The deal with FDA is subject to the approval of the court and will cost Ranbaxy US$500 million to solve the company’s outstanding regulatory problems. The company hopes it will be sufficient to resolve all potential civil and criminal liability.

Ranbaxy’s problems with FDA stem back to good manufacturing practice (GMP) violations identified by FDA at its Indian Dewas and Paonta Sahib manufacturing plants. Due to these GMP violations, FDA introduced a US import ban on 30 products from Ranbaxy in 2008. Then in early 2009, FDA halted review of drug applications for drugs manufactured at the Paonta Sahib plant, alleging that Ranbaxy had falsified data [1].

The consent decree is ‘unprecedented in scope’ according to the Department of Justice and involves Ranbaxy bringing in third-party auditors for four facilities, and this can be expanded to other plants if future inspections reveal compliance or data integrity issues.

Ranbaxy has also had to agree to relinquish any 180-day marketing exclusivity that it may have for three pending generic drug applications, and the drugmaker has also had to agree to relinquish any 180-day marketing exclusivity that it may have for several additional generic drug applications if it fails to meet certain decree requirements by specified dates, according to FDA.

Ranbaxy has apparently taken ‘systematic corrective steps’ in order ‘to upgrade and enhance the quality’ of its business and manufacturing processes and get back on track with FDA.

The Daiichi Sankyo subsidiary has stated that it is also ‘committed to the utmost levels of professionalism and integrity, and to ensuring that all Ranbaxy facilities meet the high standards that patients, prescribers and the public expect from a leading global generic pharmaceutical company’, according to Mr Arun Sawhney, Ranbaxy CEO and Managing Director. He added that ‘we look forward to continuing to work cooperatively with the FDA to strengthen the public trust in our company.’

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Reference

1.  GaBI Online - Generics and Biosimilars Initiative. Ranbaxy to launch generic atorvastatin on time [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Feb 10]. Available from: www.gabionline.net/Generics/News/Ranbaxy-to-launch-generic-atorvastatin-on-time