Extensive regulatory system for clinical trials soon

India will have an extensive regulatory system for clinical trials in place by the next 18 months

India will have an extensive regulatory system for clinical trials in place by the next 18 months, under which regular random on-the-spot inspections will be carried out from July 2010, a top official said on Thursday.

"We will completely change the regulatory landscape for clinical trials in 2010. This will be a historic year in that regard. We are putting in place a system brick-by-brick by the next one year or 18 months," drug controller general of India Surinder Singh told PTI.

Mr Singh, who was addressing a symposium on 'India—An Emerging Destination for Clinical Trials' organised by the Institute of Clinical Research, said among the key steps will be launching of random inspections of trial sites, which can be started from July this year.

"Inspectors will visit trial sites with an updated checklist. This will ensure protection of volunteers, reliability of data and proper checks and balances," he said but made it clear that industry will not be 'harassed'.

Mr Singh said that several workshops on clinical trial inspections have been held in collaboration with the US Food and Drug Administration (FDA) and the World Health Organisation (WHO) and another is scheduled to be organised in April. The number of drug inspectors will be increased, he said.

The other measures which have been or will be undertaken include mandatory registration of clinical trial proposals and forming guidelines for ethics committees.
 

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