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Health Canada Asks for Quarantine of Drugs From Indian Plant Under Investigation

Fri, 02/27/2009 - 4:04am
By Helen Branswell TORONTO — An Indian pharmaceutical firm has agreed to a Health Canada request to quarantine all drugs coming into Canada from a manufacturing plant alleged to have falsified data and test results. Health Canada said Thursday that Ranbaxy Canada has agreed to place a hold on all drugs coming into the country from the Paonta Sahib manufacturing facility. Health Canada revealed the move in a brief end-of-day email in response to questioning from The Canadian Press. The questions were provoked by a statement issued Wednesday by the U.S. Food and Drug Administration. The FDA said it was halting review of new drug applications involving the Paonta Sahib plant because it had evidence of data falsification. Health Canada provided no details of how many or what type of drugs Ranbaxy Canada imports to this country. Nor did it offer advice to people who might be taking those drugs. "Health Canada is taking appropriate actions to mitigate the potential risks to the health and safety of Canadians," said the response, sent by spokesperson Alastair Sinclair. "Following Health Canada's request, Ranbaxy Canada has quarantined all products imported into Canada from the Paonta Sahib site." "Health Canada continues to review all information to determine if there is a risk to health or whether further regulatory action is required." Requests for clarification were met with the response that no more information would be forthcoming from Health Canada on Thursday. A call to Ranbaxy's Mississauga office was answered by a receptionist who said the office was closed for the day. The company's Canadian website lists a variety of drugs presumably sold in this country, including generic versions of some statins (cholesterol-lowering drugs), a schizophrenia medication, some antibiotics and a diabetes drug. Health Canada's online drug database lists 58 licences for Ranbaxy Pharmaceuticals Canada Inc., but some appear to be for multiple formulations or strengths of some drugs. The FDA announced it was halting review of drug applications from Ranbaxy Laboratories because it had evidence the Paonta Sahib manufacturing site had falsified data and test results for both already approved drugs and some that are the subject of pending applications. The FDA statement said it had no evidence there was anything wrong with the drugs. It also said it had not identified any health risks associated with currently marketed Ranbaxy products. The U.S. drug regulator recommended that patients not disrupt their drug therapy because to do so could jeopardize their health. It said individuals concerned about their medications should talk with their health-care professional. The Paonta Sahib facility has been under an FDA import alert since last September. Wednesday's statement from the U.S. drug agency said it had invoked its application integrity policy against the Paonta Sahib facility. "The FDA's investigations revealed a pattern of questionable data raising significant questions regarding the reliability of certain applications," said Deborah Autor, director of the FDA's center for drug evaluation and research's office of compliance. The FDA statement said the policy applies only to data generated by the Paonta Sahib plant, though the halt of application review also covers some drugs made in the United States that rely on data from the facility under investigation. Last September, the FDA issued two warning letters and instituted an import alert barring entry of all finished drug products and active pharmaceutical ingredients from Ranbaxy's Dewas, Paonta Sahib and Batamandi Unit facilities due to violations of U.S. current Good Manufacturing Practices requirements. The FDA statement released Wednesday said that action — which barred the commercial importation of 30 different generic drugs into the United States — remains in effect. Following last fall's FDA move, Health Canada sent a letter to Ranbaxy's Canadian subsidiary requesting an action plan and a response to the FDA warning letter.
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