New Delhi: Clinical trials of drugs in India have seen a drastic fall this year after toughened norms were introduced following Supreme Court directives.Not only have the number of trial approvals in the country reduced, there has also been a significant reduction in the number of sponsoring pharma firms applying for such approvals.Official Health Ministry data shows that until January 31 this year, only six trials had been approved. Even these pertained to older applications where the Drug Controller General of India had asked the applying firms to make some amendments.Sources say until April, only around 12 approvals have been granted by the DCGI for trials of drugs in India. Pending applications for trials as of today are just 70.This is in sharp contrast to the past when the number of Global Clinical Trials (GCTs) approved for conduct in India was in hundreds. Though in 2008 the DCGI had granted just 65 approvals for trials, the number in 2009 rose sharply to 391. The trend continued with a whopping 500 GCTs being allowed in 2010 and 325 in 2011 followed by 262 approvals in 2012.
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