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Use of medicinal products is not completely safe and sometimes it may lead to harmful effects in the body known as the
Adverse Drug Reactions (ADRs). Pharmacovigilance is a system that improves the safe and rational use of medicines. WHO
defines Pharmacovigilance as ?the science and activities relating to the detection, assessment, understanding and prevention
of adverse effects or any other drug related problems?. The basic aims of Pharmacovigilance are improvement in patient care
and safety, to contribute in the assessment of benefit, harm, effectiveness and risk of medicines and to promote education and
clinical training on rational and safe use of medicines. India is becoming a major hub for clinical trials but the Pharmacovigilance
system in India is still in its infancy. Although ?Pharmacovigilance programme of India for assuring drug safety? was launched
in 2004 but it has yet not been implemented effectively. Discrepancies exist between the provisions of Schedule Y and Central
Drugs Standard Control Organization (CDSCO) guidelines for ADRs reporting. Need therefore exists to critically review the
present Pharmacovigilance system in the country. This paper presents an overview of the current regulatory framework for
Pharmacovigilance in India and discusses its limitations. Further, recommendations are provided to formulate a comprehensive
and vibrant Pharmacovigilance system in India to protect country?s population from the potential harm of the new drugs.
Mr. Diwakar Yadav is presently pursuing M. Pharmacy in Pharmaceutical Management & Regulatory Affairs branch at Lachoo Memorial College of
Science & Technology, Pharmacy Wing, Jodhpur, India.
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