Modified Biomedical Research Bill to be presented in Parliament shortly

The Biomedical Research Human Subjects Promotion and Regulation Bill, which has been lying in the cold storage for several years, will soon find its way to the Indian Parliament for its final nod as the Indian Council of Medical Research (ICMR) has taken the initiative to give the Bill its final shape.

ICMR director general Dr Vishwa Mohan Katoch said that the ICMR has already started the review of the Bill to make the punishment part of the Bill more severe as a deterrent. "The Bill at its present form is weak as far as punishment is concerned. We are working on it to make the punishment more severe at par with the international laws in this regard," Dr Katoch said. He said that similar laws have been passed in about 35 countries in the world and the punishment is severe in all these countries, including US, Canada, European countries, etc.

Though the proposed bill has been cleared by the Law Ministry way back in January 2006, it has been lying with the Health Ministry for a long time. After his taking over charge in the ICMR as DG, Dr Katoch has taken the initiative to give the Bill its final shape to introduce the same in Parliament. After the review, the Bill will be placed it before Union Cabinet for its nod to introduce the Bill in Parliament.

Once the bill gets the Cabinet 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 has been drafted by the Indian Council of Medical Research (ICMR).

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.