FDA Bans Imports of 28 Indian-Made Drugs

The Food and Drug Administration said yesterday that it was halting importation of 28 drugs made by the giant Indian generic drug maker Ranbaxy Laboratories because of manufacturing deficiencies at two of the company's plants.
Douglas Throckmorton, a physician with the FDA's Center for Drug Evaluation and Research, said there was "no evidence of harm to consumers" from drugs made at the Dewas and Paonta Sahib plants, both in India. He called the import ban "a preventive action."
FDA officials said numerous tests of the drugs have found they are not contaminated, sub-potent or unsafe and urged patients taking the drugs not to stop.
The drugs on the list include numerous antibiotics and antivirals, as well as medicines for high cholesterol, diabetes, high blood pressure, seasonal allergies and acne.
FDA officials said the action is not expected to disrupt availability of the medicines to U.S. consumers. All but one -- oral capsules of the antiviral drug ganciclovir -- are made by other companies. Supplies of that medicine will be allowed in after batch-by-batch testing and assurances by the company on the manufacturing process.
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