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 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
GOVERNANCE STRUCTURE - PVPI CDSCO ZONAL CENTRES PHARMA INDUSTRY Immunization Programs
Roles & Responsibilities of the Functional UnitsPharmacovigilance Programme of India
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)
Steering Committee - PvPI MEMBER SECRETARY Assistant Drug Controller, New Delhi, India
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.