Viewpoint INDIAN PEDIATRICS 27 VOLUME 43 __ JANUARY 17, 2006 them being life-threatening(1,4). Safety data generated from clinical trials is incapable of identifying infrequent or late-onset adverse drug reactions(5). When a new drug is marketed, only limited information regarding its safety in children is available. Currently, several new drugs are being launched in India almost simultaneously as in the world market. Hence even minimal post-marketing safety data is unavailable(6). The types of diseases and co-morbid conditions (e.g., malnutrition, anemia and infestations) in Indian children, diverse genetic composition, and concomitant use of drugs belonging to alternative medicine could result in unforeseeable adverse drug reactions(7-9). Hence, it is mandatory that our country should have an active pharmaco- vigilance network. Pharmacovigilance benefits everybody: The patients are protected from unsafe drugs; doctors and pharmaceutical industry keep their reputations intact and drug regulators receive pertinent data that helps them to take regulatory decisions. Although, Indian Council of Medical Research and Drugs Controller General of India began establishing Adverse Drug Reaction centers in 1980s, these activities remained confined to a few institutions and practicing doctors have remained largely oblivious of these activities(7,10). National Pharmacovigilance Program To improve the current state of functioning of pharmacovigilance activities, the central drug regulatory agency. The Central Drugs Standard Control Organization launched the National Pharmacovigilance Program in November 2004 under the aegis of Directorate General of Health Services, Union Ministry of Introduction Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems(1). An “adverse event” is defined as any untoward medical occurrence that may present during treatment with a drug but which does not necessarily have a causal relationship with its use(1). An “adverse drug reaction” is any noxious, unintended and undesired effect of a drug, which occurs at a dose used in humans for prophylaxis, diagnosis, therapy or modification of physiological functions(2). Spontaneous reporting of adverse events and adverse drug reactions is the commonest method utilized for generating safety data(3). Adverse drug reactions in children constitute a significant health issue given their reported incidence of 9.5%. They also account for 2.1% of hospital admissions, with 39.3% of National Pharmacovigilance Program Sandeep B. Bavdekar* Sunil Karande* From the *Department of Pediatrics, Seth GS Medical College and KEM Hospital, Parel, Mumbai 400012 and **Department of Pediatrics, Lokmanya Tilak Municipal Medical College and General Hospital , Sion, Mumbai 400 022, India. Correspondence to: Dr. Sandeep B. Bavdekar, 9, A2 Worli Seaside, CHS, Pujari Nagar, KAG Khan Road, Worli, Mumbai 400 018, India. E-mail: drsbavdekar@vsnl.com