Pharmaceutical Resonance 2023 Vol.

V - Issue II

REVIEW ARTICLE

PHARMACOVIGILANCE PROGRAMME OF INDIA : AN

OVERVIEW

Harshal S. Rele1, Akansha Pate1

Dr. D.Y. Patil Institute of of pharmaceutical science and research, Pimpri, Pune,41108 Maharshtra, India

ABSTRACT : Phar macovigilance, also known as dr ug safety, is the phar macological science r elating to the
collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. In
India, The National Programme of Pharmacovigilance was launched in 2005 and was renamed as the
Pharmacovigilance Programme of India (PvPI) in 2010. It has been observed that a medication that has been
shown to be effective in a large patient population frequently fails to work in other patients of different ancestry.
As a result, even if the drug has already been approved in another country, a clinical trial with rigorous
pharmacovigilance monitoring in a population of different race and ethnicity is required. This review article
provides a brief overview of the current situation and the future prospects of pharmacovigilance in India.
Keywords : Pharmacovigilance, Pharmacovigilance Programme of India, Adverse Drug Reaction

Introduction problems that cause drug-related injuries. PV is

India has one of the world's largest drug-consuming primarily post-marketing surveillance (phase 4) of
populations. In the Indian market, there are between drug development; the primary goal of PV is to
60,000 and 80,000 drug brands that are irrationally quantify previously recognized Adverse Drug
prescribed and misused. This could be due to a lack of Reactions (ADRs), identify unrecognized ADRs,
medication safety practises as well as regulatory evaluate the effectiveness of medicines in real-world
failures. Misuse and incorrect prescribing contribute situations, and reduce mortality and morbidity
significantly to the development of adverse drug associated with ADRs (5).
reactions (ADRs) (1). ADRs are one of the world's In the pharmaceutical industry, pharmacovigilance
fourth leading causes of morbidity and mortality in (PV) is a relatively new discipline. Having expanded
patients. ADRs are defined as noxious and unintended rapidly over the last two decades. Following the
effects that occur in doses normally used in humans thalidomide disaster in Germany, the World Health
for disease prevention, diagnosis, or treatment, or for Organization established this programme as
the modification of physiological functions (2). international drug monitoring in 1961 (2,6). PV's goals
The term Pharmacovigilance is derived from the Greek are to improve patient care and patient safety in the use
words "Pharmakon" (drug) and "vigilare" (to keep of medications, as well as to provide public health
watch) (3). PV is defined by the World Health programmes by providing reliable, balanced
Organization as “science and activities relating to the information for the effective assessment of a drug's
detection, assessment, understanding and prevention of risk-benefit profile (2). In India, a formal ADR
adverse effects or any other possible drug-related monitoring system with 12 regional centres was
problems”(4). PV plays several roles, including established in 1986.India joined the WHO Programme
identifying, quantifying, and documenting drug-related for International Drug Monitoring in 1997, which is
managed by the Uppsala Monitoring Centre (UMC) in
Sweden. At the outset, six regional centres for ADR
monitoring in the country were established in Mumbai,
Harshal S. Rele New Delhi, Kolkata, Lucknow, Pondicherry, and
Dr. D.Y. Patil Institute of of pharmaceutical sciences Chandigarh. Out of these 6 centres only the centres in
and research, SantTukaram Nagar, Pimpri, Pune. Mumbai and New Delhi were active, so spontaneous
411018, Maharashtra, India reporting of ADRs was limited. As a result, the
eMail : [email protected] Government of India launched the National
Contact : 7620 1488 14 Pharmacovigilance Programme (NPvP) in November
2004, with a World Bank grant of US$0.1 million
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 Pharmaceutical Resonance 2023 Vol. V - Issue II

approved for 5 years. However, World Bank funding this programme is to ensure that the benefits of using
for this programme expired in mid-2009, and the medicine outweigh the risks, thereby protecting the
programme was temporarily halted. Recognizing the health of the Indian population. The primary goal of
need for improved ADR monitoring in the country, the this programme is to collect, analyse, and archive
Health Ministry launched the Pharmacovigilance adverse drug reaction data in order to make regulatory
Programme of India in July 2010. (PvPI) (7). decisions about drugs marketed in India (21,23,24).
A new drug in the pipeline is subjected to all tests, The programme is organised into three levels:
including preclinical studies and clinical trials, before peripheral, regional, and zonal Pharmacovigilance
being released into the community and being exposed Centers, as well as the National Pharmacovigilance
to a large patient population with a diverse genetic Advisory Committee and the National
makeup, as opposed to study subjects in clinical trials. Pharmacovigilance Center, which is headquartered at
ADRs are caused by a variety of factors, including the Central Drugs Standard Control Organization in
age, gender, genetic factors, food habit pattern, New Delhi (Fig. 1). All centres can directly report
coexisting comorbidities, geographical variations, and alarming or critical adverse drug reactions to the
concomitant medications. As a result, it is critical to National Pharmacovigilance Center, allowing
keep an eye on ADRs. Thus, active participation of not regulatory decisions to be made as soon as possible.
only health workers but also ordinary citizens is Adverse reaction reports from across the country were
critical to the successful implementation of the PV to be routed to two main centres: the South West
programme in India (2). Zonal Center (Department of Clinical Pharmacology,
Necessity of Pharmacovigilance: King Edward VII Memorial Hospital, Mumbai) and
Medicines are meant to save lives, not take them away. the North East Zonal Center (Department of
Death caused by a disease is frequently unavoidable, Pharmacology, All India Institute of Medical Sciences,
but death caused by a medicine is unacceptable. ADRs New Delhi). The South West Zonal Centre would
are among the top ten causes of death in the United collect its own reports while also receiving reports
States, and it is estimated that ADRs cause 5700 from three regional centres. Similarly, the North East
deaths per year in the United Kingdom. In some Zonal Centre would collect its own reports and be
countries, the percentage of hospitalisations due to reporting to two regional centres. Each regional centre
drug-related events is around 10% (8-9). would have peripheral centres reporting data.
Why ADR monitoring in India? The programme had three broad goals: foster a
reporting culture in the short term, disseminate
It has been observed that a medication that has been information and involve a large number of healthcare
shown to be effective in a large patient population professionals in the interim, and set global benchmarks
frequently fails to work in other patients of different in the long term. This revitalised programme,
ancestry. Patients' ancestors are influenced by genetic however, was not without its challenges. With only
factors that influence drug response-drug targets, drug- World Bank funding and no regulatory support, the
metabolizing enzymes, drug transporters, and genes programme remained in 'project mode,' with no
indirectly affecting drug action-which can modulate leadership at the top, no direct contact of the centres
drug toxicity and contribute to individual variability. working with the regulator, and no impact of the work
As a result, adverse drug reactions vary greatly done on regulatory decision making. However, the
between individuals and are a significant limiting programme did not meet expectations, and it was
factor in drug therapy and development (35). For temporarily suspended in 2009 when World Bank
example, pioglitazone is banned in some developed support was discontinued (25).
countries due to a high occurrence of bladder cancer,
but it is not banned in India due to a low occurrence of Pharmacovigilance Programme in India
bladder cancer (9). As a result, even if the drug has The All India Institute of Medical Sciences (AIIMS),
already been approved in another country, a clinical New Delhi was designated as the National
trial with rigorous pharmacovigilance monitoring in a Coordination Center for the Pharmacovigilance
population of different race and ethnicity is required Programme of India (PvPI), which was established by
(35). the Indian government on July 14, 2010, with the goal
National pharmacovigilance programme of preserving public health. This Program established
22 ADR monitoring centres, including AIIMS in New
In November 2004, the Central Drugs Standard Delhi, in 2010 (26).
Control Organization launched the National
Pharmacovigilance Program under the auspices of The goals of this programme included gathering data
Directorate General of Health Services, Union on adverse reactions in the Indian population,
Ministry of Health and Family Welfare. The goal of educating healthcare professionals about the

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 Pharmaceutical Resonance 2023 Vol. V - Issue II

Evolution of the Pharmacovigilance Program of India

Year Event
Major Lawrie, a surgeon, documents the safe use of chloroform as an anaesthetic in 40 000
1888 patients without evidence of cardiac injury as a rebuttal to the Glasgow committee's report on
the lack of safety of chloroform relative to ether (10).
The first PubMed indexed case series on adverse drug reactions (ADRs) in 336 patients
1975
admitted to a general medical ward (11).
Dr. Molly Thomas, Clinical Pharmacologist at the Christian Medical College in Vellore, India,
1983 establishes a formal ADR monitoring system at the institute, trains doctors, publishes
newsletters, and identifies underreporting (12).
In India, the concept of pharmacovigilance was first proposed with a formal ADR monitoring
system comprised of 12 regional centres. The Indian regulator made the first attempt to
1986
establish a Pharmacovigilance Program for the country. Each facility to serve a population of
50 million people (13).
Six regional centres have been formally established under the supervision of India's Drugs
1989
Controller General (14).
The ICMR made an independent attempt to establish Pharmacovigilance in the country. A
1989 project involving 12 centres across the country began as a multicenter project to monitor
adverse drug reactions (14).
The project was critically evaluated by an ICMR, which identified gaps in the ADR reporting
1992
programme (14-15).
India participates in the WHO's pharmacovigilance programme. The regulator makes another
1997
attempt. Six facilities spread throughout the country (16).
India's Society for Pharmacovigilance is formed. This was an independent entity that began in
1998
Aligarh, North India (16).
The Indian regulator's third attempt. The programme gets renamed as the National
November
Pharmacovigilance Program of India. The World Bank has identified two zonal centres and has
2004
provided funding support (16).
Mid 2009 The World Bank's funding for the programme stops (17).
The Indian regulator's fourth attempt and the program's current and most recent avatar.
2010
Rechristened the PvPI. This is the most successful effort yet of the regulator (18).
The Indian Pharmacopeia Commission becomes the National Coordinating Centre for
2011 Pharmacovigilance activities in the country under the ambit of the Drugs Controller General of
India (19).
December
India's Hemovigilance Program was launched (20).
2012
October 2013 A toll-free help line for reporting adverse reactions was established (20).
Established a link with India's revised national Tuberculosis Control Program to monitor
October 2013
adverse drug reactions (20).
September Established a link with the national AIDS Control Organization in order to monitor adverse
2014 reactions to antiretrovirals (20).
Launch of India's Materio-Vigilance Program to monitor medical device safety, Development
2015
of a specific form for monitoring medical device safety (21).
Pharmacovigilance becomes a mandatory requirement under the Drugs and Cosmetics Act, with
2016 manufacturers and importers of drugs required to establish Pharmacovigilance cells in their
organisations (18).
Start of a nationwide skills development program on the basic and regulatory aspects of
January 2017
Pharmacovigilance (22).
The first WHO Collaborating Centre for Pharmacovigilance in Public Health Programs and
October 2017
Regulatory Services has arrived in India (22).
2017 The National Strategic Plan for Pharmacovigilance Scale-Up in India has been launched (18).
2017 The release of pharmacovigilance guidelines for stakeholders (18).
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 Pharmaceutical Resonance 2023 Vol. V - Issue II

importance of pharmacovigilance, continuously a well-organized programme to create synergies for

monitoring the benefits and risks of medications, tracking adverse drug reactions across the nation (27).
developing independent, objective, evidence-based Purpose
recommendations on medication safety, assisting the
regulator in making safety-related decisions, Along with informing medical professionals and the
disseminating findings to all important stakeholders, public about hazards, the PvPI's goal is to gather data,
and establishing a National Center for analyse it, and draw conclusions that can be used to
Pharmacovigilance. The programme was also intended promote wise regulatory responses.
to be implemented in four phases: beginning (2010– Pharmacovigilance's expanded patient safety focus
2011); expansion and consolidation (2011–2012); includes the identification of drugs of subpar quality as
expansion and maintenance (2012–2013); expansion well as errors in prescribing, dispensing, and
and optimization (2013–2014); and excellence (2014– administration. Other pharmacovigilance issues that
2015). Additionally, the programme has three expert need to be addressed include counterfeiting, antibiotic
panels (quality review, signal review, and core training resistance, and the requirement for real-time
panels) that provide technical advice to the regulatory surveillance during large immunisations (27).
and a steering committee and working group that Vision
provides technical input to the regulatory:
PvPI's mission is to monitor drug safety and
(1) The Quality Review Panel evaluates the consequently lower the risk associated with
accuracy and completeness of ICSRs, offers medication use in order to improve patient safety and
suggestions to the PvPI working group following welfare in the Indian population. The complexity of
data analysis, and creates formats and drug safety choices is high since they may need to take
instructions for subsequent activities. into account comparative benefit/risk analyses of
(2) The Signal Review Panel specifies biostatistical several products for related indications (27).
methodologies for analysis and actionable Capacity building
indicators, detects and assesses signals from the
In their respective regions, four regional resource
ICSRs provided to NCC, and recommends to
centres offer AMCs technical assistance and training.
CDSCO the necessary regulatory responses.
Additionally, NCC periodically plans national and
(3) The Core Training Panel works with foreign regional programmes for education, public awareness,
organisations regarding involvement in the and continuing medical education. In 2014, a
implementation of pharmacovigilance training guidebook for reporting spontaneous adverse drug
programmes as well as recognises trainers, reactions (ADRs) for drugs, vaccines, and blood
training needs, and training material (21). products was released. A national training programme
The Core Training Panel works with foreign on the fundamentals and regulations of
organisations regarding involvement in the pharmacovigilance for healthcare professionals was
implementation of pharmacovigilance training launched by PvPI in January 2017 (28).
programmes as well as recognises trainers, training Pharmacovigilance tools
needs, and training material. (Fig. 1). Since 2011, the
The PvPI toolkit, a collection of straightforward
Indian Pharmacopoeia Commission has served as the
pharmacovigilance tools in accordance with WHO
program's national coordination office (20).
recommendations and current best practise, was
As of 2018, the programme had n=250 Adverse created by PvPI in conjunction with WHO India. To
Reactions Monitoring Centers spread throughout both promote direct patient reporting, the toolbox includes
private hospitals and medical universities with an ADR reporting form that is available in Hindi and
teaching hospitals linked to them. The most centres are nine additional regional languages. A form for
located in the states of Karnataka (n=29), Uttar stakeholder comments is also available.
Pradesh (n=29), and Maharashtra (n=26).
A toll-free helpline (1800 180 3024) with an SMS
Mission feedback capability has been introduced to expand
The goal of PvPI is to protect the population's health in PvPI's reach to remote places during business hours, a
India by ensuring that the advantages of using a live person answers the helpline; missed calls are
medicine outweigh any hazards involved in doing so. followed up the following day. To enable any follow-
Given the significant social and economic costs up, the ADR reporter's information is transmitted to
associated with adverse drug reactions and the the local monitoring centres. PvPI and NSCB Medical
favourable benefit-to-cost ratio of implementing College, Jabalpur jointly released an Android mobile
appropriate risk management, it is necessary to involve application in May 2015 for reporting ADRs. The
both the general public and healthcare professionals in programme has built-in features for customising

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 Pharmaceutical Resonance 2023 Vol. V - Issue II

Fig.1. r outes of communication in India's pharmacovigilance pr ogr amme (PvPI).

reporter information, drug information auto-entry, and patients and the general public (30).
WHO algorithm-based causality assessment. An The data collected up to this point in the zonal focuses
improved version of the application with capabilities from various peripheral habitats is typically subpar and
that include source document and image attachment, poorly evaluated. The particular rate of explicit ADRs
XML production, and auto-filling of report details was is unknown in India due to inadequate assessment of
created by NCC in October 2017. ADRs (30).
PvPI also uses social media, such as Twitter Experts in medical care (in provincial territories,
(@IPCNCCPvPI), Facebook (NccPvPIIpc), WhatsApp metropolitan urban areas, and emergency rooms),
(7042343309), and LinkedIn (NCC PvPI). (28) information, and inspiration for pharmacovigilance are
Present status of PvPI: of negligible value. There is little assistance from the
In order to protect the Indian population from potential wellness branch to provide genuine preparation and
harm that could be caused by some of the new encourage greater mindfulness among them for
medications, the Pharmacovigilance framework must superior detailing (31,32).
be improved since many new pharmaceuticals are Although there is no information allowing patients to
being introduced in the nation. However, there are a submit ADRs directly to the administrative power, a
number of problems that have prevented the few consumer groups in India encourage patients to
development of a strong pharmacovigilance report any antagonistic reactions they suffer. (31,32).
framework, which are outlined below (29). Future aspects of PvPI:
An enormous country like India lacks well-funded and If medications are to be taken safely, an effective
organized pharmacovigilance frameworks to assist
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 Pharmaceutical Resonance 2023 Vol. V - Issue II

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