After dilly-dallying on the subject for the last more than nine years, the union health ministry has finalised the ‘Biomedical Research Human Subjects Promotion and Regulation Bill’, which seeks to protect the human subjects used in any form of scientific research – behavioural or intrusive - done by an academic institution or pharmaceutical company.

“We have finalised the bill and a cabinet note has been circulated,” said Dr Vishwa Mohan Katoch, secretary, department of health research (DHR). After the cabinet approval, the bill will be introduced in Parliament during the forthcoming winter session.

Once the bill gets the Parliament nod, it will become mandatory for all medical institutions conducting human research to get registered by a central agency. The ethics committees in individual institutions will also have to get registered with the agency. The bill is aimed at protecting the safety and rights of humans used in scientific research.

Apart from the mandatory clinical trials on new drugs, a number of diagnostic procedures, therapeutic interventions and preventive measures including the use of vaccines are being introduced in the country involving human subjects. The bill seeks to protect these human subjects. At present, the research on human participants have been guided by the draft guidelines announced by the ICMR long back and the approvals given by the DCGI.

The bill, prepared by the Indian Council of Medical Research (ICMR), has literally been lying in cold storage since 2004 after the first draft was made and later it was vetted by the law ministry in January, 2006. However, still it could not be cleared due to several objections from different quarters and the present ICMR director general Dr V M Katoch took initiative to put it back on the track on the priority basis.

According to sources, the ICMR has finalised the bill by incorporating several new features to make it an updated document as per the international standard. Apart from several other features, more punishment has been provided in the bill as a deterrent at par with the international laws in this regard.

The need for uniform ethical guidelines for research on human subjects, which is universally recognised, acquired a new sense of urgency as the critical issues in the areas of biogenetic research involving human subjects have become sensitive. Apart from the mandatory clinical trials on new drugs, a number of diagnostic procedures, therapeutic interventions and preventive measures including the use of vaccines are being introduced involving human subjects.

The advent of new medical devices and radio-active materials, and therapeutic benefits of recombinant DNA products have added a new dimension to the ethical issues that need to be considered before evaluating these for their efficacy, utility and safety.