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FDA Bans Import of Ranbaxy Generic Drugs

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The U.S. Food & Drug Administration (FDA) has banned 30  potentially defective generic drugs made by Indian drug-maker Ranbaxy Labs from import to the U.S. In addition to the import alert, the FDA said it won’t approve any drug applications that list the two suspect Ranbaxy plants as a source of ingredients.  FDA officials said patients shouldn’t stop taking needed medicines, and maintained they haven’t found any problems with Ranbaxy drugs currently sold in the U.S.

In the past, the FDA has come under fire for its approach to problems at Ranbaxy facilities.  The agency found quality problems in February 2006 during an inspection in India, but  said then they didn’t believe the deficiencies justified an import alert.

The FDA’s decision to ban imports from the two Ranbaxy factories was made because of the agency’s concerns about the “seriousness and extent” of violations of manufacturing standards at the facilities.  Officials said they are concerned about whether the practices employed at the facilities could ensure purity of drugs they made.

According to the FDA, the ban applies to generic versions of  popular medicines such as the anticholesterol drug Zocor; Acyclovir, which treats herpes; the heartburn pill Zantac; and AIDS drugs. The agency says it does not expect a drug shortage because the medicines can be supplied by other generics makers.

The FDA did say that it was excluding one Ranbaxy medication from the import ban – the AIDS drug called Ganciclovir.  Ranbaxy is the only company to supply Ganciclovir to the U.S., and the agency says it wants to avoid a shortage.

Based in India, Ranbaxy is one of the 10 largest generic-drug producers in the world and has been operating in the States since 1995.In July, US prosecutors filed a motion in federal court in Maryland alleging that Ranbaxy forged documents relating to an investigation into the quality of the company’s drugs sold in the this country.  The investigation is also looking into allegations that Ranbaxy  made weak or adulterated HIV drugs that were given to thousands of AIDS patients in Africa. Prosecutors have accused the company of concealing violations of good manufacturing practice regulations from FDA.

The filing followed a February raid by of the company’s the US corporate offices in New Jersey, and a  manufacturing facility in the state by Federal agents.  The raid – and criminal investigation – was prompted, in part, by problems uncovered in FDA inspections a year earlier at the company’s plant in Paonta Sahib, India.  That inspection found inconsistencies in the company’s manufacturing processes and maintenance of data.

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