Centre mulls new law to regulate medical research, set ethical standards: Report

New Delhi: The Central Government is considering introducing a new bill to revamp the framework of medical research in the country, to set ethical standards and ensure the safety and quality of medical research, the Economic Times has reported.

One of the people familiar with the matter told ET, "It is proposed to provide a regulatory framework for health research that will cover development, regulation, financing and coordination."

"The proposed Act will ensure consistent ethical standards and guidelines for research by establishing health research ethics committees and regulating research institutions, researchers and health establishments involved..." the person added.

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As per the latest media report by the Economic Times, the source added that the Indian Council of Medical Research (ICMR) is deliberating on the matter at the behest of the Prime Minister's Office.

This development comes after parliamentarian Ajeet Madhavrao Gopchade wrote to the Prime Minister and urged the Government to explore the possibility of enacting legislation for medical research, similar to frameworks in developed countries such as France.

In the letter, Gopchade had highlighted the need for attractive policies to draw the private sector into medical research. He had submitted a reference from the UK Government regarding the regulations on medical research, along with an Act from Zambia related to health research.

"It entails defining clear responsibilities, encouraging transparency and making certain that researchers are answerable for their actions and decisions, both from an ethical and legal standpoint," the letter by Gopchade stated.

He had also suggested increasing the funding for ICMR to enable the health research body to recruit more researchers and set up the latest infrastructure.

Following this, a committee was set up to provide recommendations regarding enacting a Bill for medical research, taking into account the existing regulatory framework, relevance, and applicability of similar legislation in the country.

Consequently, the PMO and Gopchade were informed by the Director General of ICMR, Rajiv Bahl, that the said committee identified a need for a Bill. "The committee has identified a potential need for a Bill and is actively deliberating on the matter for developing the possible contents of the Bill," the letter by Rajiv Bahl mentioned.

Commenting on the matter, Gopchade told ET that a comprehensive and future-ready law on medical research is "imperative" for upholding the highest standards of ethics, participant safety and scientific integrity, while enabling transparent and accountable private partnership.

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