This document provides an overview of pharmacovigilance in India, including: - The history of pharmacovigilance efforts in India from 1986 to the present. - The objectives and goals of the current Pharmacovigilance Program of India (PvPI), including establishing a nationwide safety reporting system and expanding electronic reporting. - The roles and responsibilities of stakeholders like the National Coordinating Center, Advisory Monitoring Centers, and CDSCO in the PvPI.

1. By
Sneha Khandale
Assistant Professor
Shreeyash Institute of Pharmaceutical Education and Research, Aurangabad.

2. Table of Content
 History
 Introduction of PvPI
 Objective of PvPI
 Goal of PvPI
 Flow of ADR reporting in India
 Phases of PvPI
 Communication flow of PvPI
 Responsibilities of stakeholders
 Work flow of NCC
 Achievements of PvPI
 Haemovigilance programof |India

3. Brief history of PV in India
 Even though PV is still in its infancy, the concept is not new to India.
 It was not until 1986 that a formal ADR monitoring system consisting of 12
regional centres, each covering a population of 50 million, was proposed for
India.
 In 1989, under the aegis of the drug controller of India, six regional centers
were set up in Mumbai, New Delhi, Kolkata, Lucknow, Pondicherry and
Chandigarh.
 In 1997, India joined the WHO Program for International Drug Monitoring
managed by the Uppsala Monitoring Centre, Sweden.
 The centre in New Delhi (at Dept of Pharmacology, AIIMS) was identified as
the national centre, while the centre in Mumbai (at KEM Hospital) was
identified as the WHO special centre.
 Of the six centers, only the centers in Mumbai and New Delhi were active, yet
spontaneous reporting of ADRs was poor. The monitoring centers were
considered ad hoc and appropriate levels of funding were not, made available,
which put severe constraints on them.
 Indian government launched the National Program of Pharmacovigilance
(NPP) with the support of World Bank in November 2004, and started
functioning 1 January 2005.

4.  The NPvP was overseen by the National Pharmacovigilance Advisory Committee
(NPvAC) based in the Central Drugs Standard Control Organization (CDSCO), New
Delhi coordinated the pharmacovigilance program under the Ministry of Health and
Family Welfare.
 Two zonal centers - the South-West zonal centre (located in the Dept of Clinical
Pharmacology, Seth GS Medical College and KEM Hospital, Mumbai) and the North-
East zonal centre (located in the Dept of Pharmacology, AIIMS, New Delhi), collated
information from all over the country and send it to the Committee as well as to
the Uppsala Monitoring Centre in Sweden.
 Three regional centers reported to Mumbai centre and two to New Delhi. Each
regional centre in turn would have several peripheral centers reporting to it.
 The program had three broad objectives: the short-term objective was to foster a
reporting culture, the intermediate objective was to involve a large number of
healthcare professionals in the systems in information dissemination and the long-
term objective was for the program to be a benchmark for global drug monitoring.
 However, the program did not meet the expectations and in 2009, it was
suspended as the support from World Bank was discontinued.

5. The pharmacovigilance Program of India (PvPI)
 The NPvP was renamed the Pharmacovigilance Program of India (PvPI),
which started functioning 14 July 2010, with the All India Institute of
Medical Sciences (AIIMS), New Delhi.
 In order to monitor ADRs all over India, the program had 22 ADR
monitoring centers (AMCs), including AIIMS, New Delhi.
 The NCC was later shifted from AIIMS to Indian Pharmacopoeia
Commission (IPC), Ghaziabad, on 15 April 2011.
 The PvPI collates the information received in the form of Individual Case
Safety Reports (ICSRs) from the AMCs, HCPs, pharmacists and other non-
HCPs .
 IPC-PvPI became the NCC for Materiovigilance Program of India (MvPI)
from July, 2015.
 IPC, NCC-PvPI became a WHO Collaborating Centre for Pharmacovigilance
in Public Health Programs & Regulatory services from July, 2017.

6. Objective of Program
 To create a nationwide system for patient safety reporting.
 To identify and analyze new signals from the reported cases.
 To analyze the benefit – risk balance of marketed medications.
 To generate evidence- based information on the safety of medicines.
 To support regulatory agencies in the decision-making process on the use of
medications.
 To communicate safety information on the use of medicines to various stakeholder
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 across the globe.
 To promote rational use of medicines.

7. Goal of PvPI
Short Term Goals
 To develop and implement pharmaco-vigilance 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 Goal
 To expand the pharmacovigilance program 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

8. Phases or Road Map of PvPI
1. Initiation phase (2010-2011)
2. Expansion and consolidation phase (2011-2012)
3. Expansion and maintenance phase (2012-2013)
4. Expansion and optimization (2013-2014)
5. Excellence phase (2014-2015)

11. Communication under PvPI
Uppsala
Monitoring
Center, Sweden
National
Coordinator
Center, IPC,
Gaziabad
ADRs
Monitoring
Centers
Healthcare
Professionals
CDSCO
Headquarter,
NewDehli
CDSCO Zonal Offices
South Zone: Chennai
West Zone: Mumbai
East Zone: Kolkata
North Zone: Gaziabad

12. Responsibility of stakeholders
1. Personnel at CDSCO headquarter
 Take appropriate regulatory decision & actions on the basis of
recommendations of PvPI NCC at IPC Ghaziabad.
 Propagation of medicine safety related decisions to stakeholders
 Collaboration with WHO-Uppsala Monitoring Center – Sweden
 Provide for budgetary provisions & administrative support to run
PvPI
2. Personnel at NCC
 Preparation of SOPs, guidance documents & training manuals
 Data collation, Cross-check completeness, Causality Assessment etc
as per SOPs
 Conduct Training workshops of all enrolled centers
 Publication of Medicines Safety Newsletter
 Reporting to CDSCO Headquarters
 Analysis of the PMS, PSUR, AEFI data received from CDSCO HQ

13. 3. Personnel at AMC
 Collection of ADR reports
 Perform follow up with the complainant to check completeness as per
SOPs
 Data entry into Vigiflow
 Reporting to PvPI National Coordinating Centre (PvPI NCC) through
Vigiflow with the source data (original) attached with each ADR case
 Training/ sensitization/ feedback to physicians through newsletters
circulated by the PvPI NCC
4. Personnel at Zonal/ Sub-zonal CDSCO
 Provide procurement, financial and administrative support to ADR
monitoring centers
 Report to CDSCO

15. Organization Committees under NCC
Steering Committee
PvPI Working Group
Quality Review Panel
Signal Review Panel
Core training panel

16. Working module of NCC
Letter of intent from AMCs Coordinator
NCC-PvPI
Examine the Suitability Approved by NCC
Vigi-Flow login details provided
by NCC to AMCs
AMCs- To perform the causality assessment of the ADRs and furnish
the mandatory fields in the suspected ADRs form

17. AMCs – upload the
ADRs in Vigi-Flow
Send to
NCC-PvPI Quality assessment by NCC-
PvPI
CDSCO (HQ)
WHO-UMC (Sweden)
NCC_PvPI

18. Achievements of the PvPI
 Establishment of 250 AMCs that create a framework of pharmacovigilance
and the culture of reporting all over India.
 Several awareness programmes conducted by the AMCs. The ADR
reporting culture is improving throughout the country.
 The reporting forms have been made available in ten vernacular languages
and separate forms for HCPs and consumers are available on the CDSCO
website.
 The PvPI has contributed in National Health programmes such as those for
tuberculosis (Revised National TB Control Programme in Oct/2013), HIV-
AIDS (National AIDS control Organization in Sep/2014), and immunization.
 The PvPI initiated a skill development programme on “Basic & Regulatory
Aspects of Pharmacovigilance” to train young professionals in
pharmacovigilance.

19.  Participation of Nursing Professionals NCC-PvPI oraganized a meeting with
president Nursing Coumcil of India (NCI), on July 16, 2014, New Delhi to
initiate the participation of nursing professionals in PvPI.
 The National Health Policy 2017, launched by Ministry of Health and Family
Welfare, addresses antimicrobial resistance and pharmacovigilance.
 The PvPI under the IPC, Ministry of Health and family Welfare, was
successfully assessed by the World Health Organization –National
Regulatory Authority ( WHO- NRA) 2017 Global Benchmarking Tool. As an
outcome, vigilance achieved a maturity level of 4 out of 5.

20. The Haemovigilance Programme of India
 The haemovigilance Programme of India (HvPI) was launched on 10
December 2012 by the NCC-PvPI with the National Institute of Biologicals,
Noida, Uttar Pradesh, under the Ministry of Health and Family Welfare,
Government of India.
 Under this programme monitoring of blood quality and blood products in
transfusion are monitored.
 The programme was initiated in 60 medical colleges in the country that
were already enrolled under the PvPI.
 The programme collates and analyses information about haemovigilance
and adverse events concerning biological and is constantly working toward
the advancement of the quality and safety pf blood products and
transfusion process to ensure patient care and safety.