The Union ministry of health and family welfare will soon make it mandatory for all research institutions to follow guidelines on human trials prepared by the New Delhi-based Indian Council for Medical Research (ICMR). This is being done in the wake of recent controversial drug trials carried out at the Thiruvananthapuram-based Regional Cancer Centre (RCC), during which a large number of cancer patients were used as guinea pigs without their permission (see 'Malignant trials', Down To Earth, Vol 10, No 7, August 31, 2001).
The ICMR guidelines advocate that clinical trials should be carried out in a non-exploitative manner and research laboratories should get prior permission from ethical committees for conducting any experiments. "Legalising ICMR guidelines would give authorities the power to take legal action against anybody found guilty of ignoring ethics to be observed while conducting clinical trials," says Vasantha Muthuswamy, chief of basic medical sciences department, ICMR. As per the provisions of the drug and cosmetic act, at present the drug controller general's clearance is not essential for conducting human trials of an untested drug. Clearance is needed only for marketing a new drug. Therefore, it is easier to test new drugs on humans in India -- as was the case in Thiruvananthapuram. To prevent this from happening in future, the ministry is planning to amend the act and make it mandatory for organisations to get the drug controller general's permission for conducting clinical trials. Moreover, even though the Union ministry of social justice and welfare monitors experiments carried out on animals, no such supervision is done in the case of clinical trials on humans. According to A B Ramteke, deputy drug controller of the department of health, the drug controller would now take care of this aspect.
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