th meeting of drugs registration board held on …dra.gov.pk/userfiles1/file/download/rb/minutes of...

MINUTES OF 239th

MEETING OF DRUGS REGISTRATION BOARD HELD

ON 12th

September, 2013

239th

meeting of the Drugs Registration Board was held on 12th

September,

2013 in the Committee Room, Minitrsy of National Health Regulation Service &

Coordination Division, Local Government Building, G-5, 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. Prof.Dr.Rafi-uz-Zaman Saeed-ul-Haq. Dean,

University of Lahore, Islamabad

Member

2. Lt General (R) Karamat Ahmed Karamat.

Member

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

Basic Sciences Division, Foundation Medical

University, Rawalpindi.

awalpindi.

Member

4. Mr. A.Q. Javed Iqbal, Chief Pharmacist, PIMS,

Islamabad.

Member

5. Dr. Muhammad Arshad, President, Pakistan Veterinary

Medical Council

Member

6. Dr. Muhammad Khalid Khan

Director Drugs Testing Laboratory Government of

Khyber Pakhtoonkhwa, Peshawar.

Member

7. Muhammad Jamil Anwar


Punjab, Lahore.

Member

8. Dr.Amanullah Khan


Baluchistan, Quetta

Member

9. Sheikh Muhammad Idress


Sind, Karachi

Member

10. Dr.Noor Muhammad Shah

Director Medical Devices and Medicated Cosmetics,

DRAP

Member

2

11. Abdul Samad Khan representing Director, Biological

Drug, DRAP

Member

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

Secretary/Member

Mr.Akhter Abbas Khan (DDG R.II), Mr.Muhammad Arif (DDC R.I), Mr. Babar

Khan (DDC R.III), Dr. Tariq Siddique (DDC R.IV), Ms. Sara Mehreen (ADC R.I) and

Mr. Atiq-ul-Bari (ADC R.V) assisted Secretary of the Board with agenda.

Dr. Kaiser Waheed & Mr. Hammayun Kabir, Dr.Farid Khan and Dr.M.Qasim

Awan attended the meeting as observer on behalf of PPMA, Pharma Beauru and PVPMA

respectively.

3

Item No I: Confirmation of minutes 238th

meeting Registration Board.

238th

meeting of Registration Board was held on 5th

-6th

August, 2013 and minutes

were accordingly circulated to all members through e-mail. Only 3 members confirmed

the minutes while observations of Dr. Khalid Khan, Director, DTL, Peshawar are as

follows:

The minutes of 238th RB meeting held on 5-6 Aug. 2013 are approved subject to

partial modifications i.e.

1. In Agenda item 2. Extension in contract manufacturing cases i.e. line

extension/general products/ associated company/ sister concern cases were rejected

rather than deferred.

2. Panel inspection should be conducted by the board members to the premises and

manufacturing facilities of contract givers.

3. Agenda Item delegation of Board power to Chairman, the powers mentioned in serial

v, xii, xv, xvi, xvii, xviii,, and xix should be remained with Board rather delegated to Chairman.

v. Increase/ decrease in shelf life of finished drug.

xii. Renewal of registered drugs.

xv. Change in the packing design/packaging components/ change in label, carton/ change in

shape, colour of Capsule, Tablets and shape of blister/ aluminum foil.

xvi. Change of brand names of registered drugs.

xvii. Change of formulation of already registered drug / grant of registration for

improving Safety, efficacy & quality as per recommendations of WHO / International

Agencies.

xviii. Transfer of registration from one manufacturer/importer to another

manufacture/importer.

xix. Constitution of panel of experts for inspections

4. For medical devices specifications and testing methods. a committee should be

constituted to formulate specifications and testing method procedures according to our

country need in best interest of public at large.

Decision: The Board discussed above mentioned observations of the member

and after detailed discussion decided as follows:

Cases which were not covered in Contract Manufacturing Policy were

deferred, as said policy is under consideration by the Policy Board.

4

Panel of inspectors would inspect the manufacturing premesis for grant of

new contract manufacturing permissions, if required by the Board.

Chairman, Registration Board would continue to decide cases mentioned at

point 3. However, all cases which require evaluation of technical data will be

referred to panel of experts including atleast one member of Registration

Board. The Chairman, Registration Board will decide the case keeping in

view recommendation of experts. However, Dr.Khalid Khan maintained his

view point.

Dr.Noor Muhammad Shah, Director MD & MC apprised the Board that

draft Medical Devices Rules, 2013 have already been sent to provincial

governments and also posted / uploaded on DRAP’s website for comments.

He also requested all members of the Board to give inputs on draft

regulations at the earliest.

5

Item No II: Grant of Registration (Local manufacturing).

Applications for registration (July-September, 2010 & fast track) were forwarded to

officers of DRAP. As per review, following applications were found complete.

Registration-I.

Fast track applications for registration (Locally manufactured drugs me-too)

S. # Name of

Applicant

Name of Drug(s)/Composition Price/Pack

Size

Shelf

Life

Decision

1. M/s. Baariq

Pharmaceuticals,

Raiwind Road,

Lahore.

Furosebar Water Soluble Powder

Each 1000gm contains:-

Furosemide…………….20gm

Potassium Chloride……. 4gm

Calcium Carbonate…….45gm

Magnesium Sulphate…..1gm

(Diuretic, Electrolytes).

Decontrolled

100gm

250gm

500gm

1000gm

2500gm

02

years

Approved

2. M/s. Baariq

Pharmaceuticals,

Raiwind Road,

Lahore.

Electrobar-C Water Soluble

Powder

Each gm contains:-

Aspirin………………..200mg

Vitamin C…………….600mg

Sodium Chloride………35mg

Sodium Citrate………….7mg

(Vitamin, Electrolytes, NSAID).

Decontrolled

100gm

250gm

500gm

1000gm

2500gm

02

years

Deferred for PSI

by panel

comprising of

Area FID and

Director DTL,

Lahore.

3. M/s. Baariq

Pharmaceuticals,

Raiwind Road,

Lahore.

Colibar Oral Liquid

Each 1000ml contains:-

Colistine

Sulphate……..2,000,000,000 IU

(Antibiotic).

Decontrolled

100ml

500ml

1000ml

02

years

Approved

4. M/s. Elegance

Pharmaceuticals,

Chak Belli, Pandori

Road, Rawalpindi.

Flurotin Liquid

Each ml contains

Florfenicol ….200mg

(Anti-bacterial)

Decontrolled

10ml

20ml

50ml

100ml

150 ml

200ml

250ml

500ml

1Lit

02

years

Approved

6

5. M/s. Elegance

Pharmaceuticals,

Chak Belli, Pandori

Road, Rawalpindi.

Ecotin-M Powder

Each 100g contain

Enrofloxacin HCl……10 %

Colistin Sulphate……..3 %

Amantadine HCl……..4 %

(Anti-Biotic)

Decontrolled

100gm

250gm

500gm

1Kg

5Kg

10Kg

25Kg

02

years

Approved

6. M/s. Elegance

Pharmaceuticals,

Chak Belli, Pandori

Road, Rawalpindi.

Poly Quin Liquid

Each 100ml contains

Enrofloxacin………10 g

Colistin Sulphate….48 MIU

(Anti-Biotic)

Decontrolled

10ml

20ml

50ml

100ml

150 ml

200ml

250ml

500ml

1Lit

02

years

Approved

7. M/s. D-Maarson

Pharmaceuticals,

Rawat, Islamabad.

Bella Flush Powder

Each 100g contains:-

Furosemide………………2gm

Belladonna Extract……..0.2gm

(Diuretic, Anti-spasmodic).

Decontrolled

100g

250g

500g

1Kg

5Kg

10Kg

02

years

Approved

8. M/s. Nawal

Pharmaceuticals,

Small Industrial

Estate Taxila.

BELLA RAFT Powder


Furosemide…………….2gm

Belladonna Extract…..0.2gm

(Diuretic, Anti-spasmodic).

Decontrolled

100g

250g

500g

1Kg

5Kg

10Kg

02

years

Approved

9. M/s. Leads

Pharma (Pvt) Ltd.,

Islamabad.

Virox TD Powder

Each Kg contains:-

Doxycycline HCI………200gm

Tylosin Tartrate………..100gm

Amantadine HCI…………40gm

Colistin Sulphate……...500MIU

Bromhexine HCL…………5gm

(Antibiotic).

Decontrolled

100gm

250gm

500gm

1Kg

5Kg

25Kg

02

years

Approved

10. M/s. Leads

Pharma (Pvt) Ltd.,

Islamabad.

Amandx Powder


Doxycycline HCI…..….20%

Tylosin Tartrate ……....10%

Amantadine HCI……...4.5%

(Antibiotic).

Decontrolled

100gm

250gm

500gm

1Kg

5Kg

25Kg

02

years

Approved

11. M/s. Decent Nortrim-S Oral Liquid Decontrolled 02 Approved

7

Pharma, Rawat,

Islamabad.

Each ml contains:-

Norfloxacin ……………….10%

Sulphamethoxypyridazine...15%

Trimethoprim……………..03%

(Antibacterial).

30ml

50ml

100ml

500ml

1 Liter

2.5 Liter

5 Liter

10 Liter

years

LOCALLY MANUFACTURED VETERINARY DRUGS FOR THE MONTH OF

NOVEMBER & DECEMBER, 2010.

Registration Board thoroughly discussed the following cases and decided the cases as

mentioned against each.

S. # Name of

Applicant


Size

Shelf

Life

Decision

1. M/s. Inshal

Pharmaceutical

Industries, Rawat,

Islamabad.

Nilza Shell Super Suspension


Oxyclozanide…………….3.0%

Levamisole Hcl…………..1.5%

Cobalt Chloride (6H20).0.075%

Sodium Selenite ……...0.035%

(Anthalmintic).

Decontrolled

100ml

150ml

250ml

450ml

500ml

1000ml

2.5 Liter

02

years

Approved

2. M/s. Inshal

Pharmaceutical

Industries, Rawat,

Islamabad.

Clobenda Shell Suspension

Each ml of suspension

Albendazole……….2.5%

Closantel…………..0.5%

(Anthalmintic).

Decontrolled

30ml

50ml

100ml

250ml

450ml

500ml

1000ml

2.5 Liter

02

years

Approved

3. M/s. Inshal

Pharmaceutical

Industries, Rawat,

Islamabad.

Oxfashell Suspension


Oxfendazole………2.265%

(Anthalmintic).

Decontrolled

30ml

50ml

100ml

250ml

450ml

500ml

1000ml

2.5 Liter

02

years

Approved

8

4. M/s. Inshal

Pharmaceutical

Industries, Rawat,

Islamabad.

Levashell 1.5 Suspension


Levamisole HCI…1.5%

(Anthalmintic).

Decontrolled

50ml

100ml

150ml

250ml

450ml

500ml

1000ml

2.5 Liter

02

years

Approved

5. M/s. Inshal

Pharmaceutical

Industries, Rawat,

Islamabad.

Tol Shell Liquid

Each ml contains:-

Doxycycline HCI……..200mg

Tylosin Tartrate……….100mg

Colistin Sulphate….450000 IU

Bromhexine HCI………4mg

(Antibacterial, Anti-Viral).

Decontrolled

30ml

50ml

100ml

250ml

500ml

1 Liter

5 Liter

10 Liter

25 Liter

02

years

Approved

6. M/s. Inshal

Pharmaceutical

Industries, Rawat,

Islamabad.

Mentho Flush Oral Liquid


Sorbitol……………….140mg

1,2Propane Diol………60mg

Magnesium Sulphate

(6H20)………………..40mg

Potassium Chloride……20g

Sodium Propionate……3g

(Anti fungal, Antimicrobial).

Decontrolled

30ml

50ml

100ml

250ml

500ml

1 Liter

5 Liter

10 Liter

02

years

Approved

7. M/s. Inshal

Pharmaceutical

Industries, Rawat,

Islamabad.

Albashell 10 Suspension


Albendazole USP………..10%

Cobalt Chloride

(6H20)………………….0.05%

Sodium Selenite………..0.07%

(Anthalmintic).

Decontrolled

30ml

50ml

100ml

250ml

450ml

500ml

1000ml

2.5 Liter

02

years

Deferred for

application on

Form 5 D

along with

revised Fee

and expert

views of

following;

a. Dr. M

Ashraf,

UVAS

b. Head of

Pharmacol

ogy Deptt.

UAF

Dr. M.

Arshad,

Member DRB

8. M/s. Inshal Trizo Shell Liquid Decontrolled 02 Deferred for

9

Pharmaceutical

Industries, Rawat,

Islamabad.


Trimethoprim……………..8.0g

Sulfadiazine Na Sodium….40g

(Antibacterial, Coccidial,

Bronchodilator).

50ml

100ml

200ml

250ml

500ml

1 Liter

2.5 Liter

25 Liter

years confirmation

of use as

bronchodilator

9. M/s. Inshal

Pharmaceutical

Industries, Rawat,

Islamabad.

Immunufur E Liquid


Sodium Selenite…….150mg

Vitamin E………..…10,000mg

Choline……………..50,000mg

Vitamin C………….35,000mg

Zinc sulphate….…..…4500mg

Biotin……………..…100mg

Sorbitol………….….50,000mg

(Immune boster, Multi Vitamin).

Decontrolled

100ml

250ml

500ml

1 Liter

5 Liter

10 Liter

25 Liter

02

years

Deferred for

application on

Form 5 D

along with

revised Fee

and expert

views of

following;

c. Dr. M

Ashraf,

UVAS

d. Head of

Pharmacol

ogy Deptt.

UAF

Dr. M.

Arshad,

Member DRB

10. M/s. Inshal

Pharmaceutical

Industries, Rawat,

Islamabad.

Silymar 2% Liquid

Each ml contains:-

Silymarin……….20mg

Sorbitol………….50mg

(Hepatoprotective).

Decontrolled

100ml

150ml

250ml

500ml

1 Liter

2.5 Liter

02

years

Deferred for

application on

Form 5 D

along with

revised Fee

and expert

views of

following;

e. Dr. M

Ashraf,

UVAS

f. Head of

Pharmacol

ogy Deptt.

UAF

Dr. M.

Arshad,

Member DRB

11. M/s. Inshal

Pharmaceutical

Industries, Rawat,

Islamabad.

Cyper Shell Liquid


Enrofloxacin………...10g

Colistin Sulphate……50MIU

(Antibiotic).

Decontrolled

50ml

100ml

150ml

250ml

500ml

1 Liter

02

years

Approved

10

2.5 Liter

12. M/s. Inshal

Pharmaceutical

Industries, Rawat,

Islamabad.

Sulfadine Liquid


Enrofloxacin…………...10g

Colistin Sulphate………3.5g

Amantadine HCI……….4.0g

(Antibiotic).

Decontrolled

50ml

100ml

150ml

250ml

500ml

1 Liter

2 Liter

2.5 Liter

02

years

Approved

13. M/s. Inshal

Pharmaceutical

Industries, Rawat,

Islamabad.

Bromo Shell Liquid


Bromhexine HCI……..05g

(Bronchodilator).

Decontrolled

100ml

500ml

1 Liter

02

years

Approved

14. M/s. Inshal

Pharmaceutical

Industries, Rawat,

Islamabad.

Asper Shell Water Soluble Powder


Vitamin C……………..…200g

Acetyl Salicylic Acid…….67g

(NSAIDS + Supplement).

Decontrolled

30g

50g

100g

250g

500g

1 Kg

5 Kg

10Kg

02

years

Deferred, for

PSI by panel

comprising of

Area FID and

A.Q.Javed

Iqbal Member

RB.

15. M/s. Inshal

Pharmaceutical

Industries, Rawat,

Islamabad.

Amento Water Soluble Powder

Each 100g powder contains:-

Enrofloxacin HCI……..10%

Amantadine HCI………4%

Colistin Sulphate………3%

(Antibacterial, Antiviral).

Decontrolled

100g

250g

500g

1 Kg

5 Kg

10Kg

25Kg

02

years

Approved

16. M/s. Inshal

Pharmaceutical

Industries, Rawat,

Islamabad.

Adekshell Water Soluble Powder


Vitamin A……………..20 MIU

Vitamin D……………...2 MIU

Vitamin E……………....6g

Vitamin K3……………..5g

(Multivitamins).

Decontrolled

30g

50g

100g

250g

500g

1 Kg

5 Kg

10Kg

02

years

Deferred, for

PSI by panel

comprising of

Area FID and

A.Q.Javed

Iqbal Member

RB.

17. M/s. Inshal

Pharmaceutical

Industries, Rawat,

Islamabad.

Shelldox Water Soluble Powder


Doxycycline HCI…………400g

Tylosin Tartrate…………..200g

(Antibacterial, Anti-viral).

Decontrolled

100g

250g

500g

1 Kg

02

years

Approved

11

5 Kg

10Kg

18. M/s. Inshal

Pharmaceutical

Industries, Rawat,

Islamabad.

OXY NEO 10/10 Water Soluble

Powder


Neomycin Sulphate……..10g

Oxytetracycline HCI…….10g

(Anti-infective, Antibacterial).

Decontrolled

30g

50g

100g

125g

250g

500g

1 Kg

5 Kg

03

years

Approved

19. M/s. Inshal

Pharmaceutical

Industries, Rawat,

Islamabad.

Levashell 15 Powder


Levamisole HCI……….15%

(Anthalmintic).

Decontrolled

30g

50g

100g

250g

500g

1 Kg

5 Kg

10Kg

02

years

Approved

20. M/s. Inshal

Pharmaceutical

Industries, Rawat,

Islamabad.

Tifo Shell Powder


Trichlorfon…………98%

(Antiparasites, Anti Helminths).

Decontrolled

30g

50g

100g

500g

1 Kg

2.5Kg

5 Kg

10Kg

25Kg

02

years

Approved

21. M/s. Inshal

Pharmaceutical

Industries, Rawat,

Islamabad.

Pipra Shell Water Soluble Powder


Piprazine Citrate………..1000g

(Anthelmintics).

Decontrolled

100g

250g

500g

1 Kg

5 Kg

10Kg

02

years

Approved,

with brand

name change

22. M/s. Inshal

Pharmaceutical

Industries, Rawat,

Islamabad.

Enrodine Plus Water Soluble

Powder


Enrofloxacin………..100g

Amantadine HCI……40g

Colistin Sulphate……35g

(Antibacterial, Anti-viral).

Decontrolled

100g

250g

500g

1 Kg

5 Kg

10Kg

02

years

Approved,

with brand

name change

12

23. M/s. Inshal

Pharmaceutical

Industries, Rawat,

Islamabad.

Sulpha Plus Water Soluble Powder

Each 100gm powder contains:-

Enrofloxacin………….10%

Amantadine HCI………4%

Colistin Sulphate………4%


Decontrolled

100g

250g

500g

1 Kg

5 Kg

10 Kg

25 Kg

02

years

Approved

24. M/s. Inshal

Pharmaceutical

Industries, Rawat,

Islamabad.

Amino Flush Water Soluble

Powder


Ammonium Chloride………45g

Sodium Sulphate…………..25g

Magnesium Sulphate

7H2O....................................25g

(Aminoacid, Multi-Vitamin,

Expectorant).

Decontrolled

100g

250g

500g

1 Kg

5 Kg

10Kg

02

years

Approved

25. M/s. Inshal

Pharmaceutical

Industries, Rawat,

Islamabad.

Reno Shell Water Soluble Powder


Methanamine…………90g

Sorbitol………………..5g

(Aminoacid, Multi-Vitamin,

Expectorant).

Decontrolled

30g

50g

100g

250g

500g,

1 Kg

5 Kg

10Kg

02

years

Deferred for

application on

Form 5 D

along with

revised Fee

and expert

views of

following;

g. Dr. M

Ashraf,

UVAS

h. Head of

Pharmacol

ogy Deptt.

UAF

Dr. M.

Arshad,

Member DRB

26. M/s. Inshal

Pharmaceutical

Industries, Rawat,

Islamabad.

Vita Shell Water Soluble Powder


Vitamin C………………200g

Acetylecylicic Acid…….67g

Potassium Chloride……..3g

Sodium Citrate………….7g

(NSAIDs + Suppliment).

Decontrolled

30g

50g

100g

250g

500g

1 Kg

5 Kg

10Kg

25Kg

02

years

Approved

27. M/s. Inshal Coxishell Water Soluble Powder Decontrolled 02 Approved

13

Pharmaceutical

Industries, Rawat,

Islamabad.

Each 1000g powder contains:-

Doxycycline HCI………..200g

Tylosin Tartrate………….100g

Bromhexine………………5g


30g

50g

100g

250g

500g

1 Kg

5 Kg

10Kg

25Kg

years

28. M/s. Inshal

Pharmaceutical

Industries, Rawat,

Islamabad.

Amproshell 60% Water Soluble

Powder


Amprolium Hcl………60gm

Coccididal).

Decontrolled

100g

500g

1 Kg

02

years

Approved

29. M/s. Inshal

Pharmaceutical

Industries, Rawat,

Islamabad.

Tetra Shell 20 Water Soluble

Powder


Chlortetracycline HCI……..200gm

(Anti-infective, Antibacterial,

Tetracycline).

Decontrolled

30g

50g

100g

150g

200g

250g

500g

1 Kg

02

years

Approved

30. M/s. Inshal

Pharmaceutical

Industries, Rawat,

Islamabad.

Tilco Shell Water Soluble Powder


Tilmicosin Phosphate…….10%

(Anti-infective, Antibacterial).

Decontrolled

30g

50g

100g

500g

1 Kg

2.5Kg

5Kg

10Kg

25Kg

02

years

Deferred for

application on

Form 5 D

along with

revised Fee

and expert

views of

following;

i. Dr. M

Ashraf,

UVAS

j. Head of

Pharmacol

ogy Deptt.

UAF

Dr. M.

Arshad,

Member DRB

31. M/s. Inshal

Pharmaceutical

Industries, Rawat,

Islamabad.

Doxyline Water Soluble Powder


Doxycycline HCI………200g

Tylosin Tartrate………..100g

Colistin Sulphate…….450MIU

Decontrolled

30g

50g

100g

250g

02

years

Approved

14

Bromhexine HCI…….….4g


500g

1 Kg

5 Kg

10 Kg

25Kg

32. M/s. Prix

Pharmaceutica

(Pvt) Ltd Lahore.

Pri-Dimidine 33.3% Injection

Each ml injection contains:-

Sulphadimidine

Sodium……………….333.3mg

(Sulphonamide).

Decontrolled

100ml

500ml

02

years

Approved

33. M/s. Prix

Pharmaceutica

(Pvt) Ltd Lahore.

Pri-Calcifort injection

Each 100 ml injectable solution

contains:-

Calcium gluconate………20g

Toldimphos sodium…….400mg

Magnesium sodium…….334mg

Baric acid………………..2.4g

Sorbitol………………….5g

(MineralsCalcium/Phosphrous/Ma

gnesium and Sugar)

Decontrolled

50ml

100ml

250ml

500ml

02

years

Deferred for

application on

Form 5 D

along with

revised Fee

and expert

views of

following;

k. Dr. M

Ashraf,

UVAS

l. Head of

Pharmacol

ogy Deptt.

UAF

Dr. M.

Arshad,

Member DRB

34. M/s. Prix

Pharmaceutica

(Pvt) Ltd Lahore.

PRI-Dolocam 7.5 Injection

Each ml contains:-

Meloxicam………7.5mg

(NSAID)

Decontrolled

5 x 10ml

25ml

50ml

100ml

02

years

Approved

35. M/s. Prix

Pharmaceutica

(Pvt) Ltd Lahore.

Pri-Deflame 5 Injection

Each ml injection

contains: -

Flunixin Meglumine…..50mg

(Nsaid)

Decontrolled

5x 10ml

20ml

50ml

100ml

02

years

Approved

15

36. M/s. Epoch

Pharmaceuticals,

Karachi.

Escour Oral Suspension

Each ml contains:-

Sulphadiazine BP……35.50mg

Sulphadimidine BP…28.40mg

Neomycin Sulphate BP1.80mg

Hysoine

Methylbromide…….0.040mg

Pectin USP…………7.1mg

Kaolin BP……………103.3mg

Vitamin B1 BP………0.150mg

Vitamin B2 BP………0.220mg

(Antibiotic, Anti-Toxins, anti-

spasmodic and Vitamins).

Decontrolled

100ml

500ml

2 years Approved

37. M/s. Epoch

Pharmaceuticals,

Karachi.

Epotizer Injection

Each 3ml contains:-

Thiamine HCI (Vitamin

B1)…………………..100mg

Pyridoxine Hydrochloride

(Vitamin

B6)…………………100mg

Cyanocobalamin (Vitamin

B12)…………………500mcg

(Vitamins).

Decontrolled

50ml

100ml

18

months

Approved

16

Registration-II.

Registration Applications of July, 2010.

S.No. Name of

firm(s)

Name of drug(s) &

Composition

Proposed

Pack size

Demanded

Price

Date of

application,

Diary No. &

Form

Decision

1. M/s Barret

Hodgson,

Karachi

DiaSet Plus Tablet

Each tablet contains:

Pioglitazone ……15 mg

Metformin

Hydrochloride…...850 mg

(Antidiabetic agent)

As per

PRC

As per

PRC

28-7-2010

Dy.No.1433

Form-5

Rs.8000/-

Rs.12,000/-

21-5-2013

Approved

2. M/s Nabi

Qasim

Karachi

Reliefal 6 Plus Suspension

Each 5ml contains:

Paracetamol BP……….250mg

(analgesic & antipyretic)

60ml

450ml

As per

PRC

01/07/2010

Dy. No. 1273

Form 5

Rs. 8000/-

Rs.12,000/1

14-5-2013

Approved

3. M/s Bosch

Pharmaceut

icals, Kar.

Bentocin 30mg Injection

Each vial contains:

Pentazocin As

lactate…………...…30 mg

(Narcotic analgesic, post

operative pain)

5’s

10’s

Rs.75/-

Rs.150/-

22-07-2010

Dy.No.1388

Form-5

Rs.8000/-

Rs.12,000/-

20-5-2013

Deferred

being

Controlled

Drug

4. M/s Barrett

Hodgson

Karachi

Ivabar 7.5mg Tablet


Ivabradine Hydrochloride eq.

to Ivabradine……...7.5mg

(Anti anginal, anti heart

failure)

10’s

14’s

28’s

56’s

Rs.1950/-

Rs.2730/-

Rs.5460/-

Rs.10,920/-

10/07/2013

Dy. No. 691

Form 5D

Rs. 60,000/-

Fast track

application

Deferred for

i.submission of

remaining fee.

ii.

Confirmation

for approval by

USFDA,

EMA,

regulatory

body of Japan

or Australia.

iii. Expert

opinion

byBrig.

M.H.Najmi,

Dr.Shahid

Nawaz, PIMS

Dr.Ghulam

Haider, Shifa

International

5. -do- Ivabar 5mg Tablet


10’s

14’s

Rs.1740/-

Rs.2436/-

10/07/2013

Dy. No. 690

-Do-

17

Ivabradine Hydrochloride eq.

to Ivabradine………...5mg

(Anti anginal, anti heart

failure)

28’s

56’s

Rs.4872/-

Rs.9744/-

Form 5D

Rs. 60,000/-

Fast track

application

6. M/s

Pharmatec

Pakistan

Pvt. Ltd.

Kar.

Clogrel Plus Tablet

Each film coated tablet

contains:

Aspirin (enteric coated

pellets)………………..75 mg

Clopidogrel (as Clopidogrel

Bisulphate USP)……..75 mg

(Anticoagulant/ antiplatelet)

10x2’s As per

PRC

01/07/2013

Dy. No. 683

Form 5

Rs. 60,000/-

Fast track

application

Deferred for

product

specifi

inspection for

confirmation

of

manufacturin

g & QC

facility by

area FID &

Director

DTL, Karachi

Registration Applications of August, 2010.

S.No. Name of

firm(s)

Name of drug(s) &

Composition

Proposed

Pack size

Demanded

Price

Date of

application,

Diary No. &

Form

Comments

7. M/s Nabi

Qasim

Karachi

Letol Tablet


contains:

Labetalol

Hydrochloride …200mg

(Beta Blockers)

10’s &

20’s

As per

PRC

11-08-2010

Dy.No.1553

Form-5

Rs.8000/-

Rs.12,000/-

14-5-2013

Deferred for

i.submission of

application on

Form5D. ii.

Confirmation

for approval by

USFDA,

EMA,

regulatory

body of Japan

or Australia.

iii. Expert

opinion by

Brig.

M.H.Najmi,

Dr.Shahid

Nawaz, PIMS

Dr.Ghulam

Haider, Shifa

International

8. -do- Loprot Plus Capsule

Each capsule contains:-

Omeprazole ……..20mg

Sodium Bicarbonate .1100mg

7’s

10’s

14’s

As per

PRC

03-08-2010

Dy.No.1530

Form-5

Rs.8000

Referred to

review

committee

18

(Anti Ulcerant) Rs.12,000/

14-5-2013

9. -do- Letol Tablet


contains:

Labetalol

Hydrochloride USP…300mg

(Beta Blockers)

10’s &

20’s

As per

PRC

11-08-2010

Dy.No.1554

Form-5

Rs.8000/-

Rs.12,000/1

14-5-2013

Deferred for

i.submission of

application on

Form5D. ii.

Confirmation

for approval by

USFDA,

EMA,

regulatory

body of Japan

or Australia.

iii. Expert

opinion

byBrig.

M.H.Najmi,

Dr.Shahid

Nawaz, PIMS

Dr.Ghulam

Haider, Shifa

International

10 -do- Misotec tablet


Misoprostol…100mcg

Mfg.Specs.NQ

(Prostaglandin Analogue)

10’s & 30 As per

PRC

17-08-2010

Dy.No.1578

Form-5

Rs.8000/-

Rs.12,000/1

14-5-2013

Approved

11 -do- Misotec tablet


Misoprostol…200mcg

Mfg.Specs.NQ

(Prostaglandin Analogue)

3 &10’s As per

PRC

17-08-2010

Dy.No.1577

Form-5

Rs.8000/-

Rs.12,000/1

14-5-2013

Approved

12 -do- Tensel 5mg Tab.


Nebivolol HCI equivalent to

Nebivolol…….5mg

(Anti-hypertensive)

14’s As Per

PAC

10-08-2010

1540

Form-5

Rs.8000/-

Rs.12,000/1

14-5-2013

Approved

13 -do- Letol Tablet


contains:

Labetalol

Hydrochloride ….…100 mg

(Beta Blockers)

20’s As per

PRC

11-08-2010

Dy.No.1556

Form-5

Rs.8000/-

Rs.12,000/1

14-5-2013

Approved

Applications for Fast Track Registration

19

S.No. Name of

firm(s)

Name of drug(s) &

Composition

Proposed

Pack size

Demanded

Price

Date of

application,

Diary No. &

Form

Comments

14 M/s Indus

Pharma

Karachi

Dyclo Plus 2ml Inj.

Each 2ml contains:

Diclofenac Sodium ..75 mg

Lignocaine

Hydrochloride……..20mg

(Non Steroidal Anti-

Inflammatory)

5’s

10’s

20’s

Rs.140/-

280/-

Rs.560/-

13-05-2013

Dy.No.367

Form-5

Rs.60,000/-

Approved.

Only IM

route of

administratio

n approved

15 -do- I-Flor 250mg Schet

Each sachet contains:

Saccharomyces

Boulardii………….250 mg

(Anti diarrheal)

10’s Rs.480/- 13-05-2013

Dy.No.366

Form-5

Rs.60,000/-

Referred to

H&OTC

Division

being

probiotics

16 M/S. GSK

Pakistan

Ltd.

Karachi.

Panadol sinus Caplets

Each Caplet contains:-

Paracetamol……. 500 mg

Phenylephrine HCl. 5.00mg

(Cold Preparation)

100’s Rs.300/- 24-07-2013

Dy.No.1047

Form-5

Rs,60,000/-

Deferred for

submission of

application on

Form5D &

remaining fee.

17 M/s Sante

Pvt. Ltd,

Karachi

Cipromax 250mg Tablet


Ciprofloxacin HCl eq. to

Ciprofloxacin……..250 mg

(Fluoroquinolone)

10’s As per

PRC

14-05-2013

Dy.No.371

Form-5

Rs.60,000/-

Approved.

The Board

advised to

change brand

name.

18 M/s

Medisure

Lab. Kar.

Sepride Tablet


Cinitapride…….….1 mg

(Antiemetic)

10’s

50’s

As per

PRC

20-05-2013

Dy.No.498

Form-5

Rs.60,000/-

Approved

19 -do- Dexiprofen Tablet


Dexibuprofen…….300 mg

(Analgesic agent)

10’s

30’s

As per

PRC

20-05-2013

Dy.No.496

Form-5

Rs.60,000/-

Approved

20 -do- Dexiprofen Tablet


Dexibuprofen…..400 mg

(Analgesic agent)

10’s

30’s

As per

PRC

20-05-2013

Dy.No.497

Form-5

Rs.60,000/-

Approved

21 M/s S.J &

G, Karachi

Berica 60mg Tablet


contains:

Etoricoxib…….…60 mg

(NSAID)

14’s Rs.600/- 29-04-2013

273

Form-5

Rs.20,000/-

Rs.40,000/-

20-05-2013

Approved

20

22 -do- Acenac 150mg Injection

Each ml contains:

Aceclofenac…….150 mg

(Non-Steroidal Anti

inflammatory drug)

5x1ml Rs.200/- 20-05-2013

273

Form-5

Rs.20,000/-

Rs.40,000/-

20-05-2013

Approved

23 M/s Sami

Pharmaceuti

cals, Kar.

D3 Injection

Each ml contains:

Cholecalciferol …...5 mg

(200,000 IU)

(Vitamin D3)

As per

PRC

As per

PRC

20-05-2013

518

Form-5

Rs.60,000/-

Approved.

The Board

advised to

change brand

name.

24 M/s Helix

Pharma kar.

Azil 40mg Tablet


Azilsartan kamedoxomil

eq.to Azilsartan

medoxomil……..40 mg

(Anti Hypertensive)

10’s

30’s

As per

PRC

20-05-2013

515

Form-5D

Rs.60,000/-

Rs.90,000/-

24-07-2013

Deferred for i.

Confirmation

for approval by

USFDA,

EMA,

regulatory

body of Japan

or Australia.

iii. Expert

opinion

byBrig.

M.H.Najmi,

Dr.Shahid

Nawaz, PIMS

Dr.Ghulam

Haider, Shifa

International

25 -do- Azil 80mg Tablet



eq.to Azilsartan

medoxomil………80 mg

(Anti Hypertensive)

10’s

30’s

As per

PRC

20-05-2013

514

Form-5D

Rs.60,000/-

Rs.90,000/-

24-07-2013

-Do-

26 -do- Azil 20mg Tablet



eq.to Azilsartan

medoxomil………20 mg

(Anti Hypertensive)

10’s

30’s

As per

PRC

20-05-2013

513

Form-5D

Rs.60,000/-

Rs.90,000/-

24-07-2013

-Do-

27 M/s

Mediate

Pharmaceuti

cals, kar

Tramorhage 250mg

Capsule

Each capsule contains:

Tranexamic acid...250 mg

20’s Rs.154/- 20-05-2013

502

Form-5

Rs.20,000/-

Rs.40,000/-

23-5-2013

Approved

28 -do- Tramorhage 500mg

Capsule

20’s Rs.310/- 20-05-2013

501

Approved

21


Tranexamic acid…..500 mg

Form-5

Rs.20,000/-

Rs.40,000/-

23-5-2013

29 -do- Medeiron-S Injection

20mg/ml Injection

Each ml contains:

Iron sucrose…….…20 mg

5mlx5’s Rs.1250/- 20-05-2013

500

Form-5

Rs.20,000/-

Approved.

The Board

advised to

change brand

name.

30 M/s Maple

Pharma.

Kar.

Losaan 25mg Tablet


Losartan Potassium...25 mg

(Anti hypertensive)

20’s As per

PRC

21-05-2013

526

Form-5

Rs.60,000/-

Approved

31 -do- Ciprozee 750mg Tablet


Ciprofloxacin (as

Hydrochloride)……750 mg

(Fluoroquinolone

Antibiotic)

10’s As per

PRC

21-05-2013

525

Form-5

Rs.60,000/-

Approved

32 M/s Opal

Lab.

Karachi

Febutab 80mg Tablet


contains:

Febusostat…………..80 mg

(Xanthine Oxidase

Inhibitor)

10’s

20’s

30’s

As per

PRC

04-06-2013

Dy.No.631

Form-5

Rs.60,000/-

Approved

33 M/s Helix

Pharma

Karachi

Lacosa 200mg Tablet


contains:

Lacosamide……….200 mg

(Anti epileptic/ Anti-

Convulsant)

14’s

As per

PRC

17-06-2013

Dy.No.664

Form-5

Rs.60,000/-

Approved

34 -do- Lacosa 100mg Tablet


contains:



Convulsant)

14’s

As per

PRC

17-06-2013

Dy.No.663

Form-5

Rs.60,000/-

Approved

35 -do- Lacosa 50mg Tablet


contains:



Convulsant)

14’s

As per

PRC

17-06-2013

Dy.No.665

Form-5

Rs.60,000/-

Approved

36 -do- Rozerem Tablet


contains:

10’s

30’s

As per

PRC

04-06-2013

Dy.No.633

Form-5D

Deferred for i.

Confirmation

for approval by

22

Ramelteon………..8 mg

(Hypnotics)

Rs.150,000/-

USFDA,

EMA,

regulatory

body of Japan

or Australia.

iii. Expert

opinion by

Brig.

M.H.Najmi,

Dr.Rizwan

Taj, PIMS

Dr.Saleem

Jehangeer, MH

Rawalpindi

37 M/s

Pharmatec

Pak.

Karachi

Alptec 0.5mg Tablet


Alprazolam ………..0.5 mg

(Anxiolytic)

3x10’s As per

PRC

03-06-2013

Dy.No.616

Form-5

Rs.60,000/-

Deferred

being

controlled

Drug

38 -do- Reltus Forte Cough

Expectorant

Each 5ml contains:

Ammonium

chloride……….100mg

Ephedrine

Hydrochloride……7 mg

Chlorpheniramine

maleate…………..2 mg

(Cpigj ex[ectprant)

120ml As per

PRC

07-06-2013

Dy.No.640

Form-5

Rs.60,000/-

Deferred

being

controlled

Drug

39 M/s Sanofi

Aventis,

Karachi

Aprovasc 300/10mg Tablet


Irbesartan……….300 mg

Amlodipine besylate.14 mg

eq. to amlodipine…10 mg

(Alntihypertensive,

angiotensin II receptor

antagonist)

28’s Rs.2212/- 04-06-2013

Dy.No.630

Form-5D

Rs.150,000/-

Deferred for i.

Confirmation

for approval by

USFDA,

EMA,

regulatory

body of Japan

or Australia. ii.

Expert opinion

by Brig.

M.H.Najmi,

Dr.Shahid

Nawaz, PIMS

Dr.Ghulam

Haider, Shifa

International

40 -do- Aprovasc 150/10mg Tablet




eq. to amlodipine…10 mg

28’s Rs.2620.8/- 04-06-2013

Dy.No.624

Form-5D

Rs.150,000/-

-Do-

23

(Alntihypertensive,


antagonist)





eq. to amlodipine……5 mg

(Alntihypertensive,


antagonist)

28’s Rs.1456/- 04-06-2013

Dy.No.631

Form-5D

Rs.150,000/-

-Do-





eq. to amlodipine……5 mg

(Alntihypertensive,


antagonist)

28’s Rs.2114/- 04-06-2013

Dy.No.628

Form-5D

Rs.150,000/-

-Do-

43 M/s Abbott

Laboratorie

s, kar.

Rondec E Syrup

Each 5ml contains:

Salbutamol………….2 mg

Guaifenesin ……..200 mg

Bromhexine HCl…….4mg

(Expectorant with

bronchodilator cough

syrup)

60ml

120ml

Rs.60/-

Rs.120/-

07-06-2013

Dy.No.639

Form-5D

Rs.150,000/-

Deferred for i.

Confirmation

for approval by

USFDA,

EMA,

regulatory

body of Japan

or Australia. ii.

Expert opinion

by Brig. Aslam

Khan,

Dr.Rehana

Kausar, PIMS

Head, Dept of

Chest

Diseases,

Shaikh Zayed

Hospital,

Lahore

44 M/s Barrett

Hodgson

Pak. Kar.

Megaklar DS Suspension

250mg/ml

Each 5ml contains:

Clarithromycin*…250mg

(Antibacterial and

Antibiotic)

60ml Rs.450/- 27-06-2013

Dy.No.675

Form-5

Rs.60,000/-

Deferred for

confirmation

whether

powder or

granules

24

Item No.III Miscellaneous Cases:

Registration-I

Case No:01 Transfer of Registration of Drugs from M/s. Pakistan Business

International, Karachi to M/s. Zenith International, Karachi.

M/s. Zenith International, Karachi have requested for transfer of registration of

the following registered Surgical Sutures from the name of previous agent M/s. Pakistan

Business International, Karachi to their name for import and approved the change of

manufacturer’s name of the products from M/s. Shandong Shanxian Medical Suture

Materials Co. Ltd. China to M/s. Shandong Sinorgmed Co. Ltd., China:-

S. No. Reg. No. Name of Products.

1. 031371 PLAIN CATGUT (Plain Catgut Surgical Sutures).

2. 031372 CHROMIC CATGUT (Chromic Catgut Surgical

Sutures).

3. 031373 POLYGLYCOLIC ACID (Synthetic Absorbable

Sutures).

4. 031374 SILK BRAIDED (Silk Braided Surgical Sutures).

5. 043055 Black Monofilament Nylon Surgical Suture.

6. 043056 Blue Polypropylene Surgical Suture.

7. 043057 Green Braided Polyester Surgical Suture.

The firm has deposited the fee Rs.15000 x 7 = Rs.105000/- and submitted

following supporting documents:-

i. No objection certificate to transfer the registration in the name of M/s.

Zenith International, Karachi from the manufacturer abroad M/s.

Shandong Sinorgmed Co. Ltd., China.

ii. Manufacturer declaration regarding termination of their previous agency.

iii. Manufacturer declaration of change in company name.

iv. Certificate from Heze Food and Drug Administration of Peoples Republic

of China certifying the change in company name.

No Objection Certificate of the former agent M/s. Pakistan Business International,

Karachi was not provided. M/s. Pakistan Business International, Karachi was asked either

to submit their NOC in this regard or provide their fresh agency agreement (if any) with

the manufacturer abroad. They have informed that they do have strong objection in

transferring the said drugs to other applicant/company without their consent and shall be

25

furnishing fresh Agency Agreement and relevant documents as soon as they receive.

However the principals abroad M/s. Shandong Sinorgmed Co. Ltd., China have

meanwhile confirmed that they have appointed M/s. Zenith International, Karachi as their

sole agent for all their products and have terminated their agency with M/s. Pakistan

Business International, Karachi.

Show Cause Notices were issued to M/s. Pakistan Business International, Karachi

two times for cancellation of registration of said drugs from their name. In response they

have requested to grant them an appointment to appear in person to explain the details.

They have also informed that they already pursue the matter with Wafaqi

Mohtasib (Ombudsman’s) Secretariat Regional Office Karachi to counter the challenges

and forward copies of proceedings as and when required by this office.

M/s Zenith International, Karachi have submitted relevant documents from

manufacturer abroad that are not endorsed by Pakistan embassy in China.

Accordingly, M/s. Pakistan Business International, Karachi was called for

personal hearing before the Drug Registration Board in its 237th

meeting held on 26-02-

2013.

In response, M/s. Pakistan Business International, Karachi have submitted that the

letter for personal hearing received too late leaving no time, not even a single day to

move / attend the scheduled hearing before Drug Registration Board on 26th

February,

2013.

The Drug Registration Board in its 237th

meeting held on 26-02-2013 and also

placed in 238th

meeting held on August 5-6, 2013 the board considered and deferred the

case and decided to issue final show cause notice to call the firm for personal hearing in

next board’s meeting.

Decision:

The representative of the firm Mian Abdul Jabbar CEO appeared before the

Board and informed that his firm i.e. M/s. Pakistan Business International, Karachi

is still authorized agent of M/s. Shandong Sinorgmed Co. Ltd., China for above

referred products and requested for two week time for submission of legalized New

Sole agency agreement from M/s. Shandong Sinorgmed Co. Ltd., China. The Board

26

after detailed deliberations allowed him to submit the same within 15 days for

further actions on the request of M/s. Zenith International, Karachi.

Case No:02. Re-registration of BONEFOS Capsules (REG. NO.013031).

On the request of M/s. Medipharm (Private) Limited, Karachi the Drug

Registration Board in its 236th

meeting held on 20th

November, 2012 de-registered their

drug “Bonefos Capsules (Disodium Clodronate 400mg) (Reg. No. 013466)” due to non-

available business with immediate effect.

Now M/s. Medipharm (Private) Limited, Karachi have informed that they have

two presentations of Bonefos Capsules, registered with DRAP Bonefos Capsules, 1x

100’s pack and Bonefos Capsules, 1x30’s pack. They have pointed out that they applied

for withdrawal / discontinue one of the above mentioned presentations i.e., Bonefos

Capsules, 1x100’s pack, with the intention to continue with the sale of Bonefos Capsules

1x30’s. Unintentionally wrong registration number was mentioned which was corrected

in subsequent clarification letter.

Now surprisingly, they have received the letter with the subject, “de-registration

of drug” in which there are two main confusions:-

i) The registration number (013466) mentioned is not of Bonefos capsules,

but of another unrelated product.

ii) The letter does mention Bonefos Capsule but confusingly does not

mention the de-registration presentation, i.e., Bonefos Capsules, 1x100’s

pack. While they had clearly mentioned the desired pack size in their

request letter.

They have stopped further sales of Bonefos Capsules. To avoid any further

confusion, they have requested:-

i) Please confirm withdrawal / discontinuation of Bonefos Capsules 1x100’s

presentation.

ii) Please confirm continued registration of Bonefos Capsules 1x30’s pack

size having Registration No.013031 so that it can continue to be marketed.

27

The firm has submitted that Bonefos is used on long term basis, in life threatening

cancers, so to avoid any inconvenience to the patients already on Bonefos Capsules

requested to treats this matter at the earliest.

Decision:

The Board after detailed discussion accepted the request of the firm for re-

registration of Bonefos Capsules (Registration No. 013031) in pack size of 30’s on

same terms and conditions.

Case No:03. APPEAL FILED BY M/S. FINE TRADERS INTERNATIONAL

AGAINST THE DECISION OF REGISTRATION BOARD REGARDING

REJECTION OF REGISTRATION APPLICATION OF NEOCLOXIN

POWDER.



– 27th

October,

2007 considered and rejected the application of “Neocloxin Powder” applied by M/s.

Fine Traders International Faisalabad for import from M/s. Agrar Holland BV Holland

due to irrational formulation.

Against the decision of Drug Registration Board M/s. Fine Traders International

Faisalabad filed an appeal before the Drugs Appellate Board. The Drugs Appellate Board

in its 138th

meeting held on 13-01-2010 considered and passed orders on the appeal

preferred by the firm against the decision of the Drug Registration Board regarding

rejection of their application for grant of registration due to the reason as follows: -

Name of Drug (s) & Composition. Orders Passed by the Drugs Appellate Board.

Neocloxin Powder

Each gm contains: -

Oxytetracycline HCl 100mg.

Neomycin Sulphate 50mg.

Chloramphenicol 100mg.

After hearing to arguments of the appellant and

the basis of decision by the respondent i.e. the

Registration Board as stated by its secretary and

taking into consideration all the relevant pros and

cons of the matter, the Board decided to remand

the case back to the Registration Board for

getting expert evaluation of this formulation from

University of Veterinary and Health Sciences,

Lahore and also to verify its formulation in other

countries and to decide the matter on merit

accordingly.

28



& 21st July 2010

considered and decided that the instructions of the Drugs Appellate Board be processed

accordingly.

As per decision of the Drug Registration Board in its 226th


&

21st July 2010 case was referred to Prof. Dr. Muhammad Nawaz, Vice Chancellor,

University of Veterinary and Health Sciences, Lahore for their detailed views/expert

opinion and recommendations on the matter. The views/expert opinion of Prof. Dr.

Muhammad Nawaz is not received so far.

Decision:

The Board discussed the matter in detail. Dr. Arshad, Member DRB also

recommended that chloramphenicol containing formulation should be banned in

veterinary drugs. Thus the Board rejected the request of the firm. The Board

further decided to issue cuase notices to all manufactures / importers of veterinary

drugs for de-registration of all chloramphenicol containing products.

Case No:04. Correction in Composition of Solvasole Forte Injection.

M/s. Mylab (Private) Limited, Bahawalpur have requested for correction of

composition of their registered veterinary drug “Solvasol Forte Injection (Reg.

No.075602)” that one of the ingredient “Etilefrine 10mg/ml” is written by mistake in the

registration application instead of “Etilefrine 0.2mg/ml”. They have therefore requested

for correction of composition of the product as follows. M/s. Mylab (Private) Limited,

Bahawalpur have deposited required fee Rs.20000/-:-

Incorrect composition Correct composition

Solvasol Forte Injection.

Each ml contains:-

Novaminsulfon …………….. .40mg.

Etilefrin…………………….10mg.

Calcium Gluconate …………100mg.

Magnesium Gluconate ……… 10mg.

Sodium Salicylate …………… 7mg.

Nicotinamide ………………… 0.3mg.

Caffeine………………………. 10mg.

Solvasol Forte Injection.

Each ml contains:-

Novaminsulfon …………….. .40mg.

Etilefrin……………………0.2mg.

Calcium Gluconate …………100mg.

Magnesium Gluconate ……… 10mg.

Sodium Salicylate …………… 7mg.

Nicotinamide ………………… 0.3mg.

Caffeine………………………. 10mg.

29

Boric acid………………………10mg. Boric acid………………………10mg.

The firm have further requested that the above composition is already registered

and is a Mee-Too product. They have given the following references of already registered

products:-

S. No. Name of Manufacturer. Name of Product. Reg. No.

1. M/s. Nawan Laboratories, Karachi Nevit Forte Injection 058987

2. M/s. Selmore Pharmaceuticals, Lahore Aminox Injection 029663

3. M/s. Star Laboratories, Lahore Novastar Injection 035134

4. M/s. Zakfas Pharma, Multan Novafon 052325

Keeping in view of above submitted documents request of the firm for correction

of composition of the drug “Solvasol Forte Injection (Reg. No.075602)” may be

considered for approval please.

Decision:

Request of the firm was approved by the Board

.

Case No:05. Change of Manufacturing Site of Tarceva Tablets.

M/s. Roche Pakistan Limited, Karachi have requested to approve the change of

manufacturing site of their following registered imported drugs from M/s. F. Hoffmann-

La Roche Ltd., Basel, Switzerland to M/s. Roche S.p.A., Segrate (Milano), Italy:-

S. No. Reg. No. Name of Drug (s).

1. 043002 Tarceva 100mg Tablets.

Each film-coated tablet contains:-

Erlotinib hydrochloride corresponding to

100mg of Erlotinib.

2. 043003 Tarceva 150mg Tablets.

Each film-coated tablet contains:-

Erlotinib hydrochloride corresponding to

150mg of Erlotinib.

30

M/s. Roche Pakistan Limited, Karachi has deposited required fee submitted

following supporting documents:-

i) Copy of initial registration letter.

ii) Copy of change of manufacturing site.

iii) Copy of last renewal of drugs.

iv) Original COPP of drugs issued by EMA.

M/s. Roche Pakistan Limited, Karachi was advised to confirm about status of

Tarceva 25mg Tablets (Reg. No.043001) whether it will be supplied from previous

manufacturing site. In response, M/s. Roche Pakistan Limited, Karachi have submitted

that “Tarceva 25mg Tablets” strength is not prescribed by specialist doctors, which

leaves it with no place in the market; therefore they do not intend to continue marketing

this strength.

Keeping in view the submitted documents request of the firm for change of

manufacturing site from M/s. F. Hoffmann-La Roche Ltd., Basel, Switzerland to M/s.

Roche S.p.A., Segrate (Milano), Italy is submitted for consideration of the Drug

Registration Board.

Decision:

The Board after discussion approved the change in manufacturing site of

Tarceva tablets from M/s. F. Hoffmann-La Roche Ltd., Basel, Switzerland to M/s.

Roche S.p.A., Segrate (Milano), Italy. However the Board advised to provide site

master file of new manufacturing site and authorized its Chairman to accord

approval for issuance of letter.

Case No:06. Change of Manufacturing Site of Integrilin Injections.

M/s. Schering-Plough Pakistan (Pvt) Limited, Karachi have requested to approve

the change of manufacturing site of their following registered imported drugs from M/s.

Teva Parenteral Medicines Inc., USA to M/s. Patheon Italia SPA, Ferentino, Italy, while

the Labeling, Secondary Packaging and Batch release site of the finished products remain

the same i.e. M/s. Schering-Plough Labo N.V., Belgium:-

S. No. Reg. No. Name of Drugs.

1. 033145 Integrilin 0.75mg/ml Injection.

31

2. 033146 Integrilin 2.0mg/ml Injection.

They have deposited required fee and submitted following documents in support

of their request:-

i) Original declaration letter from their parent company M/s. Schering-

Plough Corporation, USA affecting this change requirement.

ii) Patheon’s GMP and Manufacturing Certificates duly notarized and

legalized in original by Pakistan embassy, Rome, Italy.

iii) Legalized and notarized CPP (Certificate of Pharmaceutical Product) from

Italy for Integrilin 0.75mg/ml Injection.

iv) Legalized and notarized CPP (Certificate of Pharmaceutical Product) from

Italy for Integrilin 2.0mg/ml Injection.

v) FDA approval of Integrilin 0.75mg/ml &2.0mg/ml in US.

vi) Notarized Merck letter confirming availability of Integrilin in US from the

manufacturing site Patheon Italia S.p.A. Ferentino, Italy.

vii) Legalized and Notarized FDA approval of Integrilin with the source of

supply Patheon Italia S.p.A in US.

The Registration of the drug is valid till 16th

December 2013 as change in the

name of manufacturing site was approved on 17th

December 2008.

Keeping in view the submitted documents request of the firm for change

of manufacturing site from M/s. Teva Parenteral Medicines Inc., USA to M/s. Patheon

Italia SPA, Ferentino, Italy is submitted for consideration of the Drug Registration Board.

Decision:

The Board approved the change in manufacturing site of Integrilin

Injection from M/s. Teva Parenteral Medicines Inc., USA to M/s. Patheon Italia

SPA, Ferentino, Italy, while the labeling, secondary packaging and batch release site

of the finished products remain the same i.e. M/s. Schering-Plough Labo N.V.,

Belgium. However the Board advised to provide site master file of new

manufacturing site and authorized its Chairman to accord approval for issuance of

letter.

32

Case No: 07. Transfer of Registration of Imported Drugs and Change of

manufacturing site.

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 as 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: -

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 submitted 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.

M/s. Abbott Laboratories (Pakistan) Limited, Karachi was advised to provide the

33

proof of approval of the “Physiotens tablets” from EMA, US FDA, Japan & WHO form

the same source, the product is not approved from any of these regulatory bodies and as

per Import Policy the inspection of the source is required before transfer.

The case is submitted for consideration of the Drug Registration Board.

Decision:

The Board approved transfer of registration of Physiotens Tablet from M/s.

Highnoon to M/s. Abbott Laboratories (Pakistan) Ltd. Karachi alongwith 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.

Case No:08. Change of Manufacturing Site of Clozaril Tablets.

M/s. Novartis Pharma (Pakistan) Limited, Karachi have requested to approve the

change of manufacturing site of their following registered imported drugs from M/s.

Novartis Pharmaceuticals, Horsham, Great Britain to M/s. Norartis Urunleri, Kurtkoy,

Istanbul, Turkey:-

S. No. Reg. No. Name of Drug (s).

1. 016329 Clozaril Tablets 25mg.

2. 016330 Clozaril Tablets 100mg.

They have deposited required fee and submitted following supporting documents:-

i) Copy of registration letter.

ii) Original legalized GMP Certificate of new manufacturing site.

iii) Copy of evidence of approval of Clozaril Tablets by FDA.

iv) Copy of evidence of approval of Clozaril Tablets by EMEA.

v) Copy of GMP Certificate of new site issued by MHRA.

vi) Copy of NOC for CRF.

34

vii) Original legalized GMP Certificate issued by Medicines and Healthcare

Products Regulatory Agency (MHRA), United Kingdom.

viii) Original legalized CPP issued by Ministry of Health, Republic of Turkey

as an evidence of approval in the country of origin.

ix) Copies of the acknowledgement of last renewal of registration of the

products.

x) Copy of transfer of registration from M/s. Sandoz (Pakistan) Limited,

Karachi to M/s. Novartis Pharma (Pakistan) Limited, Karachi.

M/s. Novartis Pharma (Pakistan) Limited, Karachi have further submitted that

they will be importing these products from M/s. Novartis Pharma Stein AG, Switzerland

till they receive products from new manufacturing site.

M/s. Novartis Pharma (Pakistan) Limited, Karachi was advised to provide

legalized / notarized documents for approval of the “Clozaril tablets” from EMA, US

FDA, Japan & WHO form the same source. In reply the firm has provided legalized

Certificate of Pharmaceutical Product (CPP) of Australia from Australian Government,

Department of Health and Ageing, Therapeutic Goods Administration (TGA) as the proof

of approval of the “Clozaril tablets” manufactured by to M/s. Norartis Urunleri, Kurtkoy,

Istanbul, Turkey.

Decision:

Registration Board approved change in manufacturing site of Clozaril

Tablets from M/s. Novartis Pharmaceuticals, Horsham, Great Britain to M/s.

Norartis Urunleri, Kurtkoy, Istanbul, Turkey. However, the Board advised to

deposit remaining fee and provide site master file of manufacturing site. The Board

authorized its chairman to accord approval for issuance of letter after compliance of

aforementioned provisions.

Case No:09. Change of Manufacturing Site of Eloxatin Injetcion.

M/s. Sanofi-Aventis Pakistan Limited, Karachi have requested to approve the

change of manufacturing site of their following registered imported drugs from M/s.

Aventis Pharma, Rainham Road South, Dagenham, United Kingdom to M/s. Sanofi-

Aventis Deutschland GmbH, Bruningstrasse 50, D-65926 Frankfurt am Main, Germany

:-

S. No. Reg. No. Name of Products.

1. 044890 Eloxatin 50mg/10ml Concentrate for

Solution for Infusion.

35

Each ml contains:-

Oxaliplatin …………… 5mg.

2. 044891 Eloxatin 100mg/20ml Concentrate for

Solution for Infusion.

Each ml contains:-

Oxaliplatin …………… 5mg.

They have deposited required fee and submitted following supporting

documents:-

i) Copies of Registration Documents.

ii) Original Legalized Certificate of Pharmaceutical Products.

iii) Original Legalized GMP Certificate.

iv) Original Legalized Manufacturing Authorization.

M/s. Sanofi-Aventis Pakistan Limited, Karachi was advised to provide legalized /

notarized documents for approval of the “Eloxatin Injection” from EMA, US FDA, Japan

& WHO form the same source. In response the firm has submitted a letter addressed to

Director Registration, Drug Regulatory Authority of Pakistan, Islamabad regarding

confirmation of registration and approval “Eloxatin Injection” from M/s. Sanofi-Aventis

Deutschland GmbH, Bruningstrasse 50, D-65926 Frankfurt am Main, Germany.

Keeping in view the submitted documents request of the firm for change of

manufacturing site of the products from M/s. Aventis Pharma, Rainham Road South,

Dagenham, United Kingdom to M/s. Sanofi-Aventis Deutschland GmbH, Bruningstrasse

50, D-65926 Frankfurt am Main, Germany is submitted for consideration of the Drug

Registration Board.

Decision:

The Board approved the change in manufacturing site of above products

from M/s. Aventis Pharma, Rainham Road South, Dagenham, United Kingdom to

M/s. Sanofi-Aventis Deutschland GmbH, Bruningstrasse 50, D-65926 Frankfurt am

Main, Germany. However, the Board advised to provide site master file of new

manufacturing site and authorized its chairman to accord approval for issuance of

letter after compliance of aforementioned provision.

36

Registration-II

Case No.10 Permission for bulk import and local repacking – Telfast D tablets

(Reg. No: 023617).


meeting deferred request of M/s Aventis, Karachi

for extension in bulk import and local repacking of Telfast- D Tablet (Reg. No.023617)

for five years, for clarification from the firm for plan of local manufacturing of Telfast- D

Tablet. Last permission for extension for bulk import and local repacking of subject item

was granted by the Chairman, Registration Board for two years which is up to 29th

August, 2009. Firm submitted an undertaking to establish their own facilities for

manufacturing of Telfast-D Tablets within this period. Permission was subject to no

further extension in future. Later on firm submitted that Telfast-D Tablet is manufactured

at Sanofi-aventis Pharmaceuticals Inc. USA and involves sophisticated unique

technology that enables slow release of pseudoephedrine using a tan-wax matric in these

bi-layered tablets. This also follows strict analytical procedures and quality tests to

maintain specification standards and safety precautions to be taken during its

manufacturing and analysis. Due to these facts, this site is responsible for supply bulk

tablet to all sanofi-aventis subsidiaries across the world to be imported in bulk followed

by local repacking at local units.

The Registration Board in its 223rd

meeting discussed the case and advised firm to

transfer technology as committed previously and must develop facility for manufacturing

of Telfast-D Tablet. If firm is still interested for import, then they should brief the

Registration Board.

In the Registration Board’s 224th

meeting dated 21st & 22

nd April, 2010

Mr.Muhammad Amjad, Director Technical, Sanofi Aventis appeared before the board

and presented that Telfast-D Tablet cannot be manufactured in Pakistan due to low sale

volume and safety concern in manufacturing of fexofenadine and pseudoephedrine

combination. The board considered firm’s view about safety concern in manufacturing of

fexofenadine and discussed that firm is presently manufacturing fexofenadine tablets and

firm has already taken safety measures in its manufacturing. However in order to avoid

scarcity of product in market, it was decided to extended bulk import and local repacking

permission of Telfast- D Tablet (Reg. No.023617). Permission was valid till August

37

2011. The board also advised firm to transfer technology as committed previously and

must develop facility for manufacturing of Telfast-D Tablet. No further extension will be

granted after this permission. The Board after detailed discussion deferred the case for

personal hearing in next Registration Board.

Now firm has requested for further extension in the permission for bulk import

and local repacking of Telfast-D Tablets and have deposited fee amounting to

Rs.100,000/- for the purpose.

Decision:

Mr.Muhammad Idress incharge QA and Mr.Jaffar Zaida, Regulatory Officer, SITE

appeared before the Board and presented that initially M/s Sanofi Aventis, Karachi

was granted registration for finished import from M/s Sanofi Aventis, Kansas, USA

and later on permitted for bulk import and local repacking at their manufacturing

site. As per directions of Registration Board they have tried to make arrangements

for local manufacturing of the product but their principal did not agree to the

proposal as M/s Sanofi Aventis, Arkansas, USA is the only site of M/s Sanofi Aventis

for providing Telfast-D tablets across the globe.

Registration Board discussed and decided to permit M/s Sanofi Aventis, Karachi for

import of Telfast-D tablet from M/s Sanofi Aventis, Kansas, USA in tablet form and

then further processing to finished form in M/s Sanofi-Aventis, Karachi for 02 years

time. However, the Board advised firm to provide legalized COPP of the source and

authorized its chairman to accord approval for issuance of regsirtation letter.The

Board further advised the firm to apprise them about future strategy for transfer of

technology to Pakistan in 02 months time.

Case No:11: Use of packaging materials with old address.

M/s Novartis Pharma (Pakistan) Ltd, West Wharf, Karachi was granted

permission for bulk import and local repacking of their Amoxi-Clav range of products at

M/s CSH Pharmaceuticals, Lahore. They have now informed that they have imported

bulk stocks with repackaging address of 15, West Wharf Road, Karachi instead of CSH

Pharmaceuticals, Lahore due to error which was caused to due to some misunderstanding.

S. Reg. No. Name of drug(s) Quantity Value in

38

No. rupees

1. 031354 Amoxi-Clav Injection 1.2gm 980,273 116,652,463

2. 031355 Amoxi-Clav 375mg Tablet 743,492 52,044,426

3. 031356 Amoxi-Clav 625mg Tablet 2,554,843 196,722,880

4. 031357 Amoxi-Clav 1gm Tablet 417,131 43,798,734

5. 031353 Amoxi-Clav Injection 600mg 72,000 6,847,920

6. 031358 Amoxi-Clav 156.5mg/5ml Dry Suspension

60ml

732,132 51,351,738


100ml

69,048 6,503,631


60ml

921,024 83,500,036

9. 031359 Amoxi-Clav 312.5mg/5ml Dry

Suspension100ml

90,000 12,136,500

Total 6,579,942 569,558,329

Firm has requested that they may be allowed to repack the above mentioned

quantities at M/s CSH Pharmaceuticals; Lahore mentioning the address of M/s Novartis

Pharma (Pakistan) Ltd, 15, West Wharf Road, Karachi and bulk manufacturer address

will remain same i.e Sandoz Kundl, Austria.

Decision: Dr.Farid Khan, representative Pharma Beauru presented samples of

Amoxi-Clav 375mg Tablet onwhich old address has been blocked but new address

was yet to print. The Board discussed the matter in detail and advised the firm to

present samples of all drugs with blocked old address and printed new address for

its consideration.

Case No.12 Deferred Drugs.

a. M/s Healthtek Pharma, Karachi – 2SUM 500mg Injection

Registration Board in 237th

meeting deferred following application of M/s

Healthtek Pharma, Karachi

Name of drug(s) &

Composition

Proposed

Pack size

Demanded

Price

Date of

application,

Diary No.

& Form

Decision

2SUM 500mg Injection

Each vial contains:

Cefoperazone as sodium

……………...250 mg

As per

PRC

As per PRC 07-09-2012

1551

Form-5

Rs.8000/-

Deferred for

submission of

application on

form5D with

39

Sulbactam as sodium

……………..250 mg

Rs.52,000/-

27-1-2013

balance fee

Later on scrutiny of record reveals that this formulation is already registered in favour of

M/s Global Pharma, Islamabad under brand name of Toxibid Injection, Reg. No.049233.

Decision: The Board approved above product for registration for M/s Healthtek

Pharma, Karachi

b. Pharmatec Pakistan (Pvt.) Ltd, Karachi

Following product of M/s Pharmatec Pakistan, Karachi was deferred in 237th

meeting

for review the case after submission of balance fee, GMP of source, COA and stability

data by the Expert Committee of Registration Board.

Name of Drug & Composition Pack size Demanded

MRP

Prazol 40mg Capsule


Omeprazole……………..40 mg

(Anti peptic ulcerants)

14’s As per PRC

Now the firm has requisite information as under:-

i) Omeprazole Pellets will be purchased from M/s Vision Pharma, Islamabad

ii) GMP Certificate of M/s Vision Pharma, Islamabad

iii) Certificate of Analysis

iv) Stability data (for Zone IV. Both accelerated i.e 400C / 75% RH and long

term studies i.e 300C / 65% RH)

Decision: The Board approved above product for registration for M/s

Pharmatec Pakistan, Karachi.

c. M/s OBS Pakistan, Karachi

The Registration Board in 237th

meeting deferred following application of M/s

OBS Pakistan, Karachi

Name of drug(s) &

Composition

Proposed

Pack size

Demanded

Price

Date of

application,

Diary No. &

Form

Decision

C-Yalta 20mg Capsules 10’s Rs. 400.00 14-12-2010 The Sub Committee

40


Duloxetine HCL……….20

mg

(Antidepressants)

Dy.No.2168

Form-5

Rs.8000/-

Rs.52,000/-

06-2-2013

decided to review the

cases after

submission of

balance fee, GMP of

source of pellets,

COA and stability

data

C-Yalta 60mg Capsules


Duloxetine HCL……….60

mg

(Antidepressants)

10’s Rs. 1200.00 14-12-2010

Dy.No.2170

Form-5

Rs.8000/-

Rs.52,000/-

06-2-2013

-do-

C-Yalta 30mg Capsules


Duloxetine

HCL………..30 mg

(Antidepressants)

10’s Rs. 600.00 14-12-2010

Dy.No.2173

Form-5

Rs.8000/-

Rs.52,000/-

06-2-2013

-do-

M/s OBS Pakistan, Karachi has now furnished the following documents:-

i) GMP Certificate of API source M/s Spansules Formulation, India

ii) Certificate of Analysis

iii) Stability study data on accelerated and real time study of API

iv) Remaining fee Rs.240,000/- for each product for the purpose.

Decision: The Board approved above product for registration for M/s OBS

Pakistan, Karachi.

d. Correction cases:

i. M/s Sami Pharmaceuticals (Pvt.) Ltd, Karachi

M/s Sami Pharma, Karachi has requested for change of drug profile from plain to

extended release formulation for their already registered drug i.e ITP 150mg Tablet, Reg.

No.075852 containing Itopride HCl ….150mg. Firm has submitted that as the innovator

M/s Abbott Lab’s product Ganaton OD is available as extended release tablet, hence they

would like to market their product as extended release tablet. Firm has furnished

following document / information to support their request:-

i) Form-5

ii) Comparative study of Dissolution profile with innovator

41

iii) Method of analysis

iv) Stability summary

v) Fee Rs.20,000/- for the purpose.

Decision: The Board discussed firms’s request and reviewed documents

submitted by the firm and then approved their request for change of drug profile

from plain to extended release formulation for their already registered drug i.e ITP

150mg Tablet, Reg. No.075852 containing Itopride HCl 150mg.

ii. Pharmatec Pharmaceuticals, Karachi.


meeting approved the following registration of

M/s Pharmatec Pakistan (Pvt.) Ltd, Karachi and accordingly registration letter was

issued. Now the firm has pointed out some typographical mistakes in the said registration

letter. Details are as under:-

S.

No.

Existing Name & Composition Reg. No. Correct name & Composition

1 Fenzitec Depot Injection

Each ml contains:-

Fluphenazine Decanoate …25mg

(Manufacturer’s Specification)

Pack Size : 5’s x1ml

MRP : Rs.215.00

073773 Fenzitec Depot Injection

Each ml contains:-

Fluphenazine Decanoate …25mg

(Manufacturer’s Specification)

Pack Size : 1mlx1’s

MRP : Rs.100.00

Pack Size : 1mlx10’s

MRP : Rs.1000.00

Firm has stated that they have applied aforementioned product with demanded

pack and MRP as mentioned in last column, as evidence firm has furnished Form-5. Firm

has requested for issuance of correction letter.

Decision: The Board agreed to the firm’s request and referred matter to Drug

Pricing Committee for fixation of MRP of Fluphenazine Decanoate …25mg/ml in

pack sizes of 1’s and 10’s.

42

Registration-III

Case No.13 M/s Saibins Pharmaceuticals, Islamabad

The Registration Board in its 237th

meeting referred the following product of M/s

Saibins Pharmaceuticals, Islamabad to a Committee comprising of following members.

The Board further decided that the recommendations of committee will be submitted to

the Chairman, Registration Board for decision & Ten (10) products per section policy

will be followed for new License / Section in accordance with the priority as given by the

firm:-

1. Brig. (R). Prof. Dr. Muzammil Hasan Najmi (Member Registration Board/ Chairman of

the Committee).

2. Dr. Taufeeq Ur Rehman, Assistant Professor, Department of Pharmacy, Quaid-e-Azam

University, Islamabad (Member Registration Board)

3. DDG (Reg-II)

The recommendations of the above committee which were approved by the Chairman

Registration Board are reproduced in the last column as below:-

S.

No.

Brand Name / Label

Claim

Demande

d Pack

Size

Demanded Price

Date of Submission

Previous

Decision

M-237

1. Muscide 4mg Capsules


Thicolchicoside ……4mg

(Anti-rheumatics (anti-

inflammatory agents).

10’s As Per

SRO

21-01-2013

Dy.No.996

Fee

Rs.20,000

Deferred

for

confirmation

of registration

status in

international

and national

market.

Now, the firm has submitted information that the above formulation is registered in

Grece, France, Italy, Poland, Portugal, Turkey & India. The applicant has also provided

the evidence of registration of above formulation in Pakistan of M/s Searle with brand

name Muscoril 4mg Cap & Inj. Other locally registered brands are Myoron (M/s

Angelini) & Thiolax (M/s SJ & G Fazul Ellahi). They have therefore requested to register

above formulation in their name.

Decision: The Registration Board after thorough deliberation decided to refer the

case to the review committee for review of formulation.

43

Case No.14: M/s Winilton Pharmaceuticals (Pvt) Ltd, Rawat


meeting referred the following products of M/s

Winilton Pharmaceuticals (Pvt) Ltd, Rawat to a Committee comprising of following

members. The Board further decided that the recommendations of committee will be

submitted to the Chairman, Registration Board for decision & Ten (10) products per

section policy will be followed for new License / Section in accordance with the priority

as given by the firm:-


the Committee).



3. DDG (Reg-II)



S.

No.

Brand Name / Label

Claim

Demande

d Pack

Size

Demanded Price

Previous Decision

M-237

2. Kastwin 10mg Dispersible

Tabs.

Each Dispersible tablet

contains:-

Montelukast ………… 10mg

(Respiratory System)

14’s As Per SRO

Fee

Rs.60,000

Deferred

for confirmation of

me-too status.

3. Fenacwin 75mg Dispersible

Tabs.

Each Dispersible tablet

contains:-

Diclofenac

Potassium…..75mg

(Anti-Rheumatics, Systemic)

2x10’s As Per SRO

Fee

Rs.60,000

Deferred

for confirmation of

me-too status.

Now the firm has clarified that due to typographical mistake the products at Sl.No.2 & 3

have been applied as dispersible while in actual fact the dosage form of product at

Sl.No.2 is chewable tablets and for product at sl.No.3 is plain tablets instead of

dispersible tablet. The firm has therefore, requested for issuance of registration of above

product in chewable dosage form for Sl.No.2 and in Plain Tablets for Sl.No.3.

44

Decision: The Registration Board deferred the above applications for

submission of complete registration dossier on Form-5 with clarification of dosage

forms of drugs.

Case No.15. M/s Shaigan Pharmaceuticals (Pvt) Ltd, Rawalpindi


meeting referred the following product of M/s

Shaigan Pharmaceuticals (Pvt) Ltd, Rawalpindi to a Committee comprising of following

members. The Board further decided that the recommendations of committee will be

submitted to the Chairman, Registration Board for decision & Ten (10) products per

section policy will be followed for new License / Section in accordance with the priority

as given by the firm:-


the Committee).



3. DDG (Reg-II)



S.

No.

Brand Name / Label

Claim

Demande

d Pack

Size

Demande

d Price Date of

Submission Previous

Decision

M-237

4. Mark Injection

Each ampoule (5ml)

contains:-

Zoledronic Acid as

Monohydrate………..4mg

(Bisphosphonic Acid)

1’s As Per

SRO

19-12-2011

Fee

Rs.60,000

Deferred

for confirmation

of formulation

whether it is Dry

Powder or

Liquid

Ampoule.

The firm actually applied in Liquid Ampoule. Due to this reason the committee

recommended to defer the request of firm for confirmation of dosage form. Now the firm

has clarified that due to typographic error they applied in ampoule dosage form. But

actually dosage form / presentation of the formulation is Vial. The firm has therefore

requested to issue the registration of above product in Vial.

45

Decision: The Registration Board deferred the above registration application for

product specific inspection for verification of manufacturing and quality control

facility and the data / information submitted in the registration dossier by A.Q.

Javed Iqbal (Member, Registration Board) and Director DTL, Peshawar and area

FID.

Case No.16. M/s Trison Pharmaceuticals (Pvt) Ltd, Sargodha

The Registration Board in its 223rd

meeting deferred the following products firm M/s

Trison Pharmaceuticals (Pvt) Ltd, Sargodha for the reasons mentioned in the last column

as below:-

S.

No.

Brand Name / Label Claim Demande

d Pack

Size

Demanded

Price

Previous Decision

M-223

1 Triphenamol Tablets

Each tablet contains:-

Orphenadrine Citrate………35mg

Paracetamol………..450mg

(Manufacturer Specifications)

100’s Rs.350.00

Fee Rs.20,000

Deferred

2 Tricidol Tablets 0.5mcg

Each film coated tablet contains:-

Alfacalcidol BP…………0.5mcg

(USP Specifications)

10’s Rs.145.00

Fee Rs.20,000

Deferred

3 Trivelox 400mg Tablets


Moxifloxacin (as HCl)……400mg

5’s Rs.460.00

Fee Rs.20,000

Deferred

4 Trigesic 550mg Tablets


Naproxen Sodium……….550mg


20’s Rs.180.00

Fee Rs.20,000

Deferred

5 Trinolol Tablets 50mg


Atenolol USP……….50mg


20’s Rs.110.00

Fee Rs.20,000

Deferred

6 Tribastin Tablets 10mg


Esbastine BP………….10mg

10’s Rs.100.00

Fee Rs.20,000

Deferred

7 Trizadine Tablets 2mg


Tizanidine (as HCl) …………2mg


10’s Rs.102.00

Fee Rs.20,000

Deferred

Now the firm has submitted that in 2010 the Registration Board in its 223rd

meeting

granted five products per section to the new licensees and deferred the remaining product

46

as per policy. Now three years have passed it is therefore requested to grant the

registration above remaining product in their name. The firm has submitted an inspection

report dated 11-01-2011 which verifies the GMP status bearing the words “Firm was

GMP compliant at the time of inspection”.

Decision: The Registration Board deferred the above registration applications for

the evaluation of the registration dossiers. For Alfacalcidol tablet, product specific

inspection will be carried out by Director DTL, Lahore and area FID for

confirmation of manufacturing and quality control facilities.

Case No.17. M/s Trison Pharmaceuticals (Pvt) Ltd, Sargodha


meeting deferred the following products of M/s Trison

Pharmaceuticals (Pvt) Ltd, Sargodha for the reasons mentioned in the last column as

below:-

S.

No.

Brand Name / Label Claim Demanded

Pack Size

Demanded

Price Previous Decision

M-226

1 Gerdnil 40mg Capsule


Esomeprazole as Magnesium

enteric coated (Pellets) Eq. to

Esomeprazole……..40mg

(Product Complies to

Manufacturer Specifications)

14’s Rs.300.00

Fee

Rs.20,000

Deferred for toll

Policy

2 Prelin 75mg Capsules


Pregabalin……..75mg

14’s Rs.800.00

Fee

Rs.20,000

Deferred for toll

Policy

3 Prelin 150mg Capsules


Pregabalin………….150mg


14’s Rs.1200.00

Fee

Rs.20,000

Deferred for toll

Policy

4 Azotri Capsule


Azithromycin (as

diyhydrate)…..250mg


6’s Rs.500.00

Fee

Rs.20,000

Deferred for toll

Policy

5 Omegab 20mg Capsule


Omeprazole as enteric

coated Pellets.……20mg


14’s Rs.475.00

Fee

Rs.20,000

Deferred for toll

Policy

47

6 Trigab 100mg Capsules


Gabapentin USP…….100mg


10’s Rs.85.00

Fee

Rs.20,000

Deferred for toll

Policy

7 Trigab 300mg Capsules


Gabapentin USP…….300mg


10’s Rs.220.00

Fee

Rs.20,000

Deferred for toll

Policy

8 Hematose –F Syrup

Each 5ml contains:-

Iron (III) Hydroxide

Polymaltose Complex Eq. to

Elemental

Iron………………….50mg

Folic Acid BP….….0.43mg

60ml Rs.80.00

Fee

Rs.20,000

Deferred for toll

Policy

Now, the firm has informed that they have developed their own facility of Capsule

(General) and Dry Powder Suspension (General) sections. The firm has therefore

requested that the above mentioned products which were initially applied on contract

manufacturing may please be registered in their own name. For product at S.No19 (Iron

Polymaltose Syrup) the firm has clarified that the dosage form is Dry Powder

Suspension. In support of this, the firm has stated that they have already been granted

Registration of Iron Polymaltose formulation plain in Dry Powder Suspension

Reg.No.063300 (Brand name Trifer). The firm also provided the reference of already

registered same formulations in Dry Suspension of following firms:

1. M/s Pharmedic (Brand Biofer Suspension).

2. M/s Trison Labs. (Brand Trifer Suspension)

Decision: The Registration Board deferred the above registration applications for

the evaluation of the registration dossiers.

Case No.18. M/s Medley Pharmaceuticals Wah Cantt


meeting approved the following products of M/s

Medley Pharmaceuticals Wah Cantt in the same strength i.e. 20mg.

S.No

.

Name and Composition of

Product

Pack

size

Demanded

Price

Previous

Decision

M-234

48

1 Esowel Capsules 20mg

Each Capsule Contains:

Esomeprazole (Pellets)….20mg

(Antipeptic Ulcerant)

2x7’s As Per SRO Approved






At the time of issuing registration letter, the firm pointed out that, they actually applied

the above products with two different strengths as under:-

S.No

.


Product

Pack

size

Demanded

Price

Decision











The firm has deposited the fee of Rs.20,000/= for each product. The request of firm has

been verified from the dossiers. Actually due to typographic mistake the same strength

has been return in the agenda of Registration Board meeting. The firm has therefore

requested to please issue the registration of above formulation in 40mg. The registration

of above formulation in 20mg has been already issued to firm.

Decision: The Registration Board has approved request of firm.

Case No. 19. M/s Kanel Pharma, Gujranwala.


meeting approved the following product of M/s Kanel

Pharma, Gujranwala. The decision of the Registration Board is mentioned in last column

as under:-

S.No Name and Composition of Pack Demanded Previous

49

. Product size Price Decision

M-236

1 Paroxin 12.5mg Capsules


Paroxetine as HCl …………

12.5mg

(Antidepressant)

30’s As Per SRO

Fee

Rs.20,000/=

Approved subject to compliance of

following:-

1. GMP

Certificate of

Source.

2. COA

Certificate of

Analysis.

3. Stability

studies.

At the time of issuance of Registration letter, the firm informed that Paroxetine is not

available in Pellets or / Capsules dosage form & they actually, applied erroneously for

capsule dosage form. The firm has now requested to please change/correct the dosage

form as tablet. The firm has deposited Rs.5000/= in support of their request previously

the applicant had deposited Rs.15000/= for above product in capsule dosage form, at the

time of application before meeting of Registration Board. The firm has also requested to

adjust their already deposited fee of Rs.15,000/= for the instant request.

Decision: Registration Board has approved request of firm.

Case No.20. M/s Miracle Pharmaceuticals (Pvt) Ltd, Rawat


meeting deferred the following products of M/s Miracle

Pharmaceuticals (Pvt) Ltd, Rawat, with the conditions as mentioned in the second last

column against each product as under:-

S.N

o.


Product

Previous

Decision

M-235

Information

submitted by the

firm.

1 Clomin Tablets


Clomiphene Citrate …… 50mg

(Antioestrogen)

Deferred for

rectification of

following

observation in the

dossier in the

dossier:-

1. Methyline

Chloride should be

replaced with some

other suitable film

coating material

The firm has submitted

that:

1. They will use methanol

as coating material instead

of Methylene chloride.

50

2 Dimet DS Tablets


Diloxanide Furoate

(USP)..500mg

Metronidazole (USP)……

400mg

(Nitroimidazole, Amoebicide)

Deferred for

rectification of

following

observation in the

dossier in the

dossier:-

1. Methyline

Chloride should be

replaced with some

other suitable film

coating material

2. Dissolution test

is absent in finished

product

specification.


that:

1. They will use methanol

as coating material instead

o Methylene chloride.

2. Dissolution test has

been submitted by the

firm alongwith finished

specifications of products.

3 Marither Forte


Artemether ……… 80mg

Lumefantrin ……. 480mg

(Synthetic Anti-Malarial derived

from Artemisinin synthetic

Recemic Flourene Mixture)

Deferred for

rectification of

following

observation in the

dossier:-

1. Dissolution test


product

specification.


that:-

1. Dissolution test has

been submitted by the

firm alongwith finished

specifications of product.

4 Irovit Capsules


Iron III hydroxide polymaltose

complex eq. to Elemental

Iron……………. 100mg

Folic Acid ……. 0.35mg

(Haematinic)

Deferred for

rectification of

following

observation in the

dossier:-

1. Dissolution test


product

specification.

-do-

Now the firm has fulfilled all the formalities as per decision of Registration Board. The

firm therefore requested to grant the registration of above in their name.

Decision: Registration Board after thorough deliberation approved products at Sl.

No.2 (Diloxanide Furoate + Metronidazole) & 3 (Artemether + Lumefantrin). While

the products at Sl.No.1 & 4 have been deferred by the Registration Board for

product specific inspection for confirmation of manufacturing and quality control

facilities by A.Q. Javed Iqbal (Member, Registration Board) and Director, DTL,

Peshawar and area FID. Brand name of product at S.No.1 will be changed.

51

Case No.21. M/s Global Pharmaceutical, Islamabad


meeting approved the following product of M/s Global

Pharmaceutical, Islamabad. The decision of the Registration Board is mentioned in last

column as under:-

S.No. Name and Composition of

Product

Pack size Demanded

Price

Previous

Decision

M-229

5. Tamsol-D Tablets


contains:-

Tamsulosin Hydrochloride

…0.4mg

(as modified – release tablets)

Dutasteride………………0.5mg

10’s As Per SRO

Fee

Rs.8,000/=

Approved

Accordingly the Registration was granted to the firm on 11th

September, 2012. Later on,

it was identified that the above formulation does not exist in tablet dosage form

internationally or locally. However, it is available in capsule dosage form. The case is

submitted for reconsideration of formulation by the Registration Board.

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.

Case No.22. M/s Warafana Pharmaceutical, Islamabad.


& 237 meeting deferred the following products of M/s

Warafana Pharmaceutical, Islamabad. The decision of the Registration Board is

mentioned in last column as under:-

S.No. Name and Composition of

Product

Pack

size

Demande

d Price

Previous Decision

M-235th

& 237th

1 Clari-250 Tablets


Clarithromycin ……250mg

1x10’s As Per

SRO

Deferred for

rectification of

following observation

52

(Macrolide Antibiotic)

Fee

Rs.8000

Balance

fee

Rs.12000/

=

in the dossier:-

1. Methylene

Choloride should be

replaced with some

other suitable film

coating materal.

2 Fusifit-B Cream

Each gm contains:-

Fusidic Acid ……..2.0% w/w

Betamethasone as Valerate

(BP)……………. 0.1% w/w

(Anti-Inflammatory & Anti-

Pruritic Effects).

1’s As Per

SRO

Fee

Rs.60,000

Deferred

for confirmation of

steroidal section

and me-too status.

3 Fusifit-H Cream

Each gm contains:-

Fusidic Acid ……..…..20mg

Hydrocortisone Acetate

BP..10mg

(Anti-Inflammatory & Anti-

Pruritic Effects).

1’s As Per SRO

Fee

Rs.60,000

-do-

Now the firm has submitted that they have replaced Methylene Choloride with water base

film coated material FC 4-H for the product at Sl.No.30 (Clarithromycin 250mg Tablet).

For the products at Sl.No.31&32 the firm has submitted the proof / approval of steroidal

section for cream. The firm has requested for issuance of registration of above products.

Decision: The Registration Board has approved request of firm.

53

Registration-IV

Case No. 23. M/s. Saaaf Pharmaceuticals, Risalpur

The Drugs Registration Board in its 237th

meeting held on 26-02-2013 had deferred the

following products of M/s. Saaaf Pharmaceuticals, Risalpur for rectification of

shortcoming of the following products.-

S.N

o

Name of

manufactu

rer

Name of drugs (s) Pack

size

Demande

d MRP Decision

1.

M/s. Saaaf

Pharmaceutica

ls, Risalpur

Varisaf Tablets


Mebeverine

HCl……200 mg

(Antispasmodic)

3x10’s As Per

SRO

Deferred for

P.S.I & GMP

229th

Meeting

22.1.2011.

Fee paid,

confirmation of

formulation.

237th

26.02.2013

2.

-do-

XL Tablets


contains:-

Linezolid……..600

mg

(Antibiotic)

10’s As Per

SRO

Deferred for

P.S.I & GMP

229th

Meeting

22.1.2011.

Fee paid,

confirmation of

formulation.

237th

26.02.2013

3.

-do-

XL Dry Powder

Suspension

Each 5 ml contains:-

Linezolid ……..100

mg

(Antibiotic)

60 ml As Per

SRO

Deferred for

P.S.I & GMP

229th

Meeting

22.1.2011.

Fee paid,

confirmation of

formulation.

237th

26.02.2013

The firm paid the differential fee. The management could not rectify the relevant

shortcomings in comparison of the brand leader (Mebeverine HCl 200mg/ Colofac Cap of

Abbott Lab); Linezolid Film coated tablet: Incorrect M.O.T. and dissolution profile not

submitted; Linezolid Dry Powder Suspension M.O.T. incorrect, Master formulation is

54

ambiguous. The management requested to grant the registration of above mentioned

products.

Decsion: Registration Board decided to conduct product specific inspection by

Director DTL, DDG (E&M) and ADC, Peshawar, Peshawar for above products.

Moreover, firm will be advised to complete registration applications.

Case No. 24. Deferred Drug



February, 2013 had been

deferred the following application due to shortcomings in application dossiers:-

S.No. Name of Firms Name of Drugs /label

Claim

AU Price Date Remarks

1. M/s. Novae

Pharmaceuticals,

Hattar

General Tablets

General

Capsules

Dry Powder

Suspension

General

Xiben 200 mg Capsule


Celecoxib…….200 mg

(NSAID)

10’s

20’s

As

Per

SRO

25-

1-

2013

SDS > FDA limit

To be deferred

2. -do- Macrozith 250 mg

Capsule


Azithromycin dihydrate

≡ Azithromycin ……250

mg

(Macrolide)

6’s

10’s

As

Per

SRO

-do- Principally Film Coated

Tablet

Master Formulation does

not conform with film

coated tablet

Uniform decision is

required about existing

dosage form of Capsule

Azithromycin

3. -do- Voxipro 250 mg Dry

Powder Suspension


Ciprofloxacin

Hydrochloride

≡ Ciprofloxacin …..250

mg

(Quinolone) (Mfg Spec)

60 ml As

Per

SRO

-do- Master formulation

MOP

Inconformity

MOT

To be deferred.

55

4. -do Arthen Dry Powder

Suspension


Artemether……..15 mg

Lumefantrine…..90 mg

(Antimalarial)

30 ml

60 ml

As

Per

SRO

-do- SDS > FDA limit

To be deferred

5. -do- Leoflox 125 mg Dry

Powder Suspension


Levofloxacin

hemihydrates

≡ Levofloxacin

………..125 mg

(Quinolone)

60 ml As

Per

SRO

-do- Label claim

MOT’

Incorrect

To deferred.

6. -do- Zason 10 mg Dry Powder

Suspension


Zinc Sulphate

monohydrate

≡ Zinc (element)………10

mg

(Antidiarrhoeal & Zinc

Supplement)

60 ml As

Per

SRO


ambiguous /incorrect.

Deferred for

7. -do- Bevexin 20 mg Tablets


Piroxicam β-Cyclodextrin.

≡ Piroxicam………….20

mg

(NSAID)

2x10’s As

Per

SRO


MOT +Specification

Deferred.

8. -do- Leoflox Tablets 250 mg


contains:-

Levofloxacin Hemihydrate

≡ Levofloxacin ……..250

mg

(Quinolone)

1x10’s As

Per

SRO

-do- Film coated

Wrong label claim

Wrong specification.

Incorrect DIT

Chromatographic

condition not mentioned

Deferred for 9. -do- Leoflox Tablets 500 mg


contains:-

Levofloxacin Hemihydrate

≡

Levofloxacin…………500

mg

(Quinolone)

1x10’s As

Per

SRO

-do- Incorrect Specification

Incorrect MOP/MOT

Signature of QCM/PM

Deferred.

56

10. -do- Voxipro 250 mg Tablets


contains:-

Ciprofloxacin

Hydrochloride

≡ Ciprofloxacin …….250

mg

10’s As

Per

SRO

-do- Specification

MOP

MOT

Master formulation

To be deferred

11. -do- Voxipro 500 mg Tablets


contains:-

Ciprofloxacin

Hydrochloride

≡ Ciprofloxacin………

.500 mg

(Quinolone) (B.P.)

10’s As

Per

SRO

-do- Incorrect

Specification/MOP/MOT

Finished

Signature of QCM/PM

deferred

12. -do- Moxigrat 400 mg Tablets


contains:-

Moxifloxacin HCl

Moxifloxacin ……….400

mg

(Quinolone)

1x5’s

1x10’s

As

Per

SRO

-do- SDS is more than FDA

limits

MOT/MOP

Specification incorrect

Deferred.

13. -do- Arthen DS Tablets


Artemether……..40 mg

Lumefantrine…..240 mg

(Antimalarial)

1x8’s As

Per

SRO


Subject to correction

for.

14. -do- Montigrat Tablets 10 mg


contains:-

Montelukast Sodium

≡Montelukast …..….10

mg

(Leukotriene Receptor

Antagonist)

14’s

2x10’s

As

Per

SRO

-do- MOP coating procedure

is mentioned

Coating material has not

been mentioned

MOT is not correct.

To be deferred.

15. -do- Novaefen 100 mg Tablets


contains:-

Flurbiprofen....100 mg

(NSAID)

3X10’S As

Per

SRO

-do- Product Specification

MOP/MOT do not

conform

To be deferred.

57

16. -do- Painclay 75 mg Tablets

Each enteric coated tablet

contains:-

Diclofenac Potassium…75

mg

(NSAID)

1x10’s

2x10’s

3x10’s

As

Per

SRO

-do- Spec/MOT/MOP are

contradicting

To be deferred.

17. -do- Painclay 100 mg Tablets

Each enteric coated tablet

contains:-

Diclofenac Potassium..100

mg

(NSAID)

1x10’s

2x10’s

3x10’s

As

Per

SRO

-do- Spec/MOT/MOP are

contradicting

To be deferred.

Now the firm has rectified shortcomings upto S.No.16. But the master formulations

(S.No. 17) of tablet Diclofenac potassium does100mg not conform with the

internationally available dosage forms.

Decision: Registration Board approved products at S.No.1-16 while product at

S.No.17 deferred for confirmation of international availability.

Case No. 25. M/s. Hizat Pharmaceuticals, Peshawar



following products for rectification of shortcoming:-

M/s. Hizat

Pharmaceuticals,

Peshawar

Esoprazol capsule

Each delayed release

capsule contains:-

Esomeprazole enteric

coated pellets

≡Esomeprazole……...40

mg

(Proton Pump Inhibitor)

10’s Rs.159.00

Submission

of differential

fee

and

confirmation

of

formulation.

Pellet’s fee

unpaid

-do-

Lanzprazole Capsule

Each Delayed Release

Capsule contains:-

Lansoprazole enteric coated

pellets

≡ Lansoprazole……30 mg

(Proton Pump Inhibitor)

10’s Rs.160.00

Submission

of differential

fee and

confirmation

of

formulation.

Pellet’s fee

unpaid

58

The firm had rectified relevant shortcoming and paid differential fee mentioning Vision

Pharmaceutical as the source of pellets of Esomeprazole (22.5% w/w) and Lansoprazole

(8.5% w/w) .The firm requested to grant the registration of above mentioned products.

Decision: Request of firm was approved by the Board.

Case No.26 Navegal Labs, Hattar



following products of M/s. Navegal Labs Hattar for submission of complete method of

manufacturing and studies regarding dissolution/release of the following drug:-

S.

No.

Manufacturer Name of the Drug Pack

size

Demanded

Price

Decision

Navegal Labs

Hattar

Movez SR Capsule

100 mg.

Each Capsule

Contains:-

Diclofenac Sodium

Sustained Release/

Coated Pellets

≡ Diclofenac

sodium…100 mg.

1x10 Rs.8.5/capsule. Deferred in

view of

strength and

uniform

policy. Fee

paid

It is pointed out that sustained release coated pellets of Diclofenac Sodium 100mg are

manufactured by M/s. Vision Pharmaceuticals, Islamabad which can be approved subject

to submission of Specification of product, GMP, Certificate of Analysis and Stability data

for zone IV. Fee is paid according to local manufacturer.

Decision: Request of firm was approved with source of pellets will be M/s.

Vision Pharmaceuticals, Islamabad.

Case No. 27. M/s Alen Pharmaceutical (Pvt) Ltd, Risalpur.

Drug Registration Board in its 237th

meeting had deferred the following products of M/s.

Alen Pharmaceuticals (Pvt.) Ltd; Risalpur subject to the confirmation of formulation.

S.No Manufacturer Name of Drugs A/Unit Price Remarks

59

1. M/s Alen

Pharmaceutical

(Pvt) Ltd,

Risalpur

Mitex Tablets.


contains:-

Ivermectin BP………6

mg.

1’s Rs.

100.00

Confirmation

of

formulation.

Total fee

paid

The firm had rectified relevant shortcoming and paid differential fee. The firm had

requested to grant the registration of above mentioned products

Decision: Request of firm was approved by the Registration Board.

Case No.28 M/s. Aries Pharmaceuticals, Peshawar.

M/s. Aries Pharmaceuticals, Peshawar has requested for registration of the

following drugs:-

1. M/s. Aries

Pharmaceuticals,

Peshawar

1.Tab General

2. Capsule Gen

3.Tab Psycho

Levocap Capsules 250

mg


Levofloxacin

Hemihydrate

≡ Levofloxacin ….250

mg

(Quinolone)

10’s Rs.260.00 -

do-

Fee paid,

deferred for

uniform

decision.

2. -do- Levocap Capsules 500

mg


Levofloxacin

Hemihydrate

≡ Levofloxacin ….500

mg

(Quinolone)

10’s Rs.520.00 -

do-

Fee paid,

deferred for

uniform

decision.

3. -do- Pranax 1 mg Tablets


Alprazolam…….1 mg

(Antidepressant)

3x10’s Rs.369.00 -

do-

As per policy

on

psychotropic/

narcotics.

Fee paid.

Deferred.

4. -do- Pranax 2 mg Tablets


Alprazolam…….2 mg

3x10’s Rs.738.00 -

do-

As per policy on

psychotropic/

narcotics. Fee

60

paid.

Deferred

These drugs were considered in 237th

meeting of Registration Board decision mentioned

against each. Now the firm has stated that Pranax 0.5mg (Alprazolam0.5 mg) is already

registered with the firm where as Pranax 1 mg & 2 mg are the additional strengths of

Alprazolam which are requested to be registered.

Levofloxacin 250 mg/500 mg Capsules have been registered with many manufacturer

therefore the firm requested to approve registration of the Levofloxacin 250 mg/500 mg in

the form of Capsules. Levofloxacin in the form of Capsule (dosage form) has to be decided

uniformly.

Decision: The Board referred products at S.No.1 & 2 to review committee for

evaluation and recommendation. Products at S.No. 3 & 4 were deferred being

controlled drug.

Case No.29. M/s. Libra Pharma (Pvt.) Ltd; Peshawar


meeting had approved the following products of

M/s. Libra Pharma (Pvt.) Ltd; Peshawar subject to installation & verification of HVAC

system and segregated section. It is submitted that the ingredients and strength of some

products were typed incorrectly which were approved accordingly.

S.No Name of drug with

incorrect formulation

Name of drug with

correct

formulation/strength

Pack

size

Demande

d MRP

Decision

1 Cryptosad Tablets


Cyproterone acetate

…...2mg

Ethinyloestroadioe….35

mg

Cryptosad Tablets

Each sugar coated

tablet contains:-

Cyproterone acetate

…… 2 mg

Ethinyloestradiol .

…..35 mcg

21’s Rs.240.0

0

Approved

subject to

installatio

n and

verificati

on of

HVAC

System

and

Segregate

d section.

2 U-Dine 100 mg Tablets


U-Dine 100 mg

Tablets

14’s Rs.1600.

00

-do-

61

Lamivudine……..100

mg

(Anti-retroviral)

Each film coated

tablet contains:-

Lamivudine……..10

0 mg

(Anti-retroviral)

3 Osteocol Oinetment


Tacalcitol……….2mcg

(Antipsoriasis / Vitamin

Osteocol Ointment

Each gm contains:-

Tacalcitol

monohydrate

≡ Tacalcitol.…. 2

mcg

1x10’

s

Rs.275.0

0

Approved

4 Diploprate Cream

Each gam contains:-

Diflucortolone

valeate...0.001gm

Chlorquinalolol..….0.01

0gm

Diploprate Cream

Each gm contains:-

Diflucortolone

valerate.…1 mg

Chlorquinaldol……

…. 10 mg

5gm Rs.21.20 Approved

subject to

installatio

n and

verificati

on of

HVAC

System

and

Segregate

d section

The firm has furnished copy of inspection report wherein FID, Peshawar has reported that

the firm has installed HVAC and has requested to grant the registration of above

mentioned product. The Licensing Section confirmed that the firm got approval of

Hormonal Tablets Section as segregated with HVAC but Hormonal Ointment/Cream

Section is not present in record of licensing unit.

The firm has deposited remaining fee amounting Rs. 12000/- for each formulation and

furnished copy of inspection report and has requested to grant the registration of above

mentioned products. It is worthwhile to mention that Tacalcitol monohydrate equivalent

to Tacalcitol is available in the form of Ointment/Lotion (Curatoderm Ointment/Lotion)

but the strength is 4 mcg/gm in both dosage form instead of 2 mcg/gm as mentioned in

the application dossier. .

Decision: Registration Board approved products at S.No.1 &2 and advised to

review the registration dossiers before issuance of registration letter and authorized

its Chairman to grant approval for issuance of registration letter. Products at S.No3

& 4 were deferred for confirmation of steroidal section for cream and ointment. As

62

Tacalcitol is available only in 4 mcg/gm thus referred to review committee for

review.

Case No.30 Extension in contract manufacturing permissions.

The following drugs of M/s. Navegal Laboratories, Hattar for toll manufacturing

extension were left over due to oversight. The firm had deposited the Rs.8000/- each on

29th

September, 2010 and remaining fee of Rs. 42000/- each on 9th

April, 2013.

1. 045442 M/s.

Navegal

Pharmaceuti

cals, Hattar

Toll

manufactured by

M/s. Welmark

Pharma, Hattar

Uneek 250mg

Injection

Each vial contains:-

Ceftriaxone (as

Sodium)……..250mg

(USP Specification)

Dy.

No.2873

Form-not

Rs.42000/-

Rs.8000/-

dated 29-

09-2010

Cephalospori

n

2. 053219 -do- -do- Uneek 500mg

Injection


Ceftriaxone (as


(USP Specification)

Dy.

No.2873

Form-not

Rs.42000/-

Rs.8000/-

dated 29-

09-2010

Cephalospori

n

3. 045441 -do- -do- Uneek 1gm Injection


Ceftriaxone (as

Sodium)……..1gm

(USP Specification)

Dy.

No.2873

Form-not

Rs.42000/-

Rs.8000/-

dated 29-

09-2010

Cephalospori

n

4. 045443 -do- -do- Sobeta 2gm Injection


Cefoperazone (as

Sodium) ….....1gm

Sulbactam (as

Sodium)…1gm

(USP Specification)

Dy.

No.2873

Form-not

Rs.42000/-

Rs.8000/-

dated 29-

09-2010

Cephalospori

n

5. 045444 -do- -do- Sobeta 1gm Injection


Cefoperazone (as

Sodium) ….....0.5 gm

Sulbactam (as

Sodium)……..0.5 gm

(USP Specification)

Dy.

No.2873

Form-not

Rs.42000/-

Rs.8000/-

dated 29-

09-2010

Cephalospori

n

63

6. 045438 -do- -do- Effo 500mg Injection


Cefepime HCl with

L-arginine

≡Cefepime

…….500mg

(USP Specification)

Dy.

No.2873

Form-not

Rs.42000/-

Rs.8000/-

dated 29-

09-2010

Cephalospori

n

Decision: Request for extension in contract manufacturing acceded till

30.06.2015.

Case No.31. M/s. Medicraft Pharmaceuticals (Pvt.) Ltd; Peshawar

M/s. Medicraft Pharmaceuticals (Pvt.) Ltd; Peshawar has applied for registration

of following drugs for the purpose on export only:-

S. No. Name of Drug(s) Remarks

1. Phenomed 30 mg Tablet


Phenobarbiton ……..……. 30 mg

The relevant documents and

total fee received,

Approved subject to the concurrence of

Narcotic Control Department /Board.

2. Dipam 5 mg Tablet


Diazepam …………….. 5 mg

-do-

The firm has submitted following documents:-

i. Application on Form-5.

ii. Fee of Rs. 20000/- for each formulation.

The firm possesses the relevant facility to manufacture the above mentioned

products. This case was discussed in the 237th

meeting or Registration Board. The

decision of the Board is mentioned against each.

Decision: Committee on allocation of controlled Drug has already conveyed that

Registration Board may take decision according to its rules. Thus Board approved

firm’s request. Matter regarding allocation of quota will be dealt by Committee on

allocation of controlled Drug accordingly.

Case No.32. M/s. Shaheen Pharmaceuticals, Swat

64


meeting had deferred the following products of

M/s. Shaheen Pharmaceuticals, Swat subject for deletion of Methylene Chloride from the

formulation.

1. M/s. Shaheen

Pharmaceutical

s, Swat

1. Tab General

2.Tab Antibiotic

3.Cap General

4.Dry Powder

Susp (Ceph)

Finas-M 1mg

Tablets

Each tablet

contains:-

Finasteride

………..1mg

(5-alpha reductase

inhibitor)

3x10’

s

As

Per

SRO

-do- Deferred due to

Methylene

Chloride.

2. -do- Paroxet 10mg

Tablets

Each tablet

contains:-

Paroxetin (as

HCl).10mg

(Antidepressant)

3x10’

s

As

Per

SRO


Methylene

Chloride.

3. -do- Paroxet Plus 20mg

Tablets

Each tablet

contains:-

Paroxetin (as

HCl).20mg

(Antidepressant)

3x10’

s

As

Per

SRO


Methylene

Chloride.

4. -do- Nomide 20mg

Tablets

Each tablet

contains:-

Leflunomide……2

0mg

(Anti-rheumatic

systemic)

3x10’

s

As

Per

SRO


Methylene

Chloride.

Now the firm has rectified the shortcoming of the formulation. The firm had

requested to grant them the registration of above mentioned products

Decision: Registration Board approved firm’s request.

Registration-V

65

Case No. 33. Transfer of Registration of contract manufacturer from Contract

Donor.

M/s Allmed (Private) Ltd. Lahore (Formerly M/s Ever Green Pharmaceuticals (Pvt.) Ltd.

Lahore) have requested for transfer of registration of following product manufactured by

them on contract basis for M/s. Ontech Corporation, B-154 Block-13-D/2 Gulshan-e-

Iqbal, Karachi to their name.

S. No. Reg. No. Name of Drug with

Composition

1. 041199 Norepine Injectable

Each 4ml contains:-

Noradrenaline tartarate…8mg

It is submitted that the product was initially registered for import in the name of M/s.

Ontech Corporation, Karachi for finished import. Later on the product was transferred

from import to local toll manufacturing by M/s Allmed (Private) Ltd. Lahore (formerly

M/s. Evergreen Lahore).

Registration Board in 237th

meeting has already delegated the power of transfer of

registration from one manufacturer/importer to another manufacturer/importer to its

Chairman. However in this case the contract manufacturer is applying for transfer of

registration from contract giver. The firm has also applied for extension of contract

manufacturing for the said product and has submitted the following for transfer of

registration:-

1. Fee challan of Rs.20,000/-

2. Form-5

3. N.O.C on transfer from M/s Ontech Corporation, Karachi.

4. Import Registration letter in the name of M/s. Ontech Corporation, Karachi.

5. Copy of earlier toll permission letter.

Decision: Registration Board deferred the request of the firm for following:

Confirmation whether transfer of registration is permissible under

contract manufacturing policy or otherwise.

Verification of testing facility by Director DTL, Lahore and area FID.

Case No.34. M/s. Paradise Pharmaceuticals, Lahore

66

M/s. Paradise Pharmaceuticals, Lahore was granted the registration of following

product:-

S. No. Name of Drug(s) Reg. No.

1. Ampride Syrup

Each 5ml contains:-

Ammonium Chloride ……………… 100mg

071546

The firm has requested that this product in not according to products being

marketed locally. They have therefore, requested to change the formulation as under:-

Ampride Syrup

Each 5ml contains:-

Chlorpeniramine Maleate ………..… 2mg

Ammonium Chloride ……………… 100mg

They have deposited fee of Rs. 20000/- for this purpose and furnished application

dossier on Form-5.

It is submitted that the firm has attached the outer packing of British Pharma

which contains Sodium Citrate also in addition of Chlorpeniramine Maleate 2mg &

Ammonium Chloride 100mg. However, according to the firm Sodium Citrate is not an

active ingredient and has been included in in-active ingredients. US FDA also mentioned

Sodium Citrate as inactive ingredient in syrup dosage form

Decision: The request of the firm was acceded to.

Case No. 35 M/s. Medipak Ltd; Lahore

The Drugs Registration Board in its 222nd

meeting had deferred the following

product of M/s. Medipak Ltd; Lahore for review committee. Initially the case was

discussed in 141st meeting of the Drug Registration Board and was deferred for price

comparison and subsequently again deferred in 213th

meeting of DRB for getting

clarification from the firm regarding the use of the formulation:-

Medisol Solution

Each liter contains:-

Citric acid (Anhydrous)............7.30gm

Sodium Citrate (Dihydrate)…22.00gm

Dextrose (Monohydrate).24.50gm

Water for Injection....Q.S

(Anticoagulant Solution)

67

The firm has informed that the pricing section has approved the price of the subject

product in 19th

meeting of Price Recommendatory Committee held on 26-12-2006 and

has requested for grant of registration of above mentioned product. The firm has

deposited fee of Rs. 15000/- in addition to Rs.5000/- and has not submitted new form-5.

Decision: The Registration Board deferred the case for submission of new dossier,

applicable fee for the product and expert opinion by Brig. Qaiser, AFIC.

Case No. 36 M/s. CCL Pharma Lahore.

Following application of M/s. CCL Pharma Lahore was deferred in sub/expert committee

meeting 237th

of Drug Registration Board due to inadequate fee for fast track and

different formulation from originator. The originator formulation is as following

(Duodart / Jalyn capsule by GSK):-

Each Capsule contains the following:

• One dutasteride oblong, opaque, dull-yellow soft gelatin capsule, containing 0.5 mg of

dutasteride dissolved in a mixture of butylated hydroxytoluene and mono-di-glycerides of

caprylic/capric acid. The inactive ingredients in the soft-gelatin capsule shell are ferric

oxide (yellow), gelatin (from certified BSE-free bovine sources), glycerin, and titanium

dioxide.

• Tamsulosin hydrochloride white to off-white pellets, containing 0.4 mg tamsulosin

hydrochloride and the inactive ingredients: methacrylic acid copolymer dispersion,

microcrystalline cellulose, talc, and triethyl citrate.

S.No Name of the drugs with

composition

Pack

Size

Proposed

Price

Date of

Submission

Recomme

ndations of

Committe.

1. BPH Capsules


Dutasteride….0.5mg

Tamsulosin….0.4mg

10’s As per

brand

leader

15-6-2011

Fee.8000

Fast track

fee

submission

Fee.52000

21-2-2013

Deferred.

The firm has submitted fee of Rs. 300,000/- and has submitted that competitor

formulation is immediate release dutasteride pellets in soft gel capsule filled in hard

gelatin capsule along with sustained release tamsulosin pellets, which has no technical

68

advantage but a novelty. But in their formulation they are using a blend of immediate

release dutasteride pellets along with sustained release tamsulosin pellets filled in hard

gelating capsule. They have submitted 2 reference products of india Tamlocept D

Capsule by Lupin Ltd. (Pinnacle Pharmaceuticals, India) and Tamdura Capsule by Sun

Pharmaceutical industries Ltd. India. Containing Dutasteride IR + Tamsulosin SR pellets.

They have submitted comparative dissolution profile with Duodart capsules.

Decision: The Registration Board deferred the case for evaluation by the review

committee.

Case No. 37. Cases of 237th

meeting Registration Board

Following applications (Fast track) were considered in 237th

meeting and subsequently in

me-too committee on 08-03-2013 subject to differential fee. Now differential fee have

been paid for following applications.

S.No Name of Firm Name of the drugs with composition Pack

Size

Proposed

Price

Previous

Decision

Remarks

1. M/s Saffron

Pharmaceutica

ls Faisalabad

Noctis Capsule


Omeprazole…40mg

14’s Rs 300/- Approved

subject to

Source

GMP

certificate,

COA and

stability

study of

pellets.

Rs.2,40,000/-

+ Fee

deposited

Rs.60,000/-

GMP

certificate of

M/s

Metrochem

API Pvt. Ltd.,

India.,CoA,

2. M/s. English

Pharmacutical

s Industries,

Lahore

Terol 4mg SR Capsules


Tolterodine HCl equiv. to

Tolterodine SR…4mg

3×10’s Rs.2300/- Deferred for

confirmatio

n of

me-too

status and

comparative

dissolution

profile with

originator

Detrusitol

Capsule SR 4

mg (Pfizer)

Comparative

Dissolution

profile with

originator.

3. M/s. English

Pharmacutical

s Industries,

Urimax 0.4 mg Capsule


Tamsulosin HCl equiv to

3×10’s Rs.1100/- Approved

subject to

remaining

Rs.240, 000/

has been

deposited,

69

Lahore Tamsulosin…0.4mg

(Alpha-1-adrenergic blocker)

fee of

Rs.240,

000/ (in

case of

import of

pellets),GM

P certificate

of source,

COA and

stability

studies of

pellets.

GMP

certificate of

source, COA

and stability

studies of

pellets.

4. M/s. English

Pharmacutical

s Industries,

Lahore

K-Cit Tablets


Potassium Citrate…10 mEq

3×10’s Rs.650/- Deferred for

confirmatio

n of me-too

status.

Urocit K of

Universal

(Allmed

Pharma)

5. M/s. English

Pharmacutical

s Industries,

Lahore

Dutride-T Capsules


Dutasteride …….0.5mg

Tamsulosin

Hydrochloride….0.4mg

30’s Rs.

2700/-

Deferred Fee submitted.

Firm wants to

fill in pellets.

6. M/s. English

Pharmacutical

s Industries,

Lahore

Ucholin 10mg Tablet


Bethanechol Chloride equiv. to

Bethanechol …..10mg

60’s Rs.1500/- 06-02-2013 Deferred for

confirmation of

me-too status.

Decision: Registration Board decided as follows:

Approved products at S.No.1 and 3.

Product at S.No.2 deferred for verification of complete formulation with

originator (Detrusitol Capsule SR 4 mg by Pfizer) and Comparative

Dissolution profile with originator.

Product at S.No.4 deferred for Product Specific Inspection by Director DTL

Lahore, Director DTL, Quetta and Area FID.

Product at S.No.5. The firm has submitted a separate application for tablet

dosage form. The DRB deferred the case for evaluation by review committee.

Product at S.No.6 deferred for expert opinion by Gen.Dr. Tassawar Husain,

Dr. Falak Sher Bhatti, Nescom., Prof. Shoaib Shafi, RMC.

70

Case No. 38. M/s. Medipak Ltd; Lahore

The Drugs Registration Board in its 201st meeting had rejected the following

product of M/s. Medipak Ltd; Lahore as the cGMP condition of the section was not

good:-

Medisol ½+5% Infusion.


Dextrose

Monohyrate……….55gm.

Sodium Chloride….4.5gm.

(BP)

500ml As per

Policy

Rejected as the

CGMP condition

of the section is

not good.

The firm submitted application in Drug Appellate Board and the Drug Appellate Board in

its 135th

sitting held on 123-11-2008 decided and accepted the appeal to grant them the

registration of above mentioned product.

Decision: The Registration Board deferred case for product specific and GMP

inspection of the firm by Chief Drug Inspector, Punjab; Director DTL, Lahore;

DDG E&M, Lahore and Area FID.

Case No: 39 M/s. Medipak Ltd; Lahore

M/s Medipak Limited, Lahore has requested that their product “Moxidex Eye

Drops” was included in Agenda of 229th

DRB meeting, but they said product was written

under the name of M/s Vega Pharma Lahore by mistake and the product was deferred for

GMP & Product specific Inspection.

They have submitted that their Eye Drop section is already approved and GMP inspection

report dated 11-02-10 submitted. They have submitted copy of registration dossier.

Decision: The Registration Board deferred case for product specific and GMP

inspection of the firm by Chief Drug Inspector, Punjab; Director DTL, Lahore;

DDG E&M, Lahore and Area FID..

Case No.40. M/s. Medisave Pharmaceuticals, Lahore.

M/s. Medisave Pharmaceuticals, Lahore has requested for registration of

following drugs for export purpose only:-

71

S.No Name of the products with composition

1. Flusave Tablets

Each Tablet contains:-

Triprolidine HCl B.P……… 2.5mg

Pseudoephedrine HCl B.P …...60mg

2. Sorefix-P Tablets

Each Tablet contains:

Pseudoephedrine ……36mg

Triprolidine….1.5mg

Paracetamol……..300mg

3. Sorefix-DX Tablets

Each Tablet contains:

Pseudoephedrine ……..90mg

Triprolidine……2.5mg

Clemastine as hydrogen fumarate…..1mg

4. Sorefix Tablets

Pseudoephedrine ……….60mg

Triprolidine …………2.5mg

The firm submitted the following documents.

i. Fee i.e. Rs.20000/-for the each products.

ii. Copy of form 5

iii. Copy of export order from Hong Kong.


meeting referred the case to committee on

controlled drugs, Narcotic Control Division for its recommendation and authorized

Chairman Registration Board to take decision for the grant of export registration or

otherwise in light of recommendation of the committee and submission of differential

fee.

Committee of the allocation of controlled drugs in its 11th

meeting held on 6th

May, 2013 decided that Registration Board may consider the registration of Controlled

Drugs for export and local manufacturing in the light of relevant Act and rules and the

Committee on the allocation of controlled drugs will consider matter for allocation of

Controlled Drugs in the light of relevant laws and rules after registration.


Registration Board may take decision according to its rules. Thus Board approved

firm’s request. Matter regarding allocation of quota will be dealt by Committee on

allocation of controlled Drug accordingly.

72

Case No. 41. M/s. Highnoon Laboratories Ltd Lahore.

Following products of M/s. Highnoon Laboratories Ltd Lahore were deferred for expert

opinion. Two experts gave their recommendations while the opinion of 3rd

expert was

awaited. The Drug Registration Board in its 237th

meeting referred these products for expert

opinion to Brig. (R).Prof. Dr. Muzammil Hasan Najmi after submission of differential fee.

Now opinion of all experts has received as under:-

Name of Products MRP/

Pack

Size.

Name of Expert Comments by the

expert

Brig. (R).Prof. Dr.

Muzammil Hasan

Najmi

Pidogrel-CAP 75


Clopidogrel (as

bisulphate) ……75mg

Aspirin (as enteric

coated pellets) 75mg

Rs.215.0

0/10’s

Prof.Dr.

Mahmood Ahmad

Faculty of

pharmacy and

alternative

medicine,

The Islamia

University of

Bahawalpur

As this product is

already manufactured by

the same company under

Re. No. 038902 in tablet

form and according to

the available literature

and stability data

provided both the

strengths of pidogrel are

stable and retain its

efficacy in combination

in capsule form.

Therefore, the pidogrel-

Cap 75mg & pidogrel-

Cap 150mg may be

registered.

This is a combination of

clopidogrel with enteric

coated aspirin pallets in

capsule form. A

combination of

clopidogrel with aspirin

without enteric coating

is already being

marketed by the same

manufacturer and some

other companies. The

two drugs in

combination are platelet

inhibitors acting by

independent different

mechanisms. These are

used in treatment and

prophylaxis of

thromboembolic

disorders. However their

use in the form of a

fixed dose combination

is not approved by FDA

of USA.

In the formulation under

review, aspirin has been

replaced with enteric

coated aspirin and the

dosage form has been

changed from tablet to

capsule. Dissolution

profile of the new

73

dosage form has been

submitted by the

manufacturer which

shows satisfactory

pattern of dissolution.

In view of the

registration and

availability of

combinations of

clopidogrel and aspirin

in Pakistan, Pidogrel-

CAP 75 is

recommended for

registration.

Pidogrel-CAP 150


Clopidogrel (as

bisulphate) ……75mg

Aspirin (as enteric

coated pallets) 150mg

Rs.225.0

0/10’s

Brig Syed M.

Imran Majeed

Preparations are

considered suitable for

registrations.

Dr. Iqbal

Saifullah Head of

Cardiology PIMS

Islamabad

The products are

recommended for

registration.

Loprin-AT Capsules


Atorvastatin (as

calcium trihydrat)

………….10mg

Aspirin (as enteric

coated pallets)

…………… 75mg

Rs.300.0

0/10’s

Prof.Dr.Muhamm

ad Ishaq Karachi

Institute of Heart

Diseases Karachi

This combination of

Atorvastatin and Asprin

can be used for CAD

patients and potential

patients. Both drugs as

individual molecules are

established sherapeutic

agents as lipid lowering

and antiplatlets. The

advantages of

combination include

beeter compliance at

reduced cost. However

being fixed combination

the side effects can be

difficuit to as ses. The

only major country

having this combination

is India as such there are

no reasons against this

formulation to be made

It is a combination of

Atorvastatin with enteric

coated aspirin.

Atorvastatin is an

inhibitor of HMG Co A

Reductase enzyme and

helps to lower

cholesterol level in

patients of dyslipidemia

while aspirin is an

Antiplatelet drug used to

treat and prevent

thromboembolism.

While the two drugs

may be required to be

used together in several

patients, their

availability in a fixed

dose combination is not

supported by the

scientific literature.

74

available in Pakistan. Such combination is not

approved by FDA of

USA and European

Medicines Agency.

Loprin-AT is therefore

NOT

RECOMMENDED for

registration.

Dr. Iqbal

Saifullah

Head of

Cardiology PIMS

Islamabad

Additive effect of

antiplatelet therapy and

cholesterol lowering

agent has been proved in

reducing cardiovascular

events. Combination of

these two agents reduces

the risk of

cardiovascular mortality

in non-diabetic patients

with known IHD as well

as coronary artery

disease diabetics.

Combination of asprin

and Atorvastatin is

widely used in Pakistan.

Fixed dose combination

will also provide better

patient compliance.

Loprin AT is

recommended for

registration.

Syed Khalid

Saeed Bukhari

WHO Country

advisor/NPO

Essential

medicines

Pakistan

Aspirin has been used as

very effective

antiplatelet therapy in

cardiovascular diseases,

while Atorvastatin is

antihyperlipidemic and

used to lower

cholesterol levels.

Combination of these

two agents reduces the

risks of cardiovascular

mortality in non diabetic

patients with known

IHD as well coronary

artery disease diabetics.

75

Fixed dose combination

of these tow agents is

available in other

countries. Loprin-At

Capsule which is a

combination of

atorvastatin and enteric

coated aspirin pallets

will offer the benefit of

combined aspirin with

statin therapy.

Aspirin is present as

enteric coated pellets

therefore it will avoid

aspirin related GI side

effects leading to cost

effective therapy.

Aspirin is present as

enteric coated pallets

therefore it will avoid

aspirin related GI side

effects leading to

costeffectiveness; it will

definitely increase better

patient compliance. So

product may be

recommended for

registration with

positive opinion.

Nebizide 10 Tablet


Nebivolol (as

HCl)…..10mg

Hydrochlorthiazide….1

2.5mg

Rs.735.0

0/14’s

Prof.Dr.Muhamm

ad Ishaq Karachi

Institute of Heart

Diseases Karachi

Nebivolol is a novel

cardioselective beta

blocker being used as an

effective

Antihypertensive. It’s

unse in Heart failure is

not recommended so far.

The molecule is FDA

approved bot separately

and in combination.

Recommend the

availability of this

product for our

hypertensive patints.

Fised dose combination

of these two products

76

are already available in

other ountries.

Nebizide 5 Tablet


Nebivolol (as

HCl)…..5mg

Hydrochlorthiazide….1

2.5mg

Rs.385.0

0/14’s

-do- Both strength are

recommended

This is a combination of

Nebivolol with

Hydrochlorothiazide.

Nebivolol is a beta

blocker with high degree

of selectivity for beta 1

receptors and additional

vasodilator property.

Like other beta blockers,

it is used for treatment

of hypertension and

other cardiovascular

diseases.

Hydrochlorothiazide is a

diuretic which is also

useful in hypertension.

Studies have been

reported in scientific

literature showing a

synergistic action of the

two drugs in

hypertension. Many

other beta blockers are

also available in

combination with

thiazide diuretics.

Nebizide 5 mg and 10

mg is therefore,

recommended for

registration.

Syed Khalid

Saeed Bukhari

WHO Country

advisor/NPO

Essential

medicines

Pakistan

Nebivolol is a beta

blocking drug used for

hypertension while

hydrochlorothiazide is

antidiuretic which is

also used as

antihypertensive.

Combination of

Nebivolol and

Hydrochlorothiazide has

been evaluated in large

scale clinical trials.

Nebivolol and HCTZ is

and effective and well

77

Decision: The Board decided following:

Pidogrel-CAP 75: Deferred for the confirmation of approval of formulation

by USFDA, EMA, TGA, and Japan.

Pidogrel-CAP 150: Deferred for the confirmation of approval of formulation

by USFDA, EMA, TGA, and Japan.

Loprin-AT Capsules: Deferred, as the formulation is not approved by US-

FDA, EMA, TGA, Japan.

Nebizide 10 Tablet: Deferred for the confirmation of approval of formulation

by FDA, EMA, TGA, and Japan

Nebizide 5 Tablet: Deferred for the confirmation of approval of formulation

by FDA, EMA, TGA, and Japan

Case No. 42. M/s. Shrooq Pharma Lahore.

tolerated therapeutic

strategy for management

of hypertension

including diabetic and

elderly patients.

Combination of these

two products called

Nebizide is fixed dose

which is bioequivalent

to the two agents

administered

concomitantly.

This combination is

useful as monotherapy

nonresponders and for

those who required rapid

BP control to prevent

end organ damage.

Post marketing

surveillance studies

published so far has

shown that drug is

effective and well

tolerated therapeutic

strategy in clinical trials.

SO product may be

recommended for

registration with

positive opinion.

78

M/s. Shrooq Pharma Lahore applied for following applications. These were

considered in 235th

meeting of Drug Registration Board Held On 18th

September 2012

and referred to the sub-committee comprising of Prof. Rafi-Uz-Zaman, member

Registration Board, Secretary Registration Board, DDG (Reg) and concerned DDC after

completion of files. The meeting of the subcommittee was held on 08-11-2012 but

complete dossiers were not received at that time. Now the firm has submitted differential

fee and duplicate dossiers (photocopies) of these products and has requested for the

registration of these products.

S

.No

Name of

Firm

Name of the

drugs with

composition

Pack Size Proposed

Price

Decision in the

235th

meeting.

Remarks

1. M/s.

Shrooq

Pharma

Lahore

March,

2010

Isono Tablets

10mg

Each tablet

contains:-

Isotretinon…..1

0mg

(Dermatologica

l)

10’s As Per

SRO

Approved subject

to the submission

of duplicate files

and completion of

registration

dossier and

recommendations

of the committee

comprising of

Prof. Rafi-Uz-

Zaman, member

Registration

Board, Secretary

Registration

Board, DDG

(Reg) and

concerned DDC.

Five products per

section will be

granted on the

priority list of the

firm.

Me-too status of

10mg tablets not

confirmed. S.No

14 of form 5 not

correct.

Dissolution test

method not

provided.

2. -do- Isono Tablets

20mg

Each tablet

contains:-

Isotretinon…..2

0mg

(Dermatologica

10’s As Per

SRO

-do- S.No 14 of form 5

not correct.

Dissolution test

method not

provided.

79

l)

3. -do- Micin-T Lotion

Each ml

contains:-

Clindamycin

(phosphate)….

10mg

(antifungal)

30ml -do -do- The firm has no

external liquid

preparation

section; however

oral liquid and

semi solid sections

are present.

4. -do- Lumart-Forte

Dispersible

Tablets

Each tablet

contains:-

Artemether

….80mg

Lumefantrin….

480mg

(anti Malarial)

6’s -do- -do- No comments

5. -do- Benz-C Lotion

Each ml

contains:-

Clindamycin

(phosphate)…

….10mg

Benzyl

peroxide….50

mg

(Antifungal

and

dermatological)

30ml As Per

SRO

Approved subject

to the submission

of duplicate files

and completion of

registration

dossier and

recommendations

of the committee

comprising of

Prof. Rafi-Uz-

Zaman, member

Registration

Board, Secretary

Registration

Board, DDG

(Reg) and

concerned DDC.

Five products per

section will be

granted on the


firm.

Confirmation of

me-too status?

S.No 13 of Form 5

not correct (Clycin

Plus Lotion not

found). The firm

has no external

liquid preparation

section; however

oral liquid and

semi solid sections

are present.

80

6. -do- Duaba Sachet

Each sachet

contains:-

Strontium

ranelate….2.00

g

10’s -do- -do- Saccharin sodium

3.5g per sachet=

50%.

7. -do- Clerox Liquid

Each 5ml

contains;-

Ciclopirox

Olamine….1.5

%

(Anti-fungal)

60ml As per

SRO

-do- The firm has no

external liquid

preparation

section; however

oral liquid and

semi solid sections

are present. Me-

too status not

confirmed.

Stieprox by stiefel

not found in

Pharmaguide,

however pricing

minutes mention it

with Salycilic acid

which is not

present in this

formulation.

8. -do- Medison

Cream

Each gram

contains:-

Mometasone

Furoate………

0.1%

(Corticosteroid

s)

5g As per

SRO

Approved subject

to the submission

of duplicate files

and completion of

registration

dossier and

recommendations

of the committee

comprising of

Prof. Rafi-Uz-

Zaman, member

Registration

Board, Secretary

Registration

Board, DDG

(Reg) and

concerned DDC.

Five products per

section will be

granted on the


The firm has no

semi solid

steroidal section.

Raw material

specifications not

provided.

81

firm.

9. -do- Sugrel Tablets

Each tablet

contains:-

Prasugrel

Hydrochloride

…………….5

mg

(Platelet

aggregation

inhibitor)

10’s

20’s

Rs.1275.0

0

Rs.2550.0

0

Approved subject

to the submission

of duplicate files

and completion of

registration

dossier and

recommendations

of the committee

comprising of

Prof. Rafi-Uz-

Zaman, member

Registration

Board, Secretary

Registration

Board, DDG

(Reg) and

concerned DDC.

Five products per

section will be

granted on the


firm.

S.No 13 of Form 5

not filled.

10. -do- Sugrel Tablets

Each tablet

contains:-

Prasugrel

Hydrochloride

…………….2.

5mg

(Platelet

aggregation

inhibitor)

10’s

20’s

Rs.640.00

Rs.1280.0

0

Deferred for

confirmation of

formulation,

submission of

duplicate file and

completion of

registration

dossier.

S.No 13 of Form 5

not filled.

Me-too status not

confirmed in 2.5

mg strength.

11. -do- Scabease

Tablets

Each tablet

contains:-

Ivermectin……

……….6mg

(Anti-parasitic

and Anti-

scabietic)

10’s As per

SRO

Approved subject

to the submission

of duplicate files

and completion of

registration

dossier and

recommendations

of the committee

comprising of

Prof. Rafi-Uz-

Zaman, member

82

Registration

Board, Secretary

Registration

Board, DDG

(Reg) and

concerned DDC.

Five products per

section will be

granted on the


firm.

12. -do- Lite Orange

Sachet

Each sachet

contains:-

Sodium

citrate………

…..2.9

Sodium

Chloride……

……..2.6g

Potassium

chloride………

.1.5g

Dextrose

monohydrate…

……….13.50g

(Electrolyte)

10’s Rs.196.00 -do-/ and also

subject to WHO

formulation.

Formulation is

according to

WHO.

Saccharin sodium

3.5g per

sachet=14.28%

13. -do- Lumart

Dispersible

Tablets

Each tablet

contains:-

Artemether…

………20mg

Lumefantrine

…………..120

mg

(Anti-Malarial)

16’s As per

SRO

Approved subject

to the submission

of duplicate files

and completion of

registration

dossier and

recommendations

of the committee

comprising of

Prof. Rafi-Uz-

Zaman, member

Registration

Board, Secretary

Registration

Board, DDG

(Reg) and

Confirmation of

me-too status in

Dispersible form.

83

concerned DDC.

Five products per

section will be

granted on the


firm.

Decision: The Board decided following:

Isono Tablets 10mg: Deferred for confirmation of Me-too status of 10mg

tablets, submission of new complete signed form 5 and dissolution test

method.

Isono Tablets 20mg: Approved. However the Board advised to submit new

complete signed Form 5 and dissolution test method.

Micin-T Lotion: Rejected as the firm has no external liquid preparation

section.

Lumart-Forte Dispersible Tablets: Approved.

Benz-C Lotion: Rejected as the firm has no external liquid preparation

section.

Duaba Sachet: Deferred for clarification of master formula and change of

inactive ingredients according to FDA limits.

Clerox Liquid: Rejected as the firm has no external liquid preparation

section.

Medison Cream: Deferred till decision of semi solid steroidal products in

semi solid general section by licensing section and submission of raw material

specifications.

Sugrel Tablets 5mg: Approved. However the Board advised to submit new

complete and signed form 5.

Sugrel Tablets 2.5 mg: Deferred for confirmation of me-too status in 2.5 mg

strength and submission of new complete and signed form 5.

Scabease Tablets: Approved. The firm shall propose other brand names

which do not resemble with already registered brands.

Lite Orange Sachet: Deferred for clarification of master formula and change

of inactive ingredients according to FDA limits.

Lumart Dispersible Tablets: Deferred for confirmation of Me-too status in

dispersible form.

Case No. 43. M/s Pacific Pharma, Lahore.

Following application of M/s Pacific Pharma, Lahore was rejected in 189th

Meeting of the Registration Board because the experts did not recommend the product for

registration.

84

The firm got registration of the product for export purpose and applied for transfer of

registration from export to local manufacturing on 02-07-2010 on form-5D.

Now the firm has submitted the differential fee and requested for the registration of the

product because according to them the product is registered in countries like Germany,

Italy, Belgium, Spain, Greece, and Portugal.

Name of

Firm

Name of the drugs with

composition

Pack Size Proposed Price Date of

Submission

Remarks

M/s Pacific

Pharma,

Lahore.

Exituss Syrup


Levodropropizine…30mg

(Anti-tussive)

60ml

120ml

Rs. 195/-

Rs.390/-

02-07-2010

(Rs. 8000/-

+Rs.15000/-

+Rs.27000/-)

Form-5 D ,

New

application.

Decision: Registration Board deferred the case for confirmation of availability of

formulation in USFDA, EMA, Australia or Japan.

Case No.44. M/s Rasco Pharma, Lahore.

Director (Quality Control) has informed that M/s Rasco Pharma, Lahore has

manufactured Nil-Gesic Tablets which is counterfeit of Wilgesic Tablets manufactured

by M/s Wislon Pharmaceuticals, Islamabad.

He has directed the DDG (E&M) Lahore to inspect the premises and to rectify the

counterfeit packing and has requested the Drug Registration Board for cancellation of

registration of counterfeit Nilgesic manufactured by M/s Rasco Pharma, Lahore.

In this regard the FID Lahore-II has inspected the premises of the firm and he has

observed that no stock of packing of counterfeit “Nil-Gesic Tablet” was found in the

premises.

Meanwhile M/s. Rasco Pharma, Lahore has requested for change of packing

design of counterfeit “Nil-Gesic Tablet” and has submitted following documents:-

i. Undertaking that all of their current and future production will be packed

in new design of carton & Aluminum foil.

ii. Undertaking that their product “Nilgesic Tablet” with existing packing

material/design is not available in the market and has been withdrawn

from the market and there is no case pending/under process in any Court

of Pakistan and the firm has also undertake that their proposed packing

design does not resemble with already available drugs.

iii. Prescribed fee of Rs. 5000/- for the purpose.

85

Later on the firm was asked to why they have change the packing design without

prior approval of the Drug Regulatory Authority of Pakistan. As per reply of the firm and

FID report the firm was manufacturing the said drug in its original approved packing, but

on the demand of marketing department they manufactured only three batches of the

product without approval from DRAP. According to the firm as soon as they came to

know about the resemblance, they stopped manufacturing and have requested to change

the design again to its original approved packing and have tender apology for this act.

Decision: The Drug Registration Board decided to approve the packing design and

directed to change the name of the product immediately. The Board also decided to

issue warning to the firm and advised to be careful in future.

Case No.45. M/s. Mediways International, Lahore.

The Drug Registration Board in its following meetings had deferred the following

products of M/s. Mediways International, Lahore as mentioned in relevant column for

each product. The firm has deposited remaining fee of Rs. 12000/- for each product and

provided copy of inspection report dated 19-06-2013 in which the panel has verified that

the firm has installed HVAC in the manufacturing area of the premises. They have

requested to grant them the registration of these products.

Brand Name/Label claim Demande

d Pack

size

Demand

ed Price

Decision of

Board

Remarks

Coftus Syrup

Each 5ml contains:-

Dextromethorphan HBr

BP…..10mg

Pseudoephedrine HCl

BP…….30mg

Chloropheniramine Maleate

BP.......2mg

5ml Rs.2.25 Deferred

(M-223)

Formulation

contains

Pseudoephe

drine

Flucof Syrup

Each 5ml contains:-

Paracetamol B.P

…………....325mg

Dextromethorphan HBr

5ml

60ml

120ml

Rs.2.50.0

0

Rs.30.00

Rs.60.00

Deferred

(M-223)

Formulation

contains

Pseudoephe

drine

86

B.P….10mg

Pseudoephedrine HCl

B.P……30mg

Chloropheniramine as

maleate…..1mg

(analgesic)

Vomax Suspension.

Each 5ml Contains:-

Domperidone B.P………5mg.

60ml Rs.2.50/

5ml.

Deferred till

the

installation

of HVAC.

(M-201)

the firm has

installed

HVAC

Certex Syrup.

Each 5ml Contains:-

Cetirizine HCl B.P eq. to

Cetirizine base……….5mg.

60ml. Rs.3.08/

5ml.

-do-

(M-201)

the firm has

installed

HVAC

Neurotone Syrup

Each 5ml contains:-

Piracetam ………………1.0gm

5ml

120ml

Rs.15.42

Rs.370.0

0

Deferred for

Licensing

section’s

comments

on

requirement

of HVAC in

Syrup

section.

(M-225)

The firm has

installed

HVAC. The

molecule is

under

review.

Nu-Fer Syrup

Each 5ml contains:-

Iron (III) Hydroxide Polymaltose

Complex Eq. to elemental

Iron…………..…..50mg

Folic Acid………...0.35mg

60ml

120ml

Rs.6.60

per 5ml

-do- The firm has

installed

HVAC.

Decision: Registration Board decided as follows:

Coftus Syrup: Deferred till decision on controlled drugs.

Flucof Syrup: Deferred till decision on controlled drugs.

Vomax Suspension: Approved.

Certex Syrup: Approved.

Neurotone Syrup: Deferred for review committee as the formulation is under

review.

87

Nu-Fer Syrup: Deferred for product specific inspection by Director DTL,

Lahore, DDG E&M, Lahore and Area FID

Case No. 46. M/s. English Pharmaceutical Industries Lahore.

M/s. English Pharmaceutical Industries Lahore applied for following applications.

These were considered in 235th

meeting of Drug Registration Board Held On 18th

September 2012 and referred to the sub-committee comprising of Prof. Rafi-Uz-Zaman,

member Registration Board, Secretary Registration Board, DDG (Reg) and concerned

DDC after completion of files. The meeting of the subcommittee was held on 08-11-2012

but complete dossiers were not received at that time. Now the firm has submitted

differential fee and new dossiers of these products and has requested for the registration

of these products.

S

.No

Name of

Firm

Name of the drugs

with composition

Pack

Size

Proposed

Price

Decision in the 235th

meeting.

1 M/s.

English

Pharma

Lahore.

Zital 20mg Tablet

Each tablet

contains:-

Escitalopram (as

oxalate)….20mg

10’s As per

S.R.O

Approved subject to the

submission of duplicate

files and completion of

registration dossier and

recommendations of the

committee comprising

of Prof. Rafi-Uz-Zaman,

member Registration

Board, Secretary

Registration Board,

DDG (Reg) and

concerned DDC. Five

products per section will

be granted on the

priority list of the firm.

2 -do- X-Ron 15mg Tablets

Each tablet

contains:-

Mirtazapin….15mg

10’s -do- Approved subject to the

submission of duplicate

files and completion of

registration dossier and

recommendations of the

committee comprising

of Prof. Rafi-Uz-Zaman,

member Registration

Board, Secretary

88

Registration Board,

DDG (Reg) and

concerned DDC. Five

products per section will

be granted on the

priority list of the firm.

3 -do- X-Ron 30mg Tablets

Each tablet

contains:-

Mirtazapin….30mg

10’s -do- -do-

Decision: Registration Board approved above products for registration. Brand

name of Zital tablets will be changed.

Case No.47. Extension in Contract Manufacturing

S.No Applicant Contract

manufacturer

Reg. No.

Name of Drug (s) &

Composition

Date of

application,

and Form.

Category

1. M/s. Feroza

International

Pharma

Lahore

M/s.

Medisave

Pharma

Lahore

024050 Ferophin injection IM


Ceftriaxone sodium

eq.to

Ceftriaxone…..250mg

(anti-Biotic)

26-08-

2013

Rs.50000/-

Form 5

Dedicated

section

2. -do- -do- 024051 Ferophin injection IM


Ceftriaxone sodium

eq.to


(anti-Biotic)

26-08-

2013

Rs.50000/-

Form 5

Dedicated

section

3. -do- -do- 024055 Ferophin injection IV


Ceftriaxone sodium

eq.to

Ceftriaxone…..1gm

(anti-Biotic)

26-08-

2013

Rs.50000/-

Form 5

Dedicated

section

4. -do- -do- 024054 Ferophin injection IV


Ceftriaxone sodium

eq.to


(anti-Biotic)

26-08-

2013

Rs.50000/-

Form 5

Dedicated

section

5. M/s. Allmed

(Pvt) Ltd,

(formall

M/s.

Medisave

Pharma

045001 Ivoryzone 1gm

Injection


12-8-2013

Rs.50000/-

Form 5

Dedicated

section

89

M/s.

Evergreen

Pharma

Lahore

Lahore Ceftriaxone (as

sodium)….1gm

6. -do- -do- 045014 Rutex 400mg Caspule

Each capsule

contains:-

Cefixime……400mg

12-8-2013

Rs.50000/-

Form 5

Dedicated

section

7. -do- -do- 045013 Rutex 100mg Dry

Suspension

Each 5ml contains:-

Cefixime……100mg

12-8-2013

Rs.50000/-

Form 5

Dedicated

section

8. -do- -do- 044491 Greenec 2gm Injection


Cefoperazone (as

sodium)…..1.0gm

Sulbactam (as

sodium)….1.0gm

12-8-2013

Rs.50000/-

Form 5

Dedicated

section

9. -do- -do- 045002 Ivoryzone 500mg

Injection


Ceftriaxone (as

sodium)….500mg

12-8-2013

Rs.50000/-

Form 5

Dedicated

section

10. -do- -do- 044493 Puna 1.0gm Injection


Cefepime (as

HCl)…..1.0gm

12-8-2013

Rs.50000/-

Form 5

Dedicated

section

11. -do- -do- 044490 Greenec 1gm Injection


Cefoperazone (as

sodium)…..500mg

Sulbactam (as

sodium)….500mg

12-8-2013

Rs.50000/-

Form 5

Dedicated

section

12. -do- -do- 044493 Puna 500mg Injection


Cefepime (as

HCl)…..500mg

12-8-2013

Rs.50000/-

Form 5

Dedicated

section

13. -do- -do- 045003 Ivoryzone 250mg

Injection


Ceftriaxone (as

sodium)….250mg

12-8-2013

Rs.50000/-

Form 5

Dedicated

section

Decision: Registration Board extended above products till 30.06.2015. The

Board advised the firms to select either IM or IV for products at S.No. 5, 9 and 13.

90

Item No.IV New Section-New License-Anomly cases:

Registration-II

a. M/S, City Pharmaceuticals, Karachi

Capsule (General)

231st RB meeting: 05

S.No. Name of drug(s) &

Composition

Proposed

Pack size

Demanded

Price

Date of

application,

Diary No. &

Form

Decision

1 Orex-500mg Capsule


Cefadroxil………500 mg

(Anti bacterial/Antibiotic)

As per

PRC

As per PRC 27-03-2013

Dy.No.191

Form-5

Rs.20,000/-

Approved

However the

Registration

Board

advised the

registration

sections to

again review

the

Registration

Dossiers

before

issuance of

Registration

letters

Suspension (Cephalosporin)

231st RB meeting: 04


Composition

Proposed

Pack size

Demanded

Price

Date of

application,

Diary No. &

Form

Remarks

1 Orex-250mg Dry Suspension

Each 5ml contains:

Cefadroxil………250 mg


As per

PRC

As per PRC 27-03-2013

Dy.No.190

Form-5

Rs.20,000/-

Approved

However the

Registration

Board

advised the

registration

sections to

again review

the

Registration

Dossiers

before

issuance of

Registration

91

letters

2 Orex-125mg Dry Suspension

Each 5ml contains:

Cefadroxil……125 mg


As per

PRC

As per PRC 27-03-2013

Dy.No.189

Form-5

Rs.20,000/-

-Do-

b. M/S, Kaizen Pharmaceuticals, Karachi.

Dry Powder Suspension Section.

235th

RB meeting: 05

236th

RB meeting: 04


Composition

Proposed

Pack size

Demanded

Price

Date of

application,

Diary No.

& Form

Remarks

1 Proart Dry Suspension

Each 5ml contains:

Dihydroartemisinin..15mg

Piperaquine

phosphate……..…120 mg

(Anti malarial)

30ml

40ml

60ml

80ml

As per PRC 08-11-2012

Dy.No.1766

-A

Form-5

Rs.20,000/-

Deferred for

me too staus

&

confirmatio

n of WHO

approved

formulation

c. M/s, Reign Pharmaceuticals PCSIR-KLC (Pvt.) Ltd, Karachi

Tablet (General).

235th

RB meeting: 05


Composition

Proposed

Pack size

Demanded

Price

Date of

application,

Diary No.

& Form

Remarks

1 Montikol 10mg Tablet


Montelukast

Sodium………….10 mg

(Is oral leukotriene

receptor antagonist)

As per

PRC

As per PRC 21-05-2013

Dy.No.528

Form-5

Rs.20,000/-

Approved

However the

Registration

Board

advised the

registration

sections to

again review

the

Registration

Dossiers

before

issuance of

Registration

letters

2 Spastol Tablet


As per

PRC

As per PRC 21-05-2013

Dy.No.529

Deferred for

review

92

Phloroglucinol ……80 mg

Trimethylphloroglucinol…

…………………..80 mg

(Antispasmodic)

Form-5

Rs.20,000/-

committee

consideration

Capsule (General)

235th

RB meeting: 05


Composition

Proposed

Pack size

Demanded

Price

Date of

application,

Diary No.

& Form

Remarks

1 Fluben 100mg Capsule


Flurbiprofen……100 mg

(NSAID)

As per

PRC

As per PRC 21-05-2013

Dy.No.531

Form-5

Rs.20,000/-

Approved

However the

Registration

Board

advised the

registration

sections to

again review

the

Registration

Dossiers

before

issuance of

Registration

letters

2 Omzol 40mg Capsule


Omeprazole……..40 mg

(Proton pump inhibitor)

As per

PRC

As per PRC 21-05-2013

Dy.No.532

Form-5

Rs.20,000/-

-Do-

3 Omzol 20mg Capsule


Omeprazole……..20 mg

(Proton pump inhibitor)

As per

PRC

As per PRC 21-05-2013

Dy.No.530

Form-5

Rs.20,000/-

-Do-

Dry Powder (Suspension)

235th

RB meeting: 05


Composition

Proposed

Pack size

Demanded

Price

Date of

application,

Diary No.

& Form

Remarks

1 Fosfon 250mg/5ml oral

Suspension

As per

PRC

As per PRC 21-05-2013

Dy.No.533

Approved

However the

93

Each 5ml contains:

Fosfomycin

Sodium………….250 mg

(Broad Spectrum

Antibiotic of macrolide

group)

Form-5

Rs.20,000/-

Registration

Board

advised the

registration

sections to

again review

the

Registration

Dossiers

before

issuance of

Registration

letters

2 Renflox 250mg/5ml Dry

Powder Suspension

Each 5ml contains:

Ciprofloxacin ….250 mg

(Antibiotic)

As per

PRC

As per PRC 21-05-2013

Dy.No.535

Form-5

Rs.20,000/-

-Do-

3 Zinkid 20mg/5ml Susp.

Each 5ml contains:

Zinc Sulphate ……20 mg

(Astringent (for zinc

deficiency)

As per

PRC

As per PRC 21-05-2013

Dy.No.534

Form-5

Rs.20,000/-

-Do-

Sachet Section.

235th

RB meeting: 03


Composition

Proposed

Pack size

Demanded

Price

Date of

application,

Diary No.

& Form

Remarks

1 Lotrol Low Osmolarity

Sachet


Sodium chloride….1.3g

Potassium Chloride..0.75g

Trisodium Citrate

Dihydrate…….1.45 g

Glucose anhydrous…6.75g

Eq. to sodium 37.5mmol,

Potassium10.00mmol,

chloride 32.5mmol, citrate

5.00mmol, Glucose

37.5mmol.

(Low-Osmolarity

As per

PRC

As per PRC 21-05-2013

Dy.No.540

Form-5

Rs.20,000/-

Deferred for

confirmatio

n of WHO

approved

formula

94

electrolytes/ORS)

2 Fem-C Plus Sachet


Calcium Gluconate..587mg

Calcium carbonate..327mg

Calcium lactate…422 mg

Asc orbic acid….500 mg

Cyanocobalamin..250 mcg

Folic acid…………1 mg

As per

PRC

As per PRC 21-05-2013

Dy.No.539

Form-5

Rs.20,000/-

Referred to

review

committee

for

evaluation

Liquid Syrup.

235th

RB meeting: 02


Composition

Proposed

Pack size

Demanded

Price

Date of

application,

Diary No.

& Form

Remarks

1 Anafe-F Syrup

Each 15ml contains:

Iron Protein Succinylate

800mg eq. to elemental

Iron ………….40 mg

Folic acid………..2.5 mg

(Anaemia, Haematinic)

As per

PRC

As per PRC 21-05-2013

Dy.No.527

Form-5

Rs.20,000/-

Deferred for

confirmation

of me too

status

2 DuMol Syrup

Each 5ml contains:

Paracetamol…….120 mg

(Analgesic and antipyretic)

As per

PRC

As per PRC 21-05-2013

Dy.No.536

Form-5

Rs.20,000/-

Approved.

The Board

advised to

change brand

name.

The

Registration

Board also

advised the

registration

sections to

again review

the

Registration

Dossiers

before

issuance of

Registration

letters

3 Irofer-F Syrup

Each 5ml contains:


polymaltose complex eq.t o

As per

PRC

As per PRC 21-05-2013

Dy.No.541

Form-5

Rs.20,000/-

Deferred for

PSI by

Director

DTL,

Karachi and

95

elemental iron …..50mg

Folic acid………0.35 mg

(For iron deficiency

anemia, haematinic)

area FID

4 Irol-F Syrup

Each 5ml contains:

Iron Polysacharide

complex eq.t o elemental

Iron ………..100 mg

Folic Acid………..0.35 mg

(For iron deficiency

anemia, haematinic)

As per

PRC

As per PRC 21-05-2013

Dy.No.538

Form-5

Rs.20,000/-

Deferred for

confirmation

of me too

status and

PSI by

Director

DTL,

Karachi and

area FID

5 Nuprin 100mg Suspension

Each 5ml contains:

Ibuprofen………100 mg

(Analgesic and antipyretic

NSAID)

As per

PRC

As per PRC 21-05-2013

Dy.No.537

Form-5

Rs.20,000/-

Approved

Registration-V

S. No Name of

Firm

Name of the drugs with composition Pack

Size

Proposed

Price

Date of

Submission

Decsion

1. M/s. Simz

Pharma

Lahore

Diclosim-75mg Tablets


Diclofenac Potassium ….75mg

(analgesic)

10’s As Per

SRO

18-7-2013

20000/-

Deferred

for

submission

of Raw

material

specificatio

ns and latest

GMP

Inspection

report.

2. -do- Simfexo 60mg Tablets

Each tablet contins:-

Fexofenadine HCl….60mg

(anti allergic)

10’s -do- 18-7-2013

20000/-

-Do-




(anti allergic)

10’s -do- 18-7-2013

20000/-

-Do-



10’s -do- 18-7-2013

20000/-

-Do-

96


(anti allergic)

5. -do- Zithosim 500mg Tablets


Azithromycin as

dihydrate…500mg

(macrolide antibacterial)

6’s -do- 18-7-2013

20000/-

-Do-

6. -do- Diclosim 100mg SR Tablets


Diclofenac potassium….100mg

(analgesic)

10’s -do- 18-7-2013

20000/-

-Do-

7. -do- Simclar 250mg Tablets


Clarithromycin….250mg

(antibiotic)

10’s -do- 18-7-2013

20000/-

-Do-

8. -do- Simclar 500mg Tablets


Clarithromycin…..500mg

(antibiotic)

10’s -do- 18-7-2013

20000/-

-Do-

9. -do- Omepza 40mg Capsule


Omeprazole enteric coated

Pellets…..40mg

(proton pump inhibitor)

14’s -do- 18-7-2013

20000/-

-Do-

10. -do- Fansimz 80-480mg Tablets


Artemether….80mg

Lumefentrine….480mg

(anti malarial)

7’s -do- 18-7-2013

20000/-

-Do-

11. -do- Fansimz 15/90mg Dry

Suspension

Each 5ml contains:-

Artemether…15mg

Lumefentrine…90mg

(anti malarial)

60ml -do- 18-7-2013

20000/-

-Do-

12. M/s.

Novartana

Amrosal Syrup

Each 5ml contains:-

60ml As Per

SRO

22-5-2013

Rs.20000/-

Deferred

for

confirmati

97

Pharma

Lahore

Ambroxol as HCl……15mg

Salbutmol…..1gm

Guaphenesin…..50mg

Menthol….1mg

on of me

too status,

Submissio

n of

correct

signed

application

on form 5

and raw

materials

and

finished

product

specificati

ons.

13. -do- Acnov 20mg Capsule


Isotretinoin…..20mg

10’s -do- 22-5-2013

Rs.20000/-

Deferred

for

Submissio

n of

correct

signed

application

on form 5

and raw

materials

and

finished

product

specificati

ons.

14. -do- Acnov 10mg Capsule


Isotretinoin…..10mg

10’s -do- 22-5-2013

Rs.20000/-

Deferred

for

Submissio

n of

correct

signed

application

on form 5

and raw

materials

and

finished

product

specificati

98

ons.

15. -do- Vantrin Suspension

Each 5ml contains:-

Artemether……15mg

Lumefantrine….90mg

60ml -do- 22-5-2013

Rs.20000/-

Deferred

for

Submissio

n of

correct

signed

application

on form 5,

verificatio

n of

product for

dry

suspension

as

formulatio

n contains

water and

raw

materials

and

finished

product

specificati

ons.

16. -do- Irofer Syrup


Iron protein succinylate

complex 800mg equivalent to

40mg elemental iron

120ml

-do- 22-5-2013

Rs.20000/-

Deferred

for

Submissio

n of

correct

signed

application

on form 5

and raw

materials

and

finished

product

specificati

ons.

99

17. -do- Prebalin 75mg Capsule


Pregabalin….75mg

10’s -do- 22-5-2013

Rs.20000/-

Deferred

for

Submissio

n of

correct

signed

application

on form 5,

raw

materials

and

finished

product

specificati

ons and

decision of

review

committee.

18. -do- Prebalin 150mg Capsule


Pregabalin….150mg

10’s -do- 22-5-2013

Rs.20000/-

Deferred

for

Submissio

n of

correct

signed

application

on form 5,

raw

materials

and

finished

product

specificati

ons and

decision of

review

committee.

19. -do- Orthin 50mg Capsule

Each capule contains:-

Diacerein….50mg

10’s -do- 22-5-2013

Rs.20000/-

Deferred

for

Submissio

n of

100

correct

signed

application

on form 5,

raw

materials

and

finished

product

specificati

ons and

decision of

review

committee.

20. -do- Amrosal Syrup

Each 5ml contains:-


Salbutamol….1mg

Guaphenesin….50mg

Menthol….1mg

60ml -do- 22-5-2013

Rs.20000/-

Duplicate

entry

21. -do- Olit Capsule


Orlistat…..120mg

30’s As Per

SRO

1-8-2013

Rs.20000/-

Deferred

for

Submissio

n of

GMP

Certificate

of pellets

manufactu

rer,

Certificate

of

Analysis

and

stability

studies of

pellets.

22. -do- Irofol Syrup

Each 5ml contains:-


polymaltose complex….50mg

120ml -do- 1-8-2013

Rs.20000/-

-Do-

101

Folic Acid…..0.35mg

23. -do- Tamo Capsule


Tamsulosin HCl…….0.4mg

20’s -do- 1-8-2013

Rs.20000/-

Deferred

for

Submissio

n of

GMP

Certificate

of pellets

manufactu

rer,

Certificate

of

Analysis

and

stability

studies of

pellets.

24. -do- Amrosal Syrup

Each 5ml contains:-


Salbutamol BP……1mg

Guaphenesin BP…..50mg

Menthol BP….1mg

120ml -do- 21-7-2013

Rs.20000/-

Duplicate

entry

102

Item No. V. Quality Control cases

Case No.01: Deferred Cases

Sr.

#

Name of Drugs Firm CDL Report Appellate Testing Details/Decision

1. Pamectin Drench

Batch NO.

V026/PMC/H/23

(Levermectin)

(F. No. 3-16/2013-

QC)

M/s. Nawan

Laboratories

(Pvt) Ltd.,

Animal

Health

Division

Karachi.

Substandard in

respect of Assay

for Ivermectin:

Percentage: 44.8%

Limits: 90.0 % to

110.0% Does not

comply with

manufacturer’s

specifications.

Not challenged Samples drawn from manufacturer’s premises on

25-02-2013 by FID Karachi-III. The firm could not

provide any valid justification for non conformance

of the product, in question, with the specifications.

Show Cause Notice, for cancellation / suspension

of registration / prosecution, was issued on 04-05-

2013. Accused Licensee namely Naseer Ahmed

Awan, Muhammad Akram Rana, Mohammad

Younus and the Firm / their Representative were

called for personal hearing before 238th

DRB

meeting held on 06-08-2013,

Since no one appeared on behalf of the

accused/firm before the 238th

meeting of the Board

so the Board deferred the case to give final

opportunity of the personal hearing to the

firm/accused. The Board, in the same meeting,

further decided to stop production of Pamectin

Drench till final decision by the Board.

During proceeding of the 239th

meeting, the Board

was informed that the orders for stoppage of the

production of Pamactin Drench, taken in its 238th

103

Sr.

#


meeting, could not be conveyed as the approval of

minutes was not received in time from members.

Mr. Ahsan Naseer Awan, Director, Nawan

Laboratories, appeared on behalf of the firm and

stated that, as per their investigation, mal

functioning of mixer lead to improper mixing

resulting in low percentage of active drug in certain

portions of the mixture. He further informed that

problem has been rectified and the sub-standard

product has been recalled.

Decision:-

The Board in view of the personal hearing and

available record of the case decided as under:-

Production of Pamectian Drench be

stopped till further orders

Inspection of the firm by the following panel

in order to indentify the problems and

confirm the actions taken by the firm:-

Director, DTL Quetta,

DDG, (E&M) Karachi.

Area FID.

104

Sr.

#


2. Hydrogen Peroxide

Solution Batch No.

840

(F. No. 3-21/2012-

Q.C)

M/s.

Karachi

Pharmaceuti

cal

Laboratories

, Karachi

Substandard in

respect of Acidity

& Assay for

Hydrogen

Peroxide:

Assay

Determined:

3.402%w/v

Limits: 5.0%w/v to

7.0%w/v.

Does not comply

with BP 2011

Not challenged Samples drawn from JPMC, Karachi on 09-

07-2012 by FID Karachi-III. The firm could not

provide any valid justification for non conformance

of the product in question with the specifications.

Show Cause Notices, for cancellation / suspension

of registration / prosecution, were issued on 07-05-

2013. Accused Licensee namely Muhammad Saleh

Memon, Mrs. Amina Mehboob Ali, Mrs. Farida

Qureshi and the Firm / their representative, were

called for personal hearing before 238th

DRB

meeting held on 06-08-2013.

The case was deferred by the Board in its 238th

meeting on request of Mr. M. Shaban, Regional

Manager, KPL. The Board, in the same meeting,

further decided to stop production of Hydrogen

Peroxide till final decision by the Board.

During proceeding of 239th

DRB meeting, The

Board was informed that the orders for stoppage of

the production of Hydrogen Peroxide, taken in its

238th

meeting, could not be conveyed as the

approval of minutes was not received in time from

members.

Mr. Muhammad Shaban, Manager Quality

Assurance, appeared on behalf of the firm and

105

Sr.

#


submitted a written reply. As per the reply the firm

claimed to have recalled and replaced the sub-

standard stocks from the JPMC. The firm further

pointed out that a sample of the same batch, drawn

by FID from distributor of the firm, has been

declared of standard Quality by CDL. The firm’s

representative also referred to their request for

appellate testing made vide letter dated 10-09-

2012, which, as per photocopy submitted by the

firm, was received at DRAP Karachi office on 11-

09-2012.

With regards to the standard report of the same

batch issue by the CDL, the Board noted that, the

Federal Government Analyst, in this report, has

stated that quality of the bottle and sharpness,

visibility and colour of the labels text of the

sample was different from the one declared sub-

standard vide its earlier report. The Board

However, observed that appellate testing request of

the firm appears to be with in time as per

documents / evidence of the receipt submitted by

the firm.

Decision:-

The Board, in view of the personal hearing and

106

Sr.

#


available record of the case, decided as under:-

Production of Hydrogen Peroxide be


The Board’s portion of the sample

(Hydrogen peroxide Batch No 840) already

drawn from JPMC, Karachi will be sent for

appellate testing.

3. Carded Absorbent

Cotton Wool,

Batch No. 4555-C,

F.No.3-20/2012-QC

M/s

National

Absorbent

Cotton Mills

Co, Karachi

Sub-Standard:- in

respect of

description:-

Not well carded

cotton, not

bleached to a good

white, it is free

from leaf shells &

foreign mater, it

does not offer any

appreciable

resistance when

pulled and it does

not shed any

appreciable

Sub-Standard:- in

respect of

description

White cotton, free

from pieces of

thread, leaf, shell

and foreign matter.

It do not offer

appreciable

résistance when

pulled and shed

heavy dust when

gently shaken. The

staple length of fiber

is less than 08mm.

Samples drawn from M/s Pharmex Fair Price Drug

Store, JPMC, Karachi on 16-08-2012 by FID-III

Karachi. The Appellate Lab, to which Sample was

sent on firm’s request, also declared the sample sub-

standard. Show Cause Notice, issued on 05-07-2013

to the accused namely Mr.Kashif Iftikahr C.E.O,

Mr. Zahid Hussain I/C Q.C, Mr. Ilyas Khan, I/C

Production and the Firm. The Accused Licensee /

Representative were called for personal hearing

before 238th

DRB meeting held on 06-08-2013.

Since no one appeared on behalf of the

accused/firm before the 238th

meeting of the Board,

so the Board deferred the case to give final

opportunity of the personal hearing to the

firm/accused. The Board, in the same meeting,

107

Sr.

#


quantity of fiber

matter when gently

shaken.

Does not comply

with the

description

PC.1973

(Does not comply

with revised

specification which

states that the cotton

wool should be well

carded, should have

a staple length of not

less than 08mm,

should be bleached

to a good white and

be odorless, should

be free from pieces

of thread and

reasonable free from

leaf, shell and

foreign matter

should offer

appreciable

resistance when

pulled and should

not shed any

appreciable quantity

of dust when gently

shaken.

further decided to stop production of Carded

Absorbent Cotton Wool till final decision by the

Board.

During proceeding of the 239th

meeting, the Board

was informed that the orders for stoppage of the

production of Carded Absorbent Cotton Wool,

taken in its 238th

meeting, could not be conveyed as

the approval of minutes was not received in time

from members.

Mr. Raziuddin Ahmed, Manager and Mr. Ilyas

Khan, represented, National Absorbent Cotton

Mills/accused, and stated that the report of CDL

and Appellate Lab’s are contradictory.

The Board observed that the report of Appellate

Lab is conclusive evidence of the facts stated

therein under Section 22(5) of Drugs Act 1976.

Decision:-

The Board in view of the personal hearing and

available record of the case decided as under:-

Suspension of Registration of Carded

Absorbent Cotton Wool for three months

Inspection of the firm by the following panel

108

Sr.

#


for reporting on GMP Compliance:-

Director, DTL Quetta,

DDG, (E&M) Karachi.

Area FID.

Case No.02. NEW CASES

Sr.

No

Name of Drugs Firm CDL Report Appellate Testing Detail / Decision

1. (i). Normal Saline

Injection (0.9%

Sodium Chloride)

Batch No. 0105235

F. No. 3-15/2012-

DDC-QC-II

M/s Marion

Laboratories

, Karachi

Sub- Standard:-

Assay for sodium

Chloride:

Determined

amount/100ml:

1.023gm

Sated amount

/100ml: 0.9gm

Percentage:

113.67%

Limits: 95.0% to

105.0% Does not

Not Challenged Samples drawn from manufacturer’s premises

on 19-03-2012 by ADC Karachi from

consignment meant for export.

The firm could not provide any valid

justification for non conformance of the

products in question, with the specifications.

Show Cause Notice were issued on 07-08-

2013 to the accused namely Mr. Saboor,

Director, Syed Asghar Afaque, Assistant

Production manger and the Firm / through its

C.E.O.

Accused Licensee and accused were called

for personal hearing

109

comply Mr. Imran Saboor represented M/s Marion

Laboratories and informed that his father S.M

Saboor, the Director of the firm, is seriously

ill. He stated that the samples were drawn

from the 16 batches of various drugs but only

04 samples were declared sub-standard.

However, on instructions of the DRAP

authorities, they recalled all the batches,

including the one declared standard, from the

market. He further claimed that their

production was suspended due to sub-standard

manufacturing. However, The DRAP

authorities later allowed resumption of

production after confirming that the firm has

made required improvements.

The Board noted that the firm failed to give

any valid justification for sub-standard

manufacturing. The Board also considered the

recommendations of the Central Licensing

Board given its 232nd

meeting held on 29-30th

July, 2013 regarding Cancellation/ suspension

of registration of Marivel-5 Injections for sub-

standard export to Rawanda. (Case 03 (b) of

Miscellaneous Cases of the Agenda). It was

also noted that the Drug Manufacturing

License of the firm has been suspended for six

months by the Central Licensing Board.

110

Decision:-

The Board in view of the personal

hearing and available record of the case

decided to cancel registration of

Normal Saline Injection.

(ii). Normal Saline

Injection (0.9%

Sodium Chloride)

Batch No. 0105238

F. No. 3-15/2012-

DDC-QC-II

M/s Marrion

Laboratories

, Karachi

Sub- Standard:-

Assay for sodium

Chloride:

Determined

amount/100ml:

1.006gm

Sated amount

/100ml: 0.9gm

Percentage:

111.77%

Limits: 95.0% to

105.0% Does not

comply

Not Challenge Samples drawn from manufacturer’s premises





products, in question, with the specifications.

Show Cause Notice were issued on 07-08-




C.E.O.

Accused Licensee and accused were called for

personal hearing

Mr. Imran Saboor represented M/s Marion





111
























Decision:-




112

Normal Saline Injection.

(iii). Marivell-5

Injection Batch

No.0205852

(Dextrose)

F. No. 3-15/2012-

DDC-QC-II

M/s Marrion

Laboratories

, Karachi

Sub-Standard:-

In respect of

Endotoxins Test

Does not comply







Show Cause Notice, were issued on 07-08-




C.E.O.


personal hearing













113

















Decision:-




Marivell-5 Injection.

(iv). Marivell-5

Injection Batch

No.0205854

(Dextrose)

F. No. 3-15/2012-

M/s Marrion

Laboratories

, Karachi

Sub-Standard:-

In respect of

Endotoxins Test

Does not comply







114

DDC-QC-II





C.E.O.


personal hearing






















115








Decision:-




Marivell-5 injection.

2. Aerolin Syrup

Batch No. 404

(Salbutamol)

F.No.03-16/2012-

DDC QC

M/s Ankaz

Pharmex,

Karachi

Sub-Standard:

Assay for

Salbutamol:

Determined

amount/5ml:

1.4778 mg

Stated amount/5ml:

2.0mg

Percentage:

73.89%

Limits:- 90.0% to

105.0 % Does not

Adulterated

Remarks:-

During the analysis of

salbutamol Sulphate

Syrup unidentifiable

peaks eluted alongwith

active ingredient at the

retention time of 2.48and

4.803 minutes. The area

of these unidentifiable

peaks found two times

greater than the area of

active ingredient

Samples drawn from manufacturer’s premises

on 19-07-2012 by FID Karachi-III

The firm requested for appellate testing

In response to Show Cause Notice the firm did

not agree with the appellate Lab’s report.

Show Cause Notices, were issued on 07-08-

2013 to the accused namely Mr. Zafar Shah

Production Incharge, Mr. Jubair Ali, Quality

Control Manager and the Firm / through its

C.E.O.


personal hearing

116

comply with BP

2011

Mr. Nazurl Islam, Quality Assurance Manager

of Ankaz Pharmex represented the firm and

stated that the drug is of standard quality as

per test/analysis of the keeping samples by

their Q.C Department and no adulteration was

found. He further claimed that the NIH report

wrongly interpreted the eluted extra peaks as

unidentifiable which, in fact, were of

excipient.

The Boar however was of the view that the

issue needs to be thoroughly

examined/investigated

Decision:-

The Board in view of the personal hearing

and available record of the case decided as

under:-

Production of Aeroline Syrup be


Inspection of the firm by the following

panel to thoroughly investigate the

matter

Director, DTL Lahore,

DDG, (E&M) Karachi.

Area FID.

117

3. Pracmol

Suspension Batch

No. PM-28

(Paracetamol)

F.No. 03-22/2013-

QC

M/s Glitz

Pharma

Islamabad

Sub-Standard

Assay for

Paracetamol:-

Determined

amount/5ml:

99.264 mg

Stated amount:

120.0 mg

Percentage:

82.72%

Limits:- 95.0% to

105.0% Does not

comply BP 2011

Sub-Standard:-

Assay for Paracetamol:-

Stated:- 120mg/5ml

Found:- 96.03mg/5ml

Limit: 95-105%

Percentage: 80.02%

Samples drawn from manufacturer’s premises

on 18-03-2013 by FID Islamabad

The firm requested for appellate testing.


2013 to the accused namely Chaudhry

Munawar Hussain, Chief Executive Officer,

Mr. Sheikh Imran Aslam, Production

Manager, Mr. Kiramat ullah, Quality Control

Manger and the Firm / through its C.E.O.


personal hearing

Mr. Ch. Munawar Hussain, C.E, Shaikh Imran

Aslam, Prod. Manager, Kiramat ullah, Q.C

Manager, appeared before the Board and

stated that the drug is of standard quality as

per repeated test/analysis of the keeping

samples by their Q.C Department and they are

trying to find out the cause of the problem..

The Boar however was of the view that the

consistent CDL and Appellate Lab’s results

clearly indicate that the product is not up to

the specified standards.

Decision:-

The Board in view of the personal hearing

118

and available record of the case decided as

under:-

Suspend registration of Paracmol

suspension for six months.

Inspection of the firm by the following

panel to thoroughly investigate the

matter

Prof. Dr. Rafi-uz-Zaman

DDG, (E&M) Islamabad.

Area FID.

119

Case No.03: MISCELLANEOUS CASES.

Case No a. MANUFACTURE AND SALE OF SPURIOUS, SUBSTANDARD AND

ADULTERATED ISOTAB TABLETS BY M/S. EFROZE CHEMICAL

INDUSTRIES KARACHI.

In January, 2012 on receipt of reports of number of deaths / serious reaction in large

number of patients, receiving medicines from the Punjab Institute of Cardiology, the than Drug

Control Administration and Government of Punjab initiated investigation to find out facts the

case. Subsequently a foreign laboratory reported contamination of antimalarial drug

“Pyrimethamine” in samples of Isotab tablets of M/s Efroze Chemical Industries, sent by the

Punjab Government. Since at that time the subject of “Drugs and Medicines” was devolved to

the provinces under 18th

Amendment, therefore, the Drug Control Administration at Federal

level could not process the matter further.

The Punjab Government, however, initiated its own independent investigation during this

period. An FIR, against M/s Efroze Pharmaceuticals, Karachi, was lodged by Punjab

Government and a Judicial Commission, headed by Judge of High Court, had also been set up by

them for carrying out detail investigation of the case.

The Provincial Quality Control Board, Punjab later, vide its order dated 01-02-2012,

reported that the samples of Tablet Isotab-20 Batch No. J-093, manufactured by M/s Efroze

Chemical industries (Pvt) Ltd., Karachi, drawn by Drug Inspector, Data Ganj Bakhsh Town

Lahore, (from stocks of the medicines retrieved from the patients (who received free medicines

from PIC Lahore), were declared to be adulterated with “Pyrimethamine”, by the Government

Analyst, Drug Testing Laboratory, Punjab. The quantity of “Pyrimethamine” determined, was

46.21 mg per tab and percentage of Isosorbide-5-mononitrate (API) was declared to be 122.8%,

whereas the official limit of active ingredient was 95-105%. The Provincial Quality Control

Board Punjab, after considering the matter recommended cancellation of Registration of Isotab

Tablet and Drug Manufacturing License of M/s Efroze Chemical Industries, Karachi vides its

ordered dated 01-02-2012.

The recommendations regarding cancellation of Drug Manufacturing License was taken

up by Central Licensing Board in its 231st meeting held on 30-01-2013, wherein the Board,

suspended Tablet Section of Efroze Pharma and ordered to launch prosecution against the

120

responsible persons of the firm. The Board further recommended to the Registration Board for

the cancellation of registration of Isotab Tablet.


meeting held on 26-02-2013 considered the

matter and took following decisions.

i) Registration of Isotab Tablet is suspended for one year.

ii) Show Cause Notice to be issued to the Firm( for cancellation of Drug

Registration)

iii) The case be evaluated/investigated by an Expert Committee to be constituted

by the Chairman, Policy Board

As per above decisions of the Board, the following actions have been taken.

a. Firm has been issued Show Cause Notices dated 09-04-2013

b. Registration of Isotab Tablets has been suspended vide letter dated 22nd

March,

2013

c. A seven member committee headed by Prof. Dr. Tahir S. Shamsi of National

Institute of Blood Disease and Bone Marrow Transplant, has been constituted

vide letter dated 08-03-2013 to evaluate the case in detail and give its

comprehensive report and recommendations with in seven days. The CLB in its

232nd

meeting directed that the Committee may be asked to finalize its report on

top priority basis preferably with in week’s time.

The report of the Committee has been received recently. The Committee, as per its TOR,

has evaluated report of Defective Drugs Inquiry Tribunal, recommendation of PQCB Punjab,

investigation of area of FID Karachi and Inspection/investigation reports of National and

International Agencies. The Committee also inspected the firm for assessing the GMP

compliance status. The report of the Committee discussed the actions taken by Federal and

Provincial Authorities against M/s Efroze Chemical Industry and its finding related to GMP

status of the firm. The excerpts of the report and remarks of the Committee is Annexed

It is further Informed that M/s Efroze Chemical Industries, also file in appeal before

appellate Board against suspension of their Tablet Section by CLB. The Appellate Board

allowed manufacturing in Tablet Section on limited scale under strict monitoring.

M/s Efroze Chemical Industry has been called for personal hearing with reference to the

Show Cause Notice issued for cancellation of registration of Isotab Tablet.

Decision:-

The Board decided to defer the case till next meeting in order to provide final opportunity

of personal hearing to M/s Efroze Chemical Industry, Karachi, failing which an ex-parte

121

decision shall be taken. In the mean time, the members may also study the report of the

Committee and come up with their recommendations/views in next meeting.

Case No b. Manufacture and Export of Sub-Standard Marivell-5 Injections by M/s

Marion Laboratories (Pvt) Karachi

The Secretary Central Licensing Board has forwarded have the following decision of the

Central Licensing Board taken in its 232 meeting held on 29-30 July,2013 for consideration of

Drug Registration Board:-

“The Board also decided to send recommendation to the Registration Board for

cancellation/suspension of registration of Injection Marivell-5 (Dextrose 5%)

500ml under Section 42 of Drugs Act, 1976 and rules framed there under for

manufacturing and supply of Sub-Standard drug in the importing country”.

M/s Marion laboratories manufactured and exported two consignments of Marivell-

5 Injection (246240 Bottles) to Rawanda via Darussalam Tanzania through M/s Royal

Groups Karachi in early 2012. The Consignments were reported to be declared sub-

Standard by Rawanda Bio Medical Center of the importing country which also

recommended for rejection of whole consignments. A dispute between M/s Marion Labs

and M/s Royal Group arose on the issues of the destructions of stocks at Darussalam and

Rawanda and compensation. Falling to settle the matters with M/s Marion, the Royal

Group approached the DRAP Authorities for support claiming that manufacture of sub-

standard drug for export by M/s Marion Lab’s has put Pakistan reputation at stake and

could seriously effects export of drugs of Pakistani origin if the dispute is not appropriately

settled. The DRAP Authorities and Central Licensing Board asked M/s Marion

Laboratories number of times to settle the matter amicably with M/s Royal particularly

regarding destruction of the Sub-Standard exported consignments lying at the port of

Darussalam and at Rawanda, in order to avoid bringing bad name to Pakistan export. M/s

Marion, however, failed to cooperate and appeared to have resorted to delaying tactics.

With regards to substandard exports, a GMP inspection of the firm was carried out

and the production of the firm remain suspended till September, 2012. Thereafter the firm

was found closed by an inspection panel which visited the firm on 11th

, June 2013. The

panel formally closed production of the firm vides its inspection report dated 11-06-2013.

122

The matter was subsequently considered by the Central Licensing Board in its 232nd

meeting wherein Board took number of decision including suspension of Drug

Manufacturing License of M/s Marion Lab’s Karachi for six months.

Decision:-

The Board considered the case along with sub-standard cases of M/s Marion Laboratories

Karachi, included in the New Cases {Case No.2(1)}of the Q.C Agenda, wherein the Board

already decide to cancel the registration of Marivell-5 Injection for sub-standard

manufacturing.

Case No c: MANUFACTURE / SALE OF SUBSTANDARD MACRONIDE

INFUSIONS BY M/S MAC & RAIN PHARMACEUTICALS, LAHORE.

The Federal Inspector of Drugs on 31st May, 2011 and 4th June, 2011 drew samples of

five different batches of Macronid 100ml Infusion from the Main Medical Store, MCH and Store

of Children Hospital at PIMS. On 4th June, 2011 different batches of Macronid Infusions at Burn

Center, Store of Children Hospital and Main Store at PIMS were also ordered Not to Dispose off

for three months by the FID. The FID, Islamabad later reported that the reports of the

aforementioned samples were not received until May, 2012. On 17th May, 2012 photocopies of

two substandard test reports, number 489/2011 & 490/ 2011 dated 28-05-2011, issued in respect

of Macronid Infusion batch No. 105209 and 105208 were received. The other three batches of

Macronid Infusions i-e 104262, 105123 and 010271 were declared standard Quality as per

photocopies of reports of CD L provided by FID.

Immediately, on receipt, the two substandard reports were sent to PIMS and stocks of

substandard batches were again ordered Not to Dispose off 18(1)(i) of Drugs Act, 1976 by FID

on 21-05-2012 at Burn Center, Main Medical Store and MCH at PIMS and requested for

extension of not to dispose off period under Section 18 of the Act. The FID’s request for

extending not to dispose off orders was put up in June 2012, but file returned in April 2013,

without any action. The Federal Inspector of Drug in the mean time also called explanation of

the manufacturer M/s Mac & Rains Pharmaceuticals Lahore. The firm in response did not agree

with the repots and stated that one of batch of Macronid Infusion (No 105208) was already

declared standard by DTL, Punjab and further stated that the direct temperature shock applied on

123

the bottle during sealing (remarks of Federal Government Analyst) has compromised the sterility

of the product.

The Federal Inspector of Drugs is of the view that the same method of seal was applied to

all the other sample of Mecronid Infusion sent to Central Drug Laboratory and the reports of

other three batches of the product, wherein the thermal shock was also reported by the Federal

Government Analysis, were of standard quality and the firm’s contention therefore is not valid.

The Federal Inspector of Drugs, therefore, concluded that the firms has violated the section (23)

(1) (a) (V), of Drug Act 1976.

Decision:-

The Board, in view of the available record and facts of the case, decided as under:-

Show Cause Notice be issued to the firm and responsible persons.

FID may be advised to pass not to dispose off orders/make seizure, which ever is

applicable, for the sub-standard stocks at PIMS.

Initiate recall proceedings for sub-standard stocks if supplied in the market

124

Item No.V Any Other Item with permission of chair

Registraion-I

Case No: 01. Aplications for registration (locally manufactured Veterinary drugs (me-

too/new drugs) for fast track.

S. # Name of

Applicant


Size

Shelf

Life

Decision

1. M/s. Mylab (Pvt)

Ltd. Khanqah

Sharif,

Bahawalpur.

Nemasol Plus Drench

Each ml contains:-

Levamizole …………..15mg

Oxyclozanide………..30 mg

Cobalt Sulphate ...…1.67 mg

Sodium Selenite ..….0.50mg

Decontrolled

150ml

500ml

1000ml

5 Litre

10 Litre

02

years

Approved

2. M/s. Mylab (Pvt)

Ltd. Khanqah

Sharif,

Bahawalpur.

Hepanol Oral Solution


Sorbitol …………...….35gm

Acetyl Metionine …….10gm

Choline HCL ……….7.5 gm

Betain …………….6.0 gm

Lysine Hydrochloride .2.0gm

Decontrolled

100ml

250ml

500ml

1000ml

02

years

Deferred for

application on

Form 5 D along

with revised Fee

and comments of

following experts;

1. Dr. M

Ashraf,

UVAS

2. Head of

Pharmacolog

y Deptt.

UAF

3. Dr. M.

Arshad,

Member

DRB.

3. M/s. Mylab (Pvt)

Ltd. Khanqah

Sharif,

Bahawalpur.

Imnate Injection

Each ml contains:-

Imidocarb

Dipropionate………120mg

Decontrolled

10ml

20ml

50ml

100ml

02

years

Approved

4. M/s. Mylab (Pvt)

Ltd. Khanqah

Sharif,

Bahawalpur.

Melodyl Injection


Cyanocobalamine …0.05mg

Sodium Selinite ……100 mg

Adenosine Triphosphate

Tetrasodium

Trihydrate……………0.1gm

Potassium Aspartate Semihydrate

…………1.0gm

Magnesium Aspartate

Decontrolled

10ml

20ml

50ml

100ml

02

years

Deferred for

application on

Form 5 D along

with revised Fee

and comments of

following experts;

a. Dr. M Ashraf,

UVAS

b. Head of

Pharmacology

125

Tetrahydrate ……….1.5gm Deptt. UAF

c. Dr. M.

Arshad,

Member DRB

5. M/s. Mylab (Pvt)

Ltd. Khanqah

Sharif,

Bahawalpur.

Rivaflor 300 Injection

Each ml contains:-

Florfenicol ………...300mg

Decontrolled

10ml

20ml

50ml

100ml

02

years

Approved

6. M/s. Mylab (Pvt)

Ltd. Khanqah

Sharif,

Bahawalpur.

Terralon 50 Injection

Each ml contains:-

Oxytetracycline ……50mg

Decontrolled

10ml

20ml

02

years

Approved

7. M/s. Mylab (Pvt)

Ltd. Khanqah

Sharif,

Bahawalpur.

Tetrasol Injection

Each ml contains:-

Chlortetracycline.2.45% w/w

(Antibiotic)

Decontrolled

100ml

02

years

Deferred for

application on

Form 5 D along

with revised Fee

and comments of

following experts;

a. Dr. M Ashraf,

UVAS

b. Head of

Pharmacology

Deptt. UAF

c. Dr. M.

Arshad,

Member DRB

8. M/s. Mylab (Pvt)

Ltd. Khanqah

Sharif,

Bahawalpur.

Xylax Injection.

Each ml contains:-

Xylazine HCl 23.32mg.

(Analgesic, Sedative).

Decontrolled

5ml

10ml

20ml

25ml

30ml

50ml

100ml

2 years Approved

9. M/s. Mylab (Pvt)

Ltd. Khanqah

Sharif,

Bahawalpur.

Duretic Injection.

Each ml contains:-

Furosemide………50mg.

(Diuretic).

Decontrolled

5ml

10ml

20ml

30ml

50ml

100ml

2 years Approved

10. M/s. Mylab (Pvt)

Ltd. Khanqah

Sharif,

Bahawalpur.

Vantix Solution


Fipronil……….0.25gm

(Disinfectant).

Decontrolled

100ml

250ml

500ml

1000ml

03

years

Deferred for

application on Form

5 D along with

revised Fee and

comments of

following experts;

a. Dr. M Ashraf,

UVAS

126

b. Head of

Pharmacology

Deptt. UAF

c. Dr. M. Arshad,

Member DRB

11. M/s. Baariq

Pharmaceuticals,

Raiwind Road,

Lahore.

Zoleriq 10% Oral Drench

Each ml oral drench contains:-

Albendazole……100mg

(Benzimidazole).

Decontrolled

100ml

250ml

500ml

1000ml

02

years

Approved

12. M/s. Baariq

Pharmaceuticals,

Raiwind Road,

Lahore.

Oxfendaox Plus Oral Drench

Each ml contains:-

Oxyclozanide ……..62.50mg

Oxfendazole …………22.65

Cobalt Sulphate……1.67mg

Sodium Selenite…….0.50mg

(Salicylanilide, Benzimodazole,

Trace Elements).

Decontrolled

100ml

500ml

1000ml

2500ml

02

years

Approved

13. M/s. Baariq

Pharmaceuticals,

Raiwind Road,

Lahore.

Zolesel-CS Oral Drench

Each ml contains:-

Albendazole……….50mg


Sodium Selenite……0.35mg

(Benzimodazole, Trace Elements).

Decontrolled

100ml

500ml

1000ml

2500ml

02

years

Approved

14. M/s. Baariq

Pharmaceuticals,

Raiwind Road,

Lahore.

Levoxbar-Plus Drench

Each ml contains:-

Levamisole HCL..15mg

Cobalt Sulphate…1.67mg

Oxyclozanide…………30mg

Sodium Selenite……0.50mg

(Salicylanilide, Trace Elements).

Decontrolled

100ml

150ml

500ml

1000ml

2500ml

03

years

Approved

15. M/s. Baariq

Pharmaceuticals,

Raiwind Road,

Lahore.

Levacob-SS Oral Drench

Each ml contains:-

Levamisole HCL……15mg


Sodium Selenite…….0.50mg

(Salicylanilide, Trace Elements).

Decontrolled

100ml

500ml

1000ml

2500ml

03

years

Approved

16. M/s. Baariq

Pharmaceuticals,

Raiwind Road,

Lahore.

Amantadox-T Water Soluble

Powder

Each 1000 gm powder contains:-

Tylosin Tartrate

…….100gm

Doxycyline HCL……200gm

Amantadine HCl…….45gm

(Antibiotic)

Decontrolled

100gm

250gm

500gm

1000gm

2500gm

5000gm

02

years

Approved

17. M/s. Baariq

Pharmaceuticals,

Raiwind Road,

Lahore.

Colibect Water Soluble Powder


Colistin Sulphate…500,000,000 IU

(Antibiotic, Antibacterial).

Decontrolled

100gm

250gm

500gm

1Kg

02

years

Approved

127

2.5Kg

5Kg

10Kg

25Kg

18. M/s. D-Maarson

Pharmaceuticals,

Rawat, Islamabad.

LEVANIDE-CS Suspension


Oxyclozanide…….3.0g

Levamisole HCl …1.5g

Cobalt Sulphate ….0.382%

Decontrolled

100ml

150ml

250ml

400ml

500ml

1Litre

2.5Litre

25 Litre

02

years

Approved, with

Brand Name

change

19. M/s. D-Maarson

Pharmaceuticals,

Rawat, Islamabad.

ALBENMARS Suspension


Albendazole…….2.5g

Sodium selenite ...0.035%

Cobalt chloride …0.075%

Decontrolled

100ml

150ml

250ml

400ml

500ml

1Litre

2.5Litre

25 Litre

02

years

Approved

20. M/s. D-Maarson

Pharmaceuticals,

Rawat, Islamabad.

LEVAMARS Suspension


Levamisole HCl …1.5%

Decontrolled

100ml

150ml

250ml

400ml

500ml

1Litre

2.5Litre

25 Litre

02

years

Approved

21. M/s. D-Maarson

Pharmaceuticals,

Rawat, Islamabad.

TOLTRA MARS Liquid


Toltrazuril …..25g

Vitamin K3 …3g

Decontrolled

100ml

250ml

500ml

1Litre

2.5Litre

02

years

Approved, with

Brand Name

change

22. M/s. D-Maarson

Pharmaceuticals,

Rawat, Islamabad.

FENMARS Suspension

Each ml contains:-

Oxfendazole … 22.65mg

Decontrolled

100ml

150ml

250ml

400ml

500ml

1Litre

2.5Litre

25 Litre

02

years

Approved

23. M/s. Medi-Vet

(Pvt) Limited,

Floxivet-Col + Oral Solution


Decontrolled

100ml

02

years

Deferred as

production of firm

128

Lahore.

Enrofloxacin HCI

CP………………..10.0gm

Amantadine HCI

BP………………..04.0gm

Colistin Sulphate

BP…......................3.5gm

(Antibiotic/Antibacterial/Antiviral).

250ml

500ml

1000ml

has been stopped

by CLB

24. M/s. Medi-Vet

(Pvt) Limited,

Lahore.

Floxivet-C Injection

Each ml contains:-

Enrofloxacin B.P Vet…100mg/ml

Colistin Sulphate BP..250000 iu/ml

(Antibiotic/Antibacterial).

Decontrolled

100ml

250ml

500ml

1000ml

02

years

-Do-

25. M/s. Medi-Vet

(Pvt) Limited,

Lahore.

Amcol-Vet Oral Suspension


Amoxicillin base (as

Trihydrate……..B.P…15gm

Colistin Sulphate B.P…..50 MIU


Decontrolled

100ml

250ml

500ml

1000ml

03

years

Rejected as firm

does not have the

separate Penicillin

Section.

26. M/s. Medi-Vet

(Pvt) Limited,

Lahore.

Medi-Voc Injection

Each ml contains:-

Ivermectin B.P………..10mg

(Dewormer/ Anthelmintic).

Decontrolled

100ml

250ml

500ml

1000ml

02

years

Deferred as

production of firm

has been stopped

by CLB

27. M/s. Medi-Vet

(Pvt) Limited,

Lahore.

Medi-Dox Plus Solution


Tylosine Tartrate B.P

Vet………………..10gm

Doxycycline HCI

B.P……………….20gm

Colistin SulphateB.P…….500,000

IU

Bromhexine HCI

B.P…………………500mg


Decontrolled

100ml

500 ml

1000ml

02

years

-Do-

129

Case No.2: Change of formulation of already approved veterinary drugs.

M/s. D-Maarson Pharmaceuticals, Islamabad have requested for change of formulation of

their already approved veterinary drugs by the Drug Registration Board in its 237th

meeting held

on 26-02-2013. The registration letters of the drugs have not been issued so far due to new

formulation. Now the firm has requested for change of formulation as per already approved

drugs:-

S.No. Existing Formulation. New Formulation.

1. Col-Plus Oral Liquid


Florfenicol……15gm.

Colistin Sulphate … 50 MIU

Col-Plus Oral Liquid


Florfenicol…… 20gm

2. Coli En Liquid.


Enrofloxacin ……10gm.

Colistin sulphate…. 55 MIU

Coli En Liquid.


Enrofloxacin ……..20gm

Colistin sulphate …50 MIU

Decision: Request of the firm was acceded by the Board.

Case No.3: Change of manufacturing site of registered imported drug

M/s. Novartis Pharma (Pakistan) Limited, Karachi have requested to approve the change

of manufacturing site of their registered imported drug namely “Galvus Tablets 50mg (Reg.

No.059038)” from M/s. Novartis Pharma Stein AG, Stein, Switzerland to M/s. Novartis

Farmaceutica S.A., Spain.

M/s. Novartis Pharma (Pakistan) Limited, Karachi have deposited required fee

Rs.50000/= (Pages 44-45/Corr) and submitted following supporting documents:-

i) Copy of registration letter.

ii) Original legalized EMA CPP of new manufacturing site.

iii) Copy of NOC for CRF.

iv) Registration of the drug is valid.

Decision:

The board after detailed discussion approved the change in manufacturing site of

Galvus Tablets from M/s. Novartis Pharma Stein AG, Stein, Switzerland to M/s. Novartis

130

Farmaceutica S.A., Spain. The Board advised to deposit balance fee as per revised fee

schedule and site master file of new manufacturing site.

Registration-II

Case No.4 Deferred cases.

a. Adamjee Pharmaceuticals (Pvt.) Ltd, Karachi

Following product of M/s Adamjee Pharmaceuticals, Karachi was deferred for review the

case after submission of balance fee, GMP of source, COA and stability data by the Expert

Committee of Registration Board in its 237th

meeting.


MRP

Papazole Capsule


Pantoprazole sodium sesquihydrate

equivalent to Pantoprazole…………….40mg

(Selective inhibitor of Cyclic Guanosine

Monophosphate)

2x7’s As Per SRO

Now the firm has requisite information as under:-

i) Pantoprazole Pellets will be import from M/s Glukem Pharmaceuticals (Pvt.) Ltd,

Plot No. 205/2A, First Floor, IDA, Phase-II, Cherlapally, Hyderabad, Andhra

Pradesh, India

ii) GMP Certificate of bulk import source issued on 23-07-2012 valid for one year.

iii) Certificate of Analysis

iv) Stability data (Accelerated i.e 400C / 75% RH and long term studies i.e 25

0C /

65% RH)

v) Balance fee Rs.240,000/-

Decsion: Regsitartion Board approved firm’s request. However, the Borad advised to

provide valid GMP certicate or identify another manufacturer and submit its relevant

documents and authorized its Chairman to accord approval for issuance of regiatration

letter.

131

b) M/s Abbott Laboratories, Karachi


meeting deferred registration of following drug of M/s

Abbott Laboratories, Karachi reason mentioned in last column.

S.

No

Name of drug(s) &

Composition

Proposed

Pack size

Demanded

Price

Date of

application,

Diary No.

& Form

Decision

1 Klaricid-DS Granules

Each 5ml contains:

Clarithromycin 250 mg

(Antibiotics)

60ml Rs.630/- 16-06-2011

Dy.No.1601

Form-5

Rs.8000/-

Rs.12000/-

12-10-2012

Rs.40,000/-

29-1-2013

Sub-Committee

decided to review

the case after

submission of

balance fee, GMP

of source, COA and

stability data

M/s Abbott Labs, Karachi has now furnished the following documents:-

i) GMP Certificate of API source M/s Ranbaxy Laboratories Ltd, Industrial Area

No.3 A.B. Road, Dewas 455 001 (MP), India issued on 15-02-2013 valid till 15-

01-2015.

ii) Certificate of Analysis

iii) Stability data (only long term studies for 36 months at 250C / 60% RH)

iv) Remaining fee Rs.240,000/- for each product for the purpose.

Decsion: Regsitartion Board approved Klaricid-DS Granules for registration

with source of pellets mentioned above.

c) M/s PharmEvo (Pvt.) Ltd, Karachi


meeting deferred following product of M/s PharmEvo

Pakistan, Karachi

132

Name of drug(s) &

Composition

Proposed

Pack size

Demanded

Price

Decision

Acrova Tablet


Rivaroxaban ……..10mg

(Anti thrombotic agent)

7’s

14’s

Rs.1200.00

Rs.2400.00

Deferred for

confirmation of

formulation

Later on scrutiny of registration data reveals that the above formulation is already

approved in 238th

meeting of Registration Board for M/s Getz Pharma, Karachi under the brand

name “Xalto Tablets 10mg”.

Decsion: Regsitartion Board approved Acrova Tablet for registration.

d) Pharmatec Pakistan (Pvt.) Ltd, Karachi.

Following product of M/s Pharmatec Pakistan, Karachi was deferred, for submission of

application of Form-5D with balance fee, by the Expert Committee of Registration Board in its

237th

meeting.


MRP

Maltofer Fol Syrup

Each 5ml contains:

Iron as iron (III) hydro oxide

ploymaltose………..….100 mg

Folic acid…………….400 mcg

(Supplementation and treatment of ID and

IDA)

150ml As per PRC

Now the firm has furnished registration application on Form-5D along with remaining fee

Rs.90,000/-. The firm has also submitted the justification for the proposed syrup dosage form

that it has better compliance and tolerability.

133

Decision: Registration Board deferred request for PSI by Director DTL, Karachi and

area FID. Moreover, case will be referred to Head, dept of Gynacology, FGSH, PIMS and

RGH.

e) M/s Amarant Pharmaceuticals (Pvt.) Ltd, Karachi

The firm M/s Amarant Pharmaceuticals (Pvt.) Ltd, Karachi had applied for the

registration of the below mentioned formulation, which was considered in the 237th

meeting of

the Registration Board and deferred for reason recorded in the last column:

S.

No.

Name of

applicant(s)

Name of drug(s) Decision

1. M/s Amarant

Pharmaceuticals ,

Karachi

Cycline 250mg Capsule


Cycloserine……250mg

(A broad spectrum

antibiotic)

Deferred for

confirmation of

manufacturing

facility.

Now the firm has submitted that they have the facility for manufacture of the said

formulation i.e., Capsule (General) section and that a number of firms are manufacturing the

same product in Capsule (General) section.

Decision: Registration Board approved Cycline 250mg Capsule for registration.

f) M/s Pakistan Pharmaceutical Products (Pvt.) Ltd, Karachi


meeting deferred following products of

M/s Pakistan Pharmaceutical Products, Karachi for the reasons mentioned in last column.

S.

No.

Name of drug(s) & Formulation Pack

size

MRP Reason

1. Pilot Suspension 125mg/5ml Rs.11.25 / Deferred for panel

inspection to

134

Each 5ml contains:-

Cefadroxil ………….….125mg

(Antibiotics)

5ml evaluate GMP

compliance & track

record

2. Pilot Suspension 250mg/5ml

Each 5ml contains:-

Cefadroxil …………….250mg

(Antibiotics)

Rs.20.83 /

5ml

-do-

3. Pilot Capsule 500mg


Cefadroxil …………...500mg

(Antibiotics)

Rs.25.75

(Per

capsule)

-do-

Now, the firm has submitted product specific inspection report dated 28-02-2011 of panel

constituted by the Registration Board in its 227th

meeting and routine GMP inspection dated 13-

02-2013 conducted by the area FID. Where the FID has mentioned in inspection report that firm

has concerned Cephalosporin Oral Dry Syrup and Capsule Sections and concluded as follows:-

“ based on the areas inspected, the people met and the documents

reviewed , and considering the findings of the inspection of M/s Pakistan

Pharmaceutical Products, site was considered to be operating at good

level of compliance with GMP guidelines as per Drugs Act, 1976 and

rules framed there under”

Decision: Registration Board deferred request for PSI by Director DTL, Karachi and

area FID.

g) M/s Aventis Pharma, Karachi – Claforan 2.0gm Injection


meeting deferred following application of M/s Aventis

Pharma, Karachi for reason recorded in last column.

Name of drug(s) &

Composition

Proposed

Pack size

Demanded

Price

Date of

application,

Diary No.

Decision

135

& Form

Claforan 2.0g Injection


Cefotaxime as

Sodium ….2gm

(Antibiotics)

Per vial Rs.550.43 19-05-2011

1257

Form-5

Rs.8000/-

Rs.72,000/-

29-1-2013

Deferred for

approval by

USFDA, EMA,

regulatory body of

Japan & Australia.

Now the firm has submitted that the above formulation is already registered for several firms

including M/s Alina Combine, Karachi under the brand name “ Hexime Injection 2gm” Reg.

No.012814 and M/s P.D.H Pharmaceuticals, Karachi under the brand name of “Cephronate

Injection” Reg. No.019699. The said formulation has also been approved by USFDA, MHRA &

Regulatory Body of Australia.

Decision: Registration Board approved Claforan 2.0g Injection for regsitration.

h) M/s Macter International, Karachi


meeting deferred registration of following drug of M/s

Macter International, Karachi reason mentioned in last column.

S.

No

Name of drug(s) &

Composition

Proposed

Pack size

Demanded

Price

Date of

application,

Diary No.

& Form

Decision

1 Itoguard OD 150mg

Capsule


Itopride hydrochloride

(as sustained release

pellets)……….150 mg

(Gastro kinetic)

10’s

14’s

20’s

30’s

Rs.33/-

Per Cap.

06-09-2012

1515

Form-5

Rs.8000/-

Rs.52,000/-

23-1-2013

The Sub-

Committee decided

to review the case

after submission of

balance fee, GMP

of source, COA and

stability data

M/s Macter International, Karachi have now furnished the following documents:-

i) Certificate of Analysis

136

ii) Comparative Dissolution Method

iii) GMP Certificate of source M/s Spansules Formulation, India

iv) Stability study data

v) Fee Rs. 300,000/- for the purpose.

Decision: Registration Board approved Itoguard OD 150mg Capsule for regsitration.

i) M/s Amarant Pharmaceuticals, Karachi


meeting deferred for expert opinion the registration of

following drug of M/s Amarant Pharmaceuticals, Karachi

S.

No

Name of drug(s) & Composition Proposed

Pack size

Demanded

Price

1 Amprexa-F Capsules 6/25mg


Olanzapine …………..…6mg

Fluoxetine HCl ……….25mg

As per

SRO

As per SRO

Later on scrutiny of registration data reveals that the above formulation is already registered for

M/s Martin Dow Pharma, Karachi under the brand name “ Lenzif 6/25mg Capsule” Reg.

No.073778.

Decision: Registration Board approved Amprexa-F Capsules 6/25mg for regsitration.

j) M/s Nabiqasim Industries, Karachi


meeting deferred for confirmation of Me-Too status the

registration of following drug of M/s Nabiqasim Industries, Karachi

S.

No

Name of drug(s) & Composition Proposed

Pack size

Demanded

Price

1 Co-Dep 6/25 Capsule 10’s As per PRC

137


Olanzapine ……………6 mg

Fluoxetine HCl………..25 mg

(Anti psychotropic)

14’s

20’s

30’s

2 Co-Dep 3/25 Capsule


Olanzapine ……………3 mg

Fluoxetine HCl………..25 mg

(Anti psychotropic)

10’s

14’s

20’s

30’s

As per PRC

Later on scrutiny of registration data reveals that the above formulation is already registered for

M/s Martin Dow Pharma, Karachi under the brand name “ Lenzif 6/25mg Capsule” Reg.

No.073778 & Lanzif 3/25mg Capsule, Reg. No.073777

Decision: Registration Board approved above products for regsitration.

Case No.3 BULK IMPORT AND LOCAL REPACKING – M/S

GLAXOSMITHKLINE PAKISTAN LTD, KARACHI

M/s GlaxoSmithKline Pakistan Ltd, Karachi has requested for grant of permission for

bulk import from parent UK source and local repacking in limited quantity i.e 04 million tablets

in divided shipments of Zinacef 250mg, Reg. No.011340 containing Cefuroxime to avoid any

shortages in local market due to extension and renovation of their Cephalosporin facility at

Korangi Factory (DML No.000248).

Firm has also deposited fee Rs.100,000/- for the purpose.

Decision:

Registration Board deferred firm’s request and advised to provide following

documents for decision:

a. Renovation plan with time lines duly approved by manitenace department of the

firm and confirmation by licensing section, DRAP.

b. Manufacturing status of other products in same section.

138

c. Legalized COPP for proposed manufacturer.

d. Form 5.

Case No.4 Change of Formulation

a) M/s Noa Hemis Pharmaceuticals, Karachi

M/s Noa Hemis Pharmaceuticals, Karachi has requested for change of formulation of

following registered drug. Existing and proposed formulations are as under.

S.

No

Reg.

No.

Previous formulation Proposed formulation

01 032179 Mucof Syrup


Ephedrine HCl …………...100mg

Chlorpheniramine Maleate.100mg

Terpinhydrate…………….200mg

Pot. Bicarbonate …………...2mg

Ammonium Chloride…….500mg

Tr. Senega ………………..1.0ml

Menthol …………………..20mg

Bromhexine HCl ………….20mg

Pot. Guaicol Sulph ……….100mg

Pot. Citras ………………..…2mg

Tr. Ipecac …………………0.5ml

Ext. Glycyrrhiza Liq. ……….2ml

Mucof Syrup

Each 5ml contains:-

Chlorpheniramine Maleate…5mg

Terpinhydrate…………….10mg

Pot. Bicarbonate ………...0.1mg

Ammonium Chloride…….25mg

Menthol …………………..1mg

Aminophylline Ph Eur …….32mg

Pot. Guaicol Sulph ……….5mg

Pot. Citrate ………………..0.1mg

Flavour & Base ……………q.s

Firm has submitted that proposed formulation is already registered in fvaour of M/s CCL

Pharmaceuticals, Lahore i.e Pulmonol Syrup, Reg. No.000874. Firm has also furnished new

form-5 along with requisite fee Rs.20,000/- for the purpose.

139

Decsion: Registration Board deferred firm’s request for PSI by Director DTL,

Karachi and DDG (E&M), Karachi.

Case No.5 Registration for export purpose containing controlled drugs

M/s Amarant Pharmaceuticals, Karachi and M/s Pharmatec Pakistan, Karachi has

requested for registration of following drugs for export purpose only:-

S. No. Name of

Manufacturer(s)

Name of drug(s) & Composition

1 M/s Amarant

Pharma, Karachi

Amalor-D Tablet


Loratadine ……………..5mg

Pseudoephedrine HCl ….60mg

2 M/s Pharmatec

Pakistan, Karachi

Flu-Gone Day and Night Capsule (Combi Pack)

Each combi pack contains:-

Each day-time capsule contains:- (Strip-1)

Paracetamol ……………….400mg

Psedoephedrine HCl …….. 30mg

Caffeine Anhydrous ………30mg

Each night-time capsule contains:- (Strip-2)

Paracetamol ……………….400mg

Psedoephedrine HCl …….. 30mg

Cetirizine (as Dihydrochloride)..10mg

Dextramethorphan HBr ……..10mg

140


Registration Board may take decision according to its rules. Thus Board approved firm’s

request. Matter regarding allocation of quota will be dealt by Committee on allocation of

controlled Drug accordingly.

Case No. 6 De-Registration of registered drugs.

Following manufacturers have requested for de-registration of their registered drugs.

Details are as under:-

S.

No.

Name of

applicant(s)

Reg. No. Name of drug(s) Reason /

Justification

1. M/s Bosch Pharma,

Karachi

050507 Telocin 400mg Tablet


contains:

Telithromycin……400mg

Not interested

in

manufacturing

and marketing

2. -do- 030606 Arbel 50 tablets


Losartan Potassium

…50mg

-do-

3. M/s Tabros

Pharma, Karachi

004088 Paracetamol Compound

Tablets

(Paracetamol + Aspirin)

Not mentioned

4. -do- 004175 Sulphadiazine Tablets

(Sulphadiazine)

-do-

5 -do- 004173 Sulphadimidine Tablets

(Sulphadiamidine)

-do-

Decsion: Registration Board de-registered above products. However, the Board

advised firm to provide undertaking for not pending any case at any forum.

141

Case No.7 Request for withdrawal of registration application – M/s AsianContinental

(Pvt.) Ltd, Karachi

M/s AsianContinental (Pvt.) Ltd, Karachi has requested for withdrawal of their

registration application i.e Extrac Plus Tablets, containing Clopidogrel …75mg +

Aspirin…..75mg submitted on August, 2010.

Decsion: Registration Board approved firm’s request for withdrawl of above

regsitartion application (Extrac Plus Tablets).

Case No.8 Correction in minutes

a) M/s High-Q, Karachi

Following product of M/s High-Q, Karachi was considered in the 236th

meeting of the

Registration Board.

Pirokeu 20mg tablet


Piroxicam Betacyclodextrin eq. to Piroxicam ….. 20mg

(NSAID)

The aforementioned registration application was referred to the committee comprising

Prof. Dr. Rafi-uz-Zaman Saeed-ul-Haq, Member Registration Board, DDC (Reg-II), and DDG

Reg. However, in the minutes of the said subcommittee meeting, the above mentioned product

was erroneously approved as “Piroxicam 20 mg tablet” instead of “Piroxicam Betacyclodextrin

20mg tablet” and the registration letter has not been issued. The firm has now requested that the

registration may be granted with the correct formulation.

Decsion: Request of firm for correction as Piroxicam Betacyclodextrin 20mg

tablet approved by the Board.

b) M/s Getz Pharma, Karachi


meeting had considered registration application file in

Month of May & June, 2010. However, the following registration application of M/s Getz

Pharma, Karachi was erroneously not included in Agenda of 238th

meeting. Details of the case

are as under:-

142

S. No.

Name of drug(s) &

Composition

Proposed

Pack size

Demanded

Price

Date of

application,

Diary No. &

Form

Remarks

1. Trizid MR Tablets 35mg


contains:-

Trimetazidine

Dihydrochloride……35mg

(Anti-anginal)

20’s

30’s

Rs.300.00

Rs.450.00

19/05/2010

Dy. No. 1013

Form 5

Rs. 8000/-

Rs.12,000

20-2--2013

Comparative

dissolution

profile with

originator

brand and

related

documents

Decsion: Registration Board deferred firm’s request for submission of comparative

dissolution profile with brand leader.

Case No.9 Transfer of registration from import to local toll manufacturing

M/s High-Q International, Karachi has informed that following drugs are registered for

import in finished form. Now they have intend to transfer the registration from import to local

manufacturing under contract manufacturing arrangements as mentioned against each. Details

are as under:-

S.

No.

Reg.

No.

Name of Drug(s)

Existing Import

Manufacturer(s)

Proposed Contract

Manufacturer (s)

1 045616 Ruling Injection 40mg


Omeprazole

(as Sodium) ….40mg

M/s Hainan

Lingkang

Pharmaceutical Co.,

Ltd., China

(Bulk Import and

Local repacking)

M/s Nabiqasim

Industries, Karachi

2 018501 Remethan Injection

75mg

Each 3ml contains:-

Diclofenac

Sodium………….75mg

M/s Shin Poong

Pharmaceutical Co

Ltd, Seoul Korea

M/s Surge Labs,

Sheikhupura

3 019467 Cycin 100mg / 50ml

Injection I.V/ I.M


Ciprofloxacin ..100mg

M/s Shin Poong

Pharmaceutical Co

Ltd, Seoul Korea

M/s Surge Labs,

Sheikhupura

4 019468 Cycin 200mg/100ml M/s Shin Poong M/s Surge Labs,

143

Injection I.V/ I.M


Ciprofloxacin ..200mg

Pharmaceutical Co

Ltd, Seoul Korea

Sheikhupura

5 022645 Hizone Injection

250mg IM


Ceftriaxone as

Sodium………250mg

M/s Shin Poong

Pharmaceutical Co

Ltd, Seoul Korea

(Bulk import and

local repacking)

M/s Surge Labs,

Sheikhupura

6 018300 Hizone Injection 1gm

IV


Ceftriaxone as

Sodium………1gm

M/s Shin Poong

Pharmaceutical Co

Ltd, Seoul Korea

(Bulk import and

local repacking)

M/s Surge Labs,

Sheikhupura

7 014947 Cefapezone Injection

1gm


Cefoperazone

Sodium………..1gm

M/s Shin Poong

Pharmaceutical Co

Ltd, Seoul Korea

(Bulk import and

local repacking)

M/s Surge Labs,

Sheikhupura

8 015589 Fugacin Tablets


contains:-

Ofloxacin ……..200mg

M/s Shin Poong

Pharmaceutical Co

Ltd, Seoul Korea

M/s High-Q

Pharmaceuticals,

Karachi

9 019522 Cycin 500mg Tablets


Ciprofloxacin

HCl………… 500mg

M/s IL Dong

Pharmaceutical Co.

Ltd, Korea

M/s High-Q

Pharmaceuticals,

Karachi

10 019523 Cycin 250mg Tablets


Ciprofloxacin

HCl………… 250mg

M/s IL Dong

Pharmaceutical Co.

Ltd, Korea

M/s High-Q

Pharmaceuticals,

Karachi

Firm has furnished following information to support their request.

Registration dossier on Form -5.

Original consent of M/s Nabiqasim Industries (Pvt.) Ltd, Karachi (page12/Corr) and M/s

Surge Laboratories, Sheikhupura & M/s High-Q Pharmaceuticals, Karachi

144

Contract manufacturing agreement with M/s Nabiqasim Industries (Pvt.) Ltd, Karachi

and M/s Surge Laboratories, Sheikhupura (page 26/Corr) & M/s High-Q

Pharmaceuticals, Karachi

Copy of Registration letters & Renewal

Fee of Rs.50,000/- for each product for the purpose.

Decision: Registration Board deferred firm’s request till next meeting for detailed

delibrations in light of contract manufacturing policy.

Case No.10 Extension in contract manufacturing permission.


meeting had considered case for extension in contract

manufacturing permissions. However, the following case of M/s Sami Pharmaceuticals, Karachi

was erroneously not included in Agenda of 238th

meeting. Details of the case are as under:-

S.

No.

Applicant Contract

manufactur

er

Reg. No. Name of drug(s) &

Composition

Date of

applicatio

n, Diary

No. &

Form

Category

1. M/s Sami

Pharma,

Karachi

M/s

Healthek

Pvt. Karachi

037541 Oroxim 100mg Film

Coated Tablets

Each film coated

tablet contains:

Cefpodoxime proxetil

eq. to

cefpodoxime..100 mg

15-04-

2013

Dy.No.13

5

Form-05

Rs.50,000/

-

Dedicated

facility

Cephalosp

orin

Decsion: Registration Board extended above product till 30.06.2015.

145

Case No.11: Fast track registration scrutinized by evaluators.

S.N

o

Name of manufacturer

Name of drug with

composition

Pack size

Demanded price

Date Remarks

1. M/s. Ferozsons Labs, Nowshera

Valiant-M Tablets’


contains:-

Vildagliptin………….50

mg

Metformin HCl…..850

mg

(Ant-diabetic)

10’s 30’s

As Per SRO

24-4-

2013 Recommended

2. -do- Valiant-M Tablets’


contains:-

Vildagliptin……………

…….50 mg

Metformin

HCl………...1000 mg

(Ant-diabetic)

10’s 30’s

As Per SRO

-do- Recommended

3. M/s. Winbrain Research

Laboratories, Hattar

Toll manufactured

by M/s. Weather Fold

Pharmaceutical, Hattar

Cefwell 250mg Injection

IM


Ceftriaxone Sodium

≡ Ceftriaxone………..250

mg

(Anti-infective)

Per Vial

As Per SRO

22-5-

2013 The products are

recommended if manufacturer is

already producing

the same drugs as

it is an

application of toll

manufacturing

and not

manufacturing by

M/s. Winbrain.

Note:- Weather

Fold is already

having approved

section for

production of

Cephalosporin

Injection and

registered

product as well.

4. -do- Cefwell 500mg Injection

IM


Ceftriaxone Sodium

Per Vial

As Per SRO

-do- -do-

146

≡ Ceftriaxone………..500

mg

(Anti-infective)

5. -do- Cefwell 1gm Injection

IM


Ceftriaxone Sodium

≡ Ceftriaxone………..1gm

(Anti-infective)

Per Vial

As Per SRO

-do- -do-

6. M/s. Shazeb

Pharmaceutical

s, Distt

Haripur

Zeesol-5% I.V Infusion


Dextrose Anhyrous……..5

gm

(Caloric solution)

100ml As Per

SRO

13-5-2013 No Batch Size

description

Batch cycle

Sterilization

Cycle

Source of Raw

Materials

Testing of Raw

Materials

Price Paper /

Comparison of

Dextrose 5%

Not

recommended.

Shortcoming

rectified 7. -do- Zeesol-NS O.V Solution


Sodium

chloride……….0.9 gm

(Electrolyte)

100ml As Per

SRO

-do- No Batch Size

description

Batch cycle

Sterilization

Cycle

Source of Raw

Materials

Testing of Raw

Materials

Price Paper /

Comparison of

Dextrose 5%

Not

recommended.

Shortcoming

rectified 8. -do- Zee Hesta 3%


500ml As Per

SRO

-do- Check

Hydroxyethyl

147

Hydroxyethyl

Starch………30 gm

Sodium

Chloride…….……9 gm

(Plasma Substitute)

Standards

Not

recommended.

Shortcoming

rectified 9. -do- Zee Haemagel I.V

Infusion


Degraded gelatin

Polygeline) of average

molecular weight…….35

g

Sodium

Chloride….….…..8.50 g

Potassium

Chloride….……0.7 g

Calcium

chloride…….....0.38 g

(Plasma Substitute)

500ml As Per

SRO

-do- Not

recommended.

The firm has

informed that they

can’t rectify

immediately

therefore thye

requested to

postpone till next

DRB meeting.

10. M/s. Bloom Pharmaceuticals

, Hattar

Darcin-250mg Capsules


Azithromycin dihydrate)

≡ Azithromycin……..….250

mg

(Macrolide)

1x6’s As Per

SR

16-5-

2013 Method of

Manufacturing

Detail required for

>45% humidity

and >30 C

temperature.

Method of

Analysis

Method (Limits) are

for Doxycycline

Hyclate.

Method 2

Is

spectrophotometer

method but in detail

is given

Chromatograph

Specification.

Clinical

Indication Vogue.

03 years shelf

life

Stability Studies

not given

Type of Mixer

(Bottle Mixer)

148

not clear.

Not

recommended.

Shortcoming

rectified

11. M/s. Genome Pharmaceutical

s, Hattar

Ibufam Tablets


contains:-

Ibuprofen………..800

mg

Famotidine……..26.6 mg

(NSAID/H2-receptor)

10’s As Per SRO

2-5-

2013 Dual core tablet

machine

unavailable. To

be deferred.

Outline of

method of

manufacture

does not

contains the

coating process.

However, in

detailed

procedure it has

been given in

general.

IPA is

inflammable

substance.

Safety measures

for tray drawing

of materials

containing IPA

has not been

provided.

Specification of

sodium starch

glycolaed have

been provided in

dossier but the

material is not

reflecting in the

composition of

drug.

Recommended

with above

corrections.

149

12. M/s. Onyx Pharmaceutical

s, Mansehra

Sulpride 50mg Tablets


Levosulpiride………..50

mg

(Antidpressant/Anti-

gastroprokinetics)

1`0’s As Per SRO

20-5-

2013 Minor

shortcoming

rectified.

Decsion: Registration Board decided as follows:

Products at S.No. 1, 2, 6, 7, 10 and 12 approved for registration, as firms have

rectified shortcomings in registration dossiers.

Products at S.No. 3, 4 and 5 deferred for discussion in forthcoming meeting in light

of contract manufacturing policy.

Products at S.No. 8 and 9 deferred for PSI by Director DTL, Peshawar and area

FID. For product at S.No.9, firm will rectify shortcomings as mentioned above.

Products at S.No.11 for correction of shortcomings.

150

Case No.12: CCL Pharmaceuticals (Pvt.) Ltd., Lahore.

Following product of M/s. CCL Pharmaceuticals (Pvt.) Ltd., Lahore was deferred in 236th

meeting as under:-


composition Pack Size

Proposed Price

Decision

Epipro CR Tablets


Divalproex Sodium USP……..500mg

(Anti-Epileptics)

5x10’s As per SRO Deferred for submission of comparative

dissolution profile with originator and relative documents.

The firm has submitted comparative dissolution profile of their product EPIPRO CR Tablet with

originator reference product Tablet EPIVAL CR of M/s Abbott Laboratories Pakistan Ltd.

Decision: The Drug Registration Board deferred the case till expert evaluation of

comparative dissolution profile documents by Director DTL Peshawar.

Case No.13: CCL Pharmaceuticals (Pvt.) Ltd., Lahore.

Following product of M/s. CCL Pharmaceuticals (Pvt.) Ltd., Lahore was deferred in 236th

meeting for confirmation of formulation in developed countries.

Name of the drugs with composition

Pack Size

Proposed Price

Decision

CIP Suspension 10%

Each 5ml contains:-

Ciprofloxacin HCl USP……..500mg

(Anti-Biotic)

60ml

100ml

As per SRO Deferred for confirmation of formulation in

developed countries.

The firm has submitted that the drug is approved by US-FDA with the name of CIPRO for M/s

Bayer Pharmaceuticals Corporation, USA and provided copies of references (approvals / study).

The firm also submitted that the same formulation has been approved in 227th

meeting of DRB

held on 26-27 Aug 2010 for M/s Wilshire Lab. Lahore and Drug Pricing Committee fixed its

price in its 14th


January 2011. It is submitted that ciprofloxacin

microcapsules in base form is used in FDA approved Bayer’s Cipro formulation. Price has also

151

been approved for base form as Microencapsulated Ciprofloxacin eq.to Ciprofloxacin ….500mg,

while in this formulation Ciprofloxacin HCl has been applied.

Decision: The Drug Registration Board deferred the case for confirmation of USFDA

approval of formulation and confirmation of formulation with originator.

Case No.14: Grant of registration-New formulation & fast track.

Following firms have applied following products on Form 5-D as new applications and fast track

fee. Decision is recorded in last column.

S.N

o

Name of

Firm


composition

Pack

Size

Proposed

Price

Date of

Submission

Decision

1. M/s Saffron

Pharmaceut

icals (Pvt)

Ltd,

Faisalabad.

Provate GM Topical Ointment

Each gram contains:-

Betamethasone…0.05% w/w

Gentamicin….0.1% w/w

Miconazole….2% w/w

(cortisteriod/antibiotic/antifungal)

20gm

10gm

Rs.300.00

Rs.150.00

10-7-2013

Rs.60,000/-

05-09-2013

Rs. 90,000/-

Form 5-D

Deferred for

confirmation

of availability

of

formulation

in FDA,

EMA,

Australia and

Japan.

2. -do- Provate GM Topical Cream


Betamethasone…0.05% w/w

Gentamicin….0.1% w/w

Miconazole….2% w/w

(cortisteriod/antibiotic/antifungal)

20gm

10gm

Rs.300.00

Rs.150.00

10-7-2013

Rs.60,000/-

05-09-2013

Rs. 90,000/-

Form 5-D

Deferred for

confirmation

of availability

of

formulation

in FDA,

EMA,

Australia and

Japan.

3. M/s

Highnoon

Lab. Ltd.

Lahore

Tagipmet XR 100/1000Tablet

Each bilayered tablet contains:-

Sitagliptin (as

phosphate)…100mg

Metformin HCl (as sustained

release)…1000mg

(Anti-diabetic)

N.A N.A 10-04-13

Rs. 150,000/-

Form-5D

Deferred for

confirmation

of availability

of

formulation

in FDA,

EMA,

Australia and

Japan.

152

4. -do- Tagipmet XR 50/500Tablet


Sitagliptin (as phosphate)…50mg


release)…500mg

(Anti-diabetic)

N.A N.A 10-04-13

Rs. 150,000/-

Form-5D

Deferred for

confirmation

of availability

of

formulation

in FDA,

EMA,

Australia and

Japan.

5. -do- Tagipmet XR 50/1000Tablet


Sitagliptin (as phosphate)…50mg


release)…1000mg

(Anti-diabetic)

10-04-13

Rs. 150,000/-

Form-5D

Deferred for

confirmation

of availability

of

formulation

in FDA,

EMA,

Australia and

Japan.

6. -do- Axesom 10 Sachet

Each Sachet contains:-

Esomeprazole (as Magnesium

trihydrate) …10mg as Gastro-

resistant granules

22-04-13

Rs. 150,000/-

Form-5D

Deferred for

confirmation

of availability

of

formulation

in FDA,

EMA,

Australia and

Japan.

7. -do- 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

Deferred for

confirmation

of availability

of

formulation

in FDA,

EMA,

Australia and

Japan.

8. M/s Servier

Research

and

Pharmaceut

icals (pvt).

Ltd.

Lahore.

Daflon 1g Tablet


Diosmin… 900mg

Hesperidine …100mg

(Vascular protector and

Venotonic)

20’s Rs.

32.50/table

t

30-04-13

Fee Rs.

150,000/-

Form-5D

Deferred for

confirmation

of availability

of

formulation

in FDA,

EMA,

Australia and

153

Japan.

9. -do- Natrilam 10mg Tablets


Indapamide SR…..1.5mg

Amlodapine Besilate…..10mg

(Antihypertensive diuretic +

Calcium antagonist)

30’s Rs.72.52/T

ablet

20-6-2012

Rs.8000/-

30-04-13

Rs. 130,000/-

Total Fee Rs.

150,000/-

Form 5-D

Deferred for

confirmation

of availability

of

formulation

in FDA,

EMA,

Australia and

Japan.

10. -do- Natrilam 5 mg Tablets



Amlodapine Besilate…..5mg


Calcium antagonist)

30’s Rs.36.26/t

ablet

05-04-2011

Rs.8000/-

30-04-13

Rs. 130,000/-

Total Fee Rs.

150,000/-

Form 5-D

Deferred for

confirmation

of availability

of

formulation

in FDA,

EMA,

Australia and

Japan.

11. -do- Natrilam 2.5 mg Tablets



Amlodapine Besilate…..2.5mg


Calcium antagonist)

30’s Rs.26.26/t

ablet

05-04-2011

Rs.8000/-

30-04-13

Rs. 130,000/-

Total Fee Rs.

150,000/-

Form 5-D

Deferred for

confirmation

of availability

of

formulation

in FDA,

EMA,

Australia and

Japan.

12. M/s. CCL

Pharmaceut

icals,

Lahore

OAB Tablets 4mg


Fesoterodine Fumarate …. 4mg

(Muscarinic receptor antagonist)

28’s As per

brand

leader

03.02.2011

Fee 15000

20.05.2013

Fee.135,000

Form 5-D

Deferred for

confirmation

of availability

of

formulation

in FDA,

EMA,

Australia and

Japan.

154

13. -do- OAB Tablets 8mg

Each ER tablet contains:

Fesoterodine Fumarate …… 8mg

(Muscarinic receptor antagonist)

28’s As per

brand

leader

03.02.2011

Fee 15000

20.05.2013

Fee.135000

Form 5-D

Deferred for

confirmation

of availability

of

formulation

in FDA,

EMA,

Australia and

Japan.

14. -do- Virata Tablets 90mg


Ticagrelor ………. 90mg

(Platelet inhibitor)

20’s As per

brand

leader

12.01.2012

Fee 15000

20.05.2013

Fee.135000

Form 5-D

Deferred for

confirmation

of availability

of

formulation

in FDA,

EMA,

Australia and

Japan.

15. -do- Lina-Met 2.5/500 Tablet


Linagliptin....................2.5mg

Metformin HCI………500mg

14’s As per

brand

leader

08.04.2013

Fee 50000

Fee.100000

20.05.2013

Form-5D

Deferred for

confirmation

of availability

of

formulation

in FDA,

EMA,

Australia and

Japan.



Linagliptin…....................2.5mg

Metformin HCI…………850mg

14’s As per

brand

leader

08.04.2013

Fee 50000

Fee.100000

20.05.2013

Form-5D

Deferred for

confirmation

of availability

of

formulation

in FDA,

EMA,

Australia and

Japan.



Linagliptin ......................2.5mg

Metformin HCI……….1000mg

14’s As per

brand

leader

08.04.2013

Fee 50000

Fee.100000

20.05.2013

Form-5D

Deferred for

confirmation

of availability

of

formulation

in FDA,

EMA,

Australia and

Japan.

155

18. M/s Neutro

, Lahore

Nupreced Injection

Each 2ml contains:-

Dexmedetomidine

Hydrochloride…200mcg

(Sedative)

2ml Rs. 5500/-

per

ampoule

17-05-13

Fee Rs.

60,000/-+ Rs.

90,000(28-

05-13)

Form5-D

Deferred for

confirmation

of availability

of

formulation

in FDA,

EMA,

Australia and

Japan.

156

Case No.15. Extension in Contract Manufacturing Permissions:

Following cases were considered and decided by the Registration Board in 238th

meeting but erroneously missed in minutes. The

decision of Board is recroded in last column.

157

S.# Name of

Applicant

Name of

Manufacturer

Reg.

No.

Name of Drug with

composition

Date & diary #

& Fee

Category Decision

1. M/s Noble

Pharmaceutical,

Islamabad

M/s EG

Pharmaceutical

Islamabad earlier

approved

manufacturer

was Biorex

Pharmaceutical

Islamabad

023134 Cefodime Injection

Each vial contain:

Ceftazidime……..1gm

15-04-13

Dy.

No.2248R&I

Dy. No. 1356.

DDC(R-III)

Rs.50000/

Rs.8000/-(23-

06-2010)

import to local

contract

manufacturing

Extended till

30.06.2015

2. -do-

-do- 023135 Cefodime Injection

Each vial contain:

Ceftazidime…..250gm

-do- -do-

-do-

3. M/s Focus &

Rulz

Pharmaceutical,

Islamabad

M/s Bio Labs.

(Pvt) Ltd,

Islamabad earlier

approved

manufacturer

was M/s Spadix

Pharmaceutical,

Islamabad

054652 Ruzone Injection 250mg

Each Vial Contains:-

Ceftriaxone Sodium

equivalent to

Ceftriaxon…250mg

(USP Specification)

15-04-13

Dy.

No.1251R&I

Rs.20,000/

Dedicated

facility

Cephalosporin

Extended till

30.06.2015. The

firm will deposit

remaining fee &

select IM/IV

4. -do- -do- 054653

`

Ruzone Injection 500mg


Ceftriaxone Sodium

equivalent to

Ceftriaxone…500mg

(USP Specification)

-do- -do-

-do-

5. -DO- -do- 054654 Ruzone Injection 500mg


Ceftriaxone Sodium

equivalent to

-do -do-

-do-

158

Ceftriaxone…500mg

(USP Specification)

6. -do- -do- 054655 Trag Injection 250mg

Each Vial contains:-

Cefotaxime sodium

equivalent to

Ceftotaxime…250mg

-do- -do-

Extended till

30.06.2015. The

firm will deposit

remaining fee



Cefotaxime sodium

equivalent to

Ceftotaxime…500mg

-do- -do-

-do-



Cefotaxime sodium

equivalent to

Ceftotaxime…500mg

-do- -do-

-do-

9. M/s Medley

Pharmaceutical,

Plot 41-A, P.S.I.

E. Jhang Bahtar

Road Wah Cantt.

Rawalpindi

M/s Fassgen

Pharmaceutical

Hatter. Earlier

approved

contract

manufacturer

was M/s Neutro

Pharma Hattar

030245 Qsef Injection 250mg

Each vial contain:-

Cefotaxime Sodium eq.

to Cefotxime

…….250mg

15-04-13

Dy. No.2319

R&I

Dy. No.

1358D.D.C(R-

III)

Rs.50000/-

Dedicated

facility

Cephalosporin

Extended till

30.06.2015

10. -do- -do- 030246 Qsef Injection 500mg

Each vial contain:-


to Cefotxime

…….500mg

-do- -do-

-do-

11. -do- -do- 030247 Qsef Injection 1gm -do -do- -do-

159

Each vial contain:-


to Cefotxime

…….1gmmg

12. -do- -do- 030243 Kintrex 500mg Injection

I.V


Ceftriaxone Sodium eq.

to. Cefriaxone….500mg

-do- -do-

Extended till

30.06.2015. the firm

will select either

IM/IV

13. -do- -do- 030244 Kintrex 1gm Injection

I.V



to. Cefriaxone….1gm

-do- -do-

-do-

14. -do- -do- 030241 Kintrex 500mg Injection

I.M



to. Cefriaxone….500mg

-do- -do-

-do-

15. M/s Goodman

Laboratories,

Islamabad

M/s Spadix

Pharmaceutical

Islamabad.

Earlier approved

contract

manufacturer

was M/s Global

Pharmaceutical

Islamabad

056677 Martazone 250mg IM

Injection


Ceftriaxone Sodium

equivalent to

Ceftriaxone…250mg

(USP Specification)

11-02-13

Dy. No.1497

R&I

Dy. No.

41D.D.C(R-

III)

Rs.20000/-

Extended till

30.06.2015

& Rs.8000/-

(29-09-2010)

Dedicated

facility

Cephalosporin

Extended till

30.06.2015. the firm

will deposit

remaining fee &

slect IM/IV

16. 056678 Martazone 500mg IV

Injection

-do- -do-

-do-

160


Ceftriaxone Sodium

equivalent to

Ceftriaxone…500mg

(USP Specification)

17. 056679 Martazone 1gm IV

Injection


Ceftriaxone Sodium

equivalent to

Ceftriaxone…1gm

(USP Specification)

-do- -do-

-do-

18. M/s Fassgen

Pharmaceutical,

Hattar

M/s Medley

Pharmaceutical,

Wah Cantt.

Earlier approved

contract

manufacturer

was M/s

WelMark

Pharmaceuticals

Hattar

056452 Stigen 0.5mg Injection

Each ml contains:-

Neostigmine

Methylsuphate….0.5mg

(USP specification)

Fee not

deposited

Dy. No. 1378

Dated:09-05-

2013

General

products

Deferred since the

request of firm does

not fall under

present contract

policy & applicant

has to deposit fee.

19. -do- -do- 056453 Traxic 250mg Injection

Each 5ml contains:-

Tranexamic

Acid…..250mg

(B.P Specification)

-do- -do-

-do-

20. -do- -do- 056454 Traxic 500mg Injection

Each 5ml contains:-

Tranexamic

Acid…..500mg

(B.P Specification)

-do- -do-

-do-

21. -do- -do- 056456 Dyronex 500 Infusion -do- -do- -do-

161


Metronidazole USP

(USP Specification)

22. -do- -do- 056457 Cebect Infusion 200mg


Ciprofloxacin Lactate

eq. to Ciprofloxcin

USP…..200mg

(USP Specification)

-do- -do-

-do-

23. -do- -do- 056458 Vectra 75mg Injection

Each 3ml contains:-

Diclofenac Sodium

…….75mg

(Medley Specification)

-do- -do-

-do-

24. -do- -do- 056459 Pepgen 20mg Injection

Each 2ml contains:-

Famotidine………20mg


-do- -do-

-do-

25. -do- -do- 056461 Suxagen 100mg

Injection

Each 2ml contains:-

Suxamethonium

Chloride BP…..100mg


-do- -do-

-do-

26. -do- -do- 056462 Artegen 80mg Injection

Each 1ml coantains:-

Arthemether………..80

mg


-do- -do-

-do-

27. -do- -do- 056463 Vibra 40mg Injecgion

Each 1ml contain:-

Triamcinolone

acetonide

-do- -do-

-do-

162

BP………40mg

(B.P Specification)

28. -do- -do- 056464 Mecobon 500mg

Injection

Each 1ml Contain:-

Mecobalamine

………500mcg


-do- -do-

-do-

29. -do- -do- 056466 Fasdic Injection

Each 2ml ampoule

contains:-

Diclofenac sodium

75mg

Lidocain HCl…..20mg

(Medley Specification

-do- -do-

-do-

30. -do- -do- 056825 Levotar Infusion 500mg

Each vial contain:-

Levofloxacin (as

hemihydrates)…..500m

g

(Medley specification)

-do- -do-

-do-

31. -do- -do- 056826 Fasicam 20mg Injection

Each 1ml apoule

contains:

Piroxicam USP….20mg


-do- -do-

-do-

32. M/s Danas

Pharmaceutical,

Islamabad

M/s Global

Pharmaceutical,

Islamabad.

Earlier approved

contract

manufacturer

was M/s Florence

045077 Burgundy Igm Injection

Each Vial contain:

Ceftriaxone

(as Sodium)…...1gm

(USP Specification)

15-04-13

Dy. No.2218

R&I

Dy. No.

115D.D.C

(R-III)

Rs.42000/-

Dedicated

facility

Cephalosporin

Extended till

30.06.2015. The

firm will select

IM/IV

163

Islamabad

Rs.8000/-(30-

09-2010)

33. -do- -do 045078 Burgundy 250mg

Injection

Each Vial contain:

Ceftriaxone (as Sodium)

……..250mg

(USP Specification)

-do- -do-

-do-

34. -do- -do- 045079 Burgundy 500mg

Injection

Each Vial contain:

Ceftriaxone (as Sodium)

……..500mg

(USP Specification)

-do- -do-

-do-

35. -do- -do- 045080 Milkish 1gm Injection

Each Vial contain:

Cefepime (as HCl with

L-Arginine)

……..1gm

(USP Specification)

-do- -do-

Extended till

30.06.2015

36. -do- -do- 045081 Milkish 500mg

Injection

Each Vial contain:

Cefepime ( as HCl with

L-Arginine)

……..500mg

(USP Specification)

-do- -do-

-do-

37. -do- -do- 045093 Joop 1gm Injection

Each Vial contains:

Cefoperazone (as

Sodium)……….0.5gm

Sulbactam (as

Sodium)………0.5gm

-do- -do-

-do-

164

(USP Specification)

38. -do- -do- 045094 Joop 2gm Injection

Each Vial contains:

Cefoperazone (as

Sodium)…….1gm

Sulbactam (as

Sodium)……1gm

(USP Specification)

-do- -do-

-do-

39. M/s Benson

Pharmaceuticals

M/s Shawan

Pharmaceuticals,

Islamabad.

Earlier approved

contract

manufacturer

was

M/s Fassgen

Pharmaceuticals,

Lahore

060423 Triben 1gm Injection

I/V



to Ceftriaxone …..1gm

(USP Specs.)

Dy. No. 2274

R&I 15-04-13

Dy. No.1168

DDC(R-III)

(22-2-2013)

Rs.20,000/-

(22-4-2013)&

Rs. 30,000

(15-4-2013)

Dedicated

facility

Cephalosporin

Extended till

30.06.2015. The

firm will select

either IM/ IV

40. 060424 Triben 500mg Injection

I/V



to

Ceftriaxone………..500

mg

(USP Specs.)

Dy. No. 2275

R&I 15-04-13

Dy. No.1176

DDC(R-III)

(22-2-2013)

Rs.20,000/-

(22-4-2013)&

Rs. 30,000

(15-4-2013)

-do-

-do-

41. 060425 Triben 250mg Injection

I/V



to Ceftriaxone...250mg

Dy. No. 2283

R&I 15-04-13

Dy. No.1167

DDC(R-III)

(22-2-2013)

-do-

-do-

165

(USP Specs.) Rs.20,000/-

(22-4-2013)&

Rs. 30,000

(15-4-2013)

45. 060426

Benzone 1gm Injection


Cefoperazone (as


Sulbactam (as

Sodium)…………500m

g

(USP Specs.)

Dy. No. 559

R&I 22-02-13

Dy. No.1169

DDC(R-III)

(22-2-2013)

Rs.20,000/-

(22-4-2013)&

Rs. 30,000

(15-4-2013)

-do-

Extended till

30.06.2015.

46. 060427 Benzone 2gm Injection


Cefoperazone (as

Sodium)……..1gm

Sulbactam (as

Sodium)…………1gm

(USP Specs.)

Dy. No. 2280

R&I 15-04-13

Dy. No.1170

DDC(R-III)

(22-2-2013)

Rs.20,000/-

(22-4-2013)&

Rs. 30,000

(15-4-2013)

-do-

-do-

47. 060428 Benpime 1gm Injection


Cefepime (as HCl)

…….1gm

(USP Specs.)

Dy. No. 2281

R&I 15-04-13

Dy. No.1171

DDC(R-III)

(22-2-2013)

Rs.20,000/-

(22-4-2013)&

Rs. 30,000

-do-

-do-

166

(15-4-2013)

48. 060429 Benpime 500mg

Injection


Cefepime (as HCl)

…….500mg

(USP Specs.)

Dy. No. 2276

R&I 15-04-13

Dy. No.1174

DDC(R-III)

(22-2-2013)

Rs.20,000/-

(22-4-2013)&

Rs. 30,000

(15-4-2013)

-do-

-do-

49 053607 Taxiben 250mg

Injection


Cefotaxime (as

Sodium)………250mg

(USP Specs.)

Dy. No. 2282

R&I 15-04-13

Dy. No.1173

DDC(R-III)

(22-2-2013)

Rs.20,000/-

(22-4-2013)&

Rs. 30,000

(15-4-2013)

-do-

-do-

50. 053608 Taxiben 500mg

Injection


Cefotaxime (as

Sodium)………500mg

(USP Specs.)

Dy. No. 2277

R&I 15-04-13

Dy. No.1172

DDC(R-III)

(22-2-2013)

Rs.20,000/-

(22-4-2013)&

Rs. 30,000

(15-4-2013)

-do-

-do-

51. 053609 Taxiben 1gm Injection Dy. No. 2278 -do- -do-

167


Cefotaxime (as

Sodium)………1gm

(USP Specs.)

R&I 15-04-13

Dy. No.1175

DDC(R-III)

(22-2-2013)

Rs.20,000/-

(22-4-2013)&

Rs. 30,000

(15-4-2013)

52. M/s Drugs Inn

Pharmaceutical

Islamabad

M/s EG

Pharmaceutical,

Islamabad.

Earlier approved

contract

manufacturer

was M/s Biorex

Pharmaceutical

Islamabad

022619 Prezone 250mg IM/IV

Injection



to 250mg Ceftriaxone

Sodium base.

12-04-13

Dr.

No.1060R&I

Dy. No.

1212D.D.C(R-

III)

Rs.42000/-

Rs.8000/-

(23-06-2010)

import to local

contract

manufacturing

Extended till

30.06.2015. The

firm will select

either IM/ IV

53. -do- -do- 023168 Prezone 500mg

Injection



to 500mg

Ceftriaxone Sodium

base.

-do- -do-

-do-

54. -do- -do- 022654 Prezone 1GM Injection



to 1gm Ceftriaxone

Sodium base.

-do- -do-

-do-

55. -do- -do- 022694 Kefcef 250mg Injection



-do- -do-

-do-

168


Sodium base.

56. -do- -do- 022695 Kefcef 500mg Injection




Sodium base.

-do- -do-

-do-

57. -do- -do- 022696 Kefcef 1gm Injection



to 1gm Ceftriaxone

Sodium base.

-do- -do-

-do-

58. -do- -do- 022653 Gencef 1gm Injection


Ceftotaxim Sodium eq.

to 1gm Cefotaxime

Sodium base.

-do- -do-

Extended till

30.06.2015.

59. M/s Well Care

Pharmaceutical,

A/7 P.S.I.E

Sargodha

M/s Fassgen

Pharmaceutical

Hatter.Earlier

approved

contract

manufacturer

was M/s Neutro

Pharmaceutical

Lahore.

060808 Carewel 250mg

Injection

Each injection contains:

Ceftriaxone sodium eq

to Ceftriaxone

U.S.P……50mg.

15-04-13

Dr. No.2314

R&I

Dy. No.

1363D.D.C(R-

III)

Rs.50,000/-

Dedicated

facility

Cephalosporin

Extended till

30.06.2015. The

firm will select

either IM/ IV

.

60. -do -do- 060809 Carewel 500mg

Injection



to Ceftriaxone U.S.P…

500mg

15-04-13

Dr. No.2314

R&I

Dy. No.

1356D.D.C(R-

III)

Rs.50,000/-

-do-

-do-

169

61. -do -do- 060810 Carewel 1gm Injection



to Ceftriaxone

U.S.P…….1gm

-do- -do-

-do-

62. M/s Salus

Pharmaceutical

Rawalpindi

M/s Warafana

Pharmaceutical

Islamabad

021057 Salxone 0.25gm

Injection

Each Vial Contains:

Ceftriaxone Sodium

Eq. to Ceftriaxone

….0.25gm

19-12-11

Dy. No.993

R&I

Dy. No.

1415D.D.C(R-

III)

Rs.50,000

import to local

contract

manufacturing

Extended till

30.06.2015. The

firm will select

either IM/ IV.

.

63. -do- 021058 Salxone 1gm Injection

Each Vial Contains:

Ceftriaxone Sodium

Eq. to Ceftriaxone

….1gm

19-12-11

Dy. No.993

R&I

Dy. No.

1416D.D.C(R-

III)

Rs.50000

-do- -do-

64. -do- 021059 Salxone 0.5gm Injection

Each Vial Contains:

Ceftriaxone Sodium

Eq. to Ceftriaxone

….0.5gm

19-12-11

Dy. No.993

R&I

Dy. No.

1417D.D.C(R-

III)

Rs.50000

-do- -do-

170

Case No.16. Correction in minutes of 238th

meeting.

a. Grant of registration-Vetrenary Drugs:

S. # Name of

Applicant


Size

Shelf

Life

Decision

recoded in

238th

meeting

Correct

Decision

1. M/s. Noble

Pharma, Mir Pur

Azad Kashmir.

Nobiaminox Injection

Each ml contains:-

Novaminsulfon……..40.00mg

Etilefrin……………...0.20mg

Calcium Gluconate……..100.00mg

Magnesium Gluconate…..10.00mg

Nicotinamide……..….0.03mg

Caffeine………….…10.00mg

Sodium Salicylate………...7.00mg

Boric Acid………….10.00mg

(Electrolytes)

Decontrolled

100ml

200ml

450ml

500ml

1000ml

02

years

Deferred for

application

on Form 5 D

along with

revised Fee.

Approved

However the

Registration

Board

advised the

registration

sections to

again review

the

Registration

Dossiers

before

issuance of

Registration

letters.

2. M/s. A & K

Pharmaceutical,

Sargodha Road,

Faisalabad.

Adeka Injection

Each 1ml contains:-

Vitamin A………..100000 IU

Vitamin D3………40000 IU

Vitamin E………..40mg

(Nutritional Supplement).

Decontrolled

50ml

100ml

02

years

-Do- -Do-

3. M/s. A & K

Pharmaceutical,

Sargodha Road,

Faisalabad.

Genin Injection

Each 1ml contains:-

Tylosin Tartrate………..100mg

Gentamycin Sulphate….50mg

(Antibiotic).

Decontrolled

10ml

20ml

50ml

100ml

02

years

-Do- -Do-

4. M/s. A & K

Pharmaceutical,

Sargodha Road,

Faisalabad.

Genak-10 Injection

Each 1ml contains:-

Gentamycin Sulphate…100mg

Decontrolled

10ml

20ml

50ml

100ml

02

years

-Do- -Do-

171

(Antibiotic).

5. M/s. A & K

Pharmaceutical,

Sargodha Road,

Faisalabad.

Ectin Injection

Each 1ml contains:-

Ivermectin…………10mg

(Anthelemtic).

Decontrolled

10ml

20ml

50ml

100ml

02

years

-Do- -Do-

6. M/s. A & K

Pharmaceutical,

Sargodha Road,

Faisalabad.

Fenak Injection

Each 1ml contains:-

Ketoprofen…………100mg

(NSAID).

Decontrolled

10ml

20ml

50ml

100ml

02

years

-Do- -Do-

7. M/s. A & K

Pharmaceutical,

Sargodha Road,

Faisalabad.

Folak Injection

Each 1ml contains:-

Florfenicol…………300mg

(Antibiotic).

Decontrolled

10ml

20ml

50ml

100ml

02

years

-Do- -Do-

8. M/s. A & K

Pharmaceutical,

Sargodha Road,

Faisalabad.

Tine-20 Injection

Each 1ml contains:-

Tylosin Tartrate……..200mg

(Antibiotic).

Decontrolled

10ml

20ml

50ml

100ml

02

years

-Do- -Do-

9. M/s. A & K

Pharmaceutical,

Sargodha Road,

Faisalabad.

Rofox-10 Injection

Each 1ml contains:-

Enrofloxacin……….100mg

(Antibiotic).

Decontrolled

10ml

20ml

50ml

100ml

02

years

-Do- -Do-

10. M/s. A & K

Pharmaceutical,

Sargodha Road,

Faisalabad.

FMO Injection

Each 1ml contains:-

Oxytetracycline BP………..300mg

Flunixine Meglomine USP..20mg

(Antibiotic).

Decontrolled

10ml

20ml

50ml

100ml

02

years

-Do- -Do-

172

b. Grant of registration-Human drugs:

S. # Name of

Applicant


Size

MRP Decision

recoded in

238th

meeting

Correct

Decision

1 M/s. Saaaf

Pharmaceuticals,

Risalpur.

Heap Syrup

Each 5ml contains:-

Iron (III) polymaltose complex eq. to

elemental iron ………50mg

Folic Acid……………0.35mg

(Heamatinic)

120ml As Per

SRO

Deferred for

fee

Approved

The

Registration

Board

advised the

Registration

sections to

again review

the

Registration

Dossiers

before

issuance of

Registration

letters

Domprid Suspension

Each 5ml contans:-

Domperidone……….5mg

(Antidopaminergic)

60ml

120ml As Per

SRO

-Do- -Do-

Zinc Saf Suspension

Each 5ml contains:-

Zinc Sulphate ……….20mg

(Antidiarroeals)

60ml

120ml As Per

SRO

-Do- -Do-

Diasaf Plus Suspension

Each 5ml contains:-

Metronidazole……………75mg

Furazolidone……………..25mg

(Amobecide)

60ml

120ml As Per

SRO

-Do- Deferred for

review of

formulation by

review

committee

Losaf Suspension

Each 5ml contains:-

Loratadine…………5mg

(Antihistamine)

60ml

120ml As Per

SRO

-Do- Approved

The

Registration

Board

advised the

Registration

sections to

again review

the

Registration

Dossiers

before

issuance of

Registration

letters

173

c. Registration Board in 238th

meeting extended following contract manufacturing permissions for Khos Pharma, Hyderabad. But

scrutiny of record revealed that these products are registered for M/s Treat Pharma, Bannu. Correct details are as follows:

M/s Treat

Pharma, Bannu

M/s Mediate

Pharmaceuticals,

Karachi

073248 K-Xime Suspension

Each 5ml contains:

Cefixime……….200 mg

15-04-2013

DyNo.229

Form-05

Rs.42,000/-

Rs.8000/-

18.08.2011

Dedicated

facility

Cephalosporin

Extended till 30.06.2015.

-do- -do- 073247 K-Xime Suspension

Each 5ml contains:


15-04-2013

DyNo.229

Form-05

Rs.42,000/-

Rs.8000/-

18.08.2011

Dedicated

facility

Cephalosporin


-do- -do- 073246 K-Xime Capsule



15-04-2013

DyNo.229

Form-05

Rs.42,000/-

Rs.8000/-

18.08.2011

Dedicated

facility

Cephalosporin


d. Registration Board in 238

th meeting extended following contract manufacturing permissions for contract manufactured by M/s

AGP Health Care Pvt. (Formerly, Eli Lilly Gohar, Karachi). Later on scrutiny of record revealed that contract manufacturer is M/s

PharmEvo, Karachi. Submitted for correction and issuance of corrigendum as per following correct details.

M/s AGP, Kar. M/s PharmEvo,

Karachi

003755 Kefzol 500mg Injection

Each vial contains:

12-04-2013

DyNo.308

Dedicated

facility

Extended till 30.06.2015

174

Cefazolin sodium……….…500mg Form-05

Rs.42,000/-

Rs.8000/-

02-6-2011

Cephalosporin

-do- -do- 003756 Kefzol 1g Injection

Each vial contains:

Cefazolin sodium……….…1gm

29-04-2013

DyNo.309

Form-05

Rs.42,000/-

Rs.8000/-

02-6-2011

-Do- Extended till 30.06.2015

Case No.17. Extension in contract manufacturing permissions.

M/s Sapient

Pharma, Lhr

M/s Mediate

Pharmaceuticals,

Kar.

060472 COA Dry Suspension

Each 5ml contains:


15-04-2013

Form-05

Rs.42,000/-

Rs.8000/-

07.09.2010

Dedicated

facility

Cephalosporin


-do- -do- 060473 COA Capsule



15-04-2013

Form-05

Rs.42,000/-

Rs.8000/-

07.09.2010

Dedicated

facility

Cephalosporin


175

(Medical Devices)

Case No.18. Applications for registration of Medical Devices for Import.

The Registration Board considered the following applications of medical

devices and decided as mentioned against each. These applicationshave already been

recommended by Expert Committee on Medical Devices. Approved applications are subject to

inspection of manufacturer abroad, verification of storage facilities etc as per policy.

A: CATHETERS:

S.No. Name of Importer and

Manufacturer/Exporter.

Name of Medical

Device.

Demanded

price &

Pack size

Shelf life Decision

1. M/s.Cor-Med,

2nd

Floor, 36/62, Rehman

Plaza, Bank Road, Saddar,

Rawalpindi

Manufactured by

M/s. IHT, Iberhospitex

S.A, Barcelona, Spain

Fairway

Rapid Exchange

dilatation catheter for

PTCA

Length (mm):

10,15,20, 25,30, 35,40.

Dia (mm):

1.5, 2.0, 2.5, 3.0, 3.5,

4.0, 4.5.

Decontrolled

(Different

product codes

available)

24

months Approved.

B: STENTS:



Name of Medical

Device

Demanded

price &

Pack size

Shelf life Decision

1. M/s.Cor-Med,

2nd



Rawalpindi

Manufactured by

M/s. IHT, Iberhospitex S.A,

Barcelona, Spain.

Bionert Inert Coronary

Stent

(Bare Metal Stent)

Bionert :

Stent Length (mm):

9, 14, 18, 23, 28, 36.

Stent Dia (mm):

3.0, 3.50, 4.00, 4.50.

Bionert Small:

Stent Length (mm):

9, 14, 19, 23, 28.

Decontrolled

(Different

product

codes

available)

24

months Approved.

176

Stent Dia (mm):

2.0. 2.25, 2.50, 2.75.

2. M/s.Cor-Med,

2nd



Rawalpindi

Manufactured by

M/s. IHT, Iberhospitex S.A,

Barcelona, Spain.

Active Paclitaxel

Eluting Coronary

Stent.

Active :

Stent Length (mm):

9, 14, 18, 23, 28, 36.

Stent Dia (mm):

3.0, 3.50, 4.00, 4.50.

Active Small:

Stent Length (mm):

9, 14, 19, 23, 28, 36.

Stent Dia (mm):

2.0. 2.25, 2.50, 2.75.

Decontrolled

(Different

product

codes

available)

18

months Approved.

C: SYRINGES:



Name of Medical Device. Demanded

price &

Pack size

Shelf

life

Decision

1. M/s. Excel Corporation,

435 BYJ Society,

Bahadurabad, Karachi

Manufactured by

M/s. Changzhou Jinliyuan

Medical Devices, Co., Ltd.,

No.6 West Xihe Road,

Sanhekou, Zhenglu Town,

Wujin District, Changzhou

City, China.

A-Star Disposable syringe Decontrolled

1ml

3ml

5ml

10ml

20ml

5years Approved.

2. M/s. Excel Corporation,

435 BYJ Society,

Bahadurabad,Karachi

Manufactured by

M/s. Changzhou Jinliyuan

Medical Devices, Co., Ltd.,

No.6 West Xihe Road,

Sanhekou, Zhenglu Town,

Wujin District, Changzhou

City, China.

A-Star Disposable syringe Decontrolled

30ml

50ml

5years Approved.

3. M/s Becton Dickinson

Pakistan (Pvt) Ltd,

BD Emerald TM

Pro (Reuse

Prevention) Luer Slip

Decontrolled

5 years Approved.

177

19-D/1, Gulberg-III,

Lahore.

Manufactured by:

M/s Becton Dickinson, S.A.

Ctra. Mequinenza, s/n

22520 Fraga (Huesca),

Spain.

Syringe. 2ml

5ml

10ml

Case No.19. Registration of Medical Devices of M/s Otsuka Pakistan Limited, Lasbela

Distt. Balochistan.


meeting considered and approved the following

medical devices of M/s. Otsuka Pakistan Limited, Lasbela Distt. Balochistan subject to

inspection of manufacturer abroad, local storage facility etc:-


Manufacturer / Exporter.

Name of Drug (s)

Composition &

Therapeutic Group.

Demanded

Price &

Pack Size.

Shelf Life

1. M/s. Otsuka Pakistan Limited,

Lasbela Distt. Balochistan. /

M/s. Mircroport Medical

(Shanghai) Co. Ltd.,

Shanghai. P.R. China.

Jive PTCA Balloon

Catheter

(Medical Device).

Decontrolled

02 years






Mustang Stent

Stainless Steel

Coronary Stent

System

(Medical Device).

Decontrolled

02 years






Firebird Rapamycin

Eluting Stainless

Steel Coronary Stent

System

(Medical Device).

Decontrolled

12 months






Firebird 2

Rapamycin Eluting

Cobalt Chromium

Coronary Stent

System

(Medical Device).

Decontrolled

09 months

178

Accordingly inspection of M/s. Microport Medical (Shanghai) Co. Ltd., Shanghai.

P.R. China was conducted by the nominated panel. During the inspection, the panel of

inspectors observed certain shortcomings related to GMP and therefore did not recommend the

products for registration.

M/s Microport Medical (Shanghai) Co. Ltd., Shanghai. P.R. China submitted an

Action Plan for taking corrective actions on the deficiencies mentioned in the inspection report.

After that M/s Otsuka Pakistan Ltd., Karachi submitted the Corrective Action Report dated 12th

October, 2012, forwarded by their principal manufacturer in which the manufacturer submitted

that they have taken Corrective Action on the non-conformities mentioned in the inspection

report and are ready for re-inspection of their premises.

Accordingly a panel of inspectors was nominated for re-inspection. The panel

conducted the inspection of all key manufacturing areas which were involved in manufacturing

and quality control of applied products. The points observed by the previous panel were also

checked. The panel has given the following recommendations:-

(i) Mustang Stent Stainless Steel Coronary Stent System is recommended for

grant of registration with shelf life of 24 months alongwith following sizes:-

Stent Dia (mm): 2.0, 2.50, 2.75, 3.00, 3.25, 3.50, 4.00,

4.50, 5.00.

Stent Length (mm): 5 to 40.

(ii) Firebird 2 Rapamycin Eluting Cobalt Chromium Coronary Stent System is

recommended for grant of registration with shelf life of 12 months alongwith

following sizes:-

Stent Dia (mm): 2.5, 2.75, 3.0, 3.5, 4.0.

Stent Length (mm): 13, 18, 23, 29, 33.

Quantity of Rapamycin

Coated on stent (µg): 120, 160, 210, 268, 305.

(iii) Jive PTCA Balloon Dilatation Catheter is not recommended for grant of

registration because the product is neither registered by SFDA China nor

available in China. However, the firm manufactures it for export purpose only.

(iv) Firebird Rapamycin Eluting Stainless Steel Coronary Stent System is not

recommended for grant of registration because the registration status of the

product by SFDA China is valid till April, 2013 and firm has already

179

discontinued its domestic sale hence it’s not on free sale in China. Moreover,

management of M/s Microport also informed that they don’t intend to apply for

extension of its registration beyond April, 2013 for local sale. However, they

will continue to export the product, if ordered.

Decision: The Board approved Mustang Stent Stainless Steel Coronary Stent System with

shelf life 24 months and Firebird 2 Rapamycin Eluting Cobalt Chromium

Coronary Stent System with increased shelf life of 12 months as recommended by

the panel of inspectors while the Board rejected Jive PTCA Balloon Dilatation

Catheter and Firebird Rapamycin Eluting Stainless Steel Coronary Stent

System as recommended by the panel of inspectors.

180

Biological Evaluation & Registration

Case No.20: Import in GE pack and Local Printing of Reg. No., MRP and Urdu

labelling at own licensed site: F-268, SITE, Karachi having DML No. 000233

M/s GlaxoSmithKline, Karachi has requested import of Fluarix in GE packing and local

printing of Registration number, MRP, and Urdu version at their licensed site at F-268, SITE,

Karachi DML No. 000233.

The reason is because of centralized manufacturing at one Global manufacturing site at

GlaxoSmithKline, Belgium where the GE packs are now manufactured and due to production

time constraints the seasonal flu vaccine has one year shelf life and 6 month window period in

which it is to be used. Pakistan specific packing is not possible in this short time hence

availability in Pakistan is a major issue. Therefore Reg. No., MRP and Urdu instructions can

be printed at the company’s own licensed site at Karachi for a period of two years.

Fee Rs 5000/- has been paid by the firm.

Board is requested to allow the permission for import of Fluarix vaccine in GE packing and

local printing of Reg. No., MRP., and Urdu printing with inject printing at GlaxoSmithKline,

Karachi licensed site F-268, SITE, Karachi having DML No. 000233.

Decision: Board permitted the import of Fluarix vaccine in GE packing and local

printing of Reg. No., MRP., and Urdu version with inject printing at GlaxoSmithKline,

F-268, SITE, Karachi having DML No. 000233 for a period of two years.

Case No.21: Registration letter correction- Fluarix vaccine reg no. 022612.

M/s GlaxoSmithKline, Karachi’s Fluarix vaccine is an inactivated influenza vaccine (split

virion) containing antigens of at least three strains of the seasonal influenza viruses that are

notified by WHO for each year. Thus 15 mcg of haemagglutinin of each of the recommended

strain has to be added in the vaccine; therefore the wording on the Reg. letter needs to be

corrected to reflect the same as following:

Exiting wording on the Reg letter Correct wording as per CPP and Form 5

original application

“Each 0.5 ml vaccine dose contains: 15 mcg

of haemagglutinin (inactivated and purified

split influenza vaccine)”

“Each 0.5 ml vaccine dose contains: 15 mcg

of haemagglutinin of each of the

recommended strain”.

The case was submitted on 19.09.2012.

181

The Board is requested to please allow the correction to meet international requirements

subject to submission of fee by the firm.

Decision: The Board allowed the correction to meet international requirements subject

to submission of fee by the firm.

Case No. 22: Engerix B vaccines in prefilled syringes: 10 mcg Reg No. 012370; 20 mcg

Reg No. 009823

M/s GlaxoSmithKline, Karachi has requested import in GE packing and local printing of

Registration number, MRP, and Urdu version on their registered product at their licensed site

Karachi F-268, SITE, Karachi DML No. 000233. The reason is because of centralized

manufacturing at one Global manufacturing site at GSK Belgium where the GE packs are

now manufactured and due to production constraints Pakistan specific packing is not possible

hence availability is a major issue. Whereas the GE pack is readily available and can be

imported at the time of need and locally the Reg. No. MRP and Urdu instructions can be

printed at the company’s own site.

Fee Rs 5,000/- has been paid by the firm.

Board is requested to allow the permission for import of Engerix B vaccines in prefilled

syringes and in GE packing and local printing of Reg. No., MRP., and Urdu printing with

inject printing at GlaxoSmithKline, Karachi licensed site F-268, SITE, Karachi having DML

No. 000233.

Decision: Board allowed the permission to import Engerix B vaccines in prefilled

syringes in GE packing and local printing of Reg. No., MRP., and Urdu version with

inject printing at GlaxoSmithKline, F-268, SITE, Karachi having DML No. 000233 for a

period of two years.

Case No. 23: Registration of “Sterile water for injection-0.5ml vial” for reconstitution of

Vaxapox vaccine Reg No. 074628.

M/s Sind Medical Store, Karachi has requested that their varicella vaccine Vaxapox is

already registered vide reg no. 074628 to be imported from M/s Changchun BCHT

Biotechnology Co., Changchun China but the case of registration of its diluent was not

submitted at that time, hence the company is not able to market it in combo pack.

Fee Rs 50,000 has been paid by the firm, the diluent will be supplied free of cost.

Complete application on Form 5-A, product dossier, Embassy certified Free sale certificate,

182

CPP, copies of the cGMP certificate, and DML, are in file; the production and quality control

procedures are in order.

The Board is requested to grant registration of “Sterile water for injection-0.5ml” for

reconstitution of Vaxapox (Varicella) vaccine Reg No. 074628 to be supplied free of cost along

with the vaccine manufactured by the same company i.e., M/s Changchun BCHT Biotechnology

Co., Ltd., China.

Decision: The case was deferred due to payment of full fee and other codal formalities. The

Board advised to present detailed case in next meeting.

Case No. 24: Registration of “Sodium Chloride Injection BP-0.1 ml ampoule for

reconstitution of BCG vaccine reg no. 053816.

M/s Hospital Services and Sales, Karachi has requested that their product BCG vaccine is

already registered but the case of registration of diluent to be supplied with the BCG vaccine for

its reconstitution was not submitted at that time to be imported together with the vaccine from

M/s Serum Institute of India Ltd., India in combo pack.

Fee Rs 50,000 has been paid by the firm, the diluent will be supplied free of cost. Complete

application on Form 5-A, product dossier, Embassy certified Free sale certificate, CPP, copies of

the cGMP certificate, and DML, are in file; the production and quality control procedures are in

order.

The Board is requested to grant registration of diluent to be supplied free of cost with the BCG

vaccine to be imported with vaccine from the same supplier in combo pack.



Case No. 25: Registration of “Diluent for Indirab injection-1.0 ml for reconstitution of

Indirab 1ml injection.

M/s Sind Medical Store, Karachi has requested their rabies vaccine Indirab injection which

was approved in the 227th

meeting of DRB held on 26-27th

, 2010 requires a diluent for the

reconstitution. The vaccine cannot be imported without the diluent which is to be supplied

free of cost. The vaccine registration letter has not been issued due to pending inspection.

Hence both the cases may be treated together for registration. Both the products are

manufactured by M/s Bharat Biotech International Limited, Andhra Pradesh, India. Fee Rs

183

50,000 thousand has been paid by the firm. The Board is requested to allow combining the

vaccine and its diluent case together for registration.



Case No. 26: Approved cases whose foreign inspections have been successfully

conducted:

a) M/s Hitech Pharmaceuticals, Lahore had applied for new site inspection of their three already

registered products with change of brand names and one diluent for vaccine. The site inspection

has been conducted by the panel comprising of Dr Noor Muhammad Shah and Prof Dr. Ijaz

Ahmad, the report was submitted on 22.05.2013. The panel has recommended their products and

the site at Fort Dodge Saude Animal Ltda, Brazil for cGMP compliance. The products are as

follows:

S.No. Registration

Number

Existing Brand name New requested

Brand Name

Inspection

Report

Remarks

1 009677 EDS Vaccine EDS Vac. Good

2 003787 Poulvac Marek

(CVI+HVT)

Poulvac Ovoline

(CVI+HVT)

Good

3 010719 Egg Drop Syndrome-

Newcastle Disease

Infectious Bronchitis

Vaccine

EDS New Bronz

Vac.

Good

The firm had also applied for inspection of their foreign site for the manufacture of diluent for

their already registered vaccine Poulvac Ovoline CVI+HVT Reg No. 003787 under the new

DRAP policy to register the diluent as a separate entity; the same panel also visited the diluent

manufacturing site at M/s Baxter Hospitalar Ltda, Brazil and recommended the product and the

plant for cGMP compliance.

S.No. Registration

Number

Brand Name Inspection Report

Remarks

1 New to be supplied

with vaccine

Pro-Cell sterile diluent for

Marek Vaccine reg no.

003787

Good

Decision: The Board approved change of manufacturing site and brand name for above

products. The Board also approved registration of diluent for Poulvac Ovoline vaccine.

184

b) M/s Martin Dow had applied for the registration of six biological products which were

approved in the 237th

DRB meeting and for which panel inspection was conduct by a

panel consisting of Dr Uzar ul Ghani, Dr Najmus Saqib of the firm M/s Nanogen

Biopharmaceuticals, Tang NhonPhua ward, Vietnam. The panel has submitted the report

on 09.04.2013 and have recommended following products for registration:

S. No. Product Brand

Name

Generic name Inspection Report

Remarks

1. PEGNANO, PFS Peg Interferon alfa-2a 180

mcg

Good

2. FERONSURE,

PFS

Interferon alfa-2a 3MIU Good

3. FERONSURE,

VIAL

Interferon alfa-2a 3 MIU Good

4. NANOKINE,

PFS

Erythropoietin alfa, 4000

IU

Good

5. FICOCYTE, PFS Filgrastim, 30 mcg Good

6. PEGCYTE, PFS Peg Filgrastim, 6 mg Good

Decision: Registration Board deferred above cases for confirmation of evaluation by

ECBD.

c) M/s Aster had applied for the registration of their five biological products which were

approved in 237th

DRB. Panel inspections have been conducted for the inspection of their

three biological products to be imported from M/s LG Korea. The inspection has been

conducted by Mr. Ghulam Rasool Dutani and Mr. Arif Choudary. They have

recommended these products and manufacturer for cGMP compliance. The same panel

has also recommended two biological products to be imported by the same company

from M/s Beijing Shuanglu Pharmaceutical Co. Ltd., China.

S. No. Product Brand

Name

Generic name Inspection Report

Remarks

1. Consensus-

Asteron alpha 9

mcg injection

Each Vial containing

Recombinant Consensus

Interferon alpha 9 mcg,

Good

M/s Beijing Shuanglu

Pharmaceutical Co.

Ltd., China

2. Consensus-

Asteron alpha 15

mcg Injection

Each Vial containing

Recombinant Consensus

Interferon alpha 15 mcg

Good

M/s Beijing Shuanglu

Pharmaceutical Co.

185

Ltd., China

3. Epotiv

2,000IU/0.5ml Pre-

filled syringe.

Recombinant human

erythropoietin 2,000

IU/0.5ml

Good

M/s LG Lifge

Sciences. Ltd., Korea

4. Epotiv

4,000IU/0.4ml Pre-

filled syringe

Recombinant human

erythropoietin, 4,000

IU/0.4ml

Good

M/s LG Lifge


5. Epotiv 10,000I

U/ml Injection

10000 IU/ml Pre-

filled syringe

Recombinant human

erythropoietin 10,000

IU/ml

Good

M/s LG Lifge


Decision: Registration Board deferred above cases for confirmation of evaluation by

ECBD.

Case No.27: FDA/EMA/TGA/WHO approved new cases of important Biologicals for

registration as per import policy.

S.No. Product Name Drug Category/

Major Indication

Applicati

on/Dossie

r Filing

Date

Registration Status

EMA

US-FDA

Australia (TGA)

Japan

Revised

Fee/

Fee

Differential

Paid

1. PROLIA Injection

(Denosumab 60mg)

Importer M/s

GlaxoSmithKline,

Karachi

From Manufacturer:

M/s Amgen

Manufacturing

Limited, Juncos,

Puerto Rico, USA

NCE/Post

Menopausal

Osteoporosis

and bone loss in

patients

undergoing

hormone ablation

for prostate or

breast cancer.

Each prefilled

syringe contains

60mg of

denosumab in 1ml

solution

(60mg/1ml)

14.11.201

1

EMA -

Approved

US FDA -

Approved

Complete dossier

present

EMA CPP verified

by Embassy of

Pakistan present

Yes

2. XGEVA Injection

(Denosumab 120mg)

Importer M/s

NCE/Cancer

Therapy –

prevention of

skeletal related

15.05.201

2

EMA -

Approved

US FDA -

Approved

Yes

186

GlaxoSmithKline,

Karachi

From Manufacturer:

M/s Amgen

Manufacturing

Limited, Juncos,

Puerto Rico, USA

events with bone

metastates from

solid tumors.

Each vial contains

120mg of

denosumab in 1.7

ml solution

(70mg/1ml)

Shelf life 36

months

Complete dossier

present

FDA CPP verified

by Embassy of

Pakistan present

3. BENLYSTA Injection

(Belimumab 120mg)

Importer M/s

GlaxoSmithKline,

Karachi.

Manufacturer: M/s

Hospira Inc, Kansas,

USA. Supplying site:

GlaxoSmithKline

Manufacturing S.p.a.,

Pharma, Itlay.

autoantibody

positive Systemic

lupus

erythematosus

(SLE)

Each vial contains

120 mg

belimumab

(80mg/ml after

reconstitution)

Shelf life 36

months

16.05.201

2

EMA -

Approved

US FDA -

Approved

Complete dossier

present

CPP verified by

Embassy of Pakistan

present

Yes

4. BENLYSTA Injection

(Belimumab 400mg)

Importer M/s

GlaxoSmithKline,

Karachi.

Manufacturer: M/s

Hospira Inc, Kansas,

USA. Supplying site:

GlaxoSmithKline

Manufacturing S.p.a.,

Pharma, Itlay.

autoantibody

positive Systemic

lupus

erythematosus

(SLE)

Each vial contains

400 mg

belimumab

(80mg/ml after

reconstitution)

Shelf life 36

months

16.05.201

2

EMA -

Approved

US FDA -

Approved

Complete dossier

present

CPP verified by

Embassy of Pakistan

present

Yes

5. Qlaira, (eastradiol

valerate) Hormone

combination

Importer M/s Bayer

Pakistan (Pvt) Ltd.,

Karachi from

Hormone

replacement

therapy

Film coated tablet

contains: 3.0 mg

estradiol valerate

24.08.201

1

TGA approved

CPP verified by

Embassy of Pakistan

present

Complete dossier

present

Yes

187

M/s Bayer Weimer

GmbH und Co. KG

Doebereinerstrasse 20

99427 Weimer,

Germany.

as active

ingredients

6. Eylea (Aflibercept)

40mcg/ml

Importer M/s Bayer

Pakistan (Pvt) Ltd.,

Karachi from

M/s Bayer Pharma AG

Mullerstrabe 178

13353 Berlin

Germany.

Ophthalmogicals/

neurovascular

degeneration

Each vial contains

Aflibercept 40

mg/ml

Shelf life 2 years

29.03.201

3

EMA/FDA approved

EMA CPP verified

by Embassy of

Pakistan present

Complete dossier

present

Yes

7. Yellow fever vaccine

(live Freezedried) 2

doses ampoules/1.0 ml

Importer M/s Hospital

Services & Sales,

Karachi from

Federal State Unitary

Enterprise on

Manufacture of

Bacterial and Viral

Preparations of

Chumakov Institute of

Poliomyelitis & Viral

Encephalitis, Russian

Academy of Medical

Sciences, Russia.

Yellow fever

vaccine

Each single 0.5ml

dose of vaccine

contains:

Yellow fever virus

no less than 1,000

LD50 or 1,600 PFU

Supplied with

diluent water for

injection 1.25 ml

in ampoules

11.09.201

3

WHO prequalified

vaccine,

The other yellow

fever vaccine

available from M/s

Sanofi Aventis,

France has

developed some

technical problems

as notifed by the

company on

11.09.2013 so

supply of another

vaccine is necessary

to cover any

shortage, hence this

application is

presented

CPP, FSC, GMP

certificate, and other

relevant documents

verified by the

Pakistan Embassy

present

Yes

8. Yellow fever vaccine

(live Freezedried) 5

doses ampoules/2.5 ml

Importer M/s Hospital

Services & Sales,

Karachi from

Yellow fever

vaccine

Each single 0.5ml

dose of vaccine

contains:

11.09.201

3

-do- Yes

188

Federal State Unitary

Enterprise on

Manufacture of

Bacterial and Viral

Preparations of

Chumakov Institute of

Poliomyelitis & Viral

Encephalitis, Russian

Academy of Medical

Sciences, Russia.

Yellow fever virus

no less than 1,000

LD50 or 1,600 PFU

Supplied with

diluent water for

injection 3.0 ml in

ampoules

Decision: Registration Board referred above case for consideration of ECBD, as

these cases have not been yet evaluated by the aforementioned committee.

Case No. 28: Change of source of an approved vaccine for local manufacture:

The case relates to “Bulk import local repacking” of the then WHO prequalified vaccine

i.e., Pentavalent vaccine that was approved in 213 DRB meeting with the following

composition and source:

From: Amsovax-5: Diptheria, Tetanus, whole cell Pertussis, Hepatitis-B and

Haemophilus influenza type B conjugate vaccine as per WHO formula, from M/s

Shanta Biotech India, India.

At the time of application this source was WHO prequalified but latter on it

was derecognised by WHO, hence the local company applied for change of

source to a new WHO prequalified source;

To: Amsovax-5: New WHO prequalified product from M/s Biological E, Ltd., India

with the same composition of vaccine. The application was submitted on 16.09.2011

and the dossier of the new product was submitted on 28.10.2011. The vaccine is

Diphtheria, Tetanus, Pertussis (Whole cell), Hepatitis B (rDNA) and Haemophilus

Type B Conjugate Vaccine (Adsorbed)-(Hib vaccine lyophilised in separate vial

which is to be reconstituted with DTwP-rHepB vaccine filled in a separate vial).

Shelf life is 24 months. The packing applied for is 10 doses per vial. As per Schedule

I of DRAP Act, 2012 the naked vials without labels will be imported in bulk

quantities that will be locally labelled and Vaccine Vials Monitor (VVM) will be

applied before packing in cartons).

The firm was communicated the approval on 11.03.2013 and was asked to submit the

WHO approval and technical information on the CTD format; the firm submitted the

required information on 01.04.2013. The WHO approval status has been verified

from the WHO Web site as well.

189

The local facility is a licensed to manufacture vaccine by way of formulation since

1995 for HepB, TT, and antivenom serum; recommended for approval subject to

local panel inspection for facility suitability for handling such product.

Decision: Registration Board deferred firm’s request for evaluation by ECBD.

Case No. 29: Registration of WHO prequalified liquid Pentavalent vaccine to be

imported in finished form for EPI in single vial.

M/s Amson Vaccine & Pharma (Pvt) Ltd., Islamabad submitted a case for import of a

Pentavalent vaccine in finished form for EPI from M/s Biological E. Ltd., India. Rs

100,000 fee has been paid. The vaccine is WHO prequalified and has following

composition:

Source: Composition Presentation

M/s Biological E Ltd.,

Shameerpet Mandal,

Andhra Pradesh, India

Diphtheria Toxoid 25Lf(≥30IU)

Tetanus Toxoid 5.5Lf(≥60IU)

B.pertissis (Whole cell)

16IOU(≥4IU)

r-HBsAg 12.5 mcg

Purified capsular polysaccharide 11

mcg

Tetanus Toxoid (Carrier protein)

30.36.7mcg

Al+++

(as AlPO4) ≤1.25 mg

Thiomersal BP 0.01%w/v

10 dose vials

Decision: Registration Board deferred firm’s request for evaluation by ECBD.

190

Case No. 30: Registration of safe drugs.

Registration Board discussed letter written by Dr.Obaid Ali, Deputy Drug

Controller dated 22.08.2013 on matter of registration of drugs. The Board discuused points

mentioned in letter as follows:

a. Registration of Drugs without Assessment, Review and evaluation of Application

Dossier.

The Board showed their satisfaction on present system of scrutinization / evaluation of

registration applications. The Board was informed that DRAP has agreed in principal to creat a

cell for evaluation of registration applications. The cell will be operative soon and will be

entrusted with the duty of scrutinization / evaluation of registration applications as required

under Drug Act, 1976.

b. Registration of Drugs without Assessment of site master file etc and GMP inspection.

As per procedure in vogue, licensing section is responsible for the grant of licenses / sections

to pharmaceutical units after completion of all requirements as required under Drugs (Licensing,

Registering & Advertising) Rules, 1976. Registration Board considers registration application on

the basis of approvals granted by licensing section. Similarly Quality Assurance section conducts

inspections of licensed units for compliance towards GMP. Registration Board considers these

inspection reports while considering registration applications. Moreover, the Board also

constitutes its own panel for product specific inspections, where it considers necessary. Members

of the Board were satisfied with the procedure adopted for inspection of pharmaceutical units.

However, for better compliance of GMP, the Board advised QA section to strictly monitor the

GMP of the licensed units for manufacturing of quality products for ailing masses.

c. Registration of Drugs without summary of approvals and transparency.

As mentioned in point a, the evaluation cell will evaluate the registration applications and

forward its recommendation including summary of approval for consideration of the Board.

Registration applictions are included in agenda of the meeting on FIFO basis.

d. Registration of Drugs without Post Marketting Requirements & Commitments.

After promulgation of DRAP Act, 2012; Pharmacovigilance section has been established

under Pharmacy Services Division. This section will perform all the activities of

Pharmacovigilance including post marketing survelliance etc of the marketed products. The

pharmaceutical companies will coordinate with this section for matters related to

191

pharmacovigilance. Members showed their desire that Registration Board be informed about the

pharmacovigilance activities per formed by the Pharmacy Services Division.

e. Registration of drugs/ Blanket approval on its Label Claim and Promotion.

Regsitartion Board grant registration of drug based on label claim approved by the regulatory

body of country of origin / USFDA / EMA / TGA / Japan / developed countries. However,

evaluation cell for the scrutinization / evaluation of registration application will also review all

label claims of the applicant.

f. Ignorance of International Norms and implementation of Harmonized Documents.

Presently registration applications are submitted on prescribed Forms (5, 5A, 5D, 5E) as

required under Drugs (Licensing, Registering & Advertising) Rules, 1976. The matter of

submission of the application on CTD format is already under discuusion in DRAP and will be

implemented after ammendement in aforementioned rules.

g. Barricade of working of DDC (Biological Drugs) and authorization of illegitimate

working.

It is an administrative matter and not related to Registration Board.

XDr. Obaid Ullah

Secretary, Drug Registration Board

XMr. Ghulam Rasool Dutani

Chairman, Drug Registration Board