Indian Panel Accuses Big Pharma Of Colluding With Regulators

[GMAN]

Indian panel accuses Big Pharma of colluding with regulators - FiercePharma

Indian panel accuses Big Pharma of colluding with regulators

May 10, 2012 | By Tracy Staton

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.

- read the Bloomberg article
- see the Reuters story
- get more from the WSJ

Related Articles:
Reactions to poor practices, 'Dateline' special on CROs differ in India
Indian government defends country's generics industry
Bayer slams Indian government, Cipla on Nexavar copies




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[skerv]

[sarcasm]Big surprise [/sarcasm]

There is much to be said about big pharma being in bed with the FDA as well. If anyone feels inclined to read some interesting facts on this subject, please read this:
http://www.google.com/url?sa=t&rct=j...2QQEncdhU_drfw

DNDN is the poster child for manipulation and attack by big pharma, crooked wall street types, and the FDA.