Written by ForeignExchange Translations on Friday, February 08, 2013
Despite sponsors' efforts around the formation of select investigator networks, integrated site management and data-driven, hybrid monitoring, etc., India has seen a backlash against clinical researchers. Controversial reports of increasing deaths and various halfhearted efforts to address the problem have forced the Indian Supreme Court, among others, to slam regulators for shoddy oversight that has purportedly created "havoc" and led to patient deaths (see this Pharmalot story for more details).
The problem, at least as far as the clinical researchers are concerned, is that it remains unclear how much authority the Drugs Controller will have over the process. A court decision to swat down an earlier revision of the rules, effectively "puts the whole state of clinical trial regulation in a state of flux," says John Lewis of the Association of Clinical Research Organizations (quoted in Pharmalot here). But even though sponsors and CROs may not like the rules, but it is unlikely that clinical trials would come to a halt.
All of this uncertainty is not good for sponsors. But while India may have lost some its appeal, it is unlikely that clinical trials will come to a halt there.
ForeignExchange Translations provides specialized medical translation services to CROs as well as drug and device companies.