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LATEST NEWS UPDATES | Law soon to monitor clinical trials on humans

Law soon to monitor clinical trials on humans

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published Published on Jul 5, 2011   modified Modified on Jul 5, 2011

-The Hindu

 

Bill aims at making ethical committees looking into trials ‘robust'

A legislation to monitor the entire research on human bodies by a single authority is likely to be introduced in the winter session of Parliament, according to V.M. Katoch, Secretary, Department of Health Research.

The Bill will seek to make the ethical committees, presently looking into clinical trials on human beings, ‘robust' by constituting a monitoring mechanism over them.

It was felt that there was the danger of the poor being exploited if the panels were not strong, Dr. Katoch told media persons here on Monday after the release of ‘dietary guidelines for Indians' by the National Institute of Nutrition (NIN), an organisation of Indian Council of Medical Research (ICMR).

Dr. Katoch, who is also the Director General of ICMR, said the proposed legislation would provide for imprisonment ranging from five to ten years for unethical practices. It would also examine the issue of consent of people volunteering to undergo trials, surveillance of side-effects, new drugs and vaccines, and insurance norms.

He said that the ethical committees in the field of human research in India were functioning on the western model which gave supreme authority to the panels.

With the trials becoming trickier and increasingly intense every year, the need for a monitoring agency was felt.

Norms flouted

It was also found that generally the ethical considerations in trials were being flouted across the country and more particularly in tribal dominated areas of Madhya Pradesh and other States.

Dr. Katoch also said trials were necessary but they should not leave scope for exploitation.

It should be ensured that people participated in the trials voluntarily.

He, however, said the government was yet to take a view on regulation of animal ethical committees which had as tight norms as human ethical committees.

The question before it was who would check animal houses?

There was no doubt that clinical trials on animals to find solutions to human health problems had to go on.

The Hindu, 5 July, 2011, http://www.thehindu.com/todays-paper/tp-national/article2159824.ece


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