US bars 30 generics from India drug giant
WASHINGTON - The government closed US borders yesterday to more than 30 generic drugs - including popular antibiotics and cholesterol medicines - made by India's biggest pharmaceutical company, citing poor quality in two of its factories.
The Food and Drug Administration's move doesn't end US sales by Ranbaxy Laboratories Ltd. Instead, it blocks imports of generic drugs - including generic versions of the antibiotic Cipro and cholesterol pill Zocor - as well as pharmaceutical ingredients made at the two suspect plants.
FDA inspections earlier this year found violations that could lead to contamination, allergic reactions, and other problems, and the company hasn't taken proper steps to correct them, said Deborah Autor, director of FDA's compliance office.
Also, the FDA said it won't approve any new products for sale by Ranbaxy until the manufacturing violations are corrected. India has become one of the world's leading suppliers of generic drugs, and concern about Ranbaxy has been growing since FDA inspectors first uncovered quality problems at one of its factories in 2006.
The FDA told consumers who have Ranbaxy products at home not to worry or quit using them: Repeated testing hasn't found any contaminated products, just the threat of them if factory conditions don't improve. Also, it would be hard for a patient to tell if drugs were made at one of Ranbaxy's factories that follows FDA rules or at the two in question, which are in Dewas and Paonta Sahib, India.
Among the blocked drugs: the antibiotics ciprofloxacin and clarithromycin; the antiviral acyclovir; cholesterol-lowering simvastatin and pravastatin; and the diabetes drug metformin.
The showdown is separate from a continuing criminal investigation of whether Ranbaxy submitted fraudulent data to the FDA that allowed sale of substandard drugs. Ranbaxy has vigorously denied that allegation, calling it part of a conspiracy to undermine the company. A call to Ranbaxy's US headquarters yesterday was not immediately returned.
A 2007 report found FDA inspectors haven't visited two-thirds of foreign drug manufacturers - and in July, members of Congress began probing whether the FDA knew that Ranbaxy had provided potentially fraudulent information but approved its products anyway.