The proposed law seeks to establish a regulatory framework for health research, covering its development, regulation, financing and coordination.
Published Dec 24, 2025 | 7:00 AM ⚊ Updated Dec 24, 2025 | 7:00 AM
Medical research. Representative Image. (iStock)
Synopsis: The Union government is reportedly planning a new law to regulate medical research in India, a move that could reshape how clinical and health-related studies are conducted in the country. The legislation could mark a shift from the current system, where medical research is largely governed by guidelines rather than a single, comprehensive statute.
The Union government is weighing a proposal to introduce a new law to regulate medical research in India, a move that could reshape how clinical and health-related studies are conducted in the country.
While some public health experts observed the move as an opportunity to plug long-standing regulatory gaps, others raised concerns about duplication, increased bureaucratic control and the potential dilution of existing standards.
According to reports by The Economic Times, the proposed legislation is aimed at strengthening ethical standards, improving oversight, and ensuring the safety and quality of medical research.
The proposal is still at a preliminary stage, with the Indian Council of Medical Research (ICMR) examining the need and possible contours of such a law at the direction of the Prime Minister’s Office.
If taken forward, the legislation would mark a shift from the current system, where medical research is largely governed by guidelines rather than a single, comprehensive statute.
As reported, the proposed law seeks to establish a regulatory framework for health research, covering its development, regulation, financing and coordination.
The stated objective is to ensure uniform ethical standards by setting up health research ethics committees and regulating research institutions, researchers and health establishments involved in medical studies.
The move follows a letter from MP Ajeet Madhavrao Gopchade to Prime Minister Narendra Modi, who urged the government to explore a dedicated legal framework for medical research, similar to those followed in several developed countries.
Gopchade argued that a comprehensive law is necessary to uphold ethics, protect research participants and ensure scientific integrity, while also enabling transparent and accountable private sector participation in medical research.
ICMR Director General Rajiv Bahl said that a committee identified the potential need for such legislation and is actively deliberating on developing the possible contents of the Bill.
However, the draft of the proposed law has not yet been made public, and consultations remain ongoing. Gopchade also suggested increasing funding for ICMR to strengthen research capacity, including recruiting more researchers and upgrading infrastructure.
Public health activist Prasanna S of Sarvatrika Arogya Andolana Karnataka (SAAK) questioned the need for a fresh regulatory instrument when India already has the New Drugs and Clinical Trials Rules, 2019, which govern clinical research.
“It is unclear why another layer of regulation is being contemplated instead of strengthening or enforcing existing rules,” he told South First.
According to Prasanna, the proposal appears suspect in the context of the government’s broader record of diluting regulatory standards in the name of “ease of doing business”.
He argued that similar dilution could occur in medical research regulation, potentially benefiting corporate hospitals or private sector interests rather than prioritising participant safety and scientific integrity.
Prasanna also warned that the proposed law could be used to control or suppress research data that presents an unfavourable picture of the country.
He pointed to the government’s rejection of international indices such as the Human Development Index and World Hunger Index, while selectively promoting rankings related to ease of doing business.
He also flagged the functioning of the Health Ministry’s Screening Committee (HMSC) under the Department of Health Research and ICMR as an example of excessive bureaucratic oversight.
“The committee, comprising representatives from multiple ministries, including Home Affairs, Finance, Defence and External Affairs, has become a bottleneck for international research collaborations and data publication,” Prasanna said.
Referring to existing HMSC guidelines governing international collaborations, Prasanna noted that such mechanisms have already hindered genuine research partnerships.
At a time when public investment in research has seen a real-term decline, additional regulatory layers risk further constraining scientific work, he pointed out. He added that, “Without adequate funding or academic freedom, new regulations could deepen surveillance and discourage independent research.”
Not all experts are opposed to the move. Dr Anant Bhan, public health researcher and Principal Investigator at Sangath, said a more stringent legal framework could help address gaps in India’s biomedical research regulation.
“It would be useful to have a more stringent legal framework to regulate biomedical research in the country,” Dr Bhan told South First.
He noted that while regulatory research, such as clinical trials, falls under the Central Drugs Standard Control Organisation through the NDCT Rules, 2019, a large portion of non-regulatory research continues to be governed mainly by the ICMR’s 2017 ethical guidelines, which are often treated as advisory.
“A focus on transparency, accountability, participant protection, effective oversight and ensuring quality through a potential law will help build trust, but this will only work when implementation is ensured,” he said.
Referring to recent controversies, including deaths of children linked to contaminated cough syrups, Dr Bhan said these incidents exposed serious deficiencies in regulatory oversight.
He also stressed that the formulation of the law must involve wide consultations. “The process of formulating the law should involve getting inputs from all key stakeholders,” he added.
(Edited by Muhammed Fazil.)
