The Union health ministry has at last finalised the modified ‘Biomedical Research Human Subjects Promotion and Regulation Bill’, which has literally been lying in cold storage for several years. The ministry has incorporated several new features in the final draft bill, which is aimed at protecting the safety and rights of humans used in scientific research, to make it an updated document as per the international standard.

“After fine-tuning the Bill in line with the international changes witnessed during the last six years when the Bill was first drafted, we have sent the final draft bill to the legal department. The scientific part of the Bill is complete now and the Bill has been sent to the department of law for its final nod”, said Dr Vishwa Mohan Katoch, director general of ICMR, which was given the responsibility of drafting the Bill.

Dr Katoch said that the major changes in the Bill have been made in the area of punishment as the Bill in its previous form was weak as far as punishment is concerned. Since the Bill has been pending for many years, several features of the Bill have become irrelevant and have to be reviewed and changes have to be made accordingly.

Earlier, the review committee formed to give final shape to the Bill met several times to finalise the Bill, he said.

After assuming charge as the director general of ICMR more than two years ago, Dr Katoch has taken the initiative to give the Bill its final shape to introduce the same in Parliament. Apart from several other features, more punishment will be provided in the Bill as a deterrent at par with the international laws in this regard.

Once the bill gets the legal clearance, it will be placed before Union Cabinet for its nod to introduce the same in Parliament. If all goes as per the plan, the Bill will be introduced in the Budget session of Parliament which is expected to begin in the fourth week of February.

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 seeks to protect the human subjects used in any form of scientific research - behavioural or intrusive - done by an academic institution or pharmaceutical company.

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.