 250mg

Tablets


Amoxicillin (as

Trihydrate)…….250mg

18-12-2004 17-12-2009 17-10-2012 (i). Form-5

(ii). Initial

Reg. Letter

(iii). CRF

NOC

(iv). Fee

Rs.20,000/-

2. 035358 Ambrocillin 500mg

Tablets


Amoxicillin (as

Trihydrate)…….500mg

-do- -do- -do- -do-

3. 041411 Micozole N Ointment

Contains:-

Miconazole

Nitrate……………2%

04-10-2005 03-10-2010 -do- -do-

4. 041412 Isozole Vag Cream

Contains:-

Isoconazole

Nitrate…………..1%

-do- -do- -do- -do-

5. 041414 Sexatin N Cream

Each gm cream

contains:-

Bufexamac………50mg

Neomycin

Sulphate……….2500IU

Nystatin……100,000IU

-do- -do- -do- -do-

374

6. 042917 Monorate Ointment

Contains:-

Mometasone

Furoate…….0.1% w/w

-do- -do-

M/s. Woodward Pakistan (Private) LTD., Karachi.

S.

No.

Reg.

No.

Name of Drugs with

composition

Date of

Initial Reg.

Renewal

Application

Due Date

Application

Receiving

Date for

Re-Reg.

Documents

Provided

by the firm

1. 055717 Bactizith 500mg Capsule


Azithromycin (as

Dihydrate)……..500mg

(USP Specification)

07-04-2009 06-04-2014 24-06-2014 (i). Form-5

(ii). Initial

Reg. Letter

(iii). Fee

Rs.20,000/-

M/s. Macter International Limited, Karachi.

S.

No.

Reg.

No.

Name of Drugs with

composition

Date of

Initial Reg.

Renewal

Application

Due Date

Application

Receiving

Date for

Re-Reg.

Documents

Provided

by the firm

1. 000483 Genticyn HC Cream

Each gm contains:-

Gentamicin Sulphate

Hydrocotisone Acetate

06.9.2006 05.9.2011 24-11-2014 (i). Form-5

(ii). Initial

Reg. Letter

(iii). CRF

NOC

(iv). Fee

Rs.20,000/-

2. 010186 Genticyn B Cream

Each gm contains:-

Gentamicin Sulphate

Betamethasone Valerate

-do- -do- -do- -do-

3. 007701 Multigesic Cream

Each gm contains:-

Diethylamine Salicylate

-do- -do- -do- -do-

4. 000497 Genticyn Cream

Each gm contains:-

Gentamicin Sulphate

-do-

-do- -do- -do-

Decision: Registration Board decided to defer the case till opinion of stake holders in the

matter as decided in Item No. IV(c).

375

Item No. VII Registration of Biological Drugs – Biological Evaluation & Research Division

Case No. 01. Expert Committee for Biological Drugs

The Drug Registration Board in its 241st Meeting decided to strength the expert

committees on biological drugs for the technical evaluation of biological drugs. The earlier

committee was not functional due to resignation of 01 member and absence of another member

due to tour abroad. The proposal of constitutions of new expert committees on biological drugs

was floated with draft notifications for separate expert committees for human and veterinary

biological drugs and were processed as per law with the approval of Federal Government.

However, the Law, Justice and Human Rights Divisions raised certain queries/ legal aspects

regarding composition of committees and role of secretariat officers in the committees, which

needed to be rectified before the notifications are finalized. The notifications were re-visited and

necessary amendments were made in consultation with the Law, Justice and Human Rights

Division. The process of official notification of expert committees is in final stages. However,

due to non functional ECBD, no fresh cases can be placed before the Registration Board.

However, miscellaneous cases of already registered biological drugs are placed before the Board

for its consideration in this meeting.

Decision: Registration Board noted the information.

Case No. 02. Change of manufacturing site for already registered drugs of M/s. R.G.

Pharmaceutica (Pvt), Ltd., Karachi.

M/s R.G. Pharmaceutica (Pvt) Ltd., Karachi has submitted the following

applications for change in manufacturing site of their already registered drugs;

S.# Product &

Registration No.

Existing Manufacturing

site

New Manufacturing Site

1. Ferti-C 5000IU

Chorionic

gonadotrophin for

Injection

(Reg. No070931)

Livzon (Group)

Pharmaceutical Zhohai,

Guangdong, China

Livzon (Group) Pharmaceutical

Factory.

Address: No.38, Chuangye Road

North, Liangang Industrial Zone,

Zhuhai, Guangdong, China.

2. Ferti-C 1000IU

Chorionic

gonadotrophin for

Injection

Livzon (Group)


Guangdong, China


Factory.



376

(Reg. No 070930) Zhuhai, Guangdong, China.

3. Ferti-M 150IU

Menotropin for

Injection

(Reg. No 070929)

Livzon (Group)


Guangdong, China


Factory.




4. Ferti-M 75IU

Menotropin for

Injection

(Reg. No 070928)

Livzon (Group)

Pharmaceutical,

Zhohai, Guangdong,

China


Factory.




As per SOP defined by the Drug Registration Board in its 240th

Meeting, the firm has

provided following documents;

1. Application with required fee as per SRO (Rs.100, 000/- per product).

2. Copy of registration letter and last renewal status.

3. NOC for CRF clearance (Not required for Importer)

4. Original legalized CoPP, having address of new manufacturing site.

The source is from China, which falls under category, where the inspection abroad is mandatory.

Decision: Registration Board approved the request of the firm. Inspection of the foreign

manufacturer shall be conducted as per Import Policy. The Board authorized its Chairman

for issuance of letter for change in manufacturing site on the recommendation of inspection

report if it is of recommendation. If inspection report is of not recommendation, then case

will be placed before Registration Board.

Case No. 03. Request for change of importer and manufacturing site for already

registered drugs by m/s. Avior Pharmaceuticals (Pvt) Ltd., Karachi.

M/s. Avior Pharmaceuticals (Pvt) Ltd., Karachi has submitted applications for transfer of

products from M/s Global Pharmaceuticals (Pvt) Ltd. The firm has also informed that the

manufacturing site is also changed by the foreign principal. The details are as under: -

S.# Product &

Registration No.

Existing

Manufacturing site

New Manufacturing Site

1. Tropin 2000iu Inj


Recombinant Human

Erythropoietin

2000iu

M/s Harbin

Pharmaceutical Group

of Bioengineering Co.

Ltd., Harbin China

M/s Harbin Pharmaceutical Group

Bioengineering Co., Ltd., No.99

Zhuhai Road Limin Development

Zone Hulan District, Harbin,

Heilongjiang Province, P.R. of

377

Reg No. 062218 China

2. Tropin 4000iu Inj


Recombinant Human

Erythropoietin

4000iu

Reg No. 62219

M/s Harbin



Ltd. China






China

Tropin 6000iu Inj


Recombinant Human

Erythropoietin

6000iu

Reg No.066152

M/s Harbin



Ltd. China






China

4. Auspogen 300ug per

vial

Recombinant Human

G.CSF

Reg No. 062217

M/s Harbin



Ltd. China






China

5. Refron 3 MIU Inj

Each vial contains

Recombinant Human

Interferon Alpha 2b

3MIU

Reg No. 047665

M/s Harbin



Ltd. China






China

M/s Avior Pharmaceuticals (Pvt) Ltd, Karachi has provided following documents as per SOP

defined by the Drug Registration Board in its 240th

Meeting;

i) Application on Form 5 A along with fee as defined under SRO (Rs.

100,000 per product).

ii) Copy of registration letters and last renewal status.

iii) NOC for CRF clearance (Not applicable to importers)

iv) Termination letter (Original) of previous importer M/s. Global

Pharmaceuticals (Pvt) Ltd

v) Authority letter/sole agent letter (original) from manufacturer in favour of

M/s Avior Pharmaceuticals (Pvt) Karachi.

vi) No objection letter from Global Pharmaceuticals in favor of M/s. Avior

Pharmaceuticals for transfer of Registration.

vii) Original and legalized CoPP of all above products.

viii) Site Master file.

The source is from China, which falls under category, where the inspection abroad is

mandatory. The case is placed before the Board for its decision.

378






Case No. 04. Change of manufacturing site for already registered drugs of M/s.

Pharmaevo (Pvt) Ltd, Karachi.

M/s. PharmaEvo (Pvt) Ltd., Karachi has submitted application for change of

manufacturing site of their already registered drugs. The details are as under: -

Product / Registration

No.

Previous Name of

Manufacturing Site

New Name of Manufacturing

site

EPOSINO 4000IU/ML

Each pre-filled syringe

contains: -

Recombinant Human

Erythropoietin…4000IU

(Reg No. 045690)

Sandong Kexing

Bioproducts Co., Ltd.,

China

Shandong Kexing Bioproducts

Co., Ltd. No.2666, Chuangye

Road, Mingshui development

Zone, Zhangqiu, Shandong,

China.

EPOSINO 2000IU/ML

Each pre-filled syringe

contains: -

Recombinant Human

Erythropoietin…2000IU

Erythropoietin

Reg No. (045689)

Sandong Kexing

Bioproducts Co., Ltd.,

China

Shandong Kexing Bioproducts

Co., Ltd. No.2666, Chuangye

Road, Mingshui development

Zone, Zhangqiu, Shandong,

China.

M/s PharmaEvo (Pvt) Ltd, Karachi has provided following documents to support their request as

per SOP decided by the DRB in its 240th

Meeting:-



3. NOC for CRF clearance.

4. Original legalized CoPP for new manufacturing site.

5. Site Master file

The source is from China, which falls under category, where the inspection abroad is

mandatory. The case is placed before the Board for its decision.

379






Case No. 05. Change of manufacturing site for already registered drugs by M/s. Roche

Pakistan, Ltd, Karachi.

M/s. Roche Pakistan Ltd., Karachi has submitted application for change of manufacturing

site. The details are as under: -

Product / Registration

No.

Previous Name of

Manufacturing Site

New Name of Manufacturing

site

Avastin 100mg/4ml

injection

Each ml contains:

Bevacizumab 25mg

Reg No. 043004

M/s F. Hoffmann- La

Roche Ltd., Basel,

Switzerland

M/s F. Hoffmann La-Roche Ltd.,

Wurmisweg 4303, Kaiseraugst,

Switzerland.

Avastin 400mg/16ml

injection

Each ml contains:

Bevacizumab 25mg

Reg No. 043005

M/s F. Hoffmann- La

Roche Ltd., Basel,

Switzerland

M/s F. Hoffmann La-Roche Ltd.,

Wurmisweg 4303, Kaiseraugst,

Switzerland.

M/s Roche Pakistan Ltd, Karachi has provided following documents to support their claim:-

1. Application on Form 5-A with required fee as per SRO (Rs.50, 000/- per product).



4. Original CoPP provided for new manufacturing site, however the CoPP is not

notarized and legalized from Embassy of Pakistan

5. Site Master file

The drugs is used for Matastatic Carcinoma of the Colon are rectum breast cancer and other

types of cancers. The site falls under category of Stringent Regulatory Authorities. It is proposed

that the request of the firm may be approved with condition that change of site letter shall be

issued after submission of legalized CoPP through permission from Chairman Registration

Board.

Decision: Registration Board approved request of the firm. The firm will provide legalized

CoPP of the product and authorized its Chairman for issuance of letter in light of Import

Policy for Finished Drugs.

380

Case No. 06. Request for exemption of printing of registration and MRP on vial M/s.

Popular International (Pvt) Limited, Karachi

M/s Popular International (Pvt) Ltd., Karachi has submitted the following requests for

exemption of printing of Registration Number & MRP on inner vials as exemption for Urdu

Version granted to them vide letter No. F.1-19/95-Reg-I (Pt) dated 11th

July, 2007. The firm has

informed that their principal print lot number, date of manufacturing and date of expiry on each

vial and outer box and finally print registration number on each box before shipment whereas

MRP is printed locally by us on outer box. However due to limited space on the inner vial the

principal cannot print registration and MRP. Further the company has informed that laser

printing may denature the products. The details of their request are as under: -

S.# Product Name Registration

No.

Generic Name

1. KOATE – DVI 007965 Antihemophilic Factor –

VIII(Human)

2. HyperRAB S/D 007972 Rabies Immune Globulin

(Human)

3. HyperHEP B S/D 012835 &

007971

Hepatitis B Immune Globulin

(Human)

4. PLASBUMIN

UMAN

ALBUMIN

007967

059249

Albumin (human)

5. IMMUNORHO 059296

059297

Rho (D) Immune Globulin

(Human)

6. GAMMARAAS 031350 Intravenous Immune Globulin

(Human)

Decision: Registration Board decided to call firm,s representative in its forthcoming

meeting for presentation of their case along with labeling/ printing status/ evidence of

similar products available in the market.

381

Case No. 07 Request for additional pack size by M/s. Snam Pharma, Lahore

M/s Snam Pharma, Lahore has requested to approve additional pack against their

already registered products. The firm has deposited an amount of Rs.5,000/- as prescribed fee for

each product. The detail is as under with justification: -

S.# Product Name Regn

No.

Existing

pack size

Additional

Pack

Justification

1. Biocan R Injection ad

us vet

057167 10x5ml.

5x20ml

(1m1)x20

single dose

The single dose of Biocan R is

necessary as it will be used in

single dog vaccination, and it is

demanded by the market.

2. Ornipet lyof.ad.us.vet 059171 200doses.

500 doses.

1000 doses.

2500 doses.

10x200 doses

10x500 doses

10x1000

doses

10x2500

doses

5000 x 10

doses

Large dose pack size in poultry is

convenient in the large poultry

formers and dose of 5000 bird

packing is demanded by the

market.

3. Ornibron

lyof.ad.us.vet

057169 10x200 doses

10x500 doses

10x100 doses

10x2500

doses

5000 x 10

doses



formers and dose of 5000 bird


market.

4. Orniprim

lyof.ad.us.vet

057170 10x200 doses

10x500 doses

10x100 doses

10x2500

doses

5000 x 10

doses



farmers and dose of 5000 bird


market.

5. Ornibur intermediate

lyof.ad.us.vet

059172 500 doses

1000 doses

1000 doses

2000 doses

5000 doses

10x500 doses

10x1000

2500 x 10

doses.



farmers and dose of 2500 bird


market.

382

doses

10x2000

doses

10x5000

doses

Decision: Registration Board deferred the request and advised the firm to provide legalized

CoPP of the product for confirmation of availability of applied packs.

Case No. 08 Request for additional pack size by M/s Marush (Pvt) Ltd, Lahore

M/s Marush (Pvt) Ltd, Lahore with the request to approve additional pack against

their already registered products. The firm has deposited an amount of Rs.5,000/- prescribed fee.

The detail is as under with justification: -

S.# Product Name Regn

No.

Existing

pack size

Additional Pack Justification

1. CEVAC

TRANSMUNE

IBD VACCINE

039910 1000 doses. 2000 vial

4000 vial

8000 vial

More recently market trends

and demand of formers have

changed due to initiation of

multiple large sized

commercial farms and

integrated units which,

demands medium and

bigger packs keeping in

view their convenience and

economy in usage.

To demonstrate the benefits

for users regarding

introduction of additional

packs a detailed study as per

DRA’s format.

Decision: Registration Board deferred the request and advised the firm to provide legalized

CoPP of the product for confirmation of availability of applied packs.

383

Case No. 09 Withdrawal of applications for registration of finished drugs by M/s. Sami

Pharmaceuticals, Karachi.

M/s Sami Pharmaceuticals (Pvt) Ltd, Karachi has requested for surrender of

applications for registration of finished drugs to be imported from M/s Xiamen Amoytop Biotech

Co. Ltd, Xiamen, Fujian, P.R. China. These drugs were considered favourable in meeting No. M-

225 dated 15.05.2010 and registration for the same were to be granted after satisfactory

inspection of the manufacturer’s facility abroad which could not be done till to date. However,

the firm was voluntarily withdrawn these long outstanding applications and will have no

objection if registrations for the same are granted either to M/s Xiamen Amoytop Biotech Co.

Ltd and/or to any other party so authorized by them. The details of withdrawn applications are

as under: -

Sl.# Name of company Drug name with

composition

MRP Shelf life Remarks

1. M/s Sami

Pharmaceutical(Pvt)

Ltd, Karachi./M/s

Xiamen Amoytop

Biotech Co., Ltd.,

Xiamen, Fujian,

P.R. China

Relkin 1.5mg Injection


Oprelvekin Recombinant

Human Interleukin-11

(rHulL-11)…..1.5mg

(Immunostimulants)

As per latest

decision

taken by

PAC

24 months Approved

2. M/s Sami

Pharmaceutical(Pvt)

Ltd, Karachi./M/s

Xiamen Amoytop

Biotech Co., Ltd.,

Xiamen, Fujian,

P.R. China

Relkin 3mg Injection


Oprelvekin Recombinant

Human Interleukin-11

(rHulL-11)…..3mg

(immunostimulants)

As per latest

decision

taken by

PAC

24 months Approved

Decision: The request of the firm was acceded to and the Board rejected the above

registration applications.

384

Case No. 10 Grant of registration of solution for injection - M/s. Macter International

Limited, Karachi

M/s. Macter International Limited, Karachi has requested for registration of

solution for injection for local manufacturing. The firm has deposited an amount of Rs. 50,000/-.

The composition detail is as under: -

Name of Company Raw Material Quantity/0.6Ml

M/s Macter International

Limited, Karachi

Sodium Chloride 3mg

Glycine 0.225mg

Polysorbate 80 0.06mg

Water for Injection Qs to 0.6mL

The solvent is required to be co-packed with the product free of cost. The case of manufacturing

of locally manufactured biological product was decided in the 244th

Meeting of the Drug

Registration Board including lyophilized pegylated interferon products of the company which is

under implementation process.

Request of the company for grant of registration of solvent is submitted for the approval of

Registration Board.

Decision: The request of the firm for grant of registration of solvent was approved.

Case No. 11. Change of manufacturing site for already registered drugs by M/s. Hospital

Services & Sales, Karachi and change of brand name.

M/s Hospital Services & Sales, Karachi has submitted the applications for change of

manufacture site and brand name of their already registered vaccine for below mentioned

product;

Sl.No. Reg.

No.

Previous Brand

Name and

composition.

Proposed Brand

Name

Existing

Manufacturing

Site

New proposed

manufacturing

site

1. 053813 EASYFIVE –

Pentavalent

Vaccine

Each dose 0.5ml

contains: -

Diphtheria

Toxoid: 20Lf

(30IU)

Tetanus Toxoid:

EASYFIVE – TT

Pentavalent Vaccine

Each dose 0.5ml

contains: -

Diphtheria Toxoid:

20Lf (30IU)

Tetanus Toxoid:

7.5Lf(40IU in guinea

pig and 60 IU in

M/s. Panacea

Biotech Ltd.,

New Delhi,

India.

M/s. Panacea

Biotech Limited,

Malpur, Baddi,

Distt. Solan

(H.P.) 173 205,

Inda.

385

7.5Lf(40IU in

guinea pig and

60 IU in mice)

Pertussis

Vaccine: 12OU

(4IU)

r-Hepatitis B

surface antigen

(HBsAg):

10mcg

Haemophilus

type b conjugate

vaccine: 10mcg.

mice)

Pertussis Vaccine:

12OU (4IU)

r-Hepatitis B surface

antigen (HBsAg):

10mcg

Haemophilus type b

conjugate vaccine:

10mcg.

M/s Hospital Services & Sales, Karachi has provided following documents to support their

request:-

1. Application on Form 5-A with required fee as per SRO (Rs.100, 000/- per

product).



4. Original CoPP provided for new manufacturing site.

5. Site Master file

6. The firm has also provided evidence of WHO prequalification of EASYFIVE –

TT vaccine.

Decision: Request of the firm for grant of registration of solvent exclusively to be used with

EASYFIVE – Pentavalent Vaccine, Regn No. 053813 was approved.

Case No. 12. Case of import of interferon from Cuba instead of China by M/s. Macter

International (Pvt) Ltd., Karachi.

The case was discussed in the 244th

Meeting of Drug Registration Board. The decision of the

case was as below:

Decision: Registration Board discussed the matter in detail and advised

investigation officer to further clarify following points:

a) On which documents the firm obtained clearance of Heberon Alfa R-2-

b Registration No.047675 from DRAP, Karachi along with dates of

invoice, airway bill/BL, LC date and other relevant information.

b) After grant of approval of change of source, what is legal status of

renewal application submitted by the firm from previous source?

c) What is the status of recall of stocks, the legal course of

holding/restricting the stocks from sale was followed or otherwise,

after “not to dispose of order” on Form-1 dated 28.10.2013?

386

The decision of the Board was communicated to DDG (E&M) with request to clarify the points

raised by the Drug Registration Board. In response to Directorate of Biological’s letter dated 5th

November, 2014. The Deputy Director General (E&M), DRAP, Karachi has stated that.

a) The documents on which the firm obtained clearance of Heberon Alpha R 2-b,

Registration No. 047675 from DRAP, Karachi are follows: -

i. Attested invoices.

ii. Copy of Airway bill/Bill of lading.

iii. Copy of L.C. dated 23.05.2013 as swift of M/s. Meezan Bank, Karachi

Pakistan.

b) The lyophilized source from Cuba; Product name: Heberon Alpha 3MIU injection

(interferon Alpha 2b3 MIU) Registration No. 022820 vide letter No.F. 3-6/98-Reg-II

(M-137).

2. The liquid source from china product name: Heberon Alpha 3 MIU (Interferon R 2-b

3MIU) Registration No. 047675 vide letter No.F.3-1/2008-Reg-I (M-212).

3. The legal status with justification as I understand is the change of dosage form for

another Registration No.047675 which becomes legal as source was changed only for

Registration No. 047675 of the same product. The first source relates to the Heberon Alpha

3MIU (Interferon R 2-b 3MIU) (Registration No. 022820) but the change of source from Cuba to

China is for Heberon Alpha 3MIU (Inteferon R 2-b 3MIU) (Registration No. 047675) in liquid

form. T he former dosage form was lyophilized. Hence, it is concluded that M/s. Changchun

Heber Biological Technology Co. Ltd., China is the sister concern of M/s. Heber Biotech S.A.

La Havana, Cuba the basic approved site and the product release authority of both the sources

Cuba and China is same. Hence, there is no product Safety, Quality, Efficacy and Economic

value related issued found. As the lot was released by NCLB, Islamabad also the importer (M/s.

Macter International Pvt. Ltd.) applied for the renewal of the said product on form 5-B of the

rule 26 of the Drug renewal for registration on 18.07.2013 and also deposited the required fee

under SRO 1117(I)/2012 which is pending with RRR section, DRAP. Therefore there is no harm

to allow them to market the aforesaid lot in favour of the importer in public interest so required

as protected under rule 27 of the Drugs (Licensing, Registering & Advertising) Rules, 1976

(copies of both the application for registration renewal are enclosed.

As far as the grant of approval of change of source is also valid under rule 26 of

the Drugs renewal for registration dosage form of which is physically different as described

387

above. On the other hand, the legal status of renewal application submitted by the firm from

previous source is also legal as there is no legal embargo if the previous source is rejuvenated by

the applicant that is valid under SRO 145(I)/1976 if pending with the board concerned and

1117(i)/2012.

(i) The status of recall of stocks is laying hold in the cold storage area of the

importer.

(ii) The legal course of holding/restriction of the stocks were followed by the

firm. Through, they are now not bound to sell after the expiration of the

period of the order on Form-I dated 28.10.2013 which is only for the

period of 14 days by the undersigned.

Conclusion:

After having sufficient documents evidences for both the sources of same product, having

different registration for different sources and renewal also pending though applied well in time

under rules, suffice the need of legal protection to import from the either source being the

custodian of two registrations originally and subsequently renewed as per law enacted under

condition of registration under Drug Act 1976.

The intention of the importer depicts that the change of source of one registration from Cuba to

China is positive for the adequate / free availability of life saving drugs in public interest.

Concluding all pros and corns of this investigation the contention and intention of the importer

was found positive professional approach and no evidence was found to contravene the Drugs

Act 1976 and rules prevails thereunder.

Hence the DDG (E&M) has recommended to allow the importer M/s Macter International (Pvt)

LTd, to make this life saving drug available and restriction as imposed after lot release may also

be withdrawn.

Decision: Registration Board discussed that the firm has violated the Drug Act, 1976

and rules framed there under and decided to issue show cause notice to the company, as

why not the consignment be re-exported or legal action be taken as per procedure, after

giving opportunity of personal hearing to the firm in the next meeting.

388

Case No. 13. Import of Insulatard Penfill Syringe from the previous source by M/s Novo

Nordisk Pharma (Pvt ) , Cl i f ton Karachi .

The case of the firm was discussed in 244th

Meeting of Drug Registration Board. The

case details are as below: -

M/s Novo Nardisk has applied for the change of source of their registered product

namely Insulatard Penfill 100iu/ml 5x3ml (Registration No.010341). The decision of the

Registration Board in its 242nd

meeting is as follows: -

S.No. Product &

Regn.No.

API

Manufacture

Site

Existing

secondary

packaged

import site

Proposed

secondary

packaged

import site

1 Insulatard

Penfill ®

100 IU/ml 5x3

ml

(R.No. 010341)

Novo

Nordisk A/S

Novo Alle

DK-2880

Bagsvaerd

Denmark

Novo Nordisk

A/S

Novo Alle

DK-2880

Bagsvaerd

Denmark

Novo Nordisk

Production S.A.S.

5 bis, rue Edmond

Poillot

28000 Chartres

France

Past Decision: The Board approved the new EMA approved site mentioned above for import

of the above mentioned products subject to COPP from new site.

Accordingly the change of source letter was issued to the firm on 7th

April, 2014 clearly

mentioning that the previous source of import stands cancelled. The Assistant Drugs Controller,

Karachi has informed that M/s Novo Nordisk, Karachi has imported Insulatard Penfil 100IU/M

(Reg NO. 010341) from Denmark on 20th

May, 2014 which is the earlier source of import. The

ADC, Karachi was requested to submit complete case along with his recommendations. The

ADC Karachi has stated that he is of the opinion to revoke the orders of sales restrictions as the

safety, quality and economic value of drug in question. The officer has also stated that sale of the

drug may be allowed in the public interest so required.

It is submitted that the source of import was cancelled by the Drug Registration Board vide letter

No. 2-1/2014-DDC (BD)(M-242), dated 7th

April, 2014. Under section 23 subsection 1(a) (vii)

“no person shall himself or by any other person on his behalf export, import or manufacture for

sale or sell any drug which is not registered or is not in accordance with the conditions of

registration”. The firm has violated the Drugs Act, 1976.

The case of the firm was decided as under: -

389

“DECISION: Registration Board approved request of the firm. However the

Board advised firm to provide/submit copy of L/C (original or duly certified) for

establishing the fact that the import order was placed well before the date of

grant of change of manufacture site by DRAP and authorized its Chairman for

permission to issue the letter for sale of drug”.

The firm was asked to provide the documents as per decision of the Drug Registration Board,

however, the company has provided following documents: -

i) Signed distribution Agreement between Novo Nordisk A/S Novo Alle

2880 Bagsveard Denmark and Novo Nordisk Pharma (Pvt) Ltd, 113,

Shahrah-e-Iran, Mian Clifton Karachi by indicating that in place of L/C

the term of payment is 360 days from the date of invoice, which is also

mentioned on custom invoice.

ii) Customs Invoice.

The firm informed that they have not established L/C as per their own system. The case was

submitted to the Chairman Registration Board for decision. The Chairman has desired to place

the case before the Drug Registration Board for decision.

Decision: Registration Board discussed that the firm has violated the Drug Act, 1976

and rules framed there under and decided to issue show cause notice to the company for

not providing the copy of L/C with opportunity of personal hearing, as per procedure of

Drug Registration Board.

Case No. 14. Deferred case of 241st

meeting for Poulvac ® SE Vaccine by M/s. Hi-tech

Pharmaceutical, Lahore.

The following case of M/s. Hi-Tech Pharmaceutical, Lahore was deferred in 241st Meeting of Drug

Registration Board reasons mentioned in the last column below: -

Sl.# Applicant Name and Specs ECBD Committee

Recommendation

Decision

6. M/s Hi-Tech

Pharmaceutical,

Lahore

Manufactured

by:

M/s Pfizer

Animal Health

(Pfizer Inc),

Poulvac ® SE

Vaccine

Each 0.5ml dose

contains: -

Salmonella enteritidis

Phase Type

4….RP…> 1.0/dose at

release.

Recomme

nded

More data is

required

Deferred

for

clarification

from the

application

regarding

use of

formalin

390

2000 Rockford

Road, Charles

City, Iova, USA

Salmoella enteritidis

Phase Type

8…RP….>1.0/dose at

release.

Salmonella enteritidis

Phase Type

13a…RP…> 1.0/dose

at release 37%

Formaldehyde.

Solution…..0.0006ml

White oil….0.1995ml

Arlacel-83…0.1105ml

Tween-

80…0.001105ml

Saline….q.s to 0.3ml

(For Veterinary Use)

concentrati

on and

review by

already

constituted

committee

and

veterinary

expert of

ECBD.

The firm has submitted application to Animal Husbandry Commissioner Dr. Qurban Ali and

submitted clarification to Director Biological Drugs, DRAP, Islamabad. Clarification submitted to

DRAP and comments of Animal Husbandry Commissioner are tabulated below: -

Clarification submitted by the firm to DRAP Comments of Animal Husbandry

Commissioner

For inactivation, formalin is added to the

total volume of the bacterial suspension,

not over 1%

Source of formalin brand used holds 37%

formaldehyde solution, of this 37%

branded formaldehyde stock solution,

maximum upto 1% of formalin is used in

total volume of the bacterial suspension.

Dose of Poulvac SE is 0.3mL/bird and

each dose contains 0.0006mL i.e. 0.2% of

37% formaldehyde solution.

“Formalin is used to produce inactive bacterial

vaccines. For this purpose, 37% formalindehyde

gas is added to water to produce reagent

commonly known as formaline, which is then

used in a very small concentration (as is used in

the subject product “Poulvac SE” at the rate of

1% to the total volume of bacterial suspension).

Therefore, 37% formaldehyde solution or

formalin at the rate of 1% is part of normal

procedure to produce such inactivated vaccines”.

Decision: Registration Board referred the case to Expert Committee on Biological Drugs

(Vet) for its consideration.

391

Case No. 15. Change of manufacturing site for already registered drugs of M/s. Pfizer

Pakistan, Karachi.

M/s Pfizer Pakistan, Karachi had submitted the following application along with

prescribed Fee Rs. 50,000/- for the product as well as CoPP from new manufacturing site. The

details are as under: -

S.# Product &

Registration No.

Existing

Manufacturing site

New Manufacturing

Site

1. Prevenar 13

Suspension for

injection

(Reg # 066110)

Baxter Pharmaceutical

Solutions LLC 927

South City Curry Pike,

Bloomington IN, USA

Pfizer Ireland

Pharmaceuticals

Grange Castle

Business Park,

Clondalkin, Dublin 22

Ireland.

M/s Pfizer Pakistan Ltd, Karachi has provided following documents to support their claim:-

1. Application with required fee as per SRO (Rs.50, 000/- per product) being the

innovative.




5. GMP of manufacturing site.

6. Site Master file

Decision: The request of the company was acceded by the Board as per CoPP issued by the

EMA.

Case No. 16

M/s Novo Nordisk, Karachi had requested for registration of Histidine solvent in

Prefilled Syringe for already registered drugs NovoSeven 50KIU (1mg) Powder for solution for

Injection (Reg No. 066157) each vial contains: Eptacog alfa (activated)1mg and NovoSeven

100KIU (2mg) Powder for Solution for Injection (Reg No. 66158) alongwith Hisitidine 2ml each

vial contains Eptacog alfa (Activated) 2mg. The firm has deposited an amount of Rs. 50,000/- for

each product. The composition detail is as under: -

Name of Company Raw Material Quantity/0.6mL

Novo Nordisk, Karachi Powder and solvent 01mg/vial

392

for solution for

injection

(50KIU/vial)

Novo Nordisk, Karachi Powder and solvent

for injection for

injection

02mg/vial

(1000KIU/vial

Decision: Registration Board deferred the case for confirmation of status of solvent in

CoPP.

Case No. 17. Extension in exemption for the biological drugs imported from M/s Ferring

Germany.

Atco Laboratories Limited, Karachi have submitted that they are importing

following Biological drugs from M/s Ferring Pharmaceutical, Germany since 1994 that are in the

process of shifting their manufacturing facility and it would not be possible for them during this

period to incorporate all requirements according to their local labeling rules on the packaging

material. As these products are rare/ already in the market and patient needs them, therefore, M/s

Atco Laboratories Limited, Karachi has requested for extension in exemption in Labeling and

Packing Rules for the Biological Imported Drugs for at least twenty months are more: -

Sl. # Reg.

No.

Name of

Drug(s)

Exemption requested Quantity

1. 016110 Decapeptyl

0.1mg injection

i) Generic Name not in bracket.

ii) Drug registration number to be printed

locally.

iii) MRP to be printed locally.

iv) Urdu instruction to be printed locally.

v) Pharmaceutical specification.

vi)

924 units.

2. 016111 Decapeptyl

3.75mg

injection

-do- 2638 units.

3. 032143 Menogon

Injection

-do- 6106 units.

4. 016153 Glypressin 1mg

Injection

-do- 3438 units.

This case has been discussed in 243 Meeting of Drug Registration Board and deferred for

confirmation of pharmacological group. The firm has provided the pharmacological group as per

following details: -

393

Sl. # Product name Generic Name Pharmacological Group

1. Decapeptyl 0.1mg injection Triptorelin Acetate Eq.

to 95.6UG

Triptorelin/ml

Triptorelin is synthetic form

of Gonaderelin. Triptorelin

causes an increase in the

amount of FSH and LH

release from the Pituitary

gland.

2. Decapeptyl 3.75mg injection Triptorelin Acetate

Corresponding to

3.75mg/Single Dose

Triptorelin is synthetic form

of Gonaderelin. Triptorelin

causes an increase in the

amount of FSH and LH

release from the Pituitary

gland.

3. Menogon Injection Menotrophin 75IU Gonadotrophic Hormone

(used in infertility).

4. Glypressin 1mg Injection 1mg Terlipressin

Acetate Pentahydrate

In 11mg Dry Substance

Terlinpressin is an analog of

vasopressin used for Bleeding

of esophageal varices, spactic

shock and hepato-renal

syndrome.

Decision: Registration Board acceded to the request of the firm for relaxation for the

Urdu version at the time of import for the products referred above subject to local printing

at the licensed premises of M/s. Atco Laboratories Ltd. Karachi for one year. The firm will

comply with all the rest of conditions as per rules for labeling, before importing to

Pakistan.

Case No. 18. Change of manufacturing name for already registered drug of M/s. Allmed

Laboratories, Karachi

M/s Allmed Laboratories, Karachi has submitted the following application for change of

name of manufacturer along with CoPP from new manufacturer as well as fee of Rs. 50,000. The

detail is as under: -

S.# Product &

Registration No.

Existing name of

manufacturer

New Manufacturer

name

1. ATG – Fresenius S

Concentrate for

solution for

infusion.

Each ml contains:-

Rabbit

M/s Fresenius Biotech

GmbH Germany

M/s Neovii Biotech

GmbH, AM Haag 6-7,

82166 Grafelfing

Germany,

394

Immunoglobulin

20mg

(Reg No. 033134)

M/s Allmed Laboratories, Ltd, Karachi has provided following documents to support their

claim:-





Decision: The request of the firm was approved as per CoPP provided by the firm.

Case No. 19. Change of name of manufacturing site for already registered drug of M/s.

Wyeth Pakistan Limited, Karachi.

M/s Wyeth Pakistan Limited, Karachi has submitted the following application for change of

name of manufacture site for their already registered product along with copy of CoPP from new

manufacturer as well as fee of Rs. 100,000/-. The detail is as under: -

S.# Product &

Registration No.

Existing name of

manufacturer

New Manufacturer

name

1. Premarin 0.3mg

tablet Conjugated

Estropgens USP

(Desiccated with

Lactose at

4.29%)…0.3mg.

M/s. Wyeth Medica

Ireland

Little Connell New

bridge Country Kildare,

Ireland

Pfizer Ireland

Pharmaceuticals

Little Connell New

Bridge Country

Kildare, Ireland.

1. Application with required fee as per SRO (Rs.100,000/- per product).



4. Original legalized CoPP for new name of manufacturer.

5. GMP of manufacturing site.

6. Site Master file

Decision: The request of the company was approved as per CoPP.

Case No. 20. Extension in shelf life of Poliomyelitis Vaccine of M/s. Hospital Services &

Sales, Karachi.

395

M/s. Hospital Services & Sales, Karachi has submitted the following application for

extension in shelf life of already registered drug from 24 months to 36 months: -

Sl.

No.

Name of Drug with Registration No. Existing Shelf Life Demanded Shelf Life

1. Poliomyelitis Vaccines Inactivated,

Suspension for Injection 0.5ml

vial/dose (IM/SC)

24 months (02 years) 36 months (03 years)

The firm has submitted for following documents: -

a. Application on Form 5A with required fee as per relevant SRO (Rs. 5000/-).

b. Copy of registration letter and last renewal status.

c. NOC for CRF clearance (not required in case of importer).

d. Justification for proposed change.

e. Approval of regulatory body of country of origin / Original and legalized

Certificate of Pharmaceutical Product as per WHO format indicating shelf life 36

months.

f. Free sale certificate and GMP certificate

g. Stability studies for product 2-80C.

h. The firm has also provided WHO prequalification evidence indicating the shelf

life from 24month to 36 month at 2-80C.

Usually extension of shelf life case is placed before the Drug Registration Board after

getting the experts opinion from different experts. However considering the polio emergency in

the country and WHO prequalified data of the said drug, the case is placed before the board for a

decision.

Decision: The request of the firm was approved. WHO status shall be checked from

WHO website before issuance of letter to the company. It shall also be mentioned in the

registration letter that incase of any change in WHO status, the company shall immediately

report to the Board and decision of the Board shall stand cancelled.

396

Case No. 21. Local manufacturing of Allergen vaccines by M/s. Pakcure Pharma, Rawat.

The case of manufacturing of Allergen vaccines by M/s. Pakcure Pharma, Rawat was

under consideration of Board. The following products were discussed in different meetings of the

Board.

Applicant Product specifications Registration No. of

similar product

already in the

market as

manufactured by

NIH, Islamabad

Decision

M/s Pakcure

Pharma, Rawat,

Islamabad.

Allergex-MP

Each ml contains:

Beef protein extract…….10mcg

Chicken protein extract. 10mcg

Egg protein

extract……...10mcg

Fish protein

extract……..10mcg

Mutton protein extract..10mcg

Shelf Life: 6 months when

stored at +2 to +8˚C

Allergy vaccine,

immunostimulant

016742 Deferred for

Product specific

inspection by the

panel.

M/s Pakcure

Pharma, Rawat,

Islamabad.

Allergex-Px1

Each ml contains:

Cannabis sativa protein extract

10mcg

Acacia niloticaa protein extract

10mcg

Eucalyptus globulus protein

extract 10mcg

Pininus longfolia protein

extract 10mcg

House dust extract 10mcg



Allergy vaccine,

immunostimulant

-do- Deferred for

Product specific

inspection by the

panel.

397

M/s Pakcure

Pharma, Rawat,

Islamabad.

Allergex-Px2

Each ml contains:


10mcg


10mcg


extract 10mcg


extract 10mcg

Mixed grass extract of Lolim

temulentum + Cynodon

dactylon …10mcg

House dust extract ..10mcg



Allergy vaccine,

immunostimulant

-do- Deferred Product

specific inspection

by the panel.

M/s Pakcure

Pharma, Rawat,

Islamabad.

Allergex-Px3

Each ml contains:


10mcg


10mcg


extract 10mcg


extract 10mcg


Paper mulberry extract…10mcg

Thrasher extract…10mcg

Raw cotton extract…10mcg



Allergy vaccine,

immunostimulant

-do- Deferred for

Product specific

inspection by the

panel.

398

M/s Pakcure

Pharma, Rawat,

Islamabad.

Allergex-Px4

Each ml contains:


10mcg


10mcg


extract 10mcg


extract 10mcg


Paper mulberry extract…10mcg

Thrasher extract…10mcg



Allergy vaccine,

immunostimulant

-do- Deferred for

Product specific

inspection by the

panel.

The product specific inspection of the company was conducted and presented before the board in

its 243rd

Meeting wherein the deficiencies of the facility were discussed and the board decided as

under;

Past Decision: - The Board decided to defer the case till removal of deficiencies. Reference

may also be sent to the Licensing Board to ensure compliance as per requirement of Biological

Drugs.

The firm after making improvements, approached again for the inspection. The inspection of the

company was again carried out by the panel. The panel observed that the firm has not made

substantial improvements. However, the panel was also of the opinion that the company may be

allowed trial manufacturing to ensure that all necessary requirements are met by the company.

The trial manufacturing is not for utilization of allergy vaccines for human use.

In the light of inspection report and recommendations of the panel, the case is placed before the

Board for a decision.

Decision: The Board offered personal hearing to Mr. Agha Sadrad ud Din, CEO of the

company. The applicant explained his status of improvements and assured the Board for

its compliance. The Board decided to conduct the inspection of the company by already

approved panel as and when the firm informs for compliance and will be ready for

inspection. The report of panel shall be considered in the next meeting of Board.

399

Case No. 22. Court case of M/s Forward Solution V/S DRAP.

The case of M/s Forward Solution was discussed in 243rd

Meeting of the Drug Registration

Board. The board decided that since the case is sub judice and under the consideration of the

Honorable Court. The firm M/s. Well Pharma, Lahore will be asked to substantiate their claim of

sole agent of the manufacturer in order to satisfy the legal procedure.

The decision of the board was communicated both the companies. M//s Well Pharma, Lahore has

not provided any sole agent agreement.

The firm M/s Forwarded Solution filed a writ petition in the Honourable Islamabad High

Court, Islamabad on 13.09.2014 on the grounds that the Drug Regulatory Authority of Pakistan

is not granting the Registration due to inaction of the functionary of the Drug Regulatory

Authority of Pakistan (CEO, DRAP, Director, Registration and Director Biological Products).

Parawise comments have been prepared and submitted to the Lawyer of DRAP for finalization

and submission to Honourable Court. Meanwhile, Federal Investigation Agency (FIA) has also

directed to appear before them to provide the details of the case, probably on the complain of

aggrieved company for non grant of registrations. The matter is submitted for information of the

Honorable Drug Registration Board and necessary instruction/orders if any.

Decision: The information was noted by the Board.

400

Item No: VIII Quality Control Cases – Quality Assurance & Lab Testing Division

Case No. 01: Deferred Cases

Sr.

No

Name of

Drugs

Firm CDL Report Appellate Testing Detail / Decision

1 Kohsar DS

Tablets

(Artimether &

Lumifantrin)

Tablets

Batch No.001

Mfg. Sep-13

Exp. Aug-15

(F. No. 03-

63/2013)

M/s Kohs

Pharmaceuticals

(Pvt) Ltd

Hyderabad.

Substandard with

regard to :-

Assay for

Artemether:

Found:- 80.256%

Limit: 90% to

110%

Does not comply

Remarks:- The

sample is of

substandard

quality under the

Drugs Act 1976.

Test report No.

852/2013

Firm challenged

the report after 30

days as per record

provided by FID

so the request was

not valid for re

testing by the

Appellate Lab

NIH Islamabad

under Section

22(5) of Drugs Act

1976

The Board was apprised

about the background of

the case as under:-

The Sample of Kohsar DS

Tablets Batch No. 001

manufacture by M/s Kohs


Hyderabad, drawn on 10-

10-2013 from

manufacturer’s premises

by FID Hyderabad, was

declared substandard by

Federal Government

Analyst CDL, Karachi

vide Test report No.

852/2013 dated 10-12-

2013. The firm did not

respond FID’s explanation

letter dated 17-12-2013 so

reminder letters dated 06-

01-2014 and 30-01-2014

were issued by the FID.

The firm vide its response

dated 11-02-2014

disagreed and challenged

the CDL report. As per

record provided by the

FID the report was

conveyed to the firm by

the FID vide letter dated

17th

December 2013,

while the firm challenged

the report vide its letter

dated 11th

February 2014.

The FID nominated

following as responsible

persons.

401

i. Owner of the firm, M/s

Kohs Pharmaceuticals

(Pvt) Ltd.,

ii. Quality Control

Incharge of M/s Kohs


Ltd

iii. Mirza Saleemullah,

Production Manager,

M/s Kohs


Ltd

The FID has not given

any recommendations

nor made any comments

regarding validity of the

act of challenging the

CDL report by the firm.

However, as per record

provided by the FID, it

appears that firm has

challenged the report

after the 30 days period

prescribed under Section

22(4) of Drugs Act 1976,

therefore, the request was

not valid for retesting by

Appellate Lab.

As per responsibility

fixed by the FID, show

cause notices dated 05-

05-2014 were issued to

the firm and the accused

persons of the firm.

The case was placed

before Drug Registration

Board in its 244th


July 2014. The accused

402

of the firm were also

called for personal

hearing in the said

meeting of the Board but

they could not appear

before the Board. The

Board decided to defer

the case and provide a

final opportunity of

personal hearing to the

accused.

The case was again

placed before Drug

Registration Board in its

245th

meeting held on

29-30th

September 2014.

The accused of the firm

were also called for

personal hearing in the

said meeting of the

Board but they could not

appear before the Board.

The Board decided to

defer the case and

provide a final

opportunity of personal

hearing to the accused.

The case was presented

before the registration board

in its 246th

meeting on 11-

12-2014. The Board decided

the case as under in the light

of personal hearing of Mr.

Pardeep Kumar Director of

the firm:-

Decision:-

The Board took the

following decision

i. Cancellation of

Kohsar DS Tablets

Registration No

403

070898.

ii. Panel Inspection for

PSI.

iii. The panel will be

constituted by

Director QA&LT.

2. Dozabitol

(Paracetamol

Syrup.

Batch No. DB

110

Mfg-Jul -13

Exp. Jun-15

(F.No. 03-

12/2014)-QC

M/s Kohs

Pharmaceuticals

(Pvt) Ltd

Hyderabad

Sub-Standard:-

With regard to

assay for

Paracetamol

Found :-82.2984%

Limit:- 90% to

110%

Does not comply

Remarks:- The

sample is of

substandard

quality under the

Drugs Act 1976.

Test report No.

848/2013

Firm challenged

the report after 30

days as per record

provided by FID

so the request was

not valid for re

testing by the

Appellate Lab,

NIH Islamabad

under section

22(5) of Drugs Act

1976



the case as under:-

The Samples of Dozabitol

Syrup, Batch No. DB110




10-2013 from

manufacturer’s premises

by FID Hyderabad, were


Federal Government

Analyst CDL Karachi vide

Test report No. 848/2013

dated 27-11-2013. . In

response to FID’s

explanation letter, the firm

disagreed and challenged

the CDL report. As per

record provided by the

FID the report was

conveyed to the firm by

the FID vide letter dated

03rd

December 2013 and

reminder was issued vide

letter dated 30-01-2014

for firm’s response in the

matter. The firm

challenged the report vide

its letter received in

DRAP Karachi office on

13-02-2014. so the request

for retesting was not valid

as the same was received

by FID office after 30

404

days The FID has

nominated following as

responsible persons.

i. Owner of the firm,

M/s Kohs

Pharmaceuticals

(Pvt) Ltd.,

ii. Quality Control

Incharge, M/s Kohs

Pharmaceuticals

(Pvt) Ltd

iii. Mirza Saleemullah,

Production Manager,

M/s Kohs

Pharmaceuticals

(Pvt) Ltd

The FID has not given

any recommendations

nor made any comments

regarding validity of the

act of challenging the

CDL report by the firm.

However, as per record

provided by the FID, it

appears that firm has

challenged the report

after the 30 days period

prescribed under Section

22(4) of Drugs Act 1976,

therefore, the request was

not valid for retesting by

Appellate Lab.


fixed by the FID, show

case notices dated 05-05-

2014 were issued to the

firm and the accused


The case was placed


Board in its 244th

405




called for personal

hearing in the said








accused.

The case was again

placed before Drug


245th

meeting held on

29-30th

September 2014.




said meeting of the




defer the case and

provide a final





in its 246th

meeting on 11-





the firm:-

Decision:-

The Board took the

following decision

406

i.. Cancellation of

Registration of

Dozabitol

(Paracetamol Syrup

Registration

No.006201.

ii. Panel Inspection

for PSI.


constituted by

Director QA&LT

3. Dozabitol

(Paracetamol

Syrup.

Batch No. DB

089

Mfg- Jan-13

Exp- Dec-14

(F.No. 03-

31/2013)-QC

M/s Kohs

Pharmaceuticals

(Pvt) Ltd

Hyderabad

Sub-Standard with

regard to:-

Assay for

Paracetamol:-

Found:- 88.62%

Limit:- 95.0% to

105%

Does not comply

with BP 2011

Remarks:- The

sample is of

substandard

quality under the

Drugs Act 1976.

Test report No.

Sub-Standard

With regard to:-

i. Assay for

paracetamol:-

85.52%

Does not comply

with BP 2011.

ii. Description

pink colored syrup

having un

dissolved masses

which do not

disperse even on

shaking

Does not comply

with BP 2011,

which states that

suspension may

show a

sedimentation

which is readily



the case as under:-

The Sample of Dozabitol

Syrup Batch No. DB089




03-2013 from

manufacturer premises by

FID Hyderabad, was


Federal Government

Analyst, CDL Karachi


535/2013 dated 06-05-

2013. On explanation

letter issued by the FID,

the firm requested

Appellate testing under

section 22(5) of Drugs Act

1976. The Appellate

Laboratories also declared

the sample sub-standard

vide test report No.08-

MNHRS/2013 dated 06th

August 2013. The repot of

Appellate Laboratories

was forwarded to the FID

for sending complete case

407

535/2013 dispersed on

shaking.

Test report No.08-

MNHRS/2013

along with

recommendation and

name of the responsible

persons. The FID in

response has nominated

following as responsible

person with request for

permission for prosecution

and cancellation of

registration.

i. Owner of the firm,

M/s Kohs Pharmaceuticals

(Pvt) Ltd., Hyderabad.

ii. Miss Rakhshanda

Perveen (Quality Control

Manger).

iii. Production Manager

of the firm

As per responsibility fixed

by the FID, show cause

notices dated 07-05-2014

were issued to the firm

and the accused persons

of the firm..

The case was placed


Board in its 244th




called for personal

hearing in the said








accused. They have been

called for personal

hearing again

408

accordingly.

The case was again

placed before Drug


245th

meeting held on

29-30th

September 2014.




said meeting of the




defer the case and

provide a final





in its 246th

meeting on 11-





the firm:-

Decision:-

The Board took the

following decision

i.. Cancellation of

Registration of

Dozabitol

(Paracetamol Syrup

Registration

No.006201.

ii. Panel Inspection for

PSI.


constituted by

Director QA&LT.

409

4. Stearox 1ml

Injection

Batch No.

H110112

Mfg:-01-12

Exp:-01-14

(F.No.03-

25/2013 QC)

M/s Gyton

Pharmaceutical

Lahore

Sub-Standard

With regards to:-

i. pH

Determined 5.94

Limit 7.0 to 8.5

Does not comply

with USP 34

ii. Assay for

Dexamethasone

Phosphate 14.59%

Limit 90% to 115%

Does not comply

with USP 34

Not Challenged

Batch No.

H110112,

The Brief about the

background of the case is

as under:-

The samples of Stearox

Injection Batch No.

H110112, Manufactured by

M/s Guyton Pharmaceutical

Lahore drawn by FID

Karachi from Central

Pharmacy of JPMC,

Karachi on 26-02-2013, was

declared Substandard vide

test report No.261/2013

dated 03-04-2013 by

Federal Government

Analyst. The FID has

identified following persons

responsible in the case.

. Mr. Talat Ahmad

Anjum (Q.C In-

charge)

.Muhammad Imran Khalil

(Production In-charge)

As per procedure show

cause notices was issued

to the firm 20th February

2014 and above accused,

offering opportunity of

personal hearing before

the Drug Registration

Board. They have also

been called for personal

hearing accordingly.

The case was placed

before 244th meeting of

Registration Board

which decided the case

as under:-

410

“The accused of the firm

were called for personal

hearing, but they could not


The Board decided to defer

the case and a final


hearing shall be given in

next meeting of the Board”

Accused as identified by

FID Lahore has also been

called for personal hearing

accordingly. The case was

again placed before 245th

meeting of Refistration

Board which decided the

case as under:-

Decision:- Mr. Muhammad

Salman Ali, Advocate High

Court appeared on behalf of

M/s Guyton Pharmaceutical

Lahore. The Board did not

accept power of Attorney on

behalf of the firm. The

Board decided the case as

under:-

i. The production of the

injection Stearox 1ml

Registration No. 040336

shall be stopped. One more


hearing is granted with the

direction that the

Management and Technical

Personnel shall appear

before the Board failing

which the ex-parte decision

411

shall be taken.

ii. The Board further

decided that the firm will

recall all the marketed

batches of sub-standard

drugs from distribution /

sale outlets / institutional

supplies if any and area FID

shall take report from the

firm and submit a

compliance report to

Chairman Registration

Board.

In the light of decision

taken in 245th

meeting of

Registration Board The One

more opportunity of

personal hearing is granted

with the direction that the

Management and Technical

Personnel shall appear

before the Board failing

which the ex-parte decision

shall be taken.



in its 246th

meeting on 11-




Bilal Khurshid Chief

Executive of the firm:-

Decision:-

The Board took the

following decision:-

i. Area FID Mr.

412

Abdul Rasool

Shiekh to take the

samples of the

batch and submit

the investigation

report of the case

again as the firm

has disowned the

supply of specific

Batch.

ii. The production of

the firm in the

steroidal Injectable

section shall be

stopped along with

suspension of

registration of

Stearox 1ml

Registration No.

040336 which had

already been

suspended in 245th

meeting till

investigation of the

case is finalized.

iii. The firm will be

asked to provide on

stamp paper

regarding their

statement of

disownership of

supply of this

batch.

iv. The case will be

submitted before

the Registration

Board after the

completing the

investigation.

413

Case No. 02 New Cases.

414

Sr.

No

Name of Drugs Firm CDL Report Appellate Testing Detail / Decision

1. Rehumetic 50

Tablets

(Diclofenac

Potassium)

Batch No. RT012

Mfg Date:-03-14

Exp Date:- 03-16

(F.No.03-42/2014-

QC)

M/s Rehmat

Pharma

Lahore.

Sub-Standard with

regard to:-

i. Assay for diclofenac

Potassium:-

Determined

amount/tablet:- 48.44mg

Stated amount/tablet:-

50mg

Percentage:- 96.88%

Fail on Dissolution test

as under:-

ii. Dissolution test:-

Tablet No:- (%)age

1. 17.25

2. 14.37

3. 17.82

4. 13.5

5. 12.94

6. 16.10

No Challenged The background of the

case is as under:-

The FID has submitted

the investigation report.

The FID has fixed the

responsibility and

submitted the name of

Directors, Production

Incharge, Quality

Control Incharge as

under:-

i. Mr. Bashir Ahmed,

Chief Executive,

M/s Rehmat Pharma,

Sheikhupura Road,

Lahore.

ii. Mr. Muzaffar Bashir

Production Incharge

M/sp Rehmat

Pharma, Sheikhupura

Road

Lahore.

iii. Mr. Muhammad

Sarwar, Quality Control

Incharge, M/s Rehmat

Pharma, Sheikhupura

Road,

415

Limits: Not less than

75.0%

Does not comply with

USP 37

Remarks:- The sample

is of substandard

quality under the Drugs

Act 1976.

Test Report No.

LHR.136/2014

Lahore.

The FID has concluded

that the firm has violated

Section 23(1)(a)(v) of

the Drug Act, 1976 and

rules framed there under.

The tablet Rehumetic 50

was declared substandard

by CDL on the basis of

dissolution test. The firm

vide its reply dated 18-

08-2014 to FID did not

challenge the report and

requested to drop the

proceeding against them

in the interest of justice.

The FID has submitted

the copies of recall of the

product from market by

M/s Rehmat pharma,

Lahore.

Keeping in view above

since the firm has not

challenged the report of

CDL therefore the report

dated 21st July, 2014 is

the adducing evidence

under the law.

As per procedure a show

cause notice was issued

to the firm and other

accused, offering


hearing before the Drug

Registration Board.

416


before the registration

board in its 246th

meeting

on 11-12-2014. The

Board decided the case

as under in the light of

personal hearing of Mr.

Abid Hussain Awan

Technical Advisor and

Mr. Muhammad Sarwar

QC Incharge of the

firm:-

Decision:-

The Board took the

following decision

i. Warning to the

firm.

ii. Destroy the

recalled quantity

(1,34000) of

Rehumetic 50mg

tablets in

presence of area

FID Lahore. The

area FID will

submit the

report of

destruction to

the Directorate

of QA/LT.

iii. The firm will

submit the

measures taken

to overcome such

incidence in

future.

3. D. Dron

(Dexamethason)

Injection

M/s Epharm

Laboratories,

Adulterated &

Substandard with

Not challenged The Board was apprised


417

(IM/IV)

Batch No.

DF.137

Mfg:- 06-13

EXP:- 06-15

&

Karachi. regards to Description:-

Finding of Lab:-

Colorless solution in

clear glass ampoule. Out

of 25 ampoules (referred

portion of sample) one

ampoule contain black

particles and another

ampoule contains white

fibers.


Description

Remarks:-

The sample is of

“Adulterated &

Substandard” under the

Drugs Act 1976.

Adulterated &

Substandard with

regards to Description:-

Finding of Lab:-

the case as under:-

The samples of D-

Dron Injection Batch

No DF.137 & DF-138

manufactured by M/S

Epharm Laboratories,

Karachi were taken by

FID Hyderabad at

Karachi on 29-01-

2014 from

manufacturer’s

premises. The samples

were declared

Adulterated &

Substandard by

Federal Government

Analyst vide test

reports

No.KQ.60/2014 &

KQ.61/2014 dated 18th

February 2014

respectively.

The FID

communicated the test

reports to the firm

vide his letter No.05-

10/2014-FID-H (K)

255-257 dated 19-02-

2014. The firm in their

reply mentioned about

their right of exercise

the power under

subsection (4) of

Section 22 of Drugs

Act 1976 for retesting

of their samples from

appellate lab

Islamabad. As per

submission of

complete case by the

FID, the firm’s reply

was received in the

office of DRAP

Karachi on 08-04-

418

Batch No.

DF.138

Mfg:- 07-13

EXP:- 07-15

(F.No.03-

10/2014-QC)

Clourless solution in

clear glass ampoule. Out

of 15 ampoules (referred

portion of sample) two

ampoules contain black

particles.


Description

Remarks:-

The sample is of

“Adulterated &

Substandard” under the

Drugs Act 1976.

2014 which was well

after the expiry of

time allowed under

section 22(4) of the

Drugs Act 1976 and

hence not valid as per

FID’s remarks.

The FID has furnished

the names of the

following persons of

the firm responsible

for committing the

offence under the law.

i. M/S Epharm

Laboratories

Karachi.

ii. Mr. Asad Ilyas

Nainitalwala,

Director,

iii. Mr. Ahmed

Nadeem Qasmi,

QC Manager,

iv Dr. Mohammad

Khokhar

Production

Manager,

Show cause notices


and other accused,

offering opportunity

of personal hearing

before the Drug

Registration Board

after the approval of

the competent

authority. They have

been also called for

personal hearing

accordingly.



board in its 246th

meeting

419

on 11-12-2014. The




Asad Ilyas Director of

the firm and Mr. Ahmed

Nadeem Qasmi QC

Manager of the firm.

Decision:-

The Board took the

following decision

i. The Board decided

to suspended the

registration of D-

Dron Injection

Registration

No.058424 (IM/IV)

for a period of three

months.

ii. PSI Inspection by a

panel comprising of

Director DTL

Quetta and area

FID will be

conducted and they

will submit the

report to the

Registration Board

3. i. Loose pink

cloured tablets-

Rumin

(Ibuprofen)

400mg Tablets

M/s Ankaz

Pharmex

(Pvt) Ltd

Karachi

Substandard with regard

to “Assay”

for Ibuprofen:

Determined amount/Tab

=49.512mg

Substandard with

regard to “Assay”

for Ibuprofen (BP)

Stated:-



the case as under:-

The Federal Inspector

of Drug, Karachi-III

vide his letter dated

420

Batch No. Nil

Mfg Date:- Nil

Exp Date:- Nil

Stated amount/tab

=400mg

Percentage:- 12.378%

Limit: 95% to 105%

Does not comply


is of substandard


Act 1976.

Test Report No.

RKQ.212/2014.

400mg/Tab

Found:- 313mg/tab.

Percentage:-

78.29%

Limit: 95% to

105%

Does not comply

with BP 2011

Conclusion:-

The sample is of

substandard

quality on the basis

of tests performed.

21-04-2014 informed

that he alongwith Dr.

Shahid Hussain, FID

Karachi and others

raided the premises of

M/s Ankaz Pharmax

(Pvt) Ltd., Karachi on

19-04-2014 at 07.45

AM. The raid was

conducted on the

source information of

FIA Crime Circle

Karachi. Deputy

Director FIA Mr.

Fakeer Muhammad

headed the raid

alongwith his team.

Ten samples of

different products

were taken from the

manufacturers

premises for

test/analysis on the

prescribed Form-3.

The FID vide his

investigation report of

the case intimated that

eight samples of the

drugs taken have been

declared to be

substandard by the

Federal Government

Analyst, CDL

Karachi. In the light of

the same, the FID

issued explanation

letter regarding the

matter of manufacture

and sale of

substandard drugs to

the firm. As per

documents provided

by the FID, the firm

challenged the test

reports and requested

421

to get the samples

retested from the

Appellate Laboratory,

NIH Islamabad. The

Appellate Laboratory

also declared the drug

sample under

reference as

Substandard.

The FID concluded

that the manufacturer

is guilty of

manufacturing

substandard drugs and

de-registered drug in

violation to the

provisions of Drugs

Act 1976 and rules

framed there under.

He has requested for

cancellation DML of

the firm or permission

to lodge the

prosecution against

the firm.

Following persons of

the firm have been

held responsible for

committing the

offence by the FID.

i. Ali Abbass,

Managing Director

of the firm.

ii. Akbar Ali

Production Incharge.

iii. Safdar Alam,

Quality Control

Incharge.

As per procedure

Show cause notices


422

and other accused, in

the light of the test

reports of the

Appellate Lab and

report of the FID,

offering them

opportunity of

personal hearing

before the Drug

Registration Board.

They have also been

called for personal



of Drugs, Karachi-III


21-04-2014 informed


Shahid Hussain, FID

Karachi and others


M/s Ankaz Pharmax


19-04-2014 at 07.45

AM. The raid was

conducted on the


FIA Crime Circle

Karachi. Deputy

Director FIA Mr.

Fakeer Muhammad

headed the raid

alongwith his team.

The FID vide his


the case intimated that

eight samples of the

drugs taken have been

declared to be

423

substandard by the

Federal Government

Analyst, CDL

Karachi. In the light of

the same, the FID

issued explanation



and sale of


the firm. As per

documents provided


challenged the test


to get the samples

retested from the


NIH Islamabad. The


declared the drug

sample under

reference as

Misbranded.

The FID concluded


is guilty of

manufacturing



violation to the

provisions of Drugs

Act 1976 and rules

framed there under.


cancellation DML of


to lodge the

prosecution against

the firm.


the firm have been


424

-do.


committing the

offence by the FID.

i. Ali Abbass,

Managing Director

of the firm.

ii. Akbar Ali


iii. Safdar Alam,

Quality Control

Incharge.

As per procedure

Show cause notices



the light of the test

reports of the

Appellate Lab and

report of the FID,

offering them

opportunity of

personal hearing

before the Drug

Registration Board.

They have also been

called for personal


The FID vide his


the above case also

reported that the firm

was found manufacturing

its one of de-registered

product namely syrup

Rumin mentioning the

old manufacturing date

on the label. It has been

425

ii. Loose pink

cloured tablets-

Rumin

(Ibuprofen)

200mg Tablets

Batch No. Nil

Mfg Date:- Nil

Exp Date:- Nil

to :-

Assay for Ibuprofen:

Determined

amount/Tablet

=24.756mg

Stated amount/tablet

=200mg


Limit: 95% to 105%

Does not comply


is of substandard quality

under the Drugs Act

1976.

Test Report No.

RKQ.213/2014

Substandard with


for Ibuprofen (BP)

Stated:-

200mg/tab

Found:-

153.38mg/tab.

Percentage:-

76.69%

Limit: 90% to

105%

Does not comply

with BP 2011

intimated that Syrup

Rumin was found stored

in bulk in big vessel

placed in liquid

manufacturing areas of

the firm. A huge quantity

of finished goods of

same de-registered syrup

was also seen placed in

finished good wear

house

The FID concluded


is guilty of

manufacturing



violation to the

provisions of Drugs

Act 1976 and rules

framed there under.


cancellation DML of


to lodge the

prosecution against

the firm.


the firm have been


committing the

offence by the FID.

i. Ali Abbass,

Managing Director

of the firm.

ii. Akbar Ali

426

iii. Tablet

Rumin

(Ibuprofen)

400mg

(Blister packing)

-do-


to :-


Determined

amount/Tablet

=350.71mg


=400mg


Limit: 95% to 105%

Does not comply



under the Drugs Act

1976.

Conclusion:-

The sample is of

substandard


of tests performed.

Test Report

No.09-

MNHSR/2014

Substandard with


for Ibuprofen (BP)

Stated:-

400mg/tab

Found:-

319.24mg/tab.

Percentage:-

79.81%


iii. Safdar Alam,

Quality Control

Incharge.

As per record of

Quality Control

Section, registration of

this product was

cancelled by DRB in

its 237th

meeting held

on 26-02-2013, which

was communicated of

the firm vide their

officer letter bearing

No.03-16/2012-QC,

dated 22-03-2013.

As per procedure

Show cause notices



the light of report of

the FID, and record of

QC Section regarding

the de-registration of

the product offering

them opportunity of

personal hearing

before the Drug

Registration Board.

They have also been

called for personal

hearing accordingly

427

Batch No. 1105

Mfg Date:- 1-12

Exp Date:- 12-14

-do-

Test Report No.

RKQ.215/2014


to :-


Determined

amount/Tablet

=30.945mg


=200mg


Limit: 95% to 105%

Does not comply


is of substandard

Limit: 95% to

105%

Does not comply

with BP 2011

Conclusion:-

The sample is of

substandard


of tests performed.

Test Report

No.08-

MNHSR/2014

Substandard with


for Ibuprofen (BP)

Stated:-

200mg/tab

Found:-

145.60mg/tab.



the case as under:-


of Drug, Karachi-III


21-04-2014 informed


Shahid Hussain, FID

Karachi and others


M/s Ankaz Pharmax


19-04-2014 at 07.45

AM. The raid was

conducted on the


FIA Crime Circle

Karachi. Deputy

Director FIA Mr.

Fakeer Muhammad

headed the raid

alongwith his team.

Ten samples of

different products

were taken from the

manufacturers

premises for

test/analysis on the

prescribed Form-3.

The FID vide his


the case intimated

that eight samples of

the drugs taken have

been declared to be

substandard by the

Federal Government

Analyst, CDL

Karachi. In the light

428

iv. Tablet

Rumin

(Ibuprofen)

200mg

Batch No. 640

(Jar Packing)

Mfg Date:- 2-13

Exp Date:- 01-16


Act 1976.

Test Report No.

RKQ.206/2014


to :-

Assay for

Sulphamethoxazole:

Determined

amount/Tablet =101.328

mg


=800mg


Percentage:-

72.80%

Limit: 95% to

105%

Does not comply

with BP 2011

Conclusion:-

The sample is of

substandard


of tests performed.

Test Report

No.012-

NHSR/2014

Misbranded with

the following

remarks:-

“Labeling on the

immediate pack is

of the same, the FID

issued explanation



and sale of


the firm. As per

documents provided


challenged the test


to get the samples

retested from the


NIH Islamabad. The


declared the drug

sample under

reference as of

standard quality.

As per Section 22

(5) of the Drugs Act

1976 and the report of

conclusive evidence

so in the light of the

same the present case

with regard to drug

under reference may

be filed.

.

Submitted for

Information of the

Board please.

-Do-

429

v.. Biprim (Co-

Trimoxazole) DS

Tablets

Batch No. 305

(Blister packing)

-do-

Does not comply


is of substandard


Act 1976.

Test Report No.

RKQ.207/2014

not legible. More

over batch

number and

expiry date is

printed with

removable ink and

some strips found

without batch

numbers and

expiry date which

is violation of the

labeling and

packing rules of

Drugs Act 1976.

Conclusion:- The

sample is

misbranded.

Test Report

No.06-

MNHSR/2014

-Do-



board in its 246th

meeting

on 11-12-2014. The




Salim Isharat Husain,

Technical Consultant on

behalf of M.D of the

firm.

Decision:-

The Board in view of

personal hearing of Mr

Saleem Isharat Hussain

on behalf of Managing

Director Ankaz Pharmex

and available

record/facts of the case

decided as under:-

1. The Board decided

to cancel the

registration of the

following products as

per its consideration:-

i. Loose Pink Colored

Tablets- Rumin

(Ibuprofen) 400mg

Tablets. Registration

No. 007545

ii. Loose Pink colored

430

Mfg Date:- 11-13

Exp Date:- 10-16

vi. Rumin

(Iburofen)

Suspension

The sample is of

standard quality with

regard to tests

performed.

Tablets- Rumin

(Ibuprofen) 200mg

Tablets, Reg. No.

007543.

iii. Tab. Rumin 400mg.

(Blister Packing)

Reg. No. 007545

iv. Tab. Rumin 200mg

(Jar Packing) Reg. No.

007543.

v. Tab. Biprim (Co-

Trimoxazole) DS

(Blister Packing)

Reg. No. 008409

vi. Rumin (Ibuprofen)

Suspension, Reg.

No. 008526

2. The Board further

decided to recommend

to the Central

Licensing Board for

cancellation of the

Drug Manufacturing

License of the firm on

the violation of

manufacturing of

already De-registered

product i.e. Rumin

Suspension Reg. No.

008526.

431

Batch No.408

Mfg Date:-03-13

Exp Date:-02-16

vii. Biprim DS

(Co-

Trimoxazole)

Tablets

Batch No. 305

(Jar packing)

Mfg Date:- 11-13

Exp Date:- 10-16

viii. Biprim

(Co-

Trimoxazole)

Tablets

Batch No. 524

(Blister packing)

Test report No.

RKQ.210/2014.


to :-

Assay for

Sulphamethoxazole:

Determined


mg


=800mg


Does not comply


is of substandard


Act 1976.

Test Report No.

RKQ.209/2014


to :-

Assay for

Sulphamethoxazole:

432

Mfg Date:- 01-13

Exp Date:- 12-15

ix. Loose white

cores

claimed/suspecte

d of Tablets-

Rumin

(Ibuprofen)

200mg

Batch No. Nil

Mfg Date:- Nil

Exp Date:- Nil

(F.No.03-

17/2014-QC)

Determined


mg


=800mg


Does not comply



under the Drugs Act

1976.

Test Report No.

RKQ.208/2014


to :-


Determined

amount/Tablet

=30.945mg


=200mg


Limit: 95% to 105%

Does not comply


433

-Do-

is of substandard


Act 1976.

Test Report No.

RKQ.214/2014

N.A

The Sample has

been declared of

Standard Quality

on the basis of tests

performed.

Test Report

No.013-

MNHSR/2014

The Sample has

been declared of

Standard Quality of

the basis of tests

performed

Test Report No.07-

MNHSR/2014

The Sample has

been declared of

Standard Quality

on the basis of tests

performed by the

Appellate Lab,

NIH, Islamabad.

(Test Report

No.010-

MNHSR/2014)

4. Kemycillin

(Ampicillin)

M/s Alkemy

Pharmaceutica


to :-

Sub-Standard

With regard to:-



434

Syrup

Batch No. A-

1028

Mfg. Oct-13

Exp. Use with in

three years

(F. No. 03-

34/2014)

l Laboratories

Hyderabad.

Assay for Ampicillin

Determined

amount/5ml:-

=103.32mg

Stated amount /5ml

=125mg

Percentage:- 82.66%

Limit: 90% to 120%

Does not comply


is of substandard


Act 1976.

Test report No.

KQ.230/2014

Assay for

Ampicillin:-

Stated 125mg/5ml

i. First day Found

=101.14mg/5ml

Percentage:-

80.91%

i. On 07th

Day Found

=

78.53mg/5

ml

Percentage:-

62.82%

Limit:- 80-120%

Does not comply

with BP 2011.

Conclusion:-

The sample is of

substandard


the case as under:-

The Sample of

Kemycillin Syrup Batch

No A-1028,

manufactured by M/s

Alkemy Pharmaceutical

Laboratories P/9, SITE

Hyderabad Sindh was

taken by FID Hyderabad

at Karachi on 24-04-

2014 from

manufacturer’s premises.

It was declared

substandard by Federal

Government Analyst



May 2014. In response to

the explanation letter

issued by the FID, the

firm challenged the CDL

report and requested for

Appellate Testing under

Section 22(5) of Drugs

Act, 1976. The Appellate

Laboratory also declared

the sample as

Substandard vide test

report No. 015-

MNHSR/2014 dated 08th

August 2014. The FID in

response to this office

letter dated 29th

August

2014 concluded that the

firm has violated Section

23(1)(a)(v) of Drugs Act

1976. FID has

recommended immediate

action under Section

435

of tests performed.

Test report No.

015-MNHSR/2014

7(11) of the Drugs Act

1976 and has furnished

the names of the

following persons of the

firm responsible for the

offence.

i. M/s Alkemy

Pharmaceutical

Laboratories (Pvt.)

Ltd Hyderabad,

ii. Mr.Fraz Ahmed

Sheikh,

Managing Director,

iii. Mr. Asif Najeeb

Laghari,

QC Manager,

iv. Mr.Abid Ali Khoso

Production

Incharge,


fixed by the FID,

show case notices

dated 05-05-2014

were issued to the

firm and the accused




board in its 246th

meeting

on 11-12-2014. The




Asif Najeeb Laghari QC


436

Decision:-

The Board took the

following decision:

i. Suspended the

registration of

Kemycillin

(Ampicillin)

Syrup, Reg. No.

022520 for a

period of six (06)

months.


for PSI.


constituted by

Director

QA&LT

5. Empoir 500mg

(Ciprofloxacin)

Tablets.

Batch No. 283

Mfg Date- 03-14

Exp Date. 02-17

(F.No. 03-

33/2014)-QC

M/s Alkemy

Pharmaceutica

l Laboratories

Hyderabad.

Sub-Standard:-

With regard to

Dissolution test

Tablet 01= 38.23%

Tablet 02= 48.94%

Tablet 03= 39.30%

Tablet 04= 32.26%

Tablet 05= 39.15%

Tablet 06= 39.15%

Limit:- Not less than

80%


Substandard with

regard to

Dissolution test

Determined:-

59.9%

57.71% (repeated)

Limit:- Not less

than 80% of the

stated amount

Does not Complies

with USP 32

Conclusion:-

The sample is of



the case as under:-

The Sample of Empoir

500mg Tablets Batch

283 manufactured by

M/s Alkemy

Pharmaceutical

Laboratories (Pvt.) Ltd,

P/9, SITE Hyderabad

was taken by FID

Hyderabad at Karachi on

24-04-2014 from

manufacturer’s premises.

The Sample was


Federal Government

Analyst CDL Karachi



May 2014. In response to

437

USP 35.


is of substandard


Act 1976.

Test report No.

KQ.228/2014

substandard


of tests performed.

Test report No.

014-MNHSR/2014

the explanation letter

issued by the FID, the

firm challenged the CDL

report and requested for

Appellate Testing under

Section 22(5) of Drugs

Act, 1976. The Appellate

Laboratory also declared

the sample as

Substandard vide test

report No. 014-

MNHSR/2014 dated 12th

August 2014. The FID in

response to this office

letter dated 18th

September 2014 has

concluded that the firm

has violated Section

23(1)(a)(v) of Drugs Act

1976. FID has furnished

the names of the

following persons of the

firm responsible for the

offence.

i. M/s

Alkemy Pharmaceutical

Laboratories (Pvt.) Ltd

Hyderabad,

ii. Mr.Fraz

Ahmed Sheikh,

Managing Director,

iii. Mr. Asif

Najeeb Laghari,

QC Manager,

iv. Mr.Abid

Ali Khoso

438

Production Incharge,

.As per responsibility

fixed by the FID,

show case notices

have been issued to

the firm and other

accused persons of the

firm.



board in its 246th

meeting

on 11-12-2014. The








board in its 246th

meeting

on 11-12-2014. The






Decision:-

The Board took the

following decision

i. Suspended the

registration of

Empoir 500mg

(Ciprofloxacin)

Tablets Reg. No.

039367 for a

period of six (06)

months.


439

for PSI.


constituted by

Director

QA&LT

Case No. 03 Substandard Rifacin (Rifampicin Suspension BP 60ml) manufactured by M/s

Pharmawise Labs Pvt Ltd Lahore

Brief Background

The FID Islamabad-II on 03-04-2012 drew samples of Rifacin Suspension Batch No.152

of M/s Pharmawise Labs (Pvt) Lahore, from T.B Center, Asghar Mall Road Rawalpindi for

test/analysis. The samples were declared substandard by the F.G Analyst vide test report

No.T.B.64/2012 dated 01-08-2012. The firm did not challenge the report and case was

accordingly processed and decided by the Registration Board in its 237th

meeting, held on 26-02-

2013 and cancelled the registration of the product under reference. The firm filed an appeal

before Appellate Board against the decision of DRB vide appeal No.04/2013, dated 06-09-2013,

which was dismissed by the Appellate Board in its 140th

sitting.

. .The firm filed a writ petition No.4442-2013, before Honorable Islamabad High Court,

Islamabad against the decision of Appellate Board but the Court upheld the decision of Appellate

Board. The firm filed a C.P.L.A No. 2/2014 before the Honorable Supreme Court of Pakistan

which in its order dated 22-08-2014 the directed to retest the sample in accordance with law.

Accordingly the sample was sent to Appellate Lab (NIH) for retesting which also declared the

sample is of Sub-standard quality.

S.No. CDL Test Report No.

TB.64/2012 & Findings

Appellate Test Report No.016-

MNHSR/2014 & Findings

Remarks

1. i. pH Determined 5.18

ii. Limits:- 4.2 to 4.8 Does not

comply with BP 2011

Assay for Rifampicin

i. Determined amount per ml

i. pH Determined 4.75

ii. Limits:- 4.2 to 4.8 Comply with

BP 2011 .

iii. Volume Determined 60ml

Complies with volume stated on the

label

The sample is of

Substandard quality on the

basis of test

performed by

FGA CDL

440

=15.514mg/ml

ii. Stated amount / ml=

20mg/ml

iii. Percentage:- 77.57%

iv. Limits:- 90% to 110%

Does not comply with BP

2011

Assay for Rifampicin

i. Determined amount per ml

=17.31mg/ml

ii. Stated amount / ml= 20mg/ml

iii. Percentage:- 86.63%

iv. Limits:- 90% to 110%

Does not comply with BP 2011

Karachi and

Appellate Testing

Lab Islamabad.

The case is submitted of the consideration / decision of Registration Board under

intimation to Assistant Registrar motion for Deputy Registrar Judicial in the light of brief

background please.

Decision:-

The Board after through celebration decided as under:-

1. Up held the decision of cancellation of registration of substandard Rifacin

(Rifampicin Suspension BP60ml), Regn. No. 037528 manufactured by M/s

Pharmawise Labs (Pvt) Ltd., Lahore taken in 237th

meeting, Registration

Board.

2. The Board further decided that the case with brief background shall be

intimated to Assistant Registrar motion for Deputy Registrar Judicial in the

light of decision of the Board and substandard test report by the Appellate

Lab NIH Islamabad and Medical Superintended T.B Hospital Asghar Mall

Road Rawalpindi for their further necessary action if any.

3. The firm will recall all its supplied batches to T.B Hospital Asghar Mall Road

Rawalpindi under intimation to area FID-II Islamabad.

Case No. 04 Deaths of persons allegedly due to consumption of cough syrup

manufactured by M/S Ethical Laboratories (Pvt) Ltd and M/S Reko Pharmecal

Laboratories Lahore

The Registration Board in its 245th meeting decided the case as under:-

Decision:- Registration Board decided that Mr. Jamil Anwar Member of the Registration Board, Deputy

Director General (E&M) Lahore & Islamabad will furnish the pending status of these petitions filed by

M/s Ethical laboratories Pvt Ltd and M/s Reko Pharmacal Lahore for consideration of the Board in its

up-coming meeting

441

The pending status of the petitions filed by M/s Reko and Ethical Laboratories pvt Ltd Lahore

have not yet been received from the Honorable member Mr. Jamil Anwar, and DDG (E&M) Lahore and

Islamabad as communicated to them.

Decision: Registration Board again decided that that Mr. Jamil Anwar Member,

Registration Board, Deputy Director General (E&M) Lahore & Islamabad will furnish

the pending status of these petitions filed by M/s Ethical laboratories Pvt Ltd and M/s

Reko Pharmacal Lahore for consideration of the Board in its up-coming meeting

Case No. 05 Damage Samples for Board Portion

Board portion of sealed samples from ADC Quetta and FID Peshawar were received in damage

conditions (File No.13-09/2013-QC)

S.

No.

Product & Batch No. Manufacturer Condition

1. Canrce Tablets

Q18

M/s Merck (Pvt) Ltd

Quetta

Badly damaged, broken carton

and seal.

2. Optifam Tablets

38

M/s Merck (Pvt) Ltd

Quetta


and seal.

3. Naproxen Imported Raw

Material

M/s Merck (Pvt) Ltd

Quetta

Badly damaged, glass broken

bottle and seal.

4. Metformin-Hcl Imported

Raw Material

M/s Merck (Pvt) Ltd

Quetta

Badly damaged, glass broken

bottle and seal.

5. Tablet Klaribact 250mg

Q64

M/s Merck (Pvt) Ltd

Quetta


and seal.

6. Liquid Glucose

014270-Bulk

Rafhan Maiz Pakistan Badly damaged, leaked bottles

and torn memorandum.

7. Liquid Serbetol

00470114

Made in China Badly damaged, leaked bottles

and torn memorandum

. The Board portions of the samples at serial No. 1-5 have been sent by ADC Quetta

whereas the samples at serial No.6-7 have been sent by FID Peshawar. Both officers had been

informed telephonically about the status of these samples.

. The Registration Board in its 238th

meeting allowed the QC Section to get fresh samples

from the inspectors if they are received in damage conditions. In view of above following

proposal is submitted.

i. The FID Peshawar and ADC Quetta may be advised to take special care for

packing and transportation of the Boards portion of samples in future all the

442

DDGs in the field offices may also be advised to instruct FIDs/ADCs to

ensure appropriate packing and sealing of such samples.

ii. FID Peshawar and ADC Quetta may be advised to draw fresh samples, of the same

batches/raw materials, of damaged drugs for test analysis.

Decision:- The Board approved the proposals of QC Section and Directed that all

DDGs, FIDs and ADCs be asked to send the Board Portion intact form and ensure

appropriate packing and sealing of such samples before sending. In future such

approvals will be taken from Director QA/LT on file.

Case No. 06 Manufacture and supply of sub-standard Hepaferon Injection by M/s Pharmedic,

Lahore to Govt of Khyber Pakhtoonkhawa

BRIEF BACK GROUND: The case of M/s Pharmedic Laboratories (Pvt) Ltd was discussed with

reference to the decision taken in also 243rd

& 244th meeting of Registration Board which is reproduced

as under.

Decision taken in 243rd

Meeting of Registration Board

i The Federal Inspector of Drugs Peshawar is advised to get the case completed

covering details of findings, conclusion fixation of responsibilities with his

recommendations.

ii. The Board further decided to get update regarding Suo Moto notice taken by

Hounrable Peshawar High Court Peshawar and fate of case referred to NAB

Khyber Pakhtoon Khawa.

The FID Peshawar has submitted the investigation of the case fixing the responsibility of name of

persons accused & co accused in manufacture and sale of substandard Hepaferon Injection Batch No 80-

87 which are involved directly or indirectly. The FID has also submitted the suo moto judgment a copy of

Honorable High Court Peshawar but did not submitted the report regarding investigation by NAB.

Name of accused persons.

i. Mr. Iftikhar Ahmed Shiekh Director/C.E.O

ii. Mr. Mazhar Hussain Production Incharge.

iii. Mr. Asim Mehmood Quality Control Inchage

Name of Co-accused persons.

Dr. Chuhan Director

Dr. Sharif, Director

443

Dr. Ghulam Subhani Director Hapatitis Program

Mubarik Shah, Store Keeper LRH Hapatitis Program

Dr. Nigar Ahmed, Ms DHQ Mardan.

Mr. Aurengzaib, Store Incharge, DHQ Mardan.

The case was again presented before 244th meeting of the Board in the light of recommendations of

the FID Peshawer as above which decided the instant case as under:-

Decision:- The Board decided to issue show cause notices to accused of M/s Pharmadic

Laboratories (Pvt) Ltd Lahore regarding manufacture and supply of substandard Injection

Hepaferon (3MIU) Interferon Alpha 2a to government of KhyberPakhtoonKhawa.

The The FID Peshawar has submitted the complete investigation of the case fixing the

responsibility of name of persons accused / co-accused in manufacture and sale of substandard Hepaferon

Injection Batch No 80-87and proposed their names for prosecution under Section 23(1)(a)(v)(vii) and 23

(1)(a)(vii), 23(1)(b)(f) which are involved directly or Indirectly in this case some of the co-accused are

employees of Government of Khyber Pakhtoon Khawa.

As directed by Chairman Registration Board the case is again submitted for consideration of the

Registration Board keeping in view of the Public health at large, Suo Moto Notice by Peshawar High

Court, & NAB investigation in instant case please.

Decision:- The Board decided that Federal Inspector of Drugs Peshawar will be asked

to submit the certified copies of decisions of Drug Court Peshawar and Peshawar High

Court, Peshawar in the instant case with in 07 days. Reference will be sent to Law division

to ascertain whether government officials under provincial governments can be issued

show cause notice for violations any provision of Drug Act, 1976 or otherwise.

The Show Cause Notice to the accused of firms will be issued after the receipt of the

letter from the FID and approval from Chairman, Registration Board. However, show

cause to government officials will be served after clarification from Law Division.

444

Case No.07 Supply of substandard /adulterated injection of cil 100ml to DHQ hospital

Hafizabad (25000 vials) and M/s Medisearch Pharma (Pvt) Ltd., 5-km, Raiwind Manga

Road, Lahore which supplied Almajax 250ml Suspension to DHQ Hospital Hafizabad

(35600 bottles).

The Secretary Provincial Quality Control Board (PQCB) Punjab Mr. Tallat Farooq Ahmad

has forwarded two recommendations to DRAP as under:-

i. The Federal Government Cancel the Drug Manufacturing License of M/s

Mediceena Pharma, (Pvt) Ltd., 27-KM Raiwind Road Lahore on supply of Sub-

standard / Adulterated injection Ofcil 100ml to DHQ Hospital Hafizabad (25000

vials) and M/s Medisearch Pharma (Pvt) Ltd., 5-KM, Raiwind Manga Road, Lahore

which supplied substandard Almajax 120ml Suspension to DHQ Hospital

Hafizabad (35600 bottles).

ii. The Federal Government Cancel the Registrations of the said drugs of M/s

Mediceena Pharma, (Pvt) Ltd., 27-KM Raiwind Road Lahore and M/s Medisearch

Pharma (Pvt) Ltd., 5-KM, Raiwind Manga Road, Lahore.

Brief Background

The Provincial Quality Control Board (PQCB) after scrutiny of the report of Government

analyst i.e report Nos. TRA. 22863 & 22864 dated 21-11-2014 Batch No. JX168 of Almajax

suspension, and statement of the Drug Inspector observed that this is a criminal negligence on

the part of manufacturers and gross loose in GMP compliance. The Punjab Government (PQCB)

observed that there is a dire need to take quick action against the said firms to safeguard the

public health at large and submitted the above mentioned recommendations.

The case is placed before Registration Board for decision on the recommendations of

(PQCB) Punjab by Registration Board regarding cancellation of Registrations of Drugs of these

firms as per law with the proposal that recommendations may also be send to Division of

Licensing for further necessary action at their end so that public health may be saved from risk.

Decision:- The Board decided as under:-

a. To get the complete investigation along with all the reports and case

background from the Secretary Provincial Quality Control Board Health

Department Government of Punjab Lahore through the DDG (E&M)

Lahore.

445

b. The area FID Lahore will be asked to submit the case background in

writing along with all relevant reports for perusal of the Registration

Board for decision.

The Board further decided the case shall be forwarded to Directorate of Licensing for

further necessary action in the light of recommendation of the Provincial Quality Control

Board (PQCB) Punjab.

446

Item No.IX Registration of Medical Devices – Medical Devices Division

Case No.01. Applications for registration of medical devices for import.

Registration Board considered the following applications of medical

devices for import and decided as mentioned against each. Approved applications have already

been recommended by Expert Committee on Medical Devices and are subject to inspection of

manufacturer abroad, verification of storage facilities etc as per policy:-

A) Cannulas:

S.No

.

Name of Importer and

Manufacturer/Exporter.

Name of Medical

Device

Price Pack size Shelf

life

Decision

1. M/s Kaf Surgical &

Disposable Equipments,

GF-116, Panorama Centre,

Plot No.248, Staff Lines,

Fatima Jinnah Road,

Karachi/

Manufactured by

M/s Plasti Lab S.A.R.L,

Roumieh El Metn,

Industrial Area, Main

Road, Khoury Bldg,

P.O.Box 70407, Beruit,

Lebanon.

JRZ Intravenous

Canula without

Wings without

Injection Port

(Pencil Type).

Decontrolled till

policy decision

by the Policy

Board/ Federal

Government.

(14G,

16G, 18G,

20G,

22G, 24G,

26)

50 per box

5

years

Approved.

2. M/s Kaf Surgical &

Disposable Equipments,

GF-116, Panorama Centre,

Plot No.248, Staff Lines,

Fatima Jinnah Road,

Karachi/

Manufactured by

JRZ Intravenous

Canula without

Wings without

Injection Port

(Pen Type)

-do-

(14G,

16G, 18G,

20G,

22G, 24G,

26)

5

years

Approved.

447

M/s Plasti Lab S.A.R.L,

Roumieh El Metn,

Industrial Area, Main

Road, Khoury Bldg,

P.O.Box 70407, Beruit,

Lebanon.

50 per box

3. M/s Lab Link Enterprises,

192-N, Block-II, PECHS,

Karachi.

Manufactured by:

M/s PT Nipro Indonesia

Jaya, Kawaran Industri

Suryacipta, JI Surya Utama

Kav, 122B, 23 & 24, Desa

Kutamekar, Kec, Ciampel,

Karawang, Jawa Barat,

Indonesia.

Nipro Safelet

Cath (I.V

Cannula Pen

Type)

Decontrolled till

policy decision

by the Policy

Board/ Federal

Government

(16G,18G,

20G,

22G, 24G)

50 per box

5

years

Approved.



Karachi.

Manufactured by:




Kav, 122B, 23 & 24, Desa



Indonesia.

Nipro Wing Cath

(I.V Cannula with

Injection Port &

Wing)

-do-

(16G,

18G, 20G,

22G, 24G)

50 per box

5

years

Approved.

5. M/s. A. Feroz & Co.,

Medicine Street No.1,

Marriot Road, Karachi

Manufactured by

Star IV. Catheter

with Injection

Port.

-do- (14G,

16G, 18G,

20G, 22G,

24G)

5

years

Approved.

448

M/s. Engineering

Technical Plastic Industries

(Enteplin-Egypt) 10th

of

Ramadan City, Industrial

Zone, A-1 Part 41/3.

Sharqia, Egypt.

100 per

box

B: Infusion Set:

S.No

.



Name of Medical

Device

Price Pack

size

Shelf

life

Decision



Karachi.

Manufactured by:




Kav, 122B, 23 & 24, Desa



Indonesia.

Nipro Infusion

Set

(with needle)

Decontrolled till

policy decision

by the Policy

Board/ Federal

Government

1’s 5

years

Approved.

C: Syringes:

S.No

.



Name of Medical

Device

Price Pack

size

Shelf

life

Decision



Karachi.

Manufactured by:

Nipro Disposable

Syringe (with

needle)

Decontrolled till

policy decision

by the Policy

Board/Federal

Government

1ml

3ml

5ml

5

years

Deferred for

clarification

from the

applicant

regarding non-

permanent

449




Kav, 122B, 23 & 24, Desa



Indonesia.

10ml

20ml

marking of

10ml & 20ml

syringes with

delible ink.



Karachi.

Manufactured by:




Kav, 122B, 23 & 24, Desa



Indonesia.

Nipro Disposable

Syringe

(without needle)

-do- 30ml

50ml

5

years

Deferred for

clarification

from the

applicant

regarding non-

permanent

marking of

30ml & 50ml

syringe with

delible ink.



Karachi.

Manufactured by:




Kav, 122B, 23 & 24, Desa



Indonesia.

Nipro Disposable

Syringe U-100

Insulin with

needle

-do- 1 ml

5

years

Approved.

450

Case No.02. Withdrawal of registration applications of medical devices.

The following importing firms are withdrawing their registration applications of

medical devices as mentioned against each. The firms have also not deposited differential fee as

per revised fee schedule for their products:-

S.No Name of Importer and

Manufacture/Exporter.

Name of Medical

Device (s)

Demanded

price & Pack

size

Shelf

life

Remarks

1. M/s Otsuka Pakistan Ltd.

30-B Sindhi Muslim

Cooperative Housing

Society, Karachi.

Manufactured by

M/s Micro Port Medical

(Shanghai) Co. Ltd.,

China.

Jive Stent (PTCA

Balloon Catheter)

Decontrolled till

policy decision

by the Policy

Board/ Federal

Government.

2

years

Reference

No.27/12/

Stent-Reg.

Dated:

26-12-2011.


30-B Sindhi Muslim

Cooperative Housing

Society, Karachi.

Manufactured by



China.

Firebird (Rapamycin

Eluting Stainless Steel

Coronary Stent

System)

Decontrolled till

policy decision

by the Policy

Board/ Federal

Government.

12

month

s

Reference

No.26/12/

Stent-Reg.

Dated:

26-12-2011.


30-B Sindhi Muslim

Cooperative Housing

Society, Karachi.

Manufactured by



China.

Firebird-2 (Rapamycin

Cobalt Chromium

Coronary Stent

System)

Decontrolled till

policy decision

by the Policy

Board/ Federal

Government.

09

month

s

Reference

No.30/12/

Stent-Reg.

Dated:

26-12-2011.


30-B Sindhi Muslim

Cooperative Housing

Society, Karachi.

Manufactured by


(Shanghai) Co. Ltd., China.

Mustang Stent

(Stainless Steel

Coronary Stent

System)

Decontrolled till

policy decision

by the Policy

Board/ Federal

Government.

2

years

Reference

No.28/12/

Stent-Reg.

Dated :

26-12-2011.

451

5. M/s. Intek Corporation,

Rawalpindi. /

Manufacturer:

M/s. OrbusNeich

Medical B.V. Drs, W.

Van Royenstraat, AN

Hoevelaken, The

Netherlands.

Shipped From:-

M/s. Asia Cardiovascular

Products Ltd., Kwai

Chung, N.T. Hong Kong.

Blazer CoCr Alloy

Coronary Stent

Delivery System

(Cobalt Chromium

Stent).

(Medical Device).

Decontrolled till policy decision by the Policy

Board/ Federal Government.

24

months

The firm has

informed that

further action

on this

product is no

more

required.

Decision: Registration Board considered the request of the firms for withdrawal of their

applications for registration of above mentioned medical devices and approved

the request.

Case No.03. Cancellatiuon of sole agency agreement.

M/s. A.H Distributors, Kh-1183, Lane No.5, Peshawar Road, Rawalpindi had

applied for registration of Primum Guiding Catheter and Pointer Angiographic Catheter for

import from foreign manufacturer i.e. Pendra Care International B.V Van der Waalspark 22 9351

VC leek the Netherlands. The importing firm was advised to complete the

documents/information including fresh authorization letter and differential fee as per revised fee

schedule but the importing firm has not responded till now. The authorization letter of principal

manufacturer in respect of importer M/s A.H Distributors, Rawalpindi was expired on 31-12-

2011. The manufacturer M/s Pendra Care International B.V Netherlands, has sent a termination

letter in respect of M/s A.H Distributors for the above mentioned products directly to Drug

Regulatory Authority of Pakistan. In the aforementioned letter the manufacturer has confirmed

that they terminated the business relationship with A.H Distributors, Rawalpindi.

Decision: The Board after thorough discussion decided that final reminder should be

issued to the firm for submission of all deficient documents including fresh

authorization letter from the principal manufacturer, attested by the

Embassy of Pakistan in the country of origin and the prescribed differential

452

fee. If the applicant fails to provide the aforesaid documents and prescribed

differential fee within 15 days, the above mentioned applications shall not be

entertained for registration.

Case No.04. Case remanded back by the Appellate Board.


meeting held on 7th

November, 2013 considered and

rejected the following medical device of M/s Mana & Co, Karachi due to the reason mentioned

below against the product:-

S.No. Name of Importer and


Name of Medical

Device

Demanded

price &

Pack size

Shelf

life

Decision

1. M/s Mana & Co,

204 New Medicine Market, Near

Densohall, Karachi.

Manufactured by

M/s Jiangxi Huali Medical

Instrument Co.Ltd. Yudu

Industrial Zone,Ganzhou, Jiangxi,

China.

Medicare IV

Catheter with

Injection Port.

Decontrolled

(14G, 16G,

18G, 20G,

22G, 24G )

5

years

Rejected due to

incomplete and

unsatisfactory

stability profile.

Rejection letter was issued to the importing firm. The said firm filed an appeal against the

decision of Registration Board before Appellate Board. The Appellate Board in its 142nd


June, 2014 decided as under:-

“The Board in light of the stability data submitted before it and taking a lenient view

decided to remand the case to the Registration Board for decision under the rules.”

Decision: Registration Board decided to ask the importing firm to submit complete

stability profile for the above mentioned device for review.

Case No.05 Miscellaneous Cases.

a. Relaxation in the condition of Drug (Labeling & Packaging) Rules, 1986. (Deferred

in 245th

meeting of Registration Board).

M/s Johnson & Johnson Pakistan (Pvt) Ltd, Karachi has requested for relaxation in

condition of Drug (Labeling & Packaging) Rules, 1986 i.e. Urdu version, Pak Registration

453

Number and MRP of their already registered imported Prowler Micro Catheters (Registration

No.074692).

The firm has submitted that Prowler family of Micro Catheters being labeled as

per the requirement of Medical Device directives 93/42, GHTF labeling recommendation. As

Prowler Micro Catheters belongs to sterile sensitive class of medical device and it is supplied in

sterile peel open packages after carrying out all recommended package integrity and sterility

validation tests. To ensure the sterility of product till it is received by key user, packaging

qualification testing is performed on all Prowler Micro Catheters which are packaged in a

preformed tray, sealed in packaging pouch and placed in a folding carton. The same sterilized

pack being supplied in all International countries. The firm has deposited the required fee for

above mentioned product.

The firm has further submitted that the demand forecast of Prowler Micro Catheters in

Pakistan is only 1% of the global supply, so it is not viable for their Principal manufacturer to

produce country specific packs for such a small volume. Therefore, the firm requested for the

following approval:-

“That they may be allowed to import Prowler Micro Catheters in international

packs provided that company will perform ink jet printing of Urdu version, Pak

Registration No. and maximum retail price at their locally licensed premises.”

The case was placed before Registration Board in its 245th

meeting and the Board

deferred the case and decided to call the firm M/s Johnson and Johnson Pakistan (Pvt) Ltd,

Karachi for personal hearing alongwith samples of the product in the forthcoming meeting of the

Board. Accordingly letter was issued to the firm for personal hearing alongwith provision of

samples.

Decision: Registration Board deferred the case and decided to call the firm M/s Johnson

and Johnson Pakistan (Pvt) Ltd, Karachi for personal hearing alongwith

samples of the product in the next meeting of the Board.

454

b. Inspection of Manufacturer Abroad M/s Biosensors Interventional Technologies Pte

Ltd., Kampong Ubi, Industrial Estate, Singapore.


meeting held on 5TH

& 6TH

August, 2013

considered and approved the following medical devices of M/s Promed International, Islamabad

subject to inspection of manufacturer abroad, local storage facility etc:-

S.

No


Manufacturer/Exporter

Name of Medical Device

(s)

Demanded

Price &

Pack Size

Shelf

Life

1. M/s. Promed International,

Ground Floor, Jamil Mohsin

Mansion, G-6 Markaz,

Islamabad.

Manufacturer:

Biosensors Interventional

Technologies Pte Ltd.,

Kampong Ubi, Industrial

Estate, Singapore.

Power Line TM

PTCA

Catheter

Balloon Dia (mm):

1.5, 2.0, 2.5, 2.75, 3.0,

3.5, 4.0.

Balloon Length (mm):

10,15, 20, 25, 30.

(Many product codes)

Decontrolled

1’s

36

months




Islamabad

Legal Manufacturer:

Biosensors Europe SA, Ch-

1110 Morges, Switzerland.

Manufacturing Site:




Estate, Singapore.

Bio Matrix TM

Drug

Eluting Coronary Stent

System.

Stent Inner Dia (mm):

2.25, 2.5, 2.75, 3.0, 3.25,

3.50, 4.0.

Stent Length (mm):

8, 11, 14, 18, 23, 24, 28.


Decontrolled

1’s

19

months




Islamabad

BioMetrix Flex TM

Drug

Eluting Coronary Stent

System

Stent Inner Dia (mm):

Decontrolled

1’s

24

months

455

Legal Manufacturer:

Biosensors Europe SA, Ch-1110

Morges, Switzerland.

Manufacturing Site:


Technologies Pte Ltd., Kampong

Ubi, Industrial Estate,

Singapore.

2.25, 2.5, 2.75, 3.0, 3.50,

4.0.

Stent Length (mm):

8, 11, 14, 18, 24, 28, 33,

36.





Islamabad

Legal Manufacturer:

Biosensors International Pte.

Ltd, 21 Kallang Avenue,

Singapore Manufacturing

Site:




Estate, Singapore.

Gazelle Coronary Stent

System

Stent Dia (mm):

2.25, 2.5, 2.75, 3.0, 3.25,

3.50, 4.0.

Stent Length (mm):

8, 11, 14, 18, 23, 24, 28.


Decontrolled

1’s

24

months

Accordingly the inspection of manufacturer abroad has been carried out by the panel

comprising Mr. Sayyad Hussain Khan, DDC (LA) and Ms. Sara Mehreen, ADC, DRAP,

Islamabad on 1st and 2

nd September, 2014. The panel has not recommended the products for

registration on the basis of following major concerns:-

(i) Firm is importing stents in finish form either from Germany or from China. So

there was no way to verify their manufacturing standard.

(ii) Sterility testing is outsourced and either performed in Malaysia or Germany. So

the panel was not able to check the process of sterilization for the applied

products. However, final release of the products is firm itself.

(iii) As the firm was shifting to their own constructed new premises and few

operations including microbiological testing had already been shifted to the new

premises. So the panel was not able to check their microbiological testing

process as inspection of new premises was not the mandate of the panel.

(iv) One of the applied products namely BioMatrix Flex Drug Eluting Coronary Stent

is not on free sale in the country of origin, which is one of the conditions for

registration of imported drugs in Pakistan.

456

Decision: Regiastration Board discussed the inspection report in detail and keeping in

view nature of the observations being critical rejected the above applications of M/s.

Promed International, Iislamabad manufactured by M/s. Biosensors Interventional

Technologies Pte Ltd., Kampong Ubi, Industrial Estate, Singapore.

457

Item No.X: Local Manufacturing of Biological Drugs.

The following cases for the local manufacturing biological drugs were decided in the

244th

Meeting of the Drug Registration Board. The details of the cases and decisions taken by the

Drug Registration Board in its 242nd

, 243rd

and 244th

Meeting are as below: -

Sl.# Applicant Product Specifications

1. Getz Pharma, Karachi. Eptifib Solution for Infusion 75mg/100ml

2. Getz Pharma, Karachi Eptifib Solution for Injection 20mg/10ml

3. Getz Pharma, Karachi

Enoxa Injection 20mg/0.2ml Injection Each Pre-filled

syringe


Enoxa 40mg/0.4ml Injection

Each Pre-filled syringe








Gilia solution for injection

Glatiramer acetate 20mg/ml


Lira Solution for injection

6mg/ml Solution for Injection in Cartridge

9. Getz Pharma, Karachi . Menocon

Lyophilized Powders for Injection 1000 IU

USP


Menocon Lyophilized Powders for Injection 5000 IU

USP

11. Getz Pharma, Karachi Menoget

Menotropins 75IU /2ml vial


Menoget

Menotropins 150IU / 2ml vial

13. Getz Pharma, Karachi Neupeg injection

458

14. Getz Pharma, Karachi Getiferon

Solution for Injection

3 MIU in Vials


Getiferon

Solution for Injection 5MIU in Vials



3 MIU in Pre-Filled Syringes Each Pre-

Filled



5 MIU in Pre-Filled Syringes


Uniferon Solution for Injection

3 MIU in Vials



5 MIU in Vials



3MIU in Pre-Filled Syringe



5MIU in Pre-Filled Syringes

22. Getz Pharma Unipeg 80 Solution injection 180mcg/mL

in vial

23. Getz Pharma Unipeg 40 Solution injection 180mcg/0.5

mL in Prefilled Syringe

24. Getz Pharma Unipeg Solution injection 180mcg/mL in

vial

25. Getz Pharma Unipeg Solution injection 180mcg/0.5mL

in Prefilled syringe

Applicant Product Specifications

26. Macter International

Limited, Karachi

Heberon 2a Injection 3MIU/0.3ml.

(Liquid Solution)


Limited, Karachi

Heberon 2a Injection 5MIU/0.5ml.

(Liquid Solution)


Limited, Karachi

Heberon 2a Injection 3MIU/ml

(Lyophilized Powder)


Limited, Karachi

Heberon 2a Injection 5MIU/ml


459


Limited, Karachi

Peg-In Injection 50mcg /0.5ml



Limited, Karachi



Limited, Karachi




Limited, Karachi Peg-In Injection 120mcg /0.5ml



Limited, Karachi Peg-In Injection 150mcg /0.5ml



Limited, Karachi Neupeg 6mg/ml Injection Each vial

36. Macter International,

Karachi. Prance Injection Recombinant Human Basic Fibroblast

growth factor.

37. Macter International,

Karachi. Macgrastim Injection Pre-filled Syringe

Granulocyte colony stimulating factor.

Applicant Product specifications

38. Hilton Pharma (Pvt)

Ltd., Karachi.

Xiro Injection

Filgrastim 300ug


Ltd., Karachi. Lameo Injection 3MIU

Interferon alfa 2a


Ltd., Karachi. Lameo Injection 5MIU

Interferon alfa 2a

Applicant Product specifications

41. M/s Nextar Pharma

(Pvt) Ltd., Karachi

Nexfil 150 Injection


(Pvt) Ltd., Karachi

Nexfil 300 Injection

Each Prefilled syringe


(Pvt) Ltd., Karachi Pegaron Injection

460


(Pvt) Ltd., Karachi NP-POETIN 2000 INJECTION


(Pvt) Ltd., Karachi NP-POETIN 4000 INJECTION

Decision of 242nd

Meeting of Drug Registration Board. Product Approved, however, cGMP /

COPP is required of the finished Drug manufactured using this particular drug substance in the

country of origin. Biosimilarity data of locally manufactured drug needs to be disclosed by the

local manufacturer. However the minutes of the meeting were quarantine due to observation of

members of Drug Registration Board.

Decision of 243rd

Meeting of Drug Registration Board: - Decision recorded in 242nd

Meeting

upheld. Further, all firms will submit Bio-comparability data followed by regular Pharmaco-

vigilance report.

Final Decision of the Drug Registration Board in its 244th

Meeting: -

“ a) Biosimiliarity is the principal requirement for the registration of biological

drugs, as it is part of requirements of DRAP Act, 2012 mainly focusing on

patient safety and also to promote biological production and availability of

biological products.

b) All those manufacturing units which have been approved by Central

Licensing Board for manufacturing of biological drugs and also had

qualified product specific inspection by panel of Registration Board, are

allowed registrations of applied biological drugs for local manufacturing on

case to case basis. Item for which product specific inspection is required,

then it will be conducted by already constituted panel of Registration Board.

c) Local manufacturer will provide legalized documents from concerned

regulatory body confirming the status of licensed manufacturer of

concentrate/bulk source in its country of origin. Moreover manufacturer

will provide legalized documents for confirmation that finished product is

also available in market from the same biological material. Case will be

processed for issuance of registration letter after fulfillment of above

mentioned requirements, with following conditions:

i. Registration is exclusively for trial manufacturing of the drug and

manufacturer shall not be allowed in any way to sale/utilize these

trial manufactured drugs. Manufacturer will perform biosimilarity

studies as per WHO guidelines confirming the biosimilarity of

applied product to original innovator product.

ii) Manufacturer will submit actual result of conducted biosimilarity

studies to the Biological Division for its scientific evaluation

through Expert Committee on Biological Drugs (ECBD).

Moreover manufacturer will also provide sufficient quantity of

these trial manufactured drugs to Biological Division for testing by

461

National Control Laboratory for Biological (NCLLB) as per WHO

guidelines.

iii) Recommendation of ECBD and report of NCLB will be submitted

to Registration Board for permission of commercial manufacturing

of the product or otherwise.

d) This decision supersedes all the already taken decisions so far in the

earlier meetings of Registration Board on the subject cases”.

The decision of the Board was communicated to the concerned companies. In response to

which the companies have submitted documents. The documents of M/s Nextar, Karachi were

complete and inspections of the company already conducted supported the trial manufacturing of

biological products. Accordingly trial production of 04 products out of 05 products (for one

product COPP was missing) was allowed to the company. Product specific inspection of the

company has not been conducted. The Board may decide the requirement of product specific

inspection of the company.

The documents of M/s Getz Pharma, Karachi required further support (COPP not provided) of

their case and under process while M/s Hilton has not responded yet. Two products of M/s

Macter Pharma, Karachi i.e., Prance and Macgrastim are to be imported in the form of

labelled finished vial and repacked locally which may be dealt as per procedures of import policy

for finished drugs. For rest of the products the documents submitted by the company are under

review.

The case of local manufacturing of biological drugs was also under examination of

Honourable Ombudsman on the complaint of M/s Macter International, Karachi. The

findings/recommendations of the Honourable Wafaqi Mohtasib are as below: -

The record of DRAP showed that more than 300 drugs of similar formulation

were freely available in the market. Moreover, DRAP had already

registered/approval more than 500 vaccines. The complainant’s case was

approved in 243rd

board meeting with certain conditions which the complainant’s

fulfilled. He was never informed as to why without assigning any reason new

conditions were imposed. It was surprising to note that although the decision of

243rd

meeting had become final and the minutes were displayed on DRAP Website

yet again the earlier decision was revised in 244th

Board meeting and fresh

stringent requirements were proposed. The record also indicates that the drugs

registration board did not work in a systematic and organized manner. The

complainant’s case was examined and scrutinized by an expert committee and

cleared by the drug registration board which included technical experts and

eminent health professionals. It was noteworthy that the conditions prevalent at

the time of submission of application by the complainant were met and

subsequently additional conditions were applied retrospectively which was an

unfair practice. New conditions could only have been applied to fresh application.

After finalization of the decision of the 243rd

Drug Registration Board Meeting,

imposition of a new condition by DRAP tantamount to mal-administration in

462

terms of Article 2(2) of the President’s Order No.1 of 1983. It is therefore,

recommended that: -

1) The complainant’s product be registered in line with the decision of

243rd

board meeting and already done in the case of more than 300

registered biological products which are already being manufactured

in accordance with previous requirements.

2) There should be no discrimination and the complainant be allowed a

time frame as had been granted to other manufacturers of registered

biological products to bring their products in conformity with the new

requirements.

Compliance should be reported within 30 days of the receipt of a copy of these

findings or the reasons for not doing so be submitted in terms of Article 11(2) of

the President’s Order No 1 of 1983. Under provision of Article 11(2A) of P.O. 1

of 1983 read with section 13 of Federal Ombudsmen Institutional Reforms Act,

2013 and Article 32 of P.O. 1 of 1983 under which any person, aggrieved by a

decision or an order by the Wafaqi Mohtasib may also, within thirty days: -

(a) File a review petition before the Wafaqi Mohtasib; or

(b) Make a representation to the President.

Discussion:

On the direction of the Honorable Ombudsman, the case was taken up by the Drug

Registration Board on priority.

The matter related to local manufacturing of biological drugs was discussed on 10th

December, 2014 in the meeting. The Board discussed / examined in detail its earlier decisions

taken in 243rd

and 244th

Registration Board meeting regarding registration of biological drugs.

The Board observed that there is no difference in both decisions and in later meeting (244th

), the

Board only devised implementation process for decision taken in 243rd

meeting. The members of

the Board also examined the decision of Honorable Ombudsman and the whole matter of local

manufacturing of biological drugs was re-examined with holistic approach, keeping in view

ensuring the public health and safety, efficacy, quality of locally manufactured biological drugs.

It was also agreed by the Board that these local manufacturers (M/s. Macter International

Karachi, M/s. Getz Pharma Karachi, M/s. Nextar Pharma, Karachi and M/s. Hilton Pharma,

Karachi) will be provided an opportunity for appraising their views with the Registration Board

on next day.

Following representatives of four manufacturers attended the meeting for presentation of

their case.

463

i. Mr. Abdur Jabbar Saya (M/s. Nextar, Karachi)

ii. Syed Asghar Abbass Alve (M/s. Nextar, Karachi)

iii. Mr. Saleem Riaz (M/s. Hilton Pharma, Lahore)

iv. Dr. Salman Ahmad (M/s. Macter Pharma, Karachi)

v. Mr. Farooq Mustafa (M/s. Macter Pharma, Karachi)

vi. Mr. Zeeshan Ahmad (M/s. Getz Pharma, Karachi)

vii. Mr. Ayub Malik (M/s. Getz Pharma, Karachi)

viii. Mr.Shamim Ahmad, PPMA representative for the meeting

The firms unanimously presented / argued that Registration Board previously did not implement/

demand CoPP/ Free sale certificate from local manufacturer of biological drugs. But now only

GMP certificate of the foreign manufacturer can be provided which should be accepted by the

Drug Registration Board. Moreover, the condition of providing bio-similarity data should not be

imposed as per previous practice of the Registration Board for already registered locally

manufactured drugs as this condition will result in further delay which can be very damaging to

new biopharmaceutical units. Condition of clinical studies should not be imposed. The

manufacturer shall ensure the quality, safety and efficacy of locally manufactured biological

drugs by them.

Representatives of the firms, PPMA and Pharma Bureau re-iterated that already

registered biological drugs may be re-assessed in light of safety, efficacy and quality parameters.

Decision: After all detailed discussion and directions of the Ombudsman, Registration

Board decided as follows:

1. As the Registration Board in 244th

meeting has already approved registration of

biological drugs for four manufacturers (M/s. Macter International Karachi, M/s.

Getz Pharma Karachi, M/s. Nextar Pharma, Karachi and M/s. Hilton Pharma,

Karachi) for local manufacturing. In order to issue registration letter, the Board

advised these manufacturers to provide following document as discussed and agreed

during the deliberations with manufacturers:

a. The firms shall provide legalized GMP certificate of biological drug

manufacturer abroad (who will provide concentrate / ready to fill bulk of

biological drug to Pakistani manufacturers for further processing) as an

evidence that the manufacturer is an authorized manufacturer of that

particular biological drug in its country of origin.

464

b. The firm shall provide studies conducted by manufacturer abroad (dully

verified with statement for correctness / genuineness of data) regarding

structural similarity of subject biological drug product (concentrate/ ready to

fill bulk for further processing) with reference biological product

(innovator).

c. The local manufacturer shall be authorized to manufacture the finished

biological product and then perform bio-comparability studies including

identity testing to parent molecule, purity testing, in vitro biological activity,

potency and toxicity with support of iso-electro focusing data, gel

electrophoresis, Western-Blot and other analytical techniques) and stability

studies of finished biological product. Data provided by the local

manufacturer shall be evaluated by the Expert Committee on Biological

Drugs. Recommendation of the committee shall be considered by the

Registration Board for issuance of registration letter.

d. The firms shall conduct parallel bio-similarity studies as per WHO

guidelines immediately after grant of registration and shall submit complete

studies with in two (2) years in any case. Manufacturer will provide progress

report to this effect to Directorate of Biological Drugs on quarterly basis.

e. Regular monitoring through pharmacovigilance reporting system shall be

observed through proper pharmacovigilance cell of the manufacturer and

report will be forwarded to the National Pharmacovigilance Centre, Division

of Pharmacy Services and Biological Division of DRAP. In case of any severe

adverse event, immediate mandatory reporting procedure shall be followed.

f. If any of the conditions is not fulfilled or public health risk reported at any

stage, the drug registration shall stand cancelled with immediate effect.

g. All the provisions as contained in the Drugs Act, 1976 and rules made there

under including provisions of Lot Release certification from National

Control Laboratory for Biologicals shall be strictly adhered to.

2. Already registered biological drugs shall be reviewed in the same manner.

3. New applications for registration of biological drugs shall be considered after

compliance of above point.

465

Item No.XI: Applications for transfer of registrations

Various firms (column II) have applied for transfer of registrations. Registration Board

on 10.12.2014 advised P E & R Division to bring such applications for its consideration. Various

applications were considered as per following details:

S. No. Name of

applicant(s)

Name of

existing

manufacturer

Date of

application,

Diary No . &

Form

Registration

No.

Name of product with

composition

I II III IV V VI

1. M/s

GlaxoSmithKlin

e Pakistan Ltd,

Kara

M/s Akhai

Pharmaceutical

s, Karachi

20-06-2014

Dy.No.594

Form-5

Rs.40000/-

017889 Traxon 1gm IM/IV

Injection


Ceftriaxone Sodium

…………..1gm

2. -do- -do- 20-06-2014

Dy.No.595

Form-5

Rs.40000/-

017890 Traxon 500mg IM/IV

Injection


Ceftriaxone Sodium

…………..500mg

3. -do- -do- 20-06-2014

Dy.No.596

Form-5

Rs.40000/-

017891 Traxon 250mg IM/IV

Injection


Ceftriaxone Sodium

…………..250mg

4. M/s Martin Dow

Ltd, Karachi

M/s Martin

Dow

Pharmaceutical

s (Pakistan)

Ltd, 45-KM,

Multan Road,

Lahore

10-02-2014

Dy.No.113

Form-5

Rs.20,000/-

027216 Biprofin Tablets


Flurbiprofen

…………..50mg

5. -do- -do- 10-02-2014

Dy.No.112

Form-5

Rs.20,000/-

027216 Biprofin Tablets


Flurbiprofen

…………..100mg

6. -do- -do- 10-02-2014

Dy.No.111

Form-5

Rs.20,000/-

049189 Fexinol-D Tablet


Pseudoephedrine HCl

…….120mg

466

Fexofenadine HCl

………. 60mg

7. -do- -do- 10-02-2014

Dy.No.110

Form-5

Rs.20,000/-

018485 Covatine Coated Tablet


Captodiamine HCl

……….50mg

8. -do- -do- 14-04-2014

Dy.No.341

Form-5

Rs.20000/-

042810 Fexinol Tablets 30mg


Fexofenadine HCl

……30mg

9. -do- -do- 14-04-2014

Dy.No.342

Form-5

Rs.20000/-

024311 Fexinol capsule


Fexofenadine HCl

……80mg

10. -do- -do- 14-04-2014

Dy.No.340

Form-5

Rs.20000/-



Fexofenadine HCl

……120mg

11. -do- -do- 14-04-2014

Dy.No.343

Form-5

Rs.20000/-



Fexofenadine HCl

……180mg

12. M/s Novartis

Pharma

(Pakistan) Ltd,

(DML

No.000193),

West Wharf

Road, Karachi

M/s Novartis

Pharma

(Pakistan) Ltd,

(DML

No.000010),

Jamshoro.

24-06-2014

Dy.No.636

Form-5

Rs.20,000/-

18-09-2014

Dy.No.800

Rs.80,000/-

022204 Lozal 20mg Capsule


Omeprazole

…………..20mg

13. M/s Elko

Organization

(Pvt.) Ltd,

Karachi

M/s Macquin’s

International,

Karachi

12-11-2013

Dy.No.1003

Form-5

Rs.20,000/-

048507 Aqua Teas Eye Drops

Each ml contains:-

Dextran………1mg

HPMC……….3mg

Glycerin……...2mg

(Manufacturer’s

467

Specification)

14. -do- -do- 12-11-2013

Dy.No.1003

Form-5

Rs.20,000/-

044457 MetaDex Eye / Ear

Drop

Each ml contains:-

Ciprofloxacin…..3mg

Dexamethasone..1mg

(Manufacturer’s

Specification)

15. -do- -do- 12-11-2013

Dy.No.1003

Form-5

Rs.20,000/-

044449 Blepharite Eye Drop

Each ml contains:-

Sulfacetamide…0.10g

Prednisolone

Acetate.…..2mg

Phenyephrine

HCl……..1.2mg

(Manufacturer’s

Specification)

16. M/s

GlaxoSmithKlin

e Pakistan Ltd,

F-268, S.I.T.E,

(DML

No.000233)

Karachi

M/s AGP (Pvt.)

Ltd, Karachi

26-06-2013

Dy.No.1084

Form-5

Rs.20,000/-

015027 Atarax Syrup

Each 5ml contains:-

Hydroxyzine

Dihydrochloride..10mg

17. -do- -do- 26-06-2013

Dy.No.1084

Form-5

Rs.20,000/-

007591 Atarax Tablet 10mg


Hydroxyzine


18. -do- -do- 26-06-2013

Dy.No.1084

Form-5

Rs.20,000/-

002287 Navidoxine Tablet


Meclozine


Pyridoxine

Hydrochloride..50mg

19. -do- -do- 26-06-2013

Dy.No.1084

Form-5

Rs.20,000/-

034675 Xyzal Tablet


contains:-

Levocetirizine

468

Dihydrochloride………

…….5mg

20. -do- -do- 26-06-2013

Dy.No.1084

Form-5

Rs.20,000/-

016937 Zyrtec Syrup

Each ml contains:-

Cetirizine 2HCl

………….1mg

21. -do- -do- 26-06-2013

Dy.No.1084

Form-5

Rs.20,000/-

011020 Zyrtec Tablet 10mg


Cetirizine 2HCl

………….1mg

22. M/s Bosch

Pharmaceuticals

(Pvt.) Ltd,

(DML

No.000707),

Karachi (Plant-

II)

M/s Bosch

Pharmaceutical

s (Pvt.) Ltd,

(DML

No.000350),

Karachi (Plant-

I)

12-03-2014

Dy.No.190

Form-5

Rs.20,000/-

037306 Ambac Injection 0.75gm

Each vial contains:

Ampicillin sodium USP

eq. to

Ampicillin…….500 mg

Sulbactam Sodium USP

eq. to

Sulbactam……250 mg

23. -do- -do- 12-03-2014

Dy.No.188

Form-5

Rs.20,000/-

037629 Ambac Injection 1.5gm

Each vial contains:

Ampicillin sodium USP

1.06gm eq. to

Ampicillin………1gm


0.545gm eq. to

Sulbactam……500 mg

24. -do- -do- 12-03-2014

Dy.No.189

Form-5

Rs.20,000/-

042424 Bactamox Plus 0.75gm

Injection

Each vial contains:

Amoxicillin Sodium (as

Amoxicillin Sodium

Anhydrous)B.P …0.50

gm


….0.25gm

(USP Specification)

25. -do- -do- 12-03-2014

Dy.No.187

Form-5

042425 Bactamox Plus 1.5gm

Injection

Each vial contains:

469

Rs.20,000/- Amoxicillin Sodium (as

Amoxicillin Sodium

Anhydrous)B.P …1.0

gm


….0.5gm

(USP Specification)

26. -do- -do- 12-03-2014

Dy.No.186

Form-5

Rs.20,000/-

042426 Bactamox Plus 3gm

Injection

Each vial contains:

Amoxicillin Sodium (as

Amoxicillin Sodium

Anhydrous) B.P …2.0

gm


….1.0gm

(USP Specification)

27. -do- -do- 12-03-2014

Dy.No.185

Form-5

Rs.20,000/-

015906 Boschoclox Injection

250mg

Each vial contains:

Cloxacillin Sodium USP

eq. to 250mg

Cloxacillin Base

28. M/s

GlaxoSmithKlin

e Pakistan Ltd,

Korangi Plant

Karachi

M/s

GlaxoSmithKli

ne Pakistan

Ltd,

West Wharf,

Karachi

14-06-2012

Dy.No.315

Form-5

Rs.8,000/-

29-04-2013

Rs.12000/-

0001859 Kenacomb Cream


Triamcinolone

Acetonide USP …1mg

Nystatin USP

………….100,000 units

Gramidicin USP

………...0.25mg

29. -do- -do- 14-06-2012

Dy.No.314

Form-5

Rs.8,000/-

29-04-2013

Rs.12000/-

005026 Kenacomb Ointment


Triamcinolone

Acetonide USP ….1mg

Nystatin USP

………….100,000 units

Gramidicin USP

……………...0.25mg

470

Neomycin Sulphate eq.

to 2.5mg base

30. -do- -do- 14-06-2012

Dy.No.316

Form-5

Rs.8,000/-

29-04-2013

Rs.12000/-

009452 Kenalog Orabase

Ointment


Triamcinolone

Acetonide USP ….1mg

31. M/s Hilton

Pharma, Karachi

M/s Brookes

Pharma,

Karachi

11-07-2013

Dy.No.692

Form-5

Rs.20,000/-

021661 Zinum 250mg Injection


Ceftazidim Sodium

……….250mg

32. -do- -do- 11-07-2013

Dy.No.693

Form-5

Rs.20,000/-

021662 Zinum 500mg Injection


Ceftazidim Sodium

……….500mg

33. -do- -do- 11-07-2013

Dy.No.697

Form-5

Rs.20,000/-

021663 Zinum 1gm Injection


Ceftazidim Sodium

……….1gm

34. -do- -do- 11-07-2013

Dy.No.696

Form-5

Rs.20,000/-

021664 Axone 250mg Injection


Ceftriaxone Sodium

…….250mg

35. -do- -do- 11-07-2013

Dy.No.699

Form-5

Rs.20,000/-

021665 Axone 500mg Injection


Ceftriaxone Sodium

…….500mg

36. -do- -do- 11-07-2013

Dy.No.695

Form-5

Rs.20,000/-

021666 Axone 1gm Injection


Ceftriaxone Sodium

…….1gm

37. M/s Indus

Pharma, Karachi

M/s Nimrall

Laboratories,

Islamabad

05.11.2014

Dy.No.394

Form-5

054553 Rudra 5mg Tablet


Rosuvastatin (as

471

Rs.20,000/- Calcium) …….5mg

38. -do- -do- 05.11.2014

Dy.No.395

Form-5

Rs.20,000/-

054554 Rudra 10mg Tablet


Rosuvastatin (as

Calcium) …….10mg

39. M/s Sante (Pvt.)

Ltd, Karachi

M/s Elko

Organization

(Pvt.) Ltd,

Karachi

18-09-2014

Dy.No.657

Form-5

Rs.20,000/-

070516 Dequsan Throat / Mouth

Spray Solution


Dequalinium Chloride

BP………15mg

Benzalkonium Chloride

BP………..35mg

40. M/s Pfizer

Pakistan Ltd,

DML

No.000025

(Formulation) at

B-2, SITE,

Karachi

M/s wyeth

Pakistan Ltd.,

Karachi

contract

manufactured

by M/s Spencer

& Co

(Pakistan) Ltd,

Karachi.

06-02-2014

Dy.No.68

Form-5

Rs.20,000/-

000083 Ativan 1mg Tablets

(Lorazepam)

41. -do- -do- 06-02-2014

Dy.No.68

Form-5

Rs.20,000/-

000084 Ativan 2mg Tablets

(Lorazepam)

42. M/s Ambrosia

Pharmaceuticals

, Rawat

M/s Spencer &

Co, Karachi

29-10-2014

Dy.No.634

Form-5

Rs.20,000/-

006348 Calcipan-T 50 mg

Tablet


Calcium

Pantothenate……..50

mg

43. -do- -do- 29-10-2014

Dy.No.635

Form-5

Rs.20,000/-

067454 Infacol 40 mg Drops

Each ml contains:-

Simethicone

…………40 mg

44. -do- -do- 29-10-2014

Dy.No.633

Form-5

008801 Infacol Suspension


Dicyclomine HCl

……….5 mg

472

Rs.20,000/- Simethicone ………

…50 mg

45. M/s Glitz

Pharma,

Islamabad

M/s Caraway

Pharmaceutical

, Rwat

784; 09.12.2014

Rs.50000/-

Form 5

066362 G-Cal 5 mg Injection

Each ampoule contains:-

Cholecalciferol eq. to

Cholecalciferol

……………. 5 mg

46. M/s Focus &

Rulz, Islamabad

M/s Highnoon

Labs, Lahore

970; 10.12.2014

Rs.20000/-

Form 5

027104 Helezol 20 mg Capsule

Each delayed-release

capsule contains:-

Omeprazole enteric

coated pellets 8.5%

≡ Omeprazole……. 20

mg

47. -do- -do- 976; 10.12.2014

Rs.20000/-

Form 5

051054 Helezol 40 mg Capsule


capsule contains:-

Omeprazole enteric

coated pellets 8.5%

≡ Omeprazole……. 40

mg

48. -do- -do- 971; 10.12.2014

Rs.20000/-

Form 5

025098 Angiocard 2.5mg

Capsule

Each sustained-release

capsule contains:-

Nitroglycerin SR Pellets

≡ Nitorglycerin……..2.5

mg

49. -do- -do- 969; 10.12.2014

Rs.20000/-

Form 5

025099 Angiocard SR 6.5 mg

Capsule


capsule contains:-

Nitroglycerin SR Pellets

≡ Nitorglycerin……..6.5

mg

50. -do- -do- 974; 10.12.2014

Rs.20000/-

Form 5

024929 Artonec 50 mg Capsule


capsule contains:-

Diclofenac Sodium


≡ Diclofenac Sodium

…... 50 mg

473

51. -do- -do- 972; 10.12.2014

Rs.20000/-

Form 5

024930 Artonec SR-100 Capsule


capsule contains:-

Diclofenac Sodium

sustained release coated

pallets

≡ Diclofenac Sodium

….100 mg

52. -do- -do- 973; 10.12.2014

Rs.20000/-

Form 5

027105 Neopres 5 mg Tablet


Amlodipine Besylate eq.

to

Amlodipine……….5mg

53. -do- -do- 968; 10.12.2014

Rs.20000/-

Form 5

027106 Neopres 10 mg Tablet


Amlodipine Besylate eq.

to Amlodipine…10 mg

54. -do- -do- 975; 10.12.2014

Rs.20000/-

Form 5

051057 Delergic 5 mg Tablet


contains:-

Desloratidine……..5 mg

55. M/s. Synchro

Pharmaceutical

s Lahore

M/s. Obsons

Pharmaceutic

als, Lahore

05-06-2013

926

Form-5

059991 Obdin Tablet 5mg


Desloratadine…. 5mg 56. -do- -do-

05-06-2013

5549

Form-5

025404 Azrocin Suspension

Each 5ml contains:-

Azithromycin

dihydrate eq. to

Azithromycin.. 200mg 57. -do- -do- 05-06-2013

5548

Form-5

054157 Obflox Tablet


Levofloxacin

Hemihydrate

equivalent to

Levoflocaxin

…………. 500mg 58. -do- -do- 05-06-2013

5547

Form-5

030488 Obflox Tablet


Levofloxacin

Hemihydrate

equivalent to

Levoflocaxin

474

…………. 250mg 59. -do- -do- 05-06-2013

5554

Form-5

054166 Obpra Capsule 40mg

Each capsule

contains:-

Enteric coated pellets

of Esomeprazole

magnesium trihydrate

eq. to Esomeprazole

…………… 40mg 60. -do- -do- 05-06-2013

5552

Form-5

029834 Vincam Capsule 20mg

Each capsule

contains:-

Piroxicam…… 20mg 61. -do- -do- 05-06-2013

5551

Form-5

025406 Rubinol Tablet


Flurbiprofen.. 100mg 62. -do- -do- 05-06-2013

5553

Form-5

025403 Azrocin Capsule

Each capsule

contains:-

Azithromycin

dihydrate….. 250mg 63. -do- -do- 05-06-2013

5550

Form-5

054153 LevortizinTablet


Leocetirizine

dihydrate 5mg 64. -do- -do- 05-06-2013

5555

Form-5

054165 Obpra Capsule

Each capsule

contains:-

Esomeprazole

magnesium trihydrate


equivalent to

Esomeprazole

…………. 20mg 65. M/s. Searle IV

Solutions

(Pvt.) Ltd;

Lahore

M/s. the

Searle

Company,

Karachi

22-04-2014

780

Form-5

018632 Metronzine Injection

Each 100 ml

contains:-

Metronidazole

……….. 500 mg

66. -do- -do- 22-04-2014

783

Form-5

044077 Vaptor 20 mg Tablets


Rosuvastatin (as

Calsium) 20 mg

475

67. -do- -do- 22-04-2014

790

Form-5

047384 Searl-α 0.5 mcg

Tablets


Alfacalcidol

……………0.5 mcg

68. -do- -do- 22-04-2014

778

Form-5

047391 Rhulef 20 mg Tablets

Each film coated

tablet contains:-

Leflunomide

…………. 20 mg

69. -do- -do- 22-04-2014

782

Form-5

014408 Gravinate Injection

Each ml contains:-

Dimenhydrinate

………… 50 mg

70. -do- -do- 22-04-2014

779

Form-5

047383 Searl- α 1 mcg Tablet


Alfacalcidol

……………….. 1 mcg

71. -do- -do- 22-04-2014

797

Form-5

067114 Peditral Liquid


Sodium Chloride

…...... 17.50 mg

Potassium Chloride

…… 7.50 mg

Trisodium Citrate

Dihydrate .. 14.5 mg

Dextrose… 100.00 mg

(Flavour: Orange)

72. -do- -do- 22-04-2014

781

Form-5



Sodium Chloride ......

17.50 mg

Potassium Chloride

…… 7.50 mg

Trisodium Citrate

Dihydrate .... 14.5 mg


(Flavour: Regular)

73. -do- -do- 22-04-2014 047390 Rhulef 10 mg Tablets

476

787

Form-5

Each film tablet

contains:-

Leflunomide…. 10 mg

74. -do- -do- 22-04-2014

789

Form-5

047382 Searl- α 0.25 mcg

Tablet


Alfacalcidol….0.25

mcg

75. -do- -do- 22-04-2014

791

Form-5

058022 Co-Olesta Tablet


Olmesartan…... 20 mg

Hydrochlorothiazide

….. 12.5 mg

76. -do- -do- 22-04-2014

792

Form-5

044075 Vaptor Tablets


Rosuvastatine (as

Calcium) 5 mg

77. -do- -do- 22-04-2014

793

Form-5

050736 Olesta 20 mg Tablet


Olmesartan

Medoxomil … 20 mg

78. -do- -do- 22-04-2014

794

Form-5

050737 Olesta 40 mg Tablet


Olmesartan

Medoxomil … 40 mg

79. -do- -do- 22-04-2014

795

Form-5



Sodium Chloride ……

17.50 mg

Potassium Chloride

….. 7.50 mg

Trisodium Citrate

Dihydrate .. 14.5 mg


(Flavour: Banana)

80. -do- -do- 22-04-2014

796

Form-5



Sodium Chloride ……

477

17.50 mg

Potassium Chloride

….. 7.50 mg

Trisodium Citrate

Dihydrate….. 14.5 mg

Dextrose...100.00 mg

(Flavour: Bubble gum)

81. -do- -do- 22-04-2014

798

Form-5

058023 Co-Olesta Tablet


Olmesartan ... 40 mg

Hydrochlorothiazide

….. 12.5 mg

82. -do- -do- 22-04-2014

783

Form-5

044048 Simbex Tablets


Simvastatin …. 10 mg

Ezetimibe …… 10 mg

83. -do- -do- 22-04-2014

783

Form-5

044076 Vaptor Tablet


Rosuvastatin (as

Calcium) 10 mg

84. -do- -do- 22-04-2014

786

Form-5

044049 Simbex Tablets


Simvastatin.. 20 mg

Ezetimibe …… 10 mg

85. -do- -do- 22-04-2014

788

Form-5

047389 Rhulef 100 mg Tablets


Leflunomide

…………… 100 mg

86. -do- -do- 22-04-2014

876

Form-5

060631

Requested for

change of

name

Levomac Infusion

Each 100 ml

contains:-

Levofloxacin.. 500 mg

87. -do- -do- 22-04-2014

781

Form-5

060632

Requested for

change of

name

Moxirains Infusion

Each 250 ml

contains:-

Moxifloxacin as HCl

…… 400 mg

(Mac & Rains Specs)

88. M/s. The M/s. The 23-10-2013 018627 Sermol Suspension

478

Searle

Company

Limited 32-

Km Multan

Road, Lahore

(DML #

000647)

Searle

Company

Limited F-

319, S.I.T.E,

Karachi

(DML #

000016)

487

Form-5

Each 5ml contains:-

Paracetamol…..120mg

89. -do-

-do- 23-10-2013

486

Form-5

018628 Sermol Forte

Suspension

Each 5ml contains:-

Paracetamol

………….. 250mg

90. -do- -do-

23-10-2013

488

Form-5

018629 Sermol Tablet


Paracetamol ………..

500mg

91. M/s. Allmed

(Pvt.) Ltd;

Lahore at same

premises

M/s. Ever

Green

Pharmaceutic

als (Pvt.) Ltd;

Plot No. 509

Sundar

Industrial

Estate, Lahore

21-02-2013

469

Form-5

052455 Hemfil Syrup

Each 5ml contains:-

Iron Polymaltose

complex eq. to

Elemental Iron

…………….. 50mg

92. -do- -do- -do- 052434 Hemifim-F Tablet


Iron hydroxide

Polymaltose complex

…. 100mg

Folic Acid … 0.35mg

93. -do- -do- -do- 059964 Uriflow Capsule

Each capsule

contains:-

Tamsulosin

Hydrochloride

…………….. 0.4mg

94. -do- -do- -do- 052462 Protx 20mg Capsuel

Each capsule

contains:-

Esomeprazole

……………… 20mg

479

95. -do- -do- -do- 052460 Protx 40mg Capsuel

Each capsule

contains:-

Esomeprazole

……………… 40mg

96. -do- -do- -do- 052422 Everlom-400 Tablet


Lomefloxacin as HCl

….. 400mg

97. -do- -do- -do- 063136 Ichunil D Syrup


Pseudeophedrine

(HCl) . 13.3mg

Phlocodine ... 3.33mg

Paracetamol … 200mg

98. -do- -do- -do- 063135 Ichunil D Syrup


Pseudeophedrine

(HCl) . 13.3mg

Phlocodine . 3.33mg

Paracetamol… 200mg

Diphenhydramine

…….. 3.33mg

99. -do- -do- -do- 052424 Okcin-200 Tablet


Ofloxacin …. 200mg

100. -do- -do- -do- 052440 Meamin Capsule

Each capsule

contains:-

Mecobalamin..500mcg

101. -do- -do- -do- 067918 Everlose Syrup

Each 5ml contains:-

Lactulose …. 3.35mg

102. -do- -do- -do- 067898 Methemin Injection

Each ml contains:-

Mecobalamin..

500mcg

103. -do- -do- -do- 052444 Itrdym Capsule

480

Each capsule

contains:-

Itraconazole ... 100mg

104. -do- -do- -do- 052461 Sopra-Praz Capsule

Each capsule

contains:-

Lansoprazole… 30mg


Cancellation of above registrations from name of manufactyrer (column II) except

item at S.No.45 as it is case for change of contract manufacturer.

Grant of above registrations in name of manufactyrer (column III). Chairman,

Registration Board will permit issuance of registration letter after evaluation /

completion of Form 5A as per check list approved by Registration Board, renewal

status and comments of Cost & Pricing Division about MRP of the drug.

Meeting ended with a vote of thanks to and from the chair.

______________________________________________________________________________

End of the Document