Pharmacovigilance Programme of India

1. Valencia Fernandes
Department of Pharmacology and Toxicology
NIPER - Ahmedabad

2. 1986
ADR monitoring system
for India proposed (12
regional centres)
1997
India joined WHO-ADR
monitoring programme (3
centres)
2004 – 2008
National
Pharmacovigilance prog.
(2 Zonal, 5 Regional, 24
Peripheral Centres)
2010

3. MISSION/GOAL:
• To ensure that the benefit of use of medicine
outweighs the risks associated with its use.
Benefit
Risk

4. Need of estimation of benefit/Risk
• Monitoring of programmes to detect, evaluate
and prevent adverse reactions, including effects
on pregnant women, the elderly and children.
• Acceptance, misuse, pharmacological
dependence, therapeutic errors and therapeutic
failures due to poor-quality medicine.
• To judge the efficiency of the treatment.

5. Pharmacovigilance Program in India -
PvPI
The CDSCO, New Delhi initiated pharmacovigilance
programme in July 2010, with the AIIMS, New Delhi as
the National Coordinating Centre (NCC) for monitoring
Adverse Drug Reactions (ADR).
To ensure implementation of this programme in a more
effective way, the National Coordinating Centre was then
shifted from the All India Institute of Medical Sciences
(AIIMS), New Delhi to the Indian Pharmacopoeia
Commission (IPC), Ghaziabad, (U.P.) in April, 2011.

6. Methodologies in pharmacovigilance
 Passive surveillance
1. Spontaneous reporting
2. Case series
3. Stimulated reporting
 Active surveillance
1. Sentinel sites
2. Medicine event
monitoring
3. Registries
4. Cross sectional studies
5. Case control study
6. Cohort study

9. Pharmacovigilance Program in India -
PvPI
The programme will be administered &
monitored by the following two committees:
1. Steering committee.
2. Strategic advisory committee.
Technical support will be provided by the
following panels:
• Signal review panel
• Core training panel
• Quality review panel.

10. ADR Monitoring Centres under PvPI
 ADR Monitoring Centres (AMCs) under PvPI play a vital
role of collection and follow-up of ADR reports from the
patients.
 The PvPI started with the enrollment of 22 ADR
monitoring to 90 centres across the country in the year
2010, which has increased
ADR MONITORING CENTRES:
•MCI Approved Medical Colleges & Hospitals
• Private Hospitals
• Public Health Programmes
• Autonomous Institutes (ICMR etc.)

12. • VigiFlow is a web-based Individual Case Safety Report
(ICSR) management system that is specially designed for use
by national centres in the WHO Programme for International
Drug Monitoring.
• Subscription for Vigiflow is FREE in India.

13. 5 YEAR ROADMAP OF
PHARMACOVIGILANCE PROGRAMME
OF INDIA
(Year 2010—2015 )

15. HEAMOVIGILANCE & BIOVIGILANCE
• Indian Pharmacopoeia Commission in collaboration with
National Institute of Biologicals has launched a
Haemovigilance programme across the country under its
Pharmacovigilance Programme of India (PvPI)
• Was launched on 10th dec 2012.
• National Institute of Biologicals(NIB) is the co-ordinating
centre.
• The programme has currently 60 medical colleges in its
network & is growing further.
• A set of surveillance procedures covering the whole
transfusion chain ( from collection of blood & its
components to the follow up of recipients) intended to
collect & assess information on unexpected or
undesirable effects resulting from the therapeutic use of
labile blood products & to prevent their occurrence or
recurrence

16. Industries involve in Pharmacovigilance
• Wipro
• Cognizant
• Clinigene
• Accenture
• Clintech
• Avasthegen
• GSK
• Glenmark
• Genpact
• Jubilant Clinsys
 It is expected that 50 – 75 % of medical errors
are preventable.

17. REFRENCE
• www.ipc.gov.in
• http://www.aiims.edu/aiims/departments/pharmacology/
pvpi/pvmainfram.htm
• Pharmacovigilance Programme of India, Duvvuru Ashok
Kumar, Languluri Reddenna, Shaik Ayub Basha,
Department of Pharm-D, P. Rami Reddy Memorial College
of Pharmacy

18. THANK YOU