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Minutes for 267th Registration Board Meeting held on 20-21st February, 2017.

Item No. Detail of Item Page No.

Item No.I Confirmation for minutes of 266th Registration Board meeting 02

Item No.II Medical Device & Medicated Cosmetics 03 – 155

Item No.III Pharmaceutical Evaluation & Registration Division 156 – 334

Item No.IV Biological Drugs Division 335 – 359

Item No.V Additional Agenda

A. Medical Device & Medicated Cosmetics Division

B. Biological Drugs Division

C. Pharmaceutical Evaluation & Registration Division

360 – 363

364 – 376

377

Minutes for 267th Registration Board Meeting 1

267th meeting of Registration Board was held on 20-21st February, 2017 in the Committee

Room, Drug Regulatory Authority of Pakistan, G-9/4, Islamabad. The meeting was chaired by

Mr. Ghulam Rasool Dutani, Director, Pharmaceutical Evaluation & Registration Division,

DRAP. The meeting started with recitation of the Holy Verses. The meeting was attended by the

following:-

1. Dr.Rafeeq Alam KhanMeritorious Professor, Faculty of Pharmacy, University of Karachi

Member

2. Prof.Dr.Ghulam Sarwar, Dean,Faculty of Pharmacy, Jinnah Women University, Karachi

Member

3. Mr.Aslam Shah, Senior Manager Pharmacy, Indus Hospital, Karachi

Member

4. Dr.Amanullah KhanDirector, Drugs Testing Laboratory, QuettaGovt. of Baluchistan

Member

5. Dr. Muhammad Saleem ButtDirector, Drugs Testing Laboratory, RawalpindiGovt. of Punjab.

Member

6. Mr.Abid HayatRepresentative of Director, Drugs Testing Laboratory, Peshawar, Govt. of Khyber Pakhtunkhwa

Member

7. Mr. Abdul Sattar SoomroDirector, Drugs Testing Laboratory, KarachiGovt. of Sindh.

Member

8. Mr. Muhammad AslamAssistant Draftsman-II, Ministry of Law & Justice

Member

9. Mr.Ghulam MujtabaRepresentative IPO

Member

10. Dr.Noor-us-SabaDirector, Biological Drugs Division, DRAP

Member

11. Dr.Shaikh Akhter Hussain,Director, Medical Device Division, DRAP

Member

12. Dr.Abdur RasheedAdditional Director, QA&LT Division, DRAPRepresentative of QA&LT Division

Member

13. Dr. Obaidullah, Additional Director (Reg.I) Secretary

Zaheer-ud-Din M. Babar (Deputy Director R.I/R IV), Babar Khan (Assistant Director

RIII), Abdul Mughees (Assistant Director RII), Ms.Sana Kanwal (Assistant Director RV) and


Assistant Directors, Pharmaceutical Evaluation Cell, Medical Device Division, Biological Drugs

Division assisted relevant Director with agenda.

Ms. Mehvish Siddique, Nadeem Hussain Alamgeer, Dr.Zafar Hashmi and Shahzad

Hussain attended the meeting as observer on behalf of PPMA, Pharma Bureau and PCDA

respectively. Ms.Aisha Aslam attended the meeting in place of Nadeem Hussain Alamgeer

during agenda of Medical Device Division.

On the directions of the honorable Supreme Court, Pakistan Cardiac Society, Pakistan

Society of Interventional Cardiology and cardiology experts from hospitals/institution attended

the meeting during agenda of Medical Device Division. These include Prof. Dr. Khalida

Soomro, President, Pakistan Cardiac Society, Brig (R) Dr. Afsar Raza, President Pakistan

Society of Interventional Cardiology, Prof. Dr. Syed Nadeem Hasan Rizvi, Professor of

Interventional Cardiology, National Institute of Cardiovascular Diseases, Karachi and Brig. (R)

Prof. Dr. Qaisar Khan, Professor of Cardiology, Rawalpindi Institute of Cardiology, Rawalpindi.


Item No.I: Confirmation of minutes of 266th meeting Registration Board.

266th meeting of Registration Board was held on 06-07th February, 2016. Partial draft

minutes pertaining to Medical Devices were circulated to members (who attended the meeting)

on 09.02.2017 with the request to forward their comments (if any). As no comments were

received, thus these partial minutes were approved by Chairman, Registration Board.

Consolidated draft minutes for 266th meeting Registration Board were circulated on

14.02.2016 to forward comments (if any) within 05 days. No comments have been received yet.

Decision: Registration Board approved minutes for 266th meeting.


Item No.II: Medical Device & Medicated Cosmetics.

In lieu of present situation of availability of life saving medical devices and Human rights

case No. 623-P/2017 of Supreme Court of Pakistan, Registration Board in its 266 th meeting held

on 6th& 7th February, 2017 constituted an Evaluation Cell for scrutinization of registration

applications of cardiac stents, catheters and cannulas. Prof. Dr. Khalida Soomro, President,

Pakistan Cardiac Society, Karachi, Prof. Dr. Asad Ali Saleem, Chief of Cardiology, Shifa

International Hospital, Islamabad (Representative of Pakistan Society of Interventional

Cardiology), Prof. Dr. Akhter Ali Bandesha, Associate Professor of Cardiology, Shaheed

Zulfiqar Ali Bhutto Medical University, PIMS, Islamabad and Brig. (R) Prof. Dr. Qaisar Khan,

Professor of Cardiology, Rawalpindi Institute of Cardiology, Rawalpindi attended the meeting as

Technical experts for recommendations. Minutes of the meeting were circulated to the technical

experts who have agreed/approved and signed the minutes.

On the directions of the honorable Supreme Court, Pakistan Cardiac Society, Pakistan

Society of Interventional Cardiology and cardiology experts from hospitals/institution were

invited in the Registration Board meeting. Prof. Dr. Khalida Soomro, President, Pakistan

Cardiac Society, Brig (R) Dr. Afsar Raza, President Pakistan Society of Interventional

Cardiology, Prof. Dr. Syed Nadeem Hasan Rizvi, Professor of Interventional Cardiology,

National Institute of Cardiovascular Diseases, Karachi and Brig. (R) Prof. Dr. Qaisar Khan,

Professor of Cardiology, Rawalpindi Institute of Cardiology, Rawalpindi attended the meeting.

Cardiology experts strongly emphasized that registration process of cardiology and allied devices

declared as drug should be expedited in order to have un-interrupted supply of these life saving

devices in the market. Each application was thoroughly discussed by the Board with cardiology

experts and in the light of their clinical experience/recommendations regarding safety, efficacy,

quality and use, decisions were taken by the Board. It was also discussed with the cardiology

experts that how many companies they have referred to DRAP for completion of their

registration application and for applying new applications of the products needed badly in the

Institutes. Following criteria for approval or rejection was adopted on strong recommendations

of the cardiologists.

(i) Complete applications as per criteria of Registration Board in its 266 th meeting were directly approved.

(ii) Those applications which were not complete but their registration was badly needed on urgent basis or their alternatives were not available or were new inventions, on the clinical experience/ strong recommendations of cardiologists regarding safety, efficacy, quality and use for cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest, were approved subject to


fulfilment of documents like free sale certificate, sole agency agreement/authorization letter and complete fee within 2 weeks time and Chairman Registration Board was authorized for granting approval for issuance of registration certificate after completion of aforesaid documents. In case of non-compliance by the applicant, it was decided that the application shall again be placed before the Board in its next meeting for its disposal.

(iii) Those applications which were not complete but actively persuade by the applicants or their alternatives were available or were not new inventions, were deferred by the Board for completion of documents.

(iv) Those applications which were not complete even after reminders or their alternatives were available or were not new inventions, were rejected by the Board on strong recommendations of cardiologists.

Registration Board considered the following applications for registration of medical

devices for import and decided as mentioned against each on the clinical experience/ strong

recommendations of cardiologists regarding safety, efficacy, quality and use for cardiac, vascular

and ancillary procedures in the institutions (public and private) in the larger public interest.

Approved applications are subject to inspection of manufacturer abroad, verification of storage

facilities etc as per policy, as applicable:-

Case No.01: Deferred Applications of Stents:

S.No

Name of Importer &

Manufacture/ Exporter.

Name of Medical Device

(s)

Price & Pack size

Shelf life

Recommendations of Cardiologists in evaluation cell

Decision

1. M/s Trans Angio System, 507 Progressive square, P.E.C.H.S, Block-6, Shahra-e-Faisal Karachi-75400

Manufactured by:M/s Translumina GmbH, Neue Rottenburger Strabe 50, 72379, Hechingen, Germany.

Yukon ®

CC Stent System

Sizes and product codes as per FSC

As per policy decision by Policy Board/ Federal Govt. and Registration Board

1’s

03 year

s

Applied on 12-4-2011Letter for deficiencies issued on 23.10.2012Reminders issued on 4.3.2015 & 6.10.2016Reply received on 31.10.16 informing to submit the documents by 15-11-2016Documents received on 23-1-2017Final letter issued on 14.02.2017.

Deferred the product for provision of following documents:-a. Approval of shelf

life from regulatory authority or Stability data to support claimed

Approved on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality.


shelf life. (shelf life report provided)

2. M/s. TM Marketing,9/SB-2 Miran M. Shah Road, K.D.A Scheme#1 Karachi.

Manufactured by:M/s. ClearStream Technologies Ltd., Moyne Upper, Enniscorthy Co. Wexford, Ireland.

ClearFlex-X Coronary Stent

(As per FSC)


1’s

03 year

s

Applied on 18-4-2011Letter for deficiencies issued on 26-9-2012Reminders issued on4-3-2015 & 06-10-2016.No reply received.Letter communicating the Board decision issued on 10-02-2017.Not recommended the product due to following reasons:-a. Differential Fee PKR.35,000/-.b. Original Free Sale Certificatec. Original authorization letter/sole agency agreement from manufacturerd. Original Credentials of manufacturee. Clinical data, if any.f. Copy of Valid Drug Sale Licence.g. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.

Rejected due to non-submission of following documents even after multiple reminders and on strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy & quality:-

a. Differential Fee PKR.35,000/-.b. Original Free Sale Certificatec. Original authorization letter/sole agency agreement from manufacturerd. Original Credentials of manufacturee. Clinical data, if any.f. Copy of Valid Drug Sale Licence.g. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.

3. M/s.TM Marketing, 9/SB-2 Miran Muhammad Shah Road, K.D.A Scheme#1 Karachi.

Manufactured by:M/s. ClearStream

SatinFlex Coronary Stent

(As per FSC)


1’s

03 year

s

Applied on 18-4-2011Letter for deficiencies issued on 26-9-2012Reminder issued on4-3-2015.Final reminder issued on 6-10-2016No reply received.Letter communicating the Board decision issued on 10-02-2017.Not recommended the product due to following reasons:


a. Differential


Technologies Ltd., Moyne Upper, Enniscorthy Co. Wexford, Ireland.

a. Differential fee PKR.35,000/-.b. Original Free Sale Certificatec. Original authorization letter/sole agency agreement from manufacturerd. Original Credentials of manufacturee. Clinical data, if any.f. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.g. Copy of Valid Drug Sale Licence.

fee PKR.35,000/-.b. Original Free Sale Certificatec. Original authorization letter/sole agency agreement from manufacturerd. Original Credentials of manufacturee. Clinical data, if any.f. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.g. Copy of Valid Drug Sale Licence.

4. M/s. Maxims Medical,534-H-Block, Phase-5, Street No-13, DHA, Lahore.

ResponsibleManufacturer:M/s. Abbott Vascular, 3200, Lakeside Drive, Santa Clara, California CA 95054, USA.

Manufacturing Site:M/s. Abbott Vascular, Belgium.

Multilink 8 Coronary Stent

(As per FSC)

As per policy decision by Policy Board/ Federal Govt. and Registration Board1’s

02 years

Applied on 23-4-2011Letter issued on 23.10.2012Letter of required fee issued on 11-7-2013Reminder issued on07-10-2016.No reply received.Letter communicating the Board decision issued on 10-02-2017Not recommended the product due to following reasons:a. Differential Fee PKR.35,000/-.b. Original Free Sale Certificatec. Copy of Valid Drug Sale Licence.d. Original authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.e. Original

Rejected due to non-submission of following documents even after multiple reminders and on strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy & quality:-a. Differential Fee PKR.35,000/-.b. Original Free Sale Certificatec. Copy of Valid Drug Sale Licence.d. Original authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.e. Original Credentials of manufacture as


Credentials of manufacture as decided above by Registration Board.f. Clinical data, if any.g. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.

decided above by Registration Board.f. Clinical data, if any.g. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.

5. M/s. Maxims Medical, 534- H-Block, Phase-5, Street No-13, DHA, Lahore.

Responsible Manufacturer:M/s Abbott Vascular, 3200, Lakeside Drive, Santa Clara, California CA 95054, USA.

Manufacturing Site:M/s. Abbott Vascular, Instruments Deutsuhland, GmbH, Rudolf-diesel-dtrabe 29, 72414, Rangendingen, Germany.

JO Stent Graft Master Coronary stent Graft System.

(As per FSC)


1’s

02 years

Applied on 23-4-2011.Letter issued on 23.10.2012Letter of required fee issued on 11-7-2013Reminder issued on7-10-2016.No reply received.Letter communicating the Board decision issued on 10-02-2017Not recommended the product due to following reasons:a. Differential Fee PKR.35,000/-.b. Original Free Sale Certificate as decided by Registration Board.c. Original authorization letter/sole agency agreement from manufacturer as decided by Registration Board.d. Original Credentials of manufacture as decided by Registration Board.e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.f. Copy of Valid Drug Sale

Rejected due to non-submission of following documents even after multiple reminders and on strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy & quality:-a. Differential Fee PKR.35,000/-.b. Original Free Sale Certificate as decided by Registration Board.c. Original authorization letter/sole agency agreement from manufacturer as decided by Registration Board.d. Original Credentials of manufacture as decided by Registration Board.e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.f. Copy of Valid Drug Sale Licence.


Licence.6. M/s. Maxims

Medical, 534-H-Block, Phase-5, Street No-13, DHA, Lahore.

Responsible Manufacturer:M/s. Abbott Vascular, 3200, Lakeside Drive, Santa Clara, California CA 95054, USA.


Flex Master F1 Coronary Stent

(As per FSC)


1’s

02 years

Authorization letter/sole agency agreement issued by Indian region.Applied on 23-4-2011Letter for deficiencies issued on 23-10-2012Letter of required fee issued on 11-07-2013Reminder issued on7-10-2016.No reply received.Letter communicating the Board decision issued on 10-02-2017.Not recommend the product due to following reasons:a. Differential Fee PKR.35,000/-.b. Original & valid Free Sale Certificate as decided by Registration Board.c. Original and valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.d. Original Credentials of manufacture as decided by Registration Board.e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.f. Copy of Valid Drug Sale Licence.

Rejected due to non-submission of following documents even after multiple reminders and on strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:-a. Differential Fee PKR.35,000/-.b. Original and valid Free Sale Certificate as decided by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.d. Original Credentials of manufacture as decided by Registration Board.e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.f. Copy of Valid Drug Sale Licence.

7. M/s. SES Associates, 61 Bank Square Market, Model town, Lahore.

UNA TM Stent Delivery System (Stainles

As per policy decision by Policy Board/ Federal

02-years

Applied on 14-6-2011.Letter issued 23.10.2012.Reply received but incomplete.

Rejected due to non-submission of following documents even after multiple reminders and on strong non-


Manufactured byM/s. QualiMed GmbH, BoschstraBe 16, D-21423, Winsen, Germany.

s Steel Coronary Stent)

(Codes and sizes As per FSC)

Govt. and Registration Board

1’s

Letter of required fee issued on 11-07-2013 and fee deposited on 25.5.2016.Reminder issued on20-01-2017.Letter issued on 3.2.2017.Final reminder issued on 10-02-2017.

Deferred the product for the provision of following deficiencies;1. Original Credentials of manufacture as decided by Registration Board.2. Valid copy of Drug Sale Licence.3. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.4. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.

recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:-

1. Original Credentials of manufacture as decided by Registration Board.2. Valid copy of Drug Sale Licence.3. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.4. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.

8. M/s. SES Associates, 61-Bank Square Market, Model Town, Lahore.

Manufactured byM/s. QualiMed GmbH, BoschstraBe 16, D-21423, Winsen, Germany.

SUNA TM Stent Delivery System

(Cobalt Chromium Coronary Stent)



1’s

02years

Applied on 14-6-2011.Letter issued23-10-2012.Reply received but incomplete.Letter of required fee issued on 11-07-2013 and fee deposited on 25.5.2016.Reminder issued on20-01-2017.Letter issued on03-02-2017.Final reminder issued on 10-02-2017.

Deferred the product

Rejected due to non-submission of following documents even after multiple reminders and on strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:-

1. Original Credentials of manufacture as decided by Registration Board.


for the provision of following deficiencies required;1. Original Credentials of manufacture as decided by Registration Board.2. Valid copy of Drug Sale Licence.3. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.4. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.

2. Valid copy of Drug Sale Licence.3. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.4. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.

9. M/s. Stents Specialties, 47 Kahuta Triangle Industrial Area,Islamabad.

Manufactured byM/s. Plasmachem GmBH, alte gaertnerei 22-55128mainz,Germany

Bio Diamond Coronary pre-mounted Stent (stainless steel)



1’s

2 years

Applied on 23-06-2011Letter Issued on13-09-2012.Letter of required fee issued on 11-07-2013Reminder issued on20-01-2017.Final reminder issued on10-02-2017.(The firm had given undertaking on dated 04.02.2017 to furnish deficiencies, a.s.a.p.)

Deferred the product for provision of following;1. Differential Fee PKR.35,000/-.2. Original & valid Free Sale Certificate as decided by Registration Board.3. Original & valid authorization letter/sole agency agreement from manufacturer as


1. Differential Fee PKR.35,000/-.2. Original & valid Free Sale Certificate as decided by Registration Board.3. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.4. Original Credentials of manufacture as


decided by Registration Board.4. Original Credentials of manufacture as decided by Registration Board.5. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.6. Copy of Valid Drug Sale Licence.

decided by Registration Board.5. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.6. Copy of Valid Drug Sale Licence.

10. M/s. Stents Specialties, 47 Kahuta Triangle Industrial Area, Islamabad.

Manufactured by:M/s. Plasmachem gmbh, alte gaertnerei 22-55128mainz,Germany.

Bio Diamond mF12 Stent (12mm)

(stainless steel)(Codes and sizes As per FSC)


1’s

2 years

Applied on 23.6.2011.Letter issued on13-09-2012.Letter of required fee issued on 11-07-2013Reminder issued on20-01-2017.Final reminder issued on 10-02-2017.(The firm had given undertaking on dated 04.02.2017 to furnish deficiencies, a.s.a.p.)

Deferred the product for the provision of the following;1. Differential Fee PKR.35,000/-.2. Original & valid Free Sale Certificate as decided by Registration Board.3. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.4. Original Credentials of manufacture as decided by Registration Board.

Rejected due to non-submission of following documents even after multiple reminders and on strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:-

1. Differential Fee PKR.35,000/-.2. Original & valid Free Sale Certificate as decided by Registration Board.3. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.4. Original Credentials of manufacture as decided by Registration Board.5. Approval of shelf life from regulatory authority or Stability data to support claimed shelf


5. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.6. Copy of Valid Drug Sale Licence.

life.6. Copy of Valid Drug Sale Licence.

11. M/s ACP Systems,13, Naval Fleet Club, Iqbal (S.J) Shaheed RoadKarachi.

Manufactured byM/s Medtronic Ireland, Parkmore Business Park West, GalwayIreland.

Resolute Integrity Zotarolimus Eluting Coronary Stent system

(Cobalt Chromium Alloy Stent coated with Zotarolimus)

As per policy decision by Policy Board/ Federal Govt. and Registration Board.

1’s

24 mont

hs

Applied on 03.8.2012Already registered same brand from Medtronic USA source.Letter issued on23-10-2012.Letter for required fee issued on 11-07-2013Reminder issued on06.1.2015 & 20.1.2017Final reminder issued on 10-02-2017.

Deferred for following documents and called the firm for personal hearing in 267th meeting of Registration Board:1. Differential fee PKR.35,000/-,2. Clarification as product is already registered with same brand name but different manufacturer.3. Original & valid Free Sale Certificate as decided by Registration Board.4. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.5. Approval of shelf life from regulatory authority

Rejected as the firm has separately applied for change of manufacturing site from USA to Ireland and non-submission of following documents even after multiple reminders :-1. Differential fee PKR.35,000/-,2. Clarification as product is already registered with same brand name but different manufacturer.3. Original & valid Free Sale Certificate as decided by Registration Board.4. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.5. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.6. Original Credentials of manufacture as decided by Registration Board.


or Stability data to support claimed shelf life.6. Original Credentials of manufacture as decided by Registration Board.

12. M/s ACP Systems,13, Naval Fleet Club, Iqbal (S.J) Shaheed Road,Karachi.

Manufactured byM/s Medtronic Ireland, Parkmore Business Park West, GalwayIreland.

Integrity BMS Coronary Stent System

(Cobalt Chromium Stent.)


1’s

24 mont

hs

Applied on 03.8.2012Already registered same brand from Medtronic USA source.Letter issued on23-10-2012.Letter for required fee issued on 11-07-2013Reminder issued on06.1.2015 & 20.1.2017Final reminder issued on 10-02-2017.

Deferred for following documents and called the firm for personal hearing in 267th meeting of Registration Board:1. Differential fee PKR.35,000/-,2. Clarification as Product already registered with same brand name but different manufacturer.3. Original Free Sale Certificate as decided by Registration Board.4. Original authorization letter/sole agency agreement from manufacturer as decided by Registration Board.5. Clinical data, if any,6. Approval of shelf life from regulatory authority

Rejected as the firm has separately applied for change of manufacturing site from USA to Ireland and non-submission of following documents even after multiple reminders :-1. Differential fee PKR.35,000/-,2. Clarification as product is already registered with same brand name but different manufacturer.3. Original & valid Free Sale Certificate as decided by Registration Board.4. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.5. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.6. Original Credentials of manufacture as decided by Registration Board.


or Stability data to support claimed shelf life.7. Original Credentials of manufacture as decided by Registration Board.8. Copy of Valid Drug Sale License.

13. M/s ACP Systems,13, Naval Fleet Club, Iqbal (S.J) Shaheed Road,Karachi.Manufactured by:M/s Medtronic Ireland, Parkmore Business Park West, GalwayIreland.

Endeavor Sprint Zotarolimus eluting Coronary Stent system


1’s

24 mont

hs

Applied on 03.8.2012.Already registered same brand from Medtronic USA source.Letter issued on23-10-2012.Letter for required fee issued on 11-07-2013Reminders issued on 06.1.2015 & 20.1.2017Final reminder issued on 10-02-2017.

Deferred for following documents and called the firm for personal hearing in 267th meeting of Registration Board:1. Differential fee PKR.35,000/-,2. Clarification as Product already registered with same brand name but different manufacturer.3. Original Free Sale Certificate as decided by Registration Board.4. Original authorization letter/sole agency agreement from manufacturer as decided by Registration Board.5. Clinical data,

Rejected as the firm has separately applied for change of manufacturing site from USA to Ireland and non-submission of following documents even after multiple reminders :-1. Differential fee PKR.35,000/-,2. Clarification as product is already registered with same brand name but different manufacturer.3. Original & valid Free Sale Certificate as decidedby Registration Board.4. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.5. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.6. Original Credentials of manufacture as decided by Registration Board.


if any,6. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.7. Original Credentials of manufacture as decided by Registration Board.8. Copy of Valid Drug Sale License.

14. M/s Claris Medical, 54-A, Street 5, Sector F-8/3, Islamabad.

Manufactured by:M/s Biotronic AG Ackerstrasse 6, 8180 Bulach, Switzerland.

Contract Medical International GmbHLauensteiner Strasse 37, 01277 Dresden, Germany.

Orsiro Sirolimous Eluting Coronary Stentsystem



1’s

Not mentioned.

Applied on 10-12-2012Letter issued on24-04-2013.Reminders issued on 02.3.2015 & 20.1.2017.Final reminder issued on 10-02-2017.Not recommend the product due to the following deficiencies even after multiple reminders dated above:1. Original Free Sale Certificate as decided by Registration Board.2. Original authorization letter/sole agency agreement from manufacturer as decided by Registration Board.3. Original Credentials of manufacture as decided by Registration Board.4. Copy of Valid Drug Sale License.

Rejected due to non-submission of following documents even after multiple reminders andon strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy & quality:1. Original Free Sale Certificate as decided by Registration Board.2. Original authorization letter/sole agency agreement from manufacturer as decided by Registration Board.3. Original Credentials of manufacture as decided by Registration Board.4. Copy of Valid Drug Sale License.

15. M/s Claris Medical, 54-A, Street 5, F-8/3,Islamabad.

PRO Kinetic Energy cobalt

As per policy decision by Policy

Not mentioned.

Applied on 10-12-2012Letter issued on24-04-2013.

Rejected due to non-submission of following documents even after multiple


Manufactured by:M/s Biotronic AG Ackerstrasse 6, 8180 Bulach, Switzerland.


Chromium Coronary Stent system


Board/ Federal Govt. and Registration Board.

1’s

Reminders issued on 02.3.2015 & 20.1.2017Final reminder issued on 10-02-2017.

Not recommend the product due to the following deficiencies even after multiple reminders dated above:1. Original Free Sale Certificate as decided by Registration Board.2. Original authorization letter/sole agency agreement from manufacturer as decided by Registration Board.3. Original Credentials of manufacture as decided by Registration Board.4. Copy of Valid Drug Sale License.

reminders and on strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:-

1. Original Free Sale Certificate as decided by Registration Board.2. Original authorization letter/sole agency agreement from manufacturer as decided by Registration Board.3. Original Credentials of manufacture as decided by Registration Board.4. Copy of Valid Drug Sale License.

16. M/s Intek Corporation, # 30,1st Floor, Al-Amin Plaza, The Mall, Rawalpindi.

Legal Manufacturer:M/S Terumo Corporation. 44-1,2 Chome, Hatagya, Shibuya-Ka, Tokyo 151-0072Japan

Manufacturing Site:M/s Ashitaka

Tsunami ® Gold Coronary Stent System

(stainless steel)


1’s

36 mont

hs

Application date 27.3.2013.Letter issued on 14.10.2013.Reply received but not complete. Reminder issued on 19.01.2017.Final reminder issued on 10-02-2017.Recommended for consideration of Registration Board subject to provision of following documents on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the

Approved subject to provision of Free sale certificatewithin 03 months on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality.

(Mr. Irfan owner of Intek corporation was telephonically contacted by Brig (R) Dr Qaiser Khan during meeting for provision of free sale certificate who informed to submit within 3 months time.)


Factory of Terumo Corporation, 150, Maimaigi-cho, Fujinomiya city, Shizuoka Prefecture 418-0015, Japan.

institutions (public and private) in the larger public interest:1. Original & valid Free Sale Certificate as decided by Registration Board.

17. M/s Interex Company,195 Block 7/8 KMCHS Justice Inamullah Road, Karachi.

Manufactured by1. M/s.NuMed, Inc 2880 Main Street, Hopkinton, NY, 12965,USA.

CP Stent(Bare & Covered)

(aortic stent)


1’s

Not mentioned in form 5-A.

Applied on 24.9.2013Letter issued on 06.6.2014.Reminder issued on20-01-2017.Final reminder issued on 10-02-2017.

Deferred the product for the provision of the following deficiencies;1. Original & valid Free Sale Certificate as decided by Registration Board.2. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.3. Clarification as two Different Products applied in one Application.4. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.

Deferred for provision of following documents:

1. Free Sale Certificate with clear status of sale of the product in the country of origin.2. Clarification as two Different Products applied in one Application and confirmation of manufacturing site.

18. M/s Hakimsons (Pvt) Ltd, Hakimsons House, A/56/ S.I.T.E. Manghopir Pir Road, Karachi.Manufactured by:

Architect CoCr Coronary Stent System

(Codes and Sizes as per Free


3 years

.

Applied on 9-1-2014Letter Issued on 18.3.2014.Reminders issued on 2.3.2015, 18.1.2017, 3.2.2017 & 10.2.2017

Recommended for consideration of Registration Board

Approved subject to provision of following documents within 2 weeks on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and


M/s Life Vascular Devices Biotech, S.L., C.I.F.B-65405169 Cami de Ca n’Ubach, 11 (pol. IND. Les Fallulles), 08620 SANT VICENC, DELS HORTS, Barcelona, Spain.

Sale Certificate)

1’s subject to provision of following documents on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:i. Original & valid

Sole agency agreement provided but not notarized.

quality:(i) Undertaking for

providing Notarized Sole agency agreement as decided by Board.

19. M/s. Health Tec,10-B, Street No.24, Valley Road, Westrige-I Rawalpindi.Legal Manufacturer:M/s Cardionovum Sp. Z.o.o., Panska Str.73,00-834 Warsaw,PolandCoating site:DOT GmBH, Charles Darwin-Ring1a,18059 Rostock,Germany.Assembling of Finished products:Arthesys S.A.20 Rue Traversiere, 92230GENNEVILLIERS, France.

Xlimus Sirolimus Eluting Coronary Stent System

(codes and sizes As per FSC)


1’s

2 years

Applied on 27-08-2015Letter issued on25-11-2015.Reminder issued on19-01-2017.Final reminder issued on 10-02-2017.

Recommended the product for consideration of the Registration Board.


(The firm given undertaken with affidavit binding to provide Free Sale certificate of Spain within 02 weeks for exemption of inspection.)

20. M/s. Ferozsons Laboratories, P.O. Ferozsons,

RebelTM

MonorailTM PtCr Coronary


03 years


Approved subject to provision of following documents within 2 weeks on the


Amangarh, Nowshera,

Legal Manufacturer:M/s Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, USA 01752.

Manufacturing Site:M/s. Boston Scientific Corporation, Maple Grove & plymouth, MN 55311, USA.

Stent System

(Platinum chromium)

(Codes and sizes as per Free Sale Certificate)

Board/ Federal Govt. and Registration Board

1’s

Partial Reply received.Reminder issued on21-01-2017.Final reminder issued on 10-02-2017.

Recommended for consideration of Registration Board subject to provision of following documents with an undertaking on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:1. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.

strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:(i) Original & valid

authorization letter/sole agency agreement from manufactureras decided by Registration Board.

21. M/s Digital Imaging Systems, 121, Habitat Apartment, Ghaus-ul-Azam Road, Shadman II, Lahore .

Responsible Manufacturer:M/s Abbott Vascular, 3200 Lakeside Drive, Santa Clara, California 95054, USA.

Manufacturing Site:M/s Abbott Vascular, Cashel Road,

Xience Alpine Everolimus Eluting Coronary Stent System

(Codes and sizes as per Free Sale Certificate).


1’s

02 years

Applied on 3-12-2015Letter issued on17-1-2017.Reminder on10-02-2017

Recommended for consideration of Registration Board:

Rectified shortcomings of 266th

meeting.i. Sole agency

agreementii. Credentials of

manufacturer.

Approved on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:


Clonmel, County Tipperary, Ireland.

22. M/s Cardevo International (Pvt) Ltd, Office No.120, 4th Floor, Main Boulevard Mega Tower, Gulberg-II, Lahore.

Manufactured By:M/s Accura Medizintechnik GmbH, Max-Planck-Str.33, 61184, Karben, Germany.

Accura Decent S Sirolimus- Eluting Coronary Stent System

Product codes and sizes as per Free Sale Certificate.

.


12 mont

hs

Applied on 2-2-2016Letter sent on 20.1.2017Reminder issued on3.2.2017 & 10.2.2017Deferred the product for the provision of the following documents.

a. Clarification of address of applicant is different on credentials, Form-5A and letter of authorizationb. Brand name in Free Sale certificate is different than as is on Form-5A.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.

Rejected due to following reasons:a. the same product with different brand name form the same source has already been registered with DRAP, the fact was revealed through a letter received from the applicant when the firm was asked for explanation regarding Itrix and Decent S that “Decent S is being manufactured by M/s QualiMed Innovative Medizinprodukte GmbH who is also manufacturing Itrix II for AMG.A confirmation letter from M/s AMG has also been attached mentioning that Itrix II and Decent S are two indentical products with different brand name.b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life brand specific as the firm has provided studies with different brand name.

23. M/s Digital Imaging Systems, 121, Habitat Apartments, Shadman-II, Ghaus-ul-Azam Road, Lahore.

Multilink 8 Coronary Stent System

(cobalt chromium)


3 years

Recommended the product for consideration of the Registration Board



Legal Manufacturer:M/s Abbott Vascular, 3200 Lakeside Drive, Santa Clara, California 95054, USA.Manufacturing Site:M/s Abbott Vascular, Cashel Road, Clonmel, County Tipperary, Ireland.

Product sizes & codes as per Free Sale Certificate.

1’s

24. M/s. Life Cares, M-20 Falaknaz Plaza, Shahra-e-Faisal, Karachi.

Manufactured byM/s. Scitech Products Medicos Ltda, Sao Paolo Brazil.

InspironDrug Eluting Stent

Stent Length (mm): 13, 16, 19, 23, 29, 33,38.

Stent Dia (mm)2.5, 2.75, 3.0, 3.5.


1’s

2 years

Applied on 4-4-2016Letter sent on 19.1.2017 & 10.2.2017Deferred the product for the provision of the following documents.

a. Original & valid Free Sale Certificate as decided by Registration Board (photocopy provided but no signatures found, name of the product on free sale certificate different than its brand name).b. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture as

Rejected due to non-submission of following documents with in due timeand due to strong technical inputs of cardiology experts for non-recommendations, based on their clinical experience ensuring safety, efficacy , quality and availability of alternate in market:-a. Original & valid Free Sale Certificate as decided by Registration Board (photocopy provided but no signatures found, name of the product on free sale certificate different than its brand name).b. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.c. Approval of shelf life from regulatory authority


decided by Registration Board.

or Stability data to support claimed shelf life.d. Original Credentials of manufacturer as decided by Registration Board

25. M/s. Life Cares, M-20 Falaknaz Plaza, Shahra-e-Faisal, Karachi.

Manufactured byM/s. Scitech Products Medicos Ltda, Sao Paolo Brazil

Cronus Bare Metal Stent

(Cobalt Chromium)

Stent Length (mm): 13, 16, 19, 23, 29, 33,38.

Stent Dia (mm)2.5, 2.75, 3.0, 3.5.


1’s

2 years

Applied on 4-4-2016Letter issued on 20-1-2017 and 10.2.2017Deferred the product for the provision of the following documents.a. Original & valid Free Sale Certificate as decided by Registration Board (photocopy provided but no signatures found, name on free sale certificate different than its brand name).b. Clinical data.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture as decided by Registration Board.

Rejected due to non-submission of following documents and on the strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality :-a. Original & valid Free Sale Certificate as decided by Registration Board (photocopy provided but no signatures found, name on free sale certificate different than its brand name).b. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.c. Clinical data.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided by Registration Board.

26. M/s Bio Medics Medical System, F-597, F-Block, Satellite Town,

OSIRA CR Cobalt Chromium Rapamyci


18 mont

hs

Applied on 07-04-2016Letter issued on 19-01-2017.Final reminder issued on 10-02-2017.

Approved subject to provision offollowing documents within 2 weeks:-

(i) Original


Rawalpindi.

Manufactured By:M/s Alco Advanced Lightweight Constructions GmbH, Am Borsigturm 50, 13507, Berlin, Germany.

n Eluting Coronary Stent



1’s

Deferred the product for the provision of the following documents1. Original Credentials of manufacture as decided by Registration Board.2. Original & valid Free Sale Certificate as decided by Registration Board.3. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.4. Clarification of products name on Sole Agency Agreement.

credentials of manufacturer as decided by Registration Board.(ii) Notarized clarificationof Sole agency agreement regarding product name as decided by Registration Board.(iii) Original Free Sale Certificate as decided by Registration Board.

27. M/s Bio Medics Medical System, F-597, F-Block, Satellite Town,Rawalpindi.


OSIRA R4 ® 3l6 LVMRapamycin Eluting Coronary Stent System



1’s

18 mont

hs

Applied on 07-04-2016Letter issued on 19.1.2017.Final reminder issued on 10-02-2017.Deferred the product for the provision of the following documents:1. Original & valid Free Sale Certificate as decided by Registration Board.2. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.3. Original Credentials of manufacture as decided by Registration Board.4. Clarification of products name on Sole Agency

Approved subject to provision of following documents within 2 weeks:

(i) Original credentials of manufacturer as decided by Registration Board.(ii) NotarizedClarification of Sole agency agreement regarding product name as decided by Registration Board.(iii) Original Free Sale Certificate as decided by Registration Board.


Agreement.28. M/s. Promed

International, CB-6349 Amarpak Plaza, Jhelum Road, Rawalpindi

Legal Manufacturer:M/s Biosensors Europe SA, Rue De Lausanne 29, 1110 Morges, Switzerland.

Manufacturing Site:M/s Biosensors Interventional Technologies Pte Ltd, 36 JalanTukang, Singapore 619266, Singapore.

Sterilization Sites:

i. BGS-Beta-Gamma-Service GmbH & Co Kg, Fritz-Kotz-Strasse 16, 51674 Wieth, Germany.

ii. Electron Beam Sdn, Bhd, Lot 7, Jalan Sungai Pinang 4/3, Taman PerindustrianPulau Indah (Fasa 2), 42920 Port Klang, Selagnor, Malaysia.

Axxess TM

Drug Eluting Coronary Bifurcation Stent System.(Biolimus A9)Product sizes and codes as per FSC


1’s

24 months

Applied on 20-4-2016Letter issued on 18.1.2017Letter communicating the Board decision issued on 10-02-2017Deferred the product for the provision of the following documents:-a. Original & valid Free Sale Certificate as decided by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture as decided by Registration Board.e. Copy Valid Drug Sale License,

Approved subject to provision of following documents within 2 weeks on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:

a. Original Free Sale Certificate.b. Original & valid authorization letter/sole agency agreement from manufacturer.

29. M/s. ACP Driver As per 2 Applied on 4-5-2016 Approved subject to


System,13-23, Naval Fleet Club, Iqbal (S.J) Shaheed Road, KarachiLegal Manufacturer:M/s Medtronic, Inc. 710 Medtronic Parkway NE Minneapolis, MN 55432, USA.Manufacturing Site:M/s Medtronic Ireland, Parkmore Business Park West Galway, Ireland.

Sprint Rapid Exchange Coronary Stent System

(cobalt chromium)

(codes and sizes as per FSC of Ireland)

policy decision by Policy Board/ Federal Govt. and Registration Board

1’s

years Letter issued on 18.1.2017Final Reminder on 10.02.2017

Recommended for consideration of Registration Board.

provision of valid free sale certificate on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:

30. M/s. Maxims Medical, 534 H Block, St. No.13, Phase-5, DHA, Lahore.

Manufactured by:M/s Minvasys, 7, rue du Fosse Blanc-92230, Gennevilliers France.

Amazonia SIR Drug Eluting Stent(Sirolimus eluting)Stent Length (mm):8, 12, 16, 20, 24, 28, 32, 36, 40.Stent Dia (mm)2.25, 2.50, 2.75, 3.00, 3.50, 4.00. (As per FSC)


1’s

2 years

Applied on 7-6-2016Letters issued on 19.1.2017 and 10.2.2017

Deferred the product for provision of following documents.a. Original & valid Free Sale Certificate as decided by Registration Board (copy provided).b. Valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board. (copy provided)c. Original Credentials of manufacture as decided by Registration Board.d. Copy Valid Drug Sale License having address written on letter of

Rejected due to non-submission of following documents even after reminder and on the strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality :-a. Original & valid Free Sale Certificate as decided by Registration Board (copy provided).b. Valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board. (copy provided)c. Original Credentials of manufacture as decided by Registration Board.


authorization and form 5A

31. M/s SLT Saving Life Technologies 126-H, Model Town, Lahore.

Manufactured by:M/s Eucatech AG, Rebgartenweg 27, 79567 Weil and Rhein/ Germany.

EUCALIMUSSirolimus Eluting Stent System

Sizes and codes as per Free Sale Certificate.


1’s

24 mont

hs

Applied on 05-08-2016Letter issued on 20.1.2017Deferred the product due to following.(Stents from same source already registered with M/s Radiant Devices Biomedical Pvt. Lahore.Principal manufacturer has issued embassy attested letter of cancellation to previous agent and inform that previous agent is not allowed to sell any their products in Pakistan.Registration Board deferred and decided to Show cause to M/s Radiant Devices for explanation in next meeting in this regard and following shortcomings.a. Original & valid

authorization letter/sole agency agreement from manufacturer with correct address of importer as decided by Registration Board.

Deferred due to following reasons:-In 266thRegistration Board deferredand decided to Show cause to M/s Radiant Devices for explanation in next meeting in this regard and following shortcomings :-a. Original & valid

authorization letter/sole agency agreement from manufacturer as decided by Registration Board. (Original provided is expired).

In response to show cause M/s Radiant Devices Biomedical (Pvt) Limited, Lahore has informed that they never received any written notice of the termination of their agreement with the said company as per contractual requirement. The company has also never written to them about any discontinuation of sale. However, some of their products have been reported to be available in the market through some other importer.They have had no commercial transaction with the company M/s Eucatech, after 2014 and their product pipeline also does not look promising


enough. Additionally, they are not selling any of their products at moment.Registration Board decided to call the firm M/s Radiant for personal hearing as a final opportunity in the next meeting.

32. M/s Promed International, CB-6349 Amar Pak Plaza, Jhelum Road, Rawalpindi

Legal Manufacturer:M/s Biosnsor Europe SA, Rue De Lausanne 29, 1110 Morges, Switzerland.

Manufacturing Site:M/s Biosensors Interventional Technologies Pte Ltd, 36 Jalan Tukang, Singapore 619266, Singapore.Sterilization Site:1. BGS-Beta-Gamma-Service GmbH & Co Kg, Fritz-Kotz-Strasse 16, 51674 Wieth, Germany.2. Electron Beam Sdn, Bhd, Lot 7, Jalan Sungai Pinang 4/3,

BioMatrix Alpha TM Drug Eluting Coronary Stent System

(Biolimus A9)

(Codes and sizes as per FSC.)


1’s

12 mont

hs

Applied on 17-11-2016Letter issued on 20.1.20172ND Reminder issued on 02.02.2017Final reminder issued on 10-02-2017.Recommended for consideration of Registration Board subject to provision of following documents on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:1. Original

Credentials of manufacture as decided by Registration Board. (Copy provided)



Taman Perindustrian Pulau Indah (Fasa 2), 42920 Port Klang, Selagnor, Malaysia.


Case No.02: Deferred Products:Assistant Director-1

CathetersS.No

Name of Importer and Manufacture/

Exporter.


(s)

Price & Pack size

Shelf life

Recommendations Of Cardiologists in

evaluation cell

Decision

1. M/s ACP Systems, Karachi.

Manufactured by:M/s Medtronic Ireland, Parkmore Business Park West, Galway Ireland.

Shipped From:Medtronic Trading NL BV, Earl Bakkenstraat 10, Neatherland.

Sprinter NC/SC RX Balloon Dilatation, Intravascular Catheters.


1’s

24 month

s

Applied on 3-8-2012Letter issued on 23.10.2012, 11.7.2013, 06.1.2015 &10.2.2017

Deferred for following documents and called the firm for personal hearing in 267th meeting of Registration Board:a. Differential fee PKR.35,000/-,b. Original & valid Free Sale Certificate as decided by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.d. Clinical data.e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.f. Original Credentials of manufacture as decided by Registration Board.

Rejected as the firm has separately applied for change of manufacturing site from USA to Mexico and non-submission of following documents even after multiple reminders :-a. Differential fee PKR.35,000/-,b. Original & valid Free Sale Certificate as decided by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided by Registration Board.

2. M/s ACP Systems, Karachi

Sprinter Legend RXBalloon


24 month

s

Applied on 3-8-2012Letter Issued on 23.10.2012, 11.7.2013,

Rejected as the firm has separately applied for change of manufacturing site


Manufactured by:M/s Medtronic Ireland, Parkmore Business Park West, Galway Ireland.

Shipped From:Medtronic Trading NL BV, Earl Bakkenstraat 10, Neatherland.

Dilatation, Intravascular Catheters.


1’s

06.1.2015 &10.2.2017

Deferred for following documents and called the firm for personal hearing in 267th meeting of Registration Board:a. Differential fee PKR.35,000/-,b. Original & valid Free Sale Certificate as decided by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.d. Clinical data.e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.f. Original Credentials of manufacture as decided by Registration Board.

from USA to Mexico and non-submission of following documents even after multiple reminders :-a. Differential fee PKR.35,000/-,b. Original & valid Free Sale Certificate as decided by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided by Registration Board.


Manufactured byM/s Medtronic Mexico s.de R.L.de CV,Mexico

Shipped From:Medtronic Trading NL BV, Earl

Sprinter Legend RX Balloon Dilatation, Intravascular Catheters.


24 month

s

Applied on 3-8-2012Letter Issued on 23.10.2012, 11.7.2013, 6.1.2015 & 10.2.2017

Deferred for following documents and called the firm for personal hearing in 267th meeting of Registration Board:a. Differential fee PKR.35,000/-,b. Original & valid Free Sale

Rejected as the firm has separately applied for change of manufacturing site from USA to Mexico and non-submission of following documents even after multiple reminders :-a. Differential fee PKR.35,000/-,b. Original & valid Free Sale Certificate as decided by Registration Board.c. Original &


Bakkenstraat 10, Neatherland.

Certificate as decided by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.d. Clinical data.e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.f. Original Credentials of manufacture as decided by Registration Board.

valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided by Registration Board.


Manufactured byM/s Medtronic Mexico s.de R.L.de CV, Mexico

Catheters.


24 month

s

Applied on 3-8-2012Letter Issued on 23.10.2012, 11.7.2013 & 10.2.2017.

Deferred for following documents and called the firm for personal hearing in 267th meeting of Registration Board:-a. Differential fee PKR.35,000/-,b. Clarification as product applied not specified.c. Original & valid Free Sale Certificate as decided by Registration Board.d. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.

Rejected as applicant has withdrawn the registration application.


e. Clinical data,f. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.g. Original Credentials of manufacture as decided by Registration Board.h. Copy Valid Drug Sale License.


Manufactured by:M/s Medtronic, Inc, USA

Catheters.


36 month

s

Applied on 3-8-2012Letter Issued on 23.10.2012, 11.7.2013 and 10.2.2017.

Deferred for following documents and called the firm for personal hearing in 267th meeting of Registration Board:-a. Differential fee PKR.35,000/-,b. Clarification as product applied not specified.c. Original & valid Free Sale Certificate as decided by Registration Board.d. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.f. Original Credentials of manufacture as

Rejected as applicant has withdrawn the registration application.


decided by Registration Board.g. Copy Valid Drug Sale License.


Manufactured by:M/s.Datascope Corporation, `15 Law Drive, Fairfield, New Jersey 7400, USA.

Sensation Plus Intra Aortic Balloon Catheter.

(codes/sizes As per FSC)


1’s

Not mentioned

in form 5-A.

Application on 11.9.2013Letters issued on 26.3.2014 & 15.2.2017.Recommended for consideration of Registration Board subject to provision of following documents on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:

a. Original & valid Free Sale Certificate as decided by Registration Board. (Original embassy attested is expired)b. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Valid Drug Sale Licence.

Approved subject to provision of following documents within 2 weeks on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:-a. Original & valid Free Sale Certificate as decided by Registration Board. (Already provided is expired)b. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Valid Drug Sale Licence.

(Mr Bilal of applicant firm was contacted telephonically by Prof. Dr. Nadeem Hasan Rizvi who informed to provide undertaking regarding authorization letter from manufacturer in 1 day.Cardiology experts committed to peruse the applicant for submission of deficient documents)



Manufactured by:M/s.Datascope Corporation, `15 Law Drive, Fairfield, New Jersey 7400, USA.

Linear Intra Aortic Balloon Catheter.

7.5 FR.


1’s

Not mentioned

in form 5-A.

Application date 11.9.2013Letters issued on26.3.2014 & 15.2.2017.

Recommended for consideration of Registration Board subject to provision of following documents on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:a. Original & valid Free Sale Certificate as decided by Registration Board. (Original embassy attested is expired)b. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Valid Drug Sale Licence.

Approved subject to provision of following documents within 2 weeks on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:-a. Original & valid Free Sale Certificate as decided by Registration Board. (Already provided is expired)b. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Valid Drug Sale Licence.


8. M/s Interex Company,195 Block 7/8 KMCHS Justice

Mega Intra Aortic Balloon Catheter.

As per policy decision by Policy Board/

Not mentioned

in form

Application on 11.9.2013Letters issued on 26.3.2014 & 15.2.2017.

Approved subject to provision offollowing documents within 2 weeks on the strong recommendations of


Inamullah Road, Karachi.

Manufactured by:M/s Datascope Corporation, `15 Law Drive, Fairfield, New Jersey 7400, USA.

Codes and sizes as per Free Sale Certificate.

Federal Govt. and Registration Board

1’s

5-A.Recommended for consideration of Registration Board subject to provision of following documents on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:

a. Original & valid Free Sale Certificate as decided by Registration Board. (Original embassy attested is expired)b. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Valid Drug Sale Licence.

cardiology experts based on their clinical experience ensuring safety, efficacy and quality:-a. Original & valid Free Sale Certificate as decided by Registration Board. (already provided is expired)b. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Valid Drug Sale Licence.



Manufactured by:1.

Z-Med II Catheter.



1’s

Not mentioned

in form 5-A.

Applied 24-09-2013.Letters issued on06.6.2014 & 15.2.2017.

Deferred for provision of following documents and expert opinion:a. Original,


a. Original & valid Free Sale Certificate as decided by Registration Board.b. Original & valid authorization


M/s.NuMed, Inc 2880 Main Street, Hopkinton, NY, 12965, USA.

2. M/s.NuMed Canada, Inc 45 Second Street West, Cornwall, Ontario K6J1G3, Canada.

embassy attested and valid Free Sale Certificate as decided by Registration Board.b. Original, notarized and valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.c. Conformation of sourced. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Valid Drug Sale Licence.

letter/sole agency agreement from manufacturer as decided by Registration Board.c. Conformation of sourced. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Valid Drug Sale Licence.

(Mr Bilal of applicant firm was contacted telephonically by Prof. Dr. Nadeem Hasan Rizvi during Board meeting who committed to provide confirmation of source within 1 day otherwise product shall be deferred. The firm has not provided confirmation of souce i.e USA or Canada).Cardiology experts also committed to peruse the applicant for submission of deficient documents on urgent basis )

10. M/s Interex Company,195 Block 7/8 KMCHS Justice Inamullah Road, Karachi/

Manufactured by:1.

M/s.NuMed, Inc 2880 Main Street, Hopkinton,

Tyshak II Catheter



1’s

Not mentioned

in form 5-A.

Applied 24-09-2013.Letters issued on06-06-2014 and15-2-2017.

Deferred for provision of following documents and expert opinion:-a. Original, embassy attested and valid Free Sale Certificate as decided by Registration Board.b. Original,

Deferred for provision of following documents:-a. Original & valid Free Sale Certificate as decided by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.c. Conformatio


NY, 12965, USA.


notarized and valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.c. Conformation of sourced. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Valid Drug Sale Licence.

n of sourced. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Valid Drug Sale Licence.

(Mr Bilal of applicant firm was contacted telephonically by Prof. Dr. Nadeem Hasan Rizvi during Board meeting who committed to provide confirmation of source within 1 day otherwise product shall be deferred. The firm has not provided conformation of souce i.e USA or Canada).Cardiology experts also committed to peruse the applicant for submission of deficient documents on urgent basis )


Manufactured by:1.


2. M/s.NuMed

Z-5 Catheter.



1’s

Not mentioned

in form 5-A.

Applied 24-09-2013.Letter issued on06-06-2014 and15-2-2017.

Recommended for consideration of Registration Board subject to provision of following documents on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:-a. Original,

Deferred for provision of following documents:-a. Original & valid Free Sale Certificate as decided by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.c. Conformation of source.d. Approval of shelf life from regulatory authority


Canada, Inc 45 Second Street West, Cornwall, Ontario K6J1G3, Canada.

embassy attested and valid Free Sale Certificate as decided by Registration Board.b. Original, notarized and valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.c. Conformation of sourced. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Valid Drug Sale Licence.

or Stability data to support claimed shelf life.e. Valid Drug Sale Licence.



Manufactured by:1.


2. M/s.NuMed Canada, Inc 45 Second Street West, Cornwall,

BIB Stent Placement Catheter

Sizes/codes / model as per Free Sale Certificate.


1’s

Not mentioned

in form 5-A.


Recommended for consideration of Registration Board subject to provision of following documents on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:-a. Original, embassy attested and valid Free Sale Certificate as decided by

Deferredfor provision offollowing documents:

a. Original & valid Free Sale Certificate as decided by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.c. Conformation of sourced. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Valid Drug Sale Licence.


Ontario K6J1G3, Canada.

Registration Board.b. Original, notarized and valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.c. Conformation of sourced. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Valid Drug Sale Licence.



Manufactured by:1.



Bonhoeffer Multi-Track Mitral Dilatation Kit.

Sizes/codes / model as per Free Sale Certificate.


Not mentioned

in form 5-A.


Recommended for consideration of Registration Board subject to provision of following documents on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:

a. Original, embassy attested and valid Free Sale Certificate as decided by Registration Board.b. Original, notarized and valid authorization

Deferredfor provision offollowing documents:

a. Original & valid Free Sale Certificate as decided by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.c. Conformation of sourced. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Name of product as per FSC.f. Valid Drug Sale Licence.

(Mr Bilal of applicant firm was contacted


letter/sole agency agreement from manufacturer as decided by Registration Board.c. Conformation of sourced. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Valid Drug Sale Licence.

telephonically by Prof. Dr. Nadeem Hasan Rizvi during Board meeting who committed to provide confirmation of source within 1 day otherwise product shall be deferred. The firm has not provided conformation of souce i.e USA or Canada).Cardiology experts also committed to peruse the applicant for submission of deficient documents on urgent basis )

14. M/s Surgi World,303 Mohammadia Plaza, College Road, Rawalpindi

Manufactured by:M/s Medcomp, 1499 Delp Drive Harleys Villa, USA.

Pro-Picc ® Central Vein Infusion Catheter. (All sizes)


5 years

The experts did not recommended the product due to following reasons:Firm has informed to withdraw application.

Shortcomings:a. Differential fee PKR.35,000/-,b. Original & valid Free Sale Certificate as decided above by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.d. Clinical data, if any,e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.f. Original Credentials of

Rejected as the firm has withdrawn the registration application.


manufacture as decided above by Registration Board.g. Copy Valid Drug Sale License,



Vascu-Picc ® Central Vein Infusion Catheter(All sizes)


5 years


Shortcomings:a. Differential fee PKR.35,000/-,b. Original & valid Free Sale Certificate as decided above by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.d. Clinical data, if any,e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.f. Original Credentials of manufacture as decided above by Registration Board.g. Copy Valid Drug Sale License.

Rejected as the firm has withdrawn the registration application


Multi-Cath Central Vein Infusion Catheter(All sizes, Single, Double


5 years


Shortcomings:a. Differential

Rejected as the firm has withdrawn the registration application



and Triple Lumen)

fee PKR.35,000/-,b. Original & valid Free Sale Certificate as decided above by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.d. Clinical data, if any,e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.f. Original Credentials of manufacture as decided above by Registration Board.g. Copy Valid Drug Sale License.

17. M/s Johnson & Johnson Pakistan (Pvt) Limited, Fl.19, Sub Plot F-1, Kehkashan Scheme No.5, Main Boat Basin, Clifton, Karachi.

Legal Manufacturer:M/s Cordis Cashel, Cahir Road, Cashel, Co. Tipperary, Ireland

Manufacturing site:M/s Cordis de Mexico, S.A. de C.V. Circuito Interior Norte #

Aviator Plus PTA Balloon Dilatation Catheter

Codes as per FSC.


1’s

3 years

Applied on 8-9-2014Letter issued on 23.2.2015, 3.2.2017 and 10.2.2017Deferred for provision of following documents:a. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life or approval of change of name of product.c. Original Credentials of


a. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life or approval of change of name of product.c. Original Credentials of manufacture as decided by Registration Board.

(Firm regulatory Minutes for 267th Registration Board Meeting 44

1820 Parque Industrial Salvarcar Ciudad Juarez, Chihuahua CP 32574 Mexico.

manufacture as decided by Registration Board.

manager informed the Board to provide above documents on 2nd day of meeting but did not comply)

18. M/s Johnson & Johnson Pakistan (Pvt) Limited, Fl.19, Sub Plot F-1, Kehkashan Scheme#5, Main Boat Basin, Clifton, Karachi.Legal Manufacturer:M/s Cordis CashelCahir Road, Cashel Co. Tipperary, Ireland.Manufacturing site:M/s Cordis de Mexico, S.A. de C.V. Circuito Interior Norte # 1820 Parque Industrial Salvarcar Ciudad Juarez, Chihuahua CP 32574 Mexico.

Slalom PTA Balloon Dilatation Catheter

Product Codes as perFree sale certificate.


1’s

3 years

Applied on 30.10.2014.Letter issued on 23.2.2015, 3.2.2017 and 10.02.2017.

Deferred for provision of following documents:a. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.b. Original Credentials of manufacture as decided by Registration Board.


a. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.b. Original Credentials of manufacture as decided by Registration Board.

(Firm regulatory manager informed the Board to provide above documents on 2nd day of meeting but did not comply)


Manufacturer:M/s Clear Stream Technologies Ltd, Moyne

Sleek PTA Balloon Dilatation Catheter

(Sizes & codes as per Free Sale Certificate)


1’s

3 years

Applied on 11.12.2014Letter issued on 14.9.2015, 3.2.2017 and 10.2.2017.

Deferred for provision of following documents:-a. Original valid authorization letter/sole agency agreement from manufacturer as decided by

Deferred for provision of following documents:-

a. Original valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.b. Approval of shelf life from regulatory authority or Stability data to


Upper Enniscorthy County Wexford, Ireland.

Registration Board.b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life or approval of change of name.c. Original Credentials of manufacture as decided by Registration Board.

support claimed shelf life or approval of change of name.c. Original Credentials of manufacture as decided by Registration Board.

(Firm regulatory manager informed the Board to provide above documents on 2ndday of meeting but did not comply)

20. M/s Johnson & Johnson Pakistan (Pvt) Ltd, Fl.19, Sub Plot F-1, Kehkashan Scheme No.5, Main Boat Basin, Clifton, Karachi.

Manufacturer:M/s Clear Stream Technologies Ltd, Moyne Upper Enniscorthy County Wexford, Ireland.

Sleek OTW PTA Balloon Dilatation Catheter

(Sizes and codes as per Free Sale Certificate).


1’s

3 years

Applied on 11.12.2014Letter issued on 14.9.2015, 3.2.2017 and 10-02-2017.

Deferred for provision of following documents:-a. Original valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.b. Original Credentials of manufacture as decided by Registration Board.


a. Original valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.b. Original Credentials of manufacture as decided by Registration Board.

(Firm regulatory manager informed the Board to provide above documents on 2nd day of meeting but did not comply)

21. M/s Johnson & Johnson Pakistan (Pvt) Limited, Fl.19, Sub Plot F-1, Kehkashan Scheme No.5, Main Boat Basin, Clifton, Karachi.Legal Manufacturer:M/s Siemens Medical Solutions USA, Inc. 685 East Middlefield

AcuNav TM

Diagnostic Ultrasound Catheter

8F and 10F


1’s

3 years

Applied 22-4-2014Letter issued on 18.2.2015 & 10.2.2017.

Deferred for provision of following documents:-a. Application on Form-5A as per prescribed format.b. Original & valid Free Sale Certificate as decided by Registration Board


a. Application on Form-5A as per prescribed format.b. Original & valid Free Sale Certificate as decided by Registration Board (Original Embassy Attested Expired).c. Original & valid authorization


Road, Mountain View, CA 94043 USAManufacturing site:M/s Siemens Ltd Seoul, 2nd& 3rd Venture Building, Pohang Technopark, 394, Jigok-ro-Nam-gu Pohang-si, Gyeongsangbugdo, 790-834, Republic of Korea.

(Original Embassy Attested Expired).c. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided by Registration Board.

letter/sole agency agreement from manufacturer as decided by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided by Registration Board.

Stents:S.# Name of

Importer & Manufacture/

Exporter.


Price & Pack size

Shelf life


evaluation cell

Decision

1. M/s. SES Associates,61-Bank Square Market, Model Town, Lahore.

Manufactured byM/s. QualiMed Innovative Medizinproduket GmbH, BoschstraBe 16, D-21423, Winsen, Germany.

Navalis Peripheral Vascular Self Expending Stent System

Sizes and codes as per FSC.


1’s

3 years

Applied on 11.12.2012Letter issued on 24.4.2013, 02.03.2015 and 15.02.2017


a. Original & valid authorization letter/sole agency agreement from


a. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.b. Original Credentials of manufacture as decided by Registration Board.c. Copy of valid drug sale licence.


manufacturer as decided by Registration Board.b. Original Credentials of manufacture as decided by Registration Board.c. Copy of valid drug sale licence.


Assistant Director- II

Stents deferred in 266th meeting of Registration BoardS.No.

Name of Importer &



Price & Pack size

Shelf life


evaluation cell

Decision

1. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.

Legal Manufacturer:M/s Boston Scientific Corporation, 300 Boston Scientific Way Marlborough, MA, 01752, USA.

Manufacturing Site:M/s. Boston Scientific Corporation, Two Scimed Place, Maple Grove, MN 55311, USA.Sterilization Site:M/s Synergy Health (Tullamore), IDA Business and Technology Park, Tullamore County Offaly, Ireland.

Wallstent-UniTM

Endoprosthesis Self Expanding Stent



25month

s

Applied on 25.7.2016Letter issued 18.1.2017Reminder on 10.2.2017

Recommended for consideration of Registration Board subject to provision of following documents with an undertaking on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:a. Original & valid

authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.

b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.

Approved subject to provision of following documents within 2 weeks on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:-a. Original & valid




Wallgraft TM Over The Wire Endoprosthesis with


30month

s

Applied on 25-7-2016Letter issued 18.1.2017Final Reminder on 10.02.2017.

Approved subject to provision offollowing documents within 2 weeks on the strong recommendations of cardiology experts


Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752,USA.

Manufacturing Site:M/s Boston Scientific Corporation, Ballybrit Business Park, Galway, Ireland.

Unistep TM Plus Delivery System



1’s

Recommended for consideration of Registration Board subject to provision of following documents with an undertaking on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:a. Original & valid



based on their clinical experience ensuring safety, efficacy and quality:-a. Original & valid




Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.

Manufacturing Site:

Advanix Biliary Stent with NaviFlex RX Delivery SystemPre-loaded center bend.



1’s

2 Years

Applied on 24-1-2017Letter issued on 01.2.2017.Reminder issued on 10.02.2017.Recommended for consideration of Registration Board subject to provision of following documents with an undertaking on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions

Approved subject to provision of following documents within 2 weeks on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:-a. Original & valid Free Sale Certificate as decided above by Registration Board.c. Original & valid authorization letter/sole agency agreement from


M/s Boston Scientific Corporation, 780 Brookside Drive, Spencer IN-47460, USA.

(public and private) in the larger public interest:a. Original & valid Free Sale Certificate as decided above by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Boardc. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.

manufacturer as decided above by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.

4. M/s. Ferozsons Laboratories, P.O. Ferozsons, Amangarh, Nowshera.

Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, USA 01752.

Manufacturing Site:M/s. Boston Scientific Corporation, two scimed place MAPLE GROVE, MN USA 55311

Epic TM

Over The Wire Self- Expanding Nitinol Stent with Delivery System

(Product codes and sizes as per Free Sale Certificate.)


1’s

37 month

s

Applied on 15.7.2016Letter issued on 01.02.2017.Final reminder issued on 10.02.2017

Recommended for consideration of Registration Board subject to provision of following documents with an undertaking on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:a. Original & valid Free Sale Certificate as decided above by Registration Board.b. Original & valid authorization

Approved subject to provision of following documents within 2 weeks on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:-a. Original & valid

Free Sale Certificate as decided above by Registration Board.

b. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.

c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.


letter/sole agency agreement from manufacturer as decided above by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.

Stent Fresh Application

S. No.

Name of Importer &

Manufacture/Exporter.


Price & Pack size

Shelf life


evaluation cellDecision

1. M/s Digital Imaging System, 121 Habitat, Shadman II , Ghaus-ul-Azam Road,Lahore.

Legal Manufacturer:M/s Abbott Vascular, 3200 Lakeside Drive, Santa Clara, California 95054, USA.

Manufacturing Site:M/s Abbott Vascular, Cashel Road, Clonmel, County Tipperary, Ireland.

Accunet Rx Embolic Protection SystemCarotid stent.



1’s

02 years

Applied on 06.2.2017Letter issued on 15.02.2017

Recommended for consideration of Registration Board subject to provision of following documents on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:-

i. Clearly mention types of each device along with product codes and sizes.

ii. Complete specifications with details of analytical procedures.iii. Approval of

shelf life from the regulatory authority or Stability studies conducted with data.

Approved subject to provision of following documents within 2 weeks on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:-

i. Clearly mention types of each device along with product codes and sizes.

ii. Approval of shelf life from the regulatory authority or Stability studies conducted with data.iii. Original &

valid Free Sale Certificate from the regulatory authority in the country of origin.


iv. Last inspection report of concerned regulatory authority.

v. Original & valid Free Sale Certificate from the regulatory authority in the country of origin.

vi. Valid QMS-13485 certificate.

2. M/s. Digital Imaging System, 121 habitat, Shadman II , Ghaus-ul-Azam Road,Lahore.Legal Manufacturer:M/s Abbott Vascular, 3200 Lakeside Drive, Santa Clara, California 95054, USA.

Manufacturing Site:M/s Abbott Vascular, Cashel Road, Clonmel, County Tipperary, Ireland

Graft Master RX Coronary Stent Graft System

Dia (mm)2.8,3.5,4.0,4.5,4.8.Length (mm)16,19,26.


1’s

01 years/ 12 months




3. M/s Ferozsons Laboratories Limited, P.O Ferozsons Amangarh, Nowshera,

Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough,

Percuflex Duodenal Bend Bilary Stent



1’s

03 years


Recommended for consideration of Registration Board subject to provision of following documents with an undertaking on urgent basis on the recommendations of cardiologists

Deferred for the provision of following documents:

i. Clarify as product brand name different on copy of free sale certificate and on Form 5A.

ii. Original Free Sale Certificate from the country of origin duly endorsed by


MA, 01752, USA.

Manufacturing Site:M/s. Boston Scientific Corporation, 780 Brookside Drive, Spencer IN-47460, USA.

regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:

i. Clarify as product brand name different on free sale certificate and on Form 5A.

ii. Original Free Sale Certificate from the country of origin duly endorsed by Embassy of Pakistan in the country of origin.iii. Complete

specifications with details of analytical procedures.

iv. Outline of method of manufacture

v. Approval of shelf life from regulatory authority or Stability studies conducted with data.

vi. Type of container/Package/Pack size(s).vii. Complete brochure and Labels for each device.viii. Original Sole agency agreement with the manufacturer abroad/Authorization letter duly notarized.

ix. Clinical Data, if any.

x. Credentials of the manufacturer abroad duly notarized.

xi. Copy of valid Drug Sale Licence.

Embassy of Pakistan in the country of origin.

iii. Approval of shelf life from regulatory authority or Stability studies conducted with data.

iv. Original Sole agency agreement with the manufacturer abroad/Authorization letter duly notarized.

v. Credentials of the manufacturer abroad duly notarized.

vi. Copy of valid Drug Sale Licence.


4. M/s Ferozsons Laboratories Limited,P.O Ferozsons Amangarh, Nowshera,

Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.


Percuflex Duodenal Bend Bilary Stent With Introducer Kit



1’s

03 years

Letter issued on 15.2.2017.

Recommended for consideration of Registration Board subject to provision of following documents with an undertaking on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:i. Original Free Sale certificate as decided by Registration Board in 266th meeting.ii. Please clarify product brand name as per free sale certificate and on Form 5A.

iii. Complete specifications with details of analytical procedures.

iv. Outline of method of manufacturev. Approval of shelf life from regulatory authority or Stability studies conducted with data.

vi. Type of container/Package/Pack size(s).

vii. Complete brochure and Labels for each device.

viii. Original Sole agency agreement with the manufacturer abroad/Authorization letter duly

Deferred for next meeting.On the recommendation of cardiologist for following documents:-

i. Clarify as product brand name different on copy of free sale certificate and on Form 5A.

ii. Original Free Sale Certificate from the country of origin duly endorsed by Embassy of Pakistan in the country of origin.

iii. Approval of shelf life from regulatory authority or Stability studies conducted with data.

iv. Original Sole agency agreement with the manufacturer abroad/Authorization letter duly notarized.

v. Credentials of the manufacturer abroad duly notarized.

vi. Copy of valid Drug Sale Licence.


notarized.ix. Credentials of the company duly notarized.x. Clinical Data, if any.


5. M/s Atco Pharma International (Pvt) ltd.B-18, S.I.T.E.,Karachi-75700.

Manufactured by:M/s CID S.P.AStrada Per Crescentino sns, 13040 Saluggia (VC), Italy.

CRE8 AMPHILUMUS ELUTING CORONARY STENT


(Drug Eluting Stent)


1’s

2 years


Deferred the product for provision of following documents:

i. Original Sole agency agreement with the manufacturer abroad/Authorization letter duly notarized.

ii. Original Credentials of the manufacturer abroad duly notarized.iii. Analytical

Procedure and Specification.

iv. Clinical trial Data, if any

v. Labelling information.


i. Credentials of the manufacturer abroad duly notarized.

ii. Original Sole agency agreement with the manufacturer abroad/Authorization letter duly notarized.iii. Copy of valid

Drug Sale Licence.iv. Analytical


v. Clinical trial Data

vi. Labelling information.

6. M/s Atco Pharma International (Pvt) ltd.B-18, S.I.T.E.,Karachi-75700.


ADVANTGRADE CHRONO CORBOSTENT

(Sizes and codes as per Free Sale certificate)

(Bare


1’s

5 years




ii. Original Credentials of the


i. Credentials of the manufacturer abroad duly notarized.

ii. Original Sole Agency agreement with manufacturer abroad duly notarized.iii. Copy of valid

Drug Sale Licence.i. Analytical

Procedure and


Metal Stent)

manufacturer abroad duly notarized.iii. Analytical

Procedure & Specification.

iv. Clinical trial Data, if any.

v. Labelling information.

Specification.ii. Labelling

information.


Catheters deferred in 266th meeting of Registration BoardS.

No.Name of


Exporter.


(s)

Price & Pack size

Shelf life


evaluation cell

Decision

1. M/s. SES Associates Institutional Distributors & Govt. Suppliers, Lahore.

Manufactured byM/s. Kimal Plc. Arundel Road, Uxbridge, Middlesex, UB8, United Kingdom.

Angio FLOWCardiac Catheter

(Product codes and sizes as per Free Sale Certificate)


1’s

02 years

Applied on 23-8-2011.Letter issued on 24.10.2012.Reminder issued on 16.11.2016.Final reminder on 3.2.2017Not recommended due to following reasons:a. Differential fee PKR.35,000/-,b. Original & valid Free Sale Certificate as decided above by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.d. Clinical data, if any,e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.f. Original Credentials of manufacture as decided above by Registration Board.g. Copy Valid Drug Sale License,

Rejected due to non-submission of following documents even after reminder and on strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality :-a. Differential fee PKR.35,000/-,b. Original & valid Free Sale Certificate as decided above by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board.f. Copy Valid Drug Sale License,

2. M/s Hakimsons (Pvt) Ltd, Hakimsons House, A/56 S.I.T.E. Manghopir Pir Road, Karachi.

Xperience Coronary Balloon Dilatation Catheter

As per policy decision by Policy Board/ Federal Govt. and

3 years.

Applied on 9-1-2014Letter issued on 18.3.2014.reminders issued on 2.3.2015Letter Issued 18.1.2017.

Approved subject to provision of following documents within 2 weeks on the strong recommendations of cardiology experts based on their clinical


Manufactured by:M/s Life Vascular Devices Biotech, S.L., C.I.F. B-65405169, Cami de Ca n’Ubach, 11 (pol. IND. Les Fallulles), 08620 SANT VICENC, DELS HORTS, Barcelona, Spain.

Balloon Length (mm): 10, 15, 20, 25,30, 40.

Balloon Dia (cm): 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50.

Registration Board1’s

Letter issued 3.2.2017Reminder on 10.2.2017

Recommended for consideration of Registration Board subject to provision of following documents on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:a. Approval of

shelf life from regulatory authority or Stability data to support claimed shelf life.

b. Original & valid Sole agency agreement provided but not notarized.

experience ensuring safety, efficacy and quality:-a. Approval of shelf

life from regulatory authority or Stability data to support claimed shelf life.

b. Undertaking for notarization of sole agency agreement as decided by board.

3. M/s Hakimsons (Pvt) Ltd, Hakimsons House, A/56/ S.I.T.E. Manghopir Pir Road, Karachi.

Manufactured by:M/s Life Vascular Devices Biotech, S.L., C.I.F. B-65405169, Cami de Ca n’Ubach, 11 (pol. IND. Les Fallulles), 08620 SANT

Oceanus 35 PTA Balloon Dilatation Catheter

Balloon Length (mm): 20, 40, 60, 80,120, 150, 200.

Balloon Dia (cm): 5, 6, 7,8, 9, 10, 12.

Catheter


1’s

3 years.

Letter issued on 18.3.2014.reminders issued on 2.3.2015Letter issued 18.1.2017.Letter issued 3.2.2017Reminder 10-02-2017

Recommended for consideration of Registration Board subject to provision of following documents on urgent basis on the recommendations of cardiologists regarding cardiac,

Approved subject to provision of following documents within 2 weeks on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:-a. Approval of shelf


b. Undertaking for notarization of sole agency


VICENC, DELS HORTS, Barcelona, Spain.

Length (cm): 80, 140.

vascular and ancillary procedures in the institutions (public and private) in the larger public interest:a. Original & valid Free Sale Certificate as decided above by Registration Board.b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.c. Original & valid Sole agency agreement provided but not notarized.

agreement as decided by board.

d. Original & valid Free Sale Certificate as decided above by Registration Board.

4. M/s Hakimsons (Pvt) Ltd, Hakimsons House, A/56/S.I.T.E. Manghopir Pir Road, Karachi.

Manufactured by:M/s Life Vascular Devices Biotech, S.L., C.I.F. B-65405169, Cami de Ca n’Ubach, 11 (pol. IND. Les Fallulles), 08620 SANT VICENC, DELS HORTS, Barcelona, Spain.

Oceanus 14 Peripheral Balloon Dilatation Catheter

Balloon Length (mm): 40, 60, 80,120, 150, 200.

Balloon Dia (cm): 1.5, 2.0, 2.5, 3.0, 3.5, 4.0.

Catheter Length (cm): 100, 150.


1’s

3 years.

Letter Issued on 18.3.2014.reminders issued on 2.3.2015Letter issued 18.1.2017.Letter issued 3.2.2017.reminder 10-02-2017

Recommended for consideration of Registration Board subject to provision of following documents on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:a. Original & valid Free Sale Certificate as decided above by Registration Board.

Approved subject to provision of following documents within 2 weeks on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:-c. Approval of shelf


d. Undertaking for notarization of sole agency agreement as decided by board.

e. Original & valid Free Sale Certificate as decided above by Registration Board.


b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.c. Original & valid Sole agency agreement provided but not notarized.

5. M/s Genus,220, D.M.C.H.S, Block-3 Sirajuddaula Road, Karachi.

Manufactured By:M/s Umbra Medical Products, Inc, 8930 East Roan Lane, Inverness, Florida 34450 USA.

Hawk PTCA Ballon Catheter Non Compliant



1’s

2 years

Applied on 4-11-2015Letter issued on 11.8.2016. Reminder issued on 18.1.2017.Letter issued on 10.2.2017Recommended for consideration of Registration Board subject to provision of following documents on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:a. Original & valid

Free Sale Certificate provided but expired.

Approved on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality. Firm will provide undertaking for providing Embassy Attested Free sale certificate as decided by Board.


Manufactured By:M/s Umbra Medical Products, Inc, 8930 East Roan

Falcon Guiding Catheter



1’s

3 years

Applied on 5-11-2015Letter Issued on 11.8.2016.Reminder issued on 18.1.2017.Letter issued on 10.2.2017Recommended for consideration of Registration Board subject to provision of following documents on urgent

Approved on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy & quality. Firm will provide undertaking for providing Embassy Attested Free sale certificate as decided by Board.


Lane, Inverness, Florida 34450 USA.

basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:a. Original & valid



Manufactured By:M/s Umbra Medical Products, Inc, 8930 East Roan Lane, Inverness, Florida 34450 USA.

Hawk PTCA Balloon Catheter Semi Compliant



1’s

2 years

Applied on 5-11-2015Letter Issued on 11.8.2016. Reminder issued on 18.1.2017.Letter issued on 10.02.2017

Recommended for consideration of Registration Board subject to provision of following documents on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:a. Original & valid


Approved on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality. Firm will provide undertaking for providing Embassy Attested Free sale certificate as decided by Board.

8. M/s. ACP System, 13-23, Naval Fleet Club, Iqbal (S.J) Shaheed Road, Karachi.Owner Operator:

Pro-Flo Diagnostic Angiography Catheter

Types,


3 years

Applied on16-3-2016.Letter issued on 18.1.2017.Letter issued on 3.2.2017Final reminder issued on 10.2.2017



M/s Medtronic, Inc. 710 Medtronic Parkway NE Minneapolis, MN 55432, USA.Legal Manufacturer:M/s Medtronic Vascular37A Cherry Hill Dr DANVERS MA USA 01923Contract Manufacturing Site:M/s Availmed S.A. De C.V. Av. Paseo Reform No. 8950 Interior (B1, C1, E1, E2, F2, G1) (Local A.B.C.G.H) La Mesa, Tijuana, Baja California 22116, Mexico.

Sizes & Models as per Free Sale Certificate.

Registration Board

1’s

Recommended for consideration of Registration Board subject to provision of following documents on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:a. Approval of

shelf life from regulatory authority orstability data to support claimed shelf life.

experience ensuring safety, efficacy and quality:-

a. Approval of shelf life from regulatory authority or stability data to support claimed shelf life.

9. M/s. ACP System,13-23, Naval Fleet Club, Iqbal (S.J) Shaheed Road, Karachi.Owner Operator:M/s Medtronic, Inc. 710 Medtronic Parkway NE Minneapolis, MN 55432, USA.Legal Manufacturer:M/s Medtronic Vascular37A Cherry Hill Dr

Site Seer Cardiovascular Diagnostic Angiography Catheters

Types, Sizes & Models as per Free Sale Certificate.


1’s

3 years

Applied on 16-3-2016Letter issued on 18.1.2017.Letter issued on 3.2.2017Final reminder issued on 10-02-2017

Recommended for consideration of Registration Board subject to provision of following documents on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures

Approved subject to provision offollowing documents within 2 weeks on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:-

Approval of shelf life from regulatory authority or stability data to support claimed shelf life.


DANVERS MA USA 01923Contract Manufacturing Site:M/s Availmed S.A. De C.V. Av. Paseo Reform No. 8950 Interior (B1, C1, E1, E2, F2, G1) (Local A.B.C.G.H) La Mesa, Tijuana, Baja California 22116, Mexico.

in the institutions (public and private) in the larger public interest:a. Approval of

shelf life from regulatory authority or stability data to support claimed shelf life.

10. M/s. ACP System, 13-23, Naval Fleet Club, Iqbal (S.J) Shaheed Road, Karachi

Name of Owner Operartor:M/s Medtronic, Inc. 710 Medtronic Parkway NE Minneapolis, MN 55432, USA.

Manufacturing Site:M/s Medtronic Vascular37A Cherry Hill Dr DANVERS, MA USA 01923

Launcher Guiding Catheters



1’s

2 years

Applied on 16-3-2016Letter issued on 18.1.2017.Letter issued on 3.2.2017

Recommended the product for consideration of Registration Board.(Original & valid Free Sale Certificate provided but expired.)

Approved subject to provision of valid free sale certificate on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:


11. M/s. ACP System,13-23, Naval Fleet Club, Iqbal (S.J) Shaheed Road,Karachi.Owner/ Operator:M/s Medtronic, Inc. 710 Medtronic Parkway NE Minneapolis, MN 55432, USA.Manufacturing Facility:M/s Medtronic Vascular, 37-A, Cherry Hill Drive, Danvers, MA 01923, USA.

Sherpa NX Guiding Catheter



1’s

2 years

Applied on 16-3-2016Letter issued on 18.1.2017.Letter issued on 3.2.2017.

Recommended the product for consideration of Registration Board

(Original & valid Free Sale Certificate provided but expired.)

Approved subject to provision of valid free sale certificate on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:

12. M/s Hashir Surgical Services (Pvt) Ltd, 1st Floor, House# 16, Street 1, Sector F-2, Phase-6, Hayatabad, Peshawar.Sub-office: Office no.05,2nd floor syed’s tower, university road,Manufactured By:M/s Intra Special Catheter GmbH, Oststrasse 2, 66780 Rehlingen-Siersburg, Germany

Venoseld Central Venus Catheter-I Lumen.

Sizes:14G, 16G, 18G, 20G, 24G

Length (cm): 9, 13, 16, 20, 30.(As per free sale certificate)


1’s

5 years

Applied on 2-5-2016Letter issued on26-10-2016Letter issued on06-12-2016Letter issued on28-12-2016Letter issued on10-02-2017Recommended the product for consideration of Registration Board.

Approved on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality

13. M/s Hashir Surgical Services (Pvt) Ltd, 1st Floor,

Duocath Central Venus Catheter


5 years

Applied on 2-5-2016Letter issued on26-10-2016Letter issued on

Approved on the strong recommendations of cardiology experts


House #16, Street 1, Sector F-2, Phase-6, Hayatabad, Peshawar.Sub-office: Office no.05,2nd floor syed’s tower, university road,Manufactured By:M/s Intra Special Catheter GmbH, Oststrasse 2, 66780 Rehlingen-Siersburg, Germany

2-Lumen.

Sizes: 4F, 5F, 7F, 8F.

Length (cm): 5, 6, 8, 10, 13, 15, 20, 30.


1’s

06-12-2016Letter issued on28-12-2016Letter issued on10-02-2017Recommended the product for consideration of Registration Board.

based on their clinical experience ensuring safety, efficacy and quality



Manufacturing Site:M/s Boston Scientific Corporation, Two Scimed Place, Maple Grove, MN55311, USA

Coyote TM ES Monorail TM PTA Balloon Dilatation Catheter.



37 month

s

Applied on 15-7-2016Letter issued on18-1-2017. Reminder on 10.2.2017

Recommended for consideration of Registration Board subject to provision of following documents with an undertaking on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:a. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.b. Approval of shelf life from


a. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.



regulatory authority or Stability data to support claimed shelf life.c. Clinical Data, if any.

15. M/s. Ferozsons Laboratories Ltd, P.O. Ferozsons, Amangarh, Nowshera.

Legal Manufacturer:M/s Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.

Manufacturing Site:M/s Boston Scientific Corporation, Two Scimed Place, Maple Grove, MN55311, USA

Coyote TM

Monorail TM PTA Balloon Dilatation Catheter.



1’s

37 month

s

Applied on 15-7-2016Letter issued on18-1-2017.Final reminder on10-02-2017Recommended for consideration of Registration Board subject to provision of following documents with an undertaking on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:a. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.c. Clinical Data, if any.


a. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.


Legal Manufacturer:

Coyote TMES Over The Wire TM PTA Balloon Dilatation Catheter.

As per policy decision by Policy Board/ Federal Govt. and Registrati

25 month

s

Applied on 15-7-2016Letter issued on18-1-2017.Final reminder on10-02-2017

Recommended for consideration of

Approved subject to provision of following documents within 2 weeks on the strong recommendations of cardiology experts based on their clinical experience ensuring


M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.

Manufacturing Site:M/s. Boston Scientific Corporation, Two Scimed Place, Maple Grove, MN 55311, USA


on Board1’s

Registration Board subject to provision of following documents with an undertaking on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:a. Original & valid authorization letter/ sole agency agreement from manufacturer as decided above by Registration Board.b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.c. Clinical Data, if any.

safety, efficacy and quality:-




Manufacturing Site:M/s. Boston Scientific Corporation,

Mustang TM Over The Wire PTA Balloon Dilatation Catheter.



37month

s


Recommended for consideration of Registration Board subject to provision of following documents with an undertaking on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:a. Original & valid authorization


a. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.

b. Approval of shelf life from regulatory


Ballybrit Business Park, Galway, Ireland.

letter/sole agency agreement from manufacturer as decided above by Registration Board.b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.c. Clinical Data, if any.

authority or Stability data to support claimed shelf life.



ContractManufacturing Site:M/s. Teleflex Medical, Unit 7,8 & 9, Annacotty Business Park, Annacotty Country Limerick, Ireland.

Imager TM II Angiographic Catheter.



25month

s


Recommended for consideration of Registration Board subject to provision of following documents with an undertaking on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:a. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.c. Clinical Data, if any.

Approved subject to provision offollowing documents within 2 weeks on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:-


19. M/s. Ferozsons Coyote As per 37 Applied on 15-7- Approved subject to


Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.


Manufacturing Site:M/s. Boston Scientific Corporation, Two Scimed Place, Maple Grove, MN55311, USA

TM Over The Wire PTA Balloon Dilatation Catheter.


policy decision by Policy Board/ Federal Govt. and Registration Board1’s

months

2016Letter issued on18-1-2017.Final reminder on10-02-2017

Recommended for consideration of Registration Board subject to provision of following documents with an undertaking on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:

a. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.c. Clinical Data, if any.

provision of following documents within 2 weeks on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:-



Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough,

Sterling TM Monorail TM PTA Balloon Dilatation Catheter

Product codes and sizes as per Free Sale


37month

s


Recommended for consideration of Registration Board subject to provision of following documents with an undertaking on urgent basis on the


a. Original & valid authorization letter/sole agency


MA, 01752, USA.

Manufacturing Site:M/s. Boston Scientific Corporation, Two Scimed Place, Maple Grove, MN 55311, USA..

Certificate.

recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:a. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.c. Clinical Data, if any.

agreement from manufacturer as decided by Registration Board.b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.


Legal Manufacturer:M/s BioSense Webster, Inc, 15715 Arrowy Hwy, Irwidale, CA USA 91706.

Thermocool Catheters

(product codes and sizes as per Free Sale Certificate)


3 years

Applied on 20-9-2016Letter issued on 12.1.2017.Letter issued on 3.2.2017Final reminder issued on 10-02-2017


(Firm Has Requested to grant 10-12 weeks for furnishing documents)a. Application on Form 5A duly signed and stamped.b. Clarification as many types/products applies in application.c. Original & valid Free Sale

Deferred for provision of documents :-a. Application on Form 5A duly signed and stamped.b. Clarification as many types/products applies in application.c. Original & valid Free Sale Certificate as decided above by Registration Board.d. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.


Certificate as decided above by Registration Board.d. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.f. Original Credentials of manufacture as decided above by Registration Board.g. Clinical trial data, if any,

f. Original Credentials of manufacture as decided above by Registration Board.

22. M/s Hakimsons Pvt. Ltd, (2011) Hakimsons House A/56, S.I.T.E. Manghopir Road, Karachi.

Manufactured by:M/s Pennine Health Care Ltd. City Gate, London Road, Derby De, 24 8WY United Kingdom.

Catheters Nelaton/Suction.


3 years

Applied on 05.3.2011Letter issued on24-10-2012.Reminder issued on 02.03.2015Reminder issued on 06.10.2016Reminder issued on4-2-2017.Final reminder issued on 10-02-2017Not recommended the product due to following reasons:

a. Differential fee PKR.35,000/-,b. Clarification as many types are applied.c. Original & valid Free Sale Certificate as decided above by Registration Board.d. Original & valid authorization letter/sole agency agreement from

Rejected due to non-submission of following documents even after reminder and on the strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality :-a. Differential fee Rs.35,000/.b. Clarification as many types are applied.c. Original & valid Free Sale Certificate as decided above by Registration Board.d. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.e. Approval of


manufacturer as decided above by Registration Board.e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.f. Original Credentials of manufacture as decided above by Registration Board.g. Copy Valid Drug Sale License,

shelf life from regulatory authority or Stability data to support claimed shelf life.f. Original Credentials of manufacture as decided above by Registration Board.g. Copy Valid Drug Sale License,

23 M/s. Ali Gohar & Co. (Pvt) Ltd., Karachi.

Legal Manufacturer:M/s. CovidienIIc Hampshire Sstreet, Mansfield, MA, USA.

Manufacturer:M/s. Mallinckrodt Medical Cornmaddy, Athlone, Co. Westmeath, Ireland.

Endo bronchial Suction Catheters/ Tubes and accessories

Product Size and codes as per FSC


05 years

Applied on 24.3.2011Letter issued on29-03-2011Letter issued on04-12-2013Letter issued on18-04-2014Final Reminder issued on 26-10-2016Final reminder on10-02-2017

Not recommended the product due to following reasons:-a. Differential fee Rs.35,000/-,b. Original & valid Free Sale Certificate as decided above by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Boardd. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original

Rejected due to non-submission of following documents even after reminder and on the strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality :-a. Differential fee

Rs.35,000/-,b. Original & valid



d. Original Credentials of manufacture as decided above by Registration Board.

e. Copy Valid Drug Sale License,


Credentials of manufacture as decided above by Registration Board.f. Copy Valid Drug Sale License.

24 M/s Mana& Co,204 New Medicine Market, Near Densohall, Karachi.

Manufactured by:M/s SuzhouYudu Medical Co.Ltd, Eastern XinzhuangTown, ChangshuJiangsu, China.

Exported by:Ningbo Greetmed Medical Instrument Co.Ltd. 18F, Building 1, Wante Center, Ningbo, China.

Medicare Suction Catheter


05years

Applied on 16-8-2011Letter issued on25-10-2012Reminder issued on2-3-2015Final Reminder31-10-2016Final Reminder on10-02-2017

Not recommended the product due to following reasons:a. Differential fee PKR.35,000/-,b. Original & valid Free Sale Certificate as decided above by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board.f. Copy Valid Drug Sale License,

Rejected due to non-submission of following documents even after reminder and on the strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality :-

a. Differential fee Rs.35,000/-.b. Original & valid Free Sale Certificate as decided above by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board.f. Copy Valid Drug Sale License,

25 M/s Mana& Co,204 New Medicine Market, Near Densohall,

Medicare Nelton Catheter.


05 years

Applied on 16-8-2011Letter issued on25-10-2012Reminder issued on2-3-2015

Rejected due to non-submission of following documents even after reminder and on the strong non-


Karachi.

Manufactured by:

M/s SuzhouYudu Medical Co.Ltd, Eastern XinzhuangTown, ChangshuJiangsu, China.

Exported by:Ningbo Greetmed Medical Instrument Co.Ltd. 18F, Building 1, Wante Center, Ningbo, China


Final Reminder31-10-2016Final Reminder on10-02-2017Not recommended the product due to following reasons:a. Differential fee Rs.35,000/-,b. Original & valid Free Sale Certificate as decided above by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board.f. Copy Valid Drug Sale License,

recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality :-a. Differential fee Rs.35,000/-,b. Original & valid Free Sale Certificate as decided above by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board.f. Copy Valid Drug Sale License,

26 M/s Sadqain HealthCare (Pvt) Ltd, Rawalpindi.

Manufactured by:M/s Intersurgical Limited Crane House, Molly Millars Lane Wokingham, Berkshire,United Kingdom.

Intersurgical – Paediatric/ Neonatal/Adult Catheter Mount-Patient Connection-3535000-3514000-3508000


Applied on 20-8-2011Letter issued on24-10-2012Reminder 31-10-2016reminder 3-2-2017Final reminder on10-02-2017

Not recommended the product due to following reasons:a. Differential fee Rs.35,000/-,b. Original & valid Free Sale Certificate as decided above by Registration Board.

Rejected due to non-submission of following documents even after reminder and on the strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality :-a. Differential fee Rs.35,000/-,b. Original & valid Free Sale Certificate as decided above by Registration Board.


c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board.f. Copy Valid Drug Sale License.

c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board.f. Copy Valid Drug Sale License,

27 M/s Sakuf Trading, 34-G, Phase-1, Commercial Area, DHA, Lahore Cantt.

Manufactured By:M/s Balt Extrusion, 10, rue de la Croix Vigneron 95160, Montmorency, France.

Sonic (Detachtable Tip Braided Microcatheters)



5 years

Applied on 21.11.2016Letter issued 28.12.2016Letter issued on01-02-2017Final reminder on10-02-2017

Deferred the product for provision of following documents:a. Differential fee Rs.35,000/-,b. Original & valid Free Sale Certificate as decided above by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original

Approved subject to provision of following documents within 2 weeks on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:-a. Original & valid Free Sale Certificate as decided above by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture as decided above by


Credentials of manufacture as decided above by Registration Board.f. Copy Valid Drug Sale License,

Registration Board.e. Copy Valid Drug Sale License,

28 M/s Sakuf Trading, 34-G, Phase-1, Commercial Area, DHA, Lahore Cantt.


Goldballoon (Detachable Balloon)



5 years

Applied on 21.11.2016Letter issued 28.12.2016Letter Issued on01-02-2017Final reminder on10-02-2017Deferred the product for provision of following documents:a. Differential fee Rs.35,000/-,b. Original & valid Free Sale Certificate as decided above by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Boardd. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board.f. Copy Valid Drug Sale License,

Deferred for provision of documents :-

a. Original & valid Free Sale Certificate as decided above by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture as decided above by Registration Board.

29 M/s. Ferozsons Laboratories Ltd, P.O. Ferozsons, Amangarh, Nowshera.

Legal

Rubicon TM 18 Support Catheter

Product codes


37month

s

Applied on 25-7-2016Letter issued 18.1.2017Final Reminder issued on 10-02-2017

Deferred for provision of documents :-a. Original & valid authorization letter/sole agency agreement from manufacturer as


Manufacturer:M/s Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.

Manufacturing Site:M/s. Boston Scientific Corporation, Two Scimed Place, Maple Grove, MN 55311, USA.

and sizes as per Free Sale Certificate.

Registration Board

Recommended for consideration of Registration Board subject to provision of following documents with an undertaking on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:-a. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Boardb. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.

decided above by Registration Board.b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.



Manufacturing Site:M/s. Boston Scientific Corporation,

Rubicon TM 35 Support CatheterProduct codes and sizes as per Free Sale Certificate.


37month

s

Applied on 25-7-2016Letter issued 18.1.2017Final reminder issued on 10-02-2017Recommended for consideration of Registration Board subject to provision of following documents with an undertaking on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public

Deferred for provision of documents :-a. Original & valid




Two Scimed Place, Maple Grove, MN 55311, USA.

interest:a. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Boardb. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.



Manufacturing Site:M/s Boston Scientific Corporation, Business & Technology Park, Model Farm Road Cork, Ireland

Renegade Fiber Braided Microcatheter.



37month

s

Applied on 25-7-2016Letter issued 18.1.2017Final reminder issued on 10-02-2017.Recommended for consideration of Registration Board subject to provision of following documents with an undertaking on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:-a. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Boardb. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.

Approved subject to provision of following documents within 2 weeks on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:-a. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.

32 M/s. Ferozsons Laboratories

Rubicon TM 14

As per policy

37month

Applied on 25-7-2016

Deferred for provision of


Ltd, P.O. Ferozsons, Amangarh, Nowshera.


Manufacturing Site:M/s. Boston Scientific Corporation, Two Scimed Place, Maple Grove, MN 55311, USA.

Support Catheter


decision by Policy Board/ Federal Govt. and Registration Board

s Letter issued 18.1.2017Final reminder issued on 10-02-2017

Recommended for consideration of Registration Board subject to provision of following documents with an undertaking on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:a. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Boardb. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.

documents :-a. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.



Interject Clear/Contrast Injection Therapy Needle Catheter

Codes & sizes as per FSC.


37month

s

Applied on 24-1-2017Letter issued on 01.02.2017Final reminder issued on 10-02-2017Recommended for consideration of Registration Board subject to provision of following documents with an undertaking on urgent basis on the recommendations of cardiologists


a. Clarification as Brand is not as per free sale certificate.b. Original & valid Free Sale



regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:-a. Clarification as Brand is not as per free sale certificate.b. Original & valid Free Sale Certificate as decided above by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Boardd. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board

Certificate as decided above by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board.

34 M/s. Digital Imaging System,121 habitat, Shadman II , Ghaus-ul-Azam Road,Lahore.

Name of Owner Operator and manufacturing Facility:Volcano Corporation2870 Kilgore rd, Rancho cordova, CA USA 95670

Eagle Eye Paltinum & ST-IVUS Catheter



2 years

Applied on 3.2.2017Letter issued on04-02-2017Recommended for consideration of Registration Board subject to provision of following documents on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public


a. Original & valid Free Sale Certificate as decided above by Registration Board.


interest:-a. Original & valid Free Sale Certificate as decided above by Registration Board

35 M/s. Digital Imaging System,121 habitat, Shadman II, Ghaus-ul-Azam Road,LahoreResponsible Manufacturer:M/s Abbott Vascular,3200 Lakeside Drive, Santa Clara, California 95054, USA.Manufacturing Site:M/s Abbott Vascular Costa Rica, 52 Calle 3, B31, Coyol Free Zone, El Coyol, Alajuela, Costa Rica (Free Sale Costa Rica)

Traveller RX Coronary Dilatation Catheter



3 years

Applied on 03.2.2017Letter issued on04-02-2017Final reminder issued on 10-02-2017

Recommended the product for consideration of Registration Board.

Approved subject to Import Policy for Finished Drugs

36M/s Hashir Surgical Services (Pvt) Ltd, 1st Floor, H#16, St.# 1, F-2, Phase-6, Hayatabad, PeshawarManufactured By:M/s Intra Special Catheter GmbH, Oststrasse 2, 66780 Rehlingen-Siersburg, Germany

Duocath Hemodialysis Catheter 2-Lumen.

Sizes: 12FLength (cm): 13, 16, 20, 24.


5 years

Applied on 2-5-2016

Shortcoming Letter Issued on 26-10-2016.Reminders issued6.12.2016 & 28.12.2016.



37 M/s. ACP Export As per 2 Applied on 31-5- Approved on the


System, 13-23, Naval Fleet Club, Iqbal (S.J) Shaheed Road, Karachi.Legal Manufacturer:M/s Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432, USA.Manufacturing Site:M/s Medtronic Vascular, 37A Cherry Hill Drive, Danvers, MA 01923, USA.

Advance Aspiration Catheter


policy decision by Policy Board/ Federal Govt. and Registration Board1’s

years 2016

Shortcoming letter issued on 18-1-2017. Reminder issued on 3-2-2017.


strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality.


Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752,USA.

Manufacturing Site:M/s. Boston Scientific Corporation, Ballybrit Business Park, Galway, Ireland.

XXL Balloon Dilatation Catheter(Esophageal Indication)



37month

s

Applied on 25-7-2016Letter issued 18.1.2017

Recommended for consideration of Registration Board subject to provision of following documents with an undertaking on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:-a. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Boardb. Approval of shelf life from regulatory authority


a. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board



or Stability data to support claimed shelf life.



Manufacturing Site:M/s Boston Scientific Corporation, Ballybrit Business Park, Galway, Ireland.

XXL Balloon Dilatation Catheter(Vascular Indication)

Product codes and sizes as per Free Sale Certificate


1’s

37month

s

Applied on 25-7-2016Letter issued 18.1.2017

Recommended for consideration of Registration Board subject to provision of following documents with an undertaking on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:-a. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Boardb. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.


a. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board

b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life


Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough,

Wanda TM Balloon Dilatation Catheter



30month

s

Applied on 25-7-2016Letter issued 18.1.2017Letter issued on 10.2.2017

Recommended for consideration of Registration Board subject to provision of following documents with an undertaking on urgent basis on the recommendations


a. Original & valid authorization letter/sole agency


MA, 01752, USA.

Manufacturing Site:M/s. Boston Scientific Corporation, Ballybrit Business Park, Galway, Ireland.

of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:a. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Boardb. Approval of shelf life from regulatory authority or Stability data to support claimed shelf lifec. Analytical procedure and specifications.d. Layout of manufacturing.e. Labelling & brochures.

agreement from manufacturer as decided above by Registration Board.



Catheter Fresh Applications S.

No.Name of


Exporter.


Price & Pack size

Shelf life

Recommendations of Cardiologists in

evaluation cell

Decision

1. M/s COR-MED 2nd Floor, 38/62, Bank Road, Saddar, Rawalpindi

Manufactured byIberhospitex S.A,Avda.catalunya, 4-08185 Llica De Vall, Barcelona Spain

Crossway PTCA Semi-Compliant Balloon Catheter



1’s

18 month

s

Applied on 08.2.2017Letter issued on 15.2.2017.Deferred the product for provision of following documents:-

i. Application on prescribed FORM 5A each page duly singed and stamped by the authorized importer.

ii. Original Free Sale certificate duly endorsed by Embassy of Pakistan from the country of origin.iii. Proposed

route of administration.

iv. Complete specifications with details of analytical procedures.


vi. Type of container/Package/Pack size(s).vii. Complete brochure and Labels for each medical device.viii. Original Sole agency agreement with the manufacturer abroad/Authorization letter duly notarized.

ix. Credentials of the manufacturer



ii. Original Free Sale certificate duly endorsed by Embassy of Pakistan from the country of origin.iii. Complete


iv. Approval of shelf life from regulatory authority or Stability studies conducted with data.

v. Original Sole agency agreement with the manufacturer abroad/Authorization letter duly notarized.

vi. Credentials of the manufacturer abroad duly notarized.vii. Copy of valid Drug Sale Licence.


abroad duly notarized.

x. Clinical Trial Data


2. M/s COR-MED 2nd Floor, 38/62, Bank Road, Saddar,Rawalpindi.

Manufactured by:Iberhospitex S.A,Avda.catalunya, 4-08185 Llica De Vall, Barcelona Spain

Crossway NC Non-Compliant PTCA Balloon Catheter



1’s

18 month

s

Applied on 08.2.2017Letter issued on 15.2.2017Deferred product for provision of following documents:-


ii. Original Free Sale certificate duly endorsed by Embassy of Pakistan from the country of origin.iii. Proposed

route of administration.



vi. Type of container/Package/Pack size(s).vii. Complete brochure and Labels for each medical device in English.viii. Original Sole agency agreement with the manufacturer abroad/Authorizatio



ii. Original Free Sale certificate duly endorsed by Embassy of Pakistan from the country of origin.iii. Complete




vi. Credentials of the manufacturer abroad duly notarized.vii. Copy of valid Drug Sale Licence.


n letter duly notarized.

ix. Credentials of the manufacturer abroad duly notarized.

x. Clinical trial Data, if any.

xi. Copy of valid Drug Sale Licence

3. M/s COR-MED 2nd Floor, 38/62, Bank Road, Saddar, Rawalpindi.

Manufactured by:Merit Medical Systems, INC, 1600 West Merit Parkway South Jordan Ut 84095 USA.

Merit Maestro’s Micro Catheter



1’s

24 month

s

Applied on 08.2.2017Letter issued on 15.2.2017.Deferred the product for provision of following documents:

i. Clarification regarding Manufacturing site and Brand name.

ii. Proposed route of administration.iii. Complete



v. Type of container/Package/Pack size(s).

vi. Complete brochure and Labels for each medical device.vii. Original Sole agency agreement with the manufacturer abroad/Authorization letter duly notarized.viii. Credentials of the manufacturer abroad duly notarized.



ii. Original Free Sale certificate duly endorsed by Embassy of Pakistan from the country of origin.iii. Clarification

regarding Manufacturing site and Brand name.



vi. Credentials of the manufacturer abroad duly notarized.vii. Copy of valid


ix. Clinical trial Data, if any.

x. Copy of valid Drug Sale Licence.

Drug Sale Licence.



ASAP Aspiratio

n Catheter



1’s

24 month

s




regarding Brand Name.

iv. Proposed route of administration.

v. Complete specifications with details of analytical procedures.

vi. Approval of shelf life from regulatory authority or Stability studies conducted with data.vii. Type of container/Package /Pack size(s)viii. Complete brochure and Labels for each medical device.

ix. Original Sole agency agreement with the manufacturer abroad/Authorization letter duly







vi. Type of container/Package/Pack size(s).vii. Original Sole agency agreement with the manufacturer abroad/Authorization letter duly notarized.viii. Credentials of the manufacturer abroad duly notarized.

ix. Clinical trial


notarized.x. Credentials

of the manufacturer abroad duly notarized.

xi. Clinical trial Data, if any.xii. Copy of valid Drug Sale Licence.

Data, if any.x. Copy of valid

Drug Sale Licence



Impress Angiography Catheter



1’s

24 month

s





iv. Proposed route of administration.

v. Complete specifications with details of analytical procedures.

vi. Approval of shelf life from regulatory authority or Stability studies conducted with data.vii. Type of container/Package/Pack size(s).viii. Complete brochure and Labels for each medical device.

ix. Original







vi. Type of container/Package/Pack size(s).vii. Original Sole agency agreement with the manufacturer abroad/Authorization letter duly notarized.viii. Credentials of the manufacturer abroad duly notarized.

ix. Clinical trial Data, if any.

x. Copy of valid Drug Sale Licence.


Sole agency agreement with the manufacturer abroad/Authorization letter duly notarized.

x. Credentials of the manufacturer abroad duly notarized.

xi. Clinical trial Data, if any.xii. Copy of valid Drug Sale Licence.

6. M/s Atco Pharma International (Pvt) Ltd. B-18, S.I.T.E., Karachi -75700.


PRO HP PEGASO PTCA BALLOON CATHETER

(Sizes & codes as per Free Sale certificate)


1’s

5 years



ii. Original Credentials of the manufacturer abroad duly notarized.iii. Analytical


iv. Clinical trial Data, if any.

v. Labelling information



ii. Original sole agency agreement with manufacturer abroad duly notarized.iii. Clarification




vi. Type of container/Package/Pack size(s).vii. Original Sole agency agreement with the manufacturer abroad/Authorization letter duly notarized.viii. Credentials of the manufacturer abroad duly


notarized.ix. Clinical trial

Data, if any.x. Copy of valid

Drug Sale Licence.7. M/s Atco

Pharma International (Pvt) Ltd. B-18, S.I.T.E, Karachi -75700.


FLUYDO PEGASO PTCA BALLOON CATHETER

(Sizes and codes as per Free Sale certificate)


1’s

5 years

Applied on 08.2.2017Letter issued on 13.2.2017.Deferred the product for provision of following documents:-i. Original Sole agency agreement with the manufacturer abroad/Authorization letter duly notarized.ii. Original Credentials of the manufacturer abroad duly notarized.

iii. Analytical Procedure and Specification.

iv. Clinical trial Data, if any.v. Labelling information

Deferred for provision of documents :-i. Application on prescribed FORM 5A each page duly singed and stamped by the authorized importer.ii. Original sole agency agreement with the manufacturer abroad /Authorization letter duly notarized.

iii. Clarification regarding Brand Name.

iv. Complete specifications with details of analytical procedures.v. Approval of shelf life from regulatory authority or Stability studies conducted with data.

vi. Type of container/Package/Pack size(s).

vii. Original Sole agency agreement with the manufacturer abroad/Authorization letter duly notarized.

viii. Credentials of the manufacturer abroad duly notarized.

ix. Clinical trial Data, if any.x. Copy of valid Drug Sale Licence.

8. M/s Digital Imaging System, 121 Habitat,

Viatrac 14 Plus PTA Balloon


02 years

Applied on 06.2.2017Letter issued on 15.02.2017.


i. Clearly


Shadman II, Ghaus-ul-Azam Road, Lahore.

Legal Manufacturer:M/s Abbott Vascular, 3200 Lakeside Drive, Santa Clara, California 95054, USA.

Manufacturing site:M/s Abbott Vascular, 26531 YNEZ Road, Temecula, California 92591, USA.

Catheter Board/ Federal Govt. and Registration Board

1’s

Recommended for consideration of Registration Board subject to provision of following documents on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:-

i. Clearly mention types of each device along with product codes and sizes.ii. Complete

specifications with details of analytical procedures.iii. Description of the method of manufactureiv. Approval of shelf life from the regulatory authority or Stability studies conducted with data.v. Last

inspection report of concerned regulatory authority.vi. Original & valid Free Sale Certificate from the regulatory authority in the country of origin.vii. Valid QMS-13485 certificate.

mention types of each device along with product codes and sizes.ii. Approval of

shelf life from the regulatory authority or Stability studies conducted with data.iii. Original & valid Free Sale Certificate from the regulatory authority in the country of origin.


Assistant Director- IIIStents

Sr. No


Exporter.


Price & Pack size

Shelf life


evaluation cell

Decision

1. M/s. Ferozsons Laboratories Ltd, P.O. Ferozsons, Amangarh,Nowshera.

Legal Manufacturer:M/s Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s Boston Scientific Limited, Ballybrit Business Park, Galway, Ireland.

Ultraflex TM

Esophageal NG Stent System

(Codes & sizes as per FSC.)


1’s

02years

Appliedon15.7.2016Letter issued on 01.02.2017Final reminder issued on 10.2.2017.

Deferred the product for the provision of the following deficiencies;1. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.2. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.

Deferred for provision of following:1. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.2. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.

2. M/s. Ferozsons Laboratories, P.O. Ferozsons, Amangarh, Nowshera.

Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, USA 01752.

Manufacturing Site:

ExpressTM

Vascular SD MonorailTMPremounted Stent System

Product codes as per Free Sale Certificate.


1’s

37 months

Applied on 15-7-2016Letter issued on 01.02.2017Final reminder issued on 10.2.2017.

Recommended for consideration of Registration Board subject to provision of following documents with an undertaking on urgent basis on the recommendations of cardiologists regarding cardiac,

Approved subject to provision of following documents within 2 weeks on strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:

1. Original & valid authorization


M/s. Boston Scientific Corporation, Two Scimed Place, Maple Grove, MN 55311, USA.

Sterilization Site:M/s BSC Coventry, 8 Industrial Drive Coventry, RI 02816, USA.

vascular and ancillary procedures in the institutions (public and private) in the larger public interest:-1. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.2. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.

letter/sole agency agreement from manufacturer as decided by Registration Board.2. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.

3. M/s. Maxims Medical, 534-H Block, St. No.13, Phase-5, DHA, Lahore.

Manufactured by:M/s Eurocor GmbH In den Dauen 6a 53117 Bonn,Germany.

E Magic Plus Drug Eluting Stent



1’s

03 years

Applied on 27.1.2017Letter issued on 01-2-2017Final reminder issued on 10.2.2017.

Deferred the product for the provision of the following deficiencies;a. Application on Form 5A duly signed and stamped.b. Original & valid Free Sale Certificate as decided by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.d. Approval

Deferred for provision of following:

a. Application on Form 5A duly signed and stamped.b. Original & valid Free Sale Certificate as decided by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original


of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided by Registration Board.f. Copy of Valid drug sale licence.

Credentials of manufacture as decided by Registration Board.f. Copy of Valid drug sale licence.

4. M/s F.W Distributors, F.W Building, Opp Poonch House, Adamjee Road, Rawalpindi.

Legal Manufacturer:M/s Coloplast A/S, Holtedam 1, 3050Humlebaek, Denmark.

Biosoft Duo Multi Length Hydro-Coated Urethral Stent Kit Kits (Long Term)



1’s

Not mentio

ned


Deferred the product for the provision of following deficiencies, required;a. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.b. Copy of valid drug sale licence.

Approved subject to provision of following documents within 2 weeks on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:(i) Approval of shelf life from regulatory authority or Stability data to support claimed shelf life within 2 weeks.


Legal Manufacturer:M/s Coloplast A/S, Holtedam 1, 3050Humlebaek,

Double Loop Urethral Stent in PA OR PU (Short Term)



1’s

Not mentio

ned

Applied on 27.10.2016Letter issued on 01.02.2017Final reminder issued on 10.2.2017

Deferred the product for the provision of the following deficiencies, required;1. Applicatio

Approved subject to provision of following documents within 2 weeks on strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:


Denmark. n on Form 5A duly signed and stamped.2. Original & valid Free Sale Certificate as decided by Registration Board.3. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.4. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.5. Original Credentials of manufacture as decided by Registration Board.6. Copy of Valid drug sale licence.

(i) Approval of shelf life from regulatory authority or Stability data to support claimed shelf life within 2 weeks.

6. M/s. Ferozsons Laboratories, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, USA 01752.Manufacturing Site:M/s. Boston Scientific Corporation,

Express TM LD Vascular Over The Wire Premounted Stent System

Product codes as per Free Sale Certificate.


1’s

37 months

Applied on 15.7.2016Letter issued on 01.02.2017Final reminder issued on 10.2.2017.

Deferred the product for provision of following deficiencies:-1. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board2. Approval

Deferred for provision of following documents:1. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.2. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.


BAllybrit Business Park, Galway, Ireland.Sterilization Site:M/s Synergy Health Ireland Limited (Tullamore) IDA Business & Technology Park, Tullamore, Co, Offaly, Ireland., RI 02816, USA.

of shelf life from regulatory authority or Stability data to support claimed shelf life.

CathetersSr.No.

Name of Importer &



Price & Pack size

Shelf life

Recommendations Of

Cardiologists in evaluation cell

Decision

1. M/s. Saru International,Flat A/4 Mehboob heights’ Sector 11-C-1- North Karachi.

Manufactured by:M/s. Nanchang Biotek Medical Device Co. Ltd., No.18,2nd gaoxin road, high-tech development zone, Nanchang City.China.

Healthicon, Central Venous Catheter/ Kit-Single/ Double /Triple Lumen (Infusion Series).


1’s

05 years

Applied on 12.4.2011.Letter issued 26-9-2012.Reminder issued on 27.2.2015 & 07.10.2016.Final reminder issued on 10.2.2017.

Not recommend the product due to the following deficiencies even after multiple reminders dated above:-1. Differential Fee PKR.35,000/-,2. Clarification as different types applied on same application.3. Original & valid Free Sale Certificate as decided by Registration Board.4. Original & valid authorization

Rejected due to non-submission of following documents even after multiple reminder and on the strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality :-1. Differential Fee PKR.35,000/-,2. Clarification as different types applied on same application.3. Original & valid Free Sale Certificate as decided by Registration Board.4. Original & valid authorization letter/sole agency


letter/sole agency agreement from manufacturer as decided by Registration Board.5. Clinical data, if any,6. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.7. Original Credentials of manufacture as decided by Registration Board.

agreement from manufacturer as decided by Registration Board.5. Clinical data, if any,6. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.7. Original Credentials of manufacture as decided by Registration Board

2. M/s. Ontech Corporation, M-02 Mezzanine Floor, Lakhani corner Block-13-A, Gulshan-e-Iqbal, Karachi.

Manufactured by:M/s. Ameco Medical Industries, Industrial Zone B4 Plot 119, East 10th Ramadan City,Egypt.

Central Venous Catheters

Product codes as per FSC.


1’s

05 years

Applied on 5.4.2011Letter issued on 06-12-2013.Reminder issued on 07-10-2016.Final reminder issued on 10.2.2017.

Not recommend the product due to the following deficiencies even after multiple reminders dated above:1. Differential Fee PKR.35,000/-2. Original & valid Free Sale Certificate as decided by Registration Board.3. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.4. Clinical data, if any,

Rejected due to non-submission of following documents even after multiple reminder and on the strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality :-

1. Differential Fee PKR.35,000/-2. Original & valid Free Sale Certificate as decided by Registration Board.3. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration


5. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.6. Copy of Valid Drug Sale Licence.

Board4. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.5. Copy of Valid Drug Sale Licence.


Legal ManufacturerM/s Cordis Corporation, 14201 North West 60th Avenue,Miami Lakes, FL 33014, USA

ASSEMBLERM/s Cordis de Mexico, S.A. de C.V. Circuito Interior Norte # 1820 Parque Industrial Salvarcar Ciudad Juarez, Chihuahua Mexico 32574.

ADROIT TM

Guiding Catheter.

(codes and sizes as per FSC)


1’s

3 years

Applied on 04-03-2014Letter issued on 20-02-2015.2nd letter issued on 02-02-2017.Final reminder issued on 10.2.2017.

Deferred the product for provision of following documents:-1. Application on Form-5A as per format prescribed.2. Original & valid Free Sale Certificate as decided by Registration Board.3. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.4. Original Credentials of manufacture as decided by Registration Board


1. Original & valid Free Sale Certificate as decided by Registration Board.2. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.3. Original Credentials of manufacture as decided by Registration Board.

4. M/s. Health Tec,10-B, Street No.24, Valley Road, Westridge-I

Pointer Angiographic Catheter.

Sizes as per


3 years

Applied on 30-09-2015Letter Issued on 19-01-2016

Recommended for

Approved but the Board decided that letter shall be issued


Rawalpindi.

Manufacturer:M/s PendraCare International B.V. Van der Waals Park 22, 9351 VC Leek, The Netherlands.

Free Sale Certificate.


1’s

consideration of Registration Board subject to provision of following documents on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:Same product “Angiodyn Angiography Catheter” already registered with same source.Show cause notice sent to theM/s B.Braun Pakistan (Pvt) Ltd, regarding clarification of Sole Agency Agreement. Firm replied that B.Braun, Germany has authorized M/s B.Braun Pakistan (Pvt) Ltd & B.Braun, Germany is authorized distributer of this product worldwide.

afterdecision of fate of already registered same product with different name by same manufacturer i.e Angiodyn angiographic catheter in the name of B.Braun Pakistan and Board further decided for personal hearing of B.Braun Pakistan in next meeting.

5. M/s. Ferozsons Laboratories Ltd, P.O. Ferozsons, Amangarh,Nowshera.

Legal Manufacturer:M/s. Boston

NC Emerge TM Monorail TM PTCA Dilatation Catheter

(Product code and


3 years

Applied on 1.12.2015Letter issued on 11-08-2016.Further deficiencies communicated on 02-02-2017Final reminder issued on

Deferred for provision of following documents :-a. Original & valid authorization letter/sole agency agreement from manufacturer as


Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752. USA

Manufacturing Site:M/s. Boston Scientific Limited, Ballybrit Business Park, Galway, Ireland.

sizes as per FSC)

1’s

10.2.2017.

Deferred the product for the provision of the following documents1. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.

decided by Registration Board.

6. M/s Hashir Surgical Services (Pvt) Ltd,1st Floor, House No.16, Street 1, Sector F-2, Phase-6, Hayatabad, Peshawar.Sub-office: Office no.05,2nd floor syed’s tower, university road,Peshawer.Manufactured By:M/s Intra Special Catheter GmbH, Oststrasse 2, 66780 Rehlingen-Siersburg, Germany.Sterilization Site:PFM Medical msg GmBH, Am soterberg-4; D-66620 Nonnweller-Otzenhausen; Germany.

Quadrocath Central Venus Catheter4-Lumen.

(Codes and sizes as per FSC)


1’s

5 years

Applied on 02-05-2016Letters issued on 26.10.2016, 19.10.2016 and3rd shortcoming communicated on02-02-2016.Recommended the product for the consideration of Registration Board

The firm rectified the shortcomings as per form 5-A

Approved on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy & quality

7. M/s Bio Medics Medical System, F-597, F-Block,

OSIRA PTCA ® Catheter

As per policy decision

18 month

s

Applied on 01-04-2016Letter issued on

Approved subject to provision of


Satellite Town,Rawalpindi.


(Rapamycin Eluting Coronary Dilatation Catheter)

(Codes and sizes as per FSC)

by Policy Board/ Federal Govt. and Registration Board

1’s

19-01-2017.Final reminder issued on 10.2.2017

Deferred the product for the provision of following documents:1. Original Credentials of manufacture as decided by Registration Board.2. Original & valid Free Sale Certificate as decided by Registration Board.3. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.4. Clarification of products name on Sole Agency Agreement.

following documents within 2 weeks on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:

(i) Original credentials of manufacturer as decided by Registration Board.(ii) Notarized Clarification of Sole agency agreement regarding product name as decided by Registration Board.(iii) Original Free Sale Certificate as decided by Registration Board


Legal ManufacturerM/s BioSense Webster, Inc. 15715 Arrowy Hwy, Irwidale, CA USA 91706.

Pentaray Catheter



1’s

3 years

Applied on 25-08-2016.Letter issued on 19-01-2017.Reminder issued on 02-02-2017.Final reminder issued on 10.2.2017

Deferred the product for the provision of the following documents1. Application on Form-5A duly signed and stamped.

Deferred for provision of following documents :-1. Original & valid Free Sale Certificate as decided by Registration Board.2. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.


2. Original & valid Free Sale Certificate as decided by Registration Board.3. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.4. Original Credentials of manufacture as decided by Registration Board

3. Original Credentials of manufacture as decided by Registration Board.


Legal ManufacturerM/s BioSense Webster, Inc, 15715 Arrowy Hwy, Irwidale, CAUSA 91706.

EZ Steer Catheter



1’s

3 years

Applied on 25-08-2016.Letter issued on 19-01-2017.Reminder issued on 02-02-2017.Final reminder issued on 10.2.2017

Deferred the product for the provision of the following documents1. Application on Form-5A duly signed and stamped.2. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.3. Original Credentials of manufacture as decided by Registration Board

Deferred for provision of following documents :-a. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.b. Original Credentials of manufacture as decided by Registration Board.

10. M/s Johnson & Johnson Pakistan (Pvt) Ltd, Fl.19, Sub Plot F-1, Kehkashan

Webster Catheters


3 years

Applied on 25-08-2016.Letter issued on 02-11-2016.Reminder issued

Deferred for provision of following documents :-a. Original


Scheme No.5, Main Boat Basin, Clifton,Karachi.

Legal Manufacturer:M/s BioSense Webster, Inc, 15715 Arrowy Hwy, Irwidale, CAUSA 91706.



1’s

on 02-02-2017.Final reminder issued on 10.2.2017

Deferred the product for the provision of the following documents1. Original & valid Free Sale Certificate as decided by Registration Board.2. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.3. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.4. Original Credentials of manufacture as decided by Registration Board.

& valid Free Sale Certificate as decided by Registration Boardb. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture as decided by Registration Board.

11. M/s Surgi World,303 Mohammadia Plaza, College Road,Rawalpindi

Manufactured by:M/s Medcomp , 1499 Delp Drive Harleys Villa,USA.

Titan HD Long Term Dialysis Catheter.

As per policy

decision by Policy

Board/ Federal

Govt. and Registratio

n Board

1’s

5 years Applied on 17.11.2011Letter Issued on 18-09-2013.Reminders issued 31.7.2013 & 4.3.2015. Final reminder issued on 03.2.2017.Final reminder issued on 15.2.2017

Deferred the product for the provision of the following documents and asked from the applicant an

Rejected due to non-submission of following documents even after multiple reminders and on the strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality :-a. Differential fee PKR.35,000/-,b. Application on Form 5A


undertaking to continue the registration process on urgent basis.1. Differential fee PKR.35,000/-,2. Application on Form 5A as duly signed and stamped.3. Original & valid Free Sale Certificate as decided by Registration Board.4. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.5. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.6. Original Credentials of manufacture as decided by Registration Board

as duly signed and stamped.c. Original & valid Free Sale Certificate as decided by Registration Board.d. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.f. Original Credentials of manufacture as decided by Registration Board

12. M/s Surgi World, 303 Mohammadia Plaza, College Road,Rawalpindi


Duo-Flow ® Side X side Short Term Dialysis Catheter

As per policy

decision by Policy

Board/ Federal


n Board

1’s

05 years

Applied on 17.11.2011. Letter issued 18-09-2013.Reminders issued on 11.7.2013 & 04.3.20153rd reminder issued on 03-02-2017.Final reminder issued on 15.2.2017

Deferred the product for the provision of the following documents and an undertaking by the

Rejected due to non-submission of following documents even after multiple reminders and on the strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:-

a. Differential fee Rs.35,000/-,


firm whether to continue the registration process or otherwise.1. Differential fee PKR.35,000/-,2. Application on Form 5A as duly signed and stamped.3. Original & valid Free Sale Certificate as decided by Registration Board.4. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.5. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.6. Original Credentials of manufacture as decided by Registration Board.

b. Application on Form 5A as duly signed and stamped.c. Original & valid Free Sale Certificate as decided by Registration Board.d. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.f. Original Credentials of manufacture as decided by Registration Board

13. M/s Surgi World,303 Mohammadia Plaza, College Road,Rawalpindi.


Pro-Fuse CT Ports (Central Vein Infusion Catheter with port)

As per policy

decision by Policy

Board/ Federal


n Board

1’s

05 years

Applied on 17.11.2011.Shortcoming Letter issued 18-9-2013.Reminders issued 11.7.2013, 4.3.2015& 15.2.2017.

Deferred the product for the provision of the following documents and an undertaking by the firm whether to continue the registration process or otherwise.1. Differentia

Rejected due to non-submission of following documents even after multiple reminders and on the strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy & quality:a. Differential fee Rs.35,000/-,b. Applicati


l fee PKR.35,000/-,2. Application on Form 5A as duly signed and stamped.3. Original & valid Free Sale Certificate as decided by Registration Board.4. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.5. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.6. Original Credentials of manufacture as decided by Registration Board.

on on Form 5A as duly signed and stamped.c. Original & valid Free Sale Certificate as decided by Registration Board.d. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.f. Original Credentials of manufacture as decided by Registration Board

14. M/s Sakuf Trading, 34-G, Phase-1, Commercial Area, DHA Cantt.Lahore.

Manufactured By:M/s Balt Extrusion, 10, rue de la Croix Vigneron 95160, Montmorency,France.

Vasco+ (Braided Micro Catheters)



1’s

05 years

Applied on 07-12-2016Letter issued on 01-02-2017Final reminder issued on 10.2.2017.Deferred the product for the provision of the following documents1. Differential fee PKR.35,000/-,2. Original & valid Free Sale Certificate as decided by Registration Board.3. Original & valid authorization letter/sole agency

Deferred for provision of following documents :-a. Original & valid Free Sale Certificate as decided by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.c. Approval of shelf life from regulatory


agreement from manufacturer as decided by Registration Board.4. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.5. Original Credentials of manufacture as decided by Registration Board.6. Copy of Valid Drug Sale License.

authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture as decided by Registration Board.e. Copy of Valid Drug Sale License,


Legal Manufacturer:M/s Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Limited, Business & Technology Park, Model Farm Road, Cork, Ireland

CRE Pulmonary Balloon Dilatation Catheter



1’s

03 years


Deferred the product for the provision of the following documents1. Original & valid Free Sale Certificate as decided by Registration Board.2. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.3. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.

Approved subject to provision of following documents within 2 weeks on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:-a. Original & valid Free Sale Certificate as decided by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.c. Approval of shelf life from regulatory authority or


Stability data to support claimed shelf life.

16. M/s. SES Associates Distributors & Govt. Suppliers, Lahore

Manufactured by:M/s. QualiMed Innovative Medizinproduket GmbH, Winsen, Germany.

Juturna-V TM

PTA Balloon Catheter



1’s

3 years Application date 11-12-2012.Letter issued 24-4-2013.Reminder issued on 2-3-2015Final reminder issued on 15.2.2017

Deferred the product for the provision of the following documents and an undertaking by the firm whether to continue the registration process or otherwise.a. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.c. Original Credentials of manufacture as decided by Registration Board.d. Copy of Valid Drug Sale License.

Rejected due to non-submission of following documents even after reminder and on strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality :-a. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.c. Original Credentials of manufacture as decided by Registration Boardd. Copy of Valid Drug Sale License.

17. M/s. SES Associates Distributors & Govt. Suppliers, LahoreLegal Manufacture:M/s. Kimal Plc.

Central Venous Catheter Altius.

Sizes, types and products


3 years Applied on 11-12-2012.Letter issued on 24-4-2013.Reminder issued on 2-3-2015.Final reminder issued on

Rejected due to non-submission of following documents even after reminder and on the strong non-recommendation


Arundel Road, Uxbridge, Middlesex, UB8, 2SA,U.K.

Manufacturing Site:Sher Wood Road, Aston Fields Industrial Estate, Bromsgrove, Worcesterhire, UK.

codes as per FSC.

on Board

1’s

15.2.2017

Deferred the product for the provision of the following documents and an undertaking by firm whether to continue registration process or otherwise:-a. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.c. Original Credentials of manufacture as decided by Registration Board.d. Copy Valid Drug Sale License

s of cardiology experts based on their clinical experience ensuring safety, efficacy and quality :-a. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.c. Original Credentials of manufacture as decided by Registration Boardd. Copy of Valid Drug Sale License.

18 M/s Dora Enterprises, 54-B, Model Town, Lahore.

Manufactured by:M/s Giant Medical Equipment (Guangzhou) Co. Ltd, No.10, Juncheng Road, Eastern Area, Economic & Technical Development, District 510760 Guangzhoy,

Dora Hemodialysis Catheter Kits



1’s

Not mentioned

Applied on 31.10.2016Letter issued on01-02-2017Final reminder issued on 10.2.2017

Deferred the product for the provision of the following documents1. Original & valid Free Sale Certificate with clear status as decided by Registration Board.2. Approval

Deferred for provision of following documents :-

a. Original & valid Free Sale Certificate with clear status as decided by Registration Board.b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.


China. of shelf life from regulatory authority or Stability data to support claimed shelf life.3. Original Credentials of manufacture as decided by Registration Board.4. Clinical Data, if any.5. Method of manufacturing and QC Testing.6. Copy of Valid Drug Sale License.

c. Copy of Valid Drug Sale License.


Legal Manufacturer:M/s Coloplast A/S, Holtedam 1, 3050Humlebaek, Denmark.

Supraflow Suprapubic Catheter



Not mentioned

Applied on27-10-2016Letter issued on01-2-2017Final reminder issued on 10.2.2017Deferred the product for the provision of following documents:-1. Copy of Valid

Drug Sale License



Manufactured by:M/s Biotronic AG Ackerstrasse 6, 8180 Bulach,Switzerland.

Contract Medical International GmbHLauensteiner

Pantera Coronary Balloon

Balloon Length (mm)6,10,15,20,25,30.

Balloon Dia (mm): 1.25, 1.5, 2.0, 2.5,3.0, 3.5, 4.0.


Not mentio-ned.

Applied on 10.12.2012Letter issued on 24.4.2013.Reminder issued on 2-3-2015.Final reminder issued on 15.2.2017.

Not recommend the product due to the following deficiencies even after multiple reminders dated above:1. Differential fee PKR.35,000/-

Rejected due to non-submission of following documents even after reminder and on strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy & quality:-a. Differential fee Rs.35,000/-b. Original


Strasse 37, 01277 Dresden, Germany.

2. Original Free Sale Certificate as decided by Registration Board.3. Original authorization letter/sole agency agreement from manufacturer as decided by Registration Board.4. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.5. Original Credentials of manufacture as decided by Registration Board.6. Copy of Valid Drug Sale License.

Free Sale Certificate as decided by Registration Board.c. Original authorization letter/sole agency agreement from manufacturer as decided by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided by Registration Boardf. Copy of Valid Drug Sale License.


Manufactured by:M/s Biotronic AG Ackerstrasse 6, 8180 Bulach,Switzerland.


Pantera Leo- Non-Compliant High Pressure Balloon.

Balloon Length (mm) 8,12,15,20,30.

Balloon Dia (mm):2.0, 2.25,2.5, 2.75, 3.0, 3.25, 3.5, 3.75, 4.0, 4.50, 5.00.


1’s

Not mentioned.

Applied on 10.12.2012Letter issued on 24.4.2013.Reminders issued on 2.3.2015 &15.2.2017

Not recommend the product due to following deficiencies even after multiple reminders dated above:

a) Differential fee PKR.35,000/-.

b) Original Free Sale Certificate as decided by Registration Board.

c) Original

Rejected due to non-submission of following documents even after reminder & on strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy & quality:a. Differential fee PKR.35,000/-b. Original Free Sale Certificate as decided by Registration Board.c. Original


authorization letter /sole agency agreement from manufacturer as decided by Registration Board.

d) Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.

e)Original Credentials of manufacture as decided by Registration Board.

f) Copy of Valid Drug Sale License.

authorization letter/ sole agency agreement from manufacturer as decided by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided by Registration Boardf. Copy of Valid Drug Sale License.

Cardiac CanulaSr.No.


Exporter.


Price & Pack size

Shelf life


evaluation cell

Decision

1. M/s Medica,C-9-C, 24th

Commercial Street-II, Ext-DHA, Karachi.

Manufactured by:M/s Sorin GroupItalia,Italy.

Stockert Cannula.


3 years Applied on 8.5.2012Letter issued on 24-04-2013Reminder issued on 11.07.2013Letter issued on 3rd March, 20154th eminder 2.2.2017Final reminder issued on 10.2.2017Deferred the product for provision of following documents and clarification regarding sole agency agreement with M/s Sorin Group Italia, Italy.a. Differentia

Rejected due to non-submission of following documents even after multiple reminder & on strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy & quality:a. Differential fee PKR.35,000/-,b. Original & valid Free Sale Certificate clarifying the status of legal manufacturer


l fee PKR.35,000/-,b. Original & valid Free Sale Certificate clarifying the status of legal manufacturer along with manufacturing site as decided by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.

e. Original Credentials of manufacture as decided by Reg.Board.

along with manufacturing site as decided by Registration Boardc. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided by Registration Board.


Assistant Director-IV:

Deferred Application of 266th Meeting

Stents.S. No.

Name of Importer &



Price & Pack size

Shelf life


evaluation cell

Decision

1. M/s. Sakuf Trading,34-G Phase I, Commercial Area, Defence Housing Authority, LahoreCantt Pakistan.

Manufactured by:M/s BALT EXTRUSION, 10, ru de la Croix Vigneron 95160 MONTMORENCY FRANCE.

LEO+ Intracranial Stent

(Product Sizes & Codes as per FSC)


05 Year

s

Applied on 21.11.2016Letter for short comings issued on 02.02.2017Letter communicating the Board decision issued on 10.2.2017Reply received

Deferred the product for the provision of the following documents:a. Differential fee PKR.35,000/-,b. Original & valid Free Sale Certificate as decided above by Registration Board (copy given).c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board (copy given).d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board (copy given).

Approved subject to provision of following documents within 2 weeks on strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:-a. Original Free Sale Certificate.b. Original authorization letter/sole agency agreement from manufacturerc. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture.

2. M/s. Sakuf Trading, 34-G

Silk + (Intracranial

As per policy

05 Year

Applied on 21.11.2016

Approved subject to provision of


Phase-I, Commercial Area, Defence Housing Authority, Lahore Cantt.

Manufactured by:M/s BALT EXTRUSION, 10, ru de la Croix Vigneron 95160 MONTMORENCY FRANCE.

Self Expandable Stent)

(Product Sizes and Codes as per FSC- Mono diameter & bi-diameter)

decision by Policy Board/ Federal Govt. and Registration Board

s Letter of short comings issued on 02-02-2017.Letter communicating the Board decision issued on 10.2.2017

Deferred the product for the provision of the following documents:a. Differential fee PKR.35,000/-,b. Original & valid Free Sale Certificate as decided above by Registration Board. (copy given)c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board. (copy given)d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board (copy given).

following documents within 2 weeks on strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:-a. Original Free Sale Certificate.b. Original authorization letter/sole agency agreement from manufacturerc. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture

3. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s Boston Scientific Corporation, 300 Boston Scientific Way,

Flexima Biliary Stent with Delivery System



36 mont

hs

Applied on 24.1.2017Letter of shortcomings issued on 01-01-2017Letter communicating the Board decision issued on 10.2.2017


Deferred for provision of following documents:-a. Original & valid Free Sale Certificateb. Original & valid authorization letter/sole agency agreement from manufacturer


Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, 780 Brookside Drive, Spencer IN-47460, USA.Sterilization Site:

i. M/s Boston Scientific Coventry, 8 Industrial Drive Coventry, RI 02816, USA.

ii. M/s Synergy Health AST Venlo (Formally Known as Isotron Nederland B.V) Faunalaan 38, 5928 RZ Venlo Netherlands.iii. M/s

Synergy Health Ireland Ltd (Formally Known as Isotron Ireland Ltd), IDA Business & Technology Park SraghTullamore Co. Offaly, Ireland.

subject to provision of following documents with an undertaking on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:a. Original & valid Free Sale Certificate as decided above by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture as decided above by Registration Board.


4. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera, KPKLegal Manufacturer:M/s Boston Scientific Corporation, 300

C-Flex Double Pigtail Biliary Stent



03 Year

s

Applied on24-1-2017Letter of shortcomings issued on 01-01-2017.Letter communicating the Board decision issued on 10.2.2017

Recommended for

Deferred for provision of following documents:-a. Original & valid Free Sale Certificateb. Original & valid authorization letter/sole agency


Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s Boston Scientific Corporation, 780 Brookside Drive, Spencer IN-47460, USA.Sterilization Sites:i. M/s Boston Scientific Coventry, 8 Industrial Drive Coventry, RI 02816, USA.ii. M/s Synergy Health AST Venlo (Formally Known as Isotron Nederland B.V) Faunalaan 38, 5928 RZ Venlo Netherlands.

iii. M/s Synergy Health Ireland Ltd (Formally Known as Isotron Ireland Ltd), IDA Business & Technology Park SraghTullamore Co. Offaly, Ireland.

consideration of Registration Board subject to provision of following documents with an undertaking on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:a. Original & valid Free Sale Certificate as decided above by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture as decided above by Registration Board.

agreement from manufacturerc. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.


Legal Manufacturer:

Wallstent Biliary Endoscopic Biliary Endoprosthesis (Uncovered)

Codes &


24mont

hs

Applied on24-1-2017Letter of shortcomings issued on 01-01-2017.Letter communicating the Board decision issued on 10.2.2017


a. Original & valid Free Sale Certificateb. Original


M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.

Manufacturing Site:M/s. Boston Scientific Limited, Ballybrit Business Park, Galway, Ireland.

Sterilization Site:M/s Synergy Health Wesport Ltd., Lodge Road, Westport Co Mayo, Ireland.

sizes as per FSC.

on Board Recommended for consideration of Registration Board subject to provision of following documents with an undertaking on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:a. Original & valid Free Sale Certificate as decided above by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture as decided above by Registration Board.

& valid authorization letter/sole agency agreement from manufacturerc. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.


Legal Manufacturer:M/s Boston Scientific Corporation, 300 Boston

Wallstent Enteral Endoprosthesis with Unistep Plus Delivery System (Colonic and Duodenal)

Codes & sizes as per


02Year

s

Applied on24-1-2017Letter of shortcomings issued on 01.01.2017Letter communicating the Board decision issued on 10.2.2017Recommended for consideration of Registration Board subject to provision


a. Original & valid Free Sale Certificateb. Original & valid authorization letter/sole agency agreement from


Scientific Way, Marlborough, MA, 01752, USA.

Manufacturing Site:M/s. Boston Scientific Limited, Ballybrit Business Park, Galway, Ireland.Sterilization Site:M/s Synergy Health Ireland Ltd., (Isotron), IDA Business & Technology Park Co. Offaly, Ireland.

FSC. of following documents with an undertaking on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:a. Original & valid Free Sale Certificate as decided above by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture as decided above by Registration Board.

manufacturerc. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.

7. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, NowsheraLegal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing

RX Biliary Duodenal Bend BiliaryStent with RX Delivery System



03Year

s

Applied on 24-1-2017Letter of shortcomings issued on 01-01-2017.Letter communicating the Board decision issued on 10.2.2017

Recommended for consideration of Registration Board subject to provision of following documents with an undertaking on


a. Original & valid Free Sale


Site:M/s. Boston Scientific Corporation, 780 Brookside Drive, Spencer IN-47460, USA.Sterilization Sites:

i. M/s Boston Scientific Coventry, 8 Industrial Drive Coventry, RI 02816, USA.

ii. M/s Synergy Health AST Venlo (Formally Known as Isotron Nederland B.V) Faunalaan 38, 5928 RZ Venlo Netherlands.iii. M/s

Synergy Health Ireland Ltd (Formally Known as Isotron Ireland Ltd), IDA Business & Technology Park SraghTullamore Co. Offaly, Ireland.

urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in larger public interest:Original & valid Free Sale Certificate as decided above by Registration Board.a. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.c. Original Credentials of manufacture as decided above by Registration Board.

Certificate.b. Original & valid authorization letter/sole agency agreement from manufacturerc. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.


Catheters

S. No.


Exporter

Name of Medical

Device (s)

Price & Pack size

Shelf life


evaluation cell

Decision

1. M/s. TM Marketing,9/SB-2 Miran Muhammad Shah Road, K.D.A Scheme#1 Karachi.

Manufactured by:M/s. Clear Stream Technologies Ltd., Moyne Upper, Enniscorthy Co. Wexford, Ireland.

Nimbus Salvo PTCA Catheter

(As per FSC)


03 years

Applied on 18-4-2011Letter of shortcomings issued on 26-9-2012Reminder issued on4-3-2015Final reminder issued on 6-10-2016.No reply received.Letter communicating the Board decision issued on 10-02-2017

Not recommend the product due to the following reasons:a. Differential Fee PKR.35,000/-,b. Original & valid Free Sale Certificate as decided above by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board.f. Valid Drug Sale Licence.

Rejected due to non-submission of following documents even after reminder and on the strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality :-a. Differential Fee Rs.35,000/-b. Original & valid Free Sale Certificate as decided above by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board


f. Valid Drug Sale Licence.

2. M/s.TM Marketing, 9/SB-2 Miran M. Shah Road, K.D.A Scheme#1 Karachi.Manufactured by:M/s. Merit Medical Systems, Inc. 1600 Weat merit, Parkway, South Jordan, Utah, 84095-2416 U.S.A.

Manufacturing location:Merit Medical System, Inc, 1111 South Velasco Angleton, TX 77515 USA.

Concierge Guiding Catheter

(As per FSC)


03 years

Applied on 18.4.2011Letter issued on26-9-2012Reminders issued on 4-3-15 & 6-10-2016No reply received.Letter communicating the Board decision issued on 10-02-2017

Not recommend the product due to the following reasons:a. Differential Fee PKR.35,000/-,b. Original & valid Free Sale Certificate as decided above by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board.f. Valid Drug Sale Licence.

Rejected due to non-submission of following documents even after reminder and on the strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy & quality:-a. Differential Fee Rs.35,000/-,b. Original & valid Free Sale Certificate as decided above by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Boardf. Valid Drug Sale Licence.


3. M/s. TM Marketing, 9/SB-2 Miran Muhammad Shah Road, K.D.A Scheme#1 Karachi.

Manufactured by:M/s. Merit Medical Systems, Inc. 1600 Weat merit, Parkway, South Jordan, Utah, 84095-2416U.S.A.

Manufacturing location:Merit Medical System, Inc, 1111 South Velasco Angleton, TX 77515 USA.

Performa ®, Softouch ® Diagnostic Catheter

(As per FSC)


03 years

Applied on 18-4-2011Letter issued 26.9.2012Reminders issued on 4-3-15 & 6-10-2016No reply received.Letter communicating the Board decision issued on 10-02-2017

Not recommend the product due to the following reasons:a. Differential Fee PKR.35,000/-,b. Clarification as 2 major groups of catheter applied on one application.c. Original & valid Free Sale Certificate as decided above by Registration Board.d. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.f. Original Credentials of manufacture as decided above by Registration Board.g. Valid Drug Sale Licence.

Rejected due to non-submission of following documents even after reminder and on the strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality :-a. Differential Fee Rs.35,000/-.b. Clarification as 2 major groups of catheter applied on one application.c. Original & valid Free Sale Certificate as decided above by Registration Board.d. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.f. Original Credentials of manufacture as decided above by Registration Board


g. Valid Drug Sale Licence.

4. M/s. Maxims Medical, 534 H Block, St. No.13, Phase-5, DHA, Lahore.

Responsible Manufacturer:M/s. Abbott Vascular, 3200, Lakeside Drive, Santa Clara, California CA 95054, USA.


Mercury PTCA Balloon Catheter

(As per FSC)


02 years

Applied on 23-4-2011Stents and Catheters from Ireland Source already registered in favour of M/s Digital Imaging System, Lahore.Authorization letter/sole agency agreement issued by Indian region.Letter for deficiencies issued on 23-10-2012Reminder issued on 7-10-2016.No reply received.Letter communicating the Board decision issued on 10-02-2017Not recommend the product due to following reasons:a. Differential Fee PKR.35,000/-,b. Original & valid Free Sale Certificate as decided above by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by

Rejected due to non-submission of following documents even after reminder and on strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy & quality:-

a. Differential Fee Rs.35,000/-.b. Original & valid Free Sale Certificate as decided above by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Boardf. Valid Drug Sale


Registration Board.f. Valid Drug Sale Licence.g. Clarification for product sizes and codes and different sites of manufacture.

Licence.g. Clarification for product sizes and codes and different sites of manufacture.

5. M/s. Maxims Medical, 534-H-Block, Phase-5, Street No-13, DHA, Lahore.

Responsible Manufacturer:M/s. TemMed Medical Co. Ltd. No. 48, Keji road. Miyun Industrial district, Beijing, 101500, P.R. China.

Path Maker PTCA Balloon Catheter

(As per FSC)


02 years

Applied on 23-4-2011Letter for deficiencies issued on 23-10-2012Reminder issued on7-10-2016.No reply received.Letter communicating the Board decision issued on 10-02-2017

Not recommend the product due to the following reasons:a. Differential Fee PKR.35,000/-,b. Original & valid Free Sale Certificate as decided above by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board.f. Valid Drug Sale Licence.g. Clarification for product sizes and

Rejected due to non-submission of following documents even after reminder and on strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy & Quality:a. Differential Fee Rs.35,000/-.b. Original & valid Free Sale Certificate as decided above by Registration Board

c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above


codes and different sites of manufacture.h. Last inspection report

by Registration Boardf. Valid Drug Sale Licence.g. Clarification for product sizes & codes and different sites of manufacture.h. Last inspection report

6. M/s Alliance Medical, 12-B, 1st Floor, Agro Flats, Shadman, Lahore.

Manufactured by:M/s Biosensors International Pte. Ltd, 36 Jalan Tukang, Singapore 619266.

(Free Sale Certificate of Singapore provided with an affidavit binding)

Biosensors Central Venous Catheter


36 months

Applied on 8-3-2016.Letter issued on18-1-2017.Reply received but didn’t fulfill the requirementsLetter communicating the Board decision issued on 10-02-2017.

Deferred the product for the provision of the following documents:a. Original & valid Free Sale Certificate as decided by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.c. Original Credentials of manufacture as decided by Registration Board.


a. Original authorization letter/sole agency agreement from manufacturer as decided by Registration Board

b. Original Credentials of manufacture as decided by Registration Board.

7. M/s Alliance Medical, 12-B, 1st Floor, Agro Flats, Shadman,

Biosensors thermodilution catheter,


36 months

Applied on 8-3-2016.Letter issued on 18.1.2017.Letter



Lahore/

Manufactured by:M/s Biosensors International Pte. Ltd, 36 Jalan Tukang, Singapore 619266.

(Free Sale Certificate of Singapore provided with an affidavit binding)

Uncoated

(Product types and codes as per FSC)


communicating the Board decision issued on 10-02-2017

Deferred the product for the provision of the following documents:a. Application on Prescribed Form-5Ab. Original & valid Free Sale Certificate as decided by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided by Registration Board.f. Copy Valid Drug Sale License,g. Clinical Data, if any.h. Complete specifications with details of analytical procedures

a. Original authorization letter/sole agency agreement from manufacturer as decided by Registration Board


c. Original Credentials of manufacture as decided by Registration Board.

8. M/s Alliance Medical, 12-B, 1st Floor, Agro Flats, Shadman, Lahore.

Manufactured by:M/s Biosensors

Biosensors Embolectomy Catheter

(Product sizes and codes as per FSC)


36 months

Applied on 8-3-2016.Letter issued on18-1-2017.Reply received but didn’t fulfill the requirementsLetter communicating the Board decision

Approved subject to provision of following documents within 2 weeks on strong recommendations of cardiology experts based on


International Pte. Ltd, 36 Jalan Tukang, Singapore 619266.(Free Sale Certificate of Singapore provided with an affidavit binding)

issued on 10-02-2017

Recommended for consideration of Registration Board subject to provision of following documents on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:a. Original & valid Free Sale Certificate as decided above by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.c. Original Credentials of manufacture as decided above by Registration Board.d. Copy Valid Drug Sale License

their clinical experience ensuring safety, efficacy and quality:-a. Original & valid authorization letter/sole agency agreement from manufacturer.b. Original Credentials of manufacture.

9. M/s. Promed International, CB-6349 Amarpak Plaza, Jhelum Road, Rawalpindi

Legal Manufacturer:M/s Biosensors Interventional Technologies Pte Ltd, 36 Jalan Tukang, Singapore

PowerlineTM

PTCA CatheterProduct sizes and codes as per FSC


1’s

36 months

Applied on 20-4-2016Letter of shortcomings issued on 18-1-2017Letter communicating the Board decision issued on 10-02-2017

Deferred the product for the provision of the following documents:-

Approved subject to provision of following documents within 2 weeks on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy & quality:-


619266.

Manufacturing Site:M/s Biosensors Interventional Technologies Pte Ltd, 36 JalanTukang, Singapore 619266

a. Sole agency original and notarized given but term sub distributor is usedb. Original Credentials of manufacturer.c. Stability studies incomplete

a. Sole agency original and notarized

b. Complete Stability studies.

10. M/s Hashir Surgical Services (Pvt) Ltd, 1st Floor, House#16, Street#1, Sector F-2, Phase-6, Hayatabad, Peshawar.

Sub-office: Office no.05,2nd

floor syed’s tower, university road,Manufactured By:M/s Intra Special Catheter GmbH, Oststrasse 2, 66780 Rehlingen-Siersburg, Germany

Trilucath Central Venous Catheter-3 Lumen.(As per FSC)Ref:323085, 323015, 323025, 323035, 323017, 323027, 323037, 323028Sizes:5.5F, 7F, 8.5F.Length (cm): 8, 13, 16, 20, 30.


5 years

Applied on 2-5-2016Letter of shortcomings issued on 2-11-2016.Reply received.Letter issued 3.1.2017Final letter issued on 20-1-2017Reply received

Recommended the product for the consideration of the Registration Board

Provided Sole agency original with affidavit binding.


11. M/s. Sakuf Trading,34-G Phase I, Commercial Area, Defence Housing Authority, Lahore Cantt Pakistan.

Manufactured by:M/s BALT EXTRUSION, 10, ru de la Croix Vigneron 95160

Eclipse (Double Lumen Occlusion Balloon)


05 Years

Applied on 21.11.2016Letter for shortcomings issued on 02-02-2017Letter communicating the Board decision issued on 10-02-2017Reply received.

Recommended for consideration of Registration Board subject to provision of following

Deferred for provision of following documents:-a. Original Free Sale Certificateb. Original & valid authorization letter/sole agency agreement from manufacturer.c. Approval of shelf life from regulatory


MONTMORENCY FRANCE.

documents on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:a. Differential fee PKR.35,000/-,b. Original & valid Free Sale Certificate as decided above by Registration Board. (copy given)c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board (copy given).d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board (copy given).f. Clinical Data, if any.

authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture.

12. M/s. Universal Enterprises, 29 Block-3 OVCHS Stadium Road,Karachi.

Manufactured byUnit-I:M/s. Romsons International,62

Peritoneal Dialysis Catheter Set


05 years

Applied on 19-4-2011Letter of shortcomings issued on 12-10-2012.Reminder issued on02-3-2015Reminder issued on07-10-2016Reply received on24-10-2016, the firm requested for

Rejected due to non-submission of following documents even after reminder and on the strong non-recommendations of cardiology experts based on their clinical experience


industrial estate Nunhai, Agra-282006 India.

Unit-II:Romsons international Unit-II 59jC, Noida Dadri Road, Phase II, Noida-201 301, Uttar Pardesh, India.

extension for the submission of short comings till 7.11.2016No reply receivedLetter communicating the Board decision issued on 10-02-2017

Deferred the product for the provision of the following documents:a. Original & valid Free Sale Certificate as decided above by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture as decided above by Registration Board.e. Clinical Data, if any.f. Copy Valid Drug Sale License,g. Specification and analytical methods.h. Method of manufacturing.

ensuring safety, efficacy and quality :-a. Original & valid Free Sale Certificate as decided above by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture as decided above by Registration Board.e. Clinical Data, if any.f. Copy Valid Drug Sale License,g. Specification and analytical methods.h. Method of manufacturing.

13. M/s. UniversalEnterprises, 29 Block-3 OVCHS Stadium Road,Karachi.

Amecath Catheter Kit


3 years

Applied on 19-4-2011Letter of shortcomings issued on 12-10-2012.Reminder issued on

Rejected due to non-submission of following documents even after reminder & on strong non-


Manufacturer:M/s. Ameco Medical Industries, Industrial Zone, B4, Plot 119 East, 10th of Ramadan City, Arab Republic of Egypt.


2-3-2015Reply received on01-04-2015 did not fulfill requirements.Final Reminder issued on 26-10-2016No reply receivedLetter communicating the Board decision issued on 10-02-2017

Deferred the product for the provision of the following documents:a. Original & valid Free Sale Certificate as decided above by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture as decided above by Registration Board.e. Copy Valid Drug Sale License,f. Analytical procedure and outline of method of manufacturing.

recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy & quality:a. Original & valid Free Sale Certificate as decided above by Registration Boardb. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture as decided above by Registration Board.e. Copy Valid Drug Sale License,f. Analytical procedure and outline of method of manufacturing

14. M/s. UniversalEnterprises, 29 Block-3 OVCHS Stadium Road,Karachi

Amecath Double Lumen Catheter.


03 years

Applied on 19-4-2011Letter of shortcomings issued on 12-10-2012.Reminder issued on2-3-2015

Rejected due to non-submission of following documents even after reminder and on strong non-


Manufactured by:M/s Ameco Medical Industries, Industrial Zone, B4, Plot 119 East, 10th of Ramadan City, Arab Republic of Egypt.

Registration Board

Reminder issued on 07.10.2016Reply received on24-10-2016, the firm requested for extension of one month till 07.11.2016 for the submission of short comings.No Reply receivedLetter communicating the Board decision issued on 10-02-2017

Deferred the product for the provision of the following documents:a. Original & valid Free Sale Certificate as decided above by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture as decided above by Registration Board.e. Copy Valid Drug Sale License,f. Analytical procedure and outline of method of manufacturing.

recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy & quality:

a. Original & valid Free Sale Certificate as decided above by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture as decided above by Registration Board.e. Copy Valid Drug Sale License,f. Analytical procedure and outline of method of manufacturing.

15. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons,

Flexima Nasobiliary Catheter kit with


03Years

Applied on 24-1-2017Letter of shortcomings issued

Approved subject to provision of following


Amangarh, Nowshera, KPKLegal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, 780 Brookside Drive, Spencer IN-47460, USA.Sterilization Site:M/s Boston Scientific Coventry, 8 Industrial Drive Coventry, RI 02816, USA.

M/s Synergy Health AST Venlo (Formally Known as Isotron Nederland B.V) Faunalaan 38, 5928 RZ Venlo Netherlands.

M/s Synergy Health Ireland Ltd (Formally Known as Isotron Ireland Ltd), IDA Business & Technology park SraghTullamore Co. Offaly, Ireland

Guidewire



on 01-01-2017Letter communicating the Board decision issued on 10-02-2017

Recommended for consideration of Registration Board subject to provision of following documents with an undertaking on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:a. Original & valid Free Sale Certificate as decided above by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture as decided above by Registration Board.

documents within 2 weeks on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:-a. Original & valid Free Sale Certificateb. Original & valid authorization letter/sole agency agreement from manufacturerc. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.

16. M/s. Ferozsons Laboratories Limited, P.O.

MaxForce TTS High Performan


24 months

Applied on 24-1-2017Letter of

Deferred for provision of following


Ferozsons, Amangarh, Nowshera.


Manufacturing Site:M/s. Boston Scientific Limited, Business and Technology Park , Model Form Road, Cork, Ireland

Sterilization Site:M/s Synergy Health Ireland Ltd, IDA Business and Technology Park, SraghTullamore County, Offaly, Ireland.

ce Balloon Dilatation Catheter



shortcomings issued on 01-01-2017Letter communicating the Board decision issued on 10-02-2017


documents:-

a. Original & valid Free Sale Certificateb. Original & valid authorization letter/sole agency agreement from manufacturer.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.

17. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh,

Flexima Nasobiliary Catheter kit with Jagware


03Years

Applied on 24-1-2017Letter of shortcomings issued on 01-01-2017.

Approved subject to provision of following documents


Nowshera, KPKLegal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s Boston Scientific Corporation, 780 Brookside Drive, Spencer IN-47460, USA.Sterilization Site:M/s Boston Scientific Coventry, 8 Industrial Drive Coventry, RI 02816, USA.


M/s Synergy Health Ireland Ltd (Formally Known as Isotron Ireland Ltd), IDA Business & Technology park SraghTullamore Co. Offaly, Ireland

Guidewire



Letter communicating the Board decision issued on 10-02-2017

Recommended for consideration of Registration Board subject to provision of following documents with an undertaking on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:

a. Original & valid Free Sale Certificate as decided above by Registration Boardb. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture as decided above by Registration Board.

within 2 weeks on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:-


18. M/s. Ferozsons Laboratories Ltd, P.O. Ferozsons,

Flexima Nasobiliary Catheter


03Years

Applied on 24-1-2017Letter of shortcomings issued

Approved subject to provision of following


Amangarh, Nowshera.Legal Manufacturer:M/s Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Corporation, 780 Brookside Drive, Spencer IN-47460, USA.Sterilization Sites:M/s Boston Scientific Coventry, 8 Industrial Drive Coventry, RI 02816, USA.


M/s Synergy Health Ireland Ltd (Formally Known as Isotron Ireland Ltd), IDA Business & Technology park SraghTullamore Co.Offaly, Ireland



on 01-01-2017.Letter communicating the Board decision issued on 10-02-2017


documents within 2 weeks on strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy & quality:


19. M/s. Ferozsons Laboratories Limited, P.O.

Extractor TM Pro Retrieval


2 Years

Applied on 24-1-2017Letter of

Deferred for provision of following


Ferozsons, Amangarh, Nowshera, KPKLegal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way. Marlborough, MA, 01752, USA.Manufacturing Site:M/s. Boston Scientific Limited, Business and Technology Park , Model Form Road, Cork, IrelandSterilization Site:M/s Boston Scientific Corporation. 8 Industrial Drive Coventry, RI 02816, USA.M/s Synergy Health Ireland Ltd, IDA Business and Technology Park, SraghTullamore County, Offaly, Irelamabd.

M/s Synergy Health AST, Venlo Faunalaan 38, 5928 RZ Venlo, Netherlands.STERIS Isomedix Services, 3459 South Clinton Avenue, South Plainfield, New Jersey 07080,

Balloon Catheter



shortcomings issued on 01-01-2017.Letter communicating the Board decision issued on 10-02-2017


documents:-

a. Original & valid Free Sale Certificate.b. Original & valid authorization letter/sole agency agreement from manufacturer.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.


USA.M/s Synergy Health AST, SRL, B13.1, Street 4, Avenue 1, EI Coyol Free Zone, EL CoyolAlajeula 20102, Costa Rica

20. M/s. Ferozsons Laboratories Limited, P.O. Ferozsons, Amangarh, Nowshera.Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough, MA, 01752, USA.

Manufacturing Site:M/s. Boston Scientific Corporation, 780 Brookside Drive, Spencer IN-47460, USA.Sterilization Sites:i. M/s

Boston Scientific Coventry, 8 Industrial Drive Coventry, RI 02816, USA.ii. M/s Synergy Health AST Venlo (Formally Known as Isotron Nederland B.V) Faunalaan 38, 5928 RZ Venlo

Biliary Stent Introducer



03Years

Applied on 24-1-2017Letter of shortcomings issued on 01-01-2017.Letter communicating Board decision issued on 10-02-2017

Recommended for consideration of Registration Board subject to provision of following documents with an undertaking on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:a. Original & valid Free Sale Certificate as decided above by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.c. Approval of shelf life from regulatory authority

Approved subject to provision of following documents within 2 weeks on strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:-a. Original & valid Free Sale Certificate as decided above by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Boardc. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.


Netherlands.iii. Synergy Health Ireland Ltd (Formally Known as Isotron Ireland Ltd), IDA Business & Technology park SraghTullamore Co.Offaly, Ireland

or Stability data to support claimed shelf life.d. Original Credentials of manufacture as decided above by Registration Board.

Fresh applications Catheter

S.No.

Name of Importer &

Manufacture/ Exporter


Price & Pack size

Shelf life


evaluation cell

Decision

1. M/s COR-MED,2nd Floor, 40/62, Bank Road Saddar, Rawalpindi.

Manufactured by:Merit Medical Systems, INC, 1600 West Merit Parkway South Jordan Ut 84095 USA.Ph: 1 801 253 1600

Resolve TMLocking (RLC) Drainage Catheter

Sizes as per Free Sale Certificate.

As per policy

decision by Policy

Board/ Federal


n Board

2 year

s

Applied on 08.2.2017Letter of shortcomings issued on 15-02-2017

Deferredthe product for the provision of the following documents and further expert opinion from interventional radiologist:a. Form 5-A not as per formatb. Product codes not mentionedc. Original Free Sale Certificate expiredd. Original authorization letter.e. Clinical data if anyf. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.g. Original

Approved subject to provision of following documents within 2 weeks on strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy & quality:

a. Original authorization letter as decided by the Registration Board

b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life as decided by the Registration Board.


Credentials of manufacturer

(Original Free Sale Certificate provided with affidavit binding to provide legalized FSC within six months)



Resolve TM(RBC) Locking Biliary Drainage Catheter


As per policy

decision by Policy

Board/ Federal


n Board

2 year

s


Deferred the product for the provision of the following documents and further expert opinion from interventional radiologist:a. Form 5-A not as per formatb. Product codes not mentionedc. Original Free Sale Certificate expired.d. Original authorization letter.e. Clinical data if anyf. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.g. Original Credentials of manufacturer.

Original Free Sale Certificate provided with affidavit binding to provide legalized FSC within six months.

Approved subject to provision of following documents within 2 weeks on strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy & quality:

a. Original authorization letter as decided by the Registration Board

b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life as decided by the Registration Board

3. M/s COR-MED,2nd Floor, 40/62, Bank Road Saddar,

One Step Centesis Catheter

As per policy

decision by Policy

2 year

s

Applied on 08.2.2017Letter of shortcomings issued

Approved subject to provision of following documents within


Rawalpindi.



Board/ Federal


n Board

on 15-02-2017

Deferred the product for the provision of the following documents and further expert opinion from interventional radiologist:a. Form 5-A not as per formatb. Product codes not mentionedc. Original Free Sale Certificate expiredd. Original authorization letter.e. Clinical data if anyf. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.g. Original Credentials of manufacturer


2 weeks on strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:-a. Original authorization letter as decided by Registration Board.b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.



Concierge Guiding Catheter


As per policy

decision by Policy

Board/ Federal


n Board

2 year

s


Deferred the product for the provision of the following documents and further expert opinion from interventional radiologist:a. Form 5-A not as per format


a. Address of manufacturer is different in Form 5-A and FSC.

b. Original authorization letter.

c. Approval


b. Product codes not mentionedc. Original Free Sale Certificate expiredd. Original authorization letter.e. Clinical data if anyf. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.g. Original Credentials of manufacturer


of shelf life from regulatory authority or Stability data to support claimed shelf life.

StentsS.

No.Name of Importer & Manufacture/

Exporter

Name of

Medical Device

Price & Pack size

Shelf life


evaluation cell

Decision

1. M/s COR-MED,2nd Floor 38/62, Bank Road Saddar, Rawalpindi.Ph: 051-5510939Fax: 051-5120124

Manufacturer:IBERHOSPITEX S.AAdva. Catalunya, 4- 08185 Llica de Vall, Barcelona, Spain.Tel: +34 93 843 60 34Fax +34 93 843 61 [email protected] www.iht.es

iht Destiny BD Stent

As per policy

decision by

Policy Board/ Federal Govt. and

Registration

Board

18 month

s


Deferred the product for the provision of the following documents and further expert opinion from interventional radiologist:a. Form 5-A not as per formatb. Product codes not mentionedc. Details of drug in medical deviced. Components along with


a. Form 5-A not as per formatb. Product codes not mentionedc. Details of drug in medical deviced. Components along with compositione. Details of specifications and analytical methodsf. ISO-


mailto:[email protected]

compositione. Details of specifications and analytical methodsf. Details of manufacture and QCg. Last inspection report.h. Clinical data & clinical justificationi. ISO-13485j. Original Free Sale Certificate expiredk. Original authorization letter.l. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.m. Original Credentials of manufacturer

13485g. Original Free Sale Certificate expiredh. Original authorization letter.i. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.j. Original Credentials of manufacturer


Assistant Director-VCatheters

S. No.

Name of Importer & Manufacture/

Exporter

Name of

Medical Device

Price & Pack size

Shelf life


evaluation cell

Decision

1. M/s Johnson & Johnson (Pvt) Ltd, Plot.No.10 & 25, Sector 20, Korangi Industrial Area, Karachi.

Legal Manufacturer:M/s Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA, USA.

Manufacturing Site:M/s Codman & Shurtleff. Calle Cirrcuito Interior Norte No.1820, Parque Industrial Salvarcar, Ciudid Juarez, Chihuaha, CP 32575, Mexico.

Exporting & Releasing SiteEuropean Distribution Cente, Johnson & Johnson,Belgium.

Envoy Guiding Catheters-Envoy 5f-Envoy 6f-Envoy-XB

(sizes as per FSC)


03 years

Applied on 4-5-2012Differential fee not paid.Letter issued on 18.3.2013.Reminder on 24-1-17 and 10.2.2017(firm requested for 3 weeks time)Deferred the product for the provision of following documents.a. Differential fee PKR.35,000/-,b. Original & valid Free Sale Certificate as decided above by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.d. Clinical data, if any,e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.f. Original Credentials of manufacture as decided above by Registration Board.g. Copy Valid Drug Sale License,


a. Original & valid Free Sale Certificate as decided above by Registration Board.b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.c. Original Credentials of manufacture as decided above by Registration Board.

2. M/s Cardiac Care, 848-C, Shadman-I, Lahore.

Manufactured by:

Leader- Cath

Codes:115.090


60 mont

hs

Applied on 1-1-2013.Letter Issued on16-6-2014. Reminder issued on

Rejected due to non-submission of following documents even after reminders


M/s Vygon-5 rue Adeline -95440-Ecouen, France.

, 115.092, 115.094115.096, 115.11, 115.118

(sizes as per FSC)


19-1-2017 & 10.2.2017Deferred the product for provision of the following documents.a. Original & valid Free Sale Certificate as decided above by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.c. Clinical data, if any,d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board

and on strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy & quality:a. Original & valid Free Sale Certificate as decided above by Registration Board (copy provided).b. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board (copy provided).c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture as decided above by Registration Board (copy provided)


Manufactured by:M/s Vygon-5 rue Adeline -95440-Ecouen, France.

Multicath 2, Multicath 3.

Codes of Multicath 2:6202.20, 6202.24, 6202.27, 6204.17.


60 mont

hs

Applied on 1-1-2013Letter issued on16-6-2014. Reminders issued on 19.1.2017 & 10.2.2017Deferred the product for provision of following documents.a. Original & valid Free Sale Certificate as decided above by Registration Board.b. Original & valid authorization letter/sole agency

Rejected due to non-submission of following documents even after reminders and on strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality:-a. Original & valid Free Sale Certificate as decided above by


Codes of Multicath 3:6208.25, 6209.25.

(sizes as per FSC)

agreement from manufacturer as decided above by Registration Board.c. Clinical data, if any,d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board.

Registration Board (copy provided).b. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board (copy provided).c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture as decided above by Registration Board (copy provided)



Multicath 4

(sizes as per Free Sale certificate)


60 mont

hs

Applied on 1-2-2017Letter issued on03.2.2017Deferred the product for provision of the following documents.a. Original & valid Free Sale Certificate as decided above by Registration Board (copy provided having only multicath name).b. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.c. Clinical data, if any,d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.

Deferred for provision of following documents:-a. Original & valid Free Sale Certificate as decided above by Registration Board (copy provided having only multicath name).b. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Boardc. Clinical data, if any,d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of


e. Original Credentials of manufacture as decided above by Registration Board.

manufacture as decided above by Registration Board



MULTISTAR 4+As per Free Sale certificate


Not given

Applied on 1-2-2017Letter issued on03.2.2017Deferred the product for provision of following documents.a. Undertaking on form 5A not givenb. Original & valid Free Sale Certificate as decided above by Registration Boardc. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.d. Clinical data, if any,e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.f. Original Credentials of manufacture as decided above by Registration Board.

Deferred for provision of following documents:-a. Undertaking on form 5A not givenb. Original & valid Free Sale Certificate as decided above by Registration Boardc. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Boardd. Clinical data, if any,e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.f. Original Credentials of manufacture as decided above by Registration Board

6. M/s Mediland Pakistan (Pvt) Ltd, Office No. B-09, 2nd Floor, Masood Arcade, IJP Road, Near Saidpur Road, Rawalpindi.

Manufactured by:M/s Datascope

Intra Aortic Balloon Catheter

As per policy decision by Policy Board/ Federal Govt. and Registration

Not mentioned

Applied on27-10-2016.Letter issued on19.1.2017 & 10.2.2017Deferred the product for provision of the following documents.a. Application on Form-5A as per

Deferred for provision of following documents:-a. Application on Form-5A as per prescribed format.b. Original & valid Free Sale Certificate as


Corporation, 1300Macarthur Blvld MAHWAH, NJ USA 07430

Board prescribed format.b. Original & valid Free Sale Certificate as decided above by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board.f. Clinical Data, if any.

decided above by Registration Boardc. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Boardd. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board

7. M/s Iqbal & Company, Islamabad

Manufacturing Site:M/s Renax Medical Co. Ltd, Thailand.

Arrow Catheters (Blood Tubing/Lines Set for Hemodialysis) Single & Double Chamber)

(sizes as per FSC)


Not clear.

Applied on 22.5.2012Letter of shortcoming issued on 24-4-2013.Reminders issues on 2-3-2015, 1-2-2017 and 10.2.2017Not recommend the product due to the following reasons.Registration board in its 266 meeting differed the case for provision of the following documentsa. Differential fee PKR.35,000/-,b. Original & valid Free Sale Certificate as decided above by Registration Board.c. Original & valid authorization letter/sole agency

Rejected due to non-submission of following documents even after reminder and on strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy & quality:a. Differential fee Rs.35,000/-,b. Original & valid Free Sale Certificate as decided above by Registration Boardc. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration


agreement from manufacturer as decided above by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board.f. Clinical Data, if any.g. Copy Valid Drug Sale License,h. Specification and analytical methods.i. Method of manufacturing.

Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board.f. Clinical Data, if any.g. Copy Valid Drug Sale License,h. Specification and analytical methods.i. Method of manufacturing.



Umbilical Catheter

Sizes 3FR, 4FR, 5FR, 6FR, 7FR, 8FR

Length: 38cm


5 years

Applied on 1-1-2013Letter of shortcoming issued on 16-6-2014.Reminder issues on 3-2-2017.Deferred the product for the provision of the following documents.Registration board in its 266 meeting differed the case for provision of the following documentsa. Original & valid Free Sale Certificate as decided above by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.c. Approval of

Deferred for provision of following documents:-a. Original & valid Free Sale Certificate as decided above by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture as decided above by


shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture as decided above by Registration Board.e. Clinical Data, if any.

Registration Board.



Easydrain

(Catheter for Pleural/ Thoracis Drainage)

Codes:681.06,681.08, 681.082, 681.10.

(sizes as per FSC)


60 mont

hs

Applied on 1-1-2013Letter of shortcoming issued on 16-6-2014.Reminder issues on 3-2-2017.Deferred the product for provision of the following documents.Registration board in its 266 meeting differed the case for provision of the following documentsa. Original & valid Free Sale Certificate as decided above by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture as decided above by Registration Board.

Deferred for provision of following documents:-a. Original & valid Free Sale Certificate as decided above by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture as decided above by Registration Board.


e. Clinical Data, if any.

10. M/s Sakuf Trading, 34-G, Phase-1, Commercial Area, Defence Housing Authority, Lahore Cantt.


Fargo Line (Braided Guiding Catheter)



5 years

Applied on 21.11.2016Shortcoming letter issued on 20-1-2017 and 10.2.2017

Deferred the product for provision of the following documents.Registration board in its 266 meeting differed the case for provision of the following documentsa. Differential fee PKR.35,000/-,b. Original & valid Free Sale Certificate as decided above by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Clarification of different typesf. Original Credentials of manufacture as decided above by Registration Board.g. Clinical Data, if any.


a. Differential fee Rs.35,000/-,b. Original & valid Free Sale Certificate as decided above by Registration Board.c. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Clarification of different typesf. Original Credentials of manufacture as decided above by Registration Board.

11. M/s Sakuf Trading, 34-G, Phase-1, Commercial Area, Defence Housing Authority, Lahore Cantt.

Magic (Flow guided Micro Catheters)


5 years

Applied on21-11-2016Shortcoming letter issued on 20-1-2017 and 10.2.2017

Deferred the product

Deferred for provision of following documents:-a. Differential fee





for the provision of the following documents.Registration board in its 266 meeting differed the case for provision of the following documentsa. Differential fee PKR.35,000/-,b. Fresh from 5A with correct name of the product.c. Original & valid Free Sale Certificate as decided above by Registration Board.d. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.f. Orignal Credentials of manufacture as decided above by Registration Board.g. Clinical Data, if any.

PKR.35,000/-b. Fresh form 5A with correct name of the product.c. Original & valid Free Sale Certificate as decided above by Registration Board.d. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.f. Original Credentials of manufacture as decided above by Registration Board.g. Clinical Data, if any.


Legal Manufacturer:M/s Boston Scientific Corporation, 300 Boston Scientific Way, Marlborough,

Rigiflex TM II Single Use Achalasia Balloon Dilator



Oneyear

Applied on 23.1.2017Shortcoming letter issued on 02-2-2017 and 10.2.2017Recommended for consideration of Registration Board subject to provision of following documents with an undertaking on urgent basis on the recommendations


a. Original & valid Free Sale Certificate as decided above by Registration Board.

b. Original & valid authorization


MA, 01752, USA.

Manufacturing Site:M/s. TechDevice Corporation, 650 Pleasamt Street, Watertown, MA 02472, USA

Sterilization Site:M/s Boston Scientific Coventry (formally Steris Isomedix) 8 Industrial Drive Coventry, RI-02816, USA.

of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:Registration board in its 266 meeting differed the case for provision of the following documents:-

a. Original & valid Free Sale Certificate as decided above by Registration Board.b. Original & valid authorization letter/sole agency agreement from legal manufacturer as decided above by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture as decided above by Registration Board.e. Clinical Data, if any.

letter/sole agency agreement from legal manufacturer as decided above by Registration Board.



Legal Manufacturer:M/s. Boston Scientific Corporation, 300 Boston Scientific

Hurricane RX Biliary Balloon Dilatation Catheter



02years

Applied on 23.1.2017Shortcoming letter issued on 02-2-2017 and 10.2.2017Recommended for consideration of Registration Board subject to provision of following documents with an undertaking on urgent basis on the

Deferred for provision of following documents:-a. Original & valid Free Sale Certificate as decided above by Registration Board.b. Original & valid authorization letter/sole agency


Way, Marlborough, MA, 01752, USA.

Manufacturing Site:M/s. Boston Scientific Limited, Business & Technology Park, Model Farm Road, Cork, Ireland

Sterilization Site:M/s Synergy Health Ireland Ltd, IDA Business & Technology park Sragh Tullamore Co. Offaly, Ireland.

recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:Registration board in its 266 meeting differed the case for provision of the following documentsa. Original & valid Free Sale Certificate as decided above by Registration Board.b. Original & valid authorization letter/sole agency agreement from legal manufacturer as decided above by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture as decided above by Registration Board.e. Clinical Data, if any.f. Clarification as Address on letterof authorization is different than on Form 5A.

agreement from legal manufacturer as decided above by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Clarification as Address on letter of authorization is different than on Form 5A

14. M/s. Maxims Medical, 534-H Block, St. No.13, Phase 5, DHA, Lahore.

Manufactured by:M/s MINVASYS, 7

Yangtze PTCA Balloon Dilatation Catheter

As per policy decision by Policy Board/ Federal Govt.

3 years

Applied on 23.1.2017Shortcoming letter issued on 2-2-2017 and 10.2.2017Deferred the product for the provision of the following

Approved subject to provision of following documents within 2 weeks on strong recommendations of cardiology experts based on


REU DU FOSSE Blanc 92230, France. Codes

& sizes as per FSC.

and Registration Board

documents.Registration board in its 266 meeting differed the case for provision of the following documentsa. Form A with correct information regarding product name and manufacturer address.b. Original & valid Free Sale Certificate as decided above by Registration Board (copy provided).c. Valid authorization letter/ sole agency agreement from manufacturer as decided above by Registration Board. (Copy provided).d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board.f. Clinical Data, if any.g. Copy Valid Drug Sale License having valid address as written on letter of authorization and form 5A,

their clinical experience ensuring safety, efficacy & quality:a. Form 5-A with complete product name, type applied & manufacturer address.b. Original & valid Free Sale Certificate as decided above by Registration Board (copy provided).c. Valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board. (Copy provided).d. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life brand specific.e. Original Credentials of manufacture as decided above by Registration Board.f. Clinical Data, if any.g. Clarification as applicant address on DSL is different than written on Form 5-A and letter of authorization.

15. M/s Hashir Surgical Services , 1st Floor, House#.16, Street# 1, Sector F-2,

Trilucath Hemodialysis Cathete


5 years

Applied on 2-5-2016Shortcoming Letter Issued on 14.12.2016, 2.2.2017 &

Approved on the strong recommendations of cardiology experts based on


Phase-6, Hayatabad, Peshawar.

Sub-office/Godown: Office No.05,2nd

floor Syed’s Tower, University road, Peshawar

Manufactured By:M/s Intra Special Catheters GmbH, Oststrasse 2, 66780 Rehlingen-Siersburg, Germany.

r 3-Lumen.

Sizes as per Form 5-A


10.2.2017Recommended for consideration of Registration Board subject to provision of technical data sheet having sizes along with stability studies on urgent basis on recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:

Have provided affidavit that he will provide legalized letter of authorization within 15 days.

their clinical experience ensuring safety, efficacy and quality and completion of required documents specified by Registration Board.

16. M/s. Universal Enterprises, 29 Block-3 OVCHS Stadium Road,Karachi.

Manufacturer:M/s. Haidylena For Advanced Medical Industries, Egypt.

Dual Lumen Catheter Kit


3 years

Applied on 11.5.2011Shortcoming letter issued on12-10-2012.Reminders issued on 2.3.2015, 6.10.2016 and 10.2.2017Not recommend the product due to the following reasons.Registration board in its 266 meeting differed the case for provision of the following documentsa. Differential fee PKR.35,000/-,b. Clarification as Address and name of manufacturer not mentioned on Form 5A.c. Original & valid Free Sale Certificate as

Rejected due to non-submission of following documents even after reminder & on strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy & quality:-a. Differential fee Rs.35,000/-,b. Clarification as Address and name of manufacturer not mentioned on Form 5A.c. Original & valid Free Sale Certificate as decided above by Registration Board.


decided above by Registration Board.d. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.f. Original Credentials of manufacture as decided above by Registration Board.g. Clinical Data, if any.h. Copy Valid Drug Sale License,i. Specification and analytical methodsj. Method of manufacturing.

d. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.e. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.f. Original Credentials of manufacture as decided above by Registration Board.g. Clinical Data, if any.h. Copy Valid Drug Sale License,i. Specification & analytical methods.j. Method of manufacturing.

17. M/s. Ali Gohar & Co. (Pvt) Ltd., Karachi.

Legal Manufacturer:M/s. Mediquip Son, BHD., Kangar Perlis, Malaysia,

Manufacturer:M/s. Mediquip SDN, BHD., Kangar Perlis, Malaysia.

Dover Silicone/Hydrogel Coated Latex Foley Catheter (all types, sizes & accessories)


5 years


Shortcoming letter issued on 8-11-2012Reminders issued on 18.4.2014, 31.10.2016 and 10.2.2017 twice informed telephonically also.

Deferred the product for the provision of the following documents.Registration board in its 266 meeting differed the case for provision of the following documents

Rejected due to non-submission of following documents even after reminder and on the strong non-recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy and quality and availability of alternatives :-a. Original & valid Free Sale Certificate as decided above by Registration Board.


a. Original & valid Free Sale Certificate as decided above by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.c. Original Credentials of manufacture as decided above by Registration Board.d. Clinical Data, if any.e. Copy Valid Drug Sale License,f. Analytical procedureg. Clarification as product applied is silicone or hydrogel coated.

b. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.c. Original Credentials of manufacture as decided above by Registration Board.d. Clinical Data, if any.e. Copy Valid Drug Sale License,f. Analytical procedureClarification as product applied is silicone or hydrogel coated.

18. M/s 4S International, Suit No.205, 2nd Floor, Al Fiza Glass Tower, Rashid Minhas Road, Block-10-A, Gulshan-e-Iqbal, Karachi, Pakistan

Manufactured By:M/s Balton Sp. Z o.o. Ul. Nowy swiat 7/ 14, 00-496 Warsaw, Poland.Manufacturing Site.Ul. Modlinska 294 02-156 Warsaw , Poland

Introducer version braided or non-braided- kits to introduce and exchange catheters and endocavitary electrodes, with hemostasis valve


1’s

4 years & 11 mont

hs


Recommended for consideration of Registration board.

Deferred for clarification regarding brand name and generic name of the product.

19. M/s Allmed Solutions, Karachi.

Manufactured by:Not provided

Esophageal Stents

As per policy

decision by

Policy Board/

Not mentioned

Applied on7-6-2012Shortcoming letter issued on28-10-2013Reminder issued on

Rejected due to non-submission of following documents even after reminder and on the strong non-


Federal Govt. and

Registration

Board

2.3.2015 & 10.2.2017 No reply received till date.Deferred the product for provision of following documents.Registration board in its 266 meeting differed the case for provision of the following documentsa. Differential fee PKR.35,000/-,b. Form 5-A and all other relevant documents required according to form 5-A, Free sale certificate, sole agency agreement and credentials of manufacturer etc.

(According to manufacturing site decision of Registration Board for related documents will be applicable.)

recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy & quality:-

a. Differential fee Rs.35,000/-,b. Form 5-A and all other relevant documents required according to form 5-A, Free sale certificate, sole agency agreement and credentials of manufacturer etc

20. M/s Verizon 60-D, F.C.C., Zahoor Elahi Road , Gulberg-IV, Lahore

Head Office: Toray Industries , Inc.,1-1 Nihonbashi-Muromachi 2-chome,Chuo-ku,Tokyo,103-8666 Japan

Manufacturing Sit:and Address: Toray Industries,Inc. Seta Plant 1-1, Oe 1-chome,Otsu, Shiga, 520-2141 Japan

INOUE- BALLOON

Sizes and codes as per Free Sale certificate

As per policy

decision by

Policy Board/ Federal Govt. and

Registration

Board

2years

Applied on 16.1.2017.Short coming letter issued on 15.2.2017Recommended for consideration of Registration Board subject to provision of following documents on undertaking on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:


1. Affidavit for provision of original notarized and embassy attested Free Sale certificate within


1 Original Free Sale certificate provided, but having digital signatures of the issuing authority. FSC is not notarized neither attested by the embassy.2 stability study summary provided only

six months as decided by the Board.2. Accelerated /Real time stabilities studies

Cardiac CannulaS.

No.Name of Importer &

Manufacture/ Exporter


Price & Pack size

Shelf life

Recommendations of Cardiologists in

evaluation cell

Decision


Manufactured by:M/s Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO, 80004, USA.

Venous Cardiopulmonary By pass Cannulae

Product codes as Form 5-A.


3 years

Applied on 20.7.2012Letter of deficiencies issued on 31-10-2012Reminders issued on 01-02-2017 ,3.2.2017 & 10.2.2017Recommended for consideration of Registration Board subject to provision of following documents on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:Registration board in its 266 meeting deferred the case for rectification of following shortcomings after personal hearing of authorized representative:a. Original & valid Free Sale Certificate along

Approved subject to provision of following documents within 2 weeks on strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy & quality:-

a. Original & valid Free Sale Certificateb. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Boardc. Clarification of the link between Sorin group Italia and USAd. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.


with another letter clarifying the status of legal manufacturer and manufacturing site from the regulatory authority of the country of origin as decided by Registration Board.b. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture as decided above by Registration Board.

e. Original Credentials of manufacture as decided above by Registration Board.f. Provide technical data sheet of the manufacturer clarifying the name of the product with respect to codes written on Free Sale Certificate.


Manufactured by:M/s Sorin Group USA, Inc, 14401 W. 65th Way Arvada, CO, 80004, USA.

Cardiopulmonary Bypass Cannula

Product codes as per Form 5-A.


3 years

Applied on 20.7.2012Letter of deficiencies issued on 31-10-2012Reminders issued on 01.02.2017, 3.2.2017 and 10.2.2017Recommended for consideration of Registration Board subject to provision of following documents on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:

Approved subject to provision of following documents within 2 weeks on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy & quality:-a. Original & valid Free Sale Certificateb. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Board


Registration board in its 266 meeting deferred the case for rectification of following shortcomings after personal hearing of authorized representative:g. Original & valid Free Sale Certificate along with another letter clarifying the status of legal manufacturer and manufacturing site from the regulatory authority of the country of origin as decided by Registration Board.a. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Boardb. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.c. Original Credentials of manufacture as decided above by Registration Board.

c. Clarification of the link between Sorin group Italia and USAd. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board.f. Provide technical data sheet of the manufacturer clarifying the name of the product with respect to codes written on Free Sale Certificate.



Coronary Sinus Cannulae



3 years

Applied on 20-7- 2012Letter of deficiencies issued on 31-10-2012Reminders issued on 01-02-2017, 3-2-2017 and 10.2.2017


Approved subject to provision of following documents within 2 weeks on the strong recommendations of cardiology experts based on their clinical experience ensuring safety,


subject to provision of following documents on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:Registration board in its 266 meeting deferred the case for rectification of following shortcomings after personal hearing of authorized representative:a) Original & valid Free Sale Certificate along with another letter clarifying the status of legal manufacturer and manufacturing site from the regulatory authority of the country of origin as decided by Registration Board.b) Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.c) Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d) Original Credentials of manufacture as decided above by Registration Board.

efficacy & quality:-

a. Original & valid Free Sale Certificateb. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Boardc. Clarification of the link between Sorin group Italia and USAd. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board.f. Provide technical data sheet of the manufacturer clarifying the name of the product with respect to codes written on Free Sale Certificate.


e) Clarifications for product codes present on Free sale and form 5A.



Suction Tips

Product codes as per Free Sale Certificate and Form 5-A.


3 years

Applied on 20.7.2012Letter of deficiencies issued on 31-10-2012Reminders issued on 01-02-2017, 3-2-2017 and 10.2.2017Recommended for consideration of Registration Board subject to provision of following documents on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public & private) in the larger public interest:-Upon request for technical input regarding suction tip, the experts confirmed that Suction tip is a CannulaRegistration Board in its 266th meeting deferred the case for rectification of following shortcomings after personal hearing of authorized representative:a. Suction tip as a drug need to be confirmed after provision of relevant documents by the applicant.b. Original & valid Free Sale Certificate along

Approved subject to provision of following documents within 2 weeks on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy & quality:-a. Original & valid Free Sale Certificateb. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Boardc. Clarification of the link between Sorin group Italia and USAd. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board.f. Provide technical data sheet of the manufacturer clarifying the name of the


with another letter clarifying the status of legal manufacturer and manufacturing site from the regulatory authority of the country of origin as decided by Registration Board.c. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d. Original Credentials of manufacture as decided above by Registration Board.f) Clarifications for product codes present on Free sale and form 5A.

product with respect to codes written on Free Sale Certificate.



Cardioplegia Cannulae

(aortic root cannula)



3 years

Applied on 20.7.2012Letter of deficiencies issued on 31-10-2012Reminders issued on 01.2.2017 & 10.2.2017Recommended for consideration of Registration Board subject to provision of following documents on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:

Registration board

Approved subject to provision of following documents within 2 weeks on the strong recommendations of cardiology experts based on their clinical experience ensuring safety, efficacy & quality:-a. Original & valid Free Sale Certificateb. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Boardc. Clarificati


in its 266 meeting deferred the case for rectification of following shortcomings after personal hearing of authorized representative:a) Original & valid Free Sale Certificate along with another letter clarifying the status of legal manufacturer and manufacturing site from the regulatory authority of the country of origin as decided by Registration Board.b) Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.c) Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d) Original Credentials of manufacture as decided above by Registration Board.g) Clarifications for product codes present on Free sale and form 5A.

on of the link between Sorin group Italia and USAd. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board.f. Provide technical data sheet of the manufacturer clarifying the name of the product with respect to codes written on Free Sale Certificate.



Arterial Cardiopulmonary Bypass Cannulae

Product codes as per Form

As per policy decision by Policy Board/ Federal Govt. and Registrat

3 years

Applied on 20.7.2012Letter of deficiencies issued on 31-10-2012Reminders issued on 01.02.2017, 3.2.2017 and 10.2.2017Recommended for



5-A. ion Board

consideration of Registration Board subject to provision of following documents on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:

Registration board in its 266 meeting deferred the case for rectification of following shortcomings after personal hearing of authorized representative:e) Original & valid Free Sale Certificate along with another letter clarifying the status of legal manufacturer and manufacturing site from the regulatory authority of the country of origin as decided by Registration Board.a. Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.b. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.c. Original Credentials of manufacture as

experience ensuring safety, efficacy & quality:-a. Original & valid Free Sale Certificateb. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Boardc. Clarification of the link between Sorin group Italia and USAd. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board.f. Provide technical data sheet of the manufacturer clarifying the name of the product with respect to codes written on Free Sale Certificate.


decided above by Registration Board.d. Clarifications for product codes present on Free sale and form 5A.



Vessel Cannula With/ Without Wing & Valve.



3 years

Applied on 20.7.2012Letter of deficiencies issued on 31-10-2012Reminders issued on 01.2.2017& 10.2.2017Recommended for consideration of Registration Board subject to provision of following documents on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:

Registration board in its 266 meeting deferred the case for rectification of following shortcomings after personal hearing of authorized representative:a) Original & valid Free Sale Certificate along with another letter clarifying the status of legal manufacturer and manufacturing site from the regulatory authority of the country of origin as decided by Registration Board.

Deferred for provision of following documents:a. Clarification of product , brand name & codes as per Free sale certificate providedb. Original & valid Free Sale Certificatec. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Boardd. Clarification of the link between Sorin group Italia and USA

e) Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.f) Original Credentials of manufacture as decided above by Registration Board.g) Provide technical data sheet of the manufacturer clarifying the name of the product with


b) Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Boardc) Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.d) Original Credentials of manufacture as decided above by Registration Board.

respect to codes written on Free Sale Certificate.



Coronary Artery Perfusion Cannula



3 years

Applied on 20.7.2012Letter of deficiencies issued on 31-10-2012Reminders issued on 01.02.2017, 3.2.2017 and 10.2.2017Recommended for consideration of Registration Board subject to provision of following documents on urgent basis on the recommendations of cardiologists regarding cardiac, vascular and ancillary procedures in the institutions (public and private) in the larger public interest:

Registration board in its 266 meeting deferred the case for rectification of following shortcomings after personal hearing of authorized representative:


a. Original & valid Free Sale Certificateb. Original & valid authorization letter/sole agency agreement from manufacturer as decided by Registration Boardc. Clarification of the link between Sorin group Italia and USAd. Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e. Original Credentials of manufacture as decided above by Registration Board.


a) Original & valid Free Sale Certificate along with another letter clarifying the status of legal manufacturer and manufacturing site from the regulatory authority of the country of origin as decided by Registration Board.b) Valid Form-5 Ac) Original & valid authorization letter/sole agency agreement from manufacturer as decided above by Registration Board.d) Approval of shelf life from regulatory authority or Stability data to support claimed shelf life.e) Original Credentials of manufacture as decided above by Registrationf) Board.g) Clarification as for provision of name in Free sale certificate.


Case No.03: Cancellation of Sole Agency Certification.

Registration Board in its 236th meeting held on 20th November, 2012 considered and approved the following medical devices of M/s Intra Health, Karachi subject to recommendations of ECMD, inspection of manufacturer abroad, local storage facilities etc as per policy:-S. # Name of Importer and

Manufacturer / Exporter.Name of Medical

DeviceDemanded

Price & Pack Size.Shelf Life

1. M/s Intra Health, 56-A, Unit No.1, Justice Inamullah Road, Block 7/8 KCHS, Karachi.Manufactured by:M/s Uro Technology Sdn. Bhd., Malaysia.

Pro Care Foley Balloon Catheters.

(Latex Foley Catheter Silicon Coated)

Decontrolled

Different types i.e 2way, 3way with different product codes

05 years

The ECMD in its 1st meeting held on 13th December, 2012 recommended the above

product. The registration certificates of above mentioned products could not be issued as the

inspection of manufacturing facility in Malaysia could not be conducted. In the meanwhile, the

Principal manufacturer has sent a letter dated 12-01-2016, wherein they have confirmed that they

have an exclusive contract with M/s Life Cares, Karachi for the exclusive sales and distribution

of whole range of Chroma Foley Catheters and that they will not pursue the registration of their

product Foley Catheter with MOH Pakistan applied by M/s Intra Health, Karachi.

In this regard M/s Intra Health, Karachi was asked through a letter dated 22nd June, 2016

to confirm their status as being sole agent of M/s Uro Technology Sdn. Bhd., Malaysia for above

mentioned medical device or otherwise within 10 days for further processing the case.

M/s Intra Health, Karachi has informed vide letter dated 29-06-2016 that they are the

exclusive agent for Procare Foley Balloon Catheters, manufactured by M/s Uro Technology Sdn.

Bhd. Malaysia. The firm has submitted a colored copy of authorization letter/sole agency

agreement from principal manufacturer and requested not to consider any application as the

agreement is still valid. Authorization letter/sole agency agreement was issued on 1st April, 2015

for 03 years i.e. till 31st May, 2018. However, the authorization letter/sole agency agreement in

favor of M/s Life Cares, Karachi was issued on 12-01-2016.

Case was placed before the Registration Board and Registration Board discussed

the case and decided to issue show cause notice to M/s Intra Health, Karachi that why their

application may not be rejected due to the aforementioned reasons. The Board also decided to

call the firm representative for personal hearing in the next meeting of the Board.


Accordingly decision of the Board was conveyed to M/s Intra Health, Karachi. In

reply the firm has informed as below:-

(i) Our application has been submitted with the Ministry since 17-10-2011 which gives us the benefit of applying fist and also entitled to the registration of our PROCARE Brand.

(ii) Our supplier has been providing us all the documents since the day applied and fulfilled all the requirements for this registration. This shows his willingness to get this registration for the PROCARE brand through our company. We have been consistently making efforts to get this brand registered since the last five years.

(iii) We had provided the registration fee as well as the balance fee vide our letter dated 08-03-2013 which makes our file complete in all aspects.

(iv) The exclusive letter provided by the manufacturer is still valid and gives us the benefits of being rightful applicant for the brand PROCARE in Pakistani market.

Case was placed before the Board in 266th meeting and the Board decided to call the firm for hearing in the next meeting. Accordingly letter was issued to the firm for personal hearing. The firm verbally informed to appear in next meeting.

Decision: Registration Board decided to call the firm for personal hearing as a final opportunity in next meeting.

Case No.04: Transfer of Registration.M/s Asto Life Sciences Private Limited, Lahore has requested for transfer of following

registered imported drugs (Medical Devices) from the name of M/s Becton Dickinson Pakistan

(Private) Limited, Lahore to their name:-

S.# Regn.No. Brand Name of Medical Device

Packing Shelf Life Name of Manufacturer

(i) 074663 BD SoloShot TM Mini Auto Disable Syringe

0.5 ml(23G, 24G &

25G)

0.05 ml(27G X 3/8)

5 years M/s Becton Dickinson, S.A. Ctra, Mequinenza, Fraga (Huesca), Spain.

(ii) 074685 BD Emerald TM Pro (Reuse Prevention) Luer Slip Syringes

2ml, 5ml & 10ml

5 years -do-

(iii) 059218 BD Disposable Syringes

3ml, 5ml, 10ml, 20ml

5 years(Confirmation of renewal status)

M/s Becton Dickinson Medical (Singapore) Tuas Avenue, Singapore.

(iv) 059219 BD Venflon TM Pro IV Cannulas

G16, G18, G20 & G22.

5 years(Confirmation of renewal status)

-do-

2. The firm has submitted following documents:-(i) Application dossier alongwith Form 5-A for each product.(ii) Fee of Rs.100,000/- for each product.


(iii) Letters of Authorization regarding above products from the foreign manufacturer (legalized from High Commission of Pakistan/Embassy) wherein it has also been mentioned that M/s Asto Life Sciences (Private) Limited is authorized to submit the application for transfer of registration in their name to the Drug Regulatory Authority of Pakistan.

(iv) Original NOC from M/s Becton Dickinson Pakistan (Private) Limited, Lahore regarding transfer of registration of above products.

(v) Change of address of M/s Becton Dickinson Pakistan (Private) Limited from 19 D/1, Gulberg-III, Lahore to 202-B, 2nd Floor, City Towers 6-K Main Boulevard, Gulberg-II, Lahore.

(vi) Copy of drug sale licence of M/s Asto Life Sciences Private Limited, Lahore.

It is submitted that as per Free Sale Certificate of BD Venflon TM Pro IV Cannula,

product owner is Becton Dickinson Infusion Therapy AB Florettgatan 29C, PO Box 631, SE-251

06, Helsingborg, Sweden while manufacturing site is Becton Dickinson Medical (s) PTE Ltd, 30

Tuas Avenue 2, Singapore.

Case was placed before the Board in 266th meeting and the Board deferred the case till

next meeting for detail discussion.

Decision: Registration Board deferred for provision of fresh NOC from M/s Becton Dickinson Pakistan (Private) Limited, Lahore.

Case No. 05: Correction of brand name on registration letter.

M/s Becton Dickinson Pakistan (Private) Limited, Lahore have informed that their

following product manufactured by M/s Becton Dickinson and Company, USA has been

registered as per detailed below:-

S.No. Reg.No. Product Name Packing MRP Shelf Life1 059212 BD Ultra-Fine TM Insulin Syringe 0.5ml

1mlDe-controlled 05 Years

The firm has submitted that product actual name is BD Ultra-Fine II Insulin Syringe and

requested to issue new registration letter with correct name of the product. Product was

approved in 221st meeting of the Registration Board held on 6th November, 2009; wherein

following product descriptions was mentioned:-

“BD Ultra-Fine TM, Ultra-Fine TM I, Ultra-Fine TM II Insulin Syringe”

In this regard, it is submitted that RRR Section have informed that Registration Board in

its 263rd meeting considered case for renewal of registration for this product and decided as

under:-

“During meeting RRR Section informed Registration Baord that in addition to verification of fee challan by the Budget & Account Division and by R&I Section,


original application has been traced later on. Thus the Board granted the renewal till 22.11.2019. Inspection of manufacturing site will be conducted as per import policy for finished drugs.”

Copy of Free sale certificate by USFDA provided by firm mentions only insulin syringe (1ml). File for confirmation of minutes and registration letter is with R-1 section. Case was placed before the Board in 266th meeting and the Board deferred the case till next meeting for detail discussion. Decision: Registration Board approved the request of firm for correction of brand

name as “BD Ultra-Fine TM II Insulin Syringe (1ml) while other conditions of registration shall remain same.

Case No.06: Cancellation of agency agreement.

M/s Hope Pharma, Lahore have informed that M/s Delta Med, Italy IV

Catheter/Canula was registered in Pakistan under brand Name “Delta Ven” for M/s Intra Health,

Karachi under registration Nos.071613, 071614 & 071615. The Principal manufacturer did not

want to continue their business with their present distributor M/s Intra Health, Karachi. In this

regard the principal manufacturer has terminated the distribution agreement of Intra Health,

Karachi on 12-07-2016 mentioning all products in the territory of Pakistan due to the total lack

of business provided in year 2015 and 2016 (Termination letter, Embassy attested). M/s Delta

Med also nominated Hope Pharma, Lahore as their Sole Agent and distributor in registering,

importing and selling of IV Cannula and accessories range in Pakistan (Embassy attested letter of

authorization).

Case was placed before the Board in 266th meeting and the Board and Board decided that

showcause notice be issued to M/s Intra Health, Karachi that why there Registration may not be

cancelled due to termination of their distribution agreement by the principal manufacturer.

Accordingly letter was issued to the firm. Reply is awaited.

Decision: Registration Board decided to call the firm for personal hearing as a final opportunity in next meeting.

Case No.07: Clarification of sole agent of manufacturer.

It is submitted that the application of Magma Rapamycin-Eluting Coronary Stent System

manufactured by QualiMed Innovative Medzinproduckte, GmbH, Boschstr. 16, D-21423,

Winsen, Germany was approved in 265th meeting of Registration Board. It is further submitted

that Itrix Rapamycin-Eluting Coronary Stent Implantation System is already registered with

registration No. 082015 on 30th September, 2016 in the name of M/s Cardiovascular medical

system, Lahore. In this case the owner/legal manufacturer is M/s amg international GmbH,


lohnfield, Winsen-Luhe, Germany and manufactured by QualiMed Innovative Medzinproduckte,

GmbH, Boschstr, 16, 21423, Winsen, Germany.

Case was placed before the Registration Board in its 266th meeting and the Board decided

that registration certificate for Magma Rapamycin-Eluting Coronary Stent System shall not be

issued till clarification of product similarity with already registered Itrix Rapamycin-Eluting

Coronary Stent Implantation System from both the applicant and status of sole agent by the

manufacturer M/s QualiMed Innovative Medzinproduckte, GmbH, Boschstr, 16, D-21423,

Winsen, Germany.

Accordingly letters were issued to both the firms. Reply is awaited.

Decision: Registration Board deferred the case and decided to call both firms for personal hearing in next meeting along with clarification of product similarity and status of sole agent by the manufacturer M/s QualiMed Innovative Medzinproduckte, GmbH, Boschstr, 16, D-21423, Winsen, Germany.

Case No.08: Confirmation of different sites.Registration Board in its 243rd meeting approved the following drugs/medical devices of

M/s Allmed Solutions, Karachi, subject to confirmation of all the manufacturing/ processing

sites. Accordingly, the firm was advised to confirm the manufacturing sites. The firm has

submitted its reply wherein they have explained as under:-

1. BIP Foley Catheter (Latex)S.N

oDescription Previous Address Updated site Address

1 Legal Manufacturer Location

M/s Bactiguard AB, Located at Biblioteksgatan 25, P.O Box 5070, SE-102 42 Stockholm, Sweden

M/s Bactiguard located at Alfred Nobels Alle 150,146 48 Tullinge Sweden.Bactiguard AB Jarnvagsatan 9 P.O Box 12 285 21 Markaryd Sweden.

2. Supplier of Raw Latex Foley Catheter

M/s Uro Technology Sdn. Bhd, Pontian Johar, Malaysia

M/s Uro Technology Sdn. Bhd, Pontian Johar, Malaysia

3. A Production site for coating of Catheter & Packaging

Amsino Medical (Shanghai) Co.Ltd, Build No. 1-3, Lane 355, Songjiang Export Processing zone, 201613, Shanghai, P.R. China

Bactiguard Malaysia Sdn. Bhd., 660, Jalan Idaman 3/4, Taman Desa Idaman, Kawasan Perindustrian Senai, 81400 Senai, Johor, MalaysiaPh: +60(0)75993976/ +60(0)75993975 Fax: +6075909511

4. Subcontractor sterilization

Synergy Health Ede, B.V. Morsestraat 3, 6716 AH Ede, The Netherland

This is the same as in DRAP. Please note that they have also addeda sterilization site located in Malaysia (this is valid for both Latex and Silicone BIP Foleys)Additional sterilization site;Synergy Sterilization (M) Sdn. Bhd. Plot 203-Kuala Ketil Industrial Park 09300 Kuala Ketil,


Kedah, Malaysia.5. Final QC Release M/s Bactiguard AB, located at

Biblioteksgatan 25, P.O Box 5070, SE-102 42 Stockholm, Sweden

M/S Bactiguard located at Alfred Nobels Alle 150,146 48 Tullinge Sweden.Bactiguard AB Jarnvagsatan 9 PO Box 12 285 21 Markaryd Sweden.

2. BIP Foley Catheter Silicone.1. ActuaManufacturer

LocationM/s Bactiguard AB, Biblioteksgatan 25, P.O Box 5070, SE-102 42 Stockholm, Sweden

Bactiguard AB, Jarnvagsgatan 9, PO Box 12, 285 21 Markayrd, SwedenPh: +46(0)43372580Fax: +46(0)433109511

2. Supplier of Raw BIP Silicon

Well Lead Medical Co. Ltd, A4-1 Jinhu Industrial Estate, Hualong, Panyu, Guangzhou, 511434, P.R. China

Well Lead Medical Co. Ltd, A4 -1 Jinhu Industrial Estate, Hualong, Panyu, Guangzhou, 511434, P.R. China

3. Production site for coating Process

Bactiguard AB, Jarnvagsgatan 9, PO Box 12, 285 21 Markayrd, SwedenPh: +46(0)43372580Fax: +46(0)43310958

Bactiguard Malaysia Sdn. Bhd.,660, Jalan Idaman 3/4 , Taman Desa Idaman, Kawasan Perindustrian Senai, 81400 Senai, Johor, MalaysiaPh: +60(0)75993976/+60(0)75993975Fax: +6075909511

4. Subcontractor sterilization

Synergy Health Venlo, Morsestraat 3, 6716, AH Ede, The Netherland

Same as previousPlease note that we have also added a sterilization site located in Malaysia (this is valid for both latex and Silicone BIP Foleys)Additional sterilization site;Synergy Sterilization (M) Sdn. Bhd. Plot 203-Kuala Ketil Industrial Park 09300 Kuala Ketil, Kedah, Malaysia

5. Final QA/ QC Release

M/s Bactiguard AB, located at Biblioteksgatan 25, P.O Box 5070, SE - 102 42 Stockholm, Sweden

M/S Bactiguard located at Alfred Nobels Alle 150,146 48 Tullinge Sweden.Bactiguard AB Jarnvagsatan 9 P.O Box 12 285 21 Markaryd, Sweden.

Furthermore the firm has submitted that address of the legal manufacturer abroad has also been

changed which is, Bactiguard AB, Alfred Nobels Alle 150,SE-146 48 Tullinge Sweden.

In this regard, the firm has provided Original & valid Free Sale Certificate (legalized) of Sweden

having address of legal manufactureras well as the Original & valid Authorization letter

(legalized) for both the products with updated legal manufacturer address.

Decision: Registration Board discussed the case and deferred for further discussion along with reviewing of decision of Board in 261st meeting.


Case No.09: Transfer of Registration.M/s Searle Company Limited, Karachi has requested for transfer of following registered

imported drugs (Medical Devices) from the name of M/s Trowmedic International, Lahore to

their name. The firm has also requested for approval of change of brand name:-

S.# Regn.No. Approved brand Name of Medical

Device

Demanded brand name

Shelf Life

Name of Manufacturer

1 070387 Trow Set Disposable Infusion Set Single

Searle Flo Intravenous Infusion Set Single

05 years M/s Jiangsu Shenli Medical Production Co., Ltd, China.

2. The firm has submitted following documents:-(i) Application dossier alongwith Form 5-A for above product.(ii) Fee of Rs.100,000/- for aforesaid product.(iii) Letters of Authorization regarding above product from the foreign manufacturer

legalized from Consulate General of Pakistan, Shanghai wherein it has also been mentioned that M/s Searle Laboratories Pvt Ltd having office at First Floor, N.I. C.L Building, Abbasi Shaheed Road, Karachi is their sole agents/Marketing Authorization Holder for their IV Set product.

(iv) Original Marketing Cancellation letter given by the Principal manufacturer from the name of M/s Trowmedic International, Lahore legalized from Consulate General of Pakistan, Shanghai.

(v) EC Certificate (Production Quality Assurance System) legalized from Consulate General of Pakistan, Shanghai.

(vi) Quality Management Certificate (ISO-13485).

Renewal status of the product to be confirmed from the concerned Section.

Decision: Registration Board defer the case and directed the firm to provide NOC, if any, from existing registration holder and clarification regarding Searle Laboratories Authorization and confirmation of renewal status of the product from the concerned Section of DRAP.

(i)


Item No.III: Pharmaceutical Evaluation & Registration Division.A. Pharmaceutical Evaluation Cell

Items Cases No. of Cases

Case No. 1 Deferred cases 101

Case No. 2 Applications with differential fee submitted up to September, 2015 46

Case No. 3 Anomaly applications which were not included in list I 21

Case No. 4 Applications of List-I 1

Case No. 5 Stability Cases 29

Case No. 6 Verification of authenticity of stability study 1

Case No. 7 Import cases 3

Case No. 8 Miscellaneous Cases 24

Total 226


Case No.01: Deferred casesSr.#

Name and

address of

manufacturer /

Applicant

Brand Name(Proprietary

name + Dosage Form + Strength)

CompositionPharmacological

GroupFinished product

Specification

Type of FormInitial date,

diaryFee including differential

feeDemanded Price / Pack

size

Remarks on the

formulation (if any)

including International

status in stringent

drug regulatory agencies /

authoritiesMe-too status

GMP status as depicted

in latest inspection

report (with date) by the Evaluator

Previous Remarks

of the Evaluato

r.

RB Decision

1. M/s. Tayyab Laboratories, Islamabad.

Tdpam 5mg TabletEach Tablet Contains:Diazepam BP……..5mg(Benzodiazepine)

Form-510-11-16DyNO: 418Rs. 20,0003x10‘sas per PRC

Benzopine by Danas PharmaLast Inspection for grant of DML on 11-08-2016

263rd Meeting Registration Board held on 29-30th November, 2016.Deferred for confirmation of composition & evidence of approval in reference regulatory authorities

Evaluation By PEC Firm has confirmed composition as under:

Tdpam 5mg TabletEach Tablet Contains:Diazepam BP……..5mg

Following reference stated by firm has been verified“Diazepam 5 mg tablet by M/s Terry White Chemists approved by TGA-Australia”

USP monograph is available for applied formulationDecision: Approved with USP specs.


Irinic SuspensionEach 5ml Contains:Ibuprofen …… 100mgPseudoephedrine Hydrochloride …….15mg(Analgesic)

Form-501-11-16DyNO: 110Rs. 20,000Pack of bottle90&120ml as per PRC

International Availability not providedArinac by M/s. Abbott Pharma.Last Inspection for grant of DML on 11-

International Availability not provided

263rd Meeting Registration Board held on 29-30th November, 2016.

Deferred for evidence of approval of applied dosage


08-2016 form & strength in reference regulatory authorities

Evaluation By PEC Following reference stated by firm has been verified

“Children’s Advil Cold suspension by M/s approved by US-FDA”Decision: Approved with Innovator’s specs and change of brand name.

3. M/s Tayyab Laboratories, Islamabad.

Omac 20mg CapsuleEach Capsule Contains:Omeprazole as enteric coated pellets eq. to Omeprazole USP……20mg(Proton Pump Inhibitor)

Form-510-11-16DyNO: 414Rs. 20,0002*7‘sas per PRC

Antra by Astrazeneca (Italy)Meprazol 40mg by M/s. Werrick Pharmaceuticals,Last Inspection for grant of DML on 11-08-2016

Real time Stablity data of pellets not provided


Deferred for source of pellets, fee, legalized GMP, CoA and other requirements

Evaluation By PEC Firm has submitted following:

i. COA of Omeprazole EC pellets 8.5%w/w form M/s Vision Pharmaceuticals Islamabad

ii. Accelerated stability study report of one batch of Omeprazole EC pellets 8.5%w/w form M/s Vision Pharmaceuticals Islamabad.

iii. Copy of GMP certificate of M/s Vision Pharmaceuticals Islamabad, valid up to 08-02-2017



Omac 40mg CapsuleEach Capsule Contains:Omeprazole as enteric coated pellets eq. to Omeprazole USP……40mg(Proton Pump Inhibitor)


Antra by Astrazeneca (Italy)Meprazol 40mg by M/s. Werrick Pharmaceuticals,Last Inspection for grant of DML on 11-08-2016




i. COA of Omeprazole EC pellets 8.5%w/w form M/s Vision Pharmaceuticals Islamabad

ii. Accelerated stability study report of one batch of Omeprazole EC pellets 8.5%w/w form M/s Vision Pharmaceuticals Islamabad.



USP monograph is available for applied formulationDecision: Approved with USP specification.


Timol SuspensionEach 5ml Contains:Paracetamol (BP)…….120mg(BP Specs)(Analgesic)

Form-501-11-16DyNO: 107Rs. 20,000Pack of bottle60&90mlas per PRC

Almus Paracetamol 120mg/5ml Oral Suspension of M/s The Boots Company , MHRA-UK approved Calpol by M/s. GSKLast Inspection for grant of DML on 11.08.2016


Deferred for evidence of approval of applied dosage form & strength in reference regulatory authorities

Evaluation By PEC Following reference, with same formulation as applied ,stated by firm has been verified

“ Almus Paracetamol 120mg/5ml Oral Suspension of M/s The Boots Company , MHRA-UK approved”

USP & BP monograph is available for applied formulationDecision: Approved with USP specs.


Pynadal –CF TabletEach Tablet Contains:Paracetamol BP ….…….500mgPseudoephedrine HCl Bp….60mgChlorpheniramine Malete BP….4mg(Analgesic)

Form-510-11-16DyNO: 411Rs. 20,000100‘sas per PRC

Panadol-CF by M/s. GSK, PakistanLast Inspection for grant of DML on 11-08-2016


Deferred for evidence of approval of applied dosage form & strength in reference regulatory authorities.

Evaluation By PEC Firm has stated following reference:

“Demzan Cold & Flu tablet approved by TGA-Australia” Composition of reference product is different form that applied & is stated as under:

Paracetamol ….…….500mgPseudoephedrine HCl ….30mgChlorpheniramine Malete ….2mg

Decision: Deferred for evidence of approval of applied dosage form and strength in reference regulatory authorities as stated reference is of different composition & also change of brand name is recommended.

7. M/s. Tayyab Laboratories,

“ IRO-F syrupEach 5ml Contains:Iron III

Form-510-11-16DyNO: 423Rs. 20,000

Maltofer fol by Vifor International, Switzerland

263rd Meeting Registration Board held on 29-30th November,


Islamabad.

Hydroxide Poly Maltose Complex eq. to elemental Iron …..…….50mgFolic Acid ……0.35mg”(Haematinic)

60ml & 90 mlas per PRC

Biomalt-Fly by M/s. Nabi Qasim PharmacuticalsLast Inspection for grant of DML on 11-08-2016

2016.

Deferred for clarification of dosage form & evidence of approval status in reference regulatory authorities as reported evidence is not traceable

Evaluation By PEC Firm has confirmed composition as under:

“ IRO-F syrupEach 5ml Contains:Iron III Hydroxide Poly Maltose Complex eq. to elemental Iron …..…….50mgFolic Acid……0.35mg”

Firm has stated Maltofer syrup of M/s Aspen Pharma approved by TGA Australia as reference product.

Firm has also stated that RB has already approved this formulation in 260th meeting Reference product stated by firm does not contain folic acid

Decision: Registration Board approved the product as iron formulations are not considered as drugs in reference regulatory authorities.


K-Some SyrupEach 5ml Contains:Pseudoephdrine HCL (BP)…….30mgChlorpheniramine (maleate) (BP)….2mgDextromethorphan HBr USP…..10mg(Antihistamine)

Form-51-11-16DyNO: 103Rs. 20,000120mlRS. 39

Chemists' Own Dry Raspy Cough oral liquid bottle by M/s Arrow Pharma Pty Ltd approved by TGA-Australia Cosome Syrup by M/s. MerckLast Inspection for grant of DML on 11.08.2016


Deferred for evidence of approval of applied dosage form & strength in reference regulatory authorities

Evaluation By PEC Following reference, with same formulation as applied ,stated by firm has been verified“Chemists' Own Dry Raspy Cough oral liquid bottle by M/s Arrow Pharma Pty Ltd approved by TGA-Australia”

Decision: Approved with Innovator’s specs and change of brand name.9. M/s.

Tayyab Laboratories, Islamaba

Ticclo 50mg CapsuleEach Capsule Contains:Diclofenec

Form-510-11-16Dy.No: 408Rs. 20,0002*10‘s

D-Cap by M/s. English Pharma,Last Inspection



d. Sodium Pellets as enteric coated pellets eq. to Diclofenec Sodium …..…..50mg(Phenyl Acetic Acid)

as per PRC for grant of DML on 11.08.2016



i. COA of Diclofenac Sodium EC pellets 32.0%w/w form M/s Vision Pharmaceuticals Islamabad

ii. Long term stability study report (48 weeks) of one batch of Diclofenac Sodium EC pellets 32.0%w/w form M/s Vision Pharmaceuticals Islamabad


Decision: Deferred for evidence of approval of applied formulation by reference regulatory authorities.


Ticclo Sr 100mg CapsuleEach Capsule Contains:Diclofenec Sodium Sustained Released Pellets Eq. to Diclofenec Sodium BP……100mg(Phenyl Acetic Acid)


MHRA-UK ApprovedD-Cap by M/s. English Pharma,Last Inspection for grant of DML on 11-08-2016


Deferred for source of pellets, fee, legalized GMP, CoA & other requirements


i. COA of Diclofenac Sodium EC pellets 32.0%w/w form M/s Vision Pharmaceuticals Islamabad

ii. Long term stability study report (48 weeks) of one batch of Diclofenac Sodium EC pellets 32.0%w/w form M/s Vision Pharmaceuticals Islamabad


Decision: Approved with Innovator’s specs.11. M/s.

Tayyab Laboratories, Islamabad.

Tyso 40mg CapsuleEach Capsule Contains:Esomeprazole (as Magnesium trihydrate) Enteric Coated pellets ……..40mg(Proton Pump Inhibitor)


USFDA ApprovedEskeml by M/s. High Q Pharmaceuticals,.Last Inspection for grant of DML on 11-08-2016

Accelerated Stability data of 6MounthsReal Time Stability data of pellets not Provided





i. COA of Esomeprazole EC pellets 22.5%w/w form M/s Vision Pharmaceuticals Islamabad

ii. Accelerated stability study report of one batch of Esomeprazole EC pellets 22.5%w/w form M/s Vision Pharmaceuticals Islamabad.


Decision: Approved with USP specs.12. M/s.

Tayyab Laboratories, Islamabad.

Tyso 20mg CapsuleEach Capsule Contains:Esomeprazole (as Magnesium trihydrate) Enteric Coated pellets ……..20mg(Proton Pump Inhibitor)


USFDA ApprovedEskeml by M/s. High Q Pharmaceuticals,Last Inspection for grant of DML on 11-08-2016

Accelerated Stability data of 6MounthsReal Time Stability data of pellets not Provided




i. COA of Esomeprazole EC pellets 22.5%w/w form M/s Vision Pharmaceuticals Islamabad

ii. Accelerated stability study report of one batch of Esomeprazole EC pellets 22.5%w/w form M/s Vision Pharmaceuticals Islamabad.


Decision: Approved with USP specs.13. M/s

Genix Karachi

Pizogen 0.25mg/5ml SyrupEach 5ml contains:Pizotifen hydrogen malate eq. to Pizotifen ..0.25 mg(Antimigraine)

Form-506-04-2011Dy No.82Rs.8000/-Rs.12,000/-28-7-2015Rs.90/60mlRs. 200/120 ml

Sanomigran Elixir 0.25mg/5ml approved by MHRA-UK

Mosegor Syrup by Novartis PharmaInspection report dated 04-04-2016 stated GMP compliance as Acceptable.

263rd Meeting Registration Board held on 29-30th November, 2016.Deferred for evidence of approval in reference regulatory authorities and clarification of indication as “Apetite stimulant” as its not approved by Reference Regulatory Authorities

Evaluation By PEC Following reference, with same formulation as applied, stated by firm has been verified:

“Sanomigran Elixir 0.25mg/5ml approved by MHRA-UK” (The SPC of this product states Pharmaceutical form as Syrup)

Moreover firm has stated that appetite stimulant is mistakenly mentioned in indication, kindly consider it as “Anti-Migraine”


Decision: Approved with Innovator’s specs.14. M/s

Nexus Pharma Karachi.

Bisocol TabletEach film coated tablet contains:-Bisoprolol fumerate eq. toBisoprolol…2.5mg

Hydrocholorothiazide …… 6.25mg(Synthetic, beta 1 selective (cardioselective) benzothiadiazine diuretic)

Form-5Dy.#21903-01-2011Rs.15000/-Rs.12,000/-17-7-2014Rs 69/14‘s1*14‘s

Available in USFDALast inspection report conducted on 20/05/2016.The overall GMP compliance level is rated as good.

Rs 8,000 fee challan is not in original.


Deferred for evidence of approval in reference regulatory authority and me too status


“Bisoprolol/Hydrochlorthiazide 2.5mg/6.25mg Film coated tablets BY M/s TEVA approved by MHRA-UK

Following me-too reference has been verified:“Actim-H 2.5/6.25 tablet of M/s Sami Pharmaceuticals (Reg.# 076577)”

USP monograph is available for applied formulationDecision: Approved with Innovator’s specs.

15. M/s Nexus Pharma Karachi.

Serratio TabletsEach enteric coated tablet contains:-Serratiopeptidase …….5mg

(10,000 Serratiopeptidase units)(Anti Inflammatory)

03-01-2011195Form-5Rs.8000/-Rs.12,000/-17-7-2014Price as per SRA2*10‘s

Danzen By Helix pharmaLast inspection report conducted on 20/05/2016.The overall GMP compliance


263rd Meeting Registration Board held on 29-30th November, 2016Deferred for evidence of approval in reference regulator authorities

Evaluation By PEC Firm has stated following products as evidence of approval of applied formulation by

reference regulatory authorities:i. Danzen tablets by M/s Taked-USA

ii. Biosuganril 10 mg tablets –Canada None of the above reference could be verified

Decision: Deferred for evidence of approval of applie formulation by reference regulatory authorities as stated reference could not be verified.


Citicoline InjectionEach 2ml ampoule contains:-Citicoline … 250mg(Nootropics & Neurotonic)

03-01-2011248Form-5Rs.8000/-Rs.12,000/-17-7-2014Rs 275/2ml*1‘s2ml*1‘s Ampoule

ANSM-France approvedAlphacoline-HIGH QLast inspection report conducted on 20/05/2016.


263rd Meeting Registration Board held on 29-30th November,Deferred for evidence of approval in reference regulator authorities


The overall GMP compliance level is rated as good.

Evaluation By PEC Applied formulation is approved by ANSM-France



Dionex 400mg TabletEach tablet contains:Doxophylline ………400 mg(Anti-Asthematic)

21-01-2011Dy.No.266Form-5Rs.8000/-Rs.12,000/-17-7-2014Rs 138/101*14‘s

Unifyline by PlatinumLast inspection report conducted on 20/05/2016.The overall GMP compliance level is rated as good.


263rd Meeting Registration Board held on 29-30th NovemberDeferred for evidence of approval in reference regulatory authorities and verification of challan by Budget & accounts Division

Evaluation By PEC Firm has stated following product as evidence of approval of applied formulation by

reference regulatory authorities:“Doxiva ( Doxophylline) 400mg tablets by M/s Nipro Bangladesh

Decision: Deferred for following reasons: For evidence of approval in reference regulatory authorities as decided by Board in

249th RB meeting. Verification of challan by Budget & Accounts Division


Drotanex 40mg TabletEach tablet contains:Drotaverine…………40 mg(Selective inhibitor of phosphodiesterase with antispasmodic effects)Mft Specs

21-01-2011Dy.No.271Form-5Rs.8000/-Rs.12,000/-17-7-2014Rs 53.60/20‘s1*14‘s

Dytra by TabrosLast inspection report conducted on 20/05/2016.The overall GMP compliance level is rated as good.


263rd Meeting Registration Board held on 29-30th November

Deferred for evidence of approval in reference regulatory authorities and verification of challan by Budget & Accounts Division

Evaluation By PEC Firm has stated several references, none of which is from reference regulatory

authorities.Decision: Deferred for confirmation of approval status by reference regulatory authorities.

19. M/s Nexus Pharma

Drotanex 80mg TabletEach tablet

21-01-2011Dy.No.263Form-5

Dytra by TabrosLast

Rs 8,000 fee challan is

263rd Meeting Registration Board held on 29-


Karachi. contains:Drotaverine …………80 mg(Selective inhibitor of phosphodiester

Rs.8000/-Rs.12,000/-17-7-2014Rs87.59/20‘s1*14‘s

inspection report conducted on 20/05/2016.The overall

not in original.

30th

November,2016

Deferred for evidence of approval in reference regulatory authorities & verification of challan


authorities.Decision: Deferred for following reasons:

For evidence of approval in reference regulatory authorities as decided by Board in 249th RB meeting

Verification of challan by Budget & Accounts Division20. M/s


Drotanex 40mg InjectionEach 2ml contains:Drotaverine…………40 mg(Selective inhibitor of phosphodiesterase with antispasmodic effects)Mft Specs

21-01-2011Dy.No.261Form-5Rs.8000/-Rs.12,000/-17-7-2014Rs 375/2ml *25‘s2ml*1‘s Ampoule

Dytra by TabrosLast inspection report conducted on 20/05/2016.The overall GMP compliance level is rated as good.



Deferred for evidence of approval in reference regulatory authorities and verification of challan


authorities.Decision:

Deferred for following reasons: For evidence of approval in reference regulatory authorities as decided by Board in

249th RB meeting Verification of challan by Budget & Accounts Division


Loxfen 60mg TabletEach tablet contains:Loxoprofen anhydrous sodium ……60 mg(Antipyretic/ anti-inflammatory)Mft Specs

16-05-2011Dy.No.1220Form-5Rs.8000/-Rs.12,000/-17-7-2014Rs 780/100‘s1*14‘s

Loxonin (Hilton)Last inspection report conducted on 20/05/2016.The overall GMP compliance level is rated as good.


263rd Meeting Registration Board held on 29-30th November, 2016


Evaluation By PEC


Firm has stated following product as evidence of approval of applied formulation by reference regulatory authorities:

i. Roxonin (Loxoprofen) 60mg tablets of M/s Saja Pharma-Saudi Arabiaii. Lexapro (Escitalopram) tablets-USFDA

Decision: Deferred for following reasons: For evidence of approval in reference regulatory authorities as decided by Board in

249th RB meeting Verification of challan by Budget & Accounts Division


Glim-Met TabletEach tablet contains:Glimepiride ……………..1 mgMetformin HCl ……….500 mg(Anti diabetic)Mft Specs


Last inspection report conducted on 20/05/2016.The overall GMP compliance level is rated as good.





authorities.Decision: Deferred for following reasons:

For evidence of approval in reference regulatory authorities as decided by Board in 249th RB meeting

Verification of challan by Budget & Accounts Division23. M/s


Nexsot 10mg CapsuleEach capsule contains:Isotretinoin ………….10 mg(Retinoids for treatment of acne)Mft Specs


Isotretinoin 20mg CapsulesMHRALocal Availability: Arynoin by M/s Pharma HealthLast inspection report conducted on 20/05/2016.Overall GMP compliance


263rd Meeting Registration Board held on 29-30th NovemberDeferred For Confirmation Of Approval Status By Reference Regulatotry Authorities, Me Too Status And Challan By Budget & Account Division

Evaluation By PEC Applied formulation is approved by USFDA , details are as under:

“Absorica Capsules of M/s Ranbaxy (USFDA)” Following me-too reference has been verified:

“ Iret 10mg Capsule of M/s Baxter Karachi (Reg.# 073630)” USP monograph is available for applied formulation

Decision: Deferred for revision of formulation as per decision of 250 th RB meeting &


Verification of challan by Budget & Accounts Division.24. M/s


Pirotrine 20mg TabletEach tablet contains:Piroxicam beta cyclodextrine………….20 mg(Non-Steroidal anti-Inflammatory)


Feldene tabs by Pfizer pakistanLast inspection report conducted on 20/05/2016.The overall GMP compliance level is rated as good.


263rd Meeting Registration Board held on 29-30th NovemberDeferred for evidence of approval of applied formulation strength in reference regulatory authorities

Evaluation By PEC Firm has submitted several references, which are either of different composition or from

non-reference regulatory authorities.Decision: Deferred for evidence of approval in reference regulatory authorities as decided by Board in 249th RB meeting as stated reference is incorrect & verification of challan by Budget & Accounts Division


Disvanex 50mg TabletEach tablet contains:Desvenlfaxine ……50 mg(Antidepressant)

Form-516-05-2011Dy.No.1224

Rs.8000/-Rs.12,000/-17-7-2014Rs 275/14‘s1*14‘s

Khedezla extended release tablet-USFDALafaxine by genixLast inspection report conducted on 20/05/2016.Overall GMP compliance level is rated as good.



Deferred for confirmation of name of API & proof dosage form whether extended release or other wise and verification of challan by Budget & accounts Division

Evaluation By PEC Firm has stated correct name of API as “Desvenalfaxine” Following reference, stated by firm has been verified:

“Pristiq (Desvenalfaxine as succinate monohydrate) 50 mg extended release tablet approved by USFDA”

Firm has not submitted any clarification regarding dosage form whether extended release or otherwise.

Decision: Deferred for clarification of dosage form whether extended release or otherwise as reference product is available as Extended release tablet & verification of challan by Budget & Accounts Division


Nexzine 0.2% 120ml SyrupEach ml contains:Hydroxyzine…………0.2 %w/v(Anti histamine)Mfg Specs.

16-05-2011Dy.No.1209Form-5Rs.8000/-Rs.12,000/-17-7-2014Price as per

Hydroxyzine syrup 10mg/5ml-USFDALast inspection report



Deferred for evidence of me-


SRA conducted on 20/05/2016.The overall GMP compliance level is rated as good.

too status and verification of challan by Budget & accounts Division

Evaluation By PEC Firm has stated “Asmasal Syrup 3.25mg/5ml”of M/s Opal Labs (Pvt.) Ltd. Above stated reference is of different composition than applied.

Decision: Deferred for evidence of me-too status as stated refrence is of different composition & verification of challan by Budget & Accounts Division.


Bucnex 1% 120ml SyrupEach ml contains:Buclizine …….1 %(Anticholinergic)

16-05-2011Dy.No.1222Form-5Rs.8000/-Rs.12,000/-17-7-2014Rs 25.62/120mlPack of 120ml

Longifene by AGP pharmaLast inspection report conducted on 20/05/2016.The overall GMP compliance level is good



Deferred for evidence of approval in reference regulatory authorities and verification of challan by Budget & accounts Division


authorities.

Decision: Deferred for evidence of approval by reference regulatory authorities as stated references are incorrect & verification of challan by Budget & Accounts Division.


H-Sucnex InjectionEach vial contains:Hydrocartisone sodium succinate …………….100 mg(Anti-Inflammatroy)

16-05-2011Dy.No.1221Form-5Rs.8000/-Rs.12,000/-17-7-2014Rs 86/vial1‘s vial



263rd Meeting Registration Board held on 29-30th NovemberDeferred for confirmation of section approval & evidence of approval in reference regulatory authorities & me-too status


“Solu-Cortef steril powder for Injection, 100 mg” of M/s Pfizer-USFDA approved. Firm has submitted copies of letters issued by Secretary CLB confirming grant of DML

with following sections:i. Tablet (General).

ii. Capsule (General)


iii. Liquid (General)iv. Ointment (General)v. Dry Powder (Cephalosporin)

vi. Capsule (Cephalosporin)vii. Dry Powder Injectable (Cephalosporin)

viii. Injectable (Liquid General)ix. Eye Drops (Sterile).x. Dry Powder Suspension (General)

xi. Sachet (General) USP monograph is available for applied formulation.

Decision: Registration Board rejected the case as firm does not have approved Injectable steroid section.


Lignocaine 3.5ml 1%Each 3.5ml contains:Lignocaine……1%(Local anesthetic)

31-10-2011Dy.No.288Form-5Rs.8000/-Rs.12,000/-17-7-2014Rs 164/2ml *100‘s3.5ml*100‘s




Deferred for clarification of fill volume of 3.5 ml


authorities.Decision: Deferred for clarification of fill volume of 3.5ml as stated references are incorreect.

30. DeMont Research laboratories (PVT) Ltd.20 Km , Lahore Shraqpur Road Sheikhupura, Pakistan

Dekast 10mg Chewable tablet.Each film coated tablet contains Montelukast sodium equivalent to Montelukast…..…. 10 mgLeukotriene receptor antagonist.USP Specs.

Form-5Dy.No.1896 R&I date 20.10.2016Fee.20,000/20-10-2016

Me too:Amisped by Sanofi Aventis.Status in SRA:Singulair by Merck & Co Inc.New DML granted on 30.08.2016.


Deferred as confirmation of chewable tablets in 10mg strength

Evaluation By PEC Firm has stated that they had applied for registration of said product as Film coated

tablet & requested to consider the case as Film coated tabletDecision: Approved

31. M/s Shaigan Pharmaceuticals, Pvt Ltd, 14 km Adyala

Prolone InjectionEach 2ml contains:Methylprednisolone acetate usp ….40mgGlucocorticoid

Form 5Dy.No.76302-09-2016Rs.20,000/-1x2mlRs.224.62/-

Depo-medrol by Pfizer Pharma (EU)/USA,Depo-medrol by Pfizer Pharma,


Deferred for confirmation of


Road, (USP Specs) Inspection report dated17-08-2016 recommended for the grant of additional sections

steroidal section

Evaluation By PEC Firm has submitted copy of letter issued by Secretary CLB, dated 27th Sep, 2016, stating

the grant of additional section for “Liquid Injection Ampoule (Hormone). Firm has stated that Methylprednisolone is a steroid & according to the classification of

Hormone, steroids fall under the subclass of Hormone.Decision: Registration Board deferred for clarification of product pharmacological classification with respect to manufacturing facility.

32. M/s Shaigan Pharmaceuticals, Pvt Ltd, 14 km Adyala Road,

Water for InjectionEach ampoule contains:Water for Injection

Form 5Dy.No.80302-09-2016Rs.20,000/-1ml/Rs.88ml/ Rs.1516ml/Rs.20

Water for injection by PDH Pharma (Pak),Inspection report dated17-08-2016 recommended for the grant of additional sections


Deferred for approval of section

Evaluation By PEC Firm has submitted copy of GMP inspection report conducted on 13-12-2012, stating

that firm has following approved sections:i. Tablet section

ii. Capsule sectioniii. Semisolid (cream/ointment) sectioniv. Liquid Syrup sectionv. Cephalosporin dry powder for suspension.

vi. Cephalosporin Capsulevii. Cephalosporin Dry powder for injections

viii. Liquid Injectable (Ampoule and vials)ix. Ophthalmic preparations (eye drops)x. Lyophilized Powder for injections


ShaiganPharmaceuticals, Pvt Ltd, 14 km Adyala Road,

Medrone 500InjectionEach vial contains:Methylprednisolne as sodium succinate (USP) ……500mgGlucocorticoids(USP Specs)

Form 5Dy.No.77102-09-2016Rs.20,000/-1‘s x8mlRs.1150/-

International availability notprovided,Solu –Medrol by Pfizer Pharma, Inspection report dated17-08-2016 recommende




d for the grant of additional sections


the grant of additional section for “Lyophilized Injection Ampoule (Hormone). Firm has stated that Methylprednisolone is a steroid & according to the classification of



Medrone 1000 InjectionMethylprenisole as Sodium succinate USP…….1000mgGlucocorticoid(USP Specs)

Form 5Dy.No.76902-09-2016Rs.20,000/-1‘s 1‘sx16ml ampouleOf WFIRs.2150/-

International availability not provided,Solu –Medrol by Pfizer Pharma, Inspection report dated17-08-2016 recommended for the grant of additional







Medrone 125 InjectionEach vial contains:Methylprednisolne as sodium succinate (USP) ……125mgGlucocorticoids(USP Specs)

Form 5Dy.No.77002-09-2016Rs.20,000/-1‘s x2mlRs.255/-

International availability not provided,Solu –Medrol by Pfizer Pharma, Inspection report dated17-08-2016 recommended for the grant of additional sections

263rd Meeting Registration Board held on 29-30th

November, 2016.





36. M/s Anacor ointment Form 5 Diprosalic 263rd Meeting


Shaigan Pharmaceuticals, Pvt Ltd, 14 km Adyala Road,

Each gm of ointment contains:Betamethasone as dipropionate USP………0.5mgSalicylic acid BP ………..30mgTopical Corticosteroids

Dy.No.77402-09-2016Rs.20,000/-10gRs.83/-

Ointment -MHRAProvate –S Ointment by Saffron Pharma,Inspection report dated17-08-2016 recommended for the grant of additional sections.

Registration Board held on 29-30th November

Deferred for clarification of composition whether lotion or ointment

Evaluation By PEC The firm has stated that correct dosage form is ointment.

Decision: Approved with Innovator’s specs37. M/s

Shaigan Pharmaceuticals, Pvt Ltd, 14 km Adyala Road,Rawalpindi(New Section)

Hycort 100 injectionEach vial contains lyophilized powder:Hydrocortisone as sodium succinate (USP)….100mgGlucocorticoid-Minerolcorticoid(Manufacturer‘s specs)

Form 5Dy.No.77302-09-2016Rs.20,000/-1‘sRs.400/-

Hydrocortisone as sodium succinate Injection-USFDA Solu-cortef by Pfizer PharmaInspection report dated17-08-2016 recommended for the grant of additional sections


Deferred for confirmation of section


the grant of additional section for “Lyophilized Injection Ampoule (Hormone). Firm has stated that Hydrocortisone is a steroid & according to the classification of


38. M/s Shaigan Pharmaceuticals, Pvt Ltd, 14 km Adyala Road,Rawalpindi(New Section)

Hycort 250 injectionEach vial contains lyophilized powder:Hydrocortisone as sodium succinate (USP)…….250mgGlucocorticoid-Minerolcorticoid(Manufacturer‘s specs)

Form 5Dy.No.77402-09-2016Rs.20,000/ 1‘s Rs.550/-

Hydrocortisone as sodium succinate Injection-USFDA,Solu-cortef by Pfizer PharmaInspection report dated17-08-2016 recommended




Glucocorticoid-Minerolcorticoid(Manufacturer‘s specs)

for the grant of additional sections




39. M/s Shaigan Pharmaceuticals, Pvt Ltd, 14 km AdyalaRoad, Rawalpindi

Hycort 500 InjectionEach vial contains lyophilized powder:Hydrocortisone as sodium succinate (USP) …….500mgGlucocorticoid- Minralocorticoid(Manufacturer‘s specs)

Form 5Dy.No.77702-09-2016Rs.20,000/-1‘s vial1‘s x4ml ampouleRs.600/-

Solu-cortef by Pfizer Pharma (EU/USA),Solu-cortef by Pfizer PharmaInspection reportdated17-08-2016 recommended for the grant of additional sections


Deferred for approval of steroidal section




40. M/s Shaigan Pharmaceuticals, Pvt Ltd, 14 km Adyala Road, Rawalpindi

Dana-100 TabletEach tablet contains:Danazol USP ………..100mgAnti gonadotropic agent(USP Specs)

Form 5Dy.No.76502-09-2016Rs.20,000/-3x10‘sRs.485/-

International Availability not provided,Danocrine by Aventis Pharma,Inspection report dated17-08-2016 recommended for the grant of


Deferred for approval of steroidal section

Evaluation By PEC Firm has submitted copy of letter issued by Secretary CLB, dated 27th Sep, 2016,

stating the grant of additional section for “Tablet” (Hormone). Firm has stated that Danazol is an androgenic hormone i.e. steroid in nature according to

classification of hormone. .Decision: Deferred for evidence of approval of applied formulation by refrence regulatory authorities & clarification of product classification with respect to manufacturing facility.



Dexoderm LotionEach ml of lotion contains:Desonide …5mgTopical Non florinated Coticosteroids.(Manufacturer‘s specs)

Form 5Dy.No.26107-10-2016Rs.20,000/-30mlRs.110/-

Stienoide Lotion by GSK (USA),Stienoide Lotion by GSK,Inspection report dated17-08-2016 recommended for the grant of additional sections.


Deferred for confirmation of section for lotion


stating the grant of additional section for “Cream/Ointment/Gel” (Steroid) Firm has stated that Lotion is of the same category product therefore can be processed

in the said area.Decision: Deferred for confirmation from Licensing Division for confirmation of manufacturing facility of lotions.


Isopreg TabletEach tablet containsDydrogesterone (BP) ……….10mgProgestogen(BP Specs)

Form 5Dy.No.75702-09-2016Rs.20,000/-2x10Rs.850/-

Duphaston by Abbott Pharma (USA/EU),Duphaston by Abbott Pharma,Inspection report dated17-08-2016 recommended for grant of additional sections


Deferred for confirmation of isomer

Evaluation By PEC Firm has stated that applied formulation is Cis isomer Applied formulation is Discontinued in USFDA while approved by ANSM-France

Decision: Deferred as reference product is available in trans form only.43. M/s

Shaigan Pharmaceuticals, Pvt Ltd, 14 km Adyala Road, Rawalpindi

Flutisone LotionEach g oflotion containsFluticasone propionate BP…..0.5mgCorticosteroids(BP Specs)

Form 5Dy.No.77202-09-2016Rs.20,000/-1‘sx20mlRs.225

Cutivate Ointment by GSK (EU/USA),Ticovate by SAFFRON Pharma,Inspection report dated17-08-2016 recommended for the grant of


Deferred for confirmation of section for lotion


stating the grant of additional section for “Cream/Ointment/Gel (Steroid)


Firm has stated that Lotion is of the same category product therefore can be processed in the said area.

Decision: Deferred for confirmation from Licensing Division for confirmation of manufacturing facility of lotions.


Capricort lotionEach g of lotion contains:Prednicarbate BP …….2.5mgTopical Corticosteroids(Manufacturer‘s specs)

Form 5Dy.No.77102-09-2016Rs.20,000/-1x 10gRs.198/-

Zemagis Lotion by Stiefel (USA),Cebedin by Tabros Pharma,Inspection report dated17-08-2016 recommended for the grant of additional sections




stating the grant of additional section for “Cream/Ointment/Gel (Steroid) Firm has stated that Lotion is of the same category product therefore can be processed



Metasone LotionEach g of lotion containsMometasone Furoate USP…..1mgCorticosteroids(USP Specs)

Form 5Dy.No.77702-09-2016Rs.20,000/-1‘sx20mlRs.110/-

Elocon® Scalp Lotion –MHRASantomet by Sante Pharma,Inspection report dated17-08-2016 recommended for the grant of additional sections




stating the grant of additional section for “Cream/Ointment/Gel (Steroid) Firm has stated that Lotion is of the same category product therefore can be processed


46. M/s Shaigan Pharmaceuticals, Pvt Ltd, 14 km

Mergex InjectionEach ampoule contains:Noreinephrine Bitartrate……2mg

Form 5Dy.No.76002-09-2016Rs.20,000/-5‘sRs.1475/-

International availability not provided,Noradrin by Atco Pharma,Inspection



Adyala Road, Rawalpindi

Vasoconstrictor/Sympathomimetic(USP Specs)

report dated17-08-2016 recommended for the grant of additional sections



stating the grant of additional section for “Liquid Injection Ampoule (Hormone). Firm has stated that Noreinephrine Bitartrate is adrenal hormone i.e. steroid in nature

according to the classification of Hormone.Decision: Registration Board does not accede to firm’s claim stated above & deferred the case for clarification of product classification with respect to manufacturing facility.


Bacteriostatic WFIEach ml contains:Benzyl alcohol USP….9.0mgDiluent for Injection(USP Specs)

Form 5Dy.No.80402-09-2016Rs.20,000/-1‘s vial1ml,2ml,3ml,4ml5ml,6ml7ml,8ml,9ml10ml,12ml,16mlRs5/-,Rs8/-,Rs.10/-Rs.15/-,Rs25/-

Wrong provision of international brand,WFI by GSK (Pak)Inspection report dated17-08-2016 recommended for the grant of additional sections








Decision: Deferred for clarification of composition as Brand name states WFI , whereas in composition Benzyl alcohol is mentioned.


Nisale injection IVEach ml contains:Sodium Chloride USP ….9mgElectrolyte(USP Specs)

Form 5Dy.No.80102-09-2016Rs.20,000/-1‘s vial1ml,2ml,3ml4ml,5ml,6ml,7ml,8ml,9ml,10ml,12ml,16mlRs5/-,Rs8/-,Rs.

International not provided,Sodium chloride inj by Elko, Geofman,Inspection report dated17-08-2016 recommended




10/-,Rs.15/-,Rs25/

for the grant of additional sections






Decision: Approved49. M/s

Shaigan Pharmaceuticals, PvtLtd, 14 km Adyala Road, Rawalpindi

Bacteriostatic NisaleEach ml contains:Sodium Chloride USP ….9mgBenzylacohol USP ……9mgDiluent for injection(USP Specs)

Form 5Dy.No.80007-10-2016Rs.20,000/-1‘s vial1ml,2ml,3ml,4ml,5ml,6ml,7ml,8ml,9ml10ml,12ml16mlRs5/-,Rs8/-,Rs.10/-,Rs.15/-,Rs25/-

Bacteriostatic Sodium chloride solution by Hposira (USA/EU),Sodium chloride inj by Elko, Geofman,Inspection report dated 17.8.2016 recommended for grant of additional sections








Decision: Approved50. M/s

Shaigan Pharmaceuticals, Pvt Ltd, 14 km

Testogen InjectionEach 1 ml ampoule contains:Testosterone enanthate (USP)

Form 5Dy.No.76102-09-2016Rs.20,000/-3‘sRs.400/-

Testoviron by Bayer Health care (EU/USA),Testoviron by Bayer


Deferred for


Adyala Road, Rawalpindi

…..250mgAndrogen(USP Specs)

Health care,Inspection report dated17-08-2016 recommended for the grant of additional sections

approval of section


the grant of additional section for “Liquid Injection Ampoule (Hormone).Decision: Approved


Ditone F2 InjectionEach 1ml ampoule containsDinoprost as tromethamine (USP)…..5mgProstaglandins(Manufacturer‘s specs)

Form 5Dy.No.76602-09-2016Rs.20,000/-1‘sRs.485.92/-

Prostin F2 α By Pfizer (EU/USA),Protin F2 By Pfizer,Inspection report dated17-08-2016 recommended for the grant of additional sections




the grant of additional section for “Liquid Injection Ampoule (Hormone).Decision: Approved USP specifications

52. ImporterM/s Efroz Chemical Industries (Pvt) Ltd, 12-C Block 6, PECHS, off Shahrah-e- Faisal, KarachiManufacturerM/s Dae Hwa Pharmaceuticals Co., Ltd495- Hanu-ro-, Hoenseong-eup,

KETOFAST CataplasmaEach sheet (9x13cm2, 11.7gm) contains:Ketoprofen…25.07mgNSAIDManufacturer

Form-5ADy No : 468 dated 26-01-1115000/- dated 26-01-1185000/- dated 19-02-14Rs. 500/- Per 6‘s Sheets

PMDA –Japan approvedKefentech Plaster by M/s Matrix Reg #047624

Firm has stated following reference product from PMDA, Japan: Mohrus Gel-Patch 0.3%. Each patch is of dimension 10 x14 cm and mass 10gm. Mohrus contains 30 mg of Ketoprofen per ten grams of

262nd Meeting Registration Board held on 20-21st October, 2016Deferred for clarification as the composition of applied product differs from that of the reference product.


Hoenseong, Gangwon-do, Korea

mass (one patch). The composition of applied product differs from that of the reference product.

Evaluation By PEC Firm has stated that Ketofast Cataplasma has 25.07 mg of Ketoprofen in size (9x13cm2)

& reference Japanese product has 30.0 mg of Ketoprofen in size (10 x14 cm2) . Once calculated the amount per area, has the same amount of active per sheet.

Original & legalized COPP (Certificate# 2010-DI-3462) issued by Korean Food & Drug Administration dated 01-12-201 has been verified from dossier

COPP confirms GMP status of the manufacturer.Decision: Approved as per Import Policy for Finished Drugs. Firm shall provide valid original legalized agency COPP and Chairman, Registration Board will authorize issuance of registration letter.

53. Harrison Pharmaceuticals10-Km, Lahore Road, Sargodha

Clarimycin 250 mg/5ml SuspensionEach 5ml Susp contains:-Clarithromycin 250mg(Macrolide antibacterial)

Form-513-10-16DyNO: 147620,000Pack of bottle60mlas per PRC

Health CanadaBiaxin – AbbottMe to:Klaricid – AbbottInspection dated 31-3-16 for grant of new section and renewal of DML


Deferred for source of granules, fee, legalized GMP, CoA and other requirements


i. COA of Clarithromycin 27.5 % EC taste masked pellets form M/s Vision Pharmaceuticals Islamabad

ii. Accelerated (6 months) & Real time (36 months) stability study report of one batch of Clarithromycin 27.5 % EC taste masked pellets form M/s Vision Pharmaceuticals Islamabad

iii. Method of analysis for Clarithromycin 27.5 % EC taste masked pellets form M/s Vision Pharmaceuticals Islamabad

iv. Copy of GMP certificate of M/s Vision Pharmaceuticals Islamabad, valid up to 08-02-2017


54. Harrison Pharmaceuticals10-Km,

Clarimycin 125mg/5ml SuspensionEach 5ml Susp

Form-513-10-16DyNO: 147520,000

Clarithromycin 125 mg/5ml suspension



Lahore Road, Sargodha

contains:-Clarithromycin 125mgMacrolide antibacterial(Mfg specs)

Pack of bottle60mlas per PRC

(MHRA)Me too status Claritek by Getz PharmaInspection dated 31-3-16 for grant of new section and renewal of DML

Deferred for source of granules, fee, legalized GMP, CoA and other requirements


i. COA of Clarithromycin 27.5 % EC taste masked pellets form M/s Vision Pharmaceuticals Islamabad

ii. Accelerated (6 months) & Real time (36 months) stability study report of one batch of Clarithromycin 27.5 % EC taste masked pellets form M/s Vision Pharmaceuticals Islamabad

iii. Method of analysis for Clarithromycin 27.5 % EC taste masked pellets form M/s Vision Pharmaceuticals Islamabad

iv. Copy of GMP certificate of M/s Vision Pharmaceuticals Islamabad, valid up to 08-02-2017



DESTO 0.5mg /5ml SyrupEach 5ml syp contains:-Desloratadine 0.5mgAnti allergy and antihistamine(Mfg specs)

Form-513-10-16DyNO: 146020,000Pack of bottle60ml, 120ml As per PRC

Clarinex – Merck & Co incGermanyDesora – SJ & G Fazal Ellahi Khi,Inspection dated 31-3-16 for grant of new section and renewal of DML


Deferred for evidence of approval in reference regulatory authorities

Evaluation By PEC Firm has referred to USFDA-approved product with composition of Desloratadine

0.5mg/ml whereas firm has applied with composition of Desloratadine 0.5mg/5mlDecision: Deferred for clarification of composition as reference product is approved with composition of Desloratadine 0.5mg/ml whereas firm has applied with composition of Desloratadine 0.5mg/5ml


EPIO SyrupEach 5ml syp contains:-Pizotifen (Hydrogen Maleate) 0.25mgAppetite stimulant

Form-513-10-16DyNO: 142820,000Pack of bottle60mlas per PRC

Pizotifen activas by ActivisUSAMosegar syrup by Novartis PharmaInspection


Deferred for evidence of approval in


dated 31-3-16 for grant of new section and renewal of DML

reference regulatory authorities


“Sanomigran Elixir 0.25mg/5ml approved by MHRA-UK” (The SPC of this product states Pharmaceutical form as Syrup )

Decision: Deferred for clarification of indications. Approved with Innovator’s specs.57. M/s. PDH

Laboratories (Pvt) Ltd, Lahore

Ceftam Injection 1gEach vial contains:-Cefoperazone Sodium eq. to Cefoperazone ……..500mgSulbactam Sodium eq. to Sulbactam ….….500mgCefoperazone Sodium is a semi synthetic, broad-spectrum, Cephalosporin antibiotic.

Form-502-05-11Dy.No.3398000/12000/-23-7-20141‘sRs. 400/-

Sulperazone injectionPfizer (USA)2SUM-Sami PharmaceuticalsLast inspection report dated13-06-2016recommended grant of Renewal of DML.

Evidence of approval status in reference regulatory authorities is required.


Deferred for evidence of approval status in reference regulatory authorities as reported reference is not traceable

Evaluation By PEC Applied formulation is approved by BFARM-Germany

Decision: Approved with Innovator’s specs.58. M/s.

Bosch Pharmaceuticals, Karachi

Izidex Ophthalmic Solution (Eye Drops)Each ml contains:-Moxifloxacin HCl equivalent to Moxifloxacin M.S …….5mgDexamethasone Sodium Phosphate equivalent to Dexamethasone Phosphate……1mg(Synthetic Broad Spectrum Antibacterial agent, Anti-

Form 528-12-2010Dy No. 2238Fee:Rs.8000/-Rs.12,000/-Rs.450.005ml

NANAInspection report dated 12-07-2016 stated GMP compliance as Acceptable


Deferred for evidence of approval by reference regulatory authorities & me-too status


inflammatory)MFG Specs

Evaluation By PEC Firm has stated following me-too references:

i. Ocumox-D of M/s Remington Pharma, Lahore (Reg.# 067888 )ii. Comox of m/s Elko Organization, Karachi (Reg.# 067534)

Firm has not submitted any evidence of approval by reference regulatory authoritiesDecision: Deferred for evidence of approval by reference regulatory authorities.

59. M/s A & Z Health Services 686, Street 92 Sector G-9/4, Islamabad.M/s Guerbet BP 57400 – 95943 Roissy CDG cedex – France at 16/24 rue Jean Chaptal, 93600 Aulnay sous Bois France.

Patent Blue V Sodium Guerbet 2.5 Per cent, Solution for Injection.Per unit, e.g., each tablet or 5ml, etc. contains:0.050g/2ml (ampoule 2ml)Pharmacotherapeutic group: dye for vascular marking, ATC code: V04CX

Form -5-ADiary# 31/ R&IDated 15.1.2016Rs.50000/-15-01-2016Per tablet, per capsule, per 5ml etc.Rs.32,000/- PKRDUPLICATE DOSSIER

Me-too status not availableCopy of CoPP issued by France confirms its availability and GMP

This is a duplicate dossier, the firm has provided a letter that original CoPP was submitted which has been misplaced and now the copy of CoPP is available only


Deferred for clarification of formulation indications

Evaluation By PEC Firm has stated that applied formulation is a Contrast media (Dye) used in

Diagnostic/Detection, this technique is often used in conjunction with Tc99m labeled colloids for the scintigraphic detection of SLN before surgery & for localization of manual probes during surgery.

Decision: Approved as per Import Policy for Finished Drugs. Firm shall provide valid original legalized agency COPP and Chairman, Registration Board will authorize issuance of registration letter.

60. M/s Genix Karachi

Mizoflam 400mg TabletEach modified release tablet contains:Mesalazine ………400 mg(Anti-Inflammatory)BP Specs

Form-506-08-2011Dy.No.76Rs.8000/-Rs.12,000/-16-9-2015Rs.200/10‘sRs.400/20‘sRs.600/30‘s

Asacol MR tabletWarner ChilcottUKMasacol tablet by Getz PharmaInspection report dated 04-04-2016 stated GMP compliance


Deferred for clarification of dosage from as reference product is available as modified release tablets


as Acceptable.

Evaluation By PEC Firm has stated that according to their submitted application on 06-08-2011 , we have

already applied the product according to internationally available dosage form i.e. modified release tablets

Decision: Approved61. M/s.

Wnsfeild Pharmaceuticals, Plot 122, Block-A, Phase-V, Industrial estate, Hattar, KPK.304

Vagitab 100mg TabletsEach tablet contains:-Clotrimazole…… 100mg(Antifungal)Not provided

Form 526-11-2013Dy.No.272FeeRs.20,000/=1x6‘sAs Per SRO

International Availability Not Provided,Oligyn 1of Platinum Pharmaceuticals (Pvt.) Ltd.Inspection report 3.1.2014Showing compliance of GMP as Satisfactory

262nd Meeting Registration Board held on 20-21st October, 2016.

Deferred for approval status by reference regulatory authorities

Evaluation By PEC Following reference, with same formulation as applied ,stated by firm has been verified“ MYCELEX-7 (CLOTRIMAZOLE) 100mg Vaginal tablet by M/s BAYER HEALTHCARE LLC approved by USFDA” BP monograph is available for applied formulation

Decision: Approved with BP specs.62. M/s.

Amgomed,Office # 5, 1st Floor Rose 1, Plaza I-8 Markaz, Islamabad.Manufactured byM/s. West Pharma, Producoes de EspecialiaesFarmaceuticas, SA Rua Joao de Deus, n. 11,

BicalutamidaFarmoz, Film-coated tabletEach film coated tablets contains:-Bicalutamide ……….50mgAdjuant to radial prostectomy or radio-therapy in patients with locally advanced prostate cancerUSP Specifications

Form 5ADy No.510 dated09-06-2014Rs.100,000/-As per SRO

Pack Size as per CPP:- 20/Pack- 30/Pack- 60/Pack

MHRA. Bicalutamide 50mg f/c by M/s Sun pharma.Local. Calutide 50mg by M/s AJ. Mirza.

CoPP original received. CoPP shows different brand name as “BicalutamidaFarmoz, Film-coated tablet”

Product License Holder is Farmoz-SociedadeTecnico Medicinal SA, Rua da Tapada

262nd Meeting Registration Board held on 20-21st October, 2016.Deferred for clarification as brand name on COPP is different from application


Amadora, 2700-486, Portugal.

Grande, 2, Abrunheira Sintra, Portugal

Evaluation By PEC Firm has requested to consider our product brand name as mentioned on COPP i.e.,

BicalutamidaFarmoz, Film-coated tablet”Decision: Approved

63. Highnoon LaboratoriesLtd.17.5 km, Multan Road, LahoreManufactured byCipla Ltd. India

Seroflo 125 HFA InhalerSalmeterol 25 mcg + Fluticasone Propionate 125 mcgInhalation sprayAdrenergics and other anti-asthmatics ATC code: R03AK06Inhaler 120 MD

5-A27225/5/15PKR 100,000/-

IndiaOriginal COPP is checked.COPP verified by Pakistan Embassy has been expired in August 2016

262nd Meeting Registration Board held on 20-21st October, 2016Deferred for confirmation of approval status by reference regulatory authorities and me too status


i. Original & legalized COPP (Certificate#. 721/MFG/WHO-GMP/DFDA/2015/1933) issued by FDA Bambolim, GOA, India. in the name of M/s Cipla Ltd., L-139 to L-146 verna Industrial Estate, Verna Goa.

ii. COPP is valid up to 26-05-2017iii. COPP confirms the availability of product in the market of exporting countryiv. COPP confirms the GMP status of Manufacturer i.e., M/s Cipla Ltd., L-139 to

L-146 Verna Industrial Estate, Verna Goa.v. Original GMP certificate (Certificate#. 545/MFG/WHO-GMP/DFDA/2016)

issued by FDA Bambolim, GOA, India. in the name of M/s Cipla Ltd., L-139 to L-146 Verna Industrial Estate, Verna Goa. (Certificate is valid up to 08-08-2018)

Following reference, with same formulation as applied ,stated by firm has been verified“ Seretide® Evohaler® 25 microgram /125 microgram per metered dose pressurised inhalation of M/s GSK approved by MHRA-UK”

Following me too reference has been verified:“ Salmicort Inhaler of M/s Macter Int. Karachi (Reg.#045210)

Decision: Deferred for consideration on its turn as the case was erroneously presented in 262nd DRB meeting.

64. M/s. UDL Pharmaceuticals, Karachi

Xeroxyn(Dry Powder Suspension)Each 5ml contains:Clarithromycin….250mg(Macrolide antibiotic)

Form516-06-2016Dy. No 1253Rs. 20000/-As per SRO60 ml120ml

Clarithromycin 250 mg/5ml suspension (MHRA)Local Availability: malacin DS 250 mg by M/s Bosh

Clarification is required for Dissolution test in acidic medium i.e 0.1N HCl as FDA dissolution

Agenda for 265th Meeting Registration Board to be held on 24-25th

January, 2017Deferred for clarification of Dissolution test of


PakistanCaricin by M/s. Valor Pharmaceuticals, Islamabad.Inspection report of20-08-

database recommends dissolution of Clarithromycin suspension in phosphate buffer only

Clarithromycin taste masked coated granules in acidic medium i.e 0.1N HCl as FDA dissolution database recommends dissolution of Clarithromycin suspension in phosphate buffer only.

Evaluation By PEC Firm has submitted reply from the supplier of Clarithromycin taste masked granules i.e.,

M/s Surge Laboratories Pakistan, stating as under:“The reason why we do acidic media test (dissolution in 0.1NHCL) is to check whether our granules are intact at the gastric resistance stage or not. As the granules are intact at this stage so our Clarithromycin taste masked granules are certainly suitable to manufacture Clarithromycin Oral suspension as per USFDA requirements since granules will only be released in phosphate buffer pH 6.8.”

It has been verified from PUBLIC ASSESSMENT REPORT of the Medicines Evaluation Board in the Netherlands, that enteric coating polymers have been used in the formulation of clarithromycin pellets for suspension.


MacterInternationalLimited,F-216,SITE,Karachi.(2713)

Ultima 250mg/5mlSuspensionEach 5ml (afterreconstitution) contains:Clarithromycin (CoatedGranules27.5%)…250mg(Semi-syntheticMacrolide antibiotic)

Form-5Dy. No: 430Dated. 11-11-2013Rs.20,000/-Rs.400/60ml430/70ml650/100ml

Clarithromycin Suspension(Sandoz)MHRAClaritek(Getz)

Source of pellets from M/s Surge laboratories

Agenda for 265th

ng Registration Board to be held on 24-25th

January, 2017.Deferred for clarification of Dissolution test of Clarithromycin taste masked coated granules in acidic medium i.e 0.1N HCl as FDA dissolution database recommends dissolution of Clarithromycin suspension in phosphate buffer only.

Evaluation By PEC Firm has submitted reply from the supplier of Clarithromycin taste masked granules i.e.,

M/s Surge Laboratories Pakistan, stating as under:“The reason why we do acidic media test (dissolution in 0.1NHCL) is to check whether our granules are intact at the gastric resistance stage or not. As the granules are intact at


this stage so our Clarithromycin taste masked granules are certainly suitable to manufacture Clarithromycin Oral suspension as per USFDA requirements since granules will only be released in phosphate buffer pH 6.8.”

It has been verified from PUBLIC ASSESSMENT REPORT of the Medicines Evaluation Board in the Netherlands, that enteric coating polymers have been used in the formulation of clarithromycin pellets for suspension.

Decision: Approved with Innovator’s specs.66. M/s Faas

Pharmaceuticals(Pvt.) Ltd F-784/L S.I.T.E.KarachiSachet Section:F. 2-2/ 2009-LicDated15-02-2013

Uronol Sachet 3GEach Sachetcontains:-Fosfomycin (asTromethamine…3gm(Anti-bacterial)

Form 529/10/2014 Dy. No.114 Rs. 20000/-As per SRO/1×10’s

Health Canada: Monurol(Triton Pharma Inc.)Not confirmedSatisfactory level of GMPcompliance (18-03-14)1. Me-too status needsconfirmation.

246th Meeting of Registration Board meeting held on10-11th

December, 2014

Deferred forconfirmation ofme-too status otherwise the firm shall apply on form 5-D with fee & other codal formalities.

Evaluation By PEC Following reference stated by firm has been verified for me-too status:

“Focin Ultra Sachet of M/s Tabros Pharma Karachi (Reg.#061315)Decision: Approved with Innovator’s specs.

67. M/s Hiranis Pharmaceuticals,plot no. E-145-E-149, North Western Industrial Zone, Port Qasim, Karachi439

Lomac Sachet 40mgEach sachet contains:-Esomeprazole Magnesium trihydrate enteric coated granules eq. to Esomeprazole…..….40 mg(Proton Pump Inhibitor) mafg specs

Form 56-03-2014Dyn: 93

Rs.20000/-14’s

As per PRC

Nexium by Astra Zeneca

UK,Nexum of Getz Pharmaceutical

sInspection

report dated23-09-2013

showing compliance of GMP as Good

Source of pellets from /s Vision Pharmaceuticals, Islamabad

264th Meeting Registration Board held on 28-29th December, 2016Deferred for evidence of me-too status as provided reference is incorrect

Evaluation By PEC Following me-too reference has been verified:

“Esowin Plus 40mg Sachet of M/s Winthrox Pharmaceuticals, Karachi (Reg.#081519)Decision: Approved with Innovator’s specs.

68. M/s Hiranis Pharmaceuticals,plot no. E-145-E-149, North Western Industrial Zone, Port Qasim,

Lomac Sachet 20mgEach sachet contains:-Esomeprazole Magnesium trihydrate enteric coated granules eq. to Esomeprazole….20 mg

Form 56-3-2014Dyn: 92

Rs.20000/-As per PRC

14s’

Nexium by Astra Zeneca

UKNexum of Getz Pharmaceutical

sInspection

report dated23-09-2013

showing

Source of pellets from /s Vision Pharmaceuticals, Islamabad

264th Meeting Registration Board held on 28-29th December, 2016Deferred for evidence of me-too status as provided reference is


Karachi438

(Proton Pump Inhibitor) maf specs

compliance of GMP as Good”.

incorrect

Evaluation By PEC Following me-too reference has been verified:

“Esowin Insta 20mg Sachet of M/s Winthrox Pharmaceuticals, Karachi (Reg.#081520)Decision: Approved with Innovator’s specs.

69. M/s. Servier Research & Pharmaceuticals Pakaistan Pvt. Ltd., 65 Main Boulevard Gulberg, Lahore. ManufacturerM/s. Les Laboratoirie Industrie, 905, route de Saran 45520 Gidy, France.Product license holderLes Laboratories Serveir-50 rue Carnot-92284 Surenes Cedex-France

Implicor Film Coated TabletsEach film coated tablet contains:-Metoprolol Tartrate…….50mgIvabradine…………………….5mg(Antianginal)18 months

Form 5ADy no. 172 dated10-02-2016 Rs.100,000

Implicor by Serveir, SWISMEDICImplicor by Serveir, Denmark

262nd Meeting Registration Board held on 20-21st October, 2016.

Deferred for submission of Original and Legalized COPP

Evaluation by PECi. The Firm has provided Original legalized COPP Issued by Commerce and Industry Chmaber

of Paris Ile de France region on 23rd Oct, 2015 which shows that the Status of GMP compliance is in perfect agreement as recommended by WHO.

ii. The firm has stated that since October 2015 COPP & free sale certificate are no longer issued by French National Agency for Medicines and Health Products Safety (ANSM), they are issued by Commerce and Industry Chamber France. Press release issued by ANSM for the transfer of the activity is available on official site of ANSM which has been verified.

iii. Country of origin holds market authorization for the applied formulation but the formulation is not present in the market for free sale.

iv. The product is not present in available pharmacopoeia BP 2013 & USP 39.Decision: Deferred for clarification of Free sale status in country of origin i.e. France

70. M/s. Genix Pharma

Genoxaltin (Oxaliplatin)

Form 5ADy. 208 dated

MHRA. Oxaliplatin

COPP issued

The case was discussed in 262nd


(Pvt) Ltd, 44-45-B, Korangi Creek Road, Karachi-/Manufactured by:M/s. Samyang Biopharmaceuticals Corp. 79, Sinildong-ro, Daedeok-gu, 306-230, Daejeon, Republic of Korea.Product License Holder:M/s. Labosuan I+D S.L.Einsten 828108 Alcobendas, Madrid, Spain.Applicant Of certificate:M/s. Aq Vida GmbH Kaiser-Wilhelm-Str.89 20355 Hamburg, Germany.

Concentrate for solution for Infusion 50 mg/10 mlEach vial contains:-Oxaliplatin…..50mgTreatment of metastatic colorectal cancer)

02-03-2016Rs.100,000/-Not provided.

50mg & 100mg powder for solution for infusion by M/s Actavis.

dated19-03-2016 COPP strength is mentioned as 5mg/mlPack sizes are not mentioned on COPP.GMP compliant as per COPP.Single COPP for 2 products.

RB meeting where firm hadsubmitted an apology for typographical error stating as under;The dosage form of the product was mistakenly typed on the application as ―Powder for Infusion‖ instead of ―concentrate for solution for infusion.”Registration Board deferred the case for clarification of firm‘s claim from COPP

Evaluation by PEC Firm has submitted original & legalized COPP (Certificate #. 2016/236) issued by

BFAM Germany, dated 29-11-2016 COPP states composition of product as:

“Genoxaltin 50mg/10mlEach vial of 10 ml concentrate for solution for infusion contains 50 mg Oxaliplatin”Same has been incorporated above in column of product detail

Details of manufacturer & Product license holder as stated in COPP have been incorporated above in column of Applicant’s detail


USP monograph is available for applied formulationDecision: Approved as per Import Policy for finished drugs with USP specifications.

71. M/s. Genix Pharma (Pvt) Ltd, 44-45-B, Korangi Creek Road, Karachi-75190. /Manufactured by:M/s. Samyang Biopharmaceuticals Corp. 79, Sinildong-ro, Daedeok-gu, 306-230, Daejeon, Republic of Korea.Product License Holder:M/s. Labosuan I+D S.L.Einsten 828108 Alcobendas, Madrid, Spain.Applicant Of certificate:M/s. Aq Vida GmbH Kaiser-Wilhelm-Str.89 20355 Hamburg, Germany.

Genoxaltin (Oxaliplatin) Concentrate for solution for Infusion 100 mg/20 mlEach vial contains:-Oxaliplatin………..100mgTreatment of metastatic colorectal cancer)

Form 5ADy. No 209 dated 02-03-2016Rs.100,000/-

MHRA. Oxaliplatin 50mg & 100mg powder for solution for infusion by M/s Actavis.

COPP issued dated19-03-2016 COPP strength is mentioned as 5mg/mlGMP compliant as per COPP

The case was discussed in 262nd

RB meeting where firm hadsubmitted an apology for typographical error stating as under;The dosage form of the product was mistakenly typed on the application as ―Powder for Infusion‖ instead of ―concentrate for solution for infusion.”Registration Board deferred the case for clarification of firm‘s claim from COPP

Evaluation by PEC Firm has submitted original & legalized COPP (Certificate #. 2016/235) issued by

BFAM Germany, dated 29-11-2016 COPP states composition of product as:

“Genoxaltin 100mg/20mlEach vial of 20 ml concentrate for solution for infusion contains 100 mg Oxaliplatin”


Same has been incorporated above in column of product detail Details of manufacturer & Product license holder as stated in COPP have been

incorporated above in column of Applicant’s detail USP monograph is available for applied formulation

Decision: Approved as per Import Policy for finished drugs with USP specifications.

72. M/s OBSPakistan(Pvt) Ltd,C14 SITEKarachi.2543

Obsarox 125mgTabletEach dispersible tabletcontains:Deferasirox(Micronized)……..125mg(Iron Chelating agent)

Form-5Dy. No: 19Dated.25.07.2011Rs.8,000/-25.07.2013Rs.12,000/-Rs.3188/-30’s

Exjade 125,250, 500mg(Novartis)MHRADasirox 100&400mg(CCL)InspectionDated 08.04.2015

Approvalstatus ofsamestrength inPakistannotconfirmed

258th Meeting Registration Board held on 25-26th April, 2016

Deferred forconfirmationof me toostatus inPakistan

Evaluation by PEC Following me-too reference has been verified:

“Asunra Dispersible tablets 125 mg of M/s Novartis, Pakistan (Reg.# 45695)Decision: Approved with Innovator’s specs.

73. M/s OBSPakistan(Pvt) Ltd,C14 SITEKarachi.2597

Obsarox 500mgTabletEach dispersible tabletcontains:Deferasirox(Micronized)……..500mg(Iron Chelating agent)

Form-5Dy. No: 15Dated.25.07.2011Rs.8,000/-25.07.2013Rs.12,000/-Rs.15,000/-30’s

Exjade 125,250, 500mg(Novartis)MHRADasirox 100&400mg(CCL)Inspectiondated08.04.2015

Approvalstatus ofsamestrength inPakistan not confirmed.

258th Meeting Registration Board held on 25-26th April, 2016Deferred for confirmation of me-too status inPakistan

Evaluation by PEC Following me-too reference has been verified:

“Asunra Dispersible tablets 500 mg of M/s Novartis, Pakistan (Reg.# 45696)Decision: Approved with Innovator’s specs.

74. M/s Bio Labs (Pvt) LtdKahuta Road, Islamabad.2012

Fenic Gel 1%Each gm contains:-Diclofenac Sodium….… 1% (NSAID)

Form 5Dy.No.1530&3691,24-5-12Rs.8000/=23-05-2012

Rs.12,000/=15-07-2014

NAAs Per SRO

International Availability not provided.Local Availability:Artifen by Abbott PharmaLast inspection report 16.8.2016 submitted with compliance remarks

263rd Meeting Registration Board held on 29-30th November, 2016.Deferred for evidence of approval by Reference Regulatory Authorities and clarification of pharmacological group

Evaluation By PEC Following reference stated by firm has been verified:

“Voltarol 1% w/w Emulgel, Gel of M/s GSK, MHRA-UK approved Firm has revised pharmacological group as “Non-Steroidal Anti-inflammatory


Decision: Approved with innovator’s specs and change of brand name75. M/s Bio

Labs (Pvt) LtdKahuta Road, Islamabad.2012

Fenic Tablets 75mgEach enteric coated tablet contains:-Diclofenac Sodium …… 75mg (NSAID)

USP specs

Form 5Dy.No.1530&3688,24-5-12Rs.8000/=23-05-2012Rs.12,000/=15-07-20142x10‘s3x10‘sAs Per SRO

Available in MHRALocal Availability: ARDI-K by English Pharma.

263rd Meeting Registration Board held on 29-30th November, 2016Deferred for confirmation of dosage form whether modified release or otherwise and

Evaluation By PEC• Firm has submitted Form-5 stating composition as under:

“Fenic Tablets 75mg Each enteric coated tablet contains:- Diclofenac Sodium …… 75mg”• Firm has revised pharmacological group as “Non-Steroidal Anti-inflammatory” only

Decision: Approved with change of brand name76. M/s Bio

Labs (Pvt) LtdKahuta Road, Islamabad.2012

Fenic Capsules SR 100mgEach capsule contains:-Diclofenac Sodium SR.… 100mg (NSAID)

Form 5Dy.No.1530 &3683,24-05-12Rs.8000/=23-05-2012

Rs.12,000/=14-07-2014

10‘s30‘sAs Per SRO

Diclomax Retard -MHRALocal Availability: Diclopulse by M/s Pulse Pharmaceuticals.Last inspection report of 16-8-2016 submitted with compliance remarks..


Deferred source of pellets, legalized GMP, CoA with other requirement in case of delayed release and clarification of pharmacological group


i. COA of “Diclofenac Sodium SR pellets 32%” from M/s Vision Pharmaceuticals, Islamabad

ii. Copy of GMP certificate of M/s Vision Pharmaceuticals, Islamabad, valid up to 08-02-2017

iii. Firm has revised pharmacological group as “Non-Steroidal Anti-inflammatory” only

Decision: Approved with innovator’s specifications and change of brand name77. M/s Bio

Labs (Pvt) Ltd, Islamabad

Clomene 50mg TabletsEach tablet contains:-Diclofenac Sodium ……

Form 5Dy.No.1530,5088 -7-6-12Rs.8000/=05-06-2012

International availability not provided.Local Availability: Fertab by



50mg(NSAID)

Rs.12,000/=15-07-2014

10‘sAs Per SRO

M/s Shaigan .Last inspection report of 16-8-2016 submitted with compliance remarks.

Deferred for clarification of pharmacological group

Evaluation By PEC Firm has revised pharmacological group as “Non-Steroidal Anti-inflammatory” only Description of dosage form is required whether delayed release or otherwise. Applied formulation is approved in USFDA as delayed release tablet.

Decision: Deferred for clarification of dosage form whether delayed release or otherwise. Last opportunity for rectification of shortcomings

78. M/s Bio Labs (Pvt) LtdKahuta Road, Islamabad.2012

Fenic Capsules 75mgEach capsule contains:-Diclofenac Sodium..… 75mg (NSAID)

Form 5Dy.No.2681Rs.8000/=23-05-2012

Rs.12,000/=28-07-2014

20‘sAs Per SRO

Motifene capsules-MHRA.Local Availability: DICLOAP by M/s Ottoman PharmaceuticalsLast inspection report 16.8.2016 submitted with compliance


Deferred for confirmation of formulation as per innovator and clarification of pharmacological group

Evaluation By PEC Firm has revised pharmacological group as “Non-Steroidal Anti-inflammatory” only Description of dosage form is required whether delayed release or otherwise. Applied formulation is approved in MHRA as modified release. Source of pellets, legalized GMP, COA with other requirement in case of modified

release dosage form.Decision: Deferred for clarification of dosage form whether delayed release, modified release or otherwise.

79. M/s Bio Labs (Pvt) Ltd, Islamabad

Neuronit TabletsEach tablet contains:-Vitamin B1………. 100mgVitamin B6………. 200mgVitamin B12 …..… 200mcg(Vitamins)

Form 5Dy.No.1530&5069-7-6-12Rs.8000/=04-05-2012

Rs.12,000/=15-07-201410‘s20‘s30‘s

International Availability not provided.Local Availability: Theragran –NV by GSK.Last inspection report of 16.8.2016


Deferred for confirmation of approval status by reference regulatory


As Per SRO submitted with compliance remarks.

authorities

Evaluation By PEC Firm has submitted printout of a webpage of M/s Merck Consumer Health Holding

GmbH, Germany. The printout presents the description of a product “Neurobion tablets” stating

composition same as formulation applied. The printout has been verified from the said webpage

Decision: Deferred for evidence of approval by reference regulatory authorities80. M/s Bio


Kamacin 1000mg AmpouleEach 3ml ampoule contains:-Kanamycin ……….. 1000mg(Antibiotics, Aminoglycosides)USP specs

Form5Dy.No.2691Rs.8000/=31-05-2012

Rs.12,000/=28-07-2014

1‘sx3ml25‘sx3mlAs Per SRO

International Availability not provided.Local Availability: Nekacyn by M/S Amros pharma.Last inspection report 16.8.2016 submitted with compliance remarks.


Deferred for clarification of composition as reference product is available as 1000mg/3ml

Evaluation By PEC Firm has provided master formulation per vial stating fill volume of ampoule as 3 ml Applied formulation is approved in USFDA with composition of “Kanamycin eq. to

1g/3ml”Decision: Approved


Biocin 20mg AmpouleEach 2ml ampoule contains:-Gentamicin ……….20mg( Antibacterials, Anti-infective, Anti biotics, Aminoglycoside)USP specs

Form 5Dy.No.2683Rs.8000/=31-05-2012

Rs.12,000/=28-07-2014


MHRA-UK approvedLocal Availability Cidomycin by M/S Sanofi-Aventis.Last inspection report of 16-8-2016 submitted with compliance remarks.


Deferred for evidenc e of approval of applied dosage form & strength (formulation) in reference regulatory authorities.

Evaluation By PEC Following reference stated by firm has been verified.

“Gentamicin Paediatric 20mg/2ml Solution For Injection” of M/s Zentiva, approved by MHRA-UK.

Firm has submitted Form-5 stating composition as under:“Biocin 20mg ampoule

Each 2ml ampoule contains:-


Gentamicin ……….20mg”Decision: Approved

82. M/s Bio Labs (Pvt.) Ltd, Islamabad

Biocin 40mg AmpouleEach1ml ampoule contains:-Gentamicin ……….40mg( Antibacterials, Anti-infective,Anti biotics, Aminoglycoside)USP specs

Form 5Dy.No.2684Rs.8000/=31-05-2012

Rs.12,000/=28-07-2014

‘sx1mlAs Per SRO

Gentamicin sulphate injection-USFDALocal Availability:Ephagent by M/S Epharm pharmaceuticals.Last inspection report of 16-8-2016 submitted with compliance remarks.


Deferred for clarification of composition along with fill volume of ampoule & evidence of approval of applied strength (formulation) in reference regulatory authorities


“Genticin (Gentamicin) 40mg/ml Injection” of M/s Concordia International, approved by MHRA-UK.


Each 1ml ampoule contains:- Gentamicin ……….40mg”

Decision: Approved

83. M/s Bio Labs (Pvt.) Ltd, Islamabad


Form 5

Dy.No.2685Rs.8000/=31-05-2012

Rs.12,000/=28-07-2014


Internationalavailability not provided.Local Availability:Cidomycin by M/S Sanofi-aventis.Last inspection report of 16-8-2016 submitted with compliance remarks.


Deferred forclarification of composition along with fill volume of ampoule & evidence of approval of applied strength (formulation) in reference regulatory authorities



“Genticin (Gentamicin) 80mg/2ml Injection” of M/s Concordia International, approved by MHRA-UK.


Each 2ml ampoule contains:- Gentamicin ……….80mg”

Decision: Approved84. M/s Bio



Form 5Dy.No.2686Rs.8000/=31-05-2012

Rs.12,000/=28-07-2014

5‘sx1ml5‘sx2ml25‘sx2mlAs Per SRO

International Availability not provided.Local Availability: Cidomycin by M/S Sanofi-aventis.Last inspection report of 16-8-2016 submitted with compliance remarks.


Deferred for clarification of composition alongwith fill volume of ampoule & evidence of approval of applied strength (formulation) in reference regulatory authorities.

Evaluation By PEC Firm has submitted master formulation stating fill volume of ampoule equal to 2 ml. In response to evidence of approval of applied strength (formulation) in reference

regulatory authorities, firm has referred to product registered in MexicoDecision: Deferred for evidence of approval by reference regulatory authorities


Levocit 10mg TabletsEach tablet contains:-Levocetrizine (Di-hydrochloride)……….10mg(Anthistamine)

Form 5Dy.No 2699Rs.8000/=04-06-2012

Rs.12,000/=28-07-2014

10‘sAs Per SRO

International availability not provided.Local Availability:Renocit by M/s Envoy pharmaceuticals.Last inspection report of 16-8-2016 submitted with compliance remarks.


Deferred for evidence of approval of applied dosage form & strength (formulation) in reference regulatory authorities

Evaluation By PEC Firm has stated “Cetrizine 10 mg tablet UK MHRA approved as reference product Me too reference stated by firm could not be verified

Decision: Deferred for evidence of me-too status as stated refrence is incorrect86. M/s Bio Mekobal 500mcg Form 5 International 263rd Meeting



CapsulesEach capsule contains:-Mecobalamin …. 500mcg(Co-enzyme type Vitamin B12)

Dy.No.2693Rs.8000/=04-06-2012

Rs.12,000/=28-07-2014

2x10‘s10x10‘sAs Per SRO

availability not provided.Local Availability: Mecbin by M/S Ferroza pharmaceutical.Last inspection report of 16-8-2016 submitted with compliance remarks.

Registration Board held on 29-30th November, 2016


Evaluation By PEC Reference product stated by firm is not form any reference regulatory authority

Decision: Deferred for evidence of approval of applied dosage form & strength (formulation) by reference regulatory authorities as stated reference is incorrect.


Tranex 250mg CapsulesEach capsule contains:-Tranexamic Acid. 250mg(Antihaemorrhagics/ Antihaemophillic Preparations)

Form 5Dy.No.2697Rs.8000/=04-05-2012

Rs.12,000/=28-07-201410‘sAs Per SRO

International availability not provided.Local Availibility: Anetpil by Alina pharmaceutical.Last inspection report of 16-8-2016 submitted with compliance



Evaluation By PEC Following reference with similar formulation as applied,has been verified

“Hexatron capsule 250 mg by M/s Nippon Shinyaku Co., Ltd approved by (PMDA Japan)”

Decision: Approved with Innovator’s specs.88. M/s Bio


Tranex 500mg Capsules

Each capsule contains:-Tranexamic Acid .……..500mg(Antihaemorrhagics/ Antihaemophillic Preparations)

Form 5Dy.No.2695Rs.8000/=31-05-2012Rs.12,000/=28-07-20141x10‘s2x10‘s10x10‘sAs Per SRO

International Availability not provided.Local Availibility:Aneptil by Alina pharmaceuticlsLast inspection report of 16-


Deferred for evidence of approval of applied dosage form & strength (formulation) in


8-2016 submitted with compliance remarks.

reference regulatory authorities

Evaluation By PEC Reference stated by firm could not be confirmed from any reference regulatory authority

Decision: Deferred for evidence of approval of applied dosage form & strength (formulation) by reference regulatory authorities

89. M/s Bio Labs (Pvt) Ltd, Islamabad.

Omepra Plus 10mg AmpouleEach 1 ml ampoule contains:-Nalbuphine HCl ……..10mg(Syntheitc Opioid agonist-Antagonist)

Form 5Dy.No.2005Rs.8000/=04-03-2011Rs.12,000/=28-11-2014As Per SROAs Per SRO

Nalbuphine HCl Inj. 10mg/ml-USFDA.local availability: Kinz by M/sSami pharma.Last inspection report of 16-8-2016 submitted with compliance remarks

263rd Meeting Registration Board held on 29-30th November, 2016Deferred for clarification of fill volume of ampoule

Evaluation By PEC Firm has submitted Form-5 stating composition as under:

Omepra Plus 10mg Ampoule Each 1 ml ampoule contains:- Nalbuphine HCl ……..10mgDecision: Approved with change of Brand name


Omepra Plus 20mg AmpouleEach 2ml ampoule contains:-Nalbuphine HCl ……..20mg(Syntheitc Opioid agonist-Antagonist)

Form 5Dy.No.2004Rs.8000/=04-03-2011 Rs.12,000/=28-11-2014

As Per SROAs Per SRO

Nalbuphine HCl Inj. 20mg/ml-USFDA.Local Availability: Kinz by M/s Sami pharma. Last inspection report of 16.8.2016 submitted with compliance remarks

263rd Meeting Registration Board held on 29-30th November, 2016Deferred for clarification of fill volume of ampoule


Omepra Plus 20mg Ampoule Each 2 ml ampoule contains:- Nalbuphine HCl ……..20mg


Decision: Approved with change of brand name91. M/s Bio

Labs (Pvt) Ltd, Islamabad.

Omezole 12.5mg TabletsEach controlled release tablet contains:-Paroxetine as Hydrochloride……….12.5mg(BNF Edition 57).

Form 5Dy.No.2008Rs.8000/=31-05-2012Rs.12,000/=28-11-20141x10‘sAs Per SRO

Paxil CR-USFDALocal Availability: Deroxat CR Tabletby Globle Pharmaceuticals, Pakistan.Last inspection report of16-8-2016 submitted with compliance remarks.

263rd Meeting Registration Board held on 29-30th November, 2016Deferred for confirmation of applied dosage form whether extended release or otherwise


Omezole 12.5mg Tablets Each controlled release tablet contains:- Paroxetine as Hydrochloride……….12.5mg



Bioline 50mg SuspensionEach 5ml contains:-Fluconazole ……….. 50mg(Antifungal)USP specs

Form 528-11-2014Dy.No.1990Rs.8000/=Rs.12,000/=31-05-201235mlAs Per SRO

International Availability not provided.Local Availability: C-bosh by M/s Bosch PakistanLast inspection report of 16-8-2016 submitted with compliance remarks.


Deferred for evidence of approval status by reference regulatory authorities


Bioline suspension 50mg Each 5 ml contains:-

Fluconazole……….50 mg Applied formulation is approved by MHRA-UK Firm has applied other formulations with same brand name

Decision: Approved with change of Brand name93. M/s Bio

Labs (Pvt) Ltd,

Metoclar 30mg CapsulesEach capsule

Form 528-11-2014Dy.No.1984

Cmbalta-MHRA.Local

263rd Meeting Registration Board held on 29-


Islamabad.

contains:-Duloxetine as HCl………..30mg(SNRI)

Rs.8000/=Rs.12,000/=04-06-20122x7‘sAs Per SRO

Availability:Zenbar by M/s Searle Pharma .Last inspection report 16.8.2016 submitted with compliance remarks.

30th November, 2016

Deferred for source of pellets, fee legalized GMP, CoA & other requiremens


i. COA of “Duloxetine HCl EC pellets 17%” from M/s Vision Pharmaceuticals, Islamabad


COA of pellets provided by firm states In-House specifications whereas USP monograph is available for applied formulation

Decision: Deferred for clarification of specifications as COA of pellets provided by firm states In-House specifications whereas USP monograph is available for applied formulation


Melocam 60mg CapsulesEach capsule contains:-Duloxetine as HCl……...60mg(SNRI)

Form 528-11-2014Dy.No.1995Rs.8000/=Rs.12,000/=04-06-2012

Cymbalta-MHRA.Local Availability: Zenbar byM/s Searle Pharmaceuticals, Pakistan.Last inspection report of16-8-2016 submitted with compliance remarks.


Deferred for source of pellets, fee legalized GMP, CoA & other requirements


i. COA of “Duloxetine HCl EC pellets 17%” from M/s Vision Pharmaceuticals, Islamabad


COA of pellets provided by firm states In-House specifications whereas USP monograph is available for applied formulation

Decision: Deferred for clarification of specifications as COA of pellets provided by firm states In-House specifications whereas USP monograph is available for applied formulation


Bioline 25mg Tablets

Each controlled release tablet

Form 528-11-2014Dy.No.1992Rs.8000/=Rs.12,000/=

Paxil CR-USFDA

Local Availability:

Confirmation requiredwhether applied



contains:-Paroxetine as Hydrochloride…………25mg(BNF Edition 57)Manufacturer‘s Specifications

31-05-20121x10‘sAs Per SRO

Deroxat CR by M/s Global Pharma.Last inspection report of 16.8.2016 submitted with compliance remarks.

dosage form is immediate or extended reease

Deferred for Confirmation of applied dosage form whether extended reease or otherwise


Bioline 25mg Tablets Each controlled release tablet contains:- Paroxetine as Hydrochloride…………25mg

Firm has applied similar brand name for different formulations. USP monograph is avail;able for applied formulation

Decision: Approved with Innovator’s specs and change of brand name96. M/s Bio

Labs (Pvt) Ltd, Islamabad.

Metrozole 30mg AmpouleEach 1 ml ampoule contains:-Ketorolac Tromethamine…30mg(NSAID)

Form 528-11-2014Dy.No.2002Rs.8000/=Rs.12,000/=04-06-20121ml x 5’s1ml x 10’sAs Per SROAs Per SRO

Ketorolac TrometamoL solution by Beacon Pharma (MHRA)K-Dol by Akson PharmaLocal Availability:Torapan Injection by M/s Caraway pharmaceuticalLast inspection report 16.8.2016 submitted with compliance remarks.


Deferred for confirmation of pack size

Evaluation By PEC Firm has stated filled volume of ampoule as 1 ml & requested for pack sizes of 5’s &

10’s USP monograph is available for applied formulation

Decision: Approved with USP specs.97. M/s.

WelWrd Pharmaceuticals,

Welcool InjectionEach 5ml contains:-Midazolam as

18-5-2011Rs.8000/-

Dated 18-5-2011

Midazolam 1 mg/ml

Solution for Injection,

264th Meeting Registration Board held on 28-29th December,


Hattars maleate……5mg(Tranquilizer)USP Specs

Rs.12000/- dated 30-12-

2014

5ml

(MHRA Approved)

Dormicum by Roche

Last inspection report

16.4.2016The panel

recommends the grant of renewel of

DML.

2016.Deferred for confirmation of section

Evaluation By PEC Firm has submitted copy of letter issued by Secretary CLB stating the renewal of DML

for following sections:1) Tablet (General).2) Capsule (General)3) Dry Powder Suspension (General)4) Injection Ampoule / Vial (General)5) Injection Ampoule (Psychotropic)6) Injection Vial (Cephalosporin)7) Injection Dry Powder Vial (General)8) Sachet (General)

Decision: Approved98. M/s.

Welwrd Pharmaceuticals, Hattar

Weldiclof 100mg SR TabletsEach film coated tablet contains:-Diclofenac Sodium SR …..100mg(NSAID)

B.P specs.

Form 53-06-2011Dy no 524Rs.8000/-

Rs.12000/-30-12-2014

2x10’sAs Per SRO

Not provided

Defnac by Searle

Last inspection

report dated 16-04-2016,

overall evaluation

rated as Good

Confirmation required whether the salt is sodium or potassium

Diclofenac sodium is available in 100mg SR tablet in USFDA

265th Meeting Registration Board to be held on 24-25thJanuary, 2017.Deferred for confirmation whether the salt is Sodium or Potassium.

Evaluation By PEC Firm has stated composition as under :

Weldiclof 100mg SR TabletsEach film coated tablet contains:-Diclofenac sodium SR …..100mg


99. M/s Preslin Injection Form 5 Complete 260th Meeting


Surge Laboratories (Private) Limited, 10th, KM Faisalabad Road, Bikhi District, Sheikhupura.Priority # 1202 swapped

20mgEach ml contains:Hydralazine HCl USP …. 20mg(Antihypertensive)USP Specification

26-4-20128000/-12000/16-01-2014 (Photocopy)Pack size of 30ml & 60ml as per SRO

form 5 required. Original challan receipt required. Complete description of dosage form required. Commitment required as per decision of 251st

RB meeting. Latest inspection report required

Registration Board held on 28-29th June, 2016.Deferred for provision of Complete form 5. Original challan receipt. Complete description of dosage form. Proof of approval status of same dosage form in reference countires and Pakistan Commitment as per decision of 251st RB

Evaluation by PEC Firm has submitted following:

i. Complete Form 5.ii. Composition stated in Form 5 is as under

“ Preslin Injection 20mgEach 1ml ampoule contains:Hydralazine HCl USP …. 20mgUSP spec.”

iii. Firm has requested pack size of 1mlx 1’siv. Copy of receiving of challan of Rs. 12000/- dated 03-1-2014v. Copy of receiving of challan Rs. 8000/- dated 26-04-2012

Following reference with same formulatiojn as applied has been verified:“Hydralazine hydrochloride 20mg/ml Injection of M/s LUITPOLD USFDA –Approved”

Following me-too reference has been verified:“Hydralazine HCl 20mg/ml Injection of M/s Zafa Pharmaceutical, Karachi (Reg.#042157)

Commitments as per 251st RB meeting has been provided USP monograph is available for applied formulation


Genix Pharma Karachi.

Nubain 20mg/ml InjectionEach ml contains:Nalbuphine HCl……..20 mg

Opoid Antagonist

Form-5Duplicate

06-01-2012Dy.No.463

Rs.8000/-copyRs.12,000/-16-9-2015

Nubain 20mg/ml by

BMSUSA & UK

Kinz 20mg/ml by Sami Lab

264th Meeting Registration Board held on 28-29th December, 2016.Deferred for evidence of


5’s10’s

As per PRC


4-4-2016Stated GMP

compliance as acceptable.

approval by reference regulatory authorities as provided reference is not correct

Evaluation by PEC Following reference with same formulation as pplied has been verified:

“NALBUPHINE HYDROCHLORIDE 20mg/ml injection of M/s Hospira approved by USFDA”


Genix, Karachi

Piroxim 20mg /ml InjectionEach ml contains:Piroxicam….20 mg

(Anti Inflammatory)

Form-5Duplicate

16-11-2011Dy.No.354

Rs.8000/-copyRs.12,000/-16-9-2015

5’s10’s

As per PRC

Feldene 20mg/ml by

Pfizer Pharmaceutical

s

Pcam 20mg/ml by Merck

Pharmaceuticals


4-4-2016Stated GMP

compliance as acceptable.

264th Meeting Registration Board held on 28-29th December, 2016.Deferred for evidence of approval by reference regulatory authorities.

Evaluation by PEC Following reference with same formulation as pplied has been verified:

“Feldene 20mg/ml IM injection of M/s Pfizer approved by EMA”Decision: Approved with Innovator’s specs.


Case No.02: Applications with differential fee submitted up to September, 2015S.No.

Name and address of

manufacturer /

Applicant

Brand Name(Proprietary name + Dosage Form + Strength)CompositionPharmacological GroupFinished product Specification

Type of FormInitial date,diaryFee

including differenti

al fee

Demanded Price /

Pack size

Remarks on the

formulation (if any) including International

status in stringent drug

regulatory agencies /

authorities

Me-too status

GMP status as depicted in latest inspection report

(with date) by the Evaluator

Remarks of the Evaluator.

Decision

1. M/s. Aries Pharmaceuticals, Peshawar

Oscom Tablets 830mgEach tablet contains:-Ossein Mineral Complex….830mg

(Mineral supplements)

Form 516-08-2012

Dy No. 782

Rs.8000/-15-8-2012

+Rs.12,000/

-17-07-2014

3x10’sAs Per SRO

Not provided.

Osnate-800 by AGP Pvt Ltd


03-08-2016Stated grant of

additional section and

renewal of DML

Firm has claimed Mfg specs and the product is not found in available versions of BP and USP

International availability is not confirmed

Deferred for submission of complete composition of ossein mineral complex and confirmation of availability of atomic absorption spectrophotometer.


Oscom-D TabletsEachtablet contains:-Ossein Mineral Complex….830mgVitamin D …………400IU

(Mineral supplements)

Form 516-08-2012

Dy No. 793

Rs.8000/-15-8-2012

+Rs.12,000/

-17-07-2014

3x10’sAs Per SRO

Not provided.

Bonmin tablet by S.J. & G Fazul

Ellahie




renewal of DML.

Firm has claimed Mfg specs and the product is not found in available versions of BP and USP


Deferred for not providing the complete composition of ossein mineral complex and non-availability of atomic absorption spectrophotometer.


Macrocap 500mg CapsuleEach capsule contains:-Azithromycin Dihydrate eq. to Azithromycin……...500mg

Form 516-08-2012Dy No. 769

Rs.8000/-15-8-2012

+Rs.12,000/-

Not provided.

Acro by S.J. & G Fazul Ellahie


03-08-2016

Firm has provided the reference of Azithromycin 500mg Capsule of 19th

WHO model list of Essential

Deferred as the molecule is under review as per decision of 250th DRB meeting.


(Macrolide)

USP Specs

17-07-2014

1x10’sAs Per SRO

Stated grant of additional

section and renewal of DML.

medicine (April 2015).

The product is only listed for single‐dose treatment of genitalChlamydia trachomatis and trachoma.


Glucotin Tablets

Each tablet contains:-Glucosamine sulphate …….500mgChondroitin sulphate……400mg

Anti-rheumaticUSP Specs

Form 516-08-2012Dy No. 286Rs.8000/-

15-8-2012+

Rs.12,000/-17-07-2014

1x10’s2x10’s3x10’sAs Per SRO

TGA-Australia approved

Cartigen By Getz




renewal of DML.

Approved.


Droxil 125mg Dry SuspensionEach 5ml contains:-Cefadroxil………….125mg

(Cephalosporin)

USP Specs

Form 520-01-2011Dy No. 176

Rs.8000/-20-1-2011

+Rs.12,000/-17-07-2014

60mlAs Per SRO

Duricef 125mg/5ml

suspension by Ranbaxy

Pharmaceuticals(USFDA

Approved)

Evacef by Highnoon



additional section

Approved.


Risdon Tablets 2mgEach tablet contains:-Risperidone… 2mg

(Antipsychotic)

USP Specs

Form 516-08-2012Dy No. 772

Rs.8000/-15-8-2012

+Rs.12,000/-17-07-2014

1x10’s2x10’s3x10’sAs Per

Risperdal 2mg Tablets by

Janssen-Cilag(MHRA

Approved)

Persch tab by Barrett Hodgson



Firm has claimed that their formulation is of uncoated tablets while the product is internationally available as film coated or oro-dispersible tablets.

Deferred for clarification of dosage form as the firm has applied for uncoated tablets while the reference product is available as film coated.


SRO additional section and

renewal of DML.

Approved in USFDA with boxed warning of increased mortality in elderly patients with dementia related psychosis.


Risdon Tablets 4mgEach tablet contains:-Risperidone…..4mg

(Antipsychotic)

USP Specs

Form 516-08-2012Dy No. 773

Rs.8000/-15-8-2012

+Rs.12,000/-17-07-2014

1x10’s2x10’s3x10’sAs Per SRO

Risperdal 2mg Tablets by

Janssen-Cilag(MHRA

Approved)

Persch tab by Barrett Hodgson




renewal of DML.

Firm has claimed that their formulation is of uncoated tablets while the product is internationally available as film coated or oro-dispersible tablets


Deferred for clarification of dosage form as the firm has applied for uncoated tablets while the reference product is available as film coated.


Arivan 2mg Tablets

Each tablet contains:-Lorazepam……2mg

(Anxiolytic)

USP Specs

Form 516-08-2012Dy No. 776Rs.8000/-15-8-2012

+Rs.12,000/-17-07-2014

10x10’sAs Per SRO

Ativan 2mg Tablets by

Valeant(USFDA

Approved)

Tenzil by Atco




renewal of DML.

Approved in USFDA with boxed warning that concomitant use with opioids & BZ’s may cause respiratory depression, coma & death.

Present in INCB green list.Firm has Psychotropic section.

Approved with Boxed warning

9. M/s. Welwrd Pharmaceuti

Estowel 10mg TabletsEach film coated

Form 5Dy No.

30

Cipralex 10mg Tablets by

Lundbeck Ltd.

Approved


cals, Hattar tablet contains:-Escitalopram (as oxalate)…10mg

(Anti Psychotic)

USP Specs

3-06-2011

Rs.8000/-

02-06-2011

+Rs.12000

/-30-12-201410,s 14’s

As Per SRO

(MHRA Approved)

Cipralex by lundbeck

Latest inspection

report 16.04.2016

recommends the renewal of

DML

10. M/s. Legacy Pharmaceuticals, Peshawar

Legozin 5mg TabletsEach film coated tablet contains:Levocetirizine 2HCl……….5mg

(Antihistamine)

Form 521.1.2011Dy No. 40

Rs.8000/-+

Rs.12000/- 4.8.2015

10’sRs.55.047

Xyzal by UCB Inc.

(USFDA Approved)

Alergocit by Global

Pharmaceuticals

Inspection report dated 16-11-2016 shows

that overall GMP status is satisfactory.

Firm has claimed mfg. specs but product is present in USP.

Approved with USP specs.


Legrith 250mg Tablets

Each film coated tablet contains:-Clarithromycin……….250mg

(Macrolide)

Form 521-1-2011Dy No. 41

Rs.8000/-+

Rs.12000/-4-8-2015

10’sRs.202.00

Biaxin by ABBVIE(USFDA

Approved)

Claramed by Novartis Pharma

Last inspection report dated16-11-2016Shows that

GMP status is satisfactory.




Legrith Tablets

Each film coated tablet contains:-Clarithromycin……….500mg

Antibacterial

Form 521-1-2011Dy No. 48

Rs.8000/-+

Rs.12000/-4-8-2015

Biaxin by ABBVIE(USFDA

Approved)

Claramed by Novartis Pharma




(Macrolide) 10’sRs.290.04




Legafar-F Tablets

Each film coated tablet contains:-Ferrous Fumarate…150mgFolic Acid ……….0.5mg

(Anti-anemic)

Form 521.1.2011Dy No. 45

Rs.8000/-+

Rs.12000/- 4.8.2015

10’sRs.120.00

Not found.

Fefan by Amson Pharma



Firm has claimed mfg. specs but product is present in BP 2013.


Registration Board approve the product considering it Iron supplement


Ponstel Suspension

Each 5ml contains:-Mefenamic Acid ……..50mg

(Analgesic)NSAID

Form 527-10-2011Dy No. 49

Rs.8000/-+

Rs.12000/-4-8-2015

60mlRs.20.25

Mefenamic acid suspension by

Chemidex Pharma(MHRA

Approved)

Ponstan by Pfizer Labs



Firm has claimed mfg. specs and product is not present in available versions of USP & BP

Approved with Innovator’s specs.


Ponstel Forte 500mg Tablets

Each tablet contains:-Mefenamic Acid…500mg

(Analgesic)NSAID

Form 527-10-2011Dy No. 42

Rs.8000/-+

Rs.12000/-4-8-2015

100’sRs.186.42

Ponstan Forte by Chemidex Pharma Ltd

(MHRA Approved)

Ponstan Forte by Pfizer Labs



Firm has claimed mfg. specs but product is present in BP 2013.

Approved with BP specs.


Urofen 100mg Tablets

Each film

Form 527-10-2011Dy No. 51

Froben 100 mg tablet by Mylan Products Ltd.

(MHRA

Firm has claimed mfg. specs but product is

Approved with USP specs


https://www.medicines.org.uk/emc/company/641/Chemidex%20%20Pharma%20%20Ltd

https://www.medicines.org.uk/emc/company/641/Chemidex%20%20Pharma%20%20Ltd

coated tablet contains: -Flurbiprofen ……….100mg

(Propionic acid) analgesic

Rs.8000/-+

Rs.12000/-4-8-2015

30’sRs.183.11

Approved)

Froben by Abbott



present in USP.


Lexim Dry Suspension

Each 5ml contains:-Cefixime trihydrate equivalent to Cefixime….200mg

(Cephalosporin)

Form 527-10-2011Dy No. 44

Rs.8000/-+

Rs.12000/-4-8-2015

30ml/Rs.200.157

Suprax by Lupin Pharms

(USFDA Approved)

Cebosh by Bosch Pharma

Last inspection report 16-11-

2016Shows that





Ribena-FF Tablets

Each chewable tablet contains:-Iron polymaltose complex equivalent to elemental iron ……….100mgFolic Acid ……..0.75mg(Antianaemic)

Form 521-1-2010Dy No. 46

Rs.8000/-+

Rs.12000/-4-8-2015

10’sRs.120.00

Not found.

Novarise by Shrooq Pharma


2016Shows that



Firm has claimed mfg. specs and product is not present in available versions of USP & BP.

Deferred for clarification of dosage form as firm has applied for chewable tablet whereas manufacturing method states Film coating also.


Legathrocin 250mg Capsules

Each capsule contains:-Azithromycin as dehydrate ….250mg

(Macrolide Antibiotics)

Form 521-1-2011Dy No. 43

Rs.8000/-+

Rs.12000/-4-8-2015

10’s(blister)

Rs.218.22

Zithromax by Pfizer

(MHRA Approved)

Azilite by Webros Pharma


2016Shows that






Doxip 100mg CapsulesEach capsule contains:-Cefpodoxime (as Proxetil)(compacted) …..100mg

(Cephalosporin Antibiotics)

Form 521.1.2011Dy No. 26

Rs.8000/-+

Rs.12000/- 4.8.2015

12’sRs.280.00

Not found.

Cefporite by Sharooq Pharma



Deferred molecule as per 250th meeting. As the product is not available as capsule

Firm has claimed USP specs but product is not present in USP & BP

Deferred for revision of formulation as per decision of 250th DRB meeting.

21. M/s Caraway PharmaceuticalsIslamabad.

Aci 25mg Capsules

Each capsule contains:-Acitretin ………. 25mg

(Vit A)

Form 520-01-2011

Dy.No.2774

Rs.8000/=Rs.12,000/

=16-04-2015

3x10’sAs Per SRO

Soriatane by Stiefel

USFDA

Neotigason by Rosch Pharma


9-12-2016Overall GMP Compliance is

good.

Firm claimed Mfg specs and the product is present in available pharmacopoeias (USP 39 & BP 2013)

Approved in USFDA with boxed warning of severe teratogenic effects.

Approved with USP specs & Boxed warning

22. M/s Shaigan Pharmaceuticals (Pvt) Ltd, Rawalpindi

Takeze 4mg Injection

Each 2ml ampoule contains:-Thiocolchicoside ……4mg

(Muscle Relaxant)

Form 505-12-2011Dy.No.1979Rs.8000/=Rs.12,000/=25-03-20156’s

Demanded MRP 650/-

Thiocolchicoside Fornet 4mg/2ml

injANSM France

Thiolax by SJ&G

Last Inspection Report 17-08-

2016Panel granted

seven additional sections.

Firm claimed Mfg specs and the product is not present in available pharmacopoeias (USP 39 and BP2013)EMA has restricted the use of this drug and suggested to use in low doses only

Approved with boxed warning & Innovator’s specs.

23. M/s Werrick PharmaceuticalsIslamabad

Wizen Oral Solution 1mg/ml

Each ml contains:-Risperidone ….…..…1mg

Form 521-01-2011

Dy.No.1208

Rs.12,000/=

Rs.8000/=07-07-

RisperdalUSFDA

Risperidal oral solution by

janssen Cilag


Wrong Pharmacological group is written

The Firm has claimed Mfg Specs and the product is present in

Deferred for clarification of pharmacological group as stated pharmacological group is incorret


(Psychotropic agent)

201430ml,60ml

120mlAs per SRO

12-07-2016The cGMP

compliance is good

available pharmacopoeias (USP 39)


24. M/s Werrick PharmaceuticalsIslamabad

Pine Tablets 400mg

Each Film Coated Tablet contains:-Quetiapine Fumarate eq.to ….…..400mg

(Antipsychotic agent)

Form 521-01-2011

Dy.No.1759

Rs.12,000/=

Rs.8000/=13-04-201510’s,20’s, 30’s

Rs.460.00 /Tablet

Seroquel by AstraZeneca

USFDA

Repose XR tablets by

Maark Pakistan


12-07-2016The cGMP

compliance is good.

Me too status cannot be confirmed.

Firm claimed Mfg specs and the product is present in USP 39.

Approved in USFDA with boxed warning of increased mortality in elderly patients with dementia related psychosis & suicidal thoughts and behaviours.

Deferred for evidence of me-too status for applied dosage form & strength.

25. M/s Werrick Pharmaceuticals Islamabad

Thin Tablets 5mg

Each film coated tablet contains:-Prasugrel (as Hydrochloride) ….. 5mg

( Anti-Platelet)

Form 513-12-2010

Dy.No.854Rs.8000/=Rs.12,000/

=24-06-201414’s28’s

As Per SRO

Effient by Eli Lilly

USFDA

Prisa by Getz Pharma


12-07-2016The cGMP

compliance is good

Firm has claimed Mfg Specs and the product is not present in available pharmacopoeias (USP 39 and BP2013)

Approved in USFDA with boxed warning of bleeding risks.

Approved with Innovator’s specs and change of brand name.

26. M/s Werrick Pharmaceu

Anti-Koagulant TabletsEach film

Form 511-01-2011

Xarelto by Janssen

Pharmaceutica

Firm has initially applied onForm 5D but

Approved with Innovator’s specs and


ticalsIslamabad

coated tablet contains:-Rivaroxaban ………. 10mg

( Anti – coagulant )

Dy.No.1190

Rs.15,000/=

Rs.5000/=04-07-201410’s20’s30’s

Rs.735.00Per Tabs.

ls USFDA

Xeralto 10mg by Bayer


12-7-2016The cGMP

compliance is good

now the firm has applied on Form 5.Firm has

claimedMfg Specs andthe product is

notpresent inavailablepharmacopoeias(USP39 & BP

2013)

Approved in USFDA with boxed warning of spinal/ epidural hematoma if undergoing spinal puncture.

Boxed warning. Change of brand name is also recommended

27. M/s. Akson PharmaceuticalsMirpur Azad Kashmir

Aksozine-L Tablets

Each tablet contains:-Levocetirizine (as 2HCl)….5mg

(Antihistamine)

Form 5Dy.No.337

229-11-2010

Rs.8000/=26-09-2010

13-05-2015

Rs.12,000/=

10’sRs.115.00

Xyzal by UCPUSFDA

Levozine by Global


22-4-2015Firm is

complying GMP

Firm claimed Mfg specs and the product is present in USP 39


28. M/s. Alliance Pharmaceuticals, Peshawar

Artitar Forte Tablets

Each tablet contains:-Artemether ………80mgLumefantrine ……. 480mg

(Antimalarial)

Form 520-6-2012

Dy No. 569

Rs.8000/-Rs.12000

11-6-20151x4’s1x6’s

As Per SRO

WHO prequalified formulation

A-Fantrine by Atco Lab.

Last inspection report:3-05-2016

GMP found Satisfactory

Firm claimed Mfg specs and the product is not present in available pharmacopoeias (USP 39and BP2013)


29. M/S. CCL Pharma (Pvt) Ltd.

Rispa Tablet 2mg

Form 503-01-2011Dy.No.933

RisperdalUSFDA

Pharmacological group is incorrect

Approved with innovator’s specs & Boxed


Lahore Each tablet contains:-Risperidone USP……… 2mg

(Antipsychotic agent)

800003-01-2011

1200021-5-2015

2x6’s As per brand leader

Benzisox by Highnoon


21-03-2016The panel

recommended the renewal of

DML

The Firm has claimed Mfg Specs and the product is present in USP 39


warning.

30. M/s. CCL Pharma Lahore

Naptun Tablet

Each tablet contains:-Naproxen BP…….500mgSumatriptan BP……85mg

(Analgesics, Anti-migraine preparations)

Form 530-01-2012

Dy No. 1528000

30-01-2012

1200028-10-2014

10’sAs per SRO

Treximet USFDA

Suminap by SJ&G


21-03-2016For grant of

renewal of DML.

Firm claimed Mfg specs and the product is not present in available pharmacopoeias (USP 39and BP2013) Approved in

USFDA with boxed warning of risk of serious cardiovascular & gastrointestinal events.

Approved with innovator’s specs & Boxed warning

31. M/s. Friends Pharma Lahore

Nalfine-10 Injection

Each ampoule(1ml) contains:-Nalbuphine hydrochloride …… 10mg(synthetic opioid agonist)

Form 54-12-2014

Dy No. 4188000

120004-12-2014

1*1mlAs per SRO

NubainUSFDA

Kinz by Sami


6-10-2016Good level of

GMP Compliance


Approved with Innovator’s specs

32. M/s. The SChazoo Pharma Laboratories (Pvt) Ltd

Ultragab 150mg Capsule

Each capsule contains:-Pregabalin ………….150mg(anti-epileptic,

Form-520-4-2010

Dy No. 845

Rs 8,000/-20-4-2010 Rs.12,000/-

Lyrica by PfizerUSFDA

Gabica by Getz

Last Inspection report

15-10-2015Panel


Approved with Innovator’s specs


Anti-convulsant)

17-11-20142*7’s

recommend the grant of renewal

of DML33. M/s

Zanctok, Plot # F/5, SITE Hyderabad.

Calcirol DropsEach ml contains:-Cholecalciferol ……400 IU/ml

(Vitamin D)

Form-5Dy No.

495

Rs.8000/-+

Rs.12,000/-

2-4-2015

10mlAs per PRC

Not found in this strength.

Not provided

GMP inspection report dated30-08-2016

shows that firm is operating at

acceptable level of GMP

Fultium-D3 Drops by Internis Pharma UK MHRA contains cholecalciferol 2740 IU/ml.

D4U by Genix Pharma contains cholecalciferol 40 IU/ml.

Firm has claimed mfg. specs and product is present in USP-39 as cholecalciferol solution.

Deferred for evidence of approval by reference regulatory authorities & me-too status for applied dosage form & strength.

34. M/s Zanctok, Plot # F/5, SITE Hyderabad.

Lacomide 100mg TabletEach film coated tablet contains:Lacosamide………….100 mg

(Anti-Epileptic )

Form-5Dy.No.502

Rs.8000/-+

Rs.12,000/-

2-4-201510’s30’s60’s

As per PRC

Vimpat by UCB pharma

(MHRA Approved)

Lalap by Genix Pharma




Firm has claimed mfg. specs and product is not present in available versions of USP & BP 2013.

Approved with innovator’s specs.


Lacomide 150mg Tablet

Each film coated tablet contains:Lacosamide………..150 mg

(Anti-Epileptic)

Form-5Dy.No.499

Rs.8000/-+

Rs.12,000/-

2-4-201510’s30’s60’s

As per PRC

Vimpat by UCB pharma(MHRA

Approved)

LACOLEP by Hilton

GMP inspection report 30-08-

2016 shows that firm is

operating at acceptable level

of GMP





Lacomide 200mg Tablet

Each film coated tablet contains:Lacosamide ……….200 mg

(Anti-Epileptic)

Form-5Dy.No.501Rs.8000/-

+Rs.12,000/

-2-4-2015

10’s30’s60’s

As per PRC


Approved)Lalap by Genix

PharmaGMP inspection

report 30-08-2016 shows that

firm is operating at





Lacomide 50mg TabletEach film coated tablet contains:Lacosamide………….50 mg

(Anti-Epileptic)


+Rs.

12,000/-2-4-2015

10’s30’s60’s

As per PRC


Approved)LACOLEP by

Hilton




of GMP




Laurasid 80mg Tablet

Each film coated tablet contains:Lurasidone Hydrochloride ……....80mg

(Psychotropic agent/ Benzoisothiazole derivatives)


+Rs.12,000/

-2-4-2015

30’s60’s70’s90’sNot

mentioned

Latuda by Sunovion Pharms

(USFDA Approved)

Not provided




of GMP

Me-too is not available.

Firm has claimed mfg. specs and product is not present in available versions of USP & BP 2013. Approved in

USFDA with boxed warning of increased mortality in elderly patients with dementia related psychosis.

Deferred for evidence of me-too status and confirmation from INCB list.


Nimelid TabletEach film coated tablet contains:Nimesulide ………100 mg


+Rs.12,000/

-

Nexen tablet(ANSM France)

Amsolide by Amson Pharma.

GMP inspection

Firm has claimed mfg. specs and product is not present in available

Deferred for decision.


(Non-Steroidal Anti-Inflammatory)

2-4-201556

tab(blister pack)As per PRC

report 30-08-2016 shows that

firm is operating at


versions of USP & BP

40. M/s Zanctok Hyderabad.

Novafylin Cough SyrupEach 5ml contains:Acefylline piperazien+ Diphenhydramine HCl Piperazine ……….45 mgDiphenhydramine HCl..8 mg

(Xanthine, Anti Asthmatic)


+Rs.12,000/

-2-4-2015

60ml90ml120ml

As per PRC

Not found.

Acefyl Cough Syrup by

Nabiqasim Industries




International status cannot be confirmed.


Deferred for evidence of approval by reference regulatory authorities.


Novafylin SyrupEach 5ml contains:Acefylline ……….125 mg

(Xanthine, Anti Asthmatic)


+Rs.12,000/

-2-4-2015

60ml90ml120ml

As per PRC

Not found.

Acefyl by Nabiqasim industries.






Deferred for evidence of approval by reference regulatory authorities.


Revolin SyrupEach 5ml contains:Ebastine ………..…5 mg

(Anti Histamine)


+Rs.12,000/

-2-4-2015

60ml90ml120ml

As per PRC

Not found.

Kestine by Highnoon labs






Deferred for evidence of approval by reference regulatory authorities


Revolin TabletEach film coated tablet contains:Ebastine………


+Rs.12,000/

Ebarren(ANSM France)

Aerius by

Firm has claimed mfg. specs and product is not present in

Approved with Innovato’s specs


…..…10 mg

(Anti Histamine)

-7-4-2015

10’s30’s60’s

As per PRC

Dermagen Pharma




available versions of USP & BP 2013.


Rifax Tablet 550mgEach film coated tablet contains:-Rifaximin …………550mg

(Semi systemic antibiotic)

Form-5Dy No.

505Rs.8000/-

+Rs.12,000/

-2-4-2015

20’sAs per PRC

Xifaxan by Salix pharms

USFDANimixa by Getz

pharma





Approved with Innovator’s specs.


Ursolic Capsule 500mgEach capsule contains:-Ursodeoxycholic Acid ..500mg

(Bile Acid/ Cholegogue and hepatic preparation/ lexative)

Form-5Dy No.

493Rs.8000/-

+Rs.12,000/

-2-4-2015

30’sAs per PRC

Not found in this strength.

Urso by AGP




Firm has claimed mfg. specs but product is present in BP 2013.Available in UK MHRA & TGA in 250 mg strength only.

Deferred for evidence of approval y reference regulatory authorities.


Valdox 25mg TabletEach film coated tablet contains:Agomelatine………….25 mg

(Anti-depressant/ anti-psychotic)


+Rs.12,000/

-2-4-2015

30’sNot

mentioned

Valdoxan by Servier LabsUK MHRA

N/A




Me too is not availableBrand name non-resemblance undertaking is attached but is not signed by authorized persons.

Firm has claimed mfg. specs and product is not present in available versions of USP

Deferred for evidence of me-too status


& BP 2013.

Liver function of patient should be monitored during treatment with Valdoxan.


Case No.03: Anomaly applications which were not included in list I

S.No.

Name and address of

manufacturer / Applicant



CompositionPharmacolog

ical GroupFinished product

Specification

Type of Form

Initial date,diaryFee

including differential

fee

Demanded Price /

Pack size

Remarks on the formulation (if any) including International



authorities

Me-too status

GMP status as depicted in latest inspection report (with date) by the

Evaluator


Decision

1. Medisave Pharma,Lahore

Neutim 250mgInjectionEach vial contains sterile powder Ceftazidime as pentahydrate USP….250mg

3rd Generation Cephalosporin Antibiotic

Form-503-12-2009Dy No. Nil

Rs.8000/-24-11-2009(Photocopy)

+12000/-

10-09-2013

As per SRO/1’s

Fortum 250 mg by GSK

(MHRA Approved)

Nivador Injection by Sami Pharma

Last inspection report dated 09-05-2016 stated that the

firm was found satisfactory in

terms of actions taken by the firm for improvements

in light of inspection dated

09-12-2015

Firm has claimed USP specs but product is not present in USP rather it is present in B.P

Approved with B.P specs.

2. M/s. Jaens Pharmaceutical Industries

(Pvt) Ltd. Lahore

Contract manufactured

by M/s. English Pharma, Lahore

Tenum 500mg InjectionEach vial contains:-Meropenam…….. 500mg

Penicillin Antibiotic

Form-515-05-2013

Dy No. 3089

Rs.50000/-15-05-2013

1’sAs per SROs

Meronem 500mg IV injection by

Astrazaneca(MHRA

Approved)Meronem Inj by

ICI Ltd


Dated 24-11-2016 confirms

satisfactory compliance to

GMP

Firm has claimed mfg specs while the product is present in USP-39

Commitments as per 251st

DRB meeting have been provided by M/s English Pharmaceuticals

Deferred for evidence of section approval for carbapenem section & clarification of Pharmacological group

3. M/s. Jaens Pharmaceutic

Tenum 1gm Injection

Form-515-05-2013

Meronem 1gm IV injection by

Firm has claimed mfg.

Deferred for evidence of


al Industries (Pvt) Ltd.

LahoreContract

manufactured by M/s. English Pharma, Lahore

Each vial contains:-Sterile Meropenem Trihydrate eq. to Meropenem …….. 1gm

Penicillin Antibiotic

Dy No. 3087

Rs.50000/-15-05-2013

1’sAs per SROs

Astrazaneca(MHRA

Approved)Meronem Inj by

ICI Ltd




GMP

specs while the product is present in USP-39Commitments as per 251st


section approval for carbapenem section & clarification of Pharmacological group


(Pvt) Ltd. Lahore



Roficef 500mg IM/IV Injection

Each vial contains:-Ceftriaxone Sodium eq. to Ceftriaxone …….. 500mg

Cephalosporin

BP Specs

Form-515-05-2013

Dy No. 3097Rs.50000/-15-05-2013

1’sAs per SROs

Rocephin by Roche

(MHRA Approved)

Rocephin 500mg injection by

Roche




GMP



Firm has claimed B.P specs while the product is present in USP as well.

Agreement of contract manufacturing issued on 13.04.2013 is valid for three years after registration.

Deferred for confirmation of valid agreement between contract manufacturer and giver


(Pvt) Ltd. Lahore



Roficef 1.0gm IM/IV InjectionEach vial contains:-Ceftriaxone Sodium eq. to Ceftriaxone …….. 1gm

Cephalosporin

BP Specs

Form-515-05-2013

Dy No. 3096Rs.50000/-15-05-2013

1’sAs per SROs

Rocephin by Roche

(MHRA Approved)

Rocephin 1g injection by

Roche




GMP


DRB meeting have been provided by M/s English PharmaceuticalsAgreement of contract manufacturing issued on 13-04-2013 is valid for three years after registration



Firm has claimed B.P specs while the product is present in USP as well


(Pvt) Ltd. Lahore



Gaxime 400mg Capsule

Each Capsule contains:-Cefixime Trihydrate USP eq. to cefixime ….. 400mg

Cephalosporin

Form-515-05-2013

Dy No. 3094

Rs.50000/-15-05-2013

5’sAs per SROs

Suprax 400mg capsule by Lupin

Ltd(USFDA

Approved)

Cefspan 400 mg by B.H




GMP

Firm has claimed Mfg specs and the product is not present in BP or USPCommitments as per 251st




(Pvt) Ltd. Lahore



Gaxime 100mg SuspensionEach 5ml reconstituted suspension contains:-Cefixime Trihydrate USP eq. to cefixime ….. 100mg

Cephalosporin

Form-515-05-2013

Dy No. 3092

Rs.50000/-15-05-2013

30mlAs per SROs

Suprax 500mg/5ml

suspension by Lupin Ltd(USFDA

Approved)

Cefspan 100 mg/5ml by B.H




GMP

Firm has claimed Mfg specs and the product is present in USP.Commitments as per 251st




(Pvt) Ltd. Lahore



Gaxime DS 200mg SuspensionEach 5ml reconstituted suspension contains:-Cefixime Trihydrate USP eq. to cefixime ….. 200mg

Cephalospori

Form-515-05-2013

Dy No. 3093

Rs.50000/-15-05-2013

30mlAs per SROs

Suprax by Lupin Pharms

(USFDA Approved)

Cefspan 200 mg/5ml by B.H



satisfactory

Firm has claimed Mfg. specs and the product is present in USP.


DRB meeting have been provided by M/s English Pharmaceutic



n compliance to GMP

alsAgreement of contract manufacturing issued on 13.04.2013 is valid for three years after registration

9. M/s. Jaens Pharma

Industries (Pvt) Ltd,

LahoreContract

manufactured by M/s English Pharma Lahore

Surzole 40mg InjectionEach vial contains:-Esomeprazole sodium Lyophillzed equivaletn to Esomeprazole …….40mg

Proton Pump Inhibitor

Form 512-9-2013

Dy No. 217

Rs. 50,00012-9-2013

1x10ml vialAs per SRO

Nexium 40 mg IV by

Astrazaneca(MHRA

Approved)

Esso 40 by Shaigan




GMP

Firm has claimed Mfg specs and the product is not present in BP and USP



Agreement of contract manufacturing issued on 13.04.2013 is valid for 03 years after registration.



(Pvt) Ltd. Lahore



Vecocin 500 Injection IM/IVEach vial contains:-Vancomycin Hydrochloride eq. to Vancomycin….... 500mg

Antibiotic

Form-515-05-2013

Dy No. 3091

Rs.50000/-15-05-2013

1’sAs per SROs

Vancomycin 500mg injection

by Fresenius Kabi (USFDA

Approved)

Vinjec 500mg Injection by

Bosch Pharma




GMP


DRB meeting have been provided by M/s English Pharmaceuticals.


11. M/s. Remedy Pharmaceuticals (Pvt) Ltd. Lahore

Piprazo 4.50gm InjectionEach vial contains:-

Form-514-05-2013

Dy No. 3062

Rs.50000/-

Piperacillin Tazobactum by

Sandoz(MHRA

Approved)

Firm has claimed Mfg specs while the product is present in

Deferred, as the name of M/s Remedy pharmaceuticals is changed


Contract manufactured by M/s. English Pharma, Lahore.

Sterile Piperacillin Sodium eq. to Piperacilline …….4.0gmSterile Tazobactam Sodium eq. to Tazobactam … 0.50gmPenicillin antibiotic

14-05-20131’s

As per SROTazocin 4.5gm by Wyeth Ltd




GMP

USP



to Araf pharmaceuticals so it requires a new application for registration of product by M/s Araf pharmaceuticals.

12. M/s NOA HEMIS

Pharmaceuticals

Karachi

Flexem 15mg Capsule

Each extended release capsule contains:Cyclobenzaprine HCl…15mg(muscle relaxant)

USP

Form 531/05/2010

Dy. No. 1059Rs. 8000/-Rs.12,000/-13-5-2013

7’s14’s

As per policy

Amrix Extended release capsule by

Teva(USFDA

Approved)

Emrix SR by Getz

Last inspection report is 13-4-

2016Overall GMP compliance

towards maintenance of

the equipment/areas, facilitate in QC

lab.

Rs 8,000 and Rs 12,000 is not in original.

Approved. Reference will be sent to Budget & Accounts Division for verification of challan and Chairman will authorize issuance of registration letter

13.M/s. Genome Pharmaceutical

s, Hattar

Trovegin -V Tablets

Each vaginal tablet contains:-Ternidazole ….200mgNeomycin Sulfate …..100mg (65000 IU)Nystatin…20mg(100000 IU)

Prednisolone (as sodium metasulfobenzoate) ….…3mgAnti-protozoa/Antimicrobial/ Antifungal and

Form 503-01-2014

Dy No. 3061Rs 20,000

19-08-201310’s

As Per SRO

Terzhinan by France

Tergynan by highnoon

Last Inspection repot

29-08-2016The firm has

overall improved GMP System

Firm has claimed Mfg Specs and the product is not present in available pharmacopoeias (USP 39and BP2013)

International availability cannot be confirmed.

Deferred for evidence of approval of applied formulation by reference regulatory authorities & me-too status as stated references are incorrect


Anti-inflammatory)


s, Hattar

Linasia DS Tablets

Each film coated tablet contains:-Linagliptin ……2.5 mgMetformin HCl ….1000 mg

Antihyperglycemic agent

Form 518-12-2013Dy no. 3050Rs 20,000

17-12-201310’s

AsPer SRO

Jenadueto by USFDA

Lina-met by CCL




Firm has claimed Mfg. Specs and the product is not present in available pharmacopoeias (USP 39and BP2013)Me too status cannot be confirmed.Stability data is not provided

Deferred as per decision of 253rd DRB meeting for review of IPO.


s, Hattar

Linasia Tablets

Each film coated tablet contains:-Linagliptin …….…2.5 mgMetformin HCl …….500 mg

Antihyperglycemic agent

Form 518-10-2013

Dy No. 3047Rs 20,000

17-12-201310’s

AsPer SRO

Jenadueto by USFDA

Lina-met by CCL




Firm has claimed Mfg. Specs and the product is not present in available pharmacopoeias ( USP 39and BP2013)Me too status cannot be confirmed.

Stability data is not provided



s, Hattar

Linagin 5mg Tablets

Each film coated tablet contains:-Linagliptin ……….5 mg

(Inhibitor of dipeptidase-4 enzyme DPP-4)

Form 518-12-2013Dy no. 3049Rs 20,000

17-12-201310’s

AsPer SRO

TRADJENTA (LINAGLIPTIN)

USFDA




Firm has claimed Mfg. Specs and the product is not present in available pharmacopoeias (USP 39and BP2013).

Product deferred for comments of IPO in 253rd

DRB



meeting17. M/s Zafa

Pharmaceutical Lab. Pvt Ltd.L-1/B, Block

22, Federal “B” Industrial Area,

Karachi.

Zad Injection 5.0mg/ml

IM Injectable or OralEach ml contains:Cholecalciferol BP…5.00mg (200,000IU)Vitamin D Analogue (Vitamin D3)

Form-507-04-2014Dy.No.210Rs.20,000/-07-04-2014

5*1 mlas per DRA

ANSM

DX3 Mactar Pharma

Inspection report dated 20-11-2016

The Panel grant the GMP

Firm has claimed Mfg. Specs and the product is present in available pharmacopoeias. (USP 39)


18. M/s Elko Organization Pvt. Ltd Karachi

Metron Tablets 200mgEach tablet contains:Metronidazole …...200mg

(Antibiotic)

Form 522/09/2010

Dy. No. 1713

Rs. 8000/-Rs.12,000/-(Photocopy attached)

5-11-201310’s

Rs.88.61/100’s

MHRA Approved

Metrozine tablets by Searle

Latest inspection report

18-10-2016Panel

recommends the renewal of DML

Firm claims Mfg specs but finished product specs are available in USP 39



Metron Tablets 400mgEach tablet contains:Metronidazole…...400mg

(Antibiotic)

Form 522/09/2010

Dy. No. 1714Rs. 8000/-Rs.12,000/-(Photocopy attached)

5-11-2013100’s

Rs. 137/-

MHRA Approved

Metrozine tablets by

Searle


18-10-2016Panel


Firm claims Mfg specs but finished product specs are available in USP 39



Tiapin Tablets 100mg

Each Extended Release tablet contains:Quetiapine fumarate e.q to Quetiapine …..100mg(Antipsychotic)

Form 5Duplicate22/09/2010


5-11-201310’s

Rs. 1162/-


18-10-2016Panel


Firm claims Mfg. specs but finished product specs are available in USP 39

Deferred for evidence of approval of applied formulation & dosage form by reference regulatory authorities & me-too status as stated references are incorrect

21. M/s Elko Organization

Tiapin Tablets 25mg

Form 522/09/2010 Latest inspection

Firm claims Mfg. specs

Deferred for evidence of


Pvt. Ltd Karachi Each Extended

Release tablet contains:Quetiapine fumarate e.q to Quetiapine………..25mg

(Antipsychotic)


5-11-201330’s

Rs. 988/-

report18-10-2016

Panel recommends the renewal of DML

but finished product specs are available in USP 39

approval of applied formulation & dosage form by reference regulatory authorities & me-too status as stated references are incorrect


Case No.04: Applications of List-I

Case No.05: Stability CasesStability Case 1

Sr. No.

Name & Address of

Manufacturer / Applicant

Brand Name(Proprietary Name +

Dosage Form + Strength), Composition,Pharmacological Group,

Finished Product Specification

Type of Form,Initial Diary &

Date, Fee (including

differential fee),Demanded

Price / Pack size

International Availability /

Local Availability

GMP Inspection Report Date &

Remarks

Previous DRB Decision / Remarks

(if any)

1. M/s. Wilshire Ziqar Tablet Form-5D Sovaldi by Gilead Board decided in 253rd


Sr.#

Name and address of manufactu

rer / Applicant


name + Dosage Form +

Strength)Composition

Pharmacological GroupFinished product

Specification

Type of FormInitial

date, diaryFee


feeDemanded

Price / Pack size

Remarks on the formulation

(if any) including

International status in

stringent drug regulatory agencies /

authoritiesMe-too statusGMP status as

depicted in latest

inspection report (with date) by the Evaluator


Decision

1. M/s MerckQuetta(1354)

Sustin 20mg TabletEach film coated tablet contains:Rosuvastatin Calcium eq. toRosuvastatin ………20 mg(Lipid‐Lowering Agent)

Form-5Dy.#192 dated23-09-11Rs.8000/‐ (Duplicate challan)20‐09‐2011Rs.12,000/‐ (Duplicate challan)31-07-2013Rs. 40/ tablet

Crestor-MHRARolip-Hilton PharmaLast inspection report on 13th and 14th May 2016 granted revalidation of DML by the way of formulation, approved changes made by the firm as per layout plan for attaining the better level of GMP compliance

Firm has claimed Mfg. Specs and the product is not present in available pharmacopoeias (USP 39 and BP 2013).

Approved with Innovator’s specs. Reference will be sent to Budget & Accounts Division for verification of challan and Chairman registration Board will authorize issuance of registration letter

Laboratories (Pvt.) Ltd.,

Lahore.

Each film coated tablet contains:-Sofosbuvir…400mg

Antiviral

Mfg. Specs.

Dy. No. 46925-08-2014

50,000/-

As Per SRO

Sciences, Australia.

Sofvir by M/s. Sami Pharmaceuticals, Karachi.

Meeting to defer the case till provision of scientifically rationale lab scale stability data in accordance with the guidelines approved by the Board in 251st

meeting.

STABILITY STUDY DATA

Drug Ziqar Tablet (Sofosbuvir)Name of Manufacturer M/s. Wilshire Laboratories (Pvt.) Ltd., Lahore.Manufacturer of API Pharmagen Limited, Lahore.API Lot No. 00511211/002/2015Description of Pack (Container closure system) Alu-Alu pack.

Stability Storage Condition Accelerated: 40°C ± 2°C / 75% ± 5%RHReal Time: 30°C ± 2°C / 65% ± 5%RH

Time Period Accelerated: 26 WeeksReal Time: 26 Weeks

Frequency Accelerated: 0,1,2,3,4,6,8,12,16,20,24,26 (Week)Real Time: 0,1,2,3,4,6,8,12,16,20,24,26 (Week)

Batch No. T003 T004 T005

Batch Size 2.052 kg(85 Packs)

2.052 kg(85 Packs)

2.138 kg(89 Packs)

Manufacturing Date February 2016 March 2016 April 2016Date of Initiation February 2016 March 2016 May 2016No. of Batches 03Date of Submission 25-01-2017

DOCUMENTS / DATA PROVIDED BY THE APPLICANT

Sr. No. Documents To Be Provided Status

1. COA of API Yes

2. Approval of API by regulatory authority of country of origin or GMP certificate of API manufacturer issued by regulatory authority of country of origin. Yes

3. Protocols followed for conduction of stability study and details of tests. Yes

4. Data of 03 batches will be supported by attested respective documents like chromatograms, laboratory reports, data sheets etc. Yes

5. Documents confirming import of API etc.

Not Applicable (Firm has claimed local source of API

Manufacturer)

6. All provided documents will be attested (name, sign and stamp) for ensuring authenticity of data / documents. Yes

7. Commitment to continue real time stability study till assigned shelf life of the product. Yes


8. Commitment to follow Drug Specification Rules, 1978. Yes


REMARKS OF EVALUATOR(AD PEC-I)

Firm has provided 06 Months Accelerated and 06 Months Long Term Stability Data in accordance with the guidelines approved by the Board in 251st meeting.

Decision: The Registration Board decided to constitute the following panel for onsite investigation to confirm genuineness/ authenticity of stability data and associated documents, import of API, quality, specification, test analysis, facilities etc. Prof. Dr. Rafeeq Alam Khan, Member Registration Board. Dr. Obaidullah, Additional Director (Reg-I), DRAP, Islamabad. Dr. Saif ur Rehman Khattak, FGA, CDL, Karachi.

Stability Case 2Sr. No.

Name & Address of



Dosage Form + Strength),

Composition,Pharmacological

Group,Finished Product

Specification


Date, Fee (including differential

fee),Demanded

Price / Pack size

International Availability / Local

Availability


Remarks


(if any)

2. M/s. Vision Pharmaceuticals

Plot No. 22-23, Industrial Triangle, Kahuta Road, Islamabad.

Daclavir 30mg TabletEach film coated tablet contains:-Daclatasvir…30mg

HCV NS5A InhibitorJ05AX65

Mfg. Specs.

Form-5D

Diary No. 20611/08/2016

Rs. 50,000/-

As per SRO / 28’s`

Daklinza by M/s. Bristol Myers Squib, USA.

Not applicable

GMP compliant dated 09.02.2016

Undertakings provided to conduct the following studies before marketing of product:

Pharmaceutical Development, Process Validation and Analytical Method Validation.


Drug Daclavir (Daclatasvir) 30mg TabletName of Manufacturer M/s. Vision PharmaceuticalsManufacturer of API Laurus Labs Private Limited, India.API Lot No. ADCTRVSP10050316Description of Pack(Container closure system) Child Resistant HDPE Bottle


Time Period Accelerated: 06 MonthsReal Time: 06 Months

Frequency Accelerated: 0,3,6 (Month)Real Time: 0,3,6 (Month)

Batch No. NPD603 (T-01) NPD603 (T-02) NPD603 (T-03)Batch Size 500g 500g 500g


(2500 Tablets) (2500 Tablets) (2500 Tablets)Manufacturing Date July 2016 July 2016 July 2016Date of Initiation July 2016 July 2016 July 2016No. of Batches 03Date of Submission 30-01-2017



1. COA of API Yes

2.Approval of API by regulatory authority of country of origin or GMP certificate of API manufacturer issued by regulatory authority of country of origin.

Copy of GMP Certificate provided.Valid till 03-11-2016.



5. Documents confirming import of API etc.Copy of ADC

(Islamabad) attested invoice provided.






GMP certificate of API Manufacturer valid till 03-11-2016. Undertakings provided to conduct the following studies before marketing of product: Pharmaceutical

Development, Process Validation and Analytical Method Validation.




Name & Address of






Specification



fee),Demanded Price / Pack

size


Local Availability


Remarks

Previous DRB Decision / Remarks (if any)



Daclavir 60mg TabletEach film coated tablet contains:-Daclatasvir…60mg

Antiviral

Mfg. Specs.

Form-5D

Diary No. 20511/08/2016

Rs. 50,000/-

As per SRO / 28’s`

Daklinza by M/s. Bristol Myers Squib, USA.

Not applicable

GMP compliant dated 09.02.2016

Undertakings provided to conduct the following studies before marketing of product:

Pharmaceutical Development, Process Validation and Analytical Method Validation.


Drug Daclavir (Daclatasvir) 60mg TabletName of Manufacturer M/s. Vision PharmaceuticalsManufacturer of API Laurus Labs Private Limited, India.API Lot No. ADCTRVSP10050316Description of Pack(Container closure system) Child Resistant HDPE Bottle


Time Period Accelerated: 06 MonthsReal Time: 06 Months

Frequency Accelerated: 0,3,6 (Month)Real Time: 0,3,6 (Month)

Batch No. NPD604 (T-01) NPD604 (T-02) NPD604 (T-03)

Batch Size 500g(2000 Tablets)

500g(2000 Tablets)

500g(2000 Tablets)

Manufacturing Date July 2016 July 2016 July 2016Date of Initiation July 2016 July 2016 July 2016No. of Batches 03Date of Submission 30-01-2017



1. COA of API Yes


Copy of GMP Certificate provided.

Valid till 03-11-2016.3. Protocols followed for conduction of stability study and details of tests. Yes



5. Documents confirming import of API etc.Copy of ADC

(Islamabad) attested invoice provided.






GMP certificate of API Manufacturer valid till 03-11-2016. Undertakings provided to conduct the following studies before marketing of product: Pharmaceutical

Development, Process Validation and Analytical Method Validation.

Decision: The Registration Board decided to constitute the following panel for onsite investigation to confirm genuineness / authenticity of stability data and associated documents, import of API, quality, specification, test analysis, facilities etc. Prof. Dr. Rafeeq Alam Khan, Member Registration Board. Dr. Obaidullah, Additional Director (Reg-I), DRAP, Islamabad. Dr. Saif ur Rehman Khattak, FGA, CDL, Karachi.


Name & Address of Manufacturer /

Applicant





Specification



differential fee),Demanded Price / Pack

size


Local Availability


Remarks




ESONAP 375/20mgTabletsEach tablet contains:Naproxen …….375mgEsomeprazole…..20mg

NSAID / PPI

Mfg. Specs.

Form 5Diary No.205819-03-15

Rs. 20,000/- + Rs. 30,000/-

As Per SRO /Pack of 3x6’s

VIMOVO Tablets(FDA)

Not applicable

Firm had submitted just title page of Form 5-D without any enclosure along with remaining fee of Rs 30,000/- .Deferred in 262nd Meeting for the following:Submission of application on Form 5-D.Submission of Stability data as per guidelines of 251st RB meeting.



Drug ESONAP 375/20mg Tablets (Naproxen + Esomeprazole)Name of Manufacturer M/s. Vision Pharmaceuticals, Islamabad.

Manufacturer of API

Naproxen:Zhejiang Charioteer Pharmaceutical Co. Ltd., China.Esomeprazole Magnesium Trihydrate:Everest Organics Limited, India.

API Lot No.Naproxen: 156102855Esomeprazole Magnesium Trihydrate: ESM/E-144/16

Description of Pack(Container closure system)

Child resistant HDPE bottle.

Stability Storage ConditionAccelerated: 40°C ± 2°C / 75% ± 5%RHReal Time: 30°C ± 2°C / 65% ± 5%RH

Time PeriodAccelerated: 06 MonthsReal Time: 06 Months

FrequencyAccelerated: 0,3,6 (Month)Real Time: 0,3,6 (Month)

Batch No. NPD609(T-03) NPD609(T-02) NPD609(T-01)

Batch Size5kg(7,299 Tablets)

5kg(7,299 Tablets)

5kg(7,299 Tablets)

Manufacturing Date June 2016 June 2016 June 2016Date of Initiation June 2016 June 2016 June 2016No. of Batches 03Date of Submission 07-02-2017



1. COA of API Yes


Yes, Copy of GMP Certificates provided.


4.Data of 03 batches will be supported by attested respective documents like chromatograms, laboratory reports, data sheets etc.

Yes


Copy of ADC (Islamabad) attested invoice provided for Naproxen.

Copy of Invoice (Dated 01.04.2016) provided for Esomeprazole Magnesium, however ADC attestation is missing.






Firm has provided 06 Months Accelerated and 06 Months Long Term Stability Data as per guidelines of 251 st RB meeting.

Copy of Invoice (Dated 01.04.2016) provided for Esomeprazole Magnesium, however ADC attestation is missing. Submission of application dossier on Form 5-D with its enclosures is missing.

Decision: Registration Board deferred the case for submission of the following: Application dossier on Form 5-D with its enclosures. Clarification for copy of Invoice (Dated 01.04.2016) provided for Esomeprazole Magnesium, is

not ADC (DRAP) attested.


Name & Address of








size


Local Availability


Remarks


(if any)



ESONAP 500/20mgTabletsEach tablet contains:Naproxen …….500mgEsomeprazole…..20mg

NSAID / PPI

Mfg. Specs.

Form 5Diary No.203219-03-15

Rs. 20,000/- +Rs. 30,000/-

As Per SRO / Pack of 3x6‘s

VIMOVO Tablets(FDA)

Not applicable

Firm had submitted just title page of Form 5-D without any enclosure along with remaining fee of Rs 30,000/-

Deferred in 262nd

Meeting for the following:

Submission of application on Form 5-D.

Submission of Stability data as per guidelines of 251st RB meeting.



Drug ESONAP 500/20mg Tablets (Naproxen + Esomeprazole)Name of Manufacturer M/s. Vision Pharmaceuticals, Islamabad.

Manufacturer of API

Naproxen:Zhejiang Charioteer Pharmaceutical Co. Ltd., China.Esomeprazole Magnesium Trihydrate:Everest Organics Limited, India.

API Lot No.Naproxen: 156102855Esomeprazole Magnesium Trihydrate: ESM/E-144/16


Child resistant HDPE bottle.

Stability Storage ConditionAccelerated: 40°C ± 2°C / 75% ± 5%RHReal Time: 30°C ± 2°C / 65% ± 5%RH

Time PeriodAccelerated: 06 MonthsReal Time: 06 Months

FrequencyAccelerated: 0,3,6 (Month)Real Time: 0,3,6 (Month)

Batch No. NPD610(T-03) NPD610(T-02) NPD610(T-01)

Batch Size5kg(7,299 Tablets)

5kg(7,299 Tablets)

5kg(7,299 Tablets)

Manufacturing Date June 2016 May 2016 May 2016Date of Initiation June 2016 June 2016 June 2016No. of Batches 03Date of Submission 07-02-2017



1. COA of API Yes


Yes, Copy of GMP Certificates provided.




Copy of ADC (Islamabad) attested invoice provided for Naproxen.

Copy of Invoice (Dated 01.04.2016) provided for Esomeprazole Magnesium, however ADC attestation is missing.







Copy of Invoice (Dated 01.04.2016) provided for Esomeprazole Magnesium, however ADC attestation is missing. Submission of application dossier on Form 5-D with its enclosures is missing.

Decision: Registration Board deferred the case for submission of the following:- Application dossier on Form 5-D with its enclosures. Clarification for copy of Invoice (Dated 01.04.2016) provided for Esomeprazole Magnesium, is

not ADC (DRAP) attested.


Name & Address of






Specification

Type of Form,

Initial Diary & Date, Fee (including differential


size


Local Availability


Remarks


6. M/s OBS Pakistan,

Karachi.

Viratron-Plus Tablet

Each film coated tablet contains:-Sofosbuvir……400mgLedipasvir…….90mg

AntiviralMfg. Specs

Form 5-D

Dairy No.21403-06-2015

Rs.50,000/-

Rs.364,000/-28’s

Harvoni, FDA.

Harvoni, Ferozsons, Pakistan.

GMP compliant dated 07-011-2016.

Deferred in 260th Meeting for the following:- Stability studies not

submitted. Last Inspection report

required. Undertaking as per

new format not submitted.


Drug Viratron-Plus Tablet (Sofosbuvir + Ledipasvir)Name of Manufacturer M/s OBS Pakistan, Karachi.Manufacturer of API Optimus Drugs (P) Limited, India.

API Lot No. Ledipasvir: OP-800/A0542/139Sofosbuvir: OP-GLD/01/16/005, OP-GLD/10/15/037

Description of Pack(Container closure system) Alu-Alu Blister Pack





Batch No. EXP-T-26 EXP-T-36 EXP-T-37Batch Size 2,000 Tablets 2,500 Tablets 2,500 TabletsManufacturing Date March 2016 June 2016 June 2016Date of Initiation April 2016 June 2016 June 2016No. of Batches 03Date of Submission 13/02/2017



1. COA of API Yes


Yes, Copy of GMP certificates are provided.



5. Documents confirming import of API etc.Yes, Copy of ADC (Karachi) attested

invoices are provided.





In addition to the deficiencies mentioned in 260th meeting, firm has provided 06 Months Accelerated and 06 Months Long Term Stability Data in accordance with the guidelines approved by the Board in 251st meeting.

Decision: Deferred for clarification of following point:Firm has used Ledipasvir Solvate in whereas Innovator has used Ledipasvir Spray dried dispersion (50% w/w) as Ledipasvir is susceptible to the influence of gastrointestinal pH and Fed state.



Name & Address of






Specification

Type of Form,


fee),Demanded

Price / Pack size


Availability


Remarks


7. M/s. Oakdale Pharmaceuticals,Peshawar.

Sofvir 400mg Tablets

Each film coated tablet contains:

Sofosbuvir…400mg

Anti-viralMfg. Specs.

Form-5

Dy. No: 32909-02-2015

Rs. 20,000

As per SRO / 28’s

Sovaldi by Gilead Sciences, Australia.

Sofvir by M/s. Sami Pharmaceuticals, Karachi.

GMP compliant dated 10.05.2014 for Grant of DML.

-


Drug Sofvir 400mg TabletsName of Manufacturer M/s. Oakdale Pharmaceuticals, Peshawar.Manufacturer of API Suli Pharmaceutical Technology Jiangyin Co., Ltd., China.API Lot No. SLZY059-150801M-Form6Description of Pack(Container closure system) Alu-Alu Blister Pack.

Stability Storage Condition Real Time: 30°C ± 2°C / 65% ± 5%RHAccelerated: 40°C ± 2°C / 75% ± 5%RH

Time Period Real Time: 6 MonthsAccelerated: 6 Months

Frequency Real Time: 0,1,2,3,4,5,6 (Months)Accelerated: 0,1,2,3,4,5,6 (Months)

Batch No. Not MentionedBatch Size Not MentionedManufacturing Date Not MentionedDate of Initiation Not MentionedNo. of Batches 01Date of Submission 24-11-2016



1. COA of API Yes


No

3. Protocols followed for conduction of stability study and details of tests. No


4. Data of 03 batches will be supported by attested respective documents like chromatograms, laboratory reports, data sheets etc.

Only Stability Data Sheets provided for one batch without any supporting documents.

5. Documents confirming import of API etc. No

6. All provided documents will be attested (name, sign and stamp) for ensuring authenticity of data / documents. No




Only Stability Data Sheets provided for one batch without any supporting documents. Aforementioned documents as required in 251st DRB Meeting are not provided.

Decision: The Registration Board deferred the case for submission of the following documents:-

Approval of API by regulatory authority of country of origin or GMP certificate of API manufacturer issued by regulatory authority of country of origin.

Protocols followed for conduction of stability study and details of tests. Data of 03 batches supported by attested respective documents like

chromatograms, laboratory reports and data sheets etc. Documents confirming import of API etc. All provided documents will be attested (name, sign and stamp) for ensuring

authenticity of data / documents.



Name & Address of






Specification

Type of Form,



size


Availability


Remarks


8. M/s. Remington Pharmaceutical Industries (Pvt.) Ltd. 18 km Multan Road, Lahore.

Lufresh Eye Drops 0.5%

Each ml contains:Carboxymethylcellulose Sodium…5mg

Other ophthalmological, S01XA20

BP Specs.

Form 5-D

Dy. No. 46526-08-2016

Rs. 50,000/-(20,000 + 30,000)

Rs. 200/-15ml

Refresh Tears by Allergan, Inc.(US FDA, Human OTC)

Not applicable

Routine GMP Inspection dated 12th

May 2016 shows Good compliance.

Undertaking provided to submit data regarding Process Validation before marketing of the product.


Drug Lufresh Eye Drops 0.5% (Carboxymethylcellulose Sodium)Name of Manufacturer M/s. Remington Pharmaceutical Industries (Pvt.) Ltd., Lahore.Manufacturer of API Ashland Specialties, France.API Lot No. 40686Description of Pack(Container closure system)

White opaque LDPE Bottle with Polypropylene Nozzle and Hard PVC Cap.



Frequency Real Time: 0,3,6,9,12,18,24 (Months)Accelerated: 0,3,6 (Months)

Batch No. RD-14126 - -Batch Size Not mentioned - -Manufacturing Date June 2014 - -Date of Initiation June 2014 - -No. of Batches 01Date of Submission 26-08-2016



1. COA of API Yes2. Approval of API by regulatory authority of country of origin or

GMP certificate of API manufacturer issued by regulatory authority No


of country of origin.



Stability Data Sheets provided for one batch without supporting documents.


6. All provided documents will be attested (name, sign and stamp) for ensuring authenticity of data / documents.

Provided sheets are signed and stamped.


8. Commitment to follow Drug Specification Rules, 1978. No


Firm has submitted 06 Months Accelerated and 24 Months Real Time Stability Data for One batch only. Stability Data Sheets provided for one batch without supporting documents. Undertaking provided to submit data regarding Process Validation before marketing of the product. Aforementioned documents as required in 251st Meeting are missing.

Decision: The Registration Board deferred the case for submission of the following documents:-


Protocols followed for conduction of stability study and details of tests. Data of 03 batches supported by attested respective documents like


authenticity of data / documents. Commitment to follow Drug Specification Rules, 1978.



Name & Address of



Dosage Form + Strength), Composition,

Pharmacological Group,Finished Product

Specification

Type of Form,


fee),Demanded

Price / Pack size


Local Availability

GMP Inspection

Report Date & Remarks


9. M/s. Remington Pharmaceutical Industries (Pvt.) Ltd.

18 km Multan Road, Lahore.

Ketomox Eye Drops

Each ml contains:Moxifloxacin Hydrochloride equivalent to Moxifloxacin…5mgKetorolac Tromethamine…5mg

Anti-inflammatory agent + Anti-infective S01CMfg. Specs.

Form 5-D

Dy. No. 46626-08-2016

Rs. 50,000/-(20,000 + 30,000)

Rs. 350/-5ml

Moxisurge KT by Bausch & Lomb, India.

Not applicable

Routine GMP Inspection dated 12th May 2016 shows Good compliance.

International availability referred to Moxisurge KT by Bausch & Lomb, India.



Drug Ketomox Eye Drops(Moxifloxacin Hydrochloride + Ketorolac Tromethamine )

Name of Manufacturer M/s. Remington Pharmaceutical Industries (Pvt.) Ltd., Lahore.

Manufacturer of API

Moxifloxacin Hydrochloride:OREX PHARMA (PVT.) LTD., IndiaKetorolac Tromethamine:HETERO DRUGS LIMITED, India

API Lot No. ORX/MOX-L/1504011KT0040211





Frequency Real Time: 0,3,6,9,12,18 (Months)Accelerated: 0,3,6 (Months)

Batch No. RD-14170 - -Batch Size Not mentioned - -Manufacturing Date August 2014 - -Date of Initiation August 2014 - -No. of Batches 01Date of Submission 26-08-2016




1. COA of API Yes


No










International availability referred to Moxisurge KT by Bausch & Lomb, India. Firm has submitted 06 Months Accelerated and 18 Months Real Time Stability Data for One batch only. Stability Data Sheets provided for one batch without supporting documents. Undertaking provided to submit data regarding Process Validation before marketing of the product. Aforementioned documents as required in 251st Meeting are missing.

Decision: Registration Board deferred the case for submission of the following documents:

International availability in reference Regulatory Authorities. Approval of API by regulatory authority of country of origin or GMP certificate of API

manufacturer issued by regulatory authority of country of origin. Protocols followed for conduction of stability study and details of tests. Data of 03 batches supported by attested respective documents like chromatograms,

laboratory reports and data sheets etc. Documents confirming import of API etc. All provided documents will be attested (name, sign and stamp) for ensuring




Name & Address of






Specification

Type of Form,


fee),Demanded

Price / Pack size


Local Availability

GMP Inspection

Report Date & Remarks




Loxiget-P Ophthalmic Suspension

Each ml contains:Gatifloxacin…3mgPrednisolone Acetate…10mg

Corticosteroid + Anti-infectiveS01CA02Mfg. Specs.

Form 5-D

Dy. No. 47126-08-2016

Rs. 50,000/-(20,000 + 30,000)

Rs. 250/-5ml

ZYPRED by Allergan Pharmaceuticals Ltd., Brazil.

Not applicable


International availability referred to ZYPRED by Allergan Pharmaceuticals Ltd., Brazil.



Drug Loxiget-P Ophthalmic Suspension(Gatifloxacin + Prednisolone Acetate)

Name of Manufacturer M/s. Remington Pharmaceutical Industries (Pvt.) Ltd., Lahore.

Manufacturer of API

Gatifloxacin:Shangyu Jingxin Pharmaceutical Co., Ltd., China.Prednisolone Acetate:Symbiotec Pharmalab (Pvt.) Ltd., India.

API Lot No. 20150806ZPRA15003-M





Frequency Real Time: 0,3,6,9,12,18,24 (Months)Accelerated: 0,3,6 (Months)

Batch No. RD-12138 - -Batch Size Not mentioned - -Manufacturing Date December 2012 - -Date of Initiation December 2012 - -No. of Batches 01Date of Submission 26-08-2016




1. COA of API Yes


No










International availability referred to ZYPRED by Allergan Pharmaceuticals Ltd., Brazil. Firm has submitted 06 Months Accelerated and 24 Months Real Time Stability Data for One batch only. Stability Data Sheets provided for one batch without supporting documents. Undertaking provided to submit data regarding Process Validation before marketing of the product. Aforementioned documents as required in 251st Meeting are missing.


International availability in reference Regulatory Authorities. Approval of API by regulatory authority of country of origin or GMP certificate

of API manufacturer issued by regulatory authority of country of origin. Protocols followed for conduction of stability study and details of tests. Data of 03 batches supported by attested respective documents like





Name & Address of





Type of Form,


fee),Demanded

Price / Pack size


Local Availability


Remarks


(if any)



Remilak LS Eye Drops 0.4%

Each ml contains:Ketorolac Tromethamine…4mg

Anti-inflammatory agents, Non-steroids,S01BC05

Mfg. Specs.

Form 5-D

Dy. No. 47026-08-2016

Rs. 50,000/-(20,000 + 30,000)

Rs. 200/-5ml

ACULAR LS by Allergan, US FDA.

Not applicable




Drug Remilak LS Eye Drops 0.4%(Ketorolac Tromethamine )

Name of Manufacturer M/s. Remington Pharmaceutical Industries (Pvt.) Ltd., Lahore.Manufacturer of API HETERO DRUGS LIMITED, IndiaAPI Lot No. KT0040211Description of Pack(Container closure system)




Frequency Real Time: 0,3,6,9,12,18 (Months)Accelerated: 0,3,6 (Months)

Batch No. RD-13248 - -Batch Size Not mentioned - -Manufacturing Date December 2013 - -Date of Initiation December 2013 - -No. of Batches 01Date of Submission 26-08-2016




1. COA of API Yes


No










Firm has submitted 06 Months Accelerated and 18 Months Real Time Stability Data for One batch only. Stability Data Sheets provided for one batch without supporting documents. Undertaking provided to submit data regarding Process Validation before marketing of the product. Aforementioned documents as required in 251st Meeting are missing.



Protocols followed for conduction of stability study and details of tests. Data of 03 batches supported by attested respective documents like chromatograms,





Name & Address of






Specification

Type of Form,



size


Availability


Remarks


(if any)

12. M/s. Schazoo Zaka (Pvt.) Ltd.

20-km Lahore Jaraanwala Road,Sheikhupura.

Tablet RIFA 2 Junior

Each uncoated dispersible tablet contains:Rifampicin USP …75mgIsoniazid USP ...50mg

Anti TBMfg. Specs.

Form-5D

Dy. No: 187619-04-2016

Rs. 50,000/-(20,000 + 30,000)

Rs. 11.33/- Per tablet.

WHO recommended formulation.

GMP compliant section vide inspection report dated 15-09-2015.

Deferred in 262nd

Meeting of DRB for submission of stability data as per guidelines approved in 251st DRB meeting.


Drug Tablet RIFA 2 Junior (Rifampicin + Isoniazid)Name of Manufacturer M/s. Schazoo Zaka (Pvt.) Ltd., Sheikhupura

Manufacturer of API Shenyang Tonglian Medicine Co. Ltd., China.Amsal/Calyx

API Lot No. Rifampicin: 80201512041Isonazid: 16058INH

Description of Pack(Container closure system) Alu-Alu Blister Pack.


Time Period Real Time: 3 Months (12 Weeks)Accelerated: 3 Months (12 Weeks)

Frequency Real Time: 0,12 (Weeks)Accelerated: 0,4,8,12 (Weeks)

Batch No. RDT-T1-16 - -Batch Size 5,000 Tablets - -Manufacturing Date May 2016 - -Date of Initiation July 2016 - -No. of Batches 01Date of Submission 13-12-2016




1. COA of API No


No



Copies of chromatograms, laboratory reports, data sheets etc. provided for one batch only.






Firm has provided 03 months accelerated and long term stability study results for one batch only. Aforementioned documents as required in 251st DRB Meeting are missing.

Decision: Registration Board deferred the case for submission of the following documents: COA of API. Approval of API by regulatory authority of country of origin or GMP certificate of API

manufacturer issued by regulatory authority of country of origin. Data of 03 batches supported by attested respective documents like chromatograms,





Name & Address of






Specification

Type of Form,


fee),Demanded

Price / Pack size


Availability


Remarks


(if any)



RIFA 3 Junior Dispersible Tablets

Each uncoated dispersible tablet contains:Rifampicin USP…75mgIsoniazid USP…50mgPyrazinamide USP …150mg

Anti TBMfg. Specs.

Form 5-DDy. No: 187519-04-2016

Rs.20,000/-

13.33/-Per tablet



Deferred in 262nd

Meeting of DRB for submission of stability data as per guidelines approved in 251st DRB meeting.


Drug RIFA 3 Junior Dispersible Tablets(Rifampicin + Isoniazid+ Pyrazinamide)

Name of Manufacturer M/s. Schazoo Zaka (Pvt.) Ltd., Sheikhupura

Manufacturer of APIShenyang Tonglian Medicine Co. Ltd., China.Amsal Chemicals (Pvt.) Ltd., India.Calyx Chemicals and Pharmaceuticals Ltd., India.

API Lot No.Rifampicin: 80201512041Isonazid: 16058INHPyrazinamide: PZ/20151020

Description of Pack(Container closure system) Alu-Alu Blister Pack.




Batch No. RKT-T1-16 - -Batch Size 5,000 Tablets - -Manufacturing Date May 2016 - -Date of Initiation July 2016 - -No. of Batches 01Date of Submission 13-12-2016




1. COA of API No


No





6. All provided documents will be attested (name, sign and stamp) for ensuring authenticity of data / documents. Copies provided.




Firm has provided 03 months accelerated and long term stability study results for one batch only. Aforementioned documents as required in 251st DRB Meeting are missing.


COA of API. Approval of API by regulatory authority of country of origin or GMP certificate of API

manufacturer issued by regulatory authority of country of origin. Data of 03 batches supported by attested respective documents like chromatograms,






Applicant

Brand Name(Proprietary Name + Dosage

Form + Strength), Composition,


Specification




size


Availability


Remarks




RIFA 3 Junior Pediatric Tablets

Eac tablet contains:Rifampicin USP…75mgIsoniazid USP…50mgPyrazinamide USP …150mgAnti TBMfg. Specs.

Form 5-DDy. No: 233130-05-2016

Rs.20,000/- + 30,000/-

8.5/- Per tablet



-


Drug RIFA 3 Junior Pediatric Tablets(Rifampicin + Isoniazid+ Pyrazinamide)



API Lot No.Rifampicin: 80201602053Isonazid: 16058INHPyrazinamide: PZ/20151020

Description of Pack(Container closure system) Alu-PVDC Blister Pack.




Batch No. RYT-T1-16 - -Batch Size 5,000 Tablets - -Manufacturing Date May 2016 - -Date of Initiation July 2016 - -No. of Batches 01Date of Submission 13-12-2016


Sr. No. Documents To Be Provided Status1. COA of API Rifampicin: Batch No.

80201602056 on COA do not match with the batch used for Studies.


Copy of COAs of Isoziazid and Pyrazinamide are provided.


Copy of GMP certificate provided for Amsal Chemicals, valid till 5.6.2016. Scope of inspection mentioned as Bulk Drugs.Copy of GMP certificate provided for Calyx Chemicals, scope of inspection mentioned as Bulk Drugs.Copy of GMP certificate provided for Shenyang Tonglian.





Copy of ADC (Lahore) attested invoices are provided.Batch No. of Rifampicin not mentioned on invoice.





Firm has provided 03 Months Accelerated and Long Term Stability Study Results for one batch only. Batch No. 80201602056 on COA of Rifampicin do not match with the batch used for Studies; moreover

Batch No. of Rifampicin was not mentioned on invoice. Copy of GMP certificate provided for Amsal Chemicals, valid till 05-06-2016.

Decision: Registration Board deferred the case for submission of the following documents:- Batch No. 80201602056 on COA of Rifampicin do not match with the batch used for Studies;

moreover Batch No. of Rifampicin was not mentioned on invoice, clarify. Approval of API (Isoniazid / Pyrazinamide) by regulatory authority of country of origin

or GMP certificate of API manufacturer issued by regulatory authority of country of origin specifying API (Isoniazid / Pyrazinamide) in scope of inspection.

Data of 03 batches supported by attested respective documents like chromatograms, laboratory reports and data sheets etc.

All provided documents will be attested (name, sign and stamp) for ensuring authenticity of data / documents.




Applicant

Brand Name(Proprietary Name + Dosage

Form + Strength), Composition,


Specification




size


Availability

GMP Inspection Report Date & Remarks




RIFA 3 Junior Sachet

Eac sachet contains:Rifampicin USP…75mgIsoniazid USP…50mgPyrazinamide USP …150mg

Anti TBMfg. Specs.

Form 5-DDy. No: 232930-05-2016

Rs.20,000/- + 30,000/-

13.33/- Per sachet



-


Drug RIFA 3 Junior Sachet(Rifampicin + Isoniazid+ Pyrazinamide)



API Lot No.Rifampicin: 80201605054Isonazid: 160160INHPyrazinamide: PZ20160726

Description of Pack(Container closure system) Aluminium Foil Sachet


Time Period Real Time: 0 WeekAccelerated: 0 Week

Frequency Real Time: 0 (Week)Accelerated: 0 (Week)

Batch No. RES-T2-16 - -Batch Size 500 Sachets - -Manufacturing Date August 2016 - -Date of Initiation November 2016 - -No. of Batches 01Date of Submission 28-11-2016



1. COA of API Copy of COAs are provided.2. Approval of API by regulatory authority of country of origin

or GMP certificate of API manufacturer issued by regulatory Copy of GMP certificate provided for Amsal Chemicals, valid till 05-06-2016.


authority of country of origin.

Scope of inspection mentioned as Bulk Drugs.

Copy of GMP certificate provided for Calyx Chemicals, scope of inspection mentioned as Bulk Drugs.

Copy of GMP certificate provided for Shenyang Tonglian.



Copies of chromatograms, laboratory reports, data sheets etc. provided for one batch only for 0 time interval.


Copy of ADC (Lahore) attested invoices are provided.

Batch No. of Rifampicin not mentioned on invoice.





Firm has provided Accelerated and Long Term Stability Study Results for one batch only for 0 time interval.

Copy of GMP certificate provided for Amsal Chemicals, valid till 05-06-2016.

Decision: Registration Board deferred the case for submission of the following documents:- Approval of API (Isoniazid / Pyrazinamide) by regulatory authority of country of origin

or GMP certificate of API manufacturer issued by regulatory authority of country of origin specifying API (Isoniazid / Pyrazinamide) in scope of inspection.

Data of 03 batches supported by attested respective documents like chromatograms, laboratory reports and data sheets etc.

All provided documents will be attested (name, sign and stamp) for ensuring authenticity of data / documents.



Name & Address of






Specification

Type of Form,



size


Local Availability


Remarks


16. M/s StarLaboratories,

Lahore.

Starcip Suspension 125mg/5ml

Each 5ml contains:-Ciprofloxacin HCl (USP equivalent tociprofloxacin…..125mg

Quinolone / antibiotic

Mfg. Specs.

Form 5Dairy No. 9395 31.07.2013

Rs:20,000/-

Rs. 85/-60ml

International availability not submitted by the firm.

Mytil suspension125mg/5ml byM/s. Wilson’sPharma,Islamabad.

Latest inspectionreport20-09-2015.

Deferred in 258th Meeting for following:

Availability in SRA is not provided.

Reference Literature for detailed specification and analytical method for finished product Raw material is required.

Latest inspection report is required.

Analytical Procedure for API’s and excipients is not provided.

Revision of formulation as per innovator is required.


Drug Starcip Suspension 125mg/5ml (Ciprofloxacin)Name of Manufacturer M/s Star Laboratories, Lahore.Manufacturer of API Not MentionedAPI Lot No. CH 0092015Description of Pack(Container closure system) Amber glass bottle sealed with aluminium cap.




Batch No. HST-006 HST-009 HST-010Batch Size 500 Bottles 500 Bottles 500 BottlesManufacturing Date January 2015 January 2015 January 2015Date of Initiation January 2015 January 2015 January 2015No. of Batches 03Date of Submission 28-10-2016




1. COA of API No


No



Only Stability Data Sheets provided without supporting documents.




7. Commitment to continue real time stability study till assigned shelf life of the product. No



In addition to the deficiencies mentioned in 258th Meeting, above mentioned documents as required in 251st

Meeting are missing.

Decision: Registration Board rejected the applications as per decision of 260th DRB meeting where Registration Board agreed to de-register all the products having Ciprofloxacin for veterinary use




Applicant





Specification

Type of Form,



size


Local Availability


Remarks



Lahore.

Starcip Suspension 250mg

Each 5ml contains:-Ciprofloxacin HCl (USP equivalent tociprofloxacin…..250mg

Quinolone / antibiotic

Mfg. Specs.

Form 5Dairy No.939431.07.2013

Rs:20,000/-

Rs. 160/-60ml


Mytil suspension250mg/5ml byM/s. Wilson’sPharma, Islamabad.


Deferred in 258th Meeting forfollowing:

Availability in SRA is not provided.

Reference Literature for detailed specification and analytical method for finished product Raw material is required.


Revision of formulation as per innovator is required.


Drug Starcip Suspension 250mg/5ml (Ciprofloxacin)Name of Manufacturer M/s Star Laboratories, Lahore.Manufacturer of API Not MentionedAPI Lot No. CH 0092015Description of Pack(Container closure system) Amber glass bottle sealed with aluminium cap.




Batch No. HST-007 HST-008 HST-009Batch Size 500 Bottles 500 Bottles 500 BottlesManufacturing Date January 2015 January 2015 January 2015Date of Initiation January 2015 January 2015 January 2015No. of Batches 03Date of Submission 28-10-2016




1. COA of API No


No












Decision: Registration Board rejected the applications as per decision of 260th DRB meeting where Registration Board agreed to de-register all the products having Ciprofloxacin for veterinary use



Applicant





Specification

Type of Form,



size


Local Availability


Remarks



Lahore.

Tilmisin PowderEach 100gram contains:-Tilmicosin Phosphate……20gm

Antibiotic

Mfg. Specs

Form-5D

18-06-2013vide diaryNo. 703 R&I

Rs.20,000/- +500gm/ Decontrolled

The firm is GMPcompliant as per inspection dated21-09-2015

Deferred in 258th Meeting for following:

Deferred for the submission of differential fee Rs.30,000 and stability data as per guidelines approved by Registration Board in 251st meeting.



Drug Tilmisin Powder 20gm (Tilmicosin Phosphate)Name of Manufacturer M/s Star Laboratories, Lahore.Manufacturer of API Not MentionedAPI Lot No. TP 0052015Description of Pack(Container closure system) Aluminium foil sachet.




Batch No. VST-011 VST-012 VST-013Batch Size 500 Sachet 500 Sachet 500 SachetManufacturing Date March 2015 March 2015 March 2015Date of Initiation March 2015 March 2015 March 2015No. of Batches 03Date of Submission 28-10-2016



1. COA of API No


No












Decision: Registration Board deferred the case for submission of the following documents: Deficiencies mentioned in 258th DRB Meeting. Aforementioned documents as required for Stability Study Data in 251st DRB Meeting.

Stability Case 19Minutes for 267th Registration Board Meeting 287

Sr. No.


Applicant





Specification

Type of Form,



size


Local Availability


Remarks



Lahore.

Diflustar Capsule 150mgEach capsule contains:-Fluconazole (USP) ……150mg

Antifungal

Mfg. Specs

Form 5Dairy No.799 dated4.07.2013

Rs:20,000/-

Rs. 385/-1’s


Diflucancapsule150mg byM/s. Pfizer


Deferred in 258th Meeting forfollowing:

Availability is SRA is not provided.

Shelf life stated by the firm is 3years whereas 2years are allowed by DRB.

Reference Literature for description of specification and detailed analytical method for finished product and Raw material is required.



Drug Diflustar Capsule 150mg (Fluconazole)Name of Manufacturer M/s Star Laboratories, Lahore.Manufacturer of API Not MentionedAPI Lot No. F0012015Description of Pack(Container closure system) Hard Gelatin Capsule Shells blistered in Alu-PVC Pack.




Batch No. HST-012 HST-013 HST-014Batch Size 50,000 Capsules 50,000 Capsules 50,000 CapsulesManufacturing Date February 2015 February 2015 February 2015Date of Initiation February 2015 February 2015 February 2015No. of Batches 03Date of Submission 28-10-2016




1. COA of API No


No












Decision: Registration Board deferred the case for submission of the following documents:- Deficiencies mentioned in 258th DRB Meeting. Aforementioned documents as required for Stability Study Data in 251st DRB Meeting.


Name &Address of





Type of Form,Initial Diary&


differential fee),Demanded Price/

Pack size


Availability


Remarks

Remarks

20. M/S Werrick Pharmaceuticals, 216-217, I-10/3. Industrial Area, Islamabad

EZIDAY-2 film coated tablets 5/50Each Film Coated Tablet contains:Amlodipins as Camsylate…. 5mgLosartan Potassium…. 50mgAntihypertenive

Form 5DDy. No. 40113/12/2010Fee 15,000/-13/12/2010Rs. 35,000/-19/01/2017Pack Size 10’s & 20’s Price 65/- per tablet

Not ProvidedN/ALast inspection report 23/06/2010 is attached which confirms the goo level of GMP compliance.



Drug EZIDAY-2 film coated tablets 5/5Name of Manufacturer M/S Werrick Pharmaceuticals, IslamabadManufacturer of API Not providedAPI Lot No. Not providedDescription of Pack(Container closure system) Blister packaging

Stability Storage Condition Real Time: 30’C +_ 2’C / 65%+_ 5%RHAccelerated: NOT Provided

Time Period Real Time:36 MonthsAccelerated: Not provided

Frequency Real Time:0,3,6,9, 12, 18, 24, 36 (Month)Accelerated: Not provided

Manufacturing date 12/03/2007 19/03/2017 25/03/2017Date of Initiation Not Provided Not Provided Not ProvidedBatch Nos. ET 5-50-001 ET 5-50-002 ET 5-50-003Batch Size 10,00 Tablets 10,000 Tablets 10,000 TabletsNo. of Batches 03 for only long term stabiltiy


Sr.# Documents To Be Provided Status

1. COA of API No

2.Approval of API by regulatory authority of country of origin or GMP certificate of API manufacturer issued by regulatory authority of country of origin. No



Only data sheets of long term stability are provided which are signed.

5. Documents confirming import of API etc. Not Provided




REMARKS OF EVALUATOR(AD PEC-X)

The firm has provided data for only long term stability studies with no supporting documents. Data for accelerated stability studies shall be provided with all other supporting documents.

Aformentioned documents as per 251st meeting are not provided. Banned excipient Methylene Chloride is used. The firm has claimed for In House specification and the product in Not present in available pharmacopoeia

BP 2013 & USP 39. International status cannot be confirmed.

Decision: Registration Board deferred the case for submission of the following documents:- Copy of Last GMP inspection report.Minutes for 267th Registration Board Meeting 290

International Availability in reference Regulatory Authorities. Banned excipient ‘Methylene Chloride’ is used in formulation, clarify.

Aforementioned documents as required for Stability Study Data in 251st DRB Meeting.

Stability Case 2121. M/S Wilson

Pharmaceuticals, I-9 Industrial Area, Islamabad

SOFVASC FORTE film coated tablets 5/50Each Film Coated Tablet contains:Amlodipins as Camsylate…….…. 5mgLosartan Potassium…. 50mgAntihypertenive

Form 5DDy.# 3531 11/12/2010Fee 15,000/-11/12/201035,000/- 17/01/2017Pack Size 10’s & 20’sPrice 65/- per tablet

Not providedN/ALast inspection report dated 20/11/2004 is provided which is incomplete.


Drug SOFVASC FORTE film coated tabletsName of Manufacturer M/s. Wilson Pharmaceutical, IslamabadManufacturer of API Not providedAPI Lot No. Not providedDescription of Pack(Container closure system) Blister packaging

Stability Storage Condition Real Time: 30’C +_ 2’C / 65%+_ 5%RHAccelerated:

Time Period Real Time: 36 MonthsAccelerated: Not provided

Frequency Real Time:0,3,6,9, 12, 18, 24, 36 (Month)Accelerated: NOT provided

Manufacturing date 26/09/2017 26/09/2017 26/09/2017Date of Initiation Not Provided Not Provided Not ProvidedBatch Nos. SFT05-50-001 02 03Batch Size 10,00 Tablets 10,000 Tablets 10,000 TabletsNo. of Batches 03



1. COA of API No

2.Approval of API by regulatory authority of country of origin or GMP certificate of API manufacturer issued by regulatory authority of country of origin. No



Only data sheets for long term stability are provided which are signed






REMARKS OF EVALUATOR(AD PEC-X)

The firm has provided data for only long term stability studies with no supporting documents. Data for accelerated stability studies shall be provided with all other supporting documents.

Aforementioned documents as per 251st meeting are not provided. Banned excipient Methylene Chloride is used. The firm has claimed for In House specification and the product in Not present in available pharmacopoeia BP

2013 & USP 39. International status cannot be confirmed.

Decision: The Registration Board deferred the case for submission of the following documents:- Copy of Last GMP inspection report. International Availability in reference Regulatory Authorities. Clarification for using banned excipient i.e. Methylene Chloride in coating solution. Aforementioned documents as required for Stability Study Data in 251st DRB Meeting.


Stability Case 22Sr.#

Name and address of manufacturer / Applicant


Type of FormInitial date, diaryFee including differential feeDemanded Price / Pack size

Remarks on the formulation (if any) including International status in stringent drug regulatory agencies / authoritiesMe-too statusGMP status as depicted in latest inspection report (with date) by the Evaluator

Previous Remarks of the Evaluator.

RB Decision

22. M/s Welward PharmaceuticalsPlot No. 3, Block A, Phase I-II, Industrial Estate, Hattar

Sofowrd Tablet400 mgEach tablet containsSofosbuvir……400 mg(Nucleotide Analog NS5B Polymerase Inhibitor)

Form 5 D15-07-2014Rs 50,000/-Rs 85,000/ tabletBlister Pack alu alu 10‟s

Sovaldi Tablet 400 mg (USFDA)According to inspection report dated 25-07-2014, firm was considered to be operated a good level of compliance with GMP guidelines.

The case was discussed in 265th

DRB meeting along with stability data as per guidelines of 251st

DRB meeting.

265th

Meeting Registration Board to be held on 24-25th January, 2017.Deferred for complete method of analysis with test of Dissolution

Evaluation By PEC Firm has submitted Dissolution testing protocol for applied formulation. Dissolution parameters stated in protocol as per recommended by USFDA




Name and address of






Specification



feeDemanded Price / Pack

size

Remarks on the

formulation (if any) including

International status in stringent


authoritiesMe-too statusGMP

status as depicted in

latest inspection

report (with date)

by the Evaluator

Previous Remarks of the Evaluator/

RB Decision

23. M/s Atco Laboratories Limited, Karachi.

Lebuvir TabletEach film coated tablet contains:Sofosbuvir MS …400mgLedipasvir MS….90mgAnti-viralsManufacturer‘s Specs.

Form 5-D with (Photocopy) fee Rs.50,000/- vide Dy. # Nil, dated 09-12-2014.MRP: Rs.15000/-per 1s, Rs.10,5000/- per 7s, Rs.150000/- per 10s, Rs.210000/- per 14s. Rs.300000/- per 20s, Rs.315000/- per 21s, Rs.420000/- per 28s, Rs.450000/- per 30s, Rs.525000/- per 35s, Rs.630000/- per 42s, Rs.840000/-

Harvoni-USFDAEnclosed copy of last inspection report for routine GMP inspection conducted on 18-06-2014 containing the conclusive remarks as under: ―Good level of compliance of GMP‖

The case was discussed in 263rd RB meeting along with stability data & following shortcomings were recorded:

i. Commitment to follow innovator‘s brand and not to use banned excipients is not attached.

ii. Firm has used Ledipasvir in pure form for the formulation whereas innovator has used Ledipasvir spray dried dispersion with co-povidone (50% w/w)

iii. Firm has not provided laboratory reports & data sheets for the stability data.


per 56s, Rs.900000/- per 60s, Rs.945000/- per 63s, Rs.1050000/-per 70s, 1155000/- per 77s, Rs.1260000/- per 84s, Rs.1350000/- per 90s & Rs.1500000/- per 100s.Pack Size: 1s, 7s, 10s, 14s, 20s, 21s, 28s, 30s, 35s, 42s, 56s, 60s, 63s, 70s, 77s, 84s, 90s & 100s.

Evaluation By PEC Firm has submitted lab reports & raw data sheets for stability studies of all the

three batches Firm has submitted commitment for not using innovator brand name & banned

excipients Firm has stated that in the literature it is clearly mentioned that the innovator use

Ledipasvir in pure form as active & co-povidone as excipient, and in the manufacturing it will be made solid dispersion of both by using spray dried technique to improve dissolution. We have developed our formulation in this way that it meets the dissolution requirement using FDA dissolution method. Firm has referred to PIL of Harvoni in this respect.

Remarks of EvaluatorEMA assessment report for Harvoni states as under:“Ledipasvir exhibits low, but pH-dependent, solubility and high apparent permeability (BCS class II). It is susceptible to the influence of gastrointestinal pH and fed state and so an amorphous spray-dried dispersion of LDV (LDV-SDD) was developed in order to mitigate these food effects. LDV-SDD is an amorphous solid powder. It is hygroscopic and photosensitive, but physically and chemically stable for up to 6 months if protected from light and moisture in a sealed container. The physicochemical properties of LDV-SDD are amenable to formulation in a solid oral tablet.

Phase I and II clinical trials were carried out with Ledipasvir as a single agent. The phase I formulation used Ledipasvir amorphous free base in film-coated tablets. The crystalline D-tartrate salt of Ledipasvir was used for early phase II trials, and LDV-SDD introduced for later phase II trials to mitigate against food effects. An improvement in in vivo performance was demonstrated LDV-SDD as compared to the other Ledipasvir forms.”

In view of above context from EMA assessment report it is evident that innovator used


Ledipasvir spray dried dispersion to improve in-vivo pharmacokinetic parameters rather than for improvement of in vitro dissolution performance.

Proceedings: Registration Board did not accede to firm’s justification for using Ledipasvir in pure form. The Registration Board sought information regarding details of Ledipasvir raw material used in products already considered by Board. The Board was apprised of following details in this regard:

Details of Ledipasvir Raw material used in products of Sofosbuvir + Ledipasvir (400/90mg) tablets considered by DRBSr.# Product name Manufacturer name Type of Ledipasvir

usedCurrent status of Application

1. Hepacure Plus Tablet M/s. Bio-Labs (Pvt.) Ltd., Ledipasvir Deferred in 265th DRB meeting

2. Sofliver Tablet M/s Genome Pharmaceuticals (Pvt.) Ltd

Ledipasvir Deferred in 265th DRB meeting

3. Sofoled Tablet M/s Helix Pharma (Pvt) Ltd

Ledipasvir Deferred in 266th DRB meeting

4. Sofo-L Tablet M/s. Genix Pharmaceuticals (Pvt) Ltd

Ledipasvir Acetone Approved in 263rd DRB meeting

5. Ledifos Tablet M/s. Fynk Pharmaceuticals

Ledipasvir Acetone solvate

Deferred in 265th DRB meeting

6. Lesovir Tablet M/s Bosch Pharmaceuticals (Pvt.) Ltd.,

Ledipasvir Acetone solvate

Panel for onsite investigation constituted in 264th DRB meeting

7. Viratron Tablet M/s OBS Pakistan Ledipasvir Solvate Considered in 267th DRB meeting

8. Lebuvir Tablet M/s Atco Laboratories Limited

Ledipasvir Considered in 267th DRB meeting

9. Lebriva Tablet M/s. CCL Pharmaceuticals (Pvt) Ltd

Ledipasvir Spray dried dispersion (50%w/w)

Approved in 263rd DRB meeting

10. Ledifos Tablet M/s. Getz Pharmaceuticals (Pvt) Ltd


Approved in 263rd DRB meeting

11. Cure-C Tablet M/s Global Pharmaceutical Pvt. Ltd



12. HepLed Tablet M/s Crystolite Phamaceuticals



13. Sofoled Tablet M/s Hilton Pharma Ledipasvir Spray Panel for onsite Minutes for 267th Registration Board Meeting 296

dried dispersion (50%w/w)

investigation constituted in 263rd DRB meeting

Decision: Registration Board decided to seek clarification from the firms enlisted above at Sr. No. 1,2,3,4,5,6,7 & 8 for not using Ledipasvir Spray dried dispersion (50%w/w) as per innovator in formulation of their products stated above. No such clarification is demanded from rest of firms enlisted above as they have used Ledipasvir Spray dried dispersion (50%w/w) as per Innovator’s formulation







Previous Remarks of the Evaluator.

Previous DRB Decision

24. M/s. TITLIS Pharma 528-A Sundar Industrial Estate, Lahore

Delanso Capsule 30mgEach capsule containsEnteric coated pellets of Dexlansoprazole …30 mg(Proton pump inhibitor)Manufacturers specificationsSource of Pellets from M/s Lee Pharmaceuticals , India

Form-5DNew License15-09-2014196 R&IRs.50,000/-10‗s as per brand leader

DEXILANT30mgDelayed release CapsuleUSFDA

The firm has submitted the remaining fee of Rs.100, 000/- for import of pellets.The following required documents have been submitted:i. COA of pellets from Lee pharmaceuticalsii. Stability studies report from supplier (accelerated studies for 6 months & long term studies for 12 months)

GMP certificate of sourceof pellets i.e. M/s Lee Pharma Ltd, PlotNo. V, Phase-II, VSEZ, Duvvada,Sabbavaram (Mandal) Visakhapatnam

262nd Meeting Registration Board held on 20-21st October, 2016Deferred for submission of stability data of product as per guidelines of 251st RB meeting.


District, Andhra Pardesh, India.

Evaluation By PEC Firm has submitted stability data details of which is tabulated as under:


Drug Delanso Capsule (Dexlansoprazole)30mgName of Manufacturer M/s. TITLIS Pharma 528-A Sundar Industrial Estate, LahoreManufacturer of API /pellets M/s. Lee Pharma Ltd.

API Lot No. DEX-D0060-F099


Transparent orange cap & Transparent colorless body #3, hard gelatin capsule, containing white to off white greyish colored enteric coated pellets, packed in plain unit carton.

Stability Storage Condition Accelerated: 40°C ± 2°C / 75 ± 5%RHReal Time: 30°C ± 2°C / 65 ± 5%RH


Frequency Accelerated: 0,3 & 6 (Months)Real Time: 0,3 & 6 (Months)

Batch No. T-033 T-034 T-035Batch Size 350 capsules 350 capsules 350 capsulesManufacturing Date July 2016 July 2016 July 2016Date of Initiation 22-07-2016 22-07-2016 22-07-2016No. of Batches 03



1. COA of API Yes


Copy provided.Valid till 10-04-2017



Yes


Copy of Invoice provided (not attested by ADC). DHL track sheet has been submitted for courier of said API.




REMARKS OF EVALUATOR(AD PEC-II)

Firm has submitted stability data as per guidelines of 251st DRB meeting


Decision: Registration Board deferred the case for clarification of Copy of Invoice not being attested by ADC and receiving material via courier.


Name and address of



name + Dosage Form +

Strength)Composition

Pharmacological Group

Finished product

Specification

Type of Form

Initial date, diaryFee


feeDemanded

Price / Pack size

Remarks on the

formulation (if any) including International status

in stringent


authoritiesMe-too statusGMP

status as depicted in latest

inspection report (with

date) by the

Evaluator

Previous Remarks of the

Evaluator.

Previous DRB

Decision

25. M/s. TITLIS Pharma 528-A Sundar Industrial Estate, Lahore

Delanso Capsule 60mgEach capsule containsEnteric coated pellets of Dexlansoprazole …60 mg(Proton pumpinhibitor)Manufacturers specificationsSource of M/s Lee Pharmaceuticals , India

Form-5DNew License15-09-2014201 R&I10‗s as per brand leaderRs.50,000/

DEXILANT60mgDelayed release CapsuleUSFDA

The firm has submitted the remaining fee for import of pellets.The following required documents have been submitted:i. COA of pellets of M/s LEE Pharma, Indiaii. Stability studies from supplier (accelerated studies for 6 months & long term studies for 12 months)

GMP certificate of source of

262nd

Meeting Registration Board held on 20-21st October, 2016Deferred for submission of stability data of product as per guidelines of 251st RB meeting.


pellets i.e.M/s LEE Pharma, India

Evaluation By PEC Firm has submitted stability data details of which is tabulated as under:



Drug Delanso Capsule (Dexlansoprazole) 60mgName of Manufacturer M/s. TITLIS Pharma 528-A Sundar Industrial Estate, LahoreManufacturer of API /pellets M/s. Lee Pharma Ltd.API Lot No. DEX-D0060-F099


Transparent orange cap & Transparent colorless body #3, hard gelatin capsule, containing white to off white greyish colored enteric coated pellets, packed in plain unit carton.



Frequency Accelerated: 0,3 & 6 (Months)Real Time: 0,3 & 6 (Months)

Batch No. T-036 T-037 T-038Batch Size 350 capsules 350 capsules 350 capsulesManufacturing Date July 2016 July 2016 July 2016Date of Initiation 22-07-2016 22-07-2016 22-07-2016No. of Batches 03


Sr.# Documents To Be Provided Status

1. COA of API Yes


Copy provided.Valid till 10-04-2017



Yes


Copy of Invoice provided (not attested by ADC). DHL track sheet has been submitted for courier of said API.




REMARKS OF EVALUATOR(AD PEC-II)

Firm has submitted stability data as per guidelines of 251st DRB meeting


Stability Case 26Minutes for 267th Registration Board Meeting 302

Sr.#





Remarks/Previous DRB Decision

26. M/sGlaxoSmithKlinePakistan limted, F- 268 S.I.T.E.,Karachi

Panadol Sinus CapletsEach Caplet Contains:Paracetamol…500mgPhenylephrine Hcl. 5.00mg

Form 5-D (Fast Track)Rs.8,000/-09-12-2010Dy. No. notmentionedRs.60,000/-20-03-2013Dy. No. notmentionedRs.82,000/-19-11-2013Dy. No. notmentionedRs.300/-100‘s

TGA Approved

The case was discussed in 262nd DRB meeting along with stability and following shortcomings were recorded:- Lab reports & raw data

sheets for the submitted stability data are missing sheets.

Stability protocol does not describe the Product analysis method.

Registration Board deferred for submission of information as under:a. Approval of APIs by regulatory authority of country of origin or GMP certificate of APIs manufacturer issued by regulatory authority of country of origin.b. Lab reports & raw data sheets for the submitted stability datac. Product analysis method.d. Documents confirming import of Paracetamol.


i. Copy of GMP certificate issued by DCA, Andrapardesh, India in the name of Minutes for 267th Registration Board Meeting 303

M/s Divi’s Labs. Ltd, Andra Pardesh India, valid up to 04-07-2018 (Supplier of Phenylepherine)

ii. Lab reports & raw data sheets for stability study of all three batchesiii. Product analysis method

Firm has stated Zafa is local manufacturer and there is no requirement of ADC endorsed invoice in this case.

Decision: Registration Board decided to constitute the following panel for onsite investigation to confirm genuineness/ authenticity of stability data and associated documents, import of API, quality, specification, test analysis, facilities etc.

Director DTL Quetta (Chairman) Mr. Aslam Shah (Member). Area FID, DRAP (Member / Convener.







27. M/s HelixPharma, (Pvt)

Ltd., Hakimsons

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

Manghopir Road

Karachi

Declar tablets 60 mg

Each film coated Tablet :

Daclatasvir dihydrochloride

equivalent to Daclatasvir…

60mg

Direct Acting Antiviral

Form 5-DDy no: 225

dated: 16-02-2016

Rs: 50,00010’s20’s30’s

As per PRC

Status in SRA:

Daklinza by Bristol-

Myyers Squib.

USFDA

264th Meeting Registration Board held on 28-29th

December, 2016.

Deferred for submission of following: Supported documents

like chromatograms, laboratory reports and data sheets are not attested with name and stamp.

Approval of API by regulatory authority of


Manufacturer’s Specs

country of origin or GMP certificate of API manufacturer issued by regulatory authority of country of origin is not provided.

Documents confirming import of API are not ADC attested.


i. Copy of GMP certificate issued by Shaoguan FDA, People’s Republic Of China, in the name of M/s Ruyuan HEC Pharm Co., Ltd., valid up to 17-06-2018

ii. Copies of attested chromatograms, laboratory reports and data sheets.iii. Copy of Invoice & courier slip of FedEX for Daclatasvir








28. M/s HelixPharma, (Pvt)Ltd., HakimsonsHouse, A/56,S.I.T.E.Manghopir Road

Declar tablets 30 mgEach film coated Tablet :Daclatasvir dihydrochloride 33 mg equivalent to Daclatasvir

Form 5-DDy no: 224

dated: 16-02-2016

Rs: 50,00010’s20’s30’s

Status in SRA:

Daklinza by Bristol-

Myyers Squib.

264th Meeting Registration Board held on 28-29th

December, 2016.Deferred for submission of following: Supported documents

like chromatograms, laboratory reports and data sheets are not attested with name and


Karachi …………30mg As per PRC USFDA stamp. Approval of API by

regulatory authority of country of origin or GMP certificate of API manufacturer issued by regulatory authority of country of origin is not provided.

Documents confirming import of API are not ADC attested.


i. Copy of GMP certificate issued by Shaoguan FDA, People’s Republic Of China, in the name of M/s Ruyuan HEC Pharm Co., Ltd., valid up to 17-06-2018

ii. Copies of attested chromatograms, laboratory reports and data sheets.iii. Copy of Invoice & courier slip of FedEX for Daclatasvir




Applicant





Specification



differential fee),Demanded Price /

Pack size


Availability


Remarks

Previous Evaluation

29. M/s. Fynk Pharmaceuticals,

Lahore.

Ledifos Tablets 400mg

Each film coated tablet contains:Ledipasvir (as acetone solvate)…………90mgSofosbuvir ……400mgAnti-ViralJ05AX65

Form-5D

Diary No.100910-01-2017

Rs. 50,000/- (20,000/- + 30,000/-)As per SRO /28’s

Harvoni by Gilead Sciences Inc., USA./Not applicable

Inspection conducted on 03-05-2016 shows good compliance.

The case was discussed in 265th

RB meeting along with stability data, details of which are as under


Drug Ledifos Tablets 400mg (Ledipasvir + Sofosbuvir)Name of Manufacturer M/s. Fynk Pharmaceuticals, Lahore.

Manufacturer of API Sofosbuvir: Pharmagen Ltd., Lahore.Ledipasvir: Virupaksha Organics Limited., India.

API Lot No. Sofosbuvir: 00511211/002/2015Ledipasvir: ALEDC0216001

Description of Pack Alu-Alu blister pack.


(Container closure system)


Time Period Accelerated: 26 weeksReal Time: 26 weeks

Frequency Accelerated: 0,1,2,3,4,6,8,12,16,20,24,26 (Weeks)Real Time: 0,1,2,3,4,6,8,12,16,20,24,26 (Weeks)

Batch No. T01 T02 T03Batch Size 200 Tablets 200 Tablets 200 TabletsManufacturing Date 18-05-2016 18-05-2016 18-05-2016Date of Initiation 20-05-2016 20-05-2016 20-05-2016No. of Batches 03



1. COA of API Yes


Pharmagen:Yes (FID Lahore-II, 27-07-2015)

Virupaksha:Copy of cGMP Certificate valid till 23.07.2016 provided. However name of API ‘Ledipasvir’ is not confirmed in scope of inspection.



Yes





Decision: Registration Board Deferred for want of information as under: Documents confirming import of API (Ledipasvir) are not provided

Evaluation by PEC Firm has submitted copies of Invoice, Form 3 & Form 7 which have not been signed by any DRAP

official A copy of FedEx track sheet has been submitted stating delivery of Ledipasvir Acetone solvate to

M/s Fynk Pharmaceuticals on 18-05-2016. Firm has stated date of manufacturing of all three batches as 18-05-2016, which is the same date as

that of API (Ledipasvir) delivery mentioned on FedEx track sheet. Firm has used Ledipasvir Acetone in pure form whereas Innovator has used Ledipasvir Spray dried

dispersion (50% w/w) as Ledipasvir is susceptible to the influence of gastrointestinal pH and fed state.

Batch size stated by firm (200 tablets / batch) is not enough to conduct stability study as per testing


frequency stated by firm. Dissolution test stated by firm is not as per recommended by USFDA for applied formulation.

Decision: Registration Board deferred the case for clarification of following points: Firm has used Ledipasvir Acetone in pure form whereas Innovator has used Ledipasvir

Spray dried dispersion (50% w/w) as Ledipasvir is susceptible to the influence of gastrointestinal pH and Fed state.

Copy of Invoice not being attested by ADC and receiving material via courier. Firm has stated date of manufacturing of all three batches as 18-05-2016, which is the same

date as that of API (Ledipasvir) delivery mentioned on FedEx track sheet. Batch size stated by firm (200 tablets / batch) is not enough to conduct stability study as per

testing frequency stated by firm. Dissolution test stated by firm is not as per recommended by USFDA for applied formulation

Case No.06: Verification of authenticity of stability studyInspection for Verification of Authenticity of Stability Data of DAKVIR (Daclatasvir 2 HCl) 60mg Tablets submitted by M/s. Pharm Evo Pharmacreuticals (Pvt) Ltd., Karachi.

Background:

The inspection of M/s. Pharm Evo Pharmaceuticals (Pvt.) Ltd., Bin Qasim, Karachi, for re-verification of stability data submitted by the firm to DRAP, Islamabad in respect of their product namely DAKVIR (Daclatasvir.2HCl) 60mg tablets was considered on 26 th January 2017 by the panel of experts constituted vide DRAP, Islamabad Letter No.F.2-17/2016-PEC (M-263) dated: 10th January 2017.

Details of Investigations as presented in 263rd Meeting:

Q. No. Question Observation by panel1. Do you have documents confirming the

import of Daclatasvir API including approval from DRAP?

The firm has imported Daclatasvir raw material 0.5 Kg from M/s Virupaksha Organics Ltd, India and has approval from DRAP for import vide office No.16969/15-DRAP(K) dated 13.10.2015.

2. What was the rationale behind selecting the particular manufacturer of API?

Rationale behind selecting the manufacturer is GMP Status of API’s manufacturer.

3. Do you have documents confirming the import of Daclatasvir reference standard and impurity standards?

Firm imported Daclatasvir raw material 0.5 Kg from M/s Virupaksha Organics Ltd, India vide invoice No. VPPL/EXP/021/15-16 dated 15.09.2015. Firm has imported working reference standards from same source.

4. Do you have certificate of Analysis of the API, reference standards and impurity standards?

The firm has certificates of analysis for API and reference standards for API.

5. Do you have GMP certificate of API manufacturer issued by regulatory authority of country of origin?

Firm provided copy of GMP certificate issued by Drug Control Administration, Government of Telangana on 23.07.2015.

6. Do you use API manufacturer method of testing for testing API?

The firm use API manufacturer’s method of testing.

7. Do you have stability studies reports on API? The firm has stability studies reports on API.


8. If yes, whether the stability testing has been performed as per SIM method and degradation products have been quantified?

The stability testing has been performed as per SIM method and degradation products have been quantified.

9. Do you have method for quantifying the impurities in the API?

Firm has developed isocratic method for analysis of API only. However, this method has no capability to be used for determining chromatographic purity.

10. Do you have some remaining quantities of the API, its reference standard and impurities standards?

Firm have some remaining quantities of the API and reference standard.

11. Have you used pharmaceutical grade excipients?

The firm has used pharmaceutical grade excipients and include microcrystalline cellulose, lactose, aerosol, cross carmellose, silicon dioxide magnesium stearate and green color film coating material.

12. Do you have documents confirming the import of the used excipients?

The firm has necessary documents confirming the import of the used excipients except Magnesium stearate which was purchased locally.

13. Do you have test reports and other records on the excipients used?

The firm has test reports and other records on the excipients used.

14. Do you have written and authorized protocols for the development of Daclatasvir tablets?

The firm has written and authorized protocols for the development of Daclatasvir (60mg) tablets.

15. Have you performed Drug-excipient compatibility studies?

The firm has not performed Drug-excipient compatibility studies as composition of their tablets is qualitatively similar to that of the innovator product (Deklinza Tablet).

16. Have you performed comparative dissolution studies?

The firm has not performed comparative dissolution studies due to non-availability of authentic reference pack. However, dissolution study has been done and results are in acceptable limits of USP general monograph.

17. Do you have product development (R&D) section

The firm has segregated manufacturing area but analysis facility is not available in product development (R&D) section.

18. Do you have necessary equipments available in product development section for development of Daclatasvir tablets?

Product development section lacks mixer and granulator and manual procedure was done during manufacturing operation. For analysis process, equipment of quality control section was used.

19. Are the equipments in product development section qualified?

The equipment in product development section is partially qualified.

20. Do you have proper maintenance / calibration / re-qualification program for the equipment used in PD section?

It needs improvement for adequate processing.

21. Do you have qualified staff in product development section with proper knowledge and training in product development?

It needs more strengthening for human resource and their capacity building.

22. Have you manufactured three stability batches for the stability studies of Daclatasvir tablets as required?

The firm has manufactured three stability batches for the stability studies of Daclatasvir tablet 60 mg with batch number 15DTR-1668-02-S(CN-931), 15DTR-1669-03-S(CN-932) and 15DTR-1670-04-S(CN-933) and batch size for these batches is 2500 tablets each.

23. Do you have any criteria for fixing the batch size of stability batches?

As per statement of the firm the criteria for fixing the batch size of stability batches is the number of tablets per testing frequency and number of testing


frequencies.24. Do you have complete record of production

of stability batches?The firm has complete record of production of stability batches. All the log books are proper maintained.

25. Do you have protocols for stability testing of stability batches?

The firm has protocols for stability testing of stability batches, which need revision / upgradation.

26. Do you have developed and validated the method for testing of stability batches?

The firm has developed and validated method of testing for finished product based on method of testing of API manufacturer. Testing up to 06 months has been done on isocratic method which is non-stability indicating.

27. Do you have method transfer studies in case when the method of testing being used by your firm is given by any other lab?

Firm has used API manufacturer’s method of testing, which is validated but method transfer studies has not been done

28. Do you have documents confirming the qualification of equipments / instruments being used in the test and analysis of Daclatasvir API and the finished drug?

The firm has proper documents confirming the qualification of equipment / instruments being used in the test and analysis of daclatasvir API and the finished drug

29. Do your method of analysis stability indicating?

The firm has developed and validated method of testing for finished product based on method of testing of API manufacturer. Testing up to 06 months has been done on isocratic method which is non-stability indicating and further testing has been done on stability indicating gradient method.The analysis records also show that there are significant variations (out of acceptable limits) for dissolution test, intra batch and inter batches at various testing points both in accelerated and real time stability studies with about RSD 19 %, which is very much above the acceptable limits. Panel is of the view that variation is due to manual mixing caused non-uniformity of distribution of API in the formulation. These results show that the stability batches were not manufactured properly and under controlled conditions

30. Do your HPLC software 21CFR Compliant? The HPLC software is not 21CFR Compliant.

31. Can you show Audit trail reports on Daclatasvir testing?

Audit trail on the testing reports cannot be made.

32. Do you have some remaining quantities of degradation products and stability batches?

The firm has remaining quantities of stability batches.

33. Do you have commitment batches kept on stability testing?

The firm has three stability batches kept on real time stability testing

34. Do you have valid calibration status for the equipments used in Daclatasvir tablets production and analysis?

Equipment of manufacturing area was calibrated while that of quality control was found calibrated.

35. Do proper and continuous monitoring and control are available for stability chamber?

Stability chambers for real time and accelerated studies are available but adequate monitoring and control are required for these chambers.

36. Do related manufacturing area, equipment, personnel and utilities be rated as GMP compliant?

Requisite facilities are satisfactory.


Conclusions (263rd Meeting): On the basis of risk based approach the genuineness / authenticity of stability data submitted by the firm for registration of Daclavir (Daclatasvir 30mg, 60mg) Tablets is not satisfactory due to improper manufacturing procedure, huge variation in results of dissolution test, non-adequate monitoring and control on the stability batches in stability chamber. There is significant variation in dissolution parameter, which related manufacturing area, equipment, personnel and utilities are rated as GMP compliant to satisfactory level.

Decision (263rd Meeting):

Representatives of firm appeared and reported that they have complete temperature and humidity monitoring reports for stability chambers for complete stability period, which they could not show to panel during inspection. They also submitted that variation in dissolution test result in stability batches is due to manufacturing of these batches at small / laboratory scale and assured that it will not happen in commercial manufacturing of batches. Registration Board decided that panel comprising of Prof. Dr.Rafeeq Alam Khan (Member Registration Board), Dr.Saif-ur-Rehman Khattak, FGA/Director CDL, Karachi and area FID, DRAP will visit and evaluate temperature and humidity monitoring reports for stability chambers and will submit its finding / report.

Registration Board deferred the case till report of panel and for further discussion on firm’s stance on variation in dissolution test result.

Composition of Panel for Re-inspection:-1. Prof. Dr. Rafeeq Alam Khan, Meritorious Professor, University of Karachi, Karachi;

(Member Registration Board).2. Dr. Saif-ur-Rehman Khattak, Federal Government Analyst, CDL Karachi.3. Dr. Obaid Ali, Area FID, DRAP, Karachi)

2. The panel feels that since observations, as made by the previous panel of experts on the stability data related to DAKVIR (Daclatasvir.2HCl) 60mg tablets during their inspection on 22nd

November 2016, are still valid and un-attendable by design therefore, scientifically, technically and logically, re-inspection as per the enclosed format cannot be made for the same stability data. However, complete data related to humidity and temperature of stability chambers, as submitted by the firm as supplementary data, is annexed for consideration of the board.

Decision: Representative of firm upon personal hearing in 263rd Registration Board meeting could not satisfy Registration Board on the observations regarding improper manufacturing procedure, huge variation in results of dissolution test, non-adequate monitoring and control on the stability batches in stability chamber and the panel constituted for re-evaluation also recommended that observations, as made by the previous panel of experts on the stability data related to Dakvir (Daclatasvir.2HCl) 60mg tablets during their inspection on 22nd November 2016, are still valid and un-attendable by design therefore Registration Board decided to reject the registration application of Dakvir


(Daclatasvir 2 HCl) 60mg Tablets, by M/s. Pharm Evo Pharmacreuticals (Pvt) Ltd., Karachi.


Case No.07: Import CasesA. Import priority (New formulation)

Sr. No.

Name and address of


Brand Name(Proprietary name +

Dosage Form + Strength)



Specification



fee

Demanded Price /

Pack size


status in stringent drug regulatory

agencies / authorities

Me-too status


Evaluator


Decision

1. M/s Servier Research and Pharmaceuticals Pakistan (Pvt) Ltd. 65 Main Boulevard Gulberg Lahore Pakistan

Manufactured byLes Laboratoires ServierIndustrie, 905, route de saran 45520 Gidy France

Product license holderLes Laboratories Serveir – 50 rue Carnot-92284 Suresnes Cedex, France

IMPLICOR film coated TabletsEach film coated tablet contains Metoprolol Tartrate …….50mgIvabradine …….7.5mg (equivalent to 8.085 mg ivabradine as hydrochloride)Antianginal

Form 5-A

Dy No. 171PKR 100,000/- dated 10/02/2016

Unit price not provided

Pack size 14’s, 28’s

Implicor by Serveir, SWISMEDICImplicor by Serveir, Denmark

Implicor Serveir ANSMN/A(It is a new formulation)Original legalized COPP Issued by Commerce and Industry Chmaber of Paris Ile de France region on 23rd Oct, 2015 which shows that the Status of GMP compliance is in perfect agreement as recommended by WHO.

1. Country of origin holds market authorization for the applied formulation but the formulation is not present in the market for free sale.2. The firm has stated that since October 2015 COPP & free sale certificate are no longer issued by French National Agency for Medicines and Health Products Safety (ANSM), They are issued by Commerce and Industry Chamber France. Press release issued by ANSM for the transfer of the activity is available on official site of ANSM which has been verified.3. The firm has claimed Ph. Eur. But the applied formulation is not present in available Pharmacopoeia BP 2013 & USP 39.

Deferred for clarification of free sale availability in any of reference regulatory authority as approved in 256th

Registration Board Meeting

2. M/s Merixil INJECTION Form 5-A Voriconazole The firm has Approved as per


Pharma, Office NO. 28, 2nd floor, Rose Plaza, I-8 Markaz, IslamabadManufacturerLaboratories Normon, S.A., Ronda de Valdecarrizo, 6, 28760nTres Cantos (Madrid), Spain.Product License HolderLaboratories Normon, S.A., Ronda de Valdecarrizo, 6, 28760nTres Cantos(Madrid), Spain.

VORICONAZOLE NORMON 200mgPowder for Solution for IV infusionEach Vial Contains:Voriconazole….. 200mgAntifungal(Triazole Derivative)

Dy. No. 120812/01/2107Fee 50,000/-

Pack Size1’s

Price as per PRC policy

byyy Hossspira Healthcare Coorporation, HealthCanadaN/AOriginal legalized COPP issued by Agencia Espanola Del Medicomento Y Productos Sanitarios, SPAIN on 17/10/2106 confirms the free sale of product in country of origin. The Status of GMP compliance is in perfect agreement as recommended by WHO as per COPP.

claimed In House specifications while the product is not present in BP 2013 & USP 39.

Import Policy for Finished Drugs and with Innovator’s Specifications

3. M/s Atco Pharma International Private Limited, B-18, S.I.T.E Karachi-75700, Pakistan.Drug Substance manufacturing siteCelltrion Plant – 23, Academy-ro, Yeongsu-gu. Incheoon, Republic of Korea.Drug product manufacturing siteCelltrion Plant 2-20Academy-ro 51 Beon-gil, Yeonsu. Incheon, 22014, Republic of Korea.Partial

REMSIMA 100mg Powder for Concentrate for Solution of I.V InfusionEach 20ml contains:Infliximab Lyophilized Powder…. 100mg

TNF Blocker(Tumor necrosis factor)

Form 5ADy. No. 236709/12/2016Fee 100,000/-Price 110,000/-Pack SizeI’s (20ml Vial)

Inflectra by Celltrion Healthcare, Helath CanadaOriginal Legalized COPP issued by Ministry of Food and Drug Safety, Republic of Korea on 16th may 2016 is attached which confirms the free sale of drug in country of origin. The status of GMP compliance is good as per COPP.

1. The firm has claimed In-House Specs while the product is not present in available pharmacopoeia BP 2013 & USP 39.

2. Sole agency agreement is in between CELLTRION Inc. Korea and Atco Pharma International, Pakistan.

3. Address of product license holder in COPP (Plant I & Plant II) is different from the address written in sole agency agreement. The firm has stated that all of these facilities are

Referred to Biological Division


consignment to:Mustafa Nevzat Ilac Sanayii A.S, COban Cesme Mah. Sanayi Caddesi 13, 34196 Yenibosna/ Istanbol Turkey (Lyophilization & Capping in drug product)AS PER COPPMarket authorizationCELLTRION, Inc. KOREA

within CELLTRION’s Complex.

(Address as per Sole agency agreement 4 FI, 19, Academy-ro 51, Yeonsu-gu, Incheon, (406-840), Korea)

Case No.08: Miscellaneous Casesa. Registration of drugs not included in list-I

S. No.



Type of Form

Initial date,diaryFee


fee

Demanded Price /

Pack size




Me-too status


Evaluator


Decision

I. Following applications were received through Letter No. F 9-4/2016 (Reg-II) dated 13 th

December, 2016. According to the letter, the fee for following applications was completed before 22nd May 2014, but could not be added in 1st list of pending applications. Now these applications are forwarded to Pharmaceutical Evaluation Cell for evaluation.The application has now been evaluated and hereby presented before the board

1. Barrett Hodgson Pakistan Pvt. Ltd

Telbar Tablet 20mgEach tablet containsTelmisartan……20mg

Angiotensin II receptor

Form 5Duplicate

12-01-2011

8,000/-12-01-2011

+12,000

29-07-201310’s

Micardis 20mg tablet by Boehringer

Ingelheim(MHRA Approved)

Tasmi by Getz Pharma


Firm has claimed Mfg. specs but the product is present in USP-39

Approved with USP Specification. Reference will be sent to Budget & Accounts Division for verification of challan &


antagonist Rs. 200/pack Dated 18 to 21 Jan & 02 Feb 2016


Chairman registration board shall authorize issuance of registration letter


Telbar Tablet 40mgEach tablet containsTelmisartan…….40mg

Angiotensin II receptor antagonist

Form 5Duplicate

12-01-2011

8,000/-12-01-2011

+12,000

29-07-201310’s

Rs. 375/pack



Tasmi by Getz Pharma


Dated 18 to 21 Jan & 02 Feb 2016



Approved with USP Specification. Reference will be sent to Budget & Accounts Division for verification of challan and Chairman registration board shall authorize issuance of registration letter


Telbar Tablet 80mgEach tablet containsTelmisartan …….80mg

Angiotensin II receptor antagonist

Form 5Duplicate

12-01-2011

8,000/-12-01-2011

+12,000/-

29-07-201310’s

Rs. 700/pack



-Tasmi by Getz Pharma


Dated 18 to 21 Jan & 02 Feb 2016



Approved with USP Specification. Reference will be sent to Budget & Accounts Division for verification of challan & Chairman registration board shall authorize issuance of registration letter

4. Barrett Hodgson Pakistan Pvt. Ltd.

Co-Telbar Tablet

Each tablet contains :-Telmisartan ….…40mg Hydrochlorothiazide… 12.5mg

Combinatio

Form 5Duplicate

04-05-2011

8,00003-05-2011

+12,000

29-07-2013

10’sRs. 425/pack

Micardis Plus 40/12.5mg tablet by

Boehringer Ingelheim

(MHRA Approved)

Co-Tasmi by Getz Pharma


Dated 18 to 21 Jan


Approved with USP Specification. Reference will be sent to Budget & Accounts Division for verification of challan and Chairman registration


n of Angiotensin II receptor blocker plus thiazide diuretics

& 02 Feb 2016 recommends the renewal of DML

board shall authorize issuance of registration letter

II. Following application was received vide letter No.F.16-4/2013-Reg-IV from R-IV section stating that this application was received before May 2014 but could not be included in List-I. Now this application is forwarded to PEC.

The application has now been evaluated and hereby presented before the board5. Bloom

PharmaceuticalsPvt Ltd, Hattar

Moment Cream 0.1 % (W/W)Each Gm cream containsMometasone Furoate(U.S.P.) 0.1%

Corticosteroid

USP Specs

Form 512-10-2012Dy No. 919Rs. 20,00012-10-20121’s x 5gm

As per SRO

Elocon MHRA

Edme by Amarant



improved GMP

Firm has Ointment/Cream Section

Approved

III. Following applications have been received vide letter No.F.9-4/2016 Reg-II from R-II section stating that this application was received before 22nd May 2014 but could not be included in List-I. Now this application is forwarded to PEC.The application has now been evaluated and hereby presented before the board

6. M/s Martin Dow PharmaceuticalsPakistan Ltd.Karachi

Co-Valiant TabletsEach tablet contains:Valsartan …..80mg +Hydrochlorothiazide ...12.5mg

Angiotensin II Antagonist

Form 5Duplicate

30-04-2012Dy No. 775

Fee8,000

27-04-201212,000

13-11-2013Rs.

466.52/10’sRs.

653.19/14’sRs.

933.04/20’s1306.25/28’

sRs.

1339.55/30’s

Co-Diovan MHRA

Co-Diovan by Novartis Pharma


18-03-2016Showing

satisfactory GMP compliance and overall rated as

good.

Fee Challan are not in original.

The Firm has claimed Mfg Specs and the product is present in (USP 39)

Approved with USP Specification. Reference will be sent to Budget & Accounts Division for verification of challan and Chairman registration board shall authorize issuance of registration letter

7. M/s Martin Dow Pharmaceutic

Muwenta SR tablets 16mg

Form 5Duplicate

19-09-2013

Not Confirmed

Not available

EMA has restricted the use of this

Deferred for following1. Application


alsPakistan Ltd.Karachi

Each sustained release tablet contains Thiocolchicoside….16mg

Gaba Mimetic/Central Acting Agent

Dy No. 104Fee

20,00018-09-2013

Rs. 567/10’s

Rs. 1134/20’s

Rs. 1701/30’s


18-03-2016Showing


good.

drug and suggested to use in low doses only

Fee challan is not original

International availability and me too status cannot be confirmed

Firm has claimed Mfg Specs and the product is not present in available pharmacopoeias (USP 39& BP2013)

on Form 5-D with all its enclosures2. Original fee challan3. Confirmation of approval by reference regulatory authorities

8. M/s Martin Dow PharmaceuticalsPakistan Ltd.Karachi

Anzolam XR tablets0.5mgEach extended release tablet contains:Alprazolam….0.5mg

Benzodiazepine Derivative

U.S.P. Specs

Form 529-03-2013Dy No. 215

Fee20,000

29-03-2013Rs. 77/10’s

Rs. 154/20’s

Rs. 231/30’s

Xanax XR by Pfizer USFDA

Xanax XR by Pfizer


18-03-2016Showing


good.

Fee challan is not original

Me too status cannot be confirmed

Deferred for evidence of me-too status and original fee challan

IV. Following applications have been received vide letter No.F.6-4/2013 R-III from R-III section stating that the following duplicate registration applications are being forwarded to PEC for evaluation, the original dossiers have already been forwarded to PEC for evaluation vide this section letter No. NIL dated 17-02-2014 and 05-03-2014.

The application has now been evaluated and hereby presented before the board9. M/s.

Wenovo Pharmaceuticals, Plot No. 31 & 32 Punjab Small Sundar Industrial Estate Taxila

Desnova 5 mg TabletEach film coated tablet contains:-Desloratadine……..5mg(Allergies)

Form 503-02-2014Dy.No.151Rs.20,000/-03-02-2014

1x10’sas per SRO

Clarinex-Merck-USFDA

D-Lorata by Weatherfolds


22-01-2016For GMP

certificate for export

Firm has claimed Mfg Specs and the product is not present in available pharmacopoeias ( USP 39and BP2013)

Approved with Innovator’s Specification


Rawalpindi.

10. M/s. Wenovo Pharmaceuticals, Plot No. 31 & 32 Punjab Small Sundar Industrial Estate Taxila Rawalpindi.

Pramovo 10 mg TabletEach film coated tablet contains:-Escitalopram as Oxalate …….10 mgAnti psychoticUSP Specs

Form 503-02-2014Dy.No.153Rs.20,000/-03-02-2014

10’s14’s

as per SRO

Lexapro b Forest (USFDA)

Cipralex by Lundbeck


22-01-2016For GMP


Approved


Ribovo 10 mg TabletsEach film coated tablet contains:-Rivaroxaban…..10 mg(Anticoagulant)

Form 518-02-2014Dy.No.168Rs.20,000/-18-02-2014

1x5’sas per SRO

Xarelto by Janssen

Pharmaceuticals USFDA



22-01-2016Grant of GMP certificate for

export




Ribovo 15 mg Tablets

Each film coated tablet contains:-Rivaroxaban…...15 mg

(Anticoagulant)

Form 518-02-2014Dy.No.167Rs.20,000/-18-02-2014

1x5’sas per SRO

Xarelto by Janssen




22-01-2016For GMP




13. M/s. Wenovo Pharmaceuticals, Plot No. 31 & 32 Punjab Small Sundar Industrial Estate Taxila

Ribovo 20 mg Tablets

Each film coated tablet contains:-Rivaroxaban………..20 mg(Anticoagul

Form 518-02-2014Dy.No.169Rs.20,000/-18-02-2014

1x5’sas per SRO

Xarelto by Janssen




22-01-2016For GMP

Firm has claimed Mfg Specs and the product is not present in available pharmacopoeias (USP 39 and BP2013)



Rawalpindi.

ant) certificate for export


Linavo 5 mg TabletsEach film coated tablet contains:-Linagliptin …………. 5mg(Diabetes, dipeptidyl peptidase-4(DPP-4) inhibitor

Form 518-02-2014Dy.No.196Rs.20,000/-18-02-2014

10x10’sAs per SRO

Tradjenta (Linagliptin)

USFDANot provided


22-01-2016For GMP


Me too status cannot be confirmedProduct deferred for comments of IPO in 253rd

DRB meetingFirm has claimed Mfg Specs and the product is not present in available pharmacopoeias (USP 39& BP2013).

Deferred till the comments of IPO


Ketonov 30 mg Injection

Each ml contains:-Ketorolac Tromethamine≡ Ketorolac ……… 30 mg(NSAID)USP specs

Form 503-04-2014Dy.No.222Rs.20,000/-04-03-2014

1mlx5’sAs per SRO

USFDA

Torolac by Global Pharma


22-01-2016For GMP


Approved

B. Registration of drugs of Public Health urgency on priority basisFollowing three applications were received through Letter No.F 9-4/2016 (Reg-II) dated 30 th

January, 2017 stating that following applications of “ribavirin” are to be processed on priority basis as they are of public health urgency. The application has now been evaluated and hereby presented before the board

S. No.

Name and address of






Specification


diaryFee including differential fee

Demanded Price /

Pack size

Remarks on the formulation (if any)

including International status in stringent drug

regulatory agencies / authorities

Me-too status

GMP status as depicted in latest inspection report

(with date) by the Evaluator


Decision


16. M/s Barrette Hodgson Pakistan Pvt. Ltd., F/423, SITE, Karachi.

BAROVIR 600mg Tablet

Each Film Coated Tablet contains:Ribavirin….. 600mgAntiviral

USP specs

Form 5Dy. No. 258425/01/2017

Fee 20,000/-25/01/2017

Price760/- per 10’s1064/- per 14’s1520/- per 20’s2128/- per 28’s2280/- per 30’s

Ribavirin by ZYDUS PHARMS,

(USFDA Approved)Ribuvir by Martin Dow

Last inspection report Dated 14/04/2015 is

attached which confirms the good level of GMP

compliance.Latest inspection report

dated 18th to 21st Jan &02nd Feb, 2016 is attached, the panel

recommended renewal of DML

Label shows that the specifications are In House.

Approved

17. M/s Nabi Qasim Industries Pvt. Ltd., 17/24, Korangi industrial area, Karachi.

RIVAB 400mg Capsule

Each Hard Capsule Contains:Ribavirin…. 400mgAnti-Viral

USP Specs

Form 5Dy. No. 134613/01/2017Fee 20,000/-13/01/2017

Pack Size10’s, 20’s, 30’s

Price as per SRO

Not provided

Ribuvir by Martin Dow


attached which confirms acceptable level of GMP compliance.


Deferred for the confirmation of approval by reference regulatory authorities

18. M/s Nabi Qasim Industries Pvt. Ltd., 17/24, Korangi industrial area, Karachi.

RIVAB 200mg Capsule

Each Hard Capsule Contains:Ribavirin…. 200mgAnti-Viral

USP Specs

Form 5Dy. No. 134513/01/2017

Fee 20,000/-13/01/2017

Pack Size10’s, 20’s, 30’s

Price as per SRO

Ribavirin by Merk Sharp & Dohme

limited,(MHRA Approved)

Revirin by High-Q Pharma


attached which confirms acceptable level of GMP compliance.

Approved

C. Withdrawal of registration application 19. M/s Ferozesons Laboratories Ltd has submitted an application for withdrawl of

registration application for their product “Stribild” dated January 03, 2017. The firm has requested to withdraw the application upon the instruction of their legal manufacturer M/s Gilead sciences Inc. USA.

Details of applicant & manufacturer

Product details Application details

Importer M/s. Ferozsons Laboratories Limited,P.O. Ferozsons Amangar, Nowshera.

Stribild TabletsEach tablet contains:-Elvitegravir………150mg

Form -5-A

Diary No. 230/ R&IMinutes for 267th Registration Board Meeting 321

Manufacturer:M/s. Patheon Inc.,2100 Synetx Court, Mississauga, Ontario,L5N 7K9, Canada.

Cobicistat………...150mgEmtricitabine…… 200mgTenofovir DisoproxilFumarate................300mgEq. to 245mg of tenofovir disoproxil.Antiretroviral Drugs

Dated 20-03-2014.Rs.50000/-

Demanded Price PKR: 730/ Tablet

Pack size of 30 tablets.

Decision: Registration Board deferred the case for detailed clarification from the firm for reasons of withdrawal

20. M/s Sami Pharmaceuticals Pvt Ltd has requested to withdraw their registration application of “Winvir 90/400mg” dated 24th January 2017. The product was initially considered in 263rd meeting of DRB and Registartion Board decided to constitute panel for confirmation of authenticity of stability data and associated documents. Letter for verification of authenticity of stability data was issued to the firm dated 17 th January 2017. Now the firm has submitted that they are not interested in this product due to techno commercial reasons and requested that their application shall accordingly be treated as abandoned/withdrawn.

Decision: Registration Board acceded to request of firm for withdrawal of above

products

D. Deferred cases of Omeprazole + Sodium Bicarbonate Formulations21. Omeprazole and sodium bicarbonate 20mg/1100mg capsule was discussed in 250 th

Registration Board meeting with following comments and decision

OMEPRAZOLE 20MG + SODIUM BICARBONATE 1100MG CAPSULES

International availability

Me too status Remarks

ZEGERID capsule 20mg/ 1.1 grm approved by FDA

BIOS of M/s WerrickPRENAT of M/s SJ&G

Omeprazole is acid labile and thus rapidly degraded by gastric acid. ZEGERID Capsules and Powder for Oral Suspension are immediate-release formulations that contain sodium bicarbonate which raises the gastric pH and thus protects omeprazole from acid degradation. FDA approved formulation ZEGERID is supplied as immediate-release capsules. Each capsule contains either 40 mg or 20 mg of omeprazole and 1100 mg of sodium bicarbonate with the following excipients: croscarmellose sodium and sodium stearyl fumarate (Ref: US FDA)

Decision:Deferred for expert opinion for clarification as under:i. Significance/ place of therapyii. Risk vs benefit ratio especially in view of risk of systemic alkalosis associated with the drug.

Experts:i. Dr Saeed Hamid, AKUH, Karachi


ii. Dr Altaf Alam, Sheikh Zayed Hospital Lahore.iii. Brig. Amjad Salamat, Military Hospital, Rawalpindi

As the product is approved by FDA in the same dosage form and strength therefore following previously deferred cases are hereby presented before the board FDA has approved following important points in Patient Information Leafelet (PIL) for the above formulations

Take ZEGERID (Capsule and Sachet) on an empty stomach at least one hour before a meal.

Empty the contents of a packet of ZEGERID Powder for Oral Suspension into a small cup containing 1-2 tablespoons of water. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and drink immediately. Refill cup with water and drink.

S. No.

Name and address of



Dosage Form + Strength)Composition


Specification



Demanded Price /

Pack size




Me-too status

Decision of previous DRB

1. M/s Helix Pharma (Pvt) Ltd., Hakimsons House, A/ 56, S.I.T.E., Karachi

Primavera/ Omni Plus/ Ristor/ Omnita Omitag/ OSB CapsuleEach capsule containsOmeprazole…..20mgSodium Bicarbonate …….1100mg(Strength has been corrected as 1100 mg which was typed as 110mg in the agenda copy)Proton Pump Inhibitor & Antacid

Form 530-08-2010Dy No 203Rs 8000+Rs.12000/-(22-07-13)MRP of 10capsules as perPRC

International:Zegerid (FDA)Local: Rapid (global)Satisfactory GMPCompliance(11.8.2014) Verification of copy of Rs.12000/- fee challan is required.

Deferred for reviewof formulation byReview Committee.(M-246)

Defrered for Expert opinion (M-250)

2. M/s PPPP, Karachi

Xobib Capsule 20mgEach capsule contains:-Omeprazole …..20mgSodium Bicarbonate …………….1100mg(Proton Pump Inhibitor)

Form-5Dy No. 125328-06-2010Rs. 8000+Rs12000/-08-02-3013Rs 11/capsule

Deferred for review of formulation as decided by Registration Board(M-238)

Defrered for Expert opinion (M-250)

3. M/s NabiQasimKarachi

Loprot Plus CapsuleEach capsule contains:-Omeprazole ……..20mgSodium Bicarbonate .1100mg(Anti Ulcerant)

Form-503-08-2010Dy.No.1530Rs.8000Rs.12,000/14-5-2013

Referred toreviewcommittee(M-239)


7’s10’s14’sAs perPRC

4. M/s. Cibex (Private) Ltd.F-405, SITE, Karachi

Cibra Swift 20mg/1100mg CapsuleEach Capsule contains:Omeprazole …20mgSodium Bicarbonate …1100mg(Anti-Ulcerant)

Form-530-04-2014 (659)Rs.20,000/-As per SRO/14 Capsules

FDA: Zegerid(Santarus Inc.)Bimep (SPL Pharmaceuticals)Grant of DML recommended(22-10-2013)1. Formulation is under review by the review committee.

Deferred for review by the Review Committee along with change in brand name(M-245)

5. M/s GTPharma (pvt)Ltd. Plot # 713B sundarIndusterialEstateRaiwind roadLahore.

Omexia CapsulesEach CapsulecontainsOmeprazole 20mgSodium bicarbonate1100mgAntacid

Form 5Rs. 20,000/- videDy. No. 2680dated 11-12-2015Pack size of1 x 10’s / as per price fixed by Govt.

ZEGERIDUSAZoltar InstaPharmaevo

Deferred for expert opinion as per decision of 250th

Registration Board meeting.(M-256)

6. M/s. Medicraft Pharmaceuticals, Peshawar1616

Omzole 20mgCapsuleEach capsule contains:-Omeprazole …………..20mgSodium Bicarbonate…1100mg(Proton Pump Inhibitor)

Form 521-5-2012Rs.8,000/-Rs.12000/-Dated 29-7-201314’sRs. 146/-

International availability not availableRisek by Getz

Deferred for:1. Submission approval status by reference regulatory authorities2. Finished product specs.3. Commitments as per 251st DRB meeting4. Coating method not involving Methylene Chloride.5. Last inspection report conducted witin 1 year.(M-262)


Coozip-Plus CapsuleEach capsule contains:Omeprazole ……..20 mgSodium bicarbonate ……..1100mg(A Proton-Pump inhibitor with antacid)


Available in USFDAFaast capsules by CCLLast inspection report conducted on 20/05/2016.The overall GMP compliance level is rated as good.

Rs 8,000 fee challan is not in original.Deferred In light of decision of 250th Registration Board meeting(M-263)


22. Omeprazole and sodium bicarbonate 40mg/1100mg capsule was discussed in 250 th


OMEPRAZOLE 40MG + SODIUM BICARBONATE 1100MG CAPSULES



ZEGERID capsule approved by FDA

BIOS of M/s WerrickPRENAT of M/s SJ&G

Omeprazole is acid labile and thus rapidly degraded by gastric acid. ZEGERID Capsules and Powder for Oral Suspension are immediate-release formulations that contain sodium bicarbonate which raises the gastric pH and thus protects omeprazole from acid degradation. FDA approved formulation ZEGERID is supplied as immediate-release capsules. Each capsule contains either 40 mg or 20 mg of omeprazole and 1100 mg of sodium bicarbonate with the following excipients: croscarmellose sodium and sodium stearyl fumarate(Ref: US FDA)

Decision:Deferred for expert opinion for clarification as under:i. Significance/ place of therapyii. Risk vs benefit ratio especially in view of risk of systemic alkalosis associated with the drug.Experts:i. Dr Saeed Hamid, AKUH, Karachiii. Dr Altaf Alam, Sheikh Zayed Hospital Lahore.iii. Brig. Amjad Salamat, Military Hospital, Rawalpindi

As the product is approved by FDA in the same dosage form and strength therefore following previously deferred cases are hereby presented before the board

S. No.

Name and address of





Specification



Demanded Price /

Pack size






1. M/s NabiQasimKarachi

1.Loprot plus2.Capsule3.Each capsule contains:Omeprazole …….40 mgSodium Bicarbonate ……..…1100 mg4.Ani-ulcerant

1. Form-52.Routine3. 7‟s,10‟s,14‟s/ As per PRC4.14-07-2010Dy.No.1333Rs.8000/-(Original)14-5-2013

Bios (Werrick)FDA: Generic (Par Pharm)

Deferred for review of formulation by review committee(M-250)


Rs.12,000/-(Photo copy)


Cibra Swift 40mg/1100mg CapsuleEach Capsule contains:Omeprazole …40mgSodium Bicarbonate…1100mg(Anti-Ulcerant)

Form-530-04-2014 (623)Rs.20,000/-As per SRO/14 Capsules

FDA: Zegerid(Santarus Inc.)Omrel (Well & Well Pharmaceuticals)Grant of DML recommended (22-10-2013)1. Formulation is under review by the review committee.

Deferred for review by the Review Committee along with change in brand name.(M-245)

3. M/s ObsonPharmaceuticals, 209-SIndustrialEstate KotLakhpat,Lahore.

Omnat-ObCapsuleCapsuleEach capsulecontains:Omeprazole……….40mgSodiumBicarbonate...1100mg(Anti Ulcerants)

Form-5Dy. No: 2751dated.23-06-2011Rs.8000/-23-06-2011Rs.12,000/-As per SRO /10’s

Mep-B By M/sGenix

Deferred for: Commitment as per 251st meeting. Last inspection report. Copy of official monograph for testing method. Details of coating material. Form 5 in order as per Rule 26 (1). Details of product specs.

And in the light of RB decision in 250th meeting.Deferred for expert opinion for clarification (M-255)

4. M/s GTPharma (pvt)Ltd. Plot # 713B sundarIndusterialEstateRaiwind roadLahore.

Omexia PlusCapsulesEach CapsulecontainsOmeprazole 40mgSodium bicarbonate1100mgAntacid

Form 5Rs. 20,000/- videDy. No. 2675dated11-12-2015Pack size of1 x 10’s / as perprice fixed byGovernment

ZEGERIDUSAZoltar InstaPharmaevo

Deferred for expert opinion as per decision of 250th RegistrationBoard meeting.(M-256)

5. M/s MedicraftPharmaceuticalsPvt Ltd,Hayatabad,Peshawar.

Omed 40mg CapsulesEach capsule contains:-Omeprazole………….40mgSodiumBicarbonate……1100mg(Proton Pump Inhibitor)

Form-508-05-2013vide diaryNo. 200 R&IRs.20,000.As per SRO.

FDA. Zegrid20/1680mg,40/1680mg byM/s SantarusLocal. RisekInsta by M/sGetzs.Firm is GMP

Rejected as per decision of the Board in 250th

meeting.‘Deferred for expert opinion forClarification as under:


compliant asper inspectiondated 29-07-2015

1.Significance/place of therapy2. Risk vs benefit ratio especially inview of risk of systemic alkalosisassociated with the drug. (M-258)

23. Omeprazole and sodium bicarbonate 20mg/1680mg Sachet was discussed in 250 th


OMEPRAZOLE 20MG + SODIUM BICARBONATE 1680MG SACHETInternational availability


ZEGERID Sachet approved by FDA

RULLING PLUS of M/s High QOMENATE of M/s Panecea

Omeprazole is acid labile and thus rapidly degraded by gastric acid. ZEGERID Capsules and Powder for Oral Suspension are immediate-release formulations that contain sodium bicarbonate which raises the gastric pH and thus protects omeprazole from acid degradation.(Ref: FDA)


As the product is approved by FDA in the same dosage form and strength therefore following previously deferred cases are hereby presented before the board

S. No.



Type of FormInitial date,diaryFee including differential fee

Demanded Price /Pack size

Remarks on the formulation (if any) including International status in stringent drug regulatory agencies / authoritiesMe-too status


1. M/s Jaskan Pharmaceutic als (Pvt) Limited, 50 Sunder Industrial Estate Raiwind Road, Lahore

Jasom 20mg Sachet SachetEach sachet contains…Omeprazole 20mg/ Sodium bicarbonate 1680mg Proton Pump Inhibitor

Form 5New LicenseDy No 1331 dated 03-04-201402-04-2014

Zegrid of Santarus Inc

Risek Insta of Getz Pharma Karachi

Inspection of the firm was conducted on 24-


Deferred for review of


(Sachet section)

Rs.20,000As per SRO/Pack of 10’s

12-2103 by the panel of inspectors and recommend for grant of DML for sections namely Tablet (general), Capsule (general), Sachet (general) and Suspension (general)

formulation(M-250)


Cibra Swift SachetEach Sachet contains:Omeprazole (USP)…20mgSodium Bicarbonate (USP)…1680mg(Anti-Ulcerant)

Form-530-04-2014 (188)Rs.20,000/-As per SRO/14 Sachets

FDA: Zegerid(Santarus Inc.)Bimep (SPL Pharmaceuticals)Grant of DML recommended (22-10-2013)1. Formulation is under review by the review committee.

Deferred for review of formulation by the Review Committee.(M-245)

3. M/s SigmaPharmaInternational Pvt.Limited E-50,N.W.I.Z., PortQasim Karachi

Profile 20mg SachetEach Sachet contains:-Omeprazole… 20mgSodium Bicarbonate…1680mg(Proton pumpinhibitor/antacid)

Form 517-11-2014(206)Rs. 20,000/-As Per SRO/Pack 10’s

FDA: ZegeridRISEK INSTAPowder 20mg SachetGetz Pharma (Pvt.)LtdNew Licensee1. Formulation isunder review bythe ReviewCommittee ofDRB.

Deferred tillreview offormulation byReviewCommittee.(M-246)

Deferred for review of formulation

(M-250)4. M/s Weather

FoldsPharmaceuticals,Plot No. 69/2,Phase II, IndustrialEstate Hattar.

Omefold SachetEach sachet contains:-Omeprazole……20 mgSodiumbicarbonate…1680mg(Proton pump inhibitor)

Form 5Dy. No: 686dated 25-03-2015.Rs. 20,000/-As Per SRO /7’s, 14’s, 20’s,28’s, 30’s.

Zegrid ofSantarus Inc.Risek Insta byM/s GetzPharmaceuticals

Deferred for review of formulation.(M-249)

5. M/s MKBPharmaceuticals(Pvt) Ltd.66 – HayatabadIndustrial Estate,Peshawar, KPK.

Healium Insta 20 mgSachetEach Sachet contains:Omeprazole (USP)----- 20 mgSodium Bicarbonate(USP) -------- 1680mgAnti-ulcerants(Proton Pump Inhibitors)

Form 528-01-2015(Diary No. 79)Rs. 20,000/-As per DRAPPolicy / 07 &10 Sachets

Zegerid(Santarus, USA)Omega rapid 20mg sachet (FerozsonsLaboratoies )cGMPCompliance at excellent level.(25-09-2014)


6. M/s WenovoPharmaceuticals,Plot No. 31 & 32,

OMENOV SachetEach sachet contains:-Omeprazole……20 mgSodiumbicarbonate…1680mg

Form 5Dy. No: 2300dated 02-04-2015.Rs. 20,000/-

Zegrid ofSantarus Inc.Risek Insta byM/s GetzPharmaceuticals



Punjab SmallIndustrial Estate,Taxila.

(Proton pump inhibitor) As Per SRO /7’s, 14’s, 20’s,28’s, 30’s.

Firm wasinspected on 12-03-2015 by the area FID and found GMP compliant.

7. Aventek pharmaceuticals Lahore

Aveome –S SachetEach Sachet ContainOmeprazole (B.P) ………… 20mgSodium bicarbonate (B.P) …...1680mg

Form 5(03.03.15) Dy. No. 1320 Rs. 20000/-As per DRAP policy

FDA: ZegeridRISEK INSTA Powder 40mg Sachet Getz Pharma (Pvt.)Ltd

Defered as the formulation is under review.(M-250)

8. M/s KohinoorIndustriesSahiwal, Plot# 159-160/BSmallIndustrialEstate,Sahiwal.

Komizol Sachet 20Each sachet contains:-Omeprazole...20mg SodiumBicarbonate ...........1680mgPPI & Antacid

Form-529-07-2015diary No 4693.Rs20,000As per SRO/Box of 10sachet

Zegerid Powderfor oral suspension,USA, by M/s SantarusRise Insta by M/sGetz Panel videinspection vide dated 08-09-2014, new section recommended.

Deferred as theformulation is underreview(M-253)

9. M/s FAASPharmaceuticals (Pvt.) Ltd,F-748, S.I.T.E,Karachi

ULCI LOCINSTA SACHET20 mgEach Sachetcontainsi. OmeprazoleUSP … 20mgii. SodiumBicarbonateUSP 1680 mg(USPSpecification)

Form 5Rs. 20,000/-(Dy. 98)14-07-2015Pack size of1 x 10’sSachet Priceas per SRO

FDA approvedZegeridmanufacturedby SalixPharmaceuticalsRisek Insta(Getz)

Deferred as formulation is underReview(M-254)

10. M/s MartinDow Ltd,Plot No.37,Sector 19,KorangiIndustrialArea Karachi-74900

Eezoff SachetSachetEach sachet contains:Omeprazole……20mgSodiumBicarbonate..1680mg(Proton Pump Inhibitor+ Sodium Bicarbonate)

Form 5Dairy No. 1193dated 29-12-2015Rs:20,000/-7’s,14’s,28’sAs per SRO

Zegerit bySantaurs INCUSARisek Insta bygetz pharma

Deferred for expert opinion asper decision of 250th RegistrationBoard meeting.(M-256)

11. M/s Indus Pharma (Pvt.) Ltd, plot 26,27,64,65,66 & 67, Sector 27, Korangi Industrial Area, KarachiPriority 2373

Cidpro 20mg SachetEach sachet contains:Omeprazole………20mgSodium Bicarbonate…1680mg(Proton Pump Inhibitor)

Form 5Dy # 65930-06-2013Pack sizePer sachet Rs. 15/-10s Rs. 150/-20’s Rs. 290/-

FDA approved ZegeridRisek Insta - GetzGMP compliant section vide inspection report dated 10-09-2015

Deferred as product is under review(M-259)


12. Scilife Pharma (Private) LimitedPlot # FD-57/58-A2, Korangi Creek Industrial park (KCIP) Karachi

Ozon Insta Powder 20 mg SachetEach Sachet containsOmeprazole20 mgSodium Bicarbonate 1680 mg (as buffer)Proton Pump Inhibitor

Form 5Rs. 20,000/-Dy. No.119608-06-201610’s,30’sAs Per SRO

FDA Approved ZegeridSantarus INCRisek Insta Powder 20 mg manufactured by (Getz Pharma)

Deferred as formulation is under(M-260)

13. M/s Nabiqasim Industries Pvt Ltd. 17/24, Korangi industrial Area, Karachi.

1.Loprot Insta 2.Oral Suspension3.Each sachet contains:Omeprazole ………..20 mgSodium Bicarbonate (as Buffer)..1680 mg4.Ant-ulcerant

1.Form52.Routine3. 7,10‟s/As per PRC4.14-7-2010Dy.No.1332Rs.8000/-(Original)14-5-2013Rs.12,000/(Photo copy)

Omega rapid (Ferozesons)FDA: Generic (Par Pharm)



(M-250)

24. Omeprazole and sodium bicarbonate 40mg/1680mg Sachet was discussed in 250 th


OMEPRAZOLE 40MG + SODIUM BICARBONATE 1680MG SACHET



ZEGERID Sachet approved by FDA

OMEGA RAPID of FerozsonsOMEZONATE of M/s Global

Omeprazole is acid labile and thus rapidly degraded by gastric acid. ZEGERID Capsules and Powder for Oral Suspension are immediate-release formulations that contain sodium bicarbonate which raises the gastric pH and thus protects omeprazole from acid degradation.(Ref: FDA)


As the product is approved by FDA in the same dosage form and strength therefore following previously deferred cases are hereby presented before the board;


S. No.

Name and address of





Specification



Demanded Price /

Pack size

Remarks on the formulation (if any)

including International status

in stringent drug regulatory agencies /



1. M/s Jaskan Pharmaceutic als (Pvt) Limited, 50 Sunder Industrial Estate Raiwind Road, Lahore (Sachet section)

Jasom 40mg Sachet SachetEach sachet contains…Omeprazole 40mg/ Sodium bicarbonate 1680mg Proton Pump Inhibitor

Form 5New LicenseDy No 1327 dated 03-04-201402-04-2014Rs.20,000As per SRO/Pack of 10’s

Zegrid of Santarus Inc

Risek Insta of Getz Pharma Karachi

Inspection of the firm was conducted on 24-12-2103 by the panel of inspectors and recommend for grant of DML for sections namely Tablet (general), Capsule (general), Sachet (general) and Suspension (general)


Deferred for review of formulation(M-250)

2. M/s Nabiqasim Industries Pvt Ltd. 17/24, Korangi industrial Area, Karachi.

1.Loprot Insta 2.Oral Suspension 40mg3.Each sachet contains:Omeprazole……..40 mgSodium Bicarbonate (as Buffer)..1680 mg4.Ant-ulcerant

1. Form-52.Routine3. 7‟s,10‟s/As per PRC4.14-7-2010Dy.No.1331Rs.8000/-(Original)14-5-2013Rs.12,000/-(Photo copy)

Omega rapid (Ferozesons)FDA: Generic (Par Pharm)

Deferred for review of formulation by review committee.(M-244)Deferred for review of formulation

(M-250)

3. M/s SigmaPharmaInternational Pvt.Limited E-50,N.W.I.Z., PortQasim Karachi

Profile 40mg SachetEach Sachet contains:-Omeprazole… 40mgSodium Bicarbonate…1680mg(Proton pumpinhibitor/antacid)

Form 517-11-2014(212)Rs. 20,000/-As Per SRO/Pack 10’s

FDA: ZegeridRISEK INSTAPowder 40mg SachetGetz Pharma (Pvt.)LtdNew Licensee1. Formulation isunder review bythe ReviewCommittee ofDRB.

Deferred tillreview offormulation byReviewCommittee.(M-246)


(M-250)4. M/s MKB

Pharmaceuticals(Pvt) Ltd.

Healium Insta 40 mgSachetEach Sachet contains:Omeprazole (USP) ----

Form 528-01-2015(Diary No. 81)Rs. 20,000/-

Zegerid(Santarus, USA)Omega rapid 40mg sachet (Ferozsons



66 – HayatabadIndustrial Estate,Peshawar, KPK.

- 40 mgSodium Bicarbonate(USP)-------- 1680mgAnti-ulcerants(Proton Pump Inhibitors)

As per DRAPPolicy / 07 & 10Sachets

Laboratoies)cGMP Compliance at excellent level.(25-09-2014)

5. M/s Lintapharmaceuticals(Pvt) LimitedPlot No. 03,Stree no. S-5,NationalIndustiral ZoneRawat Islamabd.

Ospra Sachet.SachetEach Sachet contains:Omeprazole……40mgSodiumbicarbonate……1680mgAnti-ulcerants (ProtonPump Inhibitors)

Form-5Dy. No: 1000dated 16-04-201520000/- dated15-04-2015As per SRO

Deferred for rectification offollowing:Product is under review.Complete description ofthe product / pharmaceutical form is required.Application on form 5D required.HVAC detailsi.e humidity,temperature, airchanges,particular count,air pressure, insachet section isrequired.(M-252)Deferred as product is underreview.(M-253)

6. M/s KohinoorIndustriesSahiwal, Plot# 159-160/BSmallIndustrialEstate,Sahiwal.

Komizol SachetEach sachet contains:-Omeprazole...40mg SodiumBicarbonate ............1680mgPPI & Antacid

Form-529-07-2015diary No 4692.Rs20,000As per SRO/Box of 10sachet

Zegerid Powderfor oral suspension,USA, by M/s SantarusRisek Insta by M/sGetz Panel videinspection videdated 08-09-2014,new sectionrecommended.

Deferred as theformulation is under review.(M-253)

7. M/s FAASPharmaceuticals (Pvt.) Ltd,F-748, S.I.T.E,Karachi

ULCI LOCINSTA SACHET40 mgEach Sachetcontainsi. OmeprazoleUSP … 40 mgii. SodiumBicarbonateUSP 1680 mg

Form 5Rs. 20,000/-(Dy. 99)14-07-2015Pack size of1 x 10’sSachet Priceas per SRO

FDA approvedZegeridmanufacturedby SalixPharmaceuticalsRisek Insta(Getz)

Deferred as formulation is under Review(M-254)

8. M/s Martin Eezoff Sachet Form 5 Zegerit by Deferred for


Dow Limited,Plot No.37,Sector 19,KorangiIndustrialAreaKarachi-74900

SachetEach sachet contains:Omeprazole……40mgSodiumBicarbonate..1680mg(Proton Pump Inhibitor+ Sodium Bicarbonate)

Dairy No. 1194dated 29-12-2015Rs:20,000/-7’s,14’s,28’sAs per SRO

Santaurs INCUSARisek Insta bygetz pharmaLast Inspectionconducted02-02-2015DML renewal09-02-2011

expert opinion asper decision of250thRegistrationBoard meeting.(M-256)

9. M/s Indus Pharma (Pvt.) Ltd, plot 26,27,64,65,66 & 67, Sector 27, Korangi Industrial Area, KarachiPriority 2374

Cidpro 40mg SachetEach sachet contains:Omeprazole………40mgSodium Bicarbonate…1680mg(Proton Pump Inhibitor)

Form 5Dy # 65930-06-2013Pack sizePer sachet Rs. 25/-10s Rs. 250/-20’s Rs. 450/-

FDA approved ZegeridRisek Insta - GetzGMP compliant section vide inspection report dated 10-09-2015

Deferred as product is under review(M-259)

10. Scilife Pharma (Private) LimitedPlot # FD-57/58-A2, Korangi Creek Industrial park (KCIP) Karachi

Ozon Insta Powder 40 mg SachetEach Sachet containsOmeprazole40 mgSodium Bicarbonate 1680 mg (as buffer)Proton Pump Inhibitor

Form 5Rs. 20,000/-Dy. No.119503-06-201610’s,30’sAs Per SRO

FDA Approved ZegeridSantarus INCRisek Insta Powder 40 mg manufactured by (Getz Pharma)

Deferred as formulation is under. Also confirmation regarding approval status by reference regulatory authorities

11. M/s Hiranis Pharmaceuticals,pLot no. E-145-E-149, North Western Industrial Zone, Port Qasim, Karachi640

Refluxin Plus SachetPowder for Oral SuspensionEach Sachet contains:Omeprazole ….40 mgSodium bicarbonate..1680mg(Proton pump inhibitor, antacid)

Form-530-4-2014Dy. No.386Rs.20,000/-As per PRC/10’s Sachet

Zegerid bySantarus USAMe tooLicense renewal Inspection report dated23-09-2013 showing compliance of GMP as Good”.

Deferred for submission of COA of pellets, GMP certificate of supplier& stability studies of pellets as per Zone IV-A conditions.Fee of pellets if imported.(M-262)

Decision: Keeping in view the approval status of above formulations in USFDA, Registration Board approved following formulations of omeprazole, sodium bicarbonate and deferred the above cases for evaluation as per the checklist approved in 251st Registration Board meeting

Omperazole, Sodium Bicarbonate Capsule 20mg/1100mg Omperazole, Sodium Bicarbonate Capsule 40mg/1100mg Omperazole, Sodium Bicarbonate Sachet 20mg/1680mg Omperazole, Sodium Bicarbonate Sachet 40mg/1680mg

B. Miscellineous cases.Minutes for 267th Registration Board Meeting 333

Case No. 01: Availability of Tablet Frisium (Registration No. 002694)

Registration Board in its 261st meeting deliberated that some of the essential and life

saving medicines, including anti-tuberculosis drugs are in short supply / partially available in the

market. The Board decided that Quality Assurance & Laboratory Testing Division will direct all

concerned manufacturers, importers and registration holders of such medicines to submit current

quarterly report for importation of drug substances, manufacturing and sale record, but not later

than seven days.

In the light of above decision, Quality Assurance & Lab Testing Division provided list of

medicines from time to time that are in short supply/non-available in the market and accordingly

letters were sent to the firms whose medicines were reported to be in short supply/non-available

by PE&R Division.

Tablet Frisium of M/s. Sanofi-aventis Pakistan, Karachi is one of the medicines, which

was reported to be in short supply. The firm was advised twice vide letters to clarify and ensure

the availability of drug in order to comply the Rule 30(4) of Drugs (Licensing, Registering &

Advertising) Rules, 1976, but no response has received to this office within stipulated time.

As the matter relates to public health urgency, so the firm is advised to appear before the

Registration Board for personal hearing.

Discussion:- Dr. Shujauddin Shaikh, Director Regulatory Affairs appeared before the Board for personal hearing on behalf of M/s. Sanofi-aventis, Pakistan and informed that API manufacturing plant for the product i.e Clobazam has been shut down for maintenance purpose and will remain closed till mid of 2018. He further informed that they are in process of developing an alternate source for the API and after performing necessary validation they will be in position to make the product available.

Decision:- The Board showed serious concerns over the non-availability of Tab Frisium in the country and strictly advised the firm to ensure availability of Tab Frisium (Reg.No.002694) in the market on priority.


RRR SECTION

Case No.02: Applications received with shortcomings.This section apprised the Board that Directorate of (PE&R) is dealing with number of

applications submitted for renewal of drugs which are incomplete or have shortcoming especially with reference to the submitted prescribed renewal fees.

The following applications for renewal of drugs are submitted on Form 5-B after the expiry of validity of the certificate of registration but within sixty days after validity of certificate of registration. The applications for renewal are incomplete with reference to renewal application fee or having some other deficiency. RULE 27 Drug (Licensing, Registering & Advertising) Rules, 1976 (Duration of certificate of registration). “A certificate of registration under this chapter, [shall unless earlier suspended or cancelled, be in force for a period of five years from the date of [Registration of the drug] and may thereafter be renewed for period not exceeding five years and a certificate to this effect shall be issued within one month] at a time.Provided that an application for the renewal of registration shall not be entertained unless it has been made within sixty days after the expiry of the registration and when an application has been made aforesaid the registration shall subject to the orders passed on the application for the renewal continue in force for the next period of five years.”Provided further that in case of an imported drug, the renewal may be granted and a renewal certificate shall be issued, if in the opinion of the Registration Board it is necessary to do so in the public interest.”Following cases are placed below for the consideration of Registration Board

i) Cases for imported pellets.

a) M/s Semos Pharmaceuticals (Pvt) Ltd. Karachi.Sr.No

Reg/No Products/Name Initial Date of Registration

Application receiving date and fee submitted date/

and due date

Review

1 055876 Zumin 20mg CapsuleEach capsule contains:-Esomeprazole enteric coated Pellets eq. to esomeprazole … 20mg(Manufacturer’s Specs)

02-05-2009 Due date (01-05-2014)Fee of Rs. 10,000/- deposited on 31-03-2014. As these are imported Pellets from M/S LEE PHARMA LIMITED, INDIA. So remaining fee of Rs. 10,000/- deposited on 08-02-2017.

Registered in below mentioned Reference Regulatory Agency:-FDA

2 055877 Zumin 40mg CapsuleEach capsule contains:-Esomeprazole enteric coated Pellets eq. to esomeprazole … 40mg(Manufacturer’s Specs)

Do Do Do

Decision: Registration Board acceded to request of the firm and decided to grant the renewal till 01-05-2019.

b) M/s S.J & G Fazul Ellahie (Pvt) Ltd. Karachi.Minutes for 267th Registration Board Meeting 335

Sr.No


Application receiving date and fee submitted date/ and due date

Review

1 055698 Vify 20mg CapsuleEach capsule contains:-Omeprazole enteric coated pellets … 20mg(USP Specs)

07-04-2009Change of Brand Name on07-05-2010

Due date (06-05-2015)Fee of Rs. 10,000/- deposited on 25-03-2015. As these are imported Pellets from M/S HETRO DRUGS LIMITED, INDIA. So remaining fee of Rs.10,000/- deposited on13-02-2017.


Decision: Registration Board acceded to request of the firm and decided to grant the renewal till 06-05-2020.

ii) With Differential Feea) M/s Heal Pharma, Peshawar.

Sr.No


Application receiving date and fee submitted

date/ and due date

Review

1 049807 Hepmol CF TabletEach tablet contains:-Paracetamol … 500mgPseudoephedrine … 60mgChlorpheniramine Maleate … 4mg(Heal’s Specs)

16-07-2008 Due date (15-07-2013)Fee of RS. 10,000/- deposited on 19-07-2013. As application received within 60 days after expiry of Reg. So remaining Fee of RS. 10,000/- deposited on 10-11-2016

Registered in TGA as Paracetamol … 500mgPseudoephedrine … 30mgChlorpheniramine Maleate … 2mg

2 049811 Hefmic Tablet 250mgEach film coated tablet contains:-Mefenamic Acid … 250mg(BP Specs)

Do Do Only 250mg capsule are available in reference regulatory agencies.

3 049812 Hefmic Tablet 500mgEach film coated tablet contains:-Mefenamic Acid … 500mg(BP Specs)

Do Do Registered inMHRA(BNF) as Plain Tablet

Decision: Registration Board decided as under;

a. to grant the renewal of the product at S.No.03 till 15-07-2018.b. To defer the product at S.No.01 for the confirmation of formulation by the

firm as well as from the concerned section of PE&R Division as the firm has applied “Pseudoephedrine … 60mg and Chlorpheniramine Maleate … 4mg”, while in reference regulatory authorities it is available as “Pseudoephedrine … 30mg and Chlorpheniramine Maleate … 2mg”,

c. To defer product at S.No.02 for confirmation of approval status by reference regulatory authorities.

iii) With prescribed fee.


a) M/s Selmore Pharmaceuticals (Pvt) Ltd. Lahore.

Sr.No

Reg/No Products/Name Initial Date of

Registration


date/ and due date

Review

1 069042 Biscord Tablet 10mgEach tablet contains:-Bisoprolol fumarate … 10mg(Selmore’s Specs)

01-01-2011 Due date (31-12-2015)Received within 60 days after expiry of Reg. with Fee of Rs. 20,000/- deposited on 14-01-2016


2 069043 Biscord Tablet 5mgEach tablet contains:-Bisoprolol fumarate … 5mg(Selmore’s Specs)

Do Do Do

3 069044 Lepen Capsule 100mgEach tablet contains:-Gabapentin … 100mg(Selmore’s Specs)

Do Do Registered in below mentioned Reference Regulatory Agency:-FDA

4 069045 Irochew Tablet 100mgEach tablet contains:-Iron (III) Hydroxide polymaltose complex eq. to elemental iron … 100mg(Selmore’s Specs)

Do Do Registered in below mentioned Reference Regulatory Agency:-TGA Australia

5 069046 Depin Tablet 20mgEach tablet contains:-Paroxetine (as HCl) … 20mg(B.P Specs)

Do Do Registered in below mentioned Reference Regulatory Agency:-EMC (MHRA)

6 069047 Diclosel-P Tablet 50mgEach tablet contains:-Diclofenac Potassium … 50mg(USP Specs)


7 069048 Lepen Capsule 300mgEach tablet contains:-Gabapentin … 300mg(Selmore’s Specs)


8 069049 Itosel Tablet 50mgEach tablet contains:-Itopride (as HCl) … 50mg(Selmore’s Specs)

Do Do Registered in below mentioned Reference Regulatory Agency:-


PMDA9 069050 Fexsel Tablet 120mg

Each tablet contains:-Fexofenadine (as HCl) … 120mg(Selmore’s Specs)

Do Do Registered in Germany, EMC (MHRA) as Film Coated Tablet

10 069051 Pizosel Syrup 0.5mgEach 10ml contains:-Pizotifen (as Hydrogen maleate) … 0.5mg(Selmore’s Specs)

Do Do Only Tablet Dosage Form is available in Reference regulatory Agency.


a. to grant the renewal for products at S.No.01 to 08 till 31-12-2020.b. to defer product at S.No.09 for confirmation of formulation by the firm as

the firm has applied as “plain tablet” while it is approved as “film coated tablet” in reference regulatory authorities.

c. Deferred the case for product at S.No.10 for clarification of dosage form by the firm as the firm has applied as “Syrup Dosage Form” while in reference regulatory authorities it is available as “elixir”.

b) M/s Biorex Pharmaceuticals, Islamabad.Sr.No



date/ and due date

Review

1 068573 Biomether CapsuleEach capsule contains:-Artemether … 40mgLumefantrine … 240mg(Biorex’s Specs)

04-01-2011 Due date (03-01-2016)Received within 60 days after expiry of Reg. with Fee of Rs. 20,000/- deposited on 28-01-2016

Not found in Reference Regulatory Agency.

2 068576 Ferorex Capsule 100mgEach capsule contains:-Iron Polymaltose Complex … 100mg(Biorex’s Specs)


3 068577 Ferorex-F CapsuleEach capsule contains:-Iron Polymaltose Complex … 100mgFolic Acid … 0.35mg(Biorex’s Specs)

Do Do Not found in Reference Regulatory Agency.

4 068578 Biofantrin TabletEach tablet contains:-Artemether … 20mgLumefantrine … 120mg(Biorex’s Specs)


5 068579 Moxibay Tablet 400mgEach tablet contains:-

Do Do Do


Moxifloxacin (as HCl) … 400mg(Biorex’s Specs)

6 068580 Bioverine Tablet 40mgEach tablet contains:-Drotaverine … 40mg(Biorex’s Specs)

Do Do Not found in Reference Regulatory Agency.Available in Russia, Hungary and Czech Republic.

7 068581 Bionergics Tablet 2mgEach tablet contains:-Tizanidine (as HCl) … 2mg(USP Specs)


8 068582 Bionergics Tablet 4mgEach tablet contains:-Tizanidine (as HCl) … 4mg(USP Specs)

Do Do Do

9 068583 Paraphan Extra TabletEach tablet contains:-Paracetamol … 450mgOrphanedrine Citrate …35mg(Biorex’s Specs)


10 068584 Biospa Tablet 135mgEach tablet contains:-Mebeverine HCl) … 135mg(BP Specs)


11 068585 Ciprobay Tablet 750mgEach tablet contains:-Ciprofloxacin … 750mg(USP Specs)



a. to grant the renewal for products at S.No.02 and 04 to 11 till 03-01-2021b. to grant the renewal for products at S.No.03 till 03-01-2021 being iron containing

product.c. To defer the case for product at S.No.01 for confirmation of approval status either

by reference regulatory agency or WHO as the firm has applied the product as “Capsule” dosage form but in reference regulatory authorities / WHO it is available as in “Tablet” dosage form.

c) M/s Neutro Pharma (Pvt) Ltd. Lahore.


Sr.No


Application receiving date and fee submitted date/ and

due date

Review

1 069299 Nuzol 600 InfusionEach 300ml contains:-Linezolid … 600mg(Neutro’s Specs)

01-04-2011 Due date (31-03-2016)Received within 60 days after expiry of Reg. with Fee of Rs. 20,000/- deposited on26-05-2016


2 069300 Serliv 500mg TabletEach tablet contains:-Levetiracetam … 500mg(Neutro’s Specs)

Do Do Do

3 069417 Inovel TabletEach tablet contains:-Artemether … 80mgLumefantrine … 480mg(Neutro’s Specs)

14-04-2011 Due date (13-04-2016)Received within 60 days after expiry of Reg. with Fee of Rs. 20,000/- deposited on26-05-2016

Available in FDA as Artemether … 20mgLumefantrine … 120mg

4 069418 Ofovir 300mg TabletEach film coated tablet contains:-Tenofovir disoproxil fumarate… 300mg


Decision: Registration Board acceded to request of the firm and decided as under;

a. to grant the renewal of products at S.No.01 and 02 till 31-03-2021.b. to grant the renewal of products at S. No.03 and 04 till 13-04-2021.

d) M/s Baariq Pharmaceuticals, Lahore. (Veterinary).Sr.No


Application receiving date and fee submitted date/ and due date

1 071093 Ultrazuriq Oral SolutionEach ml contains:-Toltrazurial … 25mg

18-08-2011 Due date (17-08-2016)Received within 60 days after expiry of Reg. with Fee of Rs.20,000/- deposited on 25.8.2016

2 071094 Floxa C Oral SolutionEach 100ml contains:-Enrofloxacin … 20gmColistin Sulphate … 50MIU

Do Do

3 071095 Respibar -250 Oral SolutionEach ml contains:-Tylosin Tartrate … 55mgSulfadiazine … 175mgTrimethoprim … 35mg

Do Do

4 071096 Baflor -23 Oral SolutionEach ml contains:-Florfenicol ... 230mg

Do Do

5 071097 Noxabar-20 Oral Solution Do Do


Each 1000ml contains:-Norfloxacin … 200gm

6 072601 Floxybar 30 Water Soluble PowderEach gm contains:-Florfenicol … 150mgOxytetracycline HCl … 150mg

Do Do

7 071098 Doxityl-B Water Soluble PowderEach 1000gm contains:-Tylosin Tartrate … 100gmDoxycycline HCl … 200gmBromhexine HCl … 2.5gm

Do Do

8 071099 Tycobar -D Water Soluble PowderEach 1000gm contains:-Tylosin Tartrate … 100gmDoxycycline HCl … 200gmColistin Sulphate … 500MIUBromhexine HCl … 5gm

Do Do

9 071100 Nemobar-72 Water Soluble PowderEach 1000gm contains:-Neomycin Sulphate … 720gm

Do Do

Decision: Registration Board acceded to request of the firm and decided to grant the renewal till 17-08-2021


Registration-IHuman Import

Case No.03: Request for Change of Manufacturing Site of Registered Drug(s) by M/s. Novartis Pharma, Karachi.

M/s. Novartis Pharma (Pakistan) Limited, Karachi has applied for change of

manufacturer of their following already registered human products, as per details given below:-

S. No.

Reg. No.

Name of Product(s) with Composition.

Existing Site(s) New proposed Site(s).

1. 033172 Myfortic 180mg gastro-resistant Tablets.Each gastro-resistant tablet contains:-Mycophenolic acid 180mg (as sodium salt)

Manufacturer:M/s. Novartis Pharma Stein AG, Switzerland.

Product License Holder:M/s. Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg Germany.Manufacturer:M/s. Novartis Pharma Produktions GmbH, Oeflinger Strasse 44,79664 Wehr, Germany.

2. 033173 Myfortic 360mg gastro-resistant Tablets.Each gastro-resistant tablet contains:-Mycophenolic acid 360mg (as sodium salt)

Manufacturer:M/s. Novartis Pharma Stein AG, Switzerland.

Product License Holder:M/s. Novartis Pharma GmbH, Roonstrasse 25 90429 Nuremberg Germany.Manufacturer:M/s. Novartis Pharma Produktions GmbH, Oeflinger Strasse 44,79664 Wehr, Germany.

The firm have deposited required fee of Rs.50, 000/- for each product and submitted following supporting documents:-

i) Application on Form 5A.ii) Copies of initial registration letters and renewal status.iii) Original & legalized CoPP’s and GMP for new manufacturing site.iv) Site master plan of the manufacturer.

Decision:- Registration Board approved following changes in respect of registered products “Myfortic 180mg gastro-resistant Tablets (Reg.No: 033172) and Myfortic 360mg gastro-resistant Tablets (Reg.No 033173) on the same terms & conditions and as per import Policy for Finished Drugs.

Manufacturer: M/s. Novartis Pharma Produktions GmbH, Oeflinger Strasse 44, 79664 Wehr, Germany.

Product License Holder: M/s. Novartis Pharma GmbH Roonstrasse 25, 90429 Nuremberg Germany


Case No. 4: Request for De-registration of Drug(s).Various firms has requested for de-registration of their registered drug(s) as per following

details:-S.No. Name of firm(s) /

manufacturerName of Drug(s) Reg.No. Remarks

1. M/s. Novartis Pharma (Pakistan) Ltd, KarachiManufactured by M/s. Novartis Ophthalmics AG, Switzerland.

Nyolol Eye GelEach gm contains:-Timolol maleate …. 1.37mg

041177 The firm informed that their principal will no longer be able to produce and supply this product.

2. M/s. Chiesi Pharmaceuticals (Pvt.) Ltd; LahoreManufactured by M/s. Chiesi Farmaceutici S.p.A., Italy.

Clenil Puvinal 100 Dry Powder Inhaler.Each dose contains:-Beclomethasone- 17, 12-Dipropionate 0.100mg

033168 The firm has informed that the manufacturing of the drugs have been stopped in the country of origin i.e Italy.

2. -do- Clenil Puvinal 200 Dry Powder Inhaler.Each dose contains:-Beclomethasone- 17,12-Dipropionate 0.200mg

033169 -do-

3. -do- Clenil Puvinal 400 Dry Powder Inhaler.Each dose contains:-Beclomethasone- 17, 12-Dipropionate 0.400mg

033170 -do-

Decision:- Registration Board deliberated that as alternate brand of above products are not available, thus the Board did not accede to request of firms for de-registration/cancellation of registration of above products of M/s. Novartis Pharma (Pakistan) Ltd, Karachi and M/s. Chiesi Pharmaceuticals (Pvt.) Ltd; Lahore. The Board further advised the firms to arrange alternate manufacturing sources for the said products for ensuring their availability.


Veterinary Drugs

Case No. 05: Show Cause Notices Issued To The Firms Having Registration Of Products Containing Norfloxacin.Registration Board in its 249th meeting while rejecting applications of veterinary

drugs containing Norfloxacin due to development of resistance in human the Board also decided

to issue show cause notice to already registered products for cancellation. Accordingly show

cause notices were issued to the firms having registrations of aforementioned drug formulations.

A number of firms have responded with their point of view including request for personal

hearings.

The salient points, of the responses received are summarized as under:-

i) The drug is considered vital to combat stubborn bacterial infections faced by the poultry section.

ii) No scientific approval information regarding Norfloxacin resistance in human. iii) Extensive study needs to carry out before making a decision on this issue.iv) Under Section 7 (11) of Drugs Act, 1976, detail of the information or enquiry

conducted, on the basis of which the decision was taken, may be communicated for response.

v) The drug has no significant residual effect on human body.vi) A few firms also agreed to withdraw the products. vii) A number of the firm requested for opportunity for personal hearing.

Dr. Qurban Ali informed the Board in its 265th meeting that the case is under study for

developing policy recommendations. The Board accordingly deferred the case for further

consideration in light of recommendation.

Decision: Registration Board deferred the case and advised to request Dr. Qurban Ali for expediting expert views/comments.

Case No.06: Show cause notices issued to the firms having registration of products containing Phenylbutazone.

Registration Board in its 260th meeting while rejecting applications of veterinary drugs

containing Phenylbutazoneas drug is not recommended for use in food producing animals the

Board also decided to issue show cause notices to all registered veterinary drug formulation

containing Phenylbutazone. Accordingly show cause notices were issued to the firms having

registrations of aforementioned drug formulations. A number of firms have responded with their

point of view including request for personal hearings.

The salient points, of the responses received are summarized as under:-

i) The drug is used in equines like horse, donkeys etc. which is not meant for human consumption, therefore there is no problem of residual effect


ii) Extensive study needs to carry out before making a decision on this issue.iii) Under Section 7 (11) of Drugs Act, 1976, detail of the information or enquiry


iv) A few firms also agreed to withdraw the products





Case No. 07: Show Cause notices issued to the firms having registration of products containing Amantadine in combination with other antibiotics/ antibacterial.Registration Board in its 249th meeting decided to issue show cause notices for

cancellation of all the drug formulations having Amantadine in combination with antibiotic/

antibacterial for veterinary use for having drug interaction and resistance problem. Accordingly

show cause notices were issued to the firms having registrations of aforementioned drug

formulations. A number of firms have responded with their point of view including request for

personal hearings.

The case was placed before the Registration Board in its 257th meeting and the Board

directed to place comments of all firms / stake holders before the Board in its next meeting.

Accordingly, the responses of the firms were placed before the Board in 258th meeting. The

salient points, of the responses received are summarized as under:-

i) Huge financial losses to the firms /distributor as heavy investment have been made in the products.

ii) No complaints/information regarding interaction of Amantadine with antibiotic/ antibacterial, is reported.

iii) These combinations play very important role for treatment of diseases like Bird flu, Influenza.

iv) Extensive study needs to be carried out before making a decision on this issue.v) Under Section 7 (11) of Drugs Act, 1976, detail of the information or enquiry


vi) A few firms also agreed to withdraw the products and requested for grant of registration of other products instead.

vii) A number of the firm requested for opportunity for personal hearing.viii) Pakistan Poultry Association has claimed that Amantadine based product are

effective and safe for veterinary practices, that they have not received any complaint. The Association has requested for withdraw of the decision.


ix) Pakistan Veterinary Pharmaceutical Association has claimed that Amantadine based products are effective and safe for veterinary practices and they have received no complaint regarding such products. The Association has requested for withdrawal the decision.

Registration Board deferred the case in its 258th meeting due to paucity of time and took it again

in 259th meeting. The following decision was taken.

Registration Board referred the matter to Dr. Muhammad Arshad, Member Registration Board, for giving his detail views (approval status of products by reference regulatory authorities, pharmacological and pharmaceutical compatibility etc) on the matter after consultation with other concerned experts in veterinary field.

Since no response was received from Dr. Muhammad Arshad so the Registration Board

in its 262nd meeting decided to refer the matter to Dr. Qurban Ali, Director General, National

Veterinary Laboratory, Islamabad/ Member Registration Board for expert views.





Case No. 08: Request of M/S. Decent Pharma, Rawat, Islamabad/Registration of Drugs Under The Drugs Act, 1976.

Registration Board in its 237th meeting held on 26-02-2013 constituted a sub-committee

for evaluation of application of veterinary products for ensuring completion of codal formalities.

The Board further authorized its Chairman, Registration Board for taking decision on

recommendations of the committee following the 10 products per section policy.

The sub-committee in its meeting held on 25-04-2013 deferred various products of M/s.

Decent Pharma, Rawat, Islamabad as per detailed mentioned against each:-

S.No Name of Manufacturer/

Importer

Name of drug(s) & Composition with Demanded

MRP.

Decontrolled/Packs Size

Shelf Life

Remarks of Committee

1. M/s. Decent Pharma, National Industrial Zone Rawat. Islamabad.

Tribiotic Oral PowderEach 100g powder contains:-Amoxicillin Trihydrate..20gLincomycin HCI……...8.8gSpectinomycin 2HCI…8.8g(Antibacterial).

100gm250gm500gm

1Kg5Kg10Kg25Kg

02 years

Therapeutic Justification for formulation.

2. -do- Respowel Oral LiquidEach 100ml contains:-Tylosin Tartrate……..10gm

100ml200ml500ml

02 years

Deferred for verification of species for


Doxycycline HCI……20gmPhenylbutazone……..1.5gmBromhexin HCI……..0.5gm(Macrolide-Antibacterial).

1 Litre usage.

Now the firm M/s. Decent Pharma, Rawat, Islamabad has submitted various documents

relating to specification & usage of individual components of the above drugs combination. The

above compositions are me-too drugs.

Decision:- Registration Board referred the case for further evaluation and recommendations of Dr. Qurban Ali.

Case No.09: Request for change of importer and amending status of manufacturer/ packers of registered veterinary drugs By M/S. Orient Traders International, Karachi.

M/s. Orient Traders International, Karachi request for transfer of registration of various

registered imported veterinary drugs from the name of importer M/s. Orient Animal Health (Pvt)

Ltd, Karachi to their name and also change of manufacturer and marketing authorization holder

was considered by the Registration Board in its 256 th meeting. The Board allowed change of

registration status for the 20 products in previous meetings while cases of following product

were deferred in its 265th meeting of Registration Board for further deliberation.

S. No.

Regn. No.

Name of Drug (s)/composition

Packing as per Regn. Letter/Shelf life

Manufacturer as per

Registration Letter

Manufacturer as per CoPP

Remarks/Shortcomi

ngs

Status as per information/ documents

provided by the firm.

(i) (ii) (iii) (iv) (v) (vi) (vii) (viii)1. 049548 Diminaveto

Soluble GranulesEach gm contains:-DiminazeneDiaceturate………445mgAntipyrine ............555mg

100 Sachets

per carton

10 Sachets

per carton Sachet

05 years

M/s. V.M.D. N.V. Belgium.

Applicant for Certificate:M/s. V.M.D. n.v Hoge Mauw 900 B-2370 Arendonk, Belgium.Bulk, manufacturer, packing, lot analysis, batch release:M/s. Laboratoria Smeets BVBA, Fotografielaan

Not free sale in Belgium (For export only).

GMP not provided.

Availability status in reference country needs clarification.

Legalized GMP of M/s. Laboratoria Smeets NV.

Legalized GMP agreement of the manufacturer under contract VMD NV & M/s. Laboratoria Smeets NV.Letter stating that disease not prevalent in mfg. country or countries due to cold climate &


42, 2610, Wilrijk, Belgium.

are free from trypanasomiasis by Office International des Epizooties (“OIE”). (Free sale status in reference countries not provided)

The firm has already deposited required fee Rs.100, 000 and submitted the following

documents:-

(i) No Objection Certificate from M/s. Orient Animal Health (Pvt) Ltd, Karachi.

(ii) Legalized GMP Certificate of M/s. V.M.D. N.V., Belgium.

(vii) Legalized GMP of M/s. Laboratoria Smeets BVBA.Legalized GMP agreement of the manufacturer under contract VMD NV & NV.

(viii) Copy of registration letter & Renewal status.

(x) Copy of Drug Sale License.

(xi) Registration applications on Form-5-A.

Decision:- Registration Board deferred the case for confirming the free sale status of the Diminaveto Soluble Granules (Reg.No. 049548) by regulatory authorities of other reference countries.

Case.No. 10: Correction of Composition of Draxxin Injection (Reg.No. 044919) of M/s. M/s. Ghazi Brothers, Karachi

The Drugs Registration Board in its 260th meeting held on 28-29th June, 2016 approved

the change of manufacturing site of following imported products of M/s. Ghazi Brothers,

Karachi from M/s. Pfizer Global Manufacturing, France to M/s. Laboratorios Pfizer Ltda

Guarulhos, Avenida Presidente Tancredo de Almeida Neves, 1555 Guarulhos, SP P.P. Box

017112-070 Brazil subject to inspection of manufacturer abroad on same terms & conditions:-

S. No.

Reg. No.

Name of Drugs/Composition

Existing Source Requested/proposed changes

1. 044919 Draxxin InjectionEach ml contains:-Tulathromycin….100mgMonothioglycerol…5mg

M/s. Pfizer Global Manufacturing, France.

M/s. Laboratorios Pfizer Ltda Guarulhos, Avenida Presidente Tancredo de Almeida Neves, 1555 Guarulhos, SP P.P. Box 017112-070 Brazil.


The panel of Mr. Asim Rauf, Additional Director (E&M), Drug Regulatory Authority of

Pakistan, Lahore & Mr. Zafar Mehmood Minhas, Deputy Director (National Control

Laboratory), Islamabad was constituted for inspection of manufacturer abroad. Meanwhile, the

applicant M/s. Ghazi Brothers, Karachi has informed that the product is approved by US-FDA

and submitted Legalized CoPP and Certificate to Foreign Government issued by United States

Food and Drug Administration. The storage facility of the importer has also already been

verified by the Area FID.

While the case is being processed, it is noted that the composition of the product in

registration letter mentions Monothioglycerol 5mg which is inactive ingredient and may require

correction as in registration letter only active constituents are mentioned.

Decision:- Registration Board approved the correction of composition in registration letter of Draxxin Injection (Reg.No. 044919) by deleting Monothioglycerol 5mg being an inactive ingredient.


Registration-IICase No. 11: Permission for local contract manufacturing from Import

M/s ICI Pakistan Ltd., Karachi have applied for the permission for local contract

manufacturing for their following product, already registered as imported drug product;

S.No Contract Giver

Contract Acceptor

Reg. No Name of drug(s) & Composition

Pack Size

Application DateFormFee

Approval Status in Reference Regulatory authorities

1. M/s ICI Pakistan Ltd., Karachi

M/s Nabiqasim Industries (Pvt) Ltd., Karachi

043099 Ferriprox TabletsEach film coated tablet contains:Deferiprone…. 500 mg

100’s 03-08-2016Form-5Rs. 50,000/-

FDA Approved

The firm has submitted following documents:1. Form 5 with fee Rs. 50,000/-2. Copy of Registration Letter3. Letter of consent and agreement with M/s Nabiqasim (Pvt) Ltd.

Decision: Registration Board deferred the request of M/s ICI Pakistan Ltd., Karachi for verification of renewal status of Ferriprox Tablets.

Case No. 12: Deferred Productsa. Deferred Product of M/s Maple Pharmaceuticals, Karachi in 228th and 237th

meeting of Registration Board.M/s Maple Pharmaceuticals, Karachi have applied for the grant of registration of their

following applied product.

S.No Name of drug(s) & Composition

Decision in M-228th

Decision in M-237th Approval Status in Reference Regulatory Authorities

1. Envepe-SR TabletEach tablet contains:-Doxylamine Succinate...10mgPyridoxine HCl ……………10mg(Anti Histamine)

Deferred for application on Form 5D, remaining fee Rs 7000, international availability & expert opinion

The request of the firm was deferred by the board for the confirmation of market authorization status as per the regulatory authorities of developed countries (e.g. US-FDA, EMA, TGA and Japan) and submission of differential fee

US, FDAACTAVIS LABS FL INC

Also me tooFemiroz DR Tablet by Efferoz, Karachi

Now the firm has submitted evidence of two fee deposited with following details:Rs. 8,000/-

Endorsed by Statistical Officer, M/o Health

On 03-02-2010

Rs. 12,000/-Endorsed by STO on

16-03-2015(Photocopy)

Decision: Registration Board approved grant registration of Envepe-SR Tablet, M/s Maple Pharmaceuticals, Karachi. Photocopy challan shall be verified by Budget and Accounts Division and Chairman Registration Board will authorize issuance of registration letter.


b. Product of M/s Barret Hodgson, Karachi in 210th meeting of Registration Board.M/s Barret Hodgson Pakistan (Pvt) Ltd., Karachi have applied for registration letter of

their approved product in M-210 with following details:

S.No. Name of drug(s) & Composition Decision in Registration Board Meeting (M-210)

1. Vironil 600 mg TabletsEach tablet contains:Ribavarin…. 600 mg (Anti-Viral)

Approved with the condition that firm shall submit 6 months accelerated stability studies and validation data before marketing of drugs.

The firm has submitted that:“The same decision was made for Vironil 400 mg tablet and Vironil 50 mg/5 ml Syrup in DRB 210. However, registration letter was issued only for Vironil 400 mg tablet and Vironil 50 mg/5ml syrup with name of Barovir. With raising prevalence of Hepatitis C and other Viral infections, need of Ribavarin 600 mg tablet is also growing. Therefore, we request you to please grant us registration letter in the utmost benefit of the patients.”

Decision: Registration Board deferred for verification from minutes.

c. Deferred Product of M/s GlaxoSmithKline, Karachi in 263rd meeting of Registration Board.M/s Glaxo SmithKline Pakistan Limited, 35-Dockyard Road, West Wharf, Karachi has

applied for transfer of registration from the name of GSK West Wharf site DML No. 000017 to

GSK, factory at F-268, Karachi DML No. 000233 for manufacturing. The product had been on

contract manufacturing by M/s Akhai Pharma Karachi given as per following details:-

S.#

Regn. No.

Brand Name with Generic

Initial Registration Letter Date

Last Renewal

submission date

Applied for Transfer

Date

Status in reference

drug agencies

1. 024307 Zolanix CapsuleEach capsule contains:Fluconazole……150mg

20.03.2002Transfer of registration dated 31.01.2013

Renewal not due as yet after transfer letter

07.11.2016 Approved

The case was discussed in Registration Board 263rd meeting, wherein Board decided as follows:

Decision: Registration Board deferred for confirmation of last contract manufacturing permission / renewal status of product.

Now the firm has submitted evidence of last contract manufacturing permission which

was granted in 250th meeting of Registration Board from M/s Akhai Pharma, Karachi and is valid

till 30.06.2020.

Decision: Registration Board decided as follows:a. Cancellation of registration of Zolanix Capsule, Regn.No. 024307 form GSK

West Wharf site DML No. 000017 b. Approved grant of registration of product Zolanix Capsule in the name of GSK,

F-268, Karachi DML No. 000233. c. Reference will be sent to Cost and Pricing Division for MRP fixation.


d. Deferred product of M/s Hiranis, Karachi in 262nd meeting of Registration Board.M/s Hiranis Pharmaceuticals (Pvt) Ltd., Karachi have applied for change of registration

of following products from M/s Nexus Pharma, Karachi. The case was presented in the

Registration Board’s 262nd meeting wherein board differed the request of firm due to reasons

mentioned in the last column below:-

S.No. Reg. No. Name of the drug(s) & Composition

Pack Size

Initial date RegistrationFirm

Decision of Registration Board

1. 075975 Rapitus SyrupEach ml contains:Levodropropizine…. 6mg

60 ml 04th July, 2013 Deferred for confirmation of firm’s claim regarding approval status by 03 reference regulatory authorities

However, the case was again presented in the 264th meeting of Registration Board by

PEC which confirmed the status of approval in reference regulatory authorities and hence

Registration Board approved the product.

Now firm has submitted again for change of registration from M/s Nexus Pharma,

Karachi and registration in the name of the M/s Hiranis Pharmaceuticals (Pvt) Ltd., Karachi.

Decision: Registration Board approved grant of registration of Rapitus Syrup, M/s Hiranis Pharmaceuticals, Karachi.

e. Deferred Product of M/s S.J. & G. Fazul Ellahie (Pvt.) Ltd., Karachi in Registration Board meetings 225th and 259th

M/s S.J. & G. Fazul Ellahie (Pvt.) Ltd., Karachi have applied for the registration of their

following deferred products in meeting 259th of Registration Board for the reasons mentioned in

the last column below:

Name of drug(s) & Composition Demanded pack size

Decision in 225th Meeting

Decision in 259th Meeting

Pluliv TabletEach film coated tablet contains:-Prulifloxacin ….600mg(Antibacterial)

10’s Deferred for expert opinion.

Registration Board deferred the product for confirmation of me too status.

The firm has now submitted that the above product has been approved in Japan since

1997 and is also available in Germany, Italy, France, Spain and other countries. The firm has

therefore requested for grant of registration of above product. The firm has provided the

evidence of deposition of balance fee of Rs.35, 000/- and submitted form 5-D. However, the fee

challans are not original nor endorsed by STO DRAP.

Decision: Registration Board deferred the request of the firm for verification of fee challans from Budget and Accounts.


f. Deferred Product of M/s S.J. & G. Fazul Ellahie (Pvt.) Ltd., Karachi in 215 th and 259th meeting.Registration Board in 215th meeting approved following products of M/s S.J & G. Fazul

Ellahie (Pvt) Ltd., E/46, SITE, and Karachi. Case was again discussed in 259th meeting wherein

board deferred the following product due to reasons mentioned in last column below:

Product name with specification Demanded pack size

Decision

Vivid SuspensionEach 5ml contains:Voriconazole ……….200mg

60ml Registration Board deferred the case for confirmation of me too status.

The firm has provided evidence of fee of Rs. 15,000/- dated 29th December, 2008 and Rs.

35,000/-on 24th September, 2013 and Form-5D. However, the fee challans are not original nor

endorsed by STO DRAP.

Decision: Registration Board deferred the request of the firm for verification of fee challans from Budget and Accounts.

g. Deferred Products of M/s Helix Pharma, Karachi in 236 th meeting of Registration Board.Registration Board in its 236th meeting deferred the products of M/s Helix Pharma,

Karachi for the reasons given in the last column below:

S.No. Name of drug(s) & Composition Pack Size Decision1. Pagabin Capsules 75mg

Each capsule contains:-Pregabalin………...75mg(Anticonvulsants)

14’s Referred to the committee

2. Pagabin Capsules 150mgEach capsule contains:-Pregabalin……….150mg(Anticonvulsants)


3. Pagabin Capsules 300mgEach capsule contains:-Pregabalin……….300mg(Anticonvulsants)


Now the firm has submitted for reconsideration of the case and deposited the differential

fee of Rs. 12,000/- for each endorsed by STO DRAP on 13th December, 2016.

Decision: Registration approved grant of registration of aforementioned products at S.No. for M/s Helix Pharma, Karachi.

h. Deferred Products of M/s Espoir Pharmaceuticals PCSIR KLC, Karachi-72480 in

235th meeting of Registration Board.

Registration board in its 235th meeting has deferred the following products of M/s Espoir

Pharmaceuticals PCSIR KLC, Shahrah-e-Dr. Salim-uz-Zaman Siddiqui, Off University Road,

Karachi-72480, Pakistan as stated in the last column of the following table.Minutes for 267th Registration Board Meeting 353

S.No Name of drug(s) & Composition Date ofapplication,

Diary No. Form& Fee

Decision

1. Fluer-Disp 250mg TabletEach dispersible tablet contains:Ciprofloxacin HCl eq. to Ciprofloxacin ……250 mg(Quinolones Antibiotics)

07-09-20121537

Form-5Rs.8000/-

Deferred for review of Dispersible Dosage Form

2. Fluer-Disp 500mg TabletEach tablet contains:Ciprofloxacin HCl eq. to Ciprofloxacin ……500 mg(Quinolones Antibiotics)

07-09-20121527

Form-5Rs.8000/-


3. Fluer-Disp 750mg TabletEach tablet contains:Ciprofloxacin HCl eq. to Ciprofloxacin ……750 mg(Quinolones Antibiotics)

07-09-20121524

Form-5Rs.8000/-


4. Zorg 20mg CapsuleEach Capsule contains:Omeprazole ……….20 mgSodium bicarbonate.1100mg(Antipeptic / ulcerant/ antacid)

07-09-20121540

Form-5Rs.8000/-

Deferred for review of Formulation by experts and 5 products per Section Policy.

5. Zorg 40mg CapsuleEach Capsule contains:Omeprazole ……….40 mgSodium bicarbonate.1100mg(Antipeptic / ulcerant/ antacid)

07-09-20121539

Form-5Rs.8000/-

Deferred for review of Formulation by experts and 5 products per Section Policy

6. Ferro-One SyrupEach 5ml contains:Polysaccharide Iron Complex………….217.4 mg(Anti Anaemics)

10-09-20121558

Form-5Rs.8000/-

Deferred being new formulation

7. Rem Place SachetEach Sachet contains:Sodium Chloride…….3.5gmSodium Citrate………2.9gmPotassium Chloride….1.5gm(Calcium Salt, Supplement)

07-09-20121535

Form-5Rs.8000/-

Deferred to be revised as per WHO approved formulation

8. Krib SachetEach sachet contains:Diocotahedral smectite..3g(Antidiarrhoeals)

23-10-2012Dy.No.1706

Form-5Rs.20,000/-

Review of formulation by experts in meeting 236th

Decision: Registration Board decided as follows:

a. Deferred products at S.No 1-3 for confirmation of approval status by reference regulatory authorities and remaining fee Rs. 12,000/-.

b. Deferred products at S.No 4-7 for submission of remaining fee Rs. 12,000/-.c. Approved product at S.No. 8 for M/s Espoir Pharmaceuticals, Karachi.


Case No. 13: Permission for Import of a locally manufactured Product for an interim period.

M/s GalxoSmithKline Pakistan Limited, 35-Dockyard Road, West Wharf, Karachi

applied for local manufacturing of their product “Ventolin Evohaler” from Import in 259th

meeting of Registration Board, which was acceded and firm was granted permission for local

manufacturing of following product;

S.No.

Reg. No.

Name of drug(s) & Composition

1 041195 Ventolin EvohalerPer unit dose contains:Salbutamol Sulphate… 120.5 mcg eq. to Salbutamol……...100 mcg

Now the firm has requested that due to some technical issues at their manufacturing premises (West Wharf factory); delay in availability of imported packaging components of the product and to carry out some revalidation of processes and equipment of CFC free manufacturing area, at present they are unable to start local manufacturing of the Ventolin Evohaler which can lead to

potential risk of supplies and availability of Ventolin Evohaler in local market.

Therefore, in order to manage supply’s continuity, they may be allowed to import

Ventolin Evohaler from the previous same source, i.e. M/s Galxo Wellcome Production, France

for an interim period till December 31st, 2017.

Decision: Registration Board deliberated the case and advised to deposit prescribed fee for import and submit valid CoPP of the product. In order to ensure free availability of the product, the Board advised to rectify shortcomings at the earliest.

Case No. 14: Permission for finished drug ImportM/s Otsuka Pakistan Ltd. Karachi has applied for further extension in permission for

import in finished form for their already registered following drugs which were imported in bulk

form from Otsuka Pharmaceutical Co., Japan and contract local repacking at M/s Effroze

Chemical, Karachi:

S.No. Reg. No. Name of drug(s) & Composition

Existing permission for Finished Import

till

Source

1. 029294 Pletaal 50 mg TabletsEach tablet contains:Cilostazol….. 50 mg

04th March 2017 M/s Otsuka Pharmaceutical Co., Ltd., Kandu Tsukasa-cho, Chiyoda-ku, Tokyo, 1018535, Japan

2. 029295 Pletaal 100 mg TabletsEach tablet contains:Cilostazol….. 100 mg

-do- -do-


Now the firm has submitted that said permission should be further extended for a period

of two years and more from the expiry of the existing permission i.e. 04th March, 2017 from the

same source.The firm has submitted following documents:

Submitted Documents Required Documents1.Form 5-B 1.Form 5-A2.Fee 10,000/- each 2.Fee 100,000/- each

3.DML of Otsuka, Karachi and Effroze Karachi4.GMP of Effroze Karachi5.NOC from Effroze Karachi6. Legalized valid CoPP

Decision: Registration Board deferred the request for furnishing aforementioned requisite fee and documents for further processing of the case.

Case No. 15: Change of Registration M/s GlaxoSmithKline OTC (Pvt) Ltd., 35 Dockyard Road, West Wharf, Karachi 74000

have applied for registration of following products at their GSK OTC (Pvt) Ltd., Petaro Road,

Jamshoro DML No. 000010. These products were already registered in the name of M/s Novartis

Pharma (Pakistan) Ltd., 15-West Wharf, P.O Box 100 & 7247, Karachi-74000, which the firm

was manufacturing at Jamshoro Plant.

These products were sent to RRR section for confirmation and authentication of renewal

status as per procedure.

a. Products with valid Renewal.S.No Reg. No. Name of drug(s) &

CompositionInitial Date of Registration

Status of Renewal verified by RRR

Section

Status of Approval in Reference Regulatory Authorities

1. 058488 Lamisil Derm GelEach gram contains:Terbinafine…….10mg

07.09.2009 Renewal valid as application received within stipulated time accompanied with prescribed fee

US FDA

2. 021173 Lamisil Solution/sprayEach 1gm contains:-Terbinafine HCl….10mg

09.09.1998 -do- US FDA

3. 000172 Neo Intestopan SuspensionEach 10ml contains:-Activated Attapulgite… 1.00gm

30.12.1989 -do-

4. 003893- Santevini Plus Syrup 18.12.2012 -do-Minutes for 267th Registration Board Meeting 356

EX Each 15ml contains:Total Proteins derived from……1500mg Peptone approx ….…

750mg Soya Proteins approx

…..2700mg L-Lysine

approx…..10mg Dl-Methionine

approx………..29mg Glycine approx …..

….45mgCalcium Lactate …..….5700mgMaganese Sulphate ………3.15mgMagnesium Sulphate ……….61.50mgCyanocobalamin …….…..0.0010mgThiamin Mononitrate ……..….0.60mgRiboflavin…….0.90mgPyridoxine HCl ………1.10mgNictinamide…..10.0mg

5. 003892-EX

CaC-1000 SyrupEach 5ml contains:Calcium Glucono-galacto gluconate…..1.4375gmCalcium galco-Gluconate……0.2950gm

18.12.2012 -do- MHRA UK approved but in different strengths and combination

6. 003890-EX

Neo-Intestopan SuspensionEach 10ml contains:Activated Attapulgite Colloidal…….1.0gm

18.12.2012 -do-

7. 003891-EX

Neo-Intestopan TabletsEach tablet contains:Activated Attapulgite….630mg

18.12.2012 -do-

Decision: Registration Board decided as follows:a) Cancelled registration of aforementioned products at S.No 1-7 from M/s

Novartis Pharma Karachi.b) Approved grant of registration of products with new registration

numbers at S.No 1-7 in the name of M/s GlaxoSmithKline OTC, Jamshoro DML No. 000010.

c) Reference will be sent to Cost and Pricing Division for MRP fixation of products at S.No1-3 in the above table.

b. Products with valid renewal application and a single shortcoming


S.No

Reg. No.

Name of drug(s) & Composition

Initial Registration Letter Date

Status of Renewal verified by RRR Section

Status of Approval in Reference Regulatory Authorities

1. 006352 CaC Sandoz effervescent tabletEach tablet contains:-Ascorbic Acid…..500mgCalcium Gluconate BP…289mgCalcium Carbonate. BP …..163.5mgCalcium Lactate……… 211mg

12.06.1982 Renewal application received within stipulated time accompanied with prescribed fee.Transfer letter from Novartis west wharf to Novartis Jamshoro is required.

EMA approved in different combinations and without Ascorbic Acid.

2. 005009 CaC-1000 Effervescent TabletEach effervescent tablet contains:Calcium Lactate Cluconate …..1000mg(Calcium Gluconate ….578)(Calcium Lactate….422)Vitamin C (Ascorbic Acid) …….500mgCalcium Carbonate …….…327mg


EMA approved in different combinations and without Ascorbic Acid.

3. 014314 Calcium Factor TabletsEach tablet contains:Calcium carbonate 1250mg(equal to 500mg elemental calcium)


TGA Approved

4. 000309-EX

Lamisil 1% Cream (3gm)Each gram contains:-Terbinafine hydrochloride….10.0mg


US FDA

5. 000310-EX

Lamisil 1% cream (5gm)Each gram contains:-Terbinafine hydrochloride…10.0mg

17.03.2005 Renewal application received within stipulated time accompanied with prescribed fee.(Transfer Letter from Novartis west wharf Karachi to Novartis Jamshoro required)

US FDA

6. 000311-EX

Lamisil 1% cream (10gm)Each gram contains:-

17.03.2005 Renewal application received within stipulated

US FDA


Terbinafine hydrochloride…..10.0mg

time accompanied with prescribed fee.(Transfer Letter from Novartis west wharf Karachi to Novartis Jamshoro required)

7. 055549 T-Day SyrupEach 5ml contains:Levocetirizine dihydrochloride…..2.5mg


FDA Approved

8. 024662 Triaminic-Chest Congestion Cough SyrupEach 5ml contains:Pseudoephedrine HCl…..15mgGuaifenesin……..50mg


Approved in MHRA UK but in different strength 30/100.

9. 024663 Triaminic-Cold and Allergy SyrupEach 5ml contains:Pseudoephedrine HCl…..15mgChlorpheniramine Maleate……1mg


Approved in MHRA UK but in different strength30/2.

10. 024661 Triaminic-Cough SyrupEach 5ml contains:Pseudoephedrine HCl…..15mgDextromethorphan HBr…..5mg


Approved in MHRA UK but in different strength30/10.

11. 006432 Triaminic-SyrupEach 5ml contains:Pseudoephedrine HCl … 30mgPheniramin Maleate…12.5mg

11.07.1982 Renewal application received within stipulated time accompanied with prescribed fee.(Transfer Letter from Novartis west wharf Karachi to Novartis Jamshoro required).

12. 000592-EX

Voltaren 1% Emulgel (5gm)Each 100gm emulgel contains:-Diclofenac diethylamine… 1.16gm

17.10.2006 Renewal application received within stipulated time accompanied with prescribed fee.(Transfer Letter from Novartis west wharf Karachi to Novartis

MHRA, UK approved


Jamshoro required)13. 000593

-EXVoltaren 1% Emulgel (20gm)Each 100gm emulgel contains:-Diclofenac diethylamine… 1.16gm


MHRA, UK approved

14. 021527 Voltral EmulgelEach gram contains:-Diclofenac Sodium….100gm


US FDA

15. 008949 Neo Intestopan TabletsEach tablet contains:-Activated Attapulgite……..0.630gm


16. 002406 Optalidon TabletEach tablet contains:Prepyphenazone…..175mgCaffeine Anhydrous…25mg


17. 003074 Paradon 500mg tabletEach tablet contains:-Paracetamol … 500mg

14.02.1983 Renewal application received within stipulated time accompanied with prescribed fee.Transfer letter from Sandoz to Novartis Jamshoro is required

US FDA

18. 024893 Res-Q Oral SuspensionEach 5ml contains:Paracetamol……120mg

23.06.1999 Renewal application received within stipulated time accompanied with prescribed fee.Transfer letter from Novartis Pharma Bahria complex to Novartis Jamshoro is required.

US FDA

19. 004065 Santevini Plus Syrup 31.08.1978 Renewal application received within stipulated time accompanied with prescribed fee.(Transfer Letter from


Novartis west wharf Karachi to Novartis Jamshoro required)

20. 000937 Spasmo Cabalgin tabletsEach tablet contains:-Propyphenazone … 220mgHexahydroediphenine HCl … 20mg

18.03.1980 Renewal application received within stipulated time accompanied with prescribed fee.Transfer from Ciba Giegy to Novartis Jamshoro is required.

21. 011256 Tandegyl DS tabletsEach tablet contains:-Clemastine……..2mg(as hydrogen Fumarate)


22. 000510 Tandegyl SyrupEach 5ml contains:-Clemastine … 0.25mg(as Hydrogen Fumarate)


23. 000480 Tandegyl TabletsEach tablet contains:-Clemastine … 1mg(as Hydrogen Fumarate)

17.04.1976 Renewal application received within stipulated time accompanied with prescribed fee.(Transfer Letter from Novartis west wharf Karachi to Novartis Jamshoro Karachi required)

US FDA

24. 007719 Tandegyl-D tabletEach tablet contains:Clemastine (as Hydrogen Fumarate)…..1mgPseudoephedrine HCl….90mg

12.11.1984 Renewal application received within stipulated time accompanied with prescribed fee.(Transfer Letter from Novartis west wharf Karachi to Novartis Jamshoro Karachi required)

Decision: Registration Board deliberated that firm has not provided document for transfer of above mentioned products from Novartis West Wharf Karachi to Novartis Jamshoro. The Board also advised to provide aforementioned letter alongwith confirmation of approval status by reference regulatory authorities for items at S.No. 1, 2, 8, 9, 10, 11, 15, 16, 19-22 and 24.

c. Products with photocopy of renewal application and other shortcomings1. 055081 Qalsan D Chewable 14.02.2009 Renewal application The Spanish


TabletEach chewable tablet contains:-Calcium Carbonate ……...1250mg eq. to Elemental Calcium …500mgVitamin D3…..125IU

received within 60 days after expiry of reg. with prescribed fee.Transfer letter from Novartis west wharf to Novartis Jamshoro is required.

Agency of Medicines and Medical Devices (EU Country)

2. 028691 CaC-1000 SachetEach sachet contains:Calcium Lactate Gluconate…..1000mgVitamin C (Ascorbic Acid)…..500mg

19.09.2012 Evidence of renewal is photocopy of renewal application with fee of 4000/- PKR. Received on 30.8.2012 while the due date is 18-9-2012 and as per SRO 1117 (I-2012) dated 10-09-2012 differential fee of 6,000/- PKR is required.Transfer letter from Novartis Pharma Bahria Complex to Novartis Jamshoro Karachi required)

Approved in The Spanish Agency of Medicines and Medical Devices (EU Country)But in different combination

3. 030612 CaC 1000 plus tabletsEach tablet contains:-Calcium Carbonate….327.00mgAscrobic Acid…,500mgPyridoxine HCl..10.0mgVitamin D3…..4.0mgPineapple Flavour

08.07.2003 Evidence of renewal is photocopy of renewal application. Clarification of manufacturing site required.

4. 000165 Calcium Sandoz Syrup 17.04.1976 -do-5. 000175 CaC 1000 with Vitamin

C Injection17.04.1976 Evidence of renewal is

photocopy of renewal application. Clarification of manufacturing site required.

6. 013210 Limisil Cream 1%Each 1gm of cream contains:Terbinafine Hydrochloride….10.0mg

16.05.1992 -do- US FDA approved

7. 042172 Qalsan Jr TabletEach chewable tablet contains:Calcium (as Calcium Carbonate)…..250mgIron (as Ferrous Fumarate)….5mgZinc (as Zinc Sulphate)….5mg

26.01.2006 -do-

8. 042173 Qalsan VitEach chewable tablet

26.01.2006 -do-


contains:Calcium (as Calcium Carbonate)…..250mgZinc (as Zinc Sulphate)….5mgVitamin C (as Ascorbic Acid)……..40mgVitamin A (as Vitamin A Acctate)……0.25mgVitamin E……….4mg

9. 000169 Qalsan Ampoule 17.04.1976 Evidence of renewal is photocopy of renewal application. Clarification of manufacturing site required.Section approval letter for injectable section at Novartis Jamshoro Karachi

10. 008136 Triaminic DM SyrupEach 5ml contains:PseudoephedrineDextromethorphan HBr……..10mg


MHRA UK approved but in different strength

11. 007914 Triaminic E SyrupExpectorant SyrupEach 5ml contains:Pseudoephedrine Hydrochloride…12.5mgGuaifenesin…..100mg


MHRA UK approved but in different strength

Decision: Registration Board advised firm to provide documents for transfer of above mentioned products from Novartis West Wharf Karachi to Novartis Jamshoro. Moreover, firm shall rectify shortcomings / provide documents for matter related to renewal of products.

Case No. 16: Change of RegistrationRegistration Board in its 263rd meeting deferred the following products of M/s Scilife

Pharma (Pvt) Limited Plot # FD-57/58-A2, Korangi Creek Industrial Park (KCIP), Karachi for

confirmation/authentication of renewal status. These products are registered in the name of M/s

Getz Pharma, Karachi.

S.No. Reg. No. Name of product Date of initial registration Status of Approval in Reference Regulatory

Authorities1. 022023 Trupril 10mg Tablets

Each tablet contains:Lisinopril dihydrate 21.7756mg eq. to Lisinopril…….5mg

20.05.1998Change of brand name dated 03.06.2003Applications Received with in due time

US FDA Approved

2. 022022 Trupril 5mg Tablets 20.05.1998 US FDA Approved


Each tablet contains:Lisinopril dihydrate 21.7756mg eq. to Lisinopril…….5mg

Change of brand name dated 03.06.2003Applications Received with in due time

3. 039730 Co-Trupril TabletsEach tablet contains:Lisinopril (as dihydrate)……20mgHydrochlorothiazide.…..12.5mg

03.12.2005 Applications Received with in due time

US FDA Approved

4. 036618 Norplat 75mg TabletsEach film coated tablet contains:Clopidogrel (as bisulphate)……..75mg

28.01.2005Change of brand name04.05.2005Applications Received with in due time

MHRA, UK Approved

In support the firm has submitted following documents:

i. Application on form 5 with Rs. 20,000/- as prescribed fee for each product.ii. NOC from M/s Getz Pharma , Karachi

iii. Copy of registration letter and renewal status.iv. Undertaking of not have same product registration.v. A copy of DML of M/s Scilife Pharma, Karachi dated 01.06.2016.

vi. Copy of last panel inspection dated 29.03.2016Decision: Registration Board decided as follows:

a. Cancellation of registration of products mentioned at S.No.1-4 from M/s Getz Pharma, Karachi.

b. Registration of products mentioned at S.No.1-4 with new registration for M/s Scilife Pharma, Karachi.

c. Reference will be sent to Costing and Pricing Division for MRP fixation.

Case No. 17: Registration of Voltral Emulgel 2 %Registration Board in its 265th meeting considered case of M/s Novartis, Jamshoro for

onsite stability verification of the Voltral Emulgel 2 % stability data submitted by the firm. The

panel inspection report was presented and board decided as follows:

“Registration Board considered onsite inspection reports. The Board deliberated that as management and title of the firm has been changed and approved by Central Licensing Board, thus clarification will be obtained from the new licensee about instant registration application.”Now GlaxoSmithKline OTC, Karachi have submitted a request that due to change in the

management the said registration of Voltral Emulgel 2 % shall be issued on their name. Firm has

also provided NOC form Novartis Pharma, Karachi in support of their claim.

Decision: Firm provided photocopy of NOC by Novartis Pharma, Karachi for registration of Voltral Emulgel 2 % in the name of M/s GalaxoSmithKline OTC, Jamshoro, thus Registration Board decided to verify copy of NOC.

Registration-III


Case No.18: Deferred Cases

a) Replacement through deregistration of already granted Contract Manufacturing permission with newly applied deferred drugs (Deferred in 265th Meeting).

The Registration Board in its M-265 meeting considered the subject request and deferred

the following products of M/s Medizan Laboratories for confirmation of GMP status of contract

manufacturer M/s Nimrall Laboratories, Rawat Islamabad. The firm applied these products for

de-registration mentioned in column VI which were approved for contract manufacturing in M-

252 meeting from M/s Weather Folds, Hatar, for Sr. No. 1-5. The firm has now requested for

replacement of these products with those mentioned in column III for contract manufacturing

from M/s Nimrall laboratories, Islamabad which were earlier deferred by the Registration Board

in its M-262nd meeting

“for confirmation of already approved products for contract manufacturing to comply Contract Manufacturing policy”.

S.No.

Name of Applicant & Manufacturer

Brand name and composition

Internationally availability and observation mentioned in inspection report

Registration No. (of the products to be replaced)

Brand name & composition of already registered Products to be replaced

I II III IV V VI1. M/s Medizan

Laboratories (Pvt) Ltd, Plot 313, industrial triangle kahota road,Islamabadcontract Manufactured by M/s Nimrall Laboratories, Plot 24, street SS 3, Rawat (206)

Bone InjectionEach ml contains:-Choleclciferol…….5.0mg(Vitamin D Analogue)USP specs

Calcitrol USA (without reference provided),Indrop D of Neutro Pharma,

ANSM France

045067 Shevaz 250mg InjectionEach vial contains:-Cefotaxime (as Sodium)…….250mg(USP Specs.)

2. M/s Medizan Laboratories (Pvt) Ltd, Plot 313, industrial triangle kahota road,Islamabadcontract Manufactured by M/s Nimrall Laboratories, Plot 24, street SS 3, Rawat (205)

Medilac InjectionEach ml contains:-Ketorolac Tromethamine ……30mg(NSAID)USP specs

Toradol USA,Toradol Roche) contract manufacturing.

Approved in UK

045066 Shevaz 1000mg InjectionEach vial contains:-Cefotaxime (as Sodium).. ....1000mg(USP Specs.)


3. M/s Medizan Laboratories (Pvt) Ltd, Plot 313, industrial triangle kahota road,Islamabadcontract Manufactured by M/s Nimrall Laboratories, Plot 24, street SS 3, Rawat211

Vinco InfusionEach 100ml vial contains:-Ciprofloxacin as Lactate USP ………….200mg(Quinonones / Broad Spectrum Antibiotic)UPS specsApproved in UK

International availability not Provided, found approved in USA and UKMe too, Toll manufacturing.

045068 Shevaz 500mg InjectionEach vial contains:-Cefotaxime equivalent toCefotaxime……..500mg(USP Specs.)


Morex InfusionEach 100ml vial contains:-Moxifloxacin (as HCl)…..400mg(Quinonones / Broad Spectrum Antibiotic)(NA)

Approved in UK and USA as 400mg /250ml. the Board has already advise the firm to convert their formulation containing Moxifloxacin I.V infusion as 400mg/250ml

International availability not Provided,Not found in 400mg/100ml instead 400mg /250ml is approved in USA and UKMolox by CCL, Toll manufacturing.

045060 Glazidim 500mg InjectionEach vial contains:-CeftazidimePentahydrate with sodium carbonate eq. to Ceftazidime (anhydrous)……….500mg(USP Specs.)


Haemofer InjectionEach ml contains:-Iron Sucrose Iron (Elemental) ….20mg(Haematinic)(USP specs)

Approved in USFDA as vial and in UK as ampoule.

International availability not Provided,Me too, Toll manufacturing.

045058 Glazidim 1gm InjectionEach vial contains:-CeftazidimePentahydrate with sodium carbonate eq. to Ceftazidime (anhydrous).......1000mg(USP Specs.)

Now, the firm has submitted the inspection report of M/s Nimrall Laboratories conducted

by 14-03-2016 based on which DDG (E&M) Islamabad issued GMP Certificate to the firm for

export purpose, which is valid 13-03-2017.Minutes for 267th Registration Board Meeting 366

Decision: Registration Board approved request of the firm for cancellation of registration of products mentioned in the column VI and grant the registration of products at S.No. 1, 2, 3, and 5 and while deferred the product at S.No.4 for submission of Form-5 with correct formulation 400 mg / 250ml instead of 400 mg /100 ml Moxifloxacin infusion


Case No.19: Change in Specificationsa. Product approved with USP specificationsThe Registration Board in its 260th meeting approved the following product of M/s Regal

Pharmaceutical, Islamabad with the details below:

S.No Reg. No. Name of drug (s) & composition

Packing MRP Approved shelf life

1. 082000 PARAMOL InfusionEach 100ml contains:Paracetamol ………1gm(USP Spec) Antipyretic

100ml Rs.80/- two years

The firm has now requested that since the above product is not present in the USP and therefore requested for change in manufacturing specs from USP to manufacturer specifications.Decision: Registration Board did not approve the request of firm and advised to follow

policy decision in this regard.

b. Product approved in 218 meeting of Registration Board

M/s Pearl, Pharmaceuticals, Islamabad have requested for change in specification of

their following registered product as per following details:-

The details of requirement as per SOPs and the documents submitted by the firm are as

under:-

Now, the firm has request for change in Specification of above product form Pearl specification to “BP specification”.

Decision: Registration Board approved the request of the firm for change in specification of Aeme-Pearl (Adapalene…….0.1%w/w) Cream from Pearl Pharmaceutical Specifications to BP Specification.


S.No. Reg.No. Name of drug(s) & Composition Desired Change in Specification1. 059414 Aeme-Pearl Cream

Contains:-Adapalene…….0.1%w/w(Pearl’s Specifications)

Aeme-Pearl CreamContains:-Adapalene…….0.1%w/w(B.P. Specifications)

Requirement as per SOPs Documents submitted by the Firm.Application with required fee as per relevant SRO. If error is on part of firm.

Fee of Rs.5000/- product deposited

Copy of registration letter and renewal status.

Initial Rag.

RenewalDue

RenewalApplied

04.08.2009

03.08.2014 01.08.2014 Renewal is ok

NOC for CRF clearance. Copy of CRF (valid upto 31-12-2017.

Documents in support of proposed correction

The firm has provided copy of BP monograph

Registration-IVCase No. 20: Request for Cancellation of registrations of products from M/.S Webrose

Pharmaceutical, Rawat and registration in the name of M/S. Bloom Pharmaceuticals, Hattar.

M/s Bloom Pharmaceutical Hattar has requested for registration of following drugs, already registered in the name of M/s. Webros Pharmaceuticals, Rawat, to their name along with few changes as per details mentioned against each:-

S.# Product for registration with generic name

Reg. No. New proposed

brand name

Remarks

1 Wenamic Forte TabletEach tablet contains:-Mefenamic Acid……….500mg

032845 Mefadon The firm has also requested for following changes in the currents status of Registration letter:-i. From plain tablet to film coated tabletii. BP Specification

2 Wefen 400mg TabletEach tablet contains:-Ibuprofen………..400mg

034707 Blufen The firm has also requested for following changes in the currents status of Registration letter:-i. From plain tablet to film coated tablet

ii. USP SpecificationStatus of renewal needs to be confirmed

3 Womzol TabletEach tablet contains:-Albendazole…………..200mg

038430 Bentel The firm has also requested for following changes in the currents status of Registration letter:-i. From plain tablet to film coated tablet

ii. USP Specification4 Vercid Tablet 100mg

Each tablet contains:-Mebendazole……..100mg(USP Spec)

070041 Blobend The firm has also requested for following changes in the currents status of Registration letter:-i. USP Specification

5 Hydroheal CreamEach gram contains:-Hydrocortisone acetate…1%w/w(BP Spec)

072054 Blocort

6 Webnate OintmentEach gram contains:-Betamethasone as valerate……………..…0.1%w/w(BP Spec)

072055 Blovate

7 Webnate CreamEach gram contains:-Betamethasone valerate……………….0.1%w/w(BP Spec)

072056 Blovate The firm has also requested for following changes in the currents status of Registration letter:-i. from Betamethasone valerate to Betamethasone as valerate

8 Webnate- N OintmentEach 5gram contains:-Betamethasone valerate…0.1%Neomycin Sulphate………0.5%(BP Spec)

072057 Blovate-N The firm has also requested for following changes in the currents status of Registration letter:-i. Manufacturer Specification (as the product is not available in BP & USPii. From each 5gm contains to each gm contains:-


9 Webnate- N CreamEach 5gram contains:-Betamethasone valerate…0.1%Neomycin Sulphate………0.5%(BP Spec)

072058 Blovate-N The firm has also requested for following changes in the currents status of Registration letter:-i. Manufacturer Specification (as the product is not available in BP & USPii. From each 5gm contains to each gm contains:

10 Betaheal CreamEach gram contains:Betamethasone dipropionate……..0.1%w/w

072059 Blusone The firm requested change of brand name to Blusone and revision of formulation from 0.1% Betamethasone Dipropionate BP to Betamethasone 0.05% USP .The firm already has registration of Austazone Ointment (Reg.No.024103) having same demanded composition,

11 Webnizole TabletEach tablet contains:-Metronidazole……….200mg

034694 Zonid The firm has also requested for following changes in the currents status of Registration letter:-i. From plain tablet to film coated tablet

ii. USP SpecificationStatus of renewal needs to be confirmed

The firm has submitted the following supporting documents:-i. Application with Form-5 and required fee of Rs.20000/- each.ii. Copy of registration letter.iii. NOC for CRF clearance.iv. Copy of approved section by Central Licensing Board. v. Copy of last inspection report.vi. NOC from M/s. Webrose Pharma, permitting transfer of products.vii. Statement / undertaking that applicant do not have registration of same products.

If so, it has to apply for cancellation of product.viii. Accelerated stability studies of 6 months with undertaking to conduct real time

stability studies up to assigned shelf life & report if any result falls outside shelf life specifications (with proposed action).

ix. Undertaking for Validated method of analysis, and product development data.x. Renewal status verified from copies of renewal submission receipts provided with

their applications. Decision: Registration Board decided to cancel above registrations from M/s Webros

Pharmaceuticals, Rawat and registration in name of M/s Bloom Pharmaceutiacsl, Hattar as per following details. Reference shall be sent to Cost & Pricing division about MRP of products.

i. Product at S.No.1. is approved with proposed brand name (Mefadon) as the firm already have registration of Mefadon Tablets (Mefemanic Acid) 250mg. (Reg.No.016474).

ii. Products at S.No.3, 4, 5, 6, 7, 8 and 9 are approved with change of proposed brand names. For products at S.No. 8 and 9 the specifications approved will be in accordance with the decision of Registration Board taken in 264th and 266th

meeting for non-pharmacopoeial products i.e. “as per innovator’s specification”. iii. Product at S.No.10 is approved with the change of proposed brand name i.e

Blusone to Austazone as the firm already has registration of Austazone Ointment (Reg.No.024103).

iv. Products at S.No.2 &11 are deferred for clarification of renewal status.Minutes for 267th Registration Board Meeting 370

Registration –V

Case No. 21: Deferred product of M/s. Remington pharmaceuticals, Lahore

Registration Board in its 227th meeting deferred the case of M/s. Remington

pharmaceuticals, Lahore as per detailed below:

S/N Name of firm

Name of the drugs with composition

Pack Size

Proposed Price

Decision

1. M/s. Remington Pharma Lahore

Bimtan eye dropsEach ml contains:-Bimatoprost…0.03%(Antiglaucoma)

3ml5ml

7.5ml

Leader Price

Deferred for expert opinion (Form 5 + Fee)

The applied formulation is approved in FDA (LUMIGAN) which is synthetic structural

analog of prostaglandin which is used to decreases intraocular pressure in Glaucoma. Firm had

deposited differential fees 12000/- (Dated 30.07.2013) and Form 5.

Decision: Registration Board approved the product of M/s Remington Pharmaceutical, Lahore.

Case No. 22: Deferred product of M/s N.B.S Pharma, Lahore

Following product of M/s N.B.S Pharma, Lahore was deferred in different meetings of

Registration Board and decided as follows.

Sr.No Name of Drug Decision (215th meeting)1. Povidone-1 Solution

Each 100ml contains:-Povidone Iodine USP 7.5gm equivalent to 0.75% available iodine (USP)

Approved subject to the submission of the last Inspection report.

The firm had submitted GMP report, the case was presented in 260th meeting which was

deferred as per below mentioned.

Decision: Registration Board deferred the case for GMP status of the firm and confirmation of section either from Licensing division or from panel / renewal inspection report.

As per GMP inspection report the firm has facility of External Preparation Section.

External Preparation Section:-This section comprised of preparation and filling rooms, equipped with preparation vessels of different sizes. Silver san mixer and filling machine was installed HVAC system was provided in this area and was functional at the time of inspection. Re-packing area was equipped with filling machine and different size vessels. HVAC system was installed production area furnish with epoxy.


The case was again presented in 263rd meeting of Registration Board.

Decision: Registration Board deferred the case for latest GMP inspection report and payment of differential fee (Rs.12000/-)

The firm had deposited differential fee of Rs.12,000/- (dated 13.06.2016) and GMP inspection

report conducted by Mrs. Majida Mujahid, FID, Lahore-II (dated 30.11.2015). According to firm

no GMP inspection has been conducted in year 2016.

Decision: Registration Board referred the case to Quality Assurance Division for confirmation of last GMP inspection.

Case No. 23: Correction in minutes of 218TH meeting of Registration Board Registration Board in 218th meeting approved the following product of M/s. Jawa

Pharmaceuticals (Pvt) Ltd, Lahore as per detailed below:

S. No.

Name of firm Product name and composition

Demanded pack size

Demanded price

Remarks

1. M/s. Jawa Pharmaceuticals (Pvt) Ltd, Lahore

Ambrofen P TabletEach Tablet Contains:-Ibuprofen…….200mgPseudoephedrine HCl…….300mg

100 ‘s Rs.2.28/Tab Approved

Registration letter was also issued (02nd September, 2009) as per approved minutes. According to

firm they had applied for Pseudoephedrine HCl 30mg instead of 300mg, the applied formulation

is also approved in MHRA (UK).

S. No. Reg. No.

Existing Composition Proposed correction in composition

1. 059913 Ambrofen P TabletEach Tablet Contains:-Ibuprofen…….200mgPseudoephedrine HCl…….300mg

Ambrofen P TabletEach Tablet Contains:-Ibuprofen…….200mgPseudoephedrine HCl……..30mg

Decision: Registration Board acceded to request of M/s Jawa pharma, Lahore for correction in formulation of their registered product Ambrofen P Tablet.

Case No. 24: Change of description of dosage form of M/S. AL-FAZAL Pharma Industries (PVT) Ltd. Lahore

M/s. Al-Fazal Pharma Industries (Pvt) Ltd, lahore has requested for change of description

of dosage form from Syrup to Suspension of below mentioned products as per detailed below:-

S. No

Reg.No/Date of Registration

Name of Drug (s) & Composition Proposed correction in Dosage form

1 07889926th February, 2014

Parasyp SyrupEach 5ml contains:- Paracetamol……120mg(B.P. Specification)

Parasyp Suspension


2. 07890426th February, 2014

Ribunal Syrup 100mgEach 5ml contains:-Ibuprofen………………….100mg(B.P. Specification)

Ribunal Suspension

The applied formulations/dosage forms are approved in Reference regulatory authority

(MHRA).The firm want to correct description of dosage form as per formulation approved in

reference regulatory authority (UK)

Decision: Registration Board acceded to request of M/s Al-Fazal Pharma, Lahore for correction in description of formulation of their registered products.

Case No. 25: Transfer of registeration from import to local manufacture under contract manufacturing agreement

M/S. Angelini Pharmaceutical (Pvt) Ltd is under toll manufacturing agreement with M/s.

Pacific Pharmaceuticals Ltd, Lahore for the manufacturing of product Spasmex tablet 80mg as

per detailed below:

Registration number and date

Product name & formulation Local/international availability

021930(04.09.1998)

Spasmex tablet 80mgEach Tablet contains:1,3,5 Trihydroxybenzene dihydrate (phloroglucinol dihydrate)102,850 (equal to anhydrous phloroglucinol- 80mg)-1,3,5 trimethoxy benzene- 80mg

ANAFORTAN PLUS(Phloroglucinol 80mg, Trimethyl phloroglucinol 80mg) by AGP pharma.SPASFON (Phloroglucinol 80mg, Trimethyl phloroglucinol 80mg) by Himont pharma, Lahore. Formulation approved in Germany and France (ANSM) is:Phloroglucinol hydrate 80mg (Anhydrous phloroglucinol 62.233 mg )Trimethylphloroglucinol 80mg

The firm has submitted following documents:-i. Fee of Rs. 50,000/- for this purpose.ii. Form-5 from Pacific Pharma, Lahore.iii. NOC from exporter (Scharper SpA Italy) iv. NOC form manufacturer (Doppel Italy)v. Copy of toll manufacturing agreement (M/s Angelini Pharma, Lahore and M/s

Pacific pharma, Lahore)vi. Copy of registration and renewal (last renewal 25th Nov, 2013) vii. Technical data and manufacturing process.


viii. Last GMP inspection report of M/s Pacific Pharma, Lahore (dated 19.11.2015)The firm has requested for transfer of registration from import to local (contract)

manufacturing.

Decision: Registration Board deferred the case of M/s. Angelini Pharmaceutical (Pvt) Ltd for clarification of formulation.

Case No 26: Transfer of product registration from M/s. Welmark Pharmaceuticals, Islamabad to M/s. English Pharmaceutical, Lahore.

M/s. English Pharmaceuticals Industries, Lahore has requested for transfer of registration

of product of M/s. Welmark Pharmaceuticals, Islamabad in favor of M/s English Pharma, Lahore

as per detailed below:

S.No Registration no Name of firm Brand name of drug

Generic name

1. 078520M/s. Welmark Pharmaceuticals, Islamabad

Polysac Capsule Iron Polysacchride Complex equivalent to elemental iron= 150mg

The firm has submitted following documents:-i. Form-5 and fee of Rs. 20,000/- for this purpose.ii. Copy of registration letter (19th May, 2014)iii. NOC from M/s. Welmark Pharmaceuticals, Islamabad for transferring registration

and ownership of said product in favor of M/s English pharma, Lahore. iv. Copy of NOC for CRF.v. Undertaking/commitments for submitting stability data, analytical method

validation and pharmaceutical product development of the pilot batch and following innovator brand.

The firm has proposed new brand name for above mentioned product i.e Myfer 150mg capsule.

Decision: Registration Board decided as follows: Cancellation of Polysac Capsule, Registration no. 078520 M/s Welmark

Pharmaceuticals, Hattar. Grant of registration of Polysac Capsule, Registration no. 078520 in name of of M/s

English Pharma, Lahore. However due to resemblance of proposed brand name with already registered products, firm will submit alternate brand name and Chairman will be authorized for issuance of approval letter.

Reference shall be sent to Cost & Pricing Division for MRP of the product.


Item No.IV: Biological Drugs Division.

Summary

Items Cases No. of Cases

Case No.1 Imported Human Biologicals from Reference countries. 06

Case No.2 Imported Human Biologicals from Non-reference countries. 1

Case No. 3 Imported veterinary Biologicals from Reference countries 1

Case No. 4 Imported veterinary Biologicals from non-reference countries 6

Case No. 5 Human Biologicals for Export Purposes 6

Case No.6 Miscellaneous/Deferred cases 13

Total Cases 33


Case No.01: Imported Human biologicals from reference countries.S.

No.Name of Importer & Manufacturer

Brand Name & Composition

Type of FormDy No & Date of

applicationFee submitted

Pack size/ Demanded Price

Document details (CoPP)Me too

status/New molecule

Remarks Decision

1. Pfizer Pakistan Limited, 12, Dockyard Road, West Wharf, Karachi

Product License Holder: Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

Manufacturer: Pfizer Manufacturing Belgium NV, Rijksweg 12, B-2870 Puurs, Belgium.

Prevenar 13(Suspension for Injection in Multi-Dose Vial)

Each dose(0.5ml) contains:Pneumococcal polysaccharide serotype 1…..2.2µg Pneumococcal polysaccharide serotype 3…..2.2µg Pneumococcal polysaccharide serotype 4…..2.2µg Pneumococcal polysaccharide serotype 5…..2.2µg Pneumococcal polysaccharide serotype 6A…..2.2µg Pneumococcal polysaccharide serotype 6B…..4.4µg Pneumococcal polysaccharide serotype 7F…..2.2µg Pneumococcal polysaccharide serotype 9V…..2.2µg Pneumococcal polysaccharide serotype 14…..2.2µg Pneumococcal polysaccharide serotype 18C…..2.2µg Pneumococcal polysaccharide serotype 19A…..2.2µg Pneumococcal polysaccharide serotype 19F…..2.2µg Pneumococcal polysaccharide serotype 23F…..2.2µg

Dy No. 287/2017(R&I) 06-02-2017172-ADC(BD) 07-02-2017 Rs.100,000/- 17-01-2017Pack Size: 50 vials(4 doses)Price not mentioned.

Valid Legalized CoPP No. 02/16/102733 dated 28-09-2016 issued by EMA

Product is WHO prequalified.

Shelf life applied by the firm is of 36 months while approved shelf life in EMA and WHO is of 24 months.

Approved as per Import Policy for Finished Drugs and with 24 months shelf life as per valid legalized CoPP.


Pneumococcal Vaccine

Shelf Life: 3 years2. M/s Sanofi Aventis

Pakistan Limited Karachi

M/s Sanofi Pasteur SA, 2 Avenue du Pont Pasteur 69007 Lyon France

VaxigripTetra(Suspension for injection in prefilled syringe, quadrivalent influenza vaccine (split virion, inactivated)

Each 0.5ml contains:A/California/7/2009 (H1N1) pdmm09-like strain (A/California/7/2009, NYMC X-179A)….15mcg HAA/Texas/50/2012 (H3N2)- like strain A/Texas/15/2012/NYMC x-223A……15mcg HAB/Massachusetts/ 2/2012 (Yamagata lineage) …..15mcg HAB/Brisbane/60/2008 (Victoria lineage) …..15 mcg HA

Shelf life: 12 months

Form-5ADy. No. 1061 dated 13-02-17100000 dated 10-02-171200/- pack of 1’s

Legalized CoPP No. 007742 dated 13-10-2016

Approved as per Import Policy for Finished Drugs and as per valid legalized CoPP. The strains composition of influenza vaccines will change every year as per WHO recommendations. Therefore the firm will update the strain as per WHO recommendations accordingly.

3. Fresenius Medical Care Pakistan (Pvt.) Limited, Lahore

Product License Holder:STADA Arzneimittel AG, Stadastrasse 2-18, D-61118 Bad Vilbel, Germany

Manufacturer:ROVI Contract Manufacturing, S.L., Julian Camarillo 35, 28037 Madrid, Spain

Silapo 2000IUEach pre-filled syringe(0.6ml) contains: Epoetin Zeta….2000IU

Anti anemic

Shelf Life: 30 months

Form-5ADy. No.594(R&I) dated 28-01-2016Rs. 100000/- 15-09-2015Pack of 6 PFS/ Rs. 940./-

Legalized CoPP No. 01/15/85754 dated 06-03-2015 issued by EMACertificate of GMP compliance dated 30-06-2014

Retacrit by Hospira UK Ltd., Uk

Submitted CoPP is Photocopied but notarized and legalized from Frankfurt.

Deferred for the submission of original valid legalized CoPP issued by EMA.





Silapo 4000IUEach pre-filled syringe(0.4ml) contains: Epoetin Zeta….4000IU

Anti anemic


Form-5ADy. No. 594(R&I) dated 28-01-2016Rs. 100000/- 15-09-2015Pack of 6 PFS/ Rs. 2063./-

Legalized CoPP No. 01/15/85754 dated 06-03-2015 issued by EMACertificate of GMP compliance dated30-06-2014







Silapo 10000IUEach pre-filled syringe(1 ml) contains: Epoetin Zeta….10000IU

Anti anemic


Form-5ADy. No. 594(R&I) dated 28-01-2016Rs. 100000/- 15-09-2015Pack of 6 PFS/ Rs. 4404./-

Legalized CoPP No. 01/15/85754 dated 06-03-2015 issued by EMACertificate of GMP compliance dated30-06-2014




6. M/s AJM Pharma (Pvt.) Ltd., 1st Floor, Shafi Court, Merewether Road, Civil Lines, Karachi

M/s Bles Biochemicals Inc., 60 Pacific Court, Unit 8, London, Ontario, Canada, N5V 3K4

Bles(Bovine lipid extract surfactant)

Phospholipid….27mg/mlSurfactant associated proteins SP-B and SP-C…….500mcg/ml

Lung surfactant

Shelf Life: 36 months(Stored frozen at below -100C.)10 months (Stored at 2-80C)

Form-5ADy. No. 1589(R&I) dated 17-01-2017Rs. 50000/- 30-12-2016Pack Size: 1’s(4ml) vial/ Rs. 25000/-

Legalized CoPP No. 64812 dated 30-11-2016 valid for 01 year.

Survanta (25mg/ml) by AbbVie Inc. USA

Survanta (25mg/ml) by Getz Pharma, Karachi.

Approved as per Import Policy for Finished Drugs and as per valid legalized CoPP.


Case No.02: Imported Human biologicals from Non-reference countries.Sr. No.

Name of Importer & Manufacturer


Type of FormDy No & Date of applicationFee submittedPack size/ Demanded Price

Document details (CoPP)Me too status/New molecule

Remarks Decision

1. PharmEvo (Private) Limited, Plot A-29, North Wester Industrial Zone, Port Qasim, Karachi

Shandong Kexing Bioproducts Co., Ltd., No.2666, Chuangye Road, Mingshui development Zone, Zhangqiu, Shandong, China

Eposino 10000IUEach (ml) contains: Recombinant Human Erythropoietin ……..10000IU.

Hematopoietic


Form-5AOut Dy. No. 116027-05-2014

Rs. 100000/-04-07-2013

Pack Size:1’s (PFS)/ Rs. 5100/-

Legalized CoPP no. WHO-CPP-CERT-JN-140425 dated24-04-2014

The firm has submitted the clinical trial data of the said product.

Deferred for the submission of biosimilarity data under clinical trial data.

Case No.03: Imported veterinary biologicals from Reference countries.Sr. No.

Name of Importer &

Manufacturer


Type of FormDy No & Date of

applicationFee submitted



status/New molecule

Remarks Decision

1 Saadat International, 117 Habitat Flat, Shadman II, Jail Road, Lahore

Merial, Inc. facilities at 1168 Airport Parkway, SW, Gainesville, Georgia 30501, USA

Sterile Diluent for VexxitekEach dose contains:Sucrose…0.01025gPotassium Phosphate, monobasic...0.00009gPotassium phosphate dibasic…0.0002gNZ Amine… 0.003gPhenol Red…. ……0.000002gDeionized water… 0.2mlSodium hydroxide… qs pHDiluentShelf Life: 36 months

Form-5ADy. No. 2875(R&I)03-01-2017Rs. 100000/-07-12-2016

Pack size:400ml

Valid Legalized Free Sale Certificate dated 26-08-2016

Valid Legalized GMP certificate no. 1603314 dated 22-09-2016

The diluent is for already registered vaccine Vaxxitek Reg. No. 057114.

Approved as per Import Policy for Finished Drugs and as per valid legalized CoPP/ GMP and FSC only for Vaxxitek vaccine.


Case No.04 Imported veterinary biologicals from non-reference countries.S.

No.Name of

Importer & Manufacture

r


Type of FormDy No & Date of applicationFee submitted

Pack size/ Demanded

Price


status/New molecule

Remarks Decision

1. M/s Huzaifa International, Sargodha

M/s Komipharm International Co., Limited, 17, Gyeongje-ro, Siheung-si, Gyeonggi-do, Republic of Korea

9R-Vac

Each dose contains:Salmonella gallinarum 9 Rough Live strain….Min. 2x107CFUFowl Typhoid Live vaccine

DiluentEach 1000 ml contains:NaCl....8gKCl....0.2gNa2HPO4. 12H2O....1.15gKH2PO4....0.2gDextrose …20gPhenol red...q.s.Distilled water....upto 1000ml


Diluent Shelf Life: 36 months

Form-5ADy. No. 115(R&I)03-02-2017Rs. 200000/-17-01-2017

Pack size:10vials x 1000doses

Valid Legalized FSC dated 27-12-2016

Valid Legalized GMP certificate dated 24-11-2016

Poulshot S/9R VaccineReg. No. 063873

Approved as per Import Policy for Finished Drugs and as per valid legalized CoPP/ GMP & FSC.

2. M/s Huzaifa International Sargodha


Pro-Vac ABBN

Each dose(0.5ml) contains:Infectious Bronchitis Virus(M-41 strain), before inactivation….Min. 107.5EID50 Infectious Bronchitis Virus(KM91 strain), before inactivation….Min. 107.5EID50 Newcastle Disease Virus (Ulster 2C Strain), before

Form-5ADy. No. 115(R&I)03-02-2017Rs. 200000/-17-01-2017

Pack Size: 500doses/ bottle1000doses/ bottle

Valid Legalized FSC dated08-12-2016

Valid Legalized GMP certificate dated24-11-2016

Deferred for evaluation of strain by Dr. Qurban Ali.


inactivation….Min. 109.0EID50 Inactivated Avian Influenza Virus (A/Chicken/Korea/01310/2001(H9N2), CE20 strain)……. 108.5EID50

Multivalent vaccine.


3. M/s Huzaifa International Sargodha


Pro-Vac BBNE

Each dose (0.5ml) contains:Infectious Bronchitis Virus(M-41 strain), before inactivation……...Min. 107.5EID50 Infectious Bronchitis Virus(KM91 strain), before inactivation…........Min.107.5EID50 Newcastle Disease Virus (Ulster 2C Strain), before inactivation….Min. 109.5EID50 Egg Drop Syndrome (K-11 strain), before inactivation. …Min.108.0EID50

Inactivated Multivalent Vaccine


Form-5ADy. No. 113(R&I)03-02-2017Rs. 200000/-17-01-2017

Pack size:500doses/ bottle1000doses/ bottle

Valid Legalized FSC dated08-12-2016

Valid Legalized GMP certificate dated24-11-2016

Deferred for evaluation of strain by Dr. Qurban Ali.

4. M/s HospitalServices &Sales,Karachi.

License holder:

M/s QYH Biotech Company Limited

QYH-ND LiveVaccine

Each one dose contains:-Newcastle DiseaseVirus La SotaStrain).HA titer ofallanttoic fluids> 106.5EID50/0.1ml beforefreeze drying.

Form-5A

Dy. No.145 DDC (BD) dated 21-3-201415000 dated 29-12-201085000 dated 85000 dated 29-07-2013

Legalized CoPP No. 151100B0/ 60726 dated 21-12-2015

Legalized FSC No. dated 27-11-2015

The case was initially considered in the 253rd meeting of Registration Board held on 05-06th October, 2015. The board deferred the case for submission of Legalized regulatory certificates. Firm



Builiding No. 20 Part 11 ABP No. 188 southwest 4th Ring Road Fengtai District, Beijing, China

Manufacturer:Nanjing Bio-Pharmaceutical Factory of QYH Biotech Company Limited, No. 33 Xiaohangli, Yuhuatai Distract Nanjing City Jiangsu China

Shelf life 24 months1000 dose vial has submitted valid

legalized CoPP and GMP and FSC.The firm has also applied for1.Change in the

title of parent company/ license holder name and address.

2.Change in the title of manufacturing company name.

Firm has submitted following documents:i. Revised form 5-

A with the said change.

ii. Principal Company’s letter (justification letter) regarding change in the title of parent companies (Pak embassy attested)

iii. cGMP Certificate with the new title of manufacturing sites of QYH companies (Pak embassy attested).

iv. FSC with the new title of manufacturing sites of QYH companies (Pak embassy attested).

v. CPP with the new title of parent company i.e. QYH Biotech Company Ltd., (Pak embassy attested).

5. M/s Orion Group P-97,

PESTDOLL-SEach dose contain:

Form-5A174-ADC

Valid Legalized

Provided stability data is copy paste

Deferred for submission of


Usman Block, Muslim Town No.1, Near Lasani Pully, Sargogha Road, Faisalabad, 38090-Pakistan

Organize Sanayi Bolgesi 8. Cadde No.3 Sanliurfa/Turkey INC.

PPRV Attenueted nijerya 75/1…103

TCID/DoseLactalbumin hydrolysate …0.25mg/doseSucrose…0.50mg/doseNatrium chloridum …8.34mgDinatrii hydrogen phosphate …2.47mgNatrium dihydrogen phosphate dihydrate…2.47mgAqua ad Injectable …1.0ml


(BD)20-12-20162077/2016(R&I)07-12-2016Rs.100,000/-30/11/201610ml, 20ml, 50ml,100ml, 200ml.

GMP certificate No. GMP/TR/V/YI/S0034/2015 dated 4-10-2016

Legalized Free Sale Certificate dated 04-10-2016

from experimental batch stability data already submitted in the dossier.

stability data and confirmation of availability of formulation in other countries.

6. M/s Orion Group P-97, Usman Block, Muslim Town No.1, Near Lasani Pully, Sargogha Road, Faisalabad, Pakistan

M/s Foot and mouth disease (FMD) institute, located at SAP Institute, Ministry of food, Agriculture and Livestock, Republic of Turkey

TURVAC-OILFMD VACCINE

Turvac-OilFoot And Mouth Disease Vaccine Inactivated Oil Adjuvant Containing Serotypes A, O, Asia-1Antigen-BHK21 suspension cell cultureInactivated by BEIMini. 3PD50 Antigen per doseOil adjuvant was added as adjuvant (Montanide ISA-206)And 20-30ppb Thiomerosal per dose as protector.

Foot And Mouth Disease Vaccine


121-ADC (BD)06-12-20162075/2016(R&I)07-12-2016Rs.100,030/-02/11/201610ml, 20ml, 50ml,100ml, 200ml.

Legalized Certificate of Permission for production of Veterinary Sanitary products dated 04-10-2016 issued by General Directorate for protection and Control

Legalized Free sale Certificate with no date.

Legalized GMP certificate/ CoPP is not provided.

It is pertinent to mention that the same product from the same source applied by M/s Ittehad chemicals has been discussed in 262nd meeting of Registration Board and deferred for following:

a. Copy of GMP and FSC submitted, original documents are required.

b. Recommended clinical use along with dosage and prescribing information needs to be submitted.

c. Finished product specifications along with methods of testing need to be submitted.

d. Labeling and

Registration Board decided to issue final clarification letter to M/s Ittehad Chemicals, Lahore regarding cancellation of their sole authorization by the manufacturer.


prescribing information is incomplete.

e. Stability data (accelerated and long term) needs to be submitted.

M/s Ittehad Chemicals has not provided above documents yet.

M/S Orion Group, Faisalabad has submitted the copy of cancellation of authorization in name of M/s Ittehad Chemicals from M/s Foot and Mouth disease institute.

Case No.05: Human Biologicals for Export Purposes.Sr. No.



Type of FormDy No & Date of applicationFee submitted

Pack size/ Demanded

Price

Remarks Decision

1 Getz Pharma (Pvt) Limited 29-30/27, Korangi Industrial area, Karachi

Pedovex(Solution for Injection)

Each vial contains:Peginterferon alfa-2a …….0.180mg/ml

Form 5Dy.No 2652 (R&I)11-12-2015

Rs. 20000/-11-12-2015

Pack size: 1’s Vial + sterile needle + cleansing swab

The product is already registered by name of Unipeg vide registration No.061194

Registration Board registered above products for export purpose only subject to compliance of following conditions:a. Manufacturer will export

the product after complying all the requirements as required under Drug Act, 1976 and relevant rules including No Objection Certificate from concerned DRAP office.

b. Manufacturer will also furnish export documents endorsed from custom authorities (if required for any query) in order to ensure the export of the product.


2 Manufactured by:M/s Hybio Pharmaceuticals Co., China

Manufactured For:Getz Pharma (Pvt) Limited 29-30/27, Korangi Industrial area, Karachi

Terliget Injection

Each vial contains:Trelipressin (as acetate)…..1mg

Form-5

Dy. No. 2116 dated 14-11-12

20000/- dated 14-11-2012

The product is already registered in name of Terlip vide registration NO. 066098

Firm submitted justification that the product will be exclusively for export and after getting registration approval they will pursue for product registration in exporting countries. Export order will be furnished at that time.

Registration Board registered above products for export purpose only subject to compliance of following conditions:

a. Manufacturer will export the product after complying all the requirements as required under Drug Act, 1976 and relevant rules including No Objection Certificate from concerned DRAP office.


3 Manufactured by:M/s Hybio Pharmaceuticals Co., China

Manufactured For:Getz Pharma (Pvt) Limited 29-30/27, Korangi Industrial area, Karachi

Getterlipsin Injection

Each vial contains:Trelipressin (as acetate)…..1mg

Form-5

Dy. No. 2059 dated 06-11-12

20000/- dated 06-11-2012

The product is already registered in name of Terlip vide registration NO. 066098




4 Supplier of concentrate:M/s Shandong Kexing Bio-Products Co., Ltd, No. 2666 Chuangye Road, Mingshui Development Zone, Zhangqiu Shandong China.

Sea-Poietin Injection 2000IU PFS (Erythropoietin)Each PFS (1ml) contains:Erythropoietin………2000IU

Hematopoietic

Form-5

Dy. No. 1718(R&I)17-02-2017

Rs. 20000/-17-02-2017

Pack Size: 1’s PFS

Export order of 400 PFS.


a. Manufacturer will export the product after complying all the requirements as required under Drug Act, 1976 and relevant rules including No


Manufacturer:The Nextar Pharma Private Limited, Plot No. E-58, North Western Industrial Zone, Port Qasim, Pakistan

Shelf Life: 02 years

Objection Certificate from concerned DRAP office.





Hematopoietic


Form-5

Dy. No. 1717(R&I)17-02-2017

Rs. 20000/-17-02-2017









Hematopoietic


Form-5

Dy. No. 1719(R&I)17-02-2017

Rs. 20000/-17-02-2017







Case No.06: Miscellaneous/ Deferred Cases

i. Exemption of labeling text on the Registered Vaccine Hexaxim 0.5ml Suspension for Injection in pre-filled syringe, Reg. No. 079275 applied by M/s Sanofi Aventis Pakistan Limited, Karachi.M/s Sanofi Aventis Pakistan Limited submitted that vaccines by Sanofi Pasteur are

manufactured at a single source to fulfill the requirements of whole world and generally have

low volume sales. Therefore it is not possible to follow the packaging and labeling of every

country at the time of export plus production, packaging, quality controls of these sterile and

temperature sensitive products required specialized methods and techniques of handling under

high controlled environment. Therefore, their repackaging or over printing is generally avoided

so as not to compromise on the change process.

The firm further submitted that World Health Organization has also issued guidelines on

describing principles of packaging/labeling and shipping of vaccines to which their compliant.

The firm also submitted that in order to be compliant to the Pakistan Drugs Labeling and

Packaging rules once the vaccines are released customs and come into their warehouse, they are

giving the undertaking that they will print name in Urdu text along with the Registration number

and maximum retail price on each pack under Cold Chain Process before releasing the goods in

the market.

The firm requested for the grant of exemption in labeling text (Urdu Text, MRP and

Registration Letter) for hexaxim at the time of importation into Pakistan.

Decision: Registration Board deferred request of the firm for submission of procedure regarding handling of vaccine during the printing process being temperature sensitive item and control measure responsible to ensure effectiveness, safety and quality of these vaccines.

ii. Premission one time import of standard export pack for Thymoglobuline Vial (Reg.083176) applied by M/s Sonafi-aventis Pakistan.

M/s Sonafi-aventis Pakistan Limited informed that the letter pertaining to registration for

Thymoglobuline in the name of firm was received on 23rd January, 2017.

The firm informed that the process of change in artwork as per the new registration

certificate, shipment of the required stocks and lot release certificate (LRC) before releasing the

goods in the market takes around 6 month. Though they are expediting the process, they foresee

shortage of Thymoglobuline in the market. As Thymoglobuline is la Life Saving Product it is

critical to make it available for patients in need at earliest.


The firm have requested for the grant of one-time permission to import 1500 vials in

Standard Export Packs. Assuring that local printing of the required Urdu text, MRP and

Registration Number, along with required LRC would be completed prior to releasing goods.

The firm further informed that they have this overprinting facility available at our cold storage

warehouse in the premises of Sanofi-aventis Pakistan limited, Karachi. They are already

performing this operation for following registered vaccines:

i. Menactra Solution for Injection Reg. No. 072535ii. bOPV (Oral Bivalent Types 1 and 3 Poliomyelitis Vaccine Reg. No. 072532

iii. Vaxigrip (Purified Inactivated Influenza Vaccine) Injection Reg. No. 025266

Hence, the firm requested for one-time exemption regarding the local over printing, MRP

and Registration Number along with Urdu Text.

Decision: Registration Board acceded to request of the firm for import of 1500 vials of Thymoglobuline (083176) in standard export pack and printing of MRP, registration number and urdu text at licensed premises of M/s Sanofi Aventis, Karachi before sale of drug. This permission is granted exclusively for supply of aforesaid quantity of vials to Sindh Institute of Urology &Transplant (SIUT), Karachi and not for sale in market. M/s Sanofi Aventis Karachi is also advised to submit the compliance report to DRAP after supply of the drug to SIUT.

iii. Clarification of composition/strain name of veterinary vaccine applied by M/s Mustafa Brothers, Faisalabad.

M/s Mustafa Brothers, Faisalabad applied for the registration of following veterinary

vaccine. The product was considered in 264th meeting of Registration Board and Board decided

as follows:

Sr. No.

Brand Name & Composition approved in

Minutes of 260th

meeting of RB as per submitted

Form-5A

Brand name and composition as per Free

sale certificate submitted.

Free Sale Certificate

No.

Remarks Decision of RB in 264th

meeting

1 Associated Vaccine Against Newcastle DiseaseInfectious Chicken Bronchitis and egg drop syndrome-76

ARRIAH ND IB EDS 76(Vaccine associated against Newcastle DiseaseInfectious Chicken Bronchitis and egg drop syndrome-76 inactivated emulsified)

One immunizing dose

Legalized FSC dated 11.3.2016

Brand name and composition was not reflected in minutes, composition applied in Form-5A and

The Board advised the firm for clarification of strains for chicken infectious bronchitis and egg drop syndrome-76 virus, as two strains are mentioned for each virus.


inactivated emulsion

contains:Viruses of Newcastle disease (ND, strain “ La Sota), chiken infectious bronchitis (IB, strain “H-52”, serotype “Massachusettes” and / or “Tchapaevsky”), egg drop syndrome-76 ( EDS-76, strain “ BISS” or “B8/78”) inactivated with dimeraminoethylenimine adding the oil adjuvant montanide ISA 70 VG in the ration 30-70


FSC are same.

According to the decision of Registration Board, the firm has submitted the composition

of above vaccine with Chicken Infectious Bronchitis virus (IB, strain “Massachusetts”) and Egg

Drop Syndrome-76 (EDS-76, strain “B8/78).

Decision: Registration Board approved above product as per Import Policy for Finished Drugs and as per valid legalized CoPP/ GMP & FSC.

iv. Extension in shelf life of Gallivac IBD H2512 Reg. No. 031539 applied by M/s Saadat International, Lahore.

M/s Saadat International Lahore has applied for the extension in Shelf life of already

registered vaccine, Gallivac IBD H2512 (Reg. No. 031539) from 24 months to 27 months. The

firm submitted that initially it was registered with 2 years shelf life. However later on studies

was carried out and it is found that vaccine is stable more than 30 months.

Firm has submitted the following documents:i. Application along with Fee Challan of Rs. 5000/-

ii. Copy of Initial registration letteriii. Copy of transfer letter in name of M/s Saadat International Lahore from M/s

Marush (Pvt.) Ltd., Lahoreiv. Copy of last renewal application.v. Original Legalized Certificate of Licensing and inspection showing expiration

date of 30 months from USDA.vi. Stability data of 30 months.

The USDA approval is of 30 months, hence shelf life of 30 months may please be

considered by the Board.

Decision: Registration Board granted the extension in shelf life of Gallivac IBD H2512 vide registration No.031539 from 24 to 30 months as per valid legalized CoPP.


v. Application for deregistration of registered vaccines applied by M/s Hakimsons (Impex) (Private) Ltd., Karachi.

M/s Hakimsons (Impex) (Private) Ltd., Karachi applied for the Deregistration of their

registered vaccines. The details are as follows:

Sr. No. Reg. No. Brand Name & Composition Pack Size1 044821 Vaxepur-B 10µg

(Recombinant Hepatitis B Vaccine)Each 0.5 ml contains:Purified HbsAg……….10µg

1’s vial(0.5ml)

2 044822 Vaxepur-B 20µg(Recombinant Hepatitis B Vaccine)Each ml contains:Purified HbsAg……….20µg

1’s vial(1ml)

The firm submitted that their principal Janssen Vaccine Corporation (Formerly Berna

Biotech Korea Corporation) has discontinued the aforesaid products. The firm has enclosed the

letter of discontinuation from their principal.

Decision: Registration Board acceded to the request of firm and deregistered above products in name of M/s Hakimsons (Impex) (Private) Ltd., Karachi as multiple alternates are available in market.

vi. Veterinary vaccine applied by M/s Ghazi Brothers, Karachi deferred in 257 th

meeting of Registration Board.

M/s Ghazi Brothers, Karachi applied for the registration of following veterinary

biological product. The product was considered in 257th meeting of Registration Board and the

Board deferred the product for confirmation of formulation in reference drug agencies.

According to the decision of Registration Board, the firm has submitted the confirmation

of formulation in USFDA by the name of Equipoise NADA Number: 034-705, which is

registered for horses only and not for meat production. The firm requested to register the product

for horses use only.

S.#. Name of Importer & Manufacturer

Brand Name & Composition Type of Form

Dy No & Date of

applicationFee

submittedPack size/ Demanded

Price

Document details (CoPP)

Me too status/New molecule

Decision

1. M/s Ghazi BOLDEMAX A.P. Dy No. Legalized Free Approved as per


Brothers, GhaziHouse, D-35,K.D.A SchemeNo.1 Miranuhammad ShahRead, Karachi

Product LicenseHolder:AGROVETMARKET S.A.,Av. Canada 3792– 3798 San Luis,Lima, Peru

Manufacturerunder ProductLicense-holder:PHARMADIXCORP. S.A.CCALLE SantaLucia 218 urbanizacion LaAurora-Ate Lima3-Peru.

Each 100ml contains:-Boldenoneundecylenate…..5.0 g

Indications:Increase in weight gain, better development of bone- muscle, proteins synthesis, mineralsretention, appetiteimprove and foodconversion, help inAnemic process (bystimulus of theerythropoieses: red cells Formation). Indicated in diseases that causeweakness, rickets, fracture and stress (post surgical, weaning castrations, ambientchanges and prolong summer and winter,among others).Itsvehicle gives it a slowrelease and long acting.


4320(R&I) dated 16-7-201350000/- dated16-7-2013Pack Sizes100ml vial.Dosage form:InjectableSolution

Sale CertificateNo 0896-2012dated19-12-2012providedCopy of Power ofAttorney enclosed.Copy of GMPCertificate No.4101-2012-AGSENASADIAIA-SIPDated06-2-2013

Import Policy for Finished Drugs and as per valid legalized CoPP/ GMP & FSC for use in horses only.

vii. Extension of permission for Toll manufacturing of products applied by M/s Werrick Pharmaceuticals, Islamabad.M/s Werrick Pharmaceuticals, Islamabad has stated that the firm got permission for

contract manufacturing of the Interferon containing medicine from M/s Scotmann

Pharmaceuticals vide Defund Ministry of Health’s No. F. 3-10/2006-Reg-II-South (M-203) and

the said permission was extended from time to time till 31-08-2013 vide DRAP’s Letter no. F.6-

17/2006-Reg-II-(Pt-II) dated 10-06-2013.The firm has paid differential fee of Rs.50,000/- along

with the application for extension of permission in the prescribed form was also submitted in the

light of DRAP letter No. F.6-17/2006-Reg-II-(Pt-II) dated 29/03/2013.

The case was considered in 238th meeting of Registration Board and the Board decided as follow;Sr. No.

Contract Giver & Contract Accepter

Reg. No. Brand Name & Composition


Decision of RB in 238th

meeting

1 M/s Werrick Pharmaceutical, Islamabad

M/s Scotmann Pharmaceutical

036099 Cell-Aid Depot Injection 120mcgEach ampoule contains:Interferon alpha -2bLong acting ….120mcg

15-04-13Dy. No.2254R&IDy.No.1329. DDC(R-III)Rs.50000/-12-04-2013+Rs.50000/-

Referred to the Biological Directorate


13-07-2015



036098 Cell-Aid Depot Injection 100mcgEach ampoule contains:Interferon alpha -2bLong acting ……..100mcg

15-04-13Dy. No.2253R&IDy. No. 1330. DDC(R-III)Rs.50000/-12-04-2013+Rs.50000/-13-07-2015




035799 Cell-Aid Injection Alfa 2bEach ml contains:Interferon Alfa 2b…….3Miu

15-04-13Dy. No.225R&IRs.50000/-12-04-2013+Rs.50000/-13-07-2015





15-04-13Dy. No.2249R&IDy. No. 1342 DDC(R-III)Rs.50000/-12-04-2013+Rs.50000/-13-07-2015




035798 Cell-Aid Injection Alfa 2aEach ml contains:Interferon Alfa 2a…….3Miu








The firm has requested for the extension of permission for contract manufacturing of

aforesaid products.

Decision: Registration Board approved the request of M/s Werrick Pharmaceuticals Islamabad for extension in contract manufacturing by M/s Scotmann Pharmaceuticals Islamabad. This permission shall be valid for five years as per current contract manufacturing policy and will be effective since 31-08-2013.


viii. BCG vaccine applied by M/s Amson Vaccines and Pharma, Islamabad approved in 258th meeting of Registration Board.

BCG Freeze dried live injection was initially registered in name of M/s Shah Enterprises,

Rawalpindi vide Reg. No 018520 manufactured by M/s National Center of Infectious and

Parasitic Diseases, Bulgaria.

The firm on 16-11-2011 requested for the change of source of above said vaccine from

Bulgaria to M/s Green signal Bio Pharma, India for bulk import and local repacking. The case

was considered in 240th meeting of Registration Board held on 07-11-2013, where in the Board

decided as follows:-

“Deferred for clarification of local labeling, quality control and release site. The board also advice to prepare working papers regarding import of naked vials in light of prevailing rules.”

The application was again considered in 254th meeting of Registration Board held on 11-

12th November 2015, where in the Board again deferred the case for submission of fee and CoPP

status. Meanwhile M/s Amson Vaccines and Pharma, Islamabad submitted a request on

04.02.2016 for transfer of registration along with the change of source as applied by M/s Shah

Enterprises, Rawalpindi for import of labeled vials. The firm submitted Rs.100000/- separate fee

along NOC from M/s Shah Enterprises, authorization letter from M/s Greensignal Bio Pharma,

India. The details of the case are as follows:

S.#. Name of Importer & Manufacturer



Document details (CoPP)Me too status/New molecule

1. M/s Amson Vaccines & Pharma (Pvt.) Ltd., Islamabad

M/s Green signal Bio Pharma Private Limited.,No. 49, Pappankuppam Village, Gummidipoondi taluk, Tiruvallur District, Chennai-601201, India

BCG Vaccine(Freeze – Dried BP)

Each freeze dried vaccine vial contains:BCG Vaccine (Danish strain 1331, live, attenuated)…..1mg equivalent to 20 doses.


Form-5ADy. No. 1165(R&I)24-02-2016

Rs. 100000/-24-02-2016

1’s vial

Legalized CoPP No. L.Dis.No.15008/D1/4/2015 dated24-08-2015 valid for 01 year.

Accordingly the case was taken up in the 258th meeting of Registration Board held on 25-

26th April 2016 where in the board decided as follows:


“Registration Board reviewed the documents and approved the product in name of M/s Amson Vaccines and Pharma Islamabad as per valid legalized CoPP, as per import policy and verification of storage facility for vaccines. The firm shall provide the renewal status of product, valid drug safe license and all post-registration variation approvals for M/s Shah Enterprises, Rawalpindi. Moreover, reference will be sent to Cost and Pricing Division for comments on MRP of the product. Firm shall provide aforementioned valid documents and then Chairman shall permit issuance of registration letter.”

Therefore, as per decision of Board the Area FID was requested on 17-08-2016 to verify

the cold storage facility of M/s Amson Vaccines and Pharma, Islamabad. The FID submitted the

report on 22-08-2016 which was not accompanied with prescribed performa and without candid

recommendation. The FID was again requested to submit the report on prescribed performa with

clear recommendations on 22-09-2016. Accordingly The FID again submitted the report on 13-

10-2016 and case was again processed for issuance of registration letter to firm on 17-10-2016

and forwarded for further necessary action.

Furthermore another company/importer i.e. M/s M&M Pharma, Lahore on 24-11-2016

submitted an application for registration BCG vaccine from the same source as applied by M/s

Amson Vaccines and Pharma, Islamabad. The firm submitted notarized authority letter in name

of M/s M&M Pharma, Lahore, cancellation of authority letter in name of M/s Shah Enterprises,

Rawalpindi and cancellation of authority letter in name of M/s Amson Vaccines and Pharma,

Islamabad issued by M/s Greensignal Bio Pharma, India. The case was again taken up in 264th

meeting of Registration Board held on 28-29th December, 2016 wherein the Board decided as

follows:

Sr. no.

Nam eof importer & manufacturer

Brand name & composituion

Fee & Pack size Document details CoPP etc

Remarks

1. M & M Pharma 1st floor, Javed Plaza, Opp Gate No. 02, PEPSI Factory, Guru- Mangat Road, Gulberg-II, Lahore.

Greensignal Bio Pharma Limited,No. 49, Pappankuppam village, Gummidipoondi taluk Tiruvallur District Chennai-601201, India

BCG vaccine BPEach freeze dried vaccine vial contains: Mycobacterium bovis BCG, Danish strain 1331, Live attenuated equivalent to 20 doses…….1mg Sodium glutamate.......1.5%w/vShelf Life: 24 months

Form-5ADy No. 1331/2016 (R&I) 24-11-2016 76-AD(BD)24-11-2016 Rs.100,000/- 24-11-2012Pack Size: 50 vials (50mg) Price not mentioned.

Legalized CoPP No. L.DIS No.17307D1/4/2016 dated 30-09-2016Free Sale certificate No. L.Dis. No. 14450/D1/4/2015 dated 19-09-2015Sole agent/ Authority letter dated 19-11-2016


“Registration Board directed M/s Amson Vaccines and Pharma Pvt Ltd, Islamabad for personal hearing before Registration Board to explain their position regarding the cancellation of their authorization for registration of BCG vaccine by M/s Greensignal Bio Pharma Limited, No.49, Pappankuppam village, Gummidipoondi taluk Tiruvallur District Chennai-601201, India and authorization in name of M/s M&M Pharma 1st floor, Javed Plaza, Opp. Gate No. 02, PEPSI Factory, Guru-Mangat Road, Gulberg-II, Lahore.”

Accordingly, as per the decision of Registration Board a letter was issued to M/s Amson

Vaccines and Pharma Pvt Ltd, Islamabad for personal hearing in 267 th meeting of Registration

board to explain their position regarding aforesaid matter dated 16-02-2017.

Decision: Brig (R) Ikram-ul-Hussan, Chief Operating Officer appeared before the Board and informed that they are in contact with M/s Greensignal Bio Pharma Limited, India for their authorization letter. Thus Registration Board advised M/s Amson Vaccines and Pharma Pvt Ltd, Islamabad to get valid sole agent/ authorization letter from M/s Greensignal Bio Pharma Limited, India within fifteen days.

ix. Snake Antivenin applied by M/s Amson Vaccines & Pharma, Rawalpindi deferred in 264th meeting of Registration Board.

As per below mentioned decision in 264th meeting, the firm has provided the drug sale

license and valid Legalized CoPP vide No. Di/BPN/Sec (Mfg.)/COPP/07/09/2016-01 dated

14.09.2016 valid till 23.08.2018.

S.#.

Name of Importer &

Manufacturer


Type of Form

Dy No & Date of application

Fee submitted



Me too status/New molecule

Decision of RB in 264th

meeting

Decision

1 Amson Vaccines & Pharma (Pvt.) Ltd.,115, Industrial Triangle, kahuta Rd, Islamabad

M/s Biological E. Limited,7-4-114, Gagan pahad, Rajendra nagar, Mandal, Ranga Reddy (District), India-501323

Snake Antivenin (Polyvalent)Each ml Neutralizes:Cobra Venom (Naja naja)….0.60mgCommon Krait Venom (Bungarus caeruleus) ……..0.45mgRussels viper venom (Vipera russelli) ….….….0.60mgSaw Scaled viper venom (Echis carinatus).. …0.45mg


Form 5-ADy No. 1788/2016(R&I) 02-12-2016109-AD(BD) 05-12-2016 Rs.100,000/- 09-11-2016Pack Size: 1’s (10ml vial)Price not mentioned.

CoPP and Free Sale Certificate are not provided.Drug sale License is not provided.GMP is expired.Clinical data and clinical justification are required.

Registration Board deferred the product for following:

a.Valid legalized CoPP/FSC with GMP.

b.Drug sale license.



x. Extension in shelf life of RhoGam Ultra-Filtered Plus Injection (Anti-D) Reg. No. 005571 applied by M/s Majeed Sons, Rawalpindi.

M/s Majeed Sons, Rawalpindi has applied for the extension in Shelf life of already

registered RhoGam Ultra-Filtered Plus Injection (Anti-D) Reg. No. 005571 from 24 months to 36

months.

The firm has submitted the following documents:i. Application on form-5A along with Fee Challan of Rs. 5000/-

ii. Copy of Initial registration letteriii. Copy of evidence of renewal of productiv. Legalized approval of extension in shelf life from 24 to 36 months from US FDA.v. Stability data of 03 lots (2-80C)

S.#. Manufacturer Brand Name & Composition


Decision

1 License Holder:M/s Kedrion Biopharma Inc., 155 Duryea Road, Melville, NY, 11747, USAManufacturer:M/s Ortho-Clinical Diagnostics, Inc. 1001 US Highway 202, Raritan, NJ, 08869, USA

RhoGAM Ultra-Filtered PlusEach ml contains:Human IgG Immunoglobulin……….50±10mg of protein/ml (anti-D IgG=300µg)

BLS Approval Letter dated 02-12-2015

Registration Board granted the extension in shelf life of RhoGAM® Ultra-Filtered Plus Injection Reg. No. 005571from 24 to 36 months as per valid legalized CoPP.

xi. Rhoclone 300mcg Injection applied by M/s Venture Pharmaceuticals Limited, Karachi deferred in 264th meeting.

M/s Venture Pharmaceuticals Limited, Karachi applied for the registration of following

human biological. The case was considered in 264 th meeting of Registration Board and Board

decided as follows:

Sr. No

Name of Importer &

manufacturer

Brand Name & composition

Form/ Dy. No & Date/ Fee/ Pack

size

Documents Decision on 260th

meetingDecision in 264th meeting of RB

1. Venture Pharmaceuticals (Pvt) Ltd, Karachi.

Bharat Serums and Vaccines LimitedPlot No. K-

RHOCLONE 300 MCG

Anti Rho-D Immunoglobulin Injection (Monoclonal) (Liquid Injection)

Each ml contains:Anti Rho-D

Form-5A

Dy. No. 1218 (R&I) DRAP dated 25-2-2016

Fee Deposited: Rs.100000/-

Legalized Valid COPP No. COPP/CERT/KD/42264/2016/11/14803/73243 valid up to 01-10-2016

Deferred fora. Confirmation of approval status by reference regulatory authorities.b. References pharmacopeiasc. Importability as per import policy order from India

Registration Board deferred above product for confirmation of approval status of formulation


27, Anand Nagar, Additional M.I.D.C.Ambernath (East), India

Immunoglobulin….300mcg/ 1500 IUWater for Injection U.S.P…q.s

Immune Sera and ImmunoglobulinAnti-D (Rh) ImmunoglobulinATC code: J06B B01


dated03-2-2016vial

Product License No. KD5 in Form 28EDated07-2-2011

Legalized GMP Certificate No. NEW-WHO-GMP/CERT/KD/12788/2014/11/6320 dated04-4-2014

d. Safety profile, clinical efficacy, and clarification as the Pharmacopieal preparation (BP) contains specific antibodies against erythrocyte D- antigen and may also contain small quantities of other blood-group antibodies. However the applied formulation contains only IgG antibodies.

by reference regulatory authorities.

The firm has submitted the summary of basis for approval of Rhophylac® having same

formulation approved by USFDA STN: BL125070/0.

Decision: Registration Board deferred the product for evaluation by Directorate of DBER for quality, safety and efficacy as the product is manufactured by Hybridoma technology, while all other available products are manufactured by the technology of plasma pooling.

xii. Change of storage conditions of Snake Venom Antiserum Lyophilized Reg. No. 053882 applied by M/s Hakimsons (impex) (Private) Limited, Karachi.

M/s Hakimsons (impex) (Private) Limited, Karachi applied for the change in storage

conditions of their already registere product Snake Venom Antiserum Lyophilized (Reg. No.

053882) from 20-80C to 80-250C.

The firm has submitted the following documents:i. Application for the said change

ii. Fee challan of Rs.5000/-iii. Copy of Initial Registration letteriv. Proposed packagingv. Legalized CoPP valid upto 01-04-2016

vi. Legalized GMP certificate.vii. Legalized free sale certificate indicating storage conditions (80-250C)

viii. Credentials of the manufacturerix. Stability data for the said change (long-term at 250±20C, RH 60% ±5% and

accelerated at 400±20C, RH 75% ± 5%)


The firm submitted that such convenient storage conditions will ensure that the product

becomes available at remote medical facilities, where storage of thermo labile products is an

issue.

Decision: Registration Board approved the change of storage conditions of Snake Venom Antiserum Lyophilized Reg. No. 053882 from 2-80C to 8-250C based on approval of country of origin and as per provided stability data for already approved four years shelf life.

xiii. Permission for local over printing of manufacturing, expiry date and lot number on outer carton of Humatrope (Somatropin) 5mg (15 IU) injection.

M/s Eli Lilly has applied for local over printing of manufacturing, expiry date and lot

number on outer carton of Humatrope (Somatropin) 5mg (15 IU) injection (Reg. No.041179).

The case was considered in 264th meeting of Registration Board and the Board decided as

follows:-

“Registration Board deferred request of the firm for confirmation of facility for printing of lot No, manufacturing date & expiry date on the outer carton of Humatrope (Somatropin) 5mg (15 IU) injection (Reg. No.041179), as it is cold storage item and has special handling requirements.”

The firm submitted that they can overprint lot number, manufacturing date and expiry

date of water for injection on the outer carton of Humatrope (Somatropin) 5mg (15IU) injection

at Ali Gohar & Company with maintaining desired temperature and special handling

requirements. The firm requested for the grant of permission to overprint aforesaid information.

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

i. Confirmation of facility for handling of Humatrope (Somatropin) in M/s Ali Gohar & Company for printing of lot No, manufacturing date & expiry date on the outer carton.

ii. Submission of NOC from M/s Ali Gohar & Company regarding printing.


Case No.07: Expert opinion for Biological Drugs:

In case of veterinary vaccines the cases are unnecessarily being delayed asking for strain

verification during the meeting; it was suggested that if new strain needed to be evaluated then

the case must be forwarded by the DBER to the expert before including in the agenda. If the

same strain is already registered locally, there is no need of evaluation in term of strains.

Decision: Registration Board deliberated that in case of biological drugs if formulation is not already approved by reference regulatory authorities and thus expert opinion is needed regarding any aspect of the product, then DBER shall forward the case to experts of concerned speciality for their scientific opinion and same shall be placed before Registration Board in order to avoid delays.

Case No.08: Registration Board for Biological Drugs.

Dr. Sheikh Akhtar Hussian, Director Medical Device & Medicated Cosmetics informed

that on directives of National Consultative meeting on cardiac Stents, 04 Cardiologists were

invited to attend the Registration Board meeting for evaluationg cardiac stents. Director, DBER

recalled the comments of the Registration Board in its 243rd meeting in which it was noted that

separate Board be constituted for registration of biological products, keeping in view expertise

and special nature of biological products.

Decision: Registration Board deliberated that Medical Device Board has been constituted for medical devices as per Medical Device Rules, 2015. For separate Registration Board for Biological drugs, respective Divisions may move proposals if permissible under DRAP Act, 2012


Item No.V: Additional Agenda

A. Medical Device Division.

Catheter.S.N Name of Importer and

Manufacture/Exporter.Name of Medical

Device (s) Composition &

Therapeutic Group.

Price & Pack size

Shelf life

Decision

1. M/s B Braun Pakistan Pvt. Ltd. The Forum, Suite 216 Khayaban-e-Jami, Clifton Block-9 Karachi 75600, Pakistan.

Manufacturer:B.Braun Melsungen AGCarl-Braun –Stabe 134212 Melsungen, Germany.

Manufacturing Site:B.Braun Melsungen AG Vascular Systems Sieversufer 8, 12359 Berlin, Germany.

Sequent Please Neo

Paclitaxel Releasing Rapid Exchange PTCA Balloon Catheter

Size as per FSC.

As per policy

decision by the Policy

Board/ Federal

Govt. and Registration

Board

02 Year

s

Approved as firm has provided documents including original and embassy attested Free Sale Certificate and original notarized letter of authorization and company credentials.The case was complete, therefore, placed before the Board directly without Evaluation Cell for consideration and its decision.

2. M/s B.Braun Pakistan (Pvt) Limited, The Forum Suite # 216, Khayaban-e-Jami, Clifton Block-9, Karachi

Legal Manufacturer:M/s B.Braun Melsungen AG, Caril-Braun-StraBe 1, 34212 Melsungen, Germany.

Manufacturing Site:B. Braun Medical Industries Sdn. Bhd, Bayan Lepas Free Industrial Zone 11900 Penang, Malaysia.

Espocan(Set for Combined Spinal and Epidural Anaesthesia)

(Sizes and codes as per Free Sale Certificate)

As per policy


Board/ Federal


Board

05 years

Approved. Firm has rectified shortcomings of 266th

Meeting of Registration Board.

3. M/s B.Braun Pakistan (Pvt) Limited, The Forum Suite # 216, Khayaban-e-Jami, Clifton Block-9, Karachi

Legal Manufacturer:M/s B.Braun Melsungen AG, Caril-Braun-StraBe 1, 34212 Melsungen,

Spinocan Guide Needle & Spinal Introducer.

(Sizes and codes as per Free Sale Certificate)

As per policy


Board/ Federal


Board

05 years

Applied on 23.6.2016Letter issued on01-02-2017Final Reminder10-02-2017

Deferred for clarification from the applicant regarding


Germany.

Manufacturing Site:B. Braun Medical Industries Sdn. Bhd, Bayan Lepas Free Industrial Zone 11900 Penang, Malaysia.

the product applied under the Drug Act, 1976 and Rules framed there under.

STENTS.

S.No

Name of Importer and Manufacture/Exporter.


(s)

Price & Pack size

Shelf life

Decision

1. M/s B.Braun Pakistan Pvt. Ltd. The Forum, Suite 216 Khayaban-e-Jami, Clifton Block-9 Karachi 75600, Pakistan.

Manufacturer:B.Braun Melsungen AGCarl-Braun –Stabe 134212 Melsungen, Germany.

Manufacturing Site:B.Braun Melsungen AG Vascular Systems Sieversufer 8, 12359 Berlin, Germany

Coroflex ISAR NEOSirolimus-eluting Coronary Stent System

Sizes as per FSC.

As per policy


Board/ Federal


Board

03 years

Approved as firm has provided documents including original and embassy attested Free Sale Certificate and original notarized letter of authorization and company credentials.The case was complete, therefore, placed before the Board directly without Evaluation Cell for consideration and its decision.

Miscellaneous Cases.

A) Extension in Shelf Life from 18 months to 24 Months.

M/s Ferozsons Laboratories, Nowshera has requested for extension in shelf life from 18

months to 24 months of their following already registered imported medical devices:-

S.No. Regn. No. Name of Drug (s) Approved Shelf Life

Demanded Shelf Life

(i) 061195 Promus Element Plus Monorail (Everolimus Eluting Coronary Artery Stent) Stent

18 Months 24 months

(ii) 061196 Promus Premier Monorail Everolimus Eluting Platinum Chromium Coronary Stent System.

18 Months 24 months

The firm has submitted the stability justification summary as shelf life extension evidence

for above mentioned products alongwith fee of Rs.5000/- for each product.


Decision: Registration Board approved the case. Firm will provide document for regulatory approval of change in shelf life from country of origin and Chairman, registration Board will authorize issuance of letter.

B) Change of Manufacturing Site.

M/s ACP Systems, Karachi has informed that the following products manufactured by

M/s Medtronic, Inc, 710 Medtronic Parkway, NE Minneapolis, Minnesota 55432 USA has been

registered in the their name

S.No. Name of Medical Device Registration No.1. Sprinter Legend RX Balloon Dilatation Catheter 0716222. Sprinter NC/SC RX Balloon Dilatation Catheter 0716233. Endeavor Resolute (DES) Coronary Stent 0716244. Endeavor Sprint (DES) Coronary Stent 0716255. Resolute Integrity DES Coronary Stent 0716266. Integrity BMS Coronary Stent 071627

Later on, Principal manufacturer M/s Medtronic USA changed the manufacturing sites as below:-

1. Sprinter Legend Rapid Exchange Balloon Dilatation Catheter

071622 Legal Manufacturer:M/s Medtronic, Inc.710 Medtronic Parkway, Minneapolis, MN 55432, USA.

Manufacturing Site:M/s Medtronic Mexico S.de R.L.de CV, Av, Paseo Cucapah 10510 EI Lago, C.P. 22210 Tijuana, Baja California, Mexico.

2. Sprinter NC/SC Rapid Exchange Balloon Dilatation Catheter

071623

3. Endeavor Resolute (DES) Coronary Stent 071624 Legal Manufacturer:M/s Medtronic, Inc.710 Medtronic Parkway, Minneapolis, MN 55432, USA.

Manufacturing Site:M/s Medtronic Ireland, Parkmore Business Park West, Galway, Ireland.

4. Endeavor Sprint (DES) Coronary Stent 0716255. Resolute Integrity DES Coronary Stent 0716266. Integrity BMS Coronary Stent 071627

Applications submitted on 02-08-2012 aimed to change of manufacturing site. The firm

has requested that manufacturing site of their already registered products may be changed

accordingly.


The firm has further submitted shelf life reports of Resolute Integrity (DES) Coronary

Stent and Integrity (BMS) Coronary Stents by the M/s Medtronic extending from 2 to 3 years

and 3 to 4 years shelf life respectively.

It is submitted that for change of manufacturing site the firm has provided Free Sale

Certificate (Embassy attested) from regulatory authority of Ireland for above products. Approval

letter of USFDA is also provided for Serial No.2,4,5& 6 but site is not mentioned. Furthermore,

the name of product at serial No.2 in the Free Sale Certificate is NC Sprinter Rapid Exchange

Balloon Dilatation Catheter. Fresh Fee of Rs. 50,000 provided by the firm for each product and

also applied for renewal of above products within time.

Decision: Registration Board decided as follows:

(i) Approved new manufacturing site along with legal manufacturer and decided to issue approval letter with correct name of above products along with sizes/codes as per free sale certificate.

(ii) Deferred the extension in shelf life case for provision of approval of change in shelf life from country of origin, correct Form-5A and fee.


B. Biological Drugs Division.

Case No.01: Products applied by M/s Pakcure Pharma, Rawat deferred in 265th meeting of Registration Board to expert for evaluation of clinical data.

M/s Pakcure Pharma, Rawat applied for the registration of following drugs:

Sr. No.


Brand name & Composition

1 M/s Pakcure Pharma, Rawat, Islamabad.

Allergex-MPEach ml contains:Beef protein extract…….10mcgChicken protein extract. 10mcg Egg protein extract……...10mcgFish protein extract……..10mcgMutton protein extract..10mcg

Shelf Life: 6 months when stored at +2 to +8˚CAllergy vaccine, Immunostimulants


Allergex-Px1Each ml contains:Cannabis sativa protein extract ….10mcgAcacia niloticaa protein extract …..10mcgEucalyptus globulus protein extract…. 10mcgPininus longfolia protein extract ….10mcgHouse dust extract …..10mcg

Shelf Life: 6 months when stored at +2 to +8˚C Allergy vaccine, Immunostimulants


Allergex-Px2Each ml contains:Cannabis sativa protein extract …….10mcgAcacia niloticaa protein extract …..10mcgEucalyptus globulus protein extract…. 10mcgPininus longfolia protein extract 10mcgMixed grass extract of Lolim temulentum + Cynodon dactylon ..…10mcgHouse dust extract…….10mcg

Shelf Life: 6 months when stored at +2 to +8˚C Allergy vaccine, immunostimulant


Allergex-Px3Each ml contains:Cannabis sativa protein extract……. 10mcgAcacia niloticaa protein extract ……10mcgEucalyptus globulus protein extract …….10mcgPininus longfolia protein extract ……10mcgHouse dust extract …….10mcg


Paper mulberry extract…10mcgThrasher extract…10mcgRaw cotton extract…10mcg

Shelf Life: 6 months when stored at +2 to +8˚C Allergy vaccine, Immunostimulants


Allergex-Px4Each ml contains:Cannabis sativa protein extract …..10mcgAcacia niloticaa protein extract ……10mcgEucalyptus globulus protein extract …..10mcgPininus longfolia protein extract ……10mcgHouse dust extract……..10mcg Paper mulberry extract……..10mcgThrasher extract……..10mcg

Shelf Life: 6 months when stored at +2 to +8˚CAllergy vaccine, Immunostimulants

The case was considered in 263rd meeting of Registration Board and proceedings of the

Board are as under:

FID II Islamabad has forwarded a Product Specific Inspection report for registration of Allergen

Extracts applied by M/s Pak cure Pharma Rawalpindi. The said inspection on 8 th September 2016

by following panel

i. Dr.Masud ur Rehman, Additional Director, DRAP, Islamabadii. Mr,Abdul Samad, Director, NCLB, Islamabad

iii. Dr. Faizan Siddiqui, NIH, Islamabadiv. Mr. Khalid Mahmood FID II,DRAP, Islamabad

The undersigned was nominated for the product specific inspection of allergen extract

manufactured by the firm. Now with reference of and to the past inspection report and in

relation to the PSI applicable to all similar product being manufactured by NIH Islamabad,

following is my opinion.

a. The firm has improved and has done all the necessary GMP modification as previously prescribed.

b. Since these product are similar to NIH allergy vaccines, therefore similar requirement of safety efficacy and quality are better shall apply. Hence it was found that this film has the necessary equipment and infrastructure to assure these requirements. Both in vitro and in vivo test are being done to assure the safety quality and efficacy of these drugs (allergy extracts diluted finished product)

c. The management has informed that batch size will be small (200 vials Expected from demand issue from selected treatment center because the product is not for the open market sale

d. For a small batch size of the Allergen Extract mixture the present facility is dedicated and the required testing equipment and human resources are available and can assure quality within reasonable limits as of today.


e. The firm has informed that a limited trial was conducted in human volunteers and the data submitted to the DRB.

f. The product is liquid preparation of pollen extract, allergen extract, suspending in normal saline, the final product is sterile. The product/ allergen extract solution/biological drugs is to be stored at 4C with a shelf life of 6months for which the firm has done necessary stability tests atC. Higher temperature is not applicable.

g. Under the circumstances the undersigned is of the opinion that quality assured drug / allergen extract solution can be manufactured in this facility under the present technical management with all the necessary risk linked with biological drugs. The firm is advised to replace Manual Generator to Automatic system.

h. Therefore it is recommended that DRB may consider the registration of the allergenic extracts applied by the firm in line with similar criteria used across the board. The products are being tested in vivo & in vitro for safety as per prescribed procedures past record seen.

Points 1-8 are self-explanatory, the inspection for the PSI was conducted I response to

letter No. F.3-7/2014 DDC (BD) dated June 1st 2016. The point raised during last visit made on

21st June 2016 have been addressed regarding availability of technical staff i.e. production and

QC in charge for their basic and formulation licenses meant for manufacturing of allergen

extract( biological). Ms Farida Farzana MSC Biochemistry and Ms Sumera Naz MSC

Biochemistry were present during inspection for manufacturing of allergen extract by way of

basic manufacturing DML No. 000763 and Mr. Agha Sadrudin M,Sc Biochemistry and thrir

name were found seen on both DML except Mr. Ahmed Siddique, Pharm-D ( approval advised

to sought from Licensing division) for manufacturing of allergen extract by way of formulation

DML. No 000745. A panel consisting of Dr. Masud ur Rehman, Additional Director, DRAP,

Islamabad, Mr. Abdul Samad, Director, NCLB, Islamabad, Dr. Faizan Siddiqui, NIH, Islamabad,

along with area FID inspected the facility for the mandate given by division of biological drugs

for PSI. A comprehensive deliberation / discussions were made between the technical person and

the panel of expert and it was unanimously agreed that the firm possess the facility for

production of allergen extract (five allergen extract conventional type along with documentation

and advised to strictly adhere to the guidelines provided for manufacture of conventional type

allergen extracts and the documentation as per DRAP requirement etc. The firm was advised to

ensure the availability of their allergen extract conventional type at their approved/dedicated

centers only under intimation to Division of Biological Drugs; same shall not be marketed/sold

in open market. The center shall cater the services under the supervision of Doctors and all

necessary drugs(Adrenaline, corticosteroids Injectable etc., and equipment shall be ensured by

the manufacturer and centers, so that, the centers and doctors may combat the emergency


situations if any as there may be some idiosyncratic reactions to patients to patient. All necessary

instruction on the leaflet of each extract (vial) shall be ensured in letter and spirit.

The management agreed to the proposal of the Inspectors for PSI and the Panel

unanimously recommended that Registration Board may consider the registration dossiers of

allergen extract applied by the firm in line with similar criteria used across the board. The extract

manufactured on trial basis were tested in vivo & in vitro for safety as per Prescribed procedure

and International guidelines already submitted to Division of Biological Drugs, which may be

presented before the Registration Board by Division of Biological Drugs.

This report is limited to verification of manufacturing and quality control facility for PSI.

Quality of products of individual batches remains the responsibility of the technical staff and

manufacturer. The panel could not guarantee the quality of individual batch manufactured later

on. The Registration Board may decide the case as per their trial batch record submitted to

division of Biological Drugs in line with known Standards.

Decision:“Registration Board deliberated that as in vivo and in vitro safety data on extract manufactured on trial basis by the firm is neither available in registration dossiers nor provided by the applicant separately and panel of inspectors is referring to that data for consideration by Registration Board for grant of registration. Thus the Board decided to advise firm for provision of aforementioned data for consideration as recommended by panel of inspectors.”

The firm has submitted the clinical trial data of invivo pilot study of different allergen and the study was conducted in two private hospitals of AJK and Lahore, which requires evaluation from experts. The case was again taken up in 265 th meeting of Registration Board and board decided as follows:“Registration Board deferred above products for evaluation of clinical data by Brig. (R) Tariq.

Butt, Prof. of Pathology/ Microbiology, Foundation University Medical College RWP/ Member

Registration Board”.

Brig. (R) Tariq Butt Prof. of Pathology/Microbiology, Foundation University Medical College RWP/Member of Registration Board to whom the case was deferred for evaluation of clinical data, has resigned from membership of Registration Board.

The aforementioned products are already established vaccines. Decision: Registration Board deliberated that the as per inspection report of panel of

inspectors the firm has necessary facilities to manufacture and test the applied allergens. The Board advised the Division of Biologicals Evaluation & Research to evaluate the registration applications of M/s Pak Cure Islamabad, in line with the similar criteria used across the board for registrations of allergens granted to M/s NIH, Islamabad and come up in next meeting with comparison.


Case No.02: Shelf life extension of vaccines applied by M/s GSK, Karachi.

M/s GlaxoSmithKline, Karachi has applied for the extension in shelf life of their

following registered vaccines manufactured by M/s GlaxoSmithKline Biologicals, Rixensart,

Belgium. The firm has submitted the following documents for each product;

i. 5000/- processing feeii. Form-5A

iii. Valid Legalized CoPPiv. Copy of initial registration letter v. Copy of last renewal application

vi. Stability study Data

S. No.

Reg. No

Brand Name and Composition ApprovedShelf

DemandedShelf Life

Remarks Decision

1 066129 SynflorixVaccine (PFS).Each 1 dose (0.5ml) contains: -One microgram of saccharide for serotypes 1,5,6B,7F,9V,14 and 23F and 3 micrograms of serotypes 4,18C and 19F.Single dose PFS

03 years 04 years Valid Legalized CoPP No. 01/16/94768 dated13-01-2016

Registration Board granted the extension in shelf life from 03 years to 04 years as per valid legalized CoPP.

2 072534 SynflorixVaccineEach 1 dose (0.5ml) contains: -One microgram of saccharide for serotypes 1,5,6B,7F,9V,14 and 23F and 3 micrograms of serotypes 4,18C and 19F.Multi-dose (2-dose) vial

03 years 04 years Valid Legalized CoPP No. 22/16/103227 dated17-10-2016


3 059029 Cervarix VaccineEach 0.5ml contains: -Human Papillomavirus type 16L1 protein 16 ---- 20mcgHuman Papillomavirus type 18L1 protein 18-----20mcg3-o-deacyl-4-monophosphory lipid A (MPA)---------50mcgAluminium hydroxide, hydrate-----0.5ml Al+3

Single dose PFS

2 years 4 years Valid Legalized CoPP No. 22/16/103226 dated 17.10.2016

The firm requested for the extension from 2 to 3 years while approved shelf life by EMA is 4 years. The same is also mentioned by the firm in application. Hence 4 years shelf life may be considered.



4 012370 Engerix-B Junior 10µg/0.5ml(Suspension for Injection)Each dose (0.5ml) contains:Hepatitis B surface antigen:............10µgAdsorbed on aluminium hydroxide, hydrated Produced in yeast cells (Saccharomyces cerevisiae) by Recombinant DNA Technology.....0.25mgSingle dose PFS

2 years 3 years Valid Legalized CoPP No. GSK/00000210-03-14dated10-03-2014


5 009823 Engerix-B 20µg/1.0ml(Suspension for Injection)Each dose (1ml) contains:Hepatitis B surface antigen:............20µgAdsorbed on aluminium hydroxide, hydrated Produced in yeast cells (Saccharomyces cerevisiae) by Recombinant DNA Technology.....0.50mgSingle dose PFS

2 years 3 years Valid Legalized CoPP No. GSK/00000410-03-14dated10-03-2014


Decision: Registration Board considered request of the firm and decision is recorded in the last column against each product above.

Case No.03: Hepatitis E vaccine applied by M/s LA-VIE (Pvt.) Ltd, Lahore.

M/s La-Vie (Pvt.) Ltd., Lahore, applied for the registration of Hepatitis E vaccine.

The case was considered in 264th meeting of Registration Board and proceedings of the Board

are as follows:

“M/s La-Vie (Pvt.) Ltd., Lahore, applied for the registration of a human biological drug. Product was considered in 260th meeting of Registration Board and was deferred for confirmation of approval status by reference regulatory authorities and expert opinion pertaining to requirement of Hepatitis E virus vaccine in country, keeping in view its prevalence, epidemiology, domestic requirement etc. to following experts:

a. Prof. Dr. Muhammad Umar, Principal Rawalpindi Medical College, Rawalpindi.b. Dr. Huma Qureshi, Executive Director, Pakistan Health & Research Council,

Islamabad.


S.# Company Name and Manufacturer

Name of Drug and Composition

Date of application / Fee status

Documentary details

1 M/s La-Vie (Pvt) Ltd., Lahore

Manufacturer:M/s xiamen Innovax Biotech Co., Ltd., 130.Xinyuan Road, Haicang District, Exiamen, Fujian Province, PR China.

Hecolin ® 0.5ml/dose PFSEach 0.5ml dose contains:-30 ug of purifiedrecombinant Hepatitis E virus antigen

Shelf life : 36 month

Dy.No.2224 (R&I) DRAP (TF)Dated 12-5-2016Fee Rs.Rs. 50000/-dated 10.5.2016

New molecule

GMP Certificate No. CN20120056 dated09-7-2012 valid upto 08-7-2017

Free Sale Certificate No. 2016002 dated 8.1.2016

Expert opinion of Prof. Dr. Muhammad Umar, Principal Rawalpindi Medical College against Hepatitis E vaccine (Hecolin) of M/s LA-VIE (Pvt.) Ltd., Lahore.

I reviewed the document in detail provided regarding hepatitis E vaccine (Hecolin). The methodology of trial appears standardized. Efficacy and safety assessed in trials appears effective. Literature review although only from China showed encouraging results of said vaccine use.

Opinion: In my opinion better option would be to advise the company to have some clinical trials at some centers to evaluate the efficacy and safety in Pakistan population before registration.

Expert opinion of Prof. Dr. Huma Qureshi, Executive Director, Pakistan Research Council against Injection Hecolin (Hepatitis E vaccine) of M/s LA-VIE (Pvt.) Ltd., Lahore.

Hepatitis E is water borne disease mostly occurring in lower middle income countries due to consumption of sewage contaminating drinking water. This occurs as epidemic mostly during rains, floods and disaster situations while small outbreaks occur in localities where sewage and water pipelines are running parallel. Both situations are often seen in Pakistan. Earlier studies reported 16% exposure to hepatitis E in adults and 18% in children1. Recent figures for HEV exposure in adult population (males & females) in Pakistan is 68% (range 53%-88%) which is highest in region with almost 65% exposure in females of reproductive age group (18-45yrs) (under publication). The patients suffer from jaundice, vomiting and fever and may also have severe pruritus or rash lasting for 2-4 weeks. Liver function tests are markedly deranged but recovery ensues in 8-12 weeks in majority with no chronic squeal. The scenario is different in pregnancy where high maternal or fatal mortality is reported. Aga Khan university, Karachi reported a maternal and fatal mortality of 16.6 % and 50% respectively, while another study that collected retrospective data from public sector hospitals reported an overall prevalence of Hepatitis E in pregnancy as 15.5%(21/135) with (14%) maternal deaths and 4.7% fatal deaths2,3. Another hospital based study on pregnant women presenting with ether acute hepatitis or fulminant hepatic failure (FHF) reported that 20 out of 53 (38%) develop FHF. Non-A, Non-B was the commonest cause (62%) followed by Hepatitis B (17%) and hepatitis A (4%). Maternal mortality of 62% was reported for NANB Hepatitis while prenatal mortality was 30%4.

Death is directly proportional to the trimester of pregnancy being highest in later pregnancy and none or minimal in early pregnancy. Early delivery in many instances has saved lives, therefore early induction of labour and delivery of baby is practiced in health care settings Minutes for 267th Registration Board Meeting 411

in Pakistan. Another study at the obstetric department of public sector hospitals showed 15.5% (21/135) hepatitis E prevalence with 0.3 maternal deaths(14%) as against 3.5 % maternal deaths in non hepatitis cases (under publication). Once exposed to the virus, the protective antibodies (anti HEV IgG) remain in the body for 15-20 years after which their level goes down making the person again vulnerable to the disease. Therefore a person has a chance to get exposed to this virus at least 3-4 times in their life time. In Pakistan, there are about 35.4 million females in reproductive age group (18-45years)5. Using 65% exposure rate in reproductive age female groups. It is estimated that there will be around 23 million women who might have had an exposure to hepatitis E and therefore might be protected from it. However, 12 million women of reproductive group are at risk of risk of developing hepatitis E during pregnancy and 1.8 million might die during the disease. Using the birth cohort data, in Pakistan, 5 million children are born each year6 Economic survey; therefore, there should be at least 4 million pregnant females (including twin, triplets etc.). With an average death rate of 15% in hepatitis E during pregnancy, it is estimated that about 0.6 million will suffer from hepatitis E and will die due to its sequela. Therefore there is a dire need to protect them.

There is no WHO approved hepatitis E vaccine available for hepatitis E prevention, however in 2011, China produced a vaccine and undertook its phase 3 trials in healthy population. The results showed it to be an effective vaccine for the disease prevention7. Although no trials have been undertaken in pregnant women but it is recommended that females of reproductive age should be prioritized and vaccinated before pregnancy. The vaccine is given intramuscularly as 2 doses with lifelong protection and no serious side effects.

Making use of the available data from Pakistan and the mortality due to hepatitis E in pregnancy, it is evident that there is a need to make hepatitis E vaccine accessible and affordable for Pakistani women in particular and population in general.

Final comments: Strongly recommended for use in Pakistan.

The case was deferred in 262nd meeting of Registration Board for deliberation in next meeting.Decision:

“Registration Board deferred above product for evaluation by Brig (R) Tariq Butt, Member Registration Board to ascertain need of the product keeping in view prevalence of disease and availability of other therapeutic regimens.”It is submitted that Brig. (R) Tariq Butt has resigned from membership of registration

Board. Submitted for the deliberation of Board please.

Decision: Registration Board referred the above product to Hepatitis Control Program for their comments in view of prevalence of disease across the country, its need and availability of other therapeutic regimens.


Case No.04: Products applied by M/s Saadat International, Lahore approved in 258th


Following products of M/s Saadat International, Lahore were approved in 258 th

meeting of Registration Road. The details are as follows:

Sr.No.

Name of Importer &

Manufacturer


Type of FormDy. No.Date of

ApplicationFee Status

Documents Details

Decision of RB

1. M/s SaadatInternationalLahore.

Merial ItaliaS.p.A ViaBaviera 935027NoventaPadovana (PD) Italy

GALLIMUNE MG(inactivated vaccine in oil adjuvant againstMycoplasma gallisepticum infections of poultry)Each dose of 0.3 ml contains:Mycoplasma gallisepticum, strain S6 inactivated minimum titre before inactivation 109

CFU.Active Immunization of healthy breeding and laying stock against mycoplasma.

Route of adm: SC/IM


Form-5ADy. No 962dated 01-10-15100000/- dated01-10-2015Decontrolled /300 ml vial(1000 doses)

LegalizedCoPP No 27/2015/NC dated18-03-2015LegalizedGMP NBF/ 17/2014/V dated19-03-2014

Approved as per import policy and as per valid legalized CoPP.

2. M/s SaadatInternationalLahore.Merial ItaliaS.p.A ViaBaviera 935027NoventaPadovana (PD) Italy

GALLIMUNE 403ND+IB+IBD+REO(Inactivated vaccine in oil adjuvant against New castle disease ,Infectious bronchitis, Infectious bursal disease and Avian viral Arthritis).Each dose of 0.3 ml contains:-Newcastle disease virus(Ulster 2C strain),inactivated, minimum titre before inactivation 108

EID50

Infectious bronchitis virus (Mass 41strain),inactivated, minimum titre before inactivation 106.7

EID50

Infectious bursal virus(VNJO strain), inactivated,


LegalizedCoPP No 28/2015/NC dated18-03-2015LegalizedGMP NBF/ 17/2014/V dated19-03-2014

Approved as per import policy and asper valid legalized CoPP.


minimum titre before inactivation 105.7CCID50

Avian viral arthritisreovirus (S1133 strain),inactivated, minimum titre before inactivation 107

CCID50

Avian viral Arthritis


Route of Adm: SC/ IM

Before the issuance of registration letter, it was found that the products are not available in the market in country of origin. A letter vide F. No. 3-95/2015-DDC(BD)(Vol.I)(M-258) dated 19-12-2016 was issued to the firm for clarification regarding above matter.

The firm submitted the following reply from their principal manufacturer:

Gallimune MG:Product is not registered locally (Italy) as the disease against which it is indicated

is not prevalent or it is not the part of vaccination programs. But it is registered in various countries as per their local demand/ disease prevalence.Gallimune 403 ND+IB+IBD+REO:

Product is not registered locally (Italy) as the said combination of vaccines is not the part of vaccination programs. But it is registered in various countries as per their local demand/ disease prevalence.

Decision: Registration Board advised the firm to provide the approval status of evidence of registration of above product manufactured in the applied facility is approved by any of the regulatory authorities from USFDA, EMA, PMDA Japan, Australia TGA, Health Canada, Switzerland or any of regulatory authority of former erstwhile Westren Europe (United Kingdom, Germany, France, Switzerland, Netherlands, Austria, Belgium, Denmark, Finland, Sweden, Italy, Ireland, Luxemburg, Norway, Scotland and Spain) or three stringent regulatory bodies of former erstwhile Eastren Europe.


Case No.05: Products applied by M/s Saadat International, Lahore deferred in 258th


Following products of M/s Saadat International, Lahore were deferred in 258 th

meeting of Registration Board. The details are as follows:

Sr.No.

Name of Importer &

Manufacturer


Type of FormDy. No.Date of

ApplicationFee Status

Documents Details

Decision of RB

3. M/s SaadatInternationalLahore.

Merial ItaliaS.p.A ViaBaviera 935027NoventaPadovana (PD) Italy

GALLIMUNE ART(Inactivated vaccine in oil adjuvant againstInfectious AvianRhinotracheitis

Each dose of 0.3ml contains:Avian Rhinotracheitisvirus, VCO3 strain,inactivated, at least 60IPUActive immunization of laying and breeding stocks against avian rhinotractitis.

Shelf life: 24months

Route of adm: SC/ IM


LegalizedCoPP 123/2015/ NCDated07-08-2015LegalizedGMP NBF/ 17/2014/V dated19-03-2014

Deferred for clarification by the firm for non-availability of formulation by the competent regulatory body of country of origin.

4 M/s SaadatInternationalLahore.

Licenseholder:Merial ItaliaS.p.A Via VittorPisani 1620124 Milano

Manufacturer:IZO S.r.l. asocio unico, StradaStatale234 Km 28200,27013 ChignoloPO Italy

GALLIVAC REO(Live freeze dried vaccine against avianviral arthritis)

Each dose of 0.2 ml contains:Avian arthritis reovirus, S1133 strain, at least104TCID50

Vaccination of breeding stock against viral arthritisRoute of adm: SC

Shelf life 24Months

Form-5A

Dy. No 963dated 01-10-15100000/- dated01-10-2015Decontrolled /1 vial x 1000doses10 vial x 1000doses

LegalizedCoPP No 29/2015/NC dated18-03-2015

Deferred for clarification by the firm for non-availability of formulation by theCompetent regulatory body ofcountry of origin.


The firm submitted the following reply from their principal manufacturer:

Gallimune ART:

Product is not registered locally (Italy) as the disease against which it is indicated

is not prevalent or it is not the part of vaccination programs. But it is registered in various

countries as per their local demand/ disease prevalence.

Gallivac REO:Product is not registered locally (Italy) as the disease against which it is indicated

is not prevalent or it is not the part of vaccination programs. But it is registered in various

countries as per their local demand/ disease prevalence.

Decision: Registration Board advised the firm to provide the evidence of registration of above formulation in regulatory authorities of USFDA, EMA, PMDA Japan, TGA Australia, Health Canada, Switzerland or any of the regulatory authority of former erstwhile Western Europe or minimum three stringent regulatory bodies of erstwhile Eastern Europe.

1.


Case No.06: Expert opinion for biological drugs:

In case of veterinary vaccines the cases are unnecessarily being delayed asking for strain

verification during the meeting; it was suggested that if new strain needed to be evaluated then

the case must be forwarded by the DBER to the expert before including in the agenda. If the

same straqin is already registered locally, there is no need of evaluation in term of strains.

Decision: Registration Board deliberated that in case of biological drugs if formulation is not already approved by reference regulatory authorities and thus expert opinion is needed regarding any aspect of the product. Thus in order to avoid delay, it was decided that DBER shall forward the case to expert of concerned speciality for their scientific opinion and same shall be placed before Registration Board.

Case No.07: Registration Board for Biological drugs.

During meeting it was deliberated that 04 cardiologists attended meeting of Registration

Board on recommendations of National Consultative meeting on cardiac stents. Director, DBER

recalled comments of Registration Board in its 243rd meeting for constitution of separate

Registration Boards of biological products, keeping in view expertise and special nature of

biological products.

Decision: Registration Board deliberated that as Medical Device Board has been constituted for medical devices as per Medical Device Rules, 2015. For separate Registration Board of Biological Drugs, respective Division may process case if permissible as per DRAP Act, 2012.


C. Pharmaceutical Evaluation & Registration Division.

Case No.01: Drug Product Specifications.

Registration Board deliberated matter for Drug product specifications in its 264th and

266th meetings. The Board further discussed the matter in detail especially for generic

manufacturer’s specifications and further decided as follows:

a. The product quality depends upon its standards and specifications. For ensuring safety, efficacy and quality of products, pharmacopeial specifications are the most reliable, safe and accepted worldwide and same is required and shall be followed as per Drug Specification Rules, 1978. Moreover, Registration Board has specified reference countries including USFDA, Health Canada, EMA, TGA Australia, PMDA Japan, United Kingdom, Germany, France, Switzerland, Netherlands, Austria, Denmark, Sweden and Norway and thus pharmacopeial specifications approved by pharmacopeias of aforementioned countries are accordingly acceptable for their relevant products.

b. In case a drug product is not yet available in pharmacopeia of reference countries as specified by Registration Board, then innovator products specifications as approved by regulatory authority of reference country shall be followed. The innovator’s specifications, however, shall be valid only till inclusion of the product in the official pharmacopoeia of reference countries as specified by the Registration Board. being official specifications as approved by authorities of reference countries and same can be adopted by the generic manufacturer / importers.

c. In case product is still not available in any pharmacopeia and a generic applicant prefer to manufacture with its own (manufacturer’s) specifications, then firm shall submit following data for review and approval by Registration Board as manufacturer’s specifications as per international practices.

i. Product and formulation development data.ii. Manufacturing method development and process validation.

iii. Analytical method development and validation (accuracy, precision, specificity, linearity, ruggedness and robustness) against innovator’s analytical method and innovators’s product.

iv. Comparative pharmaceutical equivalence against innovator’s product including comparative dissolution profiling and preferably bio-equivalnec.

v. Stability study data of the product for accelerated and real time period against innovator’s product as a reference.

Meeting ended with a vote of thanks to and from the chair.

End of Document

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