Pharmacovigilance Programme of India
Dr. V. Kalaiselvan
Principal Scientific Officer
Indian Pharmacopoeia Commission
Ministry of Health & Family Welfare
Govt of India
Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India
WHO-Collaborating Centre for Pharmacovigilance in Public Health Programmes & Regulatory Services 1
IPC
Services of Indian Pharmacopoeia Commission (IPC)
Indian Pharmacopoeia
Reference
standards
National Formulary of India
PvPI
Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India
WHO-Collaborating Centre for Pharmacovigilance in Public Health Programmes & Regulatory Services
Launch of PvPI as 6th WHO-CC for Pharmacovigilnace in
PHPs & Regulatory Services
Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India
WHO-Collaborating Centre for Pharmacovigilance in Public Health Programmes & Regulatory Services 3
Pharmacovigilance Programme of India (PvPI)
Launched by the MoHFW, Govt. of India in the year 2010 at AIIMS New Delhi as
National Coordinating Centre (NCC).
The Programme transferred to IPC as NCC in April, 2011 by a Notification issued by the
MoHFW, Govt. of India.
IPC-PvPI became the NCC for Materiovigilance Programme of India (MvPI) from July,
2015
IPC, NCC-PvPI became a WHO Collaborating Centre for Pharmacovigilance in Public
Health Programmes & Regulatory services from July, 2017
Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India
WHO-Collaborating Centre for Pharmacovigilance in Public Health Programmes & Regulatory Services 4
Pharmacovigilance in Acts & Rules
• Pharmacy Council of India: Pharmacovigilance as one of the subjects in
Pharmacy Under Graduate curriculum
• Drugs & Cosmetic Act & Its rules 1945: establishment of Pharmacovigilance
cell in the pharmaceutical industry is mandatory.
• National Health Policy: Pharmacovigilance includes Prescription Audit
inclusive of Antibiotic usage, Ministry of Health & Family Welfare,
Government of India.
5
AMC’S
Pharmaceutical Industries
Safety AlertsCommunication
Mobile App
Case Processing/Quality Review
ADR Monitoring Center (s)[AMC’s]
Invalid/Incomplete Report
Valid/Complete Report
Causality assessment & data mining of reports
Case Reverted
Case Reverted
ADVERSE DRUG REACTION (ADR) REPORTING IN INDIAHOW INDIAN POPULATION GETTING BENIFITED...
Global safety data collection
Regulatory action
Reporting Tools
NCC-PvPI
6
ADRs Monitoring Centers (AMCs): 250
86
102
17
20
11
18 5
Govt. Hospitals
Non govt. hospitals
TB treament centres
ART centres
Corporate hospitals
Army hospitals
District Hospitals
Municipal Hospital
7Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India
WHO-Collaborating Centre for Pharmacovigilance in Public Health Programmes & Regulatory Services
14847
23138
28411
41926
50533
67115
71586
0
10000
20000
30000
40000
50000
60000
70000
80000
2011 2012 2013 2014 2015 2016 2017
ADRs Reporting Status in India
Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India
WHO-Collaborating Centre for Pharmacovigilance in Public Health Programmes & Regulatory Services 8
ICSRs Completeness Score: India Vs Other Countries
Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India
WHO-Collaborating Centre for Pharmacovigilance in Public Health Programmes & Regulatory Services 9
Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India
WHO-Collaborating Centre for Pharmacovigilance in Public Health Programmes & Regulatory Services
Effective from January 2018
Applicable to PvPI, CDSCO and
State(s)/UT(s) Drugs Control
department
Ensures compliance of good
Pharmacovigilance practices
Pharmacovigilance
Guidelines for
Marketing Authorization Holders of Pharmaceutical Products
Module 1
Module 2
Module 3
Module 4
Module 5
Module 6
Modules in the Guideline
Pharmacovigilance System Master File & capacity building
Processing of ICSRs
Preparation & Submission of PSURs
Site Performing Pharmacovigilance Quality Management System
Audits And Inspections of Pharmacovigilance Sites
Submission of Risk Management Plan
Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India
WHO-Collaborating Centre for Pharmacovigilance in Public Health Programmes & Regulatory Services
Drug AlertChange in
Package insertSignal
PvPI Recommendations to CDSCO
Drug Alert Updating Package insert Signal
71 24 05
Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India
WHO-Collaborating Centre for Pharmacovigilance in Public Health Programmes & Regulatory Services 12
Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India
WHO-Collaborating Centre for Pharmacovigilance in Public Health Programmes & Regulatory Services
PvPI is coordinating with AEFI Secretariat (UIP)
to monitor the safety of vaccines
PvPI-AEFI• Immediate sharing of serious AEFI report
PvPI-AEFI• Monthly sharing of non-serious AEFI reports
PvPI-AEFI
• Communicate vaccine related signals/label change
Alertness through message
NCC-PvPI also communicate message alert ofDrugs/ Vaccines to;
Team of AEFI secretariat
District Immunization officer(s)
State Immunization officer(s)
State Drug Controller(s)
Regulators
other Healthcare Professionals
Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India
WHO-Collaborating Centre for Pharmacovigilance in Public Health Programmes & Regulatory Services
WHO-NRA Assessment 13-17th February 2017
Outcome of WHO-NRA assessment
NRA Function assessed Pharmacovigilance
Indicators MET 6 out of 6
Sub Indicators MET 25 out of 25
Sub Indicators % MET 100
Maturity level 4 (Highest Ranking of Benchmarking Tool)
Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India
WHO-Collaborating Centre for Pharmacovigilance in Public Health Programmes & Regulatory Services
Reporting Tools for the Stakeholders
Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India
WHO-Collaborating Centre for Pharmacovigilance in Public Health Programmes & Regulatory Services
1800 180 3024
Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India
WHO-Collaborating Centre for Pharmacovigilance in Public Health Programmes & Regulatory Services
SEARN Members Vigilance Status – A Gap Analysis
S. No. Indicator
Yes No Noresponse
1 National Pharmacovigilance centre 8 2 1
2 Financial support from Government for PV activity 6 4 1
3 Mandatory ADR reporting – Industries 8 2 1
4 Support – Regulatory Pharmacovigilance 10 0 1
5 Collaboration of National Pharmacovigilance Centre with PublicHealth Programme (PHPs)
9 1 1
6 Separate ADR reporting form for various PHPs 6 4 1
Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India
WHO-Collaborating Centre for Pharmacovigilance in Public Health Programmes & Regulatory Services
*Out of 11 SEARN countries, 10 have replied to the Questionnaire
www.ipc.gov.in
Toll Free No.
1800 180 3024
NCC-PvPI IPC
@ IPC NCC-PvPI
ADR Mobile-app
Connect & Contact us
Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India
WHO-Collaborating Centre for Pharmacovigilance in Public Health Programmes & Regulatory Services 21