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Meeting of Registration Board Held on 23-12-2013

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Meeting of Registration Board Held on 23-12-2013 Minutes for 241st meeting of Registration Board held on 23-12-2013. Item No. Detail of Item Page No. Item No.I Confirmation of minutes 240th meeting Registration Board 05 Item No.II Evaluation of registration dossiers- Ropegra & Pak Cure 06-11 Vaccines Item No.III Registration of Drugs for export purpose-Not me too 12-13 Drugs. Item No.IV Grant of Registration (Human Drugs) 13-74 Item No.V Grant of Registration (Vetrinary Drugs) 75-76 Item No.VI Miscellineous cases 76-193 Item No.VII Biological Evaluation & Reserach 194-212 Item No.VIII Quality Control Cases 213-218 Item No.IX Medical Devices. 219-223 1 241st meeting of Registration Board was held on 23rd December, 2013 in the Committee Room, 2nd floor, Block C, Pak Secretariate, Islamabad. The meeting was chaired by Mr. Ghulam Rasool Dutani, Director, Pharmaceutical Evaluation & Registration Division. The meeting started with the recitation of Holy Verses. The meeting was attended by the following:- 1. Lt General (R) Karamat Ahmed Karamat. Member 2. Prof.Dr.Rafi-uz-Zaman Saeed-ul-Haq. Dean, Member University of Lahore, Islamabad 3. Brig (R). Dr. Muzammil Hasan Najmi, Associate Member Dean, Basic Sciences Division, Foundation Medical University, Rawalpindi. 4. Brig. Dr. Aslam Khan, Professor of Medicine, Member Military Hospital Rawalpindi 5. awalpindi.Dr. Muhammad Arshad, President, Pakistan Member Veterinary Medical Council 6. Dr. Muhammad Khalid Khan Member Director Drugs Testing Laboratory Government of Khyber Pakhtoonkhwa, Peshawar. 7. Muhammad Jamil Anwar Member Director Drugs Testing Laboratory Government of Punjab, Lahore. 8. Dr.Amanullah Khan Member Director Drugs Testing Laboratory Government of Baluchistan, Quetta. 9. Mr.Abdul Razak Member Director Drugs Testing Laboratory Government of Sind, Karachi. 10. Dr. Noor us Saba Director, Biological Drug, Member DRAP 11. Dr. Obaidullah, Deputy Director General (Reg.I). Secretary/Member Abdul Samad Khan, Director NCL, Mr.Akhter Abbas Khan (DDG R.I), Dr. Tariq Siddique (DDC R.III/IV), Mr.Muhammad Arif (DDC R.I), Mr. Babar Khan (Incharge, PEC), Dr.Obaid Ali (DDC Biological), Ms. Tehreem Sara (DDC MD&MC) and Mr. Zaheer ud Din M Babar (DDC QC) assisted Secretary of the Board with agenda. 2 Mr. Hamid Raza & Khawja Javaid, Mr.Nadeem Alamgeer and Dr.M.Qasim Awan attended the meeting as observer on behalf of PPMA, Pharma Beauru and PVPMA respectively. Meeting started at 09:30 AM and concluded at 07:30 PM. During meeting members deliberated on the agenda and also discussed various matters for efficient working of the Board with aim to make easy availability of safe, effective and quality drugs. In addition to agenda item, the Board decided various issues as follows: Registration Board in 238th meeting constituted a Review Committee for evaluation of various formulations with Mr.Babar Khan as convenier of the committee. As aforementioned officer has been posted as Incharge, Pharmaceutical Evaluation Cell, hence the Board re-constituted Review Committee as follows: o Brig (R). Dr. Muzammil Hasan Najmi, Associate Dean, Basic Sciences Division, Foundation Medical University, Rawalpindi. o Brig. Dr. Muhammad Aslam Khan, Professor of Medicine, Military Hospital Rawalpindi o Dr.Tariq Siddique, Deputy Drugs Controller. o Muhammad Arif Ch, Deputy Drugs Controller Muhammad Arif Ch will be convenier of the committee. Registration Board advised the committee to review the referred formulations in light of safety, efficacy, approval status by international regulatory bodies, therapeutic & scientific rational and domestic need. Review committee will submit its recommendations for consideration of Registration Board. Registration Board in 237th meeting constituted a committee comprising of Dr.Tariq Siddique and Dr.Obaid Ali to discuss matter regarding manufacturing requirement for steroidal topical, ophthalmic and otic preparations. The committee also held its preliminary meeting with PPMA and Pharma Bureau. The Board advised the committee to finalize its recommendations at the earliest for consideration of already deferred registration applications by Registration Board. Registration Board discussed ir-rational cough preparations and decided to discuss / review already registered cough formulations as some preparations have no therapeutic efficacy. Chairman, Registratiuon Board requested Brig. Dr. Muhammad Aslam Khan 3 (Member, Registration Board) to present position paper for consideration of Registration Board. Registration Board also discussed matter of conduction of stability study of drugs. Members of the Board reiterated that all registrations approved by the Board are subject to conduction of accelerated stability studies before sale of drug (if not performed earlier), as approved by Registration Board in 240th meeting and all such conditions must be incorporated in conditions of registrations, as follows: The manufacturer will perform pharmaceutical development, stability studies, validation of manufacturing process and method of analysis as per undertaking submitted in registration dossier. DDC (Biological) apprised the Board that he was not part of committee constituted by Registration Board for recommendations on veterinary vaccines. Matter was discussed in detail and it was decided that as the Board has constituted a committee exclusively for veterinary vaccines for its recommendation including its member (Dr.Muhammad Arshad), thus Board is considering recommendation of this committee and will decide the case accordingly. Brig (R) Dr. Muzammil Hasan Najmi was of the view that Biological Drugs and Medical Devices are specialized preparations and there must be separate Boards for registrations of aforementioned therapeutic goods. After thread bare discussion and keeping in view nature of products, following proposals were made by the members of Registration Board for consideration of any one of them by DRAP. o Separate Boards for Biological Drugs and Medical Devices be constituted. o As Registration Board always considers the evaluation and recommendations of ECBD and ECMD for the respective products, therefore these committees may be strengthened and experts from all specialities must be included in the committee for proper evaluation and recommendations for consideration of Registration Board. 4 Item No I: Confirmation of minutes 240th meeting Registration Board. 240th meeting of Registration Board was held on 07h November, 2013 and minutes were accordingly circulated to all members through e-mail. Dr.Amanullah Khan, Director DTL, Quetta forwarded his comments as follows, for consideration of registration Board: Following criteria needs further explanation: 1. In each panel, one officer from center and one officer from field office shall be nominated. Please explain what will be the status of the Registration Board members belonging from provinces? 2. Each panel shall consist of one senior and one junior officer. Please explain the criteria for senior and junior officers, and again I request about the status of the registration board members belonging from various provinces. 3. Initially Directors of the Directorates namely Pharmaceutical Evaluation & Registration; Biological Drugs; Medical devices & Medicated Cosmetics will propose panels for inspections of manufacturer aborad, keeping in view above criteria for further approval. Please elaborate on this point and also explain the criteria for their nomination in the panel. Decision: Minutes of 240th meeting approved by Registration Board. Chairman Registration Board briefed members that technical members of Registration Board will definitely be considered in panels constituted for inspection of manufacturing units abroad. 5 Item No:II. Evaluation of registration dossiers- Ropegra & Pak Cure Vaccines: In 240th Registration Board meeting, registration dossiers of Ropegra, M/s Roch and vaccines of M/s Pak cure, Rawat were handed over to Mr.A.Q. Javed Iqbal for evalution. The Board advised aforementioned member to submit its report for consideration of Registration Board in its next meeting. Accordingly, Mr.A.Q. Javed Iqbal submitted its report which is as follows for consideration of Registration Board: Ropegra (Pegylated Interferon Alpha 2 in vial) by M/S Roche Pakistan: I had an opportunity to scan through the product dossier of “Ropegra (Pegylated Interferon Alpha 2 in vial) by M/S Roche Pakistan. I was expecting a very comprehensive and complete dossier from M/S Roche, being the inventor and original patent holder of this product and being approved by the Stringent European Regulators. However, there are some observations, inconsistencies regarding this dossier as follows; According to our previous RB meeting, on the submission of Biological Directorate, it was allowed to give fast tract processing to molecules from Stringent Regulatory Authorities if they fulfill the following criteria, “2.1.3. RECOMMENDATION FOR APPROVAL OF MARKETING AUTHORIZATION OF FINISHED BIOLOGICAL DRUGS: Recommendation: All applications which have gone through the rigorous review processes and already succeeded to get market authorization from the World Health Organization (WHO) defined Stringent Regulatory Authority (SRA), International Conference of Harmonization (ICH) countries are recommended for approval and will also be forwarded under default mechanism in future within shortest period of time, if applicant could: Submit summary of regulatory review report and approval, Submit Common Technical Documents both via CD in Electronic format and paper format Manage to arrange Process Verification
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