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The ultimate aim of this paper to discuss detail about Pharmacovigilance,  its importance and the challenges that face in PV. This paper gives basic idea about the terminologies that involve in Pharmacovigilance like adverse drug reactions, adverse event, rechallenge, dechallenge, serious adverse event, expected and unexpected adverse drug reactions etc. The paper describes the Pharmacovigilance programme in India and its regulation by various government body and health authority, heath care centre. The reader can understand the necessity of PV in health care system and effect of its on large number of population in the world. The possible future aspect of Pharmacovigilance is written in brief. There is huge need of Pharmacovigilance in medicine system as it affects the health of large number of population. Drug passes through pre-clinical and clinical trial where drug exposed to less number of people (subject under study). When it comes into market it administered by large number of population globally. There is high risk of developing health related hazards to patient. Proper monitoring and assessment of such unwanted drug effect are come under Pharmacovigilance.

KEY WORDS: Pharmacovigilance, PvPI, ADRs, CDSCO, serious adverse drug event.