The Indian Council of Medical Research (ICMR) has submitted a set of draft rules for ethical practices to be followed while conducting clinical trials of drugs, to the Union ministry of health. The draft rules are the modified form of ICMR guidelines hitherto followed only voluntarily by the institutions and the pharma companies that sponsor the drug trials.

The decision to make these procedures mandatory for biomedical research is in the wake of inadequate compliance of the guidelines by a number of pharma companies and institutions in the country. Moreover the regulations and monitoring of trials and the functioning of ethical committees are also not very clear at present.

The set of norms, which includes majority of the ethical practices specified in the ICMR Guideline announced in 2000, was drafted in view of making it mandatory for approval and running of biomedical research on human subjects in the country.

In order to enforce these requirements strictly, the government wanted to bring out appropriate legislative provisions. It may also form part of the Drugs & Cosmetics Act either as a separate section in Schedule Y, which deals with clinical trials of drugs in the D&C Act, or within the section as a separate set of rules to regulate the ethical practices to the stipulated standards.

According to ICMR sources, the draft norms prepared in consultation with legal experts by the council, is currently under the consideration of the Ministry. "Depending on its decision, it may be put in the Parliament directly as a Bill to introduce a separate Act or it may go to the Drug Consultative Committee (DCC) and Drug Technical Advisory Board (DTAB) in order to make it a set of rules in the D&C Act," the sources said.