The Hindu Business Line : US blocks 30 Ranbaxy drugs

New Delhi, Sept. 17 In a blow to Ranbaxy Pharmaceuticals Ltd, the US Food and Drug Administration has blacklisted about 30 generic drugs being manufactured by the company at its Dewas and Paonta Sahib plants in India.

The US drug regulator said that it had taken the decision after the two units owned by Ranbaxy failed to meet the standards specified under the current Good Manufacturing Practice (cGMP) requirements of the US Government.

While the FDA has not imposed a ban on the drugs or sought a withdrawal of the medicines from US drugstores, it has issued an Import Alert, under which US officials may detain any products manufactured at these Ranbaxy facilities. The decision will have significant impact on Ranbaxy’s revenues as some important products are being manufactured in these two units including Ciprofloxacin HCl (anti-bacterial), Simvastatin (anti-cholesterol), Valacyclovir HCl (for skin disease) and Ofloxacin (antibiotic). “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 Ms Janet Woodcock, M.D., Director, FDA’s Center for Drug Evaluation and Research. The FDA, however, added that Ranbaxy was free to sell the same drugs in the US if it was manufactured from any of its other plants.

‘Disappointed’

Ranbaxy said it was disappointed with the decision. “The company has responded to each concern which FDA has raised during the past two years. 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. 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 as unresolved. Once it has had an opportunity to review the issues, the company looks forward to continuing to co-operate with FDA to resolve the remaining issues.”

‘Minimal impact’

Ranbaxy said the impact on revenues would be minimal since about 10 of the 30 drugs on the FDA’s list are also being manufactured from its plants in the US itself. While the FDA acknowledged that it has no evidence that Ranbaxy has shipped defective products, it has informed the company that until Ranbaxy resolves the deficiencies at each of the two facilities it will not approve any New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) that list the Paonta Sahib or Dewas plants as the manufacturer.

Lone exception

The US regulator exempted one drug product, Ganciclovir oral capsules (an antiviral drug), being manufactured in the two facilities since Ranbaxy is the only company that sells the drug in the US. “To avoid creating a shortage of the drug, FDA generally will not detain shipments of this product, and plans to arrange for additional oversight and controls until the company resolves these manufacturing issues,” the FDA said.

Earlier in March this year, the drug regulator had sent its inspectors to the two units and found deficiencies in the manufacturing processes. In mid-April and May, Ranbaxy responded in writing to these findings.

“Ultimately, FDA concluded that the firm’s responses were not adequate and that the warning letters were the appropriate regulatory response,” the US drug regulator said.

List of drugs

Related Stories:
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We’re committed to high quality generics: Ranbaxy
Ranbaxy refutes allegations by US Govt
Ranbaxy: Uncertainty about USFDA investigation
Ranbaxy consolidated Q2 profit flat at Rs 160 cr

More Stories on : Pharmaceuticals | Regulatory Bodies & Rulings | Standards & Benchmarks | Ranbaxy Laboratories Ltd

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