With the Government facing increased heat on monitoring the research involving human subjects in the country, the long-pending Biomedical Research Human Subjects Promotion and Regulation Bill will finally be pushed to the Parliament, at least in the next session.

The Indian Council of Medical Research (ICMR) which had finalized the draft had already sent the Bill to the Law Department which is vetting the same. It would be sent to the Cabinet then for the approval, before placing it in the Parliament, it is learnt. “It is nearly ready for sending to the Cabinet,” sources said.

The Bill has been pending since 2004 and was expected to be placed before the House last year. However, it could not get through the clearance yet from the Law Ministry which had put up some queries on the same.

ICMR sources said the agency wanted to make sure that the Bill is passed in the current year itself and hopes that it can table the bill during the Monsoon session, as the currently the budget session is going on and could not accommodate the same.

The modified Bill had incorporated sufficient provisions to protect the safety and rights of humans used in scientific research and 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 Department of Health Research is learnt to have revived its efforts after the health ministry came in flaks, also from the Supreme Court recently, about the quality of monitoring the clinical trials in the country. The Central Drugs Standard Control Organisation (CDSCO) had already issued several guidelines and the Ministry had also issued notifications to raise the bar in clinical trials and research in the recent past.

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 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.