The generic drug giant Ranbaxy falsified data on shelf life and efficacy on products made in their Paonta Sahib plant in India, the FDA said in a press conference today (Feb.26). In response, the FDA has invoked a regulatory action called the Application Integrity Policy (AIP). Until the company complies with the FDA, the "FDA will stop all scientific review of pending applications at Paonta Sahib, and no new applications will be reviewed," said Doug Throckmorton, a supervisory medical officer at the agency. Ranbaxy fudged data on the shelf life of the drugs by reporting that it had tested compounds at room temperature when products were actually stored in a refrigerator, said Deborah Autor, director of the Office of Compliance at the FDA. In addition, it tested data at different time points than claimed in drug applications. The FDA has found no evidence that the breaches affected the effectiveness or...
Interested in reading more?
Become a Member of
Receive full access to more than 35 years of archives, as well as TS Digest, digital editions of The Scientist, feature stories, and much more!