In an increasingly globalised world, the impact of public policy is far reaching. In this context, effective drug1 regulation isan important concern for promoting and protecting public health, both domestically and across the world. The extent of quality and efficacy of the medicines also contributes to strengthening of faith in health systems, health professionals, pharmaceutical manufacturers and distributors of the country (WHO 2003). Given the asymmetry of information between the manufacturers, the doctors who prescribe medicines and the patients who eventually consume them, the need for regulatory supervision is widely acknowledged amongst all stakeholders in the realm of public health. In light of the foregoing, this document forms a part of the study on ‘Administrative Structure and Functions of Drug Regulatory Authorities in India’, which is the first of its kind on the legal architecture, administrative structure and functioning
of drug regulatory authorities in India,
