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Indian Journal of Pharmacology
Medknow Publications on behalf of Indian Pharmacological Society
ISSN: 0253-7613 EISSN: 1998-3751
Vol. 37, Num. 6, 2005, pp. 347-347
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Indian Journal of Pharmacology, Vol. 37, No. 6, November-December, 2005, pp. 347
Editorial
National pharmacovigilance programme
Adithan C
Department of Pharmacology,JIPMER, Pondicherry-605
006, India
Correspondence Address:C. Adithan, Member, National Pharmacovigilance
Advisory Committee, Department
of
Pharmacology,JIPMER,
Pondicherry-605
006, Insia, E-mail: adithan@vsnl.com
Code Number: ph05094
Safety and efficacy are the two major concerns about any drug. While the efficacy of a drug can be detected with relative ease, the same cannot be said about safety because the adverse effect of a drug may be uncommon but very serious and many patients may be affected or subjected to a potential risk before the relationship with the drug is established. This gave birth to a new branch of pharmacology called pharmacovigilance. By definition, pharmacovigilance is " the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. Recently, its concerns have been widened to include herbals, traditional and complementary medicines, blood products, biologicals, medical devices and vaccines" (WHO, 2002). It is fast emerging as an important approach for the early detection of unwanted effects of the drugs and to take appropriate regulatory actions if necessary. This may ensure the safer use of drugs.
The Uppsala Monitoring Centre (UMC, WHO), Sweden is maintaining the
international database of adverse drug reaction (ADR) reports received
from several National Centres. In September 2005, the database had 3.5
million adverse drug reaction reports and 78 countries were participating
in this programme. Vigibase online (web based) system is used for submission
of ADR reports. Although, India is participating in this programme, its
contribution to UMC database is very little. This is essentially due
to the absence of a vibrant ADR monitoring system and also the lack of
a reporting culture among health care workers.
Appreciating the importance and benefits of pharmacovigilance, Central
Drugs Standard Control Organization (CDSCO), Ministry of Health and Family
Welfare, Govt. of India launched the National Pharmacovigilance Programme
(NPP) in November, 2004. It is largely based on the recommendations made
in the WHO document titled "Safety Monitoring of Medicinal Products - Guidelines for Setting Up and Running a Pharmacovigilance Centre".
The immediate aim of NPP is to foster the culture of ADR notification
by health care workers. Subsequently, it seeks to generate broad based
ADR
data on the Indian population and share this with UMC, WHO database. This
would ensure optimum safety of drug products in the Indian market.
Under this programme, the whole country is divided into zones and regions
for operational efficiency. CDSCO, New Delhi is at the top of the hierarchy
followed by two zonal pharmacovigilance centres viz, Seth GS Medical College,
Mumbai and AIIMS, New Delhi. There are 5 regional pharmacovigilance centers
located at Kolkata (IPGMR-SSKM Hospitals) , Mumbai (TN Medical College & BYL Nair Charitable Hospital) ,
Nagpur (Indira Gandhi Medical College) , New Delhi (Lady Hardinge Medical College) and
Pondicherry (JIPMER) . Twenty eight peripheral centers, spread
country-wide, are attached to their nearest peripheral centres.
ADR reports can be sent only by health care workers (doctors including
dentists, nurses, pharmacists) to any one of the nearest pharmacovigilance
centre. The full list of centres is available at CDSCO web site (www.cdsco.nic.in).
Some centres like JIPMER, Pondicherry (www.jipmer.edu) and AIMS, Kochi
(www.aimshospital.org) have web based facility for ADR reporting. ADR
reports sent by lay public are not acceptable. Data received at the peripheral
centres are forwarded to the respective regional centers which will carry
out the causality analysis. This information will be forwarded to the
zonal
centres. From there the data will be forwarded to the CDSCO and UMC database.
The functioning of NPP is to be periodically reviewed by the National
Pharmacovigilance Advisory Committee" - a 16 member committee appointed by the Govt. of India. The committee will also evaluate the pharmacovigilance data received from various centres and recommend possible regulatory measures.
ADR monitoring programmes are not new to India. In 1982, five centres
were established by Drug Controller General of India for nationwide monitoring
of ADR. In 1987, ICMR had collected about 58,000 ADR cases through its
multi-institutional study but they all stopped functioning after few
years
due to several reasons such as insufficient funds, lack of enthusiasm
etc. The present programme may be successful since this has been structured
taking into consideration the past deficiencies. Three interactive workshops
were conducted by CDSCO/WHO for training the participants of the programme.
Further, the World Bank has committed to provide US$1,00,000 for this
project.
The success of this programme depends on the continuous active support
by CDSCO and the dedicated work of the pharmacovigilance centres.
Copyright 2005 - Indian Journal of Pharmacology
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