USFDA bans import of Ranbaxy drugs

Washington, Sept 17 : The Food and Drug Administration (FDA) of the United States has banned the import of 28 drugs made by Ranbaxy Laboratories, India's giant generic drugs maker, due to manufacturing lapses at its Dewas and Paonta Sahib plants.

Numerous antibiotics and anti-virals, as well as medicines for high cholesterol, diabetes, high blood pressure, seasonal allergies and acne drugs figure on the FDA list.

Terming the ban as a preventive action and not harmful to consumers, FDA officials said numerous tests of the drugs have found that they are not contaminated, sub-potent or unsafe and urged patients taking the drugs not to stop.

Douglas Throckmorton, a physician with the FDA's Center for Drug Evaluation and Research, while calling the import ban "a preventive action," said, "There is no evidence of harm to consumers from drugs made at the Dewas and Paonta Sahib plants."

Stressing the seriousness of the violations while offering assurances that the risk to the public is essentially zero, Deborah M. Autor, director of the office of compliance at the Centre for Drug Evaluation and Research, said, "We believe this step is warranted because of the seriousness and the extent of the violations."

However she added, "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 and we did not find any defects in the products themselves," said Autor.

Earlier, the FDA had sent two warning letters, the first in 2006, informing the Ranbaxy management that inspectors had found numerous deviations from current good manufacturing process.

Autor said, "Since then, we've done a lot of work with the company to correct the deficiencies. But many persisted, so the agency took the next step."

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 were cited as some of the problems.

The FDA inspects the factories of foreign drug companies seeking to sell their products in the United States. As 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.

Ranbaxy, India's biggest pharmaceutical company and one of the 10 biggest producers of generic drugs in the world, will be unable 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.

ANI