In the absence of any law to deal with biomedical and health research, government has decided to regulate all such activities in medical colleges, universities, hospitals and public and private organisations.
The Ministry of Health has proposed the Biomedical and Health Research Bill to ensure ethical research in all institutions with proper care and compensation policy for human participants in such task.
The proposed law will ensure compulsory registration and evaluation of ethics committees set up in all kinds of research institutions and provide for penal provisions against those engaged in unauthorised research, officials told PTI.
The law will also cover institutions and sponsors undertaking unethical biomedical research at places with inadequate facilities.
At present, only clinical trials of new drugs are regulated under Drugs and Cosmetics Act, 1940, and post- marketing surveillance of health products such as vaccines are not covered by any law.
The decision to enact a new law comes in the wake of a castigating report of the Parliamentary Committee on Health which slammed the government and the Indian Council of Medical Research (ICMR) for failing to prevent deaths of adolescent tribal girls in two states during post-marketing surveillance of anti-cervix cancer HPV vaccine.
The surveillance was jointly conducted by a foreign NGO PATH and ICMR and was suspended by the Health Ministry in the wake of deaths of adolescent participants. The new bill seeks to ensure this kind of a mishap does not happen again.
The bill is critical considering more than 1,500 research institutions, colleges, universities and public and private organisations that are currently engaged in biomedical and health research and over 1,000 ethics committees are involved in the review of research protocols.
The Ministry has drafted a cabinet note and circulated it to various ministries for their views on the bill.
