Citing “serious manufacturing deficiencies” at plants belonging to Indian drug manufacturer Ranbaxy, the U.S. Food and Drug Administration has banned import of over 30 different generic drugs from the company.
The Ranbaxy plants under fire are located at Dewas and Paonta Sahib in India.
The FDA also sent out two warning letters to Ranbaxy, the second time the agency has issued a warning letter to this company in less than three years.
According to FDA oficials, the problems at the two Ranbaxy plants relate to deficiencies in the company’s drug manufacturing process including inadequate sterile processing operations, cleaning of equipment used to make drugs, cross-contamination concerns and quality control issues.
The ban excludes Ganciclovir oral capsules because Ranbaxy is the sole supplier of this drug to the U.S.
So if you live in the U.S. (like we do), you might want to think twice before taking any Ranbaxy drugs. Given the high cost of healthcare in the U.S., you just can’t afford to take chances (Apart from the FDA’s seriousÂ concerns, Ranbaxy is also being investigated separately by the U.S. Justice Department).Â
According to the FDA’s director of its Center for Drug Evaluation and Research Janet Woodcock, M.D.:
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. 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.
Until Ranbaxy fixes deficiencies at the two facilities and the plants come into compliance with U.S. specifications, FDA will not approve new drug applications that list the Paonta Sahib or Dewas plants respectively as the manufacturer of active pharmaceutical ingredients or finished drug products.
In its statement, Ranbaxy did not address the specific concerns cited by the FDA in the two letters but claimed:
Ranbaxy 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 company has just received the warning letters that FDA has issued and has not had the opportunity to review those concerns that FDA has determined are unresolved.
The FDA, however, is not removing the Ranbaxy products from the market, and found no evidence to date that the company has shipped defective products.
FDA is asking consumers to continue taking their RanbaxyÂ medications and not disrupt their drug therapy.Â
One of the largest foreign suppliers of generic drugs to the U.S., Ranbaxy makes several drug products including some that compete with drugs made by giant U.S. companies such as Bristol-Myers Squibb.