The decision comes in the wake death of tribal girls during post-marketing surveillance of anti-cervix cancer vaccine

The government proposes to regulate all biomedical and health research activities by bringing them under a law to ensure ethical research in all institutions with proper care, and a compensation policy for human participants.

It is estimated that more than 1,500 research institutions are engaged in biomedical and health research in India and more than 1,000 ethics committees are reviewing research protocols involving human participants. At present, only clinical trials with new drugs are regulated under the Drugs and Cosmetics Act, 1940 and this law is not applicable to the enormous quantum of biomedical research being conducted in universities, medical colleges and hospitals on subjects ranging from basic sciences and clinical research to applied, operational or behavioural research.

The decision to enact a new law comes in the wake of the report of the Parliamentary Committee on Health, flaying the government and the Indian Council of Medical Research for failing to prevent deaths of adolescent tribal girls in Andhra Pradesh and Gujarat during post-marketing surveillance of anti-cervix cancer HPV vaccine. The surveillance had been jointly conducted by a foreign non-governmental organisation, PATH, and the ICMR, and was suspended by the Ministry following the deaths of the participants.

Now the Biomedical and Health Research Bill will provide ways to protect ethical values in accordance with both local cultural values and international standards so as to generate, maintain and restore public trust in research.

Seeking to set up a Biomedical Research Authority, the proposed law will ensure compulsory registration and evaluation of ethics committees set up in all kinds of research institutions and will have penal provisions for unauthorised research and unethical practices. It will also cover institutions and sponsors undertaking unethical biomedical research at places with inadequate facilities.

The Authority will register, monitor and evaluate the performance of ethics committees; evolve performance appraisal systems, and norms and mechanisms for enforcing accountability and transparency; and assess the need for providing protection to vulnerable sections.

The Bill entitles a child in the womb to claim compensation for any research-related injury, caused in utero by the participation of its mother. There is a provision for establishing a “Research Related Injury Relief Fund” from which compensation will be paid.

The Bill will confer statutory powers on the Ethical Guidelines for Biomedical Research on Human Subjects, drafted in 2000 by the ICMR’s Central Ethics Committee on Human Research, under the chairmanship of the former Chief Justice of India, Justice M. N. Venkatachaliah. The guidelines were revised in 2006.

All research on human participants will now come under the government scanner by way of the proposed regulatory authority. The Health Ministry has drafted a Cabinet note and circulated it to various ministries for their views on the Bill. Once vetted by the Law Ministry, it is likely to be introduced in the winter session of Parliament.

  • At present Drugs and Cosmetics Act, 1940 is not applicable to biomedical research

  • New Bill will entitle child in womb to claim compensation for research-related harm