Pharmacovigilance Programme of India YK GUPTA National Coordinator, Pharmacovigilance Programme of India Prof. & Head, Department of Pharmacology AIIMS, New Delhi, India

Pharmacovigilance Programme of India (PVPI) Pharmacovigilance Programme of India (PVPI) was launched in July 2010. Goal: To ensure that the benefits of use of medicine outweighs the risks and thus safeguard the health of the Indian population

Pharmacovigilance Programme of India (PVPI) Objectives: To monitor Adverse Drug Reactions (ADRs) in Indian population To create awareness amongst health care professionals about the importance of ADR reporting in India To monitor benefit-risk profile of medicines Generate independent, evidence based recommendations on the safety of medicines

Pharmacovigilance Programme of India (PVPI) Objectives: Support the CDSCO for formulating safety related regulatory decisions for medicines Communicate findings with all key stakeholders Create a national centre of excellence at par with global drug safety monitoring standards

Programme Governance - PvPI Steering Committee Director , AIIMS ex officio Strategic Advisory Committee To be constituted by CDSCO Signal Review Panel Coordinator, National Coordinating Centre, AIIMS Core Training Panel Quality Review Panel

GOVERNANCE STRUCTURE - PVPI Steering Committee Strategic Advisory Committee Signal Review Panel Core Training Panel Quality Review Panel MINISTRY OF HEALTH & FAMILY WELFARE (MOHFW) Central Drugs Standards Control Organisation (CDSCO) Drugs Controller General of India (DCGI) Pharmacovigilance Programme of India (PVPI) – National Coordinating Centre (NCC) All India Institute of Medical Sciences (AIIMS), New Delhi M O N C I E A T D R S G NORTH, Ghaziabad SOUTH, Chennai EAST, Kolkata WEST, Mumbai CDSCO ZONAL CENTRES GOVERNANCE STRUCTURE - PVPI PHARMA INDUSTRY Immunization Programs

National Pharmacovigilance Coordinating Centre at AIIMS Roles & Responsibilities of the Functional Units Pharmacovigilance Programme of India ADR Monitoring Centre Collection of ADR reports Follow up of ADR reports, check completeness for a valid case, causality assessment Data entry – Vigiflow Monthly reports to National Coordinating Centre at AIIMS Training/sensitization/ feedback to physicians/ students/patients National Pharmacovigilance Coordinating Centre at AIIMS Review completeness, Quality Check, Causality Assessment, transmit ADRs to Vigiflow Training to ADR Monitoring centres Feedback to the ADR Monitoring centres Educate and inform medical community via MEDICINE SAFETY NEWSLETTER Consult Signal Review Committee Reporting to DCGI Office Zonal CDSCO Centres Provide administrative support to the ADR Monitoring Centres Report to DCGI (CDSCO) CDSCO Report to DTAB (Ministry of Health & Family Welfare) Formulate and communicate safety related regulatory decisions for medicines

Pharmacovigilance Programme of India (PVPI) PvPI Headquarters, CDSCO National Coordinating Center, AIIMS, New Delhi 40 PvPI AMCs Ghaziabad Mumbai Kolkata Chennai PHASE 1 4 Zonal CDSCO Offices (provide operational and logistical support)

The centres included in the first wave of the Programme - 12

Steering Committee - PvPI Director, AIIMS (ex officio) Drugs Controller General (India), (ex officio) Head of Department, Pharmacology, AIIMS (ex officio) Scientific Director, Indian Pharmacopeia Commission (ex officio) Nominee of Director General, ICMR (ex officio) Nominee of Vice Chancellor of Medical/Pharmacy University (ex officio) MEMBER SECRETARY Assistant Drug Controller, New Delhi, India

Monitoring and Evaluation – key indicators to measure efficiency Process Indicators No. of AMCs participating in the PvPI No. of AMC personnel trained in a year Funds budgeted for PvPI & actual spent AMC personnel working full time for PvPI Outcome Indicators Software platform established No. of ADR reports received in a year No. of ADR reports processed in a year No. of ADR reports submitted to Vigiflow Impact Indicators No. of signals generated & confirmed No. of safety related alerts issued by CDSCO

Focused ADR monitoring watchlist CRITERIA Restriction/Withdrawal by any other regulatory agency in the world Reports in media Adverse reports published in WHO Newsletters Diseases of public health importance in relation to Indian population Drugs, Vaccines for Epidemics/Pandemics Signals generated from the spontaneous reports received under the PvPI

Proposed drugs for focused ADR monitoring Concerns about drug safety in other countries Oseltamivir Letrozole Nimesulide Pioglitazone Rosiglitazone Tegaserod PPA Gatifloxacin Regulatory action based on Indian AND global data Proactive & focused ADR monitoring in dedicated pharmacovigilance centres Absent/ Minimal safety data from India

  Workshop on Operationalizing Pharmacovigilance Programme of India (PvPI) 24th – 25th November 2010 Key Achievements Vigiflow Training orientation for AMC Coordinators Vigiflow ‘hands on’ training for all 12 AMCs completed SOPs deliberated and finalized through collective brainstorming sessions by all AMCs coordinators. Training imparted & training records completed ‘State of art’ videoconferencing facility (AIIMS Telemedicine department) Proof of concept for ‘real time’ distance learning fulfilled and can be utilized for future purposes “Face to Face” SOP training for Technical Associates will be imparted over next 2 days. ADR forms received by the AMCs will be entered in Vigiflow over next 3 days – experiential learning

Seamless synergistic pharmacovigilance partnership Policy makers (regulators) Patient Pharmacovigilance Physician and medical associations Pharmaceutical Industry and associations Public Press (media)

ACADEMIA INDUSTRY REGULATOR

Potential for synergy 289 medical colleges and 282 dental colleges More than 837 Pharmacy colleges More than 657 recognized nursing colleges (B.Sc and M.Sc) Over 600 pharmaceutical companies (IDMA members) CDSCO, WHO, ICMR, other affiliates MCI, DCI, PCI, Consumer associations etc.

Thank you