Feds Ban Ranbaxy Generics

Imports of more than 30 generic drugs made by India’s Ranbaxy Laboratories have been banned by the Food and Drug Administration, citing concerns about the safety of the company’s production processes. The FDA also noted that it would not approve applications for any drugs that listed the Ranbaxy plants as a source of ingredients.

Some Washington observers see the FDA action as a response to criticism by lawmakers that it has acted too slowly against the company. Agency inspectors first uncovered quality violations at Ranbaxy plants in February of 2006, but until recently claimed that the problems did not justify an import ban.

Although the FDA found no evidence of unsafe drugs in the US, it said that it acted because of the “seriousness and extent” of the violations of safety standards at Ranbaxy’s plants. The ban will affect imports of generic versions of Zocor, Zantac, the herpes drug Acyclovir, and several AIDS medications. The agency noted that there should be no shortages of medicines, since other generic drug makers are able to step in to provide the drugs. The FDA did make an exception for Ganciclovir, a key AIDS medication, to avoid a possible shortage. Ranbaxy is the only supplier of the drug in the US.

With worldwide sales of $1.62 billion last year, including $400 million in the US, Ranbaxy is India’s largest drug maker and among the largest manufacturers of generic drugs in the world. The company is also the subject of a probe by the US Department of Justice involving charges that it made substandard generic drugs.