Chapter 6 - Indian Regulatory Framework

Abstract

This chapter discusses the Indian Regulatory Framework. The Indian pharmaceutical sector has witnessed a remarkable growth, from around $1 billion in 1990 to $20 billion in 2009–2010. In India, the import, manufacture, sale, and distribution of medical devices are regulated under the Drugs and Cosmetics Act, 1940, and Rules, 1945. Those medical devices that are notified by central government in the official gazette are regulated by Central Drugs Standard Control Organization (CDSCO) that grants permission for the conduct of global clinical trials in India. To enhance the transparency, accountability, and accessibility of clinical trials, registration of a clinical trial in the ICMR's Registry, the Clinical Trials Registry – India (CTRI), was made mandatory by the DCGI's office with effect from June 15, 2009. The CTRI data set includes all the 20 data set points of the WHO. For clinical trials to be conducted in India with foreign collaboration, approval of the Government of India through the Health Ministry's Screening Committee (HMSC) is mandatory. The application is to be submitted to the International Health Division (IHD) of ICMR, which is the secretariat of HMSC. The Act and Rules are liable to undergo amendments. Furthermore, in view of the number of new initiatives and policies under active consideration, interested sponsors are advised to go through the detailed version of the Drugs and Cosmetics Act and Rules as well as the amendments that are notified from time to time and displayed on the CDSCO website.