The Draft Rules prepared by the Indian Council of Medical Research (ICMR) on ethical practices to be followed while conducting biomedical research would be presented in the Parliament after the clearance from Law ministry shortly. The Rules, which was submitted to the Union Health Ministry in 2002, is based on the Biomedical Research Guideline of ICMR.
The ICMR guidelines, which are now followed only voluntarily by the institutions and the pharma companies that sponsor the drug trials and other biomedical research, would become mandatory procedures once the Rules are passed in the Parliament. The Draft, which was sent to the Law ministry by the Ministry of Health, is awaiting the former's clearance now. The Law ministry is likely to give its approval to the Draft by the first week of September, it is learnt.
According to ICMR sources, the draft norms prepared by the Council in consultation with legal experts, has already got the approval from the Health ministry. "Now, depending on the decision of the Law Ministry, 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.
The decision to make the biomedical research guidelines mandatory comes in the wake of inadequate compliance of the guidelines by a number of pharma companies and institutions in the country. Moreover, the 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.