pharmacovigilance programme of india · signal pvpi recommendations to cdsco drug alert updating...

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


WHO-Collaborating Centre for Pharmacovigilance in Public Health Programmes & Regulatory Services

Launch of PvPI as 6th WHO-CC for Pharmacovigilnace in

PHPs & Regulatory Services



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



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


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



ICSRs Completeness Score: India Vs Other Countries





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



Drug AlertChange in

Package insertSignal

PvPI Recommendations to CDSCO

Drug Alert Updating Package insert Signal

71 24 05





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



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)



Regulatory Matters Reflected in WHO Newsletter

17

Reporting Tools for the Stakeholders



1800 180 3024

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



*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

[email protected]

ADR Mobile-app

Connect & Contact us



Thank You

22Indian Pharmacopoeia Commission - Pharmacovigilance Programme of India


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