India Cracks Down: Sun Pharma Clinical Work At Lab Is Halted

In a sign that the Indian government may be cracking down on clinical trial work conducted by its domestic pharmaceutical industry, the Drug Controller General of India ordered Sun Pharmaceuticals, which is one of the country’s largest drugmakers, to suspend clinical research activities at a key laboratory in Mumbai, according to reports. The regulator took this step after discovering that Sun did not have needed approval from the central government to operate the lab, The Economic Times writes. And the DCGI will not accept any future applications or process existing new filings made by the Mumbai lab until Sun receives formal approval, the paper adds. It is not clear if the move will affect new filings in other countries. The move comes after the Indian Supreme Court earlier this year slammed regulators for shoddy oversight that was creating “havoc” and for going into a “deep slumber” that was placing participants at risk. A government committee report found that between January 2008 and October 2010, regulators approved 33 new drugs without trials on Indian patients (back story). There has been ongoing controversy that drugmakers have taken advantage by providing inadequate informed consent or that compensation for harm was sometimes not paid or negligible. There have also been reports of a rising number of deaths during studies (see this). The Indian health ministry reportedly acknowledged that 2,644 people died during clinical trials of 475 new drugs from 2005 t...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs