Report on. Pharmacovigilance Inspections of Market. Authorization Holders - Orientation training. At CDSCO HQ, New Delhi.

Transcription

1 Report on Pharmacovigilance Inspections of Market Authorization Holders - Orientation training programme, on 15 th December 2017 At CDSCO HQ, New Delhi.

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3 Table of Contents Sr no Content Page no 1 Background 3 2 Summary Pre Lunch Session Post Lunch Session 6 3 Outcome 8 4 Annexure Agenda List of Speakers List of Participants 10 Page 2 of 11

4 Background Strengthening of Pharmacovigilance activities and ensuring patient safety has been enforced by CDSCO continuously. Requirements for the Pharmacovigilance have been there as a part of conditions to permissions issued to the applicants eg. new drug permissions, registration certificate eg., Condition no.05 of Form 45 (permission for import of new drugs) and Form 46 (permission for manufacture of new drug) requires PSUR submission and Condition 4 in Form 41 (Registration Certificate for import of Drugs into India) which requires the manufacturer or his authorized agent in India shall inform the licensing authority in the event of any administrative action taken due to adverse reaction. Further, Para 28 of part 1 of Schedule M of Drugs and Cosmetics Rules, 1945 states that the serious adverse reaction should be reported to licensing authority by the licensee. Government of India vide notification no GSR 287(E) also published on 8 th March, 2016 to amend Schedule Y of the Drugs and Cosmetics Rules, As per the amendment for post marketing surveillance the applicant should have a pharmacovigilance system in place. In order to encourage active surveillance it is proposed to carryout inspections of the pharmacovigilance system of the applicants. Further, CDSCO, Indian Pharmacopoeia Commission and the Ministry of Health and Family Welfare have published vaccine guidance documents like Pharmacovigilance Guidance Document for the Market Authorisation Holders for Pharmaceutical Products, Guidance for Industry on Pharmacovigilance Requirements for Biological Products, Adverse Events following Immunization-surveillance and response operational guidelines etc. India has a well-established Pharmacovigilance programme of India (PvPI) with the national coordination centre at Indian Pharmacopoeia Commission (IPC), Ghaziabad. IPC has 250 ADR monitoring centers. The Pharmacovigilance division, Indian Pharmacopoeia Commission (IPC), Ministry of Health and Family Welfare has also been designated as WHO collaborating centre for Pharmacovigilance in public health programmes and regulatory services. The expected outcome of this one day orientation training was to prepare the CDSCO inspectors for the Pharmacovigilance inspections of applicants. The training programme was designed to impart comprehensive knowledge to CDSCO Inspectors on the legal provisions on Pharmacovigilance, vaccine national guidelines, international practices and the knowledge on actual framework of Pharmacovigilance with the market authorization holders. Page 3 of 11

5 Summary The training on Pharmacovigilance Inspections of Market Authorization Holders at CDSCO HQ New Delhi held on 15 th Dec 2017 was organized by CDSCO, FDA Bhawan, New Delhi. The participants included 38 Drugs Inspectors from CDSCO Zonal, Sub zonal offices and CDSCO HQ, The other technical staff of CDSCO HQ also attended the training programme. The speakers included various stakeholders in Pharmacovigilance eg. Indian Pharmacopoeia Commission, Adverse Events Following Immunization (AEFI) Secretariat, WHO country office, representatives from marketing authorization holders etc. Session wise Proceedings Inaugural Session: 1. Dr. G. N. Singh, Drugs Controller General of India Dr. G. N. Singh, DCG (I)welcomed all the dignitaries, speakersand participants to the training programme. He apprised the participants that a strong Pharmacovigilance system amongst all the stakeholders would contribute to patient safety. He put forth the importance of knowledge upgradation and emphasis on science based decision making. DCG(I) informed the participants that PvPI has been declared as WHO collaborating centre for Pharmacovigilance in public health programmes and regulatory services. He wished the participants success in the programme. 2. Dr. S. Eswara Reddy, Joint Drugs Controller of India Dr. S. Eswara Reddy, JDC (I) emphasized the importance of Pharmacovigilance strengthening in India especially from the perspective of patient safety. He told the participants that establishing safety of the drug after its approval can be achieved effectively only if all the stakeholders like MAHs have a robust system in place. He said that the training has been designed to make the participants aware on the Drugs and Cosmetics Rules on Pharmacovigilance, expectations from stakeholders, roles of various partners like PvPI, AEFI Secretariat, WHO and MAHs etc. The inspectors of CDSCO should make a concentrated effort to improve the Pharmacovigilance system. 3. Dr. K. Bangarurajan, Joint Drugs Controller of India Dr. K. Bangarurajan, JDC (I) welcomed the participants and conveyed his best wishes to them. He said that strong Pharmacovigilance system is the need of hour and today s orientation training would be helpful in training the inspectors on the requirement of Pharmacovigilance to further Page 4 of 11

6 strengthen the system with the applicants/ market authorisation holder. 4. Dr. Nilima Kshirsagar, National Chair Clinical Pharmacology, ICMR Dr. Nilima Kshirsagar welcomed the participants and expressed her happiness to be part of the training. She explained the importance of Pharmacovigilance to the inspectors and said that she felts proud to see such young and enthusiastic enforcement officers of CDSCO. She congratulated Drugs controller General (I) and Dr. S.E. Reddy, Joint Drugs Controller (I) for their efforts and success in establishing a robust Pharmacovigilance system in India. Pre Lunch Session: 1. Mrs. Swati Srivastava, Deputy Drugs Controller, presented Pharmacovigilance Requirements in India Gist of the Presentation Mrs. Swati spoke on PharmacovigilanceLegal requirements as per the Drugs and CosmeticsRules 1945, she elaborated on CDSCO s role as a regulatory agency for Pharmacovigilance Inspections. She also gave a snapshot of different guidance available for the stakeholders. The recent achievement in NRA 2017 and recommendation on Pharmacovigilance were shared with the participants. 2. Dr. Madhur Gupta, Technical Officer- Pharmaceuticals, WHO India, shared views on Pharmacovigilance Inspection in India- Expectation from Stakeholders Including Regulators Gist of Presentation Dr. Madhur Spoke on the Good Pharmacovigilance practices which apply to Marketing authorization holders as well as regulatory authorities. She further elaborated on the pharmacovigilance guidance document for MAHs module 1-5, She elaborated each module giving emphasis on module 5 including internal audits, types of inspections, inspection findings etc. She explained the importance of Risk management plan in Pharmacovigilance Page 5 of 11

7 Inspections and concluded her remarks with WHO s announcement of conducting two workshops on PV inspections in India in Dr. Moin Don, CEO, M/s PVCON focussed on Risk Management Plan in PharmacovigilanceInspections in his presentation Gist of Presentation Dr. Moin Don gave details about the Marketing Authorization holder s current Pharmacovigilance system in respective organizations. He spoke on Risk management including identification of Risk, Characterization of Risk, risk management plan and system. He also gave references to respective guidelines occasionally. Risk management cycle was explained by him including contents of safety specification coupled with suitable elaborations. Post Lunch Session: 1. Mr. Somnath Basu, Assistant Drugs Controller (I)presented Periodic Safety Update Reports (PSURs) and Periodic Benefit- Risk Evaluation Reports (PBRERs) Gist of Presentation He explained the need of Pharmacovigilance by explaining ADRs, SAEs and its economic impact coupled with well-known examples to the audience such as Thalidomide. He discussed the difference between PSURs and PBRERs and on summary of Product Characteristics SmPCs for a product (especially vaccines). He further mentioned the active role of CDSCO in Pharmacovigilancefor vaccines in India giving examples of vaccines (topv, bopv, varicella etc.) in 12 PSUR meeting conducted in FDA Bhawan, New Delhi. 2. Dr. Nammi Sriniwas, Head of Chief Medical Office & Patient Safety, M/s. Novartis shared views on Pharmacovigilance System Master File-Requirements for applicants Page 6 of 11

8 Gist of Presentation Dr. Nammi Sriniwas spoke on the Pharmacovigilance master file (PvMF), its scope, purpose, different outlines, contents and annexes to the PvMF. He advised the participants for the applicability of PvMF for PharmacovigilanceInspections. He concluded the presentation by giving stress on making the Pharmacovigilanceguideline a legal document and re looking the timelines for implementation of PvMF. 3. Deepak Polpakara, Programme Lead - Adverse Events Following Immunization (AEFI) Secretariat shared his thoughts on Adverse Events Following Immunization Surveillance and Data Analysis Gist of Presentation Dr. Deepak gave the snapshot of the Immunization programme of India to the audience and from there shifted the focus of the participants to AEFIs. Starting with definition he then talked at length on the classification of AEFIs, reporting systems of AEFI, state (SIPSA) and District (DIPSA).The presentation was full of important statistics facts and figures on reporting of AEFIs in India. 4. V. Kalaiselvan, Principal Scientific officer, PvPI explained on Adverse Drug ReactionsReporting System in India Gist of Presentation Dr. Kalaiselven enlightened the participants on the overall working of the Pharmacovigilance programme of India. He shared with audience the information made available by PvPI through their resources for the above programme and the important facts, figures of the overall programme. He concluded his presentation giving stress on points such as Availability of Prescription Information Leaflet, Training on Good PV practices to the stakeholders, PV audit/inspection, and Compliance of Good PV practices. Page 7 of 11

9 Outcomes of Training The training provided to the participants gave them comprehensive knowledge on the requirements of Pharmacovigilance system in India. The participants exchanged their views during the plenary session. All sessions were useful to appraise the participants to the relevant Drugs and Cosmetics Rules, Progress of Pharmacovigilance programme of India, Adverse Events Following Immunization (AEFI) Secretariat Ministry of Health and Family welfare, National and International guidance, Pharmacovigilance Inspections, Pharmacovigilance techniques and Pharmacovigilance systems of Marketing Authorization Holders. Annexure Annexure I: Agenda Time Topic Time Speaker/Facilitator 10:00-10:10 Opening Address 10 Min Dr. G. N. Singh, DCG(I) 10:10-10:20 Introduction and Dr.S. Eswara Reddy 10 Min welcome JDC(I) 10:20-11:00 Pharmacovigilance Mrs. Swati Srivastava, Requirements in 40 min DDC(I) India-An overview 11:00-11:45 12:00-12:30 Pharmacovigilance Inspection in India- Expectation from stakeholders including regulators. 45 min Tea Break 11:45-12:00 AM ADR reporting system in India 30 min 12:30-13:00 PSURs/PBRERs 30 min 14:00-14:30 Lunch Break 13:00-14:00 PM Pharmacovigilance System Master File- Requirements for applicants 30 min Dr. Madhur Gupta WHO-Country office Principal Scientific officer, PvPI Mr.Somnath Basu, ADC(I) Dr.Nammi Sriniwas, Head of Chief Medical Office & Patient Safety, M/s. Novartis Page 8 of 11

10 14:30-15:00 15:15-15:45 Risk Management 30 min Plan Tea Break 15:00-15:15 PM AEFI reporting and analysis in India 30 min Dr. Moin Don, CEOM/s. PVCON Programme Lead - Adverse Events Following Immunization (AEFI) Secretariat 15:45-16:05 Plenary Discussion 20 min All participants 16:05-16:20 Closing Remarks 15 min Dr.S. Eswara Reddy, JDC(I) Annexure II: List of Speakers Sr # Name Designation Organization 1 Mrs. Swati Srivastava Deputy Drugs Controller (I) CDSCO 2 Mr. SomnathBasu Assistant Drugs Controller (I) CDSCO 3 Dr.Madhur Gupta Technical Officer WHO Country office 4 Dr. V.Kalaiselvan Principal Scientific Officer Pharmacovigilance Programme of India 5 Dr. Deepak Polpakara Programme Lead AEFI Secretariat (ITSU) 6 Dr. Moin Don CEO M/s. PVCON 7 Dr. NammiSriniwas Head of CMO & PS M/s. Novartis Annexure III: List of Participants Sr CDSCO HQ/ Zonal/Sub- Name Designation # Zonal Office 1. Ms. Suniti Choudhary DI CDSCO (North Zone) 2. Mr. Dharmvir Singh DI CDSCO (North Zone) 3. Mr. Abhinav Kapoor DI CDSCO (Baddi Sub Zone) 4. Mr. Neeraj Katiyar DI CDSCO (East Zone) 5. Mr.Chandra Shekhar DI CDSCO (East Zone) 6. Dr.Kasi Shankar Venugopal DI CDSCO (South Zone) 7. Mr. Balakumar Mahalingam DI CDSCO (South Zone) 8. Mr. Bikramaditya Chowdhury DI CDSCO (Hyderabad Zone) 9. Mr. G.Narendra Kumar DI CDSCO (Hyderabad Zone) 10. Ms. A.Anitha DI CDSCO (Bangalore Sub Zone) 11. Mr. Naveen Mehta DI CDSCO (West Zone) 12. Mr. Akash Rama Kondalkar DI CDSCO (West Zone) 13. Mr. Surender Kumar Kaswan DI CDSCO (Goa Subzone) 14. Mr.Ketankumar P. Panchal DI CDSCO (Ahmedabad Zone) Page 9 of 11

11 15. Mr.PranabJyoti Das DI CDSCO (Guwahati Sub Zone) 16. Mr.Pushpraj Kumar Singh DI CDSCO (Indore ) 17. Mr.Vinay Kumar Gupta DI CDSCO (Varanasi) 18. Mr. Rakesh Sharma DI CDSCO (HQ) 19. Mr. Rakesh Kumar DI CDSCO (HQ) 20. Mr.Varun Kumar DI CDSCO (HQ) 21. Ms.Shraddha Srivastava DI CDSCO (HQ) 22. Mr. Shoeb Bismilla Khan DI CDSCO (HQ) 23. Dr. Manoj Gambhire DI CDSCO (HQ) 24. Mr.Deepak Nipunge DI CDSCO (HQ) 25. Mr.Hemant Kumar DI CDSCO (HQ) 26. Ms.Smrithi Sharma DI CDSCO (HQ) 27. Mr.Vishal Kachare DI CDSCO (HQ) 28. Mr.Sachin Kapse DI CDSCO (HQ) 29. Mr.Satinder Pal Singh DI CDSCO (HQ) 30. Mr.MillindPatil DI CDSCO (HQ) 31. Mr.Sushant Sarkar DI CDSCO (HQ) 32. Mr. Manvendra Sanjay Teli DI CDSCO (HQ) 33. Mr. Shashi Kant DI CDSCO (HQ) 34. Mr.Shriniwas Laxman Vasalwar DI CDSCO (HQ) 35. Ms. Heema Naik DI CDSCO (HQ) 36. Ms.Sunita Joshi DI CDSCO (HQ) 37. Mr.Dev Kumar DI CDSCO (HQ) 38. Mr. Sakthivel P. DI CDSCO (HQ) 39. Mr. Umesh DI CDSCO(HQ) Page 10 of 11