MSF statement on FDA warning to Ranbaxy

Use of Ranbaxy products in MSF Projects

Médecins Sans Frontières (MSF) takes all questions or concerns about quality of medicines extremely seriously, and will continue to monitor developments in current US Food and Drug Administration action surrounding Ranbaxy products.

As a result of an ongoing evaluation of deviations from current U.S. Good Manufacturing Practice (cGMP), the US Food and Drug Administration (FDA) has issued a warning to Ranbaxy with regards to its Indian manufacturing sites at Dewas and Paonta Sahib. The agency has also blocked the importation of products manufactured at these sites into the US. Importantly, the FDA will not issue a recall of existing products in the U.S. market and it has stated that there is no evidence that Ranbaxy has shipped defective products. The FDA has also stated that patients should not stop taking their medications. In fact they have allowed for the continued importation of another generic drug known as ganciclovir from the Dewas site so as not to cause shortages.

MSF currently purchases antiretrovirals and other essential drugs from several companies, including the manufacturing sites named in the FDA action. In keeping with the FDA recommendations, MSF strongly urges patients not to interrupt their treatment.

It is important to note that the WHO Prequalification of Medicines Program (WHO PQ), which consists of international regulatory and Good Manufacturing Practice experts, has performed several inspections at the Ranbaxy Paonta Sahib site—most recently in June 2008, and has made a statement today confirming the Paonta Sahib site is considered to be operating at an acceptable level of compliance. There will be no amendments to the currently listed WHO PQ products at this stage. WHO PQ is further investigating the questions raised by the US FDA.

MSF has based their approval of Ranbaxy antiretrovirals on the approval of the WHO pre-qualifications and through marketing authorization in Europe as well as on approval through MSF’s internal validation process.