Advancing Patient Healthcare: Clarifying The 2019 Changes In India's Drug And Clinical Trial Rules

By Kinjal Mehta

In 2019, only 1.2 percent of global clinical studies included India, even though it’s estimated that the country bears 20 percent of the global disease burden.¹ One reason for the slow growth of clinical research in India has been the country’s stringent regulatory requirements. The Ministry of Health and Family Welfare, responsible for all health policy in India, took steps to clarify these requirements and address many of sponsors’ concerns with the publication of its New Drugs and Clinical Trials Rules in 2019.²

These regulations include provisions covering numerous topics, providing a comprehensive, well-balanced approach to improve ethics and quality standards for clinical trials while speeding up the process, and providing patients with earlier access to trial medications. With these changes, it is worthwhile for sponsors, especially biotech and specialty pharmaceutical companies, to consider the many opportunities that India and other Asia-Pacific countries offer. We have summarized some of the most significant changes here.