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Govt tightening clinical trial norms

Mandatory ethics panel oversight, explanation within 30 days of a death & compensation rules coming

Sushmi Dey  |  New Delhi 

The Union health ministry and the drug regulator’s office are preparing to introduce norms and notifications to monitor clinical trials in a better way.

In the wake of criticism of the existing guidelines, the ministry has planned to make it mandatory for every clinical trial site to have an internal ethics committee.

It wants these committees to be registered with the The ministry is also working on norms for payment of timely compensation to victims in such trials.

“All these plans are in process. The health ministry and the drug regulator’s office are working on draft notifications. Some notifications will be issued very soon…maybe in a month’s time,” a government official said.

An ethics committee is a panel of experts from multiple disciplines, including medical academicians, social work and law, to monitor the rights and well-being of patients or subjects participating in a research study.

At present, every pharmaceutical company has to seek approval from the and from an ethics committee before starting any trial, but these panels are often located far from the trial sites.

“Often, the ethics committee is not privy to the situation on the site because it is located at a very distant (place). This must be revisited because it doesn’t serve the purpose at all,” says C M Gulati, editor, Monthly Index of Medical Specialities.

An official in the Indian Council of Medical Research says it is also a matter of concern that there is no legal requirement for investigators or members of the ethics committees to declare a conflict of interest.

In some cases, it was found that the principal investigator in the trial was also a member of the ethics committee, the official said. has published detailed guidelines on the composition and responsibilities of ethics committees and established guidelines for biomedical research on human subjects. However, none of these are binding on companies.

The government’s latest move also includes norms mandating companies to explain any death during a clinical trial within 30 days to the ethics committee, failing which the drug and the trial will be considered the cause for death, the government official said. The move is aimed at restricting companies and clinical research organisations from violating best practices.

Mortality rates in clinical trials in India have remained consistently high. While 438 deaths were reported in 2011, as many as 668 had died in 2010, another 637 in 2009 and 228 in 2008, according to government data.

According to information given to Parliament, of the 668 deaths during clinical trials in 2010, compensation was paid in only 22 cases, with many as low as Rs 150,000. However, companies claim they are already complying with globally harmonised standards.

Experts note over half of all trials worldwide are conducted in developing countries. However, the growth of clinical research in India is slowing.

According to projections made a few years earlier, this market was to be a $2-billion one by 2010-12, with a growth rate of a little over 35 per cent yearly between 2006 and 2010. However, the current market size is just $400 million and the growth is flat.

First Published: Mon, August 06 2012. 00:02 IST