Mandatory registration for Indian clinical trials

April 17, 2009

From June onwards drug firms and CROs conducting trials in India are required to record full details of the research, including the funding source, on the ICMR’s Clinical Trials Registry India website.

Surinder Singh, drugs controller general of India (DCGI), told Livemint that: “Until now, clinical trials were being registered on the website of the Indian Council of Medical Research (ICMR) voluntarily. From January, it was made advisory. But by June, we will make it mandatory.”

Last August the Indian trials sector was rocked by the revelation that 49 infants have died during clinical trials at the All India Institute of Medical Sciences (AIIMS) in New Delhi since January 2006.

While subsequent investigation showed that the mortality rate was below the national average and did not link the deaths to the drugs under assessment, the scandal led some members of the Indian congress to call for a halt on all trials.

The issue was compounded in October when news emerged that an infant had died after during a trial of a pneumonia vaccine being developed by US drugmaker Wyeth Pharmaceuticals.

According to data gathered by the Indian Government’s Planning Commission, outsourced trials were worth some $300m (€229m) in 2008, up a 65 per cent on 2006. The commission estimates that the sector will be worth $1bn a year by 2010.

As a result, starting on June 1, study sponsors and partner CROs must supply information on the trial, the source of funding and details of an ethics committee that will monitor the study all before the first patient is enrolled.

Source: Outsourcing Pharma

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