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.

Over the years, various bodies in national jurisdictions have also laid down general and specific principles in specific areas of scientific research entailing the use of human beings as subjects in medical research. These national codes (drawn from the international codes and the universal principles underlying them) sketch guidelines to be followed in their respective jurisdictions.

The ICMR had brought out in February 1980, a document 'Policy statement on ethical considerations involved in research on human subjects' prepared by the ethical committee under the chairmanship of Justice HR Khanna. This document is being widely used by not only ICMR but also by other government agencies, research institutions and scientists. The document, however, needs to be updated in view of the recent developments in modern biology as also in different branches of medical science so as to add to its contemporary relevance.

Therefore, a Central Ethics Committee on Human Research (CECHR) was constituted under the chairmanship of Justice M N Venkatachaliah by the then director general, Dr G V Satyavati to consider various issues related to the ethical, legal and social dimensions of research involving human subjects. The committee first met on 10th September, 1996 and identified major areas and set up sub-committees of experts for drawing up a set of guidelines that included clinical evaluation of drugs, devices, diagnostics, vaccines, herbal remedies, epidemiological research, human genetics research, transplantation research, including foetal tissue transplantation and assisted reproductive technologies.

The CECHR met on 10th August 1997 to consider the draft guidelines prepared by all the five groups and a draft consultative document was prepared for wide circulation and subsequent regional and national debates before finalisation. A series of four regional public debates at Kolkata, Mumbai, Hyderabad and New Delhi on the draft consultative document were conducted in the years 1998-99.

The CECHR of the Indian Council of Medical Research has laid down ethical guidelines for biomedical research on human subjects in September 2000. It is expected that all institutions in the country which, carry out any form of biomedical research involving human beings should follow these guidelines in letter and spirit to protect the safety and well being of all individuals who participate in such research for the progress of science through acquisition of new knowledge.