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
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

6. 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

8. 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

9. 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)

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

11. 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

12. 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

13. 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

14. 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

15. 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

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

17. ACADEMIA
INDUSTRY
REGULATOR

18. 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.

19. Thank you