Mumbai: The United States Food and Drug Administration has banned the import of more than 30 generic drugs, including antibiotics and cholesterol medicines, produced by Ranbaxy Laboratories at two of its plants in India, alleging ''serious'' manufacturing deficiencies.
The FDA banned import of the drugs saying the poor quality control at the firm's factories could be harmful to users of the drugs used to treat high cholesterol, Type 2 diabetes and everyday allergies.
The banned drugs include Ranbaxy's popular generic equivalents for antibiotic Cipro and cholesterol reducing Zocor and Metformin as also the generic used for the treatment of Type 2 diabetes and the allergy fighting generics for Claritin and Alavert.
The issued warning letters to Ranbaxy and an import alert for the generic drugs manufactured at Ranbaxy's Dewas and Paonta Sahib plants, which, the agency said,
relate to deficiencies in the company's drug manufacturing process.
The FDA, however, said these actions are proactive measures taken to assure that all drugs that reach the American public are manufactured according to the current good manufacturing practices (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 in a press release.
The import alert issued by the FDA empowers customs authorities to detain 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 at the US border.
The measures, however, would 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, the sole supplier to the US of Ganciclovir oral capsules (an antiviral drug), is one of the largest foreign suppliers of generic drugs to the United States.
''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,'' she added.
FDA said its inspection, in early 2008, of Ranbaxy's Dewas facility had found that the facility's beta-lactam containment programme (measures taken to control cross-contamination) was inadequate to prevent the potential for cross-contamination of pharmaceuticals; kept inadequate batch production and control records; laxity in failure investigations (investigation done to address any manufacturing control or product rejection to determine the root cause and prevent recurrence); and had inadequate aseptic (sterile) processing operations.
FDA said the inspection also found that Ranbaxy's Paonta Sahib facility lacked assurance that responsible individuals were present to determine the firm was taking necessary steps under cGMP; kept inaccurate written records of the cleaning and use of major equipment; lacked complete batch production and control records; and that procedures for the review and approval of production and control records for drug products were inadequate.
FDA said it had also provided Ranbaxy with a separate list of inspectional findings for each of the facilities.
Ranbaxy had since responded in writing to these findings in lengthy submissions to FDA. The current measures followed an evaluation of the findings and Ranbaxy's responses, and the firm's overall inspectional history.
FDA said Ranbaxy's responses were inadequate and that the warning letters were the appropriate regulatory response.
''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," said Deborah M Autor, director, CDER's Office of Compliance, FDA.
This is the second time in less than three years that the 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, however, said it will continue to work with Ranbaxy to resolve the issues.
Reacting to the FDA decision, Ranbaxy said it ''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 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 are unresolved. 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.''
''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 said in a statement.
The warning letters and Import Alert do not apply to Ranbaxy's other facilities, including its three manufacturing facilities in the US, Ohm's Laboratories facilities in New Brunswick, NJ, North Brunswick, NJ, and Gloversville, NY, from which Ranbaxy delivers some 59 drug products to the US healthcare system, including: Simvastatin, Acyclovir, Minocycline, Clindamycin, Lorazepam, Loratadine-D, Cetirizine, Acetaminophen Extended release tablets, Lisinopril and Zolpidem.
Ranbaxy Laboratories Limited, now a part of Japanese drug major Daiichi Sankyo, is India's largest pharmaceutical company. An integrated, research based, international pharmaceutical company, Ranbaxy produces a wide range of quality, affordable generic medicines.