NATIONAL PROGRAMMES RELATED

TO PHARMACOVIGILANCE

Mithulaa Maheswari. S
M. Pharm – 2nd sem.,
Dept. of Pharmacology
 HISTORY
1986 – ADR monitoring system (12 regional centres)
1997 – India joined WHO-ADR reporting program
based in Uppsala, Sweden
3 centres for ADR reporting:
• All India Institute of Medical Sciences, New Delhi
• KEM hospital, Pune
• Aligarh Muslim University, Chandigarh
 NATIONAL
PHARMACOVIGILANCE
PROGRAM (NPP)
2004 – NPP inaugurated by Central Health Minister at New
Delhi
2005 – The Ministry of Health and Family Welfare in India
initiared NPP, coordinated by the Central Drugs Standard
Control Organization (CDSCO)
NPP:
• 2 zonal centres
• 5 regional centres
• 24 peripheral centres
 PHARMACOVIGILANCE PROGRAMME
OF INDIA (PvPI)
July 2010 - Initiated with AIIMS, New Delhi as National Coordination
Centre (NCC)
15 April 2011 – NCC shifted from AIIMS to IPC, Ghaziabad
MISSION:
Safeguard the health of the Indian population by ensuring that the
benefits of use of medicine outweigh the risks associated with its use.
VISION:
To improve patient safety and welfare in Indian population by
monitoring the drug safety and thereby reducing the risk associated with
use of medicines
 OBJECTIVES
To create a nation-wide system for patient safety reporting
To identify and analyze the new signal (ADR) from the reported cases
To analyses the benefit - risk ratio of marketed medications
To generate the evidence based information on safety of medicines
To support regulatory agencies in the decision making process on use of
medications
To communicate the safety information on use of medicines to various
stakeholders to minimize the risk
To emerge as a national center of excellence for pharmacovigilance activities
To collaborate with other national centers for the exchange of information and
data management
To provide training and consultancy support to other national pharmacovigilance
centers located across globe
 SHORT TERM GOALS
To develop and implement pharmacovigilance system in India
To enroll, initially, all MCI approved medical colleges in the program
covering north, south, east and west of India
To encourage healthcare professionals in reporting of adverse
reaction to drugs, vaccines, medical devices and biological products
Collection of case reports and data
 LONG TERM GOALS
To expand the pharmacovigilance programme to all hospitals (govt. &
private) and centers of public health programs located across India
To develop and implement electronic reporting system (e-reporting)
To develop reporting culture amongst healthcare professionals
To make ADR reporting mandatory for healthcare professionals
 PHARMACOVIGILANCE METHODS
 PASSIVE SURVEILLANCE
• Spontaneous reports
• Case series
 STIMULATED REPORTING
 ACTIVE SURVEILLANCE
• Sentinel sites
• Medicine event monitoring
• Registries
 COMPARATIVE OBSERVATIONAL STUDIES
• Cross sectional study
• Case control study
• Cohort study
 TARGETED CLINICAL INVESTIGATIONS
 DESCRIPTIVE STUDIES
• Natural history of disease
• Drug utilization study
STRUCTURE
 WORKING MODULE
Letter of intent from AMCs Coordinator

NCC - PvPI

Examine the suitability

Approved by NCC

Vigi-Flow details provided by NCC to AMCs

AMCs - perform the causality assessment of ADR and furnish the

required details

AMCs – upload details in Vigiflow

NCC - PvPI
Analysed by CDSCO
Uppsala monitoring centre, Sweden
WHO, WHAT AND WHOM TO REPORT?
 VIGIFLOW
Vigiflow is an Individual Case Safety Report (ICSR)
management system developed and hosted by Uppsala
Monitoring Centre (UMC)
Minimum information to complete the report include:
• Report tittle
• Patient initial
• Patient age
• Onset date of reaction
• Reaction term
• Drug name
 ADR MONITORING CENTRE
Collection of ADR reports
Perform follow up with the complaints to check
completeness as per SOPs
Data entry in Vigiflow
Postgraduate/undergraduate training in
pharmacovigilance
NATIONAL COORDINATING CENTRE
Preparation of SOPs, guidance documents and
training manuals
Cross check completeness, causality assessment as
per SOPs
Reporting to CDSCO headquarters
Conduct training workshops of all enrolled centers
Publications of medicine safety newsletters
 CDSCO
Take appropriate regulatory decision and actions on
the basis of recommendations of NCC
Propagation of medicine safety related decision to
stakeholders
Collaborations with WHO-Uppsala Monitoring Center
Provide for budgetary provision and administrative
support to run PvPI
 REGIONAL CENTRES UNDER PvPI
Eastern region: IPGMER, Kolkata
Western region: KEM Hospital, Mumbai
Northern region: PGIMER, Chandigarh
Southern region: JSS Hospital, Mysore
 EXPANSION OF PvPI
2010 – mandatory for every medical college in India to have
Pharmacovigilance Committee
10 dec 2012 – IPC in collaboration with National Institute of
Biologicals launched Haemovigilance Program of India
11 October 2013 – Revised National TB Control Programme
collaborated with PvPI to improve patient care and safety in relation
to anti-TB drugs
16 July 2014 – initiation of participation of nursing professionals in
PvPI
15 September 2014 – collaboration between National AIDS Control
Organisation and PvPI to ensure safety of ARV medicines
THANK YOU