Abstract

A COMPARATIVE STUDY OF REGULATORY ISSUES ON PHARMACOVIGILANCE IN US, EUROPE AND IN INDIA: A REVIEW

B. V. Satyanarayana*, D. Nagarjuna Reddy, M. V. Nagabhushanam and Santosh Kumar Chamarthi

Abstract

The primary focus of the pharmacovigilance (PV) practice has been on the collection, assessment, and reporting of the adverse drug reactions to medicinal products. Globalization of the pharmaceutical industry has prompted efforts to toward harmonization of PV practices worldwide to enable improved knowledge of medicine's benefit-risk profile and risk communication. Even as PV has evolved over the past decade, there still exist few areas of discordance across global PV practices. This article compares the PV legislation in the US, EUROPE and INDIA with a view to understand areas of harmony in the current legislation across regions. Work helps to design solutions and strategies toward creation of a comprehensive PV system, which can be easily implemented across the globe, thus promoting the safer use of medicines.

Keywords: Adverse drug reaction, drug safety, pharmacovigilance.