US inspection of Ranbaxy plant triggered crisis

The genesis of the current crisis for Ranbaxy stems from a USFDA (Food and Drugs Administration) inspection carried out at the company's manufacturing facility at Paonta Sahib in Himachal Pradesh (HP) in February 2006.

Post-inspection, the FDA had issued a warning letter to Ranbaxy citing apparent violations of FDA regulations at the facility. Soon after, Ranbaxy appointed US-based consultancy Parexel to help the company understand the good manufacturing practices of the FDA.

Nearly 12 separate reports on Ranbaxy's Paonta Sahib operations were prepared. According to Ranbaxy, two of these documents were directly relevant to FDA's expressed concerns.

In the meetings with FDA that followed, Ranbaxy disclosed that Parexel had conducted two audits directly relevant to FDA concerns.

In January 2007, the US Department of Justice conducted a search at Ranbaxy's US facilities and seized documents which included some of the documents prepared by Parexel as part of its quality improvement audit for Ranbaxy. By then, it was clear that FDA was seeking complete documents related with Parexel's audits from the company.

Towards 2007-end, FDA informed Ranbaxy that it will not clear applications for drug manufacturing approvals from Paonta Sahib facility unless FDA has access to Parexel's complete audit. Ranbaxy obliged and provided all the documents to the FDA.

According to Ranbaxy's response filed in the US court in Maryland two days ago, it has taken a decision to stop making confidentiality claims on these data and provide the entire audit details to FDA.

The US Department of Justice, in its motion filed on July 3, had in fact sought the same "� two specific draft standard operating procedures (SOPs), details on the Toansa plant and the API facilities of Paonta Sahib, validation protocols and reports for two products and certain quality control procedures, detailed by Parexel.

Ranbaxy said that the US government already has hundreds of thousands of pages of Ranbaxy documents. It also says that it has waived its privileges or rights over all audits conducted by Parexel and there is no dispute requiring adjudication by the court.