From
The Washington Post:
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.
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 yesterday, stressing the seriousness of the violations while offering assurances that the risk to the public is essentially zero.
"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.
Among the problems were "inadequate sterile processing operations"; failure to keep certain areas from being contaminated with compounds that can cause allergic reactions in some people; and inadequate record-keeping.
The company will not be able to export any of the 28 drugs to the United States until the deficiencies are fixed. In the interim, the FDA also will not consider any new drug applications for substances made at the two plants.