The FDA has banned imports of 28 drugs manufactured by Ranbaxy Laboratories after it discovered quality issues at two manufacturing facilities. Ranbaxy is one of world’s largest generic drug manufacturers. Its corporate offices are in Gurgaon, India.
The FDA has found no evidence that consumers have been harmed and views its move to be preventative in nature. In particular, FDA tests revealed no evidence of contamination, incorrect potency or unsafe ingredients in drugs produced at offending facilities.
The FDA instituted the prohibition after finding ineffective sterilization procedures, inadequate protections against contamination from allergy-causing ingredients, and incomplete records at the plants.
The FDA can inspect facilities of companies that export products to the US, but it has no regulatory control over them. All it can do is prohibit companies from exporting to the US.
The FDA has been hassling Ranbaxy about its production processes since 2006. Ranbaxy has addressed many but not all issues that the FDA had raised.
The prohibited drugs include those for diabetes, high cholesterol, allergies, acne and high blood pressure. The only drug not produced by other generic manufacturers is ganciclovir. This medication will be allowed into the US after careful inspection and additional assurances from Ranbaxy.
Ranbaxy’s response to the ban is here.