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Review Article

Pharmacovigilance in India: A Rising Concern towards Safe


Medication Use
Deep Inder*, Pawan Kumar**
Abstract
Pharmacovigilance deals with studying the safety and efficacy of new as well as already
existing drugs with an objective to minimize the possibility of associated risk involved with
drug use. Awareness regarding pharmacovigilance is rising in response to the new challenges
it faces. With the modern computer aids and technology, rapid spread of information,
increased communication across borders and easy access to variety of medicinal products is
possible, thus increasing public expectation regarding safety of drugs in use. To meet the
challenges, there is a need to plan a strategy. We need to conduct continuing medical
education programs and dynamic progress of all aspects of pharmacovigilance with
interdisciplinary approach by sharing information within and across the borders to improve
public health and safety of humans.

Keywords: Pharmacovigilance, Health care, Adverse drug reaction.

Introduction
Use of drug for any indication always involves some patients are considered when therapeutic decisions are
benefit and possible risk. This risk can be minimized made. It ensures that health care providers and
using quality medicine in appropriate dose and consumers have the information they need to make
frequency as advised by prescribing physician. But their decision about treatment.3
possibility of risk is still there with drugs due to variable
patient factors. The issue of drug safety was initiated in 1961, following
the thalidomide disaster resulting in phocomelia in
Reporting of an adverse drug reaction (ADR) is an thousands of newborns. Lack of laws regulating drug
integral component of medical treatment. ADRs are one development and marketing led to many more tragedies
of the leading causes of morbidity and mortality, adding related to drugs. Thalidomide use by pregnant mothers
to overall healthcare cost. The estimated burden of resulted in birth of thousands of congenitally deformed
ADRs is approximately 2.9-5.6% of all hospital infants.4 After that incidence, some important
admissions.1 The overall incidence of serious ADRs is guidelines were framed to monitor safety of drugs,
6.7% and of fatal ADRs is 0.32% in hospitalized patients, foods and environmental contaminants for adverse
making these ADRs a leading cause of deaths. reactions and toxicity.

Pharmacovigilance can be defined as a discipline to The need of universal drug monitoring system was
identify, review and understand drug adverse effects recognized after world globalization to ensure safety of
and take required precautionary actions to curtail these medicinal products due to trading and communication
drug linked problems as per World Health Organization across borders. Such efforts led to emergence of
(WHO).2 Pharmacovigilance has emerged an art and practice and science of pharmacovigilance. Many
science to assess the safety and efficacy of drugs and countries have their established pharmacovigilance
other therapeutic products. It helps in reducing the risk systems, laws, regulatory bodies and framed guidelines
of harm by ensuring that good quality medicines are for health care providers as well as for consumers.5, 6
used appropriately and expectations and concerns of

*
Associate Professor, Department of Pharmacology, FOD, Jamia Millia Islamia, New Delhi-110025.
**
Additional Director, Directorate General of Health Services (DGHS), Govt. of NCT of Delhi, New Delhi-110032.
Correspondence to: Dr Deep Inder, Department of Pharmacology, FOD, Jamia Millia Islamia, New Delhi-110025.
E-mail Id: drdeep73@gmail.com

© ADR Journals 2015. All Rights Reserved.


Inder D et al. J. Adv. Res. Med. 2015; 2(3)

Inclusions Required in Pharmacovigilance Status of National Pharmacovigilance Program


(NPP) in India
The field of pharmacovigilance should be expanded to
include new kind of safety concerns such as illegal sale The National Pharmacovigilance Program was officially
and drug abuse over internet, increasing self-medication inaugurated by Health Minister Dr. Anbumani Ramadoss
practices, widespread manufacture and sale of on 23 November, 2004 at New Delhi and was
alternatives for existing medicines.2,7,8 implemented in 2009. The main focus of National
Pharmacovigilance Program is to collate, analyze and
In present time, range of pharmacovigilance has been archive adverse drug reaction data on the existing as
expanded to include herbals medicines, blood products, well as drugs to be marketed in India, for promoting
biologics, medical devices and vaccines. Additionally, healthy India. The Central Drugs Standard Control
there has been an increasing use of traditional/ herbal Organization (CDSCO) has initiated a countrywide
medicines outside the boundaries of the traditional pharmacovigilance program under the aegis of Director
culture and with other medicines and food that can General of Health Services (DGHS), Ministry of health
cause the potentially adverse drug-drug or drug-food and family welfare, Government of India.13 National
interaction.7,8,9 Pharmacovigilance Program is a three tier structure
consisting of peripheral, regional and zonal centers
The pharmacovigilance faces new challenges by
which are monitored by National Pharmacovigilance
increasing demands and availability of range of new
products. Advisory Committee (NPAC) and the National
Pharmacovigilance based Central Drugs Standard
Role of Pharmacovigilance Control Organization (CDSCO), New Delhi.

1. Collecting new drug information from The three layered structure report the serious,
pharmaceutical companies conducting clinical trials, unexpected adverse drug reactions (ADRs) to the
reliable scientific resources, healthcare providers, National Pharmacovigilance Centre (PVC) directly.
consumers, reputed journals, published literature Possible regulatory steps are taken by NPAC based on
etc. the data received from various centers. After causality
2. Causality risk assessment and analysis of the above assessment done at PVCs, all these reports are sent to
information. the WHO-ADR Monitoring Centre at Uppsala, Sweden,
3. Disseminating its outcome contents as well as any which helps to update the world pool of information on
action taken on specific drug to all health sectors. this topic.

An ADR form of Malaysia and Canada covers the highest Under this program, periodic safety update reports
number of data (43), while Brazil falls to the opposite (PSURs) need to be submitted every 6 months for the
end with a number of 17 data elements.10,11 first 2 years of marketing of drug in India, and annually
for the subsequent 2 years.
Causality Assessment
Training programs, CMEs, discussions, and interaction
One of the most important, and challenging, problems meetings need to be held every 6 months after the
in pharmacovigilance is that of the determination of initial training to sensitize health care providers. All data
causality. Based on causality assessment, signal is generated (including reporting forms) should be
determined. Usually more than one report is required to archived for a minimum period of 5 years at the Zonal
generate a signal, depending upon the event and quality pharmacovigilance centers (PVCs).
of the information available.12

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J. Adv. Res. Med. 2015; 2(3) Inder D et al.

CDSCO (Centre for drugs standard control organization)


acts as national pharmacovigilance advisory committee

Figure 1.Adverse Drug Reaction reports collection and monitoring from peripheral centers to CDSCO

National Pharmacovigilance Program of India is an 3. Ignorance of spontaneous reporting ADR utility


attempt to promote a culture of notification by among health care providers (objectives, and utility
involving healthcare professionals and Non-Government of spontaneous reporting system of ADRs not clear).
Organizations (NGOs) in drug monitoring, thereby Minor side effects are ignored and not at all
creating awareness to promote reporting of even reported.
common adverse reactions which can address a 4. Inadequate reporting cards/ forms, information and
widespread prescribing problem.13 feedback of reported ADR on physician’s table.
5. Doctors feel that it is unethical to breach the
confidentiality of patients’ data, thus increasing
Obstacles in Proper Implementation of National
chances of legal liability and possible judicial claims
Pharmacovigilance Program in India by patients.
6. Fear of losing name, fame among health care
According to the 2011 census, India has the 2nd highest providers if something goes wrong with patient due
population in the world with over 1.21 billion14 people. to prescribed drug. Liability to medical negligence
India is the 4th largest producer of pharmaceuticals in leads to under-reporting of ADRs. Due to more
the world. Some of the ADRs are avoidable. awareness of Consumer Protection Act, both
Spontaneous reporting by healthcare professionals is a patient and prescriber have lost faith in each other,
crucial step for preventing or reducing ADRs.8,14 The which has adversely affected the system of
ADR reporting rate in India is below 1% compared to the reporting ADRs.
worldwide rate14 of 5%. ADR management can cost the 7. Patients do not report ADRs in some societies due
institution or the patient as much as US $15-150 in to attached stigma and they move to quacks and
India. worsen their condition sometimes.
8. Clinicians are very busy in outpatient departments
Developing countries like India has to face many due to huge rush of patients and low doctor:
challenges. Spontaneous reporting of adverse drug patient ratio in India. Therefore they hardly pay
reactions (ADRs) in India is almost lacking due to these attention to filling ADR form for reporting. Thus
potential obstacles.15,16 Following are the possible many ADRs remain unidentified and get
reasons for non-reporting of adverse drug reactions: symptomatic treatments. Health care providers’
forgetfulness in reporting ADRs is also contributing.
1. Uncertain/ unconfirmed diagnosis. 9. Medical profession has become commercial these
2. Ignorance of hospital pharmacovigilance system days. Even most doctors charge fee for the
and lack of strict regulation for reporting the ADRs treatment of their own professionals forgetting the
within a time frame leads to inadequate reporting. ethical etiquettes. Few clinicians tend to prescribe

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Inder D et al. J. Adv. Res. Med. 2015; 2(3)

easy working medicines to patients for quick action, 4. Health care providers should decide priorities for
to develop trust and faith in patients, irrespective of spontaneous reporting, e.g. type of drugs, severity
thinking any harmful effect of drugs. Even if any of ADR, unexpected ADR.
ADR occurs, they don’t report for the fear of losing 5. Hospital administration and management should
monetary benefits. facilitate easy contact and quick access to a hospital
10. Roles and responsibilities of human resource are pharmacovigilance system, e.g. use of Information
not clearly delegated which is a flaw in health Technology (toll free phone calls, fax, worldwide
management. Structural and policy changes are web, e-mail, use of reminders or circulating
required within the drug regulatory authorities.17 advertisements in newspapers and television).
11. Self medicine by people based on the claims 6. There should be a separate column provided for
produced by different pharmaceutical companies as ADR reporting in patient’s prescription slip/ file.
advertisements on media and social sites is another 7. Information and support for reporting ADRs should
factor leading to ADRs. ADRs arising due to self be facilitated by means of therapeutic consultation
medication are rarely reported. among clinicians about evidence of suspected ADRs
12. Lack of safety data on drug interaction between the and causality assessment of suspected ADRs.
existing/ established allopathic medicines and 8. Feedback information on hospital
traditional drugs and vaccines.18 pharmacovigilance activities should be made
13. Lack of safety data on adverse drug reaction due to available to health care providers’ e.g. periodic
any interaction of allopathic medicines with Unani, summary of reported ADRs in hospital, periodic
herbal or other traditional systems of medicine. summary of specific type of ADR and information
ADR reporting for traditional and herbal medicines, about ADR warnings.
especially the multicomponent and adulterated 9. Consolidating ADR monitoring and
ones is not done seriously and reports present are pharmacovigilance reports at specified centers to
negligible. be sent to National Pharmacovigilance center
14. Problems related to competition within clinicians to (AIIMS, New Delhi).
publish rare adverse effects in medical journals 10. There should be an involvement of all categories of
without sharing information among Health care healthcare professionals in ADR reporting and
providers for job promotions. pharmacovigilance planning to incorporate the
15. Most of drug manufacturers do not care to invest in sense of ownership.
ADR monitoring for economic reasons. Moreover, a 11. ADR reporting forms should always be available. An
lot of sensitization and setting up of new systems acknowledgment receipt should always be issued
will consume resources such as good labs, along with a code number to each department for
recruitment of human resource, patient′s ability to further follow up to avoid fake reporting.
pay for tests, infrastructure for proper causality 12. Periodic meetings of experts from National
assessment, funding agency etc. Even government’s Pharmacovigilance Program with physicians,
participation to sensitize community regarding pharmacists and nurses should be arranged to
ADRs reporting is not adequate.19 create awareness regarding objectives and to boost
reporting. Moreover National Pharmacovigilance
How to Overcome these Obstacles/ Hurdles to Unit should periodically collect ADR forms from
Promote Reporting of Adverse Drug Reactions hospitals by sending their representatives.
(ADRs)? 13. All ADRs (common and unidentified) should be
published in newspapers and reputed journals and
Following steps may be taken to foster culture of should be projected by media to spread information
reporting ADRs: about ADR among masses. Each hospital should
have a database on ADRs, which can be easily
1. Each hospital (primary, district level, tertiary care) accessible to all.
should establish its local “Pharmacovigilance 14. ADR reporting awareness should be introduced in
center” for reporting, collecting ADRs. the curriculum in all types of academic institutions,
2. Identity of ADR reporter (doctor, dentist, e.g. schools, colleges, universities etc. ADR drop
physiotherapist, nurse, and pharmacist) should be boxes/ suggestion boxes should be introduced at
kept confidential to promote pharmacovigilance. strategic sites in and around hospitals for public
3. To spread awareness among physicians, convenience.
pharmacists and nurse, pharmacovigilance 15. ADR monitoring should be made mandatory in all
workshops/ CMEs should be conducted periodically. government sponsored public health programs, e.g.

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J. Adv. Res. Med. 2015; 2(3) Inder D et al.

RCH program, Cancer awareness program, vector make pharmacovigilance an integral part of all
born disease control program, National AIDS government run national programs. All this is possible
control program etc. by positively changing the mindset of all stake holders in
16. Certain new medicines are approved on urgent government and hospitals, so that ADR reporting
basis during epidemics, e.g. Ebola, H1N1, H1N5 etc becomes an accepted and understood routine in health
based on phase III/IV studies or without any care system, thus boosting Indian economy.
evidence of preliminary studies. Data regarding
such drugs should be procured from the population Source(s) of Support: Nil
which was prescribed such medicines. National
drug regulatory authorities should collaborate on Conflict of Interest: Nil
harmonizing the terms of conditional approval, and
develop systems to allow sharing of information on References
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