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| Extensive regulatory system for clinical trials soon |
| Press Trust of India / New Delhi Jan 14, 2010, 13:27 IST |
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 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 today.
"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 said.
Singh, who was addressing a symposium on 'India - An Emerging Destination for Clinical Trials' organised by 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 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".
Singh said that several workshops on clinical trial inspections have been held in collaboration with USFDA and 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.
"A national directory of GLP (good laboratory practice)-trained investigators will also be put on the website," Singh said.
He also said there will be more manpower for his department with induction of 250 contractual workers and over 50 others from WHO to handle the increasing volume of work.
On phase I and 0 clinical trials in India, Singh said while on phase 0 (first-in-human trials) there is need to exercise much caution, there are still inconsistencies about definition of phase I trials, which involves first stage of testing in human subjects from animals. A core group has been formed along with the industry players for discussions on these issues, he said.
Singh noted that India has potential to become a hub for clinical research with large patient population, genetic variety and other such advantages.
ICRI Director General S K Gupta said India is in third position in overall attraction as clinical trial destination after the US and China and is looking to position itself a global hub. "There are a host of issues from regulatory to ethics that need to be addressed urgently."
G J Swaminathan, Advisor to Ministry of Science and Technology, T S Rao, Advisor to Department of Biotechnology and Arvind Pandey, director National Institute of Medical Statistics also addressed the inaugural session of the seminar.
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