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ICMR to revise clinical trial guidelines

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The revision will clarify some of the key issues of the guidelines to encourage research centres towards undertaking clinical trial

In an effort to streamline clinical trials in the country, the Indian Council of Medical Research (ICMR) said that it has taken up revision of its guidelines to create a conducive environment for conducting such trials.

“We are working on the revised guidelines on biomedical ethics and research as it is important for public health as well as for manufacturers and pharma companies to conduct clinical trials in India,” Soumya Swaminathan, Director General. ICMR said.

Clinical trials across the country came to a halt few years ago due to a case in the Supreme Court for bringing stringent rules and greater transparency into the process.

“In past few years after the SC judgement, very stringent guidelines were drawn and as a result many clinical trials came to a halt. The impact was felt more in academic centres rather than the industry. This is an area where we are now working with Drug Controller General (India), DCG (I) as well as with the health ministry,” she said.

Swaminathan informed that the revision will clarify some of the key issues of the guidelines to encourage research centres towards undertaking clinical trial.

“Academic centres used to do a lot of trials which are all stopped, so they need a clarification. We will clarify some of the issues and will not change any of the rules. For instance any trial that does not need registration of the product will not have to come to the DCGI for approval,” she said.

The ICMR Director General also noted that the compensation will be limited to death or disability resulting from clinical trials directly.

“Compensation is also a big issue as people are scared to undertake a trial as they do not know what to do in case of a loss. So, it will be clarified that compensation will only be limited to death or disabilities from trial,” Swaminathan explained.

The last guidelines for clinical trials were released in 2006. ICMR had also recently come up with guidelines on research on children and is working on a separate document of research on tribal population which focuses on protecting their rights.

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