Potentially defective generic drugs made at two Ranbaxy Laboratories plants in India have been banned from the U.S. by federal regulators. According to the U.S. Food & Drug Administration (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.
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 February, federal agents raided the US corporate offices of Ranbaxy in New Jersey, as well as a manufacturing facility in the state. 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.
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 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.
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.
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.
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.
In a letter written to the FDA this July, Rep. John Dingell and Rep. Bart Stupak, both Michigan Democrats who head up the House Committee on Energy and Commerce, wrote that court documents related to the Justice Department probes of Ranbaxy indicated that for 18 months the FDA was aware of problems but “did nothing to remove the suspect products from the market, or even notify the pharmacists in this country”.
“If true, these statements would call into serious question whether the leadership of the Agency … [has] met even the minimum requirements” of the FDA’s primary mission under the Federal Food Drug and Cosmetic Act, the letter said.