Abstract

IMPACT AND NEED OF BETTER PHARMACOVIGILANCE- A REVIEW

*Samruddhi Madhukar Deokar, Geeta Ramdas Zine, Vikas Arjun Cholke and Shubham Vasant Gholap

ABSTRACT

Pharmacovigilance is an important & integral part of clinical research. Pharmacovigilance is "the activities involved in the detection, assessment, understanding & prevention of adverse effect or any other drug related problems. It is structured activity in the professional health field, with important social and commercial implications aimed at monitoring the risk/benefits ratio of the drugs, improving patients safety & the quality of life. Spontaneous reporting of adverse drug reaction (ADR's) is an essential component of pharmacovigilance. However, there is significant under reporting of ADR's, Adverse drug reactions (ADR) have become a major problem in developing countries. Knowledge of pharmacovigilance could from the basis for interventions aimed at improving reporting rates & decreasing ADR's. In terms of volume India pharmaceutical industry of third largest in the world so india has a core of clinical research & drug design & development, this expains the need of pharmacovigilance in pharma companies, the process of pharmacovigilance, the growth of pharmacovigilance in different centuries & current status of pharmacovigilance in the country. National PV programmes has been introduced which occupies aprime role in increasing the public awareness about drug safety.

Keywords: Pharmacovigilance, Adverse drug reaction, ADR Reporting, Risk Management, MedDRA, SAE etc.