The U.S. Food and Drug Administration barred Ranbaxy from importing more than 30 medicines made in two factories by the Indian drugmaker, including generic versions of the popular antibiotic Cipro and the cholesterol pill Zocor, because of deficiencies in manufacturing processes. The drugs on the list include numerous antibiotics and antivirals, as well as medicines for high cholesterol, diabetes, high blood pressure, seasonal allergies and acne. The FBA said these actions were "proactive measures" that the agency was taking in order to assure that all drugs that reach the American public are manufactured according to cGMP requirements.
Ranbaxy Laboratories Ltd., India’s biggest drugmaker, issued a statement saying that the company is "very disappointed in the action FDA has taken today. The company has responded to each concern FDA has raised during the past two years and had thought that progress was being made." The Indian company said the FDA hasn’t given enough time to address the issues raised in the latest letter. The agency also issued warning letters to Ranbaxy for failing to meet acceptable manufacturing standards at two plants in India.
"The company looks forward to continuing to cooperate with FDA to resolve the remaining issues," the statement read.
The FDA stated that they were seeking major improvements by the food industry to make food allergen labeling more clear for consumers. This measure comes as a result of worries about the safety and effectiveness of imported drugs.
The agency said earlier this year it found manufacturing violations at the company’s factories in Dewas and Paonta Sahib in central and northern India.
The FDA said it wouldn’t approve any new products for sale by Ranbaxy until the manufacturing violations are corrected, the Associated Press reported.
Last year, Ranbaxy’s sales in the U.S. accounted for 23 percent of Ranbaxy’s total revenues.
There is no evidence the Ranbaxy drugs are harmful, though the violations could lead to defective products, Deborah M. Autor, director of the FDA’s drug compliance office, said on a conference call with reporters yesterday. "The nature of the violations really relates to the [manufacturing] process," Autor said. "We did not find any defects in the products themselves." Among the problems were "inadequate sterile processing operations"; failure to keep certain areas from being contaminated with compounds that can cause allergic reactions in some people; and inadequate record-keeping. The agency told consumers they could keep using the drugs they had at home. Patients who are concerned about their medications should discuss their concerns with their health care professional.
Meanwhile, Ranbaxy is also the focus of a separate criminal investigation into whether it submitted fraudulent data to the FDA that allowed sale of substandard drugs. The company has denied the accusations.
Ranbaxy is India’s biggest pharmaceutical company and one of the 10 biggest producers of generic drugs in the world.
"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, M.D., director, FDA’s Center 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."
