WebMD Medical News
Louise Chang, MD
Sept. 16, 2008 -- The FDA today slapped an import alert on generic drugs
made at two plants in India run by Ranbaxy Laboratories Ltd. of India.
But the FDA recommends that consumers keep taking their Ranbaxy drugs.
"To date, we have seen no evidence of harm to consumers from drugs
produced at these two facilities and have no reason to believe that drugs
already in the U.S. from these plants pose a safety problem," Douglas
Throckmorton, MD, deputy director of the FDA's Center for Drug Evaluation and
Research, said today at a news conference.
The import alert focuses on manufacturing practices at two Ranbaxy
facilities -- one in Dewas, India, and the other in Paonta Sahib, India. The
problems, summed up in two FDA warning letters issued today, include inadequate
sterile processing operations and inadequate written records of the cleaning
and use of major equipment.
Even so, FDA officials say they haven't found any problems with Ranbaxy
drugs made at those facilities. Ranbaxy's other drug-making facilities aren't
part of the import alert.
Ranbaxy is one of the largest foreign suppliers of generic drugs to the U.S.
The FDA's import alert covers more than 30 different genetic drugs. A
full list of those drugs is posted on the FDA's web site.
One Ranbaxy drug, ganciclovir oral capsules (an antiviral drug), is exempt
from the import alert because Ranbaxy is its sole supplier to the U.S. The FDA
is asking Ranbaxy to take extra steps to make sure ganciclovir oral capsules
meet the FDA's standards.
The FDA doesn't expect the import alert to result in any drug shortages
because except for ganciclovir, there are other drugmakers that can meet the
need for those drugs in the U.S., notes Throckmorton.
This is the second time in less than three years that the FDA has
issued a warning letter to Ranbaxy. In 2006, the FDA cited Ranbaxy for
violations of good manufacturing practices at Ranbaxy's Paonta Sahib, India
In a statement emailed to WebMD, Ranbaxy says it is "very
disappointed" in the FDA's action. Ranbaxy says it "has responded
to each concern FDA has raised during the past two years and had thought
that progress was being made. We are, however, pleased that FDA's testing and
review led the agency to conclude that there is no reason question the safety
or effectiveness of Ranbaxy's drugs."
Ranbaxy says it "looks forward to continuing to cooperate with
FDA to resolve the remaining issues" at the two Indian plants
noted in the import alert. Ranbaxy also confirms that the company's other
facilities, three of which are in the U.S., aren't subject to the FDA's warning
SOURCES:News release, FDA.Douglas Throckmorton, MD, deputy director, Center for Drug Evaluation and
Research, FDA.News release, Ranbaxy Laboratories Ltd.
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