Administrative Structure & Functions of Drug Regulatory Authorities in India

Abstract

The research findings presented in this study are based on legal and policy analysis, field research in terms of stakeholder interviews conducted nationally (Delhi, Gujarat, Himachal Pradesh, Bihar, and Kerala) and internationally (USA, Europe, China and Indonesia), and information gathered through RTI applications. Admittedly, drug regulation encompasses substantive policy areas such as pharmaceutical pricing, clinical trials, medical devices, post marketing surveillance, objectionable advertisement and marketing, which are beyond the scope of the present study. Some of these policy areas are expected to be covered in the subsequent years of the Research Program on Drug Regulatory Reforms in India under the Health Policy Initiative of ICRIER