India’s Largest Pharmaceutical Maker Lied about Test Results for Two dozen of its generic drugs
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Jessica SmagaczFebruary 27, 2009 10:14 AMAccording to U.S. regulators, “India’s largest pharmaceutical maker lied about test results for more than two dozen of its generic drugs,” reports the Associated Press.
Officials from Ranbaxy’s Paonta Sahib plant falsified data on drugs submitted to the FDA. Because of this, FDA said Wednesday “it will halt any consideration of new drugs from Ranbaxy’s Paonta Sahib plant.
Just six months ago, FDA closed U.S. borders to more than 30 generic drugs at that same plant and another Indian plant where inspectors “uncovered manufacturing problems.”
Ranbaxy has been under investigation for about a year by regulators who have revealed the company didn’t properly test the shelf-life and other measures of its drugs. Along with this, they lied about the results to the FDA. Apparently, Ranbaxy officials refrigerated drugs undergoing tests and then said they had stored them at room temperature.
However, all 25 drugs that have been affected by the problems have likely reached the U.S. Regulators say that “the September import ban means it has been months since new pills reached pharmacy shelves.”
FDA says that “they have no evidence the drugs are dangerous and recommended patients continue taking their prescriptions.”
The company has three other plants in India that import drugs into the U.S. Those drugs include low-cost versions of cholesterol drugs and antibiotics.
Deborah Autor, director of drug compliance said, “Companies must provide truthful and accurate information to the FDA, and when they don’t, there will be some serious consequences.”
In recent years, India has “become one of the world’s leading suppliers of generic drugs.”