The Food and Drug Administration said Tuesday 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 FDA's Center for Drug Evaluation, said there was “no evidence of harm to consumers” of drugs made at the Dewas and Paonta Sahib plants, both in India. He characterized the import ban as “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.
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FDA officials said the action is not expected to disrupt availability of the medicines to American 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 that it is being made properly.
Ranbaxy is India's biggest pharmaceutical company and one of the 10 biggest producers of generic drugs in the world.
FDA officials walked a delicate line Tuesday, stressing the seriousness of the violations while offering assurances that the risk to the public is essentially zero.
“We believe this step is warranted because of the seriousness and the extent of the violations,” said Deborah Autor, director of the office of compliance at the Center for Drug Evaluation and Research.
She added, however, that “all the products that we have tested met specifications” and there is “no reason” to consider them hazardous.
“The nature of the violations really relates to the (manufacturing) process,” Autor said. “We did not find any defects in the products themselves.”
The FDA inspects the factories of foreign drug companies seeking to sell products in the United States.
Because the plants are on foreign soil, the agency has no direct regulatory control over them. Its only leverage is to ban importation of the substances.
The Justice Department is investigating Ranbaxy for allegedly submitting fraudulent data to FDA as part of its application for approval to sell certain AIDS drugs to organizations funded by the Bush administration's $15-billion President's Emergency Program for AIDS Relief.
One of the drugs on Tuesday's list is the antiretroviral AZT.