Drug Safety and Pharmacovigilance in India: Current Status and Future Prospects

Abstract

Pharmacovigilance (PV) is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. With the growing complexity of drug therapy, PV has become an essential component of public health to ensure the safe and rational use of medicines. This review highlights the history, objectives, processes, methods, challenges, and future perspectives of pharmacovigilance, with special reference to its global and Indian context. 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.Thisarticlesummarizedaimsobjectivesandmethodologiesusedinpharmacovigilance with acritical overview of existing pharmacovigilance system in India,challenges to overcome and future prospects with respect to Indian context.