Drug trial regulation: The changing scenario in India

The Indian drug trial industry has witnessed regulatory challenges in the area of clinical trials, new drug pricing policy, compulsory licences and foreign direct investment cap for brownfield projects in the past year. A public interest litigation pending in the Supreme Court coupled with regulatory uncertainties has halted clinical trials in India.

However amid the uncertainties and delays, there have also been developments that are likely to bring impetus to the drug trial industry, which was estimated to be worth US$19.2 billion in 2012. These include: (1) the recommendations of an expert committee report on clinical trials, new drug approval and banning of drugs; (2) the Drugs and Cosmetics (Amendment) Bill, 2013; and (3) a web-based petition to the Supreme Court by People for the Advancement of Clinical Research – India.

Clinical trials

Clinical trials are an essential component of drug discovery. In order to generate adequate evidence to establish safety and efficacy of a substance for any specific indication, it is necessary that in addition to all in vitro, in vivo, and ex vivo experimentation, the product is administered to healthy volunteers and patients and clinically studied under a well defined protocol.

India’s provisions for regulating and ensuring quality, safety and efficacy of drugs are contained in the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945. The regulatory provisions for conducting clinical trials are prescribed under rules 122DA, 122DAA, 122 DAB, 122DAC, 122DD, 122E and Schedule Y of the 1945 rules. Clinical trials can be initiated only after approval by the Drugs Controller General of India and clinical trial registration with the Clinical Trials Registry – India.

Dr Rachna Bharadwaj is an associate at Krishna & Saurastri Associates and an advocate registered with the Bar Council of India.