Ranbaxy Disappointed By U.S. FDA’s Warning Letters And “Import Alert”

MUMBAI - India's largest drug maker Ranbaxy expressed its disappointment over U.S. FDA's move to issue warning letters and import alerts against drug products manufactured at its sites in Dewas in Madhya Pradesh and Paonta Sahib in Himachal Pradesh.

The U.S. FDA had been investigating serious deviations from Good Manufacturing Practices at the two Ranbaxy plants for the last two years. The U.S. Department of Justice had also issued subpoenas against Ranbaxy in July but the company pleaded for abeyance for 60 days to enable Ranbaxy to furnish the requested documents (Also see "Ranbaxy Will Produce Internal Audits To U.S. DOJ But Warns Of Impact To Industry From "Bad Policy"" - Scrip, 15 Jun, 2008.).

In a press statement issued in Mumbai, Ranbaxy stated, "The company has responded to each concern FDA has raised during the past two years and had thought that progress was being made. We are, however, pleased that FDA's testing and review led the agency to conclude that there is no reason to question the safety or effectiveness of Ranbaxy's drugs."

Expressing the company's commitment to work closely with the drug regulator, Ranbaxy said, "Once it has had an opportunity to review the issues, the company looks forward to continuing to cooperate with FDA to resolve the remaining issues."

Ranbaxy also noted that the FDA action does not include its U.S.-based facilities of Ohm Labs in Brunswick and Gloversville and as much as 59 products are supplied from those facilities. Some of those products include simvastatin, acyclovir, minocycline, clindamycin, lorazepam, loratadine-D, cetirizine, acetaminophen extended-release tablets, lisinopril and zolpidem.

The U.S. FDA in a press release charged that, "the agency concluded that the firm's (Ranbaxy) responses were not adequate and that the warning letter was the appropriate regulatory response." The FDA said that the problems related to the Dewas plant include inadequacies in prevention of cross-contamination of pharmaceuticals, inadequate batch production and control records, and inadequate failure investigations. For the Paonta Sahib plant, the FDA noted that there were inadequate written records, lack of cGMP norms, inadequate batch production and control records followed by Ranbaxy (Also see "Ranbaxy Woes Continue With 30-plus Product Import Alert" - Scrip, 16 Sep, 2008.).

FDA's CDER Office of Compliance Director Deborah Autor said that "until the company addresses these deficiencies, APIs and finished drug products from these plants will remain on the Import Alert, and we will not approve any Abbreviated new Drug Applications or new Drug Applications that list either of the two facilities as the manufacture of APIs or finished products."

- Vikas Dandekar ([email protected])