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Clinical Trials
Clinical trials remain an underregulated area in India despite the potential for negative health effects. An overview of the nature and scale of clinical trials currently underway in the country discusses the specifi c aspects of the regulatory framework and identifi es gaps.
India has emerged as one of the foremost countries for holding clinical trials of New Chemical Entities (NCEs) or untested pharmaceutical products.1 Government reports have estimated the market value of outsourced clinical trials at $300 million in 2006 to $400 million in 2012.2 Clinical trials are divided into three phases (phase I, II and III) on the basis of the scale of the study. Phase I clinical trials involve the test of new drugs on humans, phase II are exploratory in nature and build on the data emerging from phase I and phase III are confirmatory trials that in turn are based on data from phase i or II.
Pre-2005, phase i clinical trials were not permitted for foreign drugs (with the exception of those with special relevance to the Indian population)3 and permission for phase II was conditional on the prior conduct of phase III clinical trials in other countries. After 2005 with the coming into effect of the amendment of Schedule Y of the Drugs and Cosmetics Rules,4 this requirement of time lag between phases was withdrawn and concurrent trials were permitted. This essentially allowed drug manufacturers to initiate and conduct trials simultaneously in India and other foreign countries and thereby accelerated the process of clinical trials.
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