The United States Food and Drug Administration on Tuesday banned the import of more than 30 generic drugs manufactured by Ranbaxy Laboratories Limited alleging that poor quality control at the firm's factories could be harmful to users of these medications used to treat everything from high cholesterol to Type 2 diabetes to everyday allergies.
Among the drugs banned from Ranbaxy are the popular generic for the antibiotic Cipro to the generic for the cholesterol reducing Zocor and Metformin, the generic used for the treatment of Type 2 diabetes to the popular allergy fighting generics for Claritin and Alavert.
FDA issued two warning letters to Ranbaxy and an import alert for generic drugs produced by Ranbaxy's Dewas and Paonta Sahib plants in India.
The letters identify the agency's concerns about deviations from US' current Good Manufacturing Practice requirements.
Under the import alert officials have the right to detain, at the US border, any active pharmaceutical ingredients -- the primary therapeutic component of a finished drug product -- and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities.
The problems at these two Ranbaxy plants relate to deficiencies in the company's drug manufacturing process. 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," a press release from the FDI said.
However, the announcement does not impact products from Ranbaxy's other plants which the FDA had inspected and have found up to the standard.
"We recommend that consumers continue taking their medications manufactured by Ranbaxy and not disrupt their drug therapy, which could jeopardise their health. Patients who are concerned about their medications should discuss their concerns with their health care professional," the FDI said.
Ranbaxy is one of the largest foreign suppliers of generic drugs to the United States. The company makes a number of drug products.
The FDA Import Alert covers more than 30 different generic drug products (Drug List) produced in multiple dosage forms and dosage amounts ( i.e., 25 mg, 50 mg, and 100 mg) at these two locations.
FDA has evaluated whether these actions would create any potential drug shortages in the United States, and has determined that other suppliers can meet market demand, with one exception.
Ranbaxy is the sole supplier to the US of Ganciclovir oral capsules (an antiviral drug). 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.
"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 Janet Woodcock, MD, director, FDA's Center for Drug Evaluation and Research. "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."
FDA's inspection, in early 2008, of Ranbaxy's Dewas facility found:
- The facility's beta-lactam containment program (measures taken to control cross-contamination), which appeared inadequate to prevent the potential for cross-contamination of pharmaceuticals;
- Inadequate batch production and control records;
- Inadequate failure investigations; (A failure investigation is done to address any manufacturing control or product rejection to determine the root cause and prevent recurrence); and,
- Inadequate aseptic (sterile) processing operations.
It's inspection, also in early 2008, of the Paonta Sahib facility concluded:
- The lack of assurance responsible individuals were present to determine the firm was taking necessary steps under 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.
Following the two inspections, FDA provided Ranbaxy with a separate list of inspectional findings for each of the facilities.
In mid-April and May, Ranbaxy responded in writing to these findings in lengthy submissions to FDA. The agency then evaluated its findings, Ranbaxy's responses, and the firm's overall inspectional history, an evaluation that required substantial time due to the complex scientific and technical nature of both the identified deficiencies, particularly at the Dewas site, and the firm's responses.
Ultimately, FDA concluded that the firm's responses were not adequate and that the warning letters were the appropriate regulatory response.
"Today's actions are clearly warranted by the serious violations established by FDA's investigations at these two sites," said Deborah M. Autor, director, CDER's Office of Compliance, FDA. "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 manufacturer of APIs or finished drug products."
This represents the second time in less than three years FDA has issued a warning letter to Ranbaxy. In 2006, FDA cited Ranbaxy for violations of US cGMP at its Paonta Sahib facility.
The FDA said will continue to work with Ranbaxy's Dewas and Paonta Sahib plants to resolve these issues.
Consumers and health-care professionals can report adverse events to FDA's MedWatch program at 1-800-FDA-1088; by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787; or online, at the following Internet address: www.fda.gov/medwatch/report.htm.
