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Pharmacovigilance Programme Pharmacovigilance Programme of Indiaof India
YK GUPTANational Coordinator, Pharmacovigilance Programme of IndiaProf. & 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
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
Pharmacovigilance Programme of India (PVPI)
Programme Governance - PvPI
CDSCO ZONAL CENTRES
GOVERNANCE STRUCTURE - PVPI
PHARMAINDUSTRY PHARMA
INDUSTRY
Immunization Programs
Roles & Responsibilities of the Functional UnitsPharmacovigilance Programme of India
40 PvPI AMCs
National Coordinating Center,AIIMS, New Delhi
4 Zonal CDSCO Offices (provide operational and logistical support)
Ghaziabad Mumbai Kolkata Chennai
PvPI Headquarters, CDSCO
Pharmacovigilance Programme of India (PVPI)
PHASE 1
The centres included in the first wave of the Programme - 12
Steering Committee - PvPI
MEMBER SECRETARYAssistant Drug Controller, New Delhi, India
Monitoring and Evaluation – key indicators to measure efficiency
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
1. Oseltamivir2. Letrozole3. Nimesulide4. Pioglitazone5. Rosiglitazone6. Tegaserod7. PPA 8. Gatifloxacin
Concerns about drug safety in other countries
Absent/ Minimal safety data from India
Proactive & focused ADR
monitoring in dedicated
pharmacovigilancecentres
Regulatory action based on Indian AND global data
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
Pharmacovigilance
Patient Policy makers(regulators)
Physician and medical associations
Public Press (media)
Pharmaceutical Industry and associations
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