The Central government is examining the introduction of a dedicated legislation to regulate medical and health research in India, intending to set enforceable ethical standards and strengthen oversight across the research ecosystem. The proposal has emerged from formal representations made in Parliament and subsequent consultations involving the Indian Council of Medical Research (ICMR) and the Prime Minister’s Office. The discussion gained traction after Member of Parliament Ajeet Madhavrao Gopchade wrote to the Prime Minister, highlighting the absence of a comprehensive statutory framework governing medical research in the country.

In his communication, he argued that reliance on guidelines alone is insufficient and called for a clear legal structure that defines responsibilities, ensures ethical accountability, and protects research participants. In support of his recommendation,…