The Centre is considering a new law to regulate medical research in India, focusing on ethical standards, accountability, and participant safety. The proposal is under review by the Indian Council of Medical Research following directions from the Prime Minister’s Office.
The Central Government is examining the possibility of introducing a new law to regulate medical and health research in India, with a focus on ethical standards, safety, and accountability. The proposal aims to create a unified legal framework that would govern how medical research is conducted, reviewed, funded, and monitored across the country.
At present, medical research in India follows multiple guidelines and regulatory mechanisms, but there is no single comprehensive law that specifically addresses ethical oversight and governance of health research. The proposed legislation seeks to bridge this gap by defining clear responsibilities for researchers, institutions, and regulatory bodies.
The Indian Council of Medical Research (ICMR) is playing a central role in evaluating the need for this legislation. The initiative follows communication from Member of Parliament Ajeet Madhavrao Gopchade, who urged the Prime Minister to consider a dedicated legal framework for medical research.
Following this, the Prime Minister’s Office (PMO) directed ICMR to examine the feasibility of such a law. ICMR subsequently constituted a committee to review existing research regulations and assess whether new legislation is required to strengthen ethical oversight.
The discussions are currently taking place at the central government level in New Delhi. As of now, authorities have not announced a timeline for drafting or introducing the bill in Parliament. The proposal remains under review, and deliberations are ongoing.
Several factors have prompted the government to consider this move:
Lack of a unified legal framework: Medical research is governed by guidelines rather than a single enforceable law.
Need for uniform ethical standards: Ethical review processes and compliance vary across institutions.
Protection of research participants: Clear legal provisions can improve safeguards for patients and volunteers.
Encouraging private sector research: A defined regulatory structure may increase confidence among private and international research stakeholders.
Strengthening accountability: Legal clarity can define obligations and consequences for ethical violations.
While the exact provisions have not been made public, the proposed law is expected to:
Define ethical standards for medical and health research
Outline the roles and responsibilities of researchers and institutions
Strengthen oversight through ethics committees
Improve coordination between regulatory bodies
Support infrastructure and funding mechanisms for research
The law may also complement existing frameworks such as national research and innovation policies, while specifically focusing on medical and health research ethics.
If implemented, the legislation could lead to more consistent ethical practices across research institutions. It may also improve transparency, enhance participant safety, and align Indian medical research with international regulatory standards.
However, officials have clarified that discussions are still at an early stage, and any future law would require further consultations before formal implementation.
As of now, the government has not finalized the draft or confirmed when the bill may be introduced. The committee formed by ICMR continues to examine the need and structure of the proposed legislation.
(Rh/SS)