Drug Quality and Safety Issues in India

Abstract

This document summarizes the study’s broad policy recommendations along with measures for their operationalization. Some of the major policy recommendations include uniformity in the interpretation of legal terminology contained in the relevant act and guidelines, rationalization of work distribution across regulatory personnel, use of technological tools to bridge the gap in the data available to policymakers, and need for driving the industry towards voluntary compliance and self-regulation. Participation of all stakeholders towards making dedicated efforts in these critical reform areas can pave the way for India to become a widely acknowledged source of good quality and efficacious medicines.