Clinical trials: compensation may be given only if injury directly relates to trials

Health authority says final decision on the matter may take time

By Kundan Pandey
Published: Friday 12 July 2013

In a move that may not really work in the interest of people participating in clinical drug trials, the Union Ministry of Health and Family Welfare (MoHFW) is gearing up to change the compensation model and promote drug trials in the country. Under the changed rules, patients may be entitled to get compensation only if he or she sustains direct injury because of drug trial, said ministry sources.

As per the existing norms, it is mandatory for companies to compensate the subject of the trial, if he or she suffers injury during the trail. This would include even those injuries that might not be directly related to the trial. But now, the ministry is looking to change it. Media reports also suggest that the patients would be compensated only if it is proved that the trial has caused the injury or death.

Following the Supreme Court comment that unregulated drug trials are causing ‘havoc’ in the country in January 2013, the health ministry amended the Drugs and Cosmetics Rules by passing three notifications between January and February. The notifications specify procedures for compensation, definition of injury and functioning of the ethics committee, which is constituted by an institution conducting the trial.

In the first notification, it was said that the patients will get treatment as long as they need even if their injuries are not associated with the drug trial. But new policy will change that. Drugs Controller General of India (DGCI) G N Singh said that a change is in process but it may take time. He said that apex committee had met several times recently to discuss the drug trials-related matters and have recommended many things. He refused to give details of the changes proposed. He said that all changes will be done to protect the right of the patients participating in drug trials.

However, he said that there are still many steps before the ministry arrives at the final conclusion.

Pharma industry pressure?

It is believed that ministry has decided to change the compensation policy to promote clinical trials in the country which were almost put on halt after the Supreme Court’s tough stand on the issue. Indore-based activist Anand Rai who has continuously followed the drug trials matter in the country, said that the recent notifications are not up to the mark. If the ministry further dilutes the norms and conditions, it will not have moved forward at all. He also said that it is all done under the pressure of pharma industry and said that the activists would not hesitate to drag the administration to court again, if required.


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