September 23, 2013
For the third time in five years, the U.S. Food and Drug Administration has blocked imports of medicine from a Ranbaxy Laboratories Ltd. plant in India for manufacturing violations.
The latest ban involves a Ranbaxy plant in Mohali, which is the company’s newest manufacturing facility. The plant manufactures generic forms of popular drugs including the blood-pressure medicine Diovan and the stomach-ulcer medicine Nexium.
In November 2012, Ranbaxy stopped production of generic Lipitor after tiny pieces of glass were found in the tablets. The company resumed production in 2013 when Ranbaxy began producing the drug within the United States.
The Department of Justice has been using the False Claims Act, with the help of whistleblowers, to crack down on pharmaceutical plants to ensure they are producing safe products. Phillips & Cohen partner Erika Kelton discusses the issue in her article “Filthy Pharma: Justice Department Taking ‘Especially Hard Look’ At Manufacturing Plants.”