There has been a great deal of international interaction and cooperation in the area of public health, particularly since the conception of the Millennium Development Goals (MDGs). However, while world leaders agreed upon and signed a specific set of health goals and targets as part of the MDGs, and recently under the Sustainable Development Goals (SDGs)—which are to be achieved by 2030— international cooperation vis-à-vis mechanisms to achieve those shared goals is still very limited. Regulation of medicines/drugs is one of them. Drug regulation aims at protecting and promoting public health by establishing the safety, efficacy and quality of medicines. Despite commonalities in the science and objectives of regulation, drug regulatory authorities differ significantly in their respective requirements and capacities, contributing to inequalities in access to medicines as well as health outcomes across nations. Such a realisation has inspired a number of efforts to minimise divergences and pool the capacities of national regulators. In India, the need for an efficient and easier drug registration process assumes greater significance in the backdrop of rapidly changing pattern of diseases — requiring newer and better treatments — and the pharmaceutical industry increasingly involved in drug innovation/discovery.

This report — the first of its kind — seeks to identify key areas of concern in the process of medicine registration in India and the supportive role that international cooperation can play in this context. It reviews some of the major international cooperation initiatives for registration of medicines to identify lessons as well as opportunities that the Government of India could potentially leverage to address its regulatory challenges and achieve the goals of public health in particular. Although there are a range of economic and political factors that impact access to medicines in a country, this study focuses on institutional factors that have a bearing on regulatory processes related to registration.

For more information, you may write to amehdi@icirier.res.in