Int. J. Pharm. Sci. Rev. Res., 26(2), May – Jun 2014; Article No. 41, Pages: 237-241 ISSN 0976 – 044X International Journal of Pharmaceutical Sciences Review and Research Available online at www.globalresearchonline.net © Copyright protected. Unaut horised republicat ion, reproduction, distribution, dissemination and copying of this document in whole or in part is strictly prohibited. 237 Rajkumar Soni 1 * , Bikrant Kesari 2 1. Asst. Professor, Management Department, Indian Institute of Planning and Management (IIPM), Bhopal, (M.P.), India. 2. Asst. Professor, Department of Management Studies, Maulana Azad National Institute of Technology (MANIT), Bhopal, (M.P.), India. * Corresponding author’s E-mail: rajsoni49@gmail.com Accepted on: 07-04-2014; Finalized on: 31-05-2014. ABSTRACT Pharmacovigilance, defined by the World Health Organization as ‘the science and series of activities relating to the detection, evaluation, understanding and avoidance of adverse effects or any other drug-related problem’ plays an important role in ensuring that patients be given safe drugs. The knowledge of a drug’s Adverse Drug Reactions (ADRs) can be augmented by various means such database studies, intensive monitoring, spontaneous reporting, and other new processes at dictatorial and a scientific level are being developed with the intention of escalation pharmacovigilance. On dictatorial level, these include risk management plans and conditional approval and on scientific level, increased patient involvement and transparency are two vital elements. The main objective of review is to unfold various aspects of pharmacovigilance including new methodological developments. Keywords: Pharmacovigilance, Adverse Drug Reactions, WHO, Drug safety. INTRODUCTION ccording to the World Health Organization, “ Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problem, particularly long term and short term adverse effects of medicines” . 1 Pharmacovigilance is also known as Drug Safety and abbreviated PV or PhV. The etymological roots for the word "pharmacovigilance" are: Pharmakon (Greek word for ‘drug’) and vigilare (Latin word for ‘to keep watch’). 2 Pharmacovigilance greatly focuses on adverse drug reactions (ADRs) which are defined as any reaction to a drug which is harmful and unintended including lack of efficacy used for the prophylaxis, analysis or therapy of illness or for the modification of physiological function. 2 History of Pharmacovigilance in India Pharmacovigilance in India started from 1986. A formal Adverse Drug Reactions (ADR) monitoring system was initiated with 12 regional centres, each covering a population of 50 million. However, no noteworthy growth was made. Afterward in 1997, India joined the World Health Organization (WHO) and Adverse Drug Reaction (ADR) scrutinizing program based at 2 Uppsala, Sweden but got fail. Hence, after 2005 WHO supported and World Bank – funded National Pharmacovigilance Programme (NPPV) of India was made operational. 2, 17, 21, 19 Table 1: The sequential pharmacovigilance developments with special reference to India: 1, 11, 16. Year Developments 1747 Very first known clinical trials by James Lind, proving the usefulness of lemon juice in preventing scurvy. 1937 Death of more than 100 children due to toxicity of sulfanilamide. 1950 Apalstic anemia reported due to chloramphenicol toxicity. 1961 Worldwide tragedy due to thalidomide toxicity. 1963 16th World Health congregation recognize significant to rapid action on Adverse Drug Reactions (ADRs). 1968 WHO research project for international drug monitoring on pilot scale. 1996 Global standards level clinical trials initiated in India. 1997 India attached with WHO Adverse Drug Reaction Monitoring Program. 1998 Initiation of pharmacovigilance in India. 2002 67th National Pharmacovigilance Center established in India. 2004 -05 India launched National Pharmacovigilance Program. 2005 Accomplishment of structured clinical trials in India. 2009 -10 Pharmacovigilance Program (PvPI) started. Need of pharmacovigilance The forceful marketing of new drug products by pharmaceutical companies and the consequential rapid disclosure over a short period of time of large numbers of patients to them necessitate the formation of a system for global assessment of drug safety concerns. These actions need an effective and efficient pharmacovigilance system that has been realized more than ever to make sure safe use of drugs. There are several rationales for A Review on Pharmacovigilance A Review Article