The US Food and Drug Administration has blocked the import of more than 30 Ranbaxy drugs that have been manufactured in two plants in India after concerns were raised about the manufacturing practice.
The agency issued two Warning Letters to the generics drug maker yesterday and issued an Import Alert to detain at the US border any drugs manufactured at Ranbaxy’s Dewas and Paonta Sahib facilities. This is the second time in less than three years that the FDA has issued a Warning Letter to Ranbaxy.
The Warning Letters identify the agency’s concern about deficiencies and deviations from US current Good Manufacturing Practice requirements at the two Indian plants. The extent and nature of the violations led to the issuing of the Import Alert, the FDA said in a statement.
“These actions are proactive measures that the FDA is taking in order to assure that all drugs that reach the American public are manufactured according to cGMP requirements. While this action does not involve removing products from the market, FDA has no evidence to date that Ranbaxy has shipped defective products. We will continue to monitor the situation,” the agency said.
According to the FDA investigations of the Dewas facility, there were problems regarding inadequate prevention of the potential for cross-contamination of drugs, inadequate batch production and control records, inadequate failure investigations, and inadequate sterile processing operations.
Investigations at the Paonta Sahib facility found lack of controls to follow cGMP, inaccurate written records of the cleaning and use of major equipment, incomplete batch production and control records, and inadequate procedures for the review and approval of production and control records for drug products.
Ranbaxy responded to the FDA’s findings but the agency concluded the firm’s responses were not adequate thereby requiring the Warning Letters.
Ranbaxy, one of the largest foreign suppliers of generics to the US, received a further hit yesterday after also being informed by the FDA that until it resolved the deficiencies at the two facilities, no New Drug Applications or Abbreviated New Drug Applications will be approved should they list that either of the affected plants will manufacture the active pharmaceutical ingredient or the finished drug product.
The announcements do not impact products from Ranbaxy’s other plants, which currently meet cGMP requirements.
Dr Janet Woodcock, Director of the FDA’s Centre for Drug Evaluation and Research said: “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.”
In response, Ranbaxy released a statement saying: “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. We are, however, pleased that FDA’s testing and review led the agency to conclude that there is no reason to question the safety and effectiveness of Ranbaxy’s drugs.”
The company said it had not had a chance to review the concerns listed in the Warning Letters, but once reviewed “the company looks forward to continuing to cooperate with FDA to resolve the remaining issues.”
The FDA has evaluated whether the actions would create drug shortages in the US and has determined other suppliers can meet the demand. However, shipments of the antiviral Ganciclovir oral capsules will not be detained as Ranbaxy is the sole supplier to the US. Plans will be arranged for additional oversight and controls until the company resolves the manufacturing issues.
