Evolution of post-trial access in India: An analysis of ethical and regulatory guidelines

Post-trial access (PTA) is an important element of any ethics or regulatory guidance document. It was first introduced in the Declaration of Helsinki (DoH) in the year 2000 but has only recently gained momentum. The objective of this narrative review was to examine the evolution of PTA in Indian bioethical and regulatory guidelines.

Websites of all Indian government agencies that issue ethics guidelines periodically as well as the website of the Indian regulator was searched by three authors and the guidelines downloaded. Identification of PTA in the guidelines was done by all authors and a consensus was reached. The Scale for the Assessment of Narrative Review Articles (SANRA) criteria were used as the reference framework.

The Indian Council of Medical Research (ICMR) guidelines of 2000 and 2006 mention PTA, though the most comprehensive coverage can be seen in the 2017 ICMR guidelines. This was followed by a good coverage of PTA in the New Drugs and Clinical Trials (NDCT) rules of 2019. Other guidelines have also briefly alluded to PTA.

In the years to come, Indian guidelines must evolve beyond PTA towards post-trial provisions (as introduced in DoH, 2024) or post-trial care, which are broader in their vision and go beyond the individual participant in a clinical trial.