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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.

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Pharmacovigilance Programme of India


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

    2. 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

    3. 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

    4. 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

    5. Programme Governance - PvPI

    6. GOVERNANCE STRUCTURE - PVPI CDSCO ZONAL CENTRES PHARMA INDUSTRY Immunization Programs

    7. Roles & Responsibilities of the Functional UnitsPharmacovigilance Programme of India

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

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

    10. Steering Committee - PvPI MEMBER SECRETARY Assistant Drug Controller, New Delhi, India

    11. Monitoring and Evaluation – key indicators to measure efficiency

    12. 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

    13. 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

    14. 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

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

    16. ACADEMIA INDUSTRY REGULATOR

    17. 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.

    18. Thank you