An Indian government report has hit the domestic pharma business like a whirlwind--and sucked Big Pharma into the fury. A parliamentary panel alleges that drug regulators and pharma companies worked together to circumvent rules on clinical trials, pushing drugs through the approval process before their time.
The report is based on a review of 42 drugs approved between 2004 and 2010; of those, 31 won approval without clinical trials in Indian patients. "There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers," regulators and medical experts, the report states, adding that "irregular approvals" save companies money and time, but put patients at risk.
As Bloomberg reports, GlaxoSmithKline ($GSK), Novartis ($NVS), Eli Lilly ($LLY) and Cipla allegedly won approvals without Indian trials required by law. Sanofi's ($SNY) heart drug Multaq and Novartis' blood pressure drug Tekturna allegedly won approval on the basis of small Indian studies, with fewer than the 100-patient minimum. The drugs cited in news reports already had won approval from FDA, but sought clearance under India's approval system, which requires tests in domestic patients.
Novartis says it will investigate the allegations laid forth in the report, Reuters reports. The Swiss drugmaker said it follows "one global ethical standard" when it comes to conducting clinical trials. Glaxo says it received a local waiver on trials for Letairis, which treats a rare form of high blood pressure. The rules allow for exceptions for medicines targeted at a "rare disease which is life threatening and debilitating," the company said (as quoted by The Wall Street Journal).