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 Services of Indian Pharmacopoeia Commission (IPC)

Indian Pharmacopoeia

PvPI IPC Reference standards

National Formulary of India

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 ADVERSE DRUG REACTION (ADR) REPORTING IN INDIA HOW INDIAN POPULATION GETTING BENIFITED...

ADR Monitoring Pharmaceutical Center (s) Industries [AMC’s]

SafetyAMC’S Alerts Communication

Mobile App Reporting Tools

NCC-PvPI

Case Processing/ Quality Review

Case Invalid/ Case Reverted Incomplete Report Reverted Valid/ Complete Report

Causality assessment & data mining of reports Global safety data Regulatory collection action 6 ADRs Monitoring Centers (AMCs): 250

1 5 8 Govt. Hospitals 11

20 Non govt. hospitals 86 TB treament centres 17 ART centres

Corporate hospitals

Army hospitals

District Hospitals

102 Municipal Hospital

Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India WHO-Collaborating Centre for Pharmacovigilance in Public Health Programmes & Regulatory Services 7 ADRs Reporting Status in India

80000 71586 70000 67115

60000 50533 50000 41926 40000

30000 28411 23138 20000 14847

10000

0 2011 2012 2013 2014 2015 2016 2017

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 Pharmacovigilance Guidelines for Marketing Authorization Holders of Pharmaceutical Products

.Effective from January 2018

.Applicable to PvPI, CDSCO and State(s)/UT(s) Drugs Control department

.Ensures compliance of good Pharmacovigilance practices

Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India WHO-Collaborating Centre for Pharmacovigilance in Public Health Programmes & Regulatory Services Modules in the Guideline

Pharmacovigilance System Master File & Module capacity building 1

Submission of Risk Management Plan Module Module 6 2 Processing of ICSRs

Audits And Inspections of Module Module Preparation & Submission Pharmacovigilance Sites 5 3 of PSURs

Module Site Performing Pharmacovigilance 4 Quality Management System

Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India WHO-Collaborating Centre for Pharmacovigilance in Public Health Programmes & Regulatory Services PvPI Recommendations to CDSCO

Change in Signal Drug Alert Package insert

Drug Alert Updating Package insert Signal

71 24 05

• Immediate sharing of serious AEFI report PvPI-AEFI

• Monthly sharing of non-serious AEFI reports PvPI-AEFI

• Communicate vaccine related signals/label change PvPI-AEFI

Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India WHO-Collaborating Centre for Pharmacovigilance in Public Health Programmes & Regulatory Services

Alertness through message

NCC-PvPI also communicate message alert of Drugs/ 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 Regulatory Matters Reflected in WHO Newsletter

17 Reporting Tools for the Stakeholders

1800 180 3024

Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India WHO-Collaborating Centre for Pharmacovigilance in Public Health Programmes & Regulatory Services 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. Yes No No No. Indicator response

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 Public 9 1 1 Health Programme (PHPs)

6 Separate ADR reporting form for various PHPs 6 4 1

*Out of 11 SEARN countries, 10 have replied to the Questionnaire

Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India WHO-Collaborating Centre for Pharmacovigilance in Public Health Programmes & Regulatory Services Connect & Contact us

www.ipc.gov.in

Toll Free No. 1800 180 3024

NCC-PvPI IPC

@ IPC NCC-PvPI

[email protected]

ADR Mobile-app

Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India WHO-Collaborating Centre for Pharmacovigilance in Public Health Programmes & Regulatory Services 21 Thank You

Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India WHO-Collaborating Centre for Pharmacovigilance in Public Health Programmes & Regulatory Services 22