Thursday, July 12, 2012

Generic Drug Plant Caught Falsifying Data

The FDA has ordered a halt to approvals of drugs relying on data from a generic drug factory in India that was found to be falsifying data. "We took this action after it became apparent that this facility was submitting falsified scientific data in applications for FDA approval of marketed drugs in the United States," said Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research. The facility in question, Paonta Sahib, is operated by Ranbaxy Laboratories, one of the largest makers of generic drugs for the United States. The Paonta Sahib lab, along with another facility in Dewas, India, was also involved in a September scandal, in which the FDA placed a hold on importation of 30 products from the plants due to suspected contamination during the manufacturing process. Now Paonta Sahib has been implicated in supplying false data -- such as fake shelf life figures -- in applications for approval of its generic drugs. In response, the FDA has placed a hold on the approval or consideration of any new applications involving the plant. The applications on hold include approval for drugs manufactured in the United States using data from the plant as well as for drugs manufactured at the plant itself -- including generic versions of currently approved drugs and drugs not currently marketed in the United States. The FDA is also seeking confirmation that no Ranbaxy products currently manufactured in the United States relied for their approval on data from the Paonta Sahib plant. These products include the cholesterol drugs imvastatin (also known as simvastatin) and pravastatin (a generic form of Pravachol), and the antihistamine pheniramine (a generic form of Avil). The agency cautioned patients taking these drugs not to stop using them without consulting a physician first. No reports of harm have been received from Ranbaxy products made at Paonta Sahib or in the United States, according to Deborah Autor, director of the Center for Drug Evaluation and Research's Office of Compliance. Source -

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