After keeping it dormant for many years, the Department of Health Research is fast-tracking for the final approval from the Cabinet a comprehensive bill to regulate and monitor the entire research on the human subjects in the country.

Sources said the modified Biomedical Research on Human Subjects Bill is in the final stages. “The Cabinet note is being prepared for submission and approval. The plans are afoot to place it before the Parliament this year itself and put into effect,” sources said.

The Bill assumes significance in the wake of the recent findings by the Parliamentary panel on the state of affairs in the clinical trials segment and the widespread concerns about the alleged approval of drugs without trials in the country.

The Bill which has been debated for over five years now aims to protect the safety and rights of humans used in scientific research. It has been modified by the DHR keeping in view of the international guidelines and to include provisions of punishment at par with international laws, sources said. The bill was drafted based on the existing guidelines in the sector.

“Apart from regulating the clinical trials, the Bill also seeks to create a single authority for the entire research on the human subjects. It will have guidelines for clinical trials on new drugs/vaccines, diagnostic procedures and insurance aspect, if something goes wrong,” sources said.

The Bill seeks to protect the human subjects used in any form of scientific research – behavioural or intrusive—done by an academic institution or pharmaceutical company. 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 is going to put these guidelines as statutes, so that it can be enforced sternly. Though the companies were asked to follow the guidelines, there are no provisions to take action against the errant researchers now.

The Bill provides for setting up a Biomedical Research Authority to monitor research on humans. One of the key highlights of the Bill is provision for increasing the penalty for violation of ethical guidelines. The revised Bill increases the maximum penalty from Rs.1 lakh fine and six months imprisonment to Rs.10 lakh fine and an imprisonment between five and 10 years. Penalty would be graded as per the nature of violations like not taking consent of participants, misinformation to the ethics committee, serious injuries etc. The punishments also include debarring from research and forfeiting of registration, apart from imprisonment.

The Bill prepared by the Indian Council of Medical Research (ICMR) was in fact pending 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 many reasons and the present ICMR director general Dr V M Katoch took initiative to put it back on the track on a priority basis.