Ranbaxy forged data, test results: FDA
Washington, Feb 26: The US Food and Drug Administration (FDA) accused of Ranbaxy Laboratories, India's pharma giant, manipulating data and laboratory tests for generic drugs that had been approved for sale in the United States at its Himachal Pradesh facility.
FDA investigators said that the problems centered on the company's plant in Paonta Sahib, which has produced 25 drugs that have been approved by the FDA. Most of those medications are not thought to be on US pharmacy shelves; since Sep, Ranbaxy has been prevented from exporting more than two dozen drugs to the United States. The FDA is not seeking a recall, because regulators do not believe the drugs pose a health risk.
"There is no concern about the safety or efficacy of Ranbaxy's drugs on the US market," said Deborah Autor, director of compliance at the FDA. The affected drugs include medications for high cholesterol and an antihistamine, but the FDA would not provide a specific list. Patients using the drugs should not stop, said Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research. But federal officials said they were concerned enough by their investigation into Ranbaxy's Paonta Sahib plant that they decided to halt approvals of any new or pending applications from the company.