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

The article reviews how the principle of post-trial access (PTA)—the obligation to provide participants with continued access to beneficial treatments after clinical trials—has developed in India. First introduced globally in the Declaration of Helsinki in 2000, PTA was briefly mentioned in India’s 2000 and 2006 ICMR guidelines, but received comprehensive treatment in the 2017 ICMR guidelines, which detailed benefit sharing, stakeholder responsibilities, and ethics committee roles. During COVID-19, PTA and community benefits were highlighted, while the 2023 ICMR guidelines on Controlled Human Infection Studies emphasized provisions for placebo participants and informed consent. The 2019 New Drugs and Clinical Trials (NDCT) Rules marked a regulatory milestone by mandating free PTA in specific situations, while other frameworks like stem cell research guidelines also addressed benefit sharing. Overall, India’s PTA framework has advanced from limited references to more structured obligations, but the authors argue it must evolve further toward broader concepts such as post-trial care (PTC) or post-trial provisions, aligning with the 2024 Declaration of Helsinki, to ensure continuity of care, equity, and community-level benefits.