The Central government is planning to impose mandatory procedures for conducting medical research involving human subjects in the country. The draft rules, finalized a few days ago, will also call for the formation of a Biomedical Regulatory Authority, aimed at strict implementation of the new rules. The exact composition of the new authority is yet to be clear.

The draft rules have been vetted by legal experts and are likely to be introduced in the parliament soon, it is learnt. The draft is known to contain all important requirements that had been warranted in the "Ethical Guidelines for Biomedical Research on Human Subjects" prepared by the Indian Council of Medical Research (ICMR) two years ago. Presently ICMR guidelines are only of recommendatory nature.

The regulatory authority is expected to be in line with the Institutional Review Boards of the US that can make sure that the risks associated with the trials are as low as possible and is worth the potential benefits. The body could consist of physicians, statisticians, and community advocates etc.

Highly placed ICMR sources informed that all major recommendations in the ethical guidelines have been retained in the draft. The legislation would cover all ethical practices to be followed while engaging human beings in medical research.

The Authority is likely to be a separate body similar to the office Drugs Control General of India (DCGI). The government will also attempt to give sufficient powers to the authority in order to ensure effective monitoring and strict enforcement of the Act.

Going by the ICMR guidelines (also known as ICMR Code), there is likely to be general rules on research using human subjects and also specific rules for specific areas of biomedical research.

Patient's consent and rights for permission and conduct of clinical trials of new drugs, organ transplantation, blood donation, in vitro fertilization etc are likely to be included. The new Act will also have specific instructions to regulate human genetic research, clinical evaluation of drugs / devices / diagnostics / vaccines / herbal remedies etc.

Specific rules have become necessary after biomedical research acquired dimensions which are at once exciting and awesome. The rules would try to strike a sensitive balance between the risks and benefits that are associated with research involving human subjects.

Health Ministry may fine-tune the new rules with the Drugs & Cosmetics Act as Schedule Y of the Drugs & Cosmetics Act talks about the conducting of clinical trials. As of now, Schedule Y barely covers the ethical practices for clinical trials. It merely states that the investigator must consult the institutional ethics committees or the Drug Controller of India for obtaining patient consent and enrolment of patients for the trials. Its has been pointed out that there are no adequate safeguards against wrongful conduction of clinical trials in the Schedule Y at present.