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Shivam Yadav And Prabhat Kumar Yadav*


Pharmacovigilance is a pharmacological science that relates with drug safety. It relates to the collection, assessment, monitoring and prevention of Adverse Drug Reactions (ADRs) caused by any type of pharmaceutical products.[1] The World Health Organization (WHO) defines Pharmacovigilance as “the study of activities related to the detection, assessment, understanding and prevention of adverse effects or any other drug related problem” (WHO 2004). After the disaster of Thalidomide in 1961, the WHO has established a Programme for International Drug Monitoring.[2] The main Aim of Pharmacovigilance Programme is to ensure the safety of public for use of medicines. Pharmacovigilance is needed to ensure the safety of medicines. The scope of pharmacovigilance is to monitoring continuously of any Adverse Drug Reactions. To reassess and update the Benefit/Risk ratio profile of any drug through the Periodic Safety Update Reports (PSURs).[3] Government of India started the Pharmacovigilance Program of India in July 2010 at All India Institute of Medical Sciences (AIIMS), New Delhi. It was the National Coordinating Centre (NCC) for monitoring of adverse drug reactions until it shifted to Indian Pharmacopoeia Commission (IPC), Ghaziabad in April 2011. The objective of PvPI is to create a national system for the safety of patients and to analyse any new signals from reported cases. It analyses the Benefit/Risk ratio of marketed formulations, and generate evidence-based information on safety of medicines. Adverse Drug Reaction is a response to a drug, which is noxious and unintended. It occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function. Causality Assessment is a method used to evaluate a relationship between a drug exposure and the occurrence of the Adverse Drug Reactions. Clinician, pharmacists, pharmaceutical industry and healthcare professionals can do it.[4] Signal is defined as ―Reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously‖.

Keywords: Adverse Drug Reactions, Thalidomide, Pharmacovigilance, PSUR, NCC-PvPI, Causality Assessment, Signal.

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