Bill on biomedical research to come before Parliament soon

Updated on: Wednesday, July 06, 2011

A comprehensive Bill that aims to regulate and monitor the entire research on the human subjects will be introduced in the Parliament, Indian Council of Medical Research (ICMR) said.

Our goal is to introduce it (proposed Bill) in the winter session of the Parliament, Director General of ICMR V M Katoch said here.

The Bill on 'Biomedical Research on the Human Subjects' is almost ready after being debated for the last four years, Katoch said, it has now come to the DHR and has been modified, keeping in view the international guidelines that will enable same type of punishment at par with the international laws.

"Not only the clinical trials will be regulated...once the Bill is passed there will be a single authority for the entire research on the human subjects. It will have guidelines for clinical trials on new drugs/vaccines, diagnostic procedures and insurance aspect, if something goes wrong," he said.

Ethical committee approvals and accreditation and their monitoring has to be very accurate and would be ensured through the Bill, Katoch, who is also the secretary, Department of Health Research (DHR), said.

Monitoring has to be a different mechanism, as the people who are at fault, should be caught and punished, he said, adding, marginalised people should not be exploited, surveillance of the side effects (clinical trials), compensation/insurance of people, who are participating in trials, has to be very tightened.

Reacting to a query on the incident in Guntur district of Andhra Pradesh, where poor women were administered a drug by a pharma company, without obtaining their necessary consent, Katoch said, clinical trial is a very tricky issue.

There are marginalised people and you have to put in their interests. There should be no exploitation of anybody and people who are participating (in trials) should do it voluntarily, he said.

Ethical committees are improving and things in India were changing. However, monitoring of local (ethical) committees is a critical issue and that system should be made robust, he added.

DHR will look into the aspect of registration of volunteers (known to government system from the beginning) while finalising the guidelines for implementing the Bill.

Bill on biomedical research to come before Parliament soon

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