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
GOVERNANCE STRUCTURE - PVPI
MINISTRY OF HEALTH & FAMILY WELFARE (MOHFW)
Steering
Committee
Central Drugs Standards Control Organisation
(CDSCO)
Drugs Controller General of India (DCGI)
Pharmacovigilance Programme of India
(PVPI) –
Strategic
Advisory
Committee
CDSCO ZONAL CENTRES
National Coordinating Centre (NCC)
NORTH,
Ghaziabad
SOUTH,
Chennai
EAST,
Kolkata
WEST,
Mumbai
Quality Review Panel
Core Training Panel
Signal Review Panel
All India Institute of Medical Sciences
(AIIMS), New Delhi
M
O
N
C
I
E
A
T
N
D
O
T
R
R
R
PHARMA
INDUSTRY
I
E
N
S
G
Immunization
Programs
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
CDSCO
• Provide administrative support to the ADR Monitoring Centres
• Report to DCGI (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
4 Zonal CDSCO Offices
(provide operational and logistical support)
Chennai
PHASE 1
The centres included in the first wave of the Programme - 12
Steering Committee - PvPI
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
1.
2.
3.
4.
5.
6.
7.
8.
Oseltamivir
Letrozole
Nimesulide
Pioglitazone
Rosiglitazone
Tegaserod
PPA
Gatifloxacin
Absent/ Minimal safety
data from India
Proactive & focused
ADR
monitoring in
dedicated
pharmacovigilance
centres
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
Policy makers
(regulators)
Patient
Physician and
medical
associations
Pharmacovigilance
Public
Pharmaceutical
Industry and
associations
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