Regulation of Clinical Trials and the Need for Comprehensive Reform

The Ministry of Health and Family Welfare is currently inviting comments on the draft Drugs and Cosmetics (Amendment) Bill, 2015 (henceforth the bill).¹ It seeks to make key changes to the Drugs and Cosmetics Act, 1940 (henceforth the act) and extend its ambit to medical devices, reconstitute the existing Drugs Technical Advisory Board,² and introduce a new chapter on clinical trials. This last change, in particular, is a welcome move given the many patchwork attempts at reforming the regulatory regime on clinical trials over the last few years. However, this article argues that the bill does not go far enough in giving the regime the complete overhaul that it needs.³ There are three main problems with the changes proposed by the bill, each problem at a different level of abstraction.

At the most fundamental level, the bill misses the opportunity to clarify crucial provisions regarding the liability of sponsors, investigators and ethics committees. This, in turn, is because of its failure to make a principled distinction between matters that ought to be governed directly by the act and those that are best regulated by secondary legislation. This lack of clarity about the appropriate hierarchy of regulatory provisions is ultimately responsible for the fact that there continue to remain inconsistent provisions in the act and the Drugs and Cosmetics Rules, 1945 (henceforth the rules). The bill must be accompanied by a thorough review and consolidation of the rules⁴ to ensure a coherent and accessible code that is capable of safeguarding the rights of clinical trial participants while encouraging clinical research in the country.