FDA Blocks Imported Drugs from India’s Ranbaxy
The U.S. Food and Drug Administration has blocked the import of generic drugs made by the Indian company Ranbaxy Laboratories Ltd. citing violations encountered during an inspection earlier this year and poor quality in two of its factories. The generic drugs affected include the generic version of the antibiotic Cipro and cholesterol pill Zocor as well as any pharmaceutical ingredients made at the two plants in India. Further blocked drugs are the antibiotics clarithromycin, the antiviral acyclovir, the cholesterol drugs simvastatin and pravastatin and the diabetes drug metformin. During investigation of the two plants the FDA found violations that could lead to contamination, allergic reactions and other problems and Ranbaxy has not taken the proper steps to correct them, said Deborah Autor, director of FDA’s compliance office. In addition to the import block 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. However, the FDA told consumers not to worry and not to quit using the generic drugs because as yet repeated testing has found no evidence of contamination, 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 the suspect factories or at one of Ranbaxy's numerous other factories in 11 countries.
