FDA takes aim at generic drug imports — and Ranbaxy

by Anne Law, September 19th, 2008, 6:30 am

The FDA, seeking to build up its reputation for protecting the public, is asserting greater authority over drug imports, and the target this time is Indian pharmaceutical firm Ranbaxy.

India’s top drugmaker has made headlines several times this year. In June, it agreed to sell a majority of its shares to Japanese firm Daiichi Sankyo. The following month brought the news that the Department of Justice is investigating the possibility that Ranbaxy sold substandard drugs in the US and other markets.

This week’s announcement that the FDA has banned some 30 generic products manufactured at two of Ranbaxy’s facilities in India casts an even wider shroud over the company’s recent success in the generic drug industry. According to the FDA, the Ranbaxy plants have failed to meet good manufacturing standards during inspections. And although none of the drugs recently sourced to the plant have come up contaminated, the FDA intends to ban imports from those facilities until the company meets standards.

Ranbaxy is understandably displeased that its name is being raked through the mud, and it has even hired former New York Mayor Rudy Giuliani’s consulting firm to help it resolve the FDA’s issues. The company seems to think it was already addressing the FDA’s concerns, but the FDA started warning Ranbaxy in 2006 and obviously felt that the changes it requested were not being made quickly enough.

Recent concerns over contaminated imports require response, both to solve the problem and to reassure American consumers that the FDA is on the job. Ranbaxy appears to be the perfect target, with its growing size and recent allegations of substandard products.

It may be that the regulatory agency is looking to make an example of Ranbaxy, or it may be that Ranbaxy is truly the most heinous offender –- either way, the case should spur other drug importers to improve their processes or face losing US revenues.