WHO is aware of the recent actions taken by the USA Food and Drug Administration (FDA) against the Ranbaxy, Paonta Sahib, India manufacturing site. These include the Import Alert and Application Integrity Policy.
All Ranbaxy products prequalified by WHO are manufactured at the site affected by USA FDA actions. As part of ongoing monitoring of this site by WHO, follow-up and routine inspections — which include data verification and assessment for compliance with Good Manufacturing Practices (GMP) — were performed at frequent intervals over recent years (see WHO Public Inspection Reports available at: www.who.int/prequal).
The latest inspection of this site was done in November 2008 by a team of six inspectors — three from WHO Prequalification Programme, one each from Therapeutic Goods Administration (TGA, Australia), Health Canada (Canada) and Medicines and Healthcare products Regulatory Agency (MHRA, United Kingdom). During this inspection, various products destined for different markets were inspected, including verification of source data, quality control, and investigation of computer systems and related data.
Some non-compliances were identified during inspections, however, the corrective actions taken by Ranbaxy Paonta Sahib were evaluated by the inspectors and were, in general, considered to be acceptable. A few minor non-compliances are still being addressed by Ranbaxy.
Currently, WHO has no evidence of any activity by Ranbaxy Paonta Sahib that renders any immediate action to be taken by WHO for any prequalified product from this site. WHO will continue to monitor Ranbaxy (as well as all other manufacturers participating in the Medicines Prequalification Programme) closely to ensure the safety, efficacy and quality of products.
Related Link: USA Food and Drug Administration