New Regulatory Framework in the Works
New Delhi: The Central Government is reportedly considering a new bill aimed at revamping the framework of medical research in India. The proposed legislation seeks to set clear ethical standards and ensure the safety and quality of medical research across the country, according to sources cited by the Economic Times.
Comprehensive Coverage of Health Research
A person familiar with the matter told ET that the bill is expected to provide a regulatory framework covering all aspects of health research, including development, regulation, financing, and coordination. This framework will aim to bring consistency and transparency to medical research practices.
Ethical Oversight and Standards
The proposed Act will establish health research ethics committees and regulate research institutions, researchers, and health establishments involved in studies. The objective is to ensure that research activities adhere to uniform ethical standards and guidelines.
ICMR’s Role in Deliberations
The Indian Council of Medical Research (ICMR) is reportedly deliberating on the bill at the behest of the Prime Minister’s Office. The move reflects growing attention on formalizing regulatory mechanisms for health research in India.
Parliamentary Push for Legislation
This initiative follows a letter by parliamentarian Ajeet Madhavrao Gopchade to the Prime Minister, urging the government to consider legislation for medical research, drawing inspiration from developed countries such as France. Gopchade highlighted the need for clear policies to attract private sector participation in health research.
Focus on Transparency and Accountability
In his communication, Gopchade emphasized defining responsibilities, promoting transparency, and ensuring that researchers are answerable for their actions both ethically and legally. He also suggested increasing funding for ICMR to hire researchers and develop modern infrastructure.
Committee Recommends Bill
Following the parliamentary recommendation, a committee was constituted to evaluate the need for legislation. The committee reviewed the existing regulatory framework and international practices, ultimately identifying a potential requirement for a dedicated Bill on medical research.
Call for Future-Ready Legislation
Commenting on the matter, Gopchade told ET that a comprehensive and future-ready law is “imperative” for upholding high ethical standards, participant safety, and scientific integrity. The legislation would also facilitate transparent and accountable collaboration with private partners in health research.
