PHARMACOVIGILANCE IN INDIA: PERSPECTIVES AND PROSPECTS

  • Sumit Kumar Department of Quality Assurance, I.S.F. College of Pharmacy, Moga, Punjab – 142001
  • Ashish Baldi Principal & Professor, I.S.F. College of Pharmacy, Moga-142001, India

Abstract

In the scenario of ever-increasing range and potency of medicines, safety of medicines is one of the key parameters along with therapeutic efficacy for success of any drug. India is now a preferred clinical trials destination for to be launched drug entities. By keeping in view the increasing incidences, dug related mortality, proper identification, reporting, evaluation and understanding of adverse drug reaction lead to development of pharmacovigilance. It is a branch of pharmacological science critical to effective clinical practices and public health with immense capability for growth. These necessities the utmost need of effective regulations for drug approval and conscious pre and post approval vigilance of undesired effect especially in India. This article summarized aims objectives and methodologies used in pharmacovigilance with a critical overview of existing pharmacovigilance system in India, challenges to overcome and future prospects with respect to Indian context.

Key-words: Adverse drug reaction, Clinical trial, Drug safety, Pharmacovigilance, Post marketing surveillance.

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1.
Kumar S, Baldi A. PHARMACOVIGILANCE IN INDIA: PERSPECTIVES AND PROSPECTS. JDDT [Internet]. 11Aug.2013 [cited 25Feb.2020];3(4):237-46. Available from: http://jddtonline.info/index.php/jddt/article/view/619