By Arun Kumar, IANS,
Washington : The US has banned import of more than 30 generic drugs, including popular antibiotic Cipro and cholesterol pill Zocor, made by India’s Ranbaxy Laboratories Ltd, citing poor quality in two of its factories.
The ban imposed by the US Food and Drug Administration (FDA) Tuesday does not stop US sales by the Indian drug major and only blocks imports of generic drugs and pharmaceutical ingredients made at Ranbaxy’s Dewas and Paonta Sahib plants in India.
FDA inspections earlier this year found violations at the two sites 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 wouldn’t approve for sale any new products made by Ranbaxy at the two plants until the manufacturing violations are corrected. Ranbaxy is one of the largest foreign suppliers of generic drugs to the US.
The blocked drugs include: the antibiotics ciprofloxacin and clarithromycin; the antiviral acyclovir; cholesterol-lowering simvastatin and pravastatin; and the diabetes drug metformin.
Two FDA warning letters issued to Ranbaxy Tuesday, listing its concerns about deviations from US current Good Manufacturing Practice (cGMP) requirements, suggest the problems at the two suspect plants relate to deficiencies in the company’s drug manufacturing process.
The FDA said “action does not involve removing products from the market” as the agency has no evidence to date that Ranbaxy has shipped defective products, but it “will continue to monitor the situation”.
The FDA ban also does not impact products from Ranbaxy’s other plants. FDA said it has inspected those facilities and, to date, they have met US cGMP requirements for drug manufacturing.
The FDA said enough number of other generic companies make the blocked drugs so there should be no shortages, with one exception – Ganciclovir oral capsules, an antiviral drug used to treat an eye infection called cytomegalovirus that is common in HIV patients.
FDA is making this exception to avoid creating a shortage of because Ranbaxy is the sole supplier to the US of this product. But FDA plans to arrange for additional oversight and controls until the manufacturing issues are resolved.
“With this action, we are sending a clear signal that drug products intended for use by American consumers must meet our standards of safety and quality,” said Janet Woodcock, director, FDA’s Centre for Drug Evaluation and Research (CDER).
“The FDA has notified other agencies and health care professionals to make them aware of today’s actions so that they can take appropriate action and advise patients as needed.”
This is the second time in less than three years that FDA has issued a warning letter to Ranbaxy. In 2006, FDA cited Ranbaxy for violations of US cGMP at its Paonta Sahib facility.
Tuesday’s action against the Indian drug major 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.
The FDA move also could affect a US programme that funds AIDS drugs for Africa as Ranbaxy is one supplier of the low-cost generics being used. The FDA said it had notified charities and officials involved in the AIDS drug programme of its concerns about drug quality.
The Ranbaxy warning comes amid mounting concern in the US about the safety and effectiveness of imported drugs.
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.