FDA Bans Generic Drug Imports From Ranbaxy Laboratories in India
September 19, 2008
With the recent string of tainted products produced in China, there has been growing concern in the United States over the issue of importation. And in light of the recent contaminated Heparin tragedy, the concern pertains to the importation of prescription drugs, as well as drug components manufactured overseas and imported into the United States.
Perhaps in response to the growing concern over U.S. drug importation, the U.S. Food and Drug Administration (FDA) banned imports of more than 30 generic drugs made in India by Ranbaxy Laboratories Ltd. In banning the generic drugs’ importation, the FDA cited safety concerns over Ranbaxy’s production practices.
The import ban affects generic versions of several popular medicines, including Zocor, the anti-cholesterol drug; Acyclovir, the herpes treatment drug; Zantac, the heartburn pill; and various AIDS drugs. Because these drugs can be supplied by other generic drug manufacturers, the FDA does not expect a medicine shortage.
The FDA said that while it has not found any safety problems in drugs manufactured by Ranbaxy and imported into the U.S., it acted out of concerns about the “seriousness and extent” of manufacturing standards violations at two Ranbaxy plants in India.
Ranbaxy is India’s largest drug manufacturer by sales and is among the world’s biggest generic-drug makers. In 2007, Ranbaxy had world-wide sales of $1.62 billion, with nearly $400 million in the United States. Tokyo-based Daiichi Sankyo Co. has made an offer to take over Ranbaxy in a $4.6 billion deal that is awaiting Indian government approval.
Despite the current Ranbaxy import ban, the FDA said it will allow Ranbaxy to continue to import an important AIDS drug called Ganciclovir in order to avoid a shortage. Ranbaxy is the sole supplier of Ganciclovir in the United States. Additionally, the FDA stated it will not approve any new drug applications that list the two suspect Ranbaxy plants as a source of ingredients.
The FDA is currently under fire from U.S. lawmakers who say the agency acted too slowly against Ranbaxy. Although the FDA found quality problems at Ranbaxy’s Indian plants in February 2006, the agency claims it wasn’t until recently that the deficiencies justified an import alert.
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