Report on Challenges and Prospects for Clinical Trials in India: A Regulatory Perspective (Academic Foundation), April 2017

Rahul Mongia, Deepmala Pokhriyal, Seema Rao and Ali Mehdi
April 2017

Clinical trials (CTs) are integral to drug discovery and bringing out newer and better medicines into the market. With the growing burden of disease and evolution of the nation’s pharmaceutical industry, the need for clinical trials in India has increased manifold. India has had favourable prerequisites for conducting clinical research—a large and diverse patient pool, a highly skilled workforce of qualified scientists, medical colleges, etc. Yet, an unfavourable ecosystem has undermined its potential—only 19 trials were approved in 2013, a drop of roughly 93 per cent from 2012 (262 trials), and a fraction of its peak of 500 trials in 2010. India is home to 16 per cent of the world population and 20 per cent of the global burden of disease; yet, it has less than 2 per cent of clinical trials registered worldwide. A critical area of concern where the country continues to underperform despite enormous potential to be a world leader.


This report analyses prospects and challenges of clinical trials in India, focusing on New Chemical Entities (NCEs) and new drugs. It contextualises the debate around clinical research in the context of new drug approval process. Likewise, it proposes actionable policy recommendations for Indian drug regulatory landscape so that the country could realise its untapped potential while addressing concerns raised regarding the conduct and quality of clinical trials. The objective of drug regulation is both protection and promotion of public health. It is high time India’s drug regulatory landscape delivers on both. Regulatory lacunas surrounding clinical trials have impacted promotion of public health severely—they need to be addressed promptly to bring about transparency and fairness so that the pharmaceutical industry and clinical research organisations can move ahead within a clear-cut framework of regulatory expectations and contribute to public health.


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