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More downs than ups for Ranbaxy Posted 29/06/2012

A further problem with Indian generics manufacturer Ranbaxy Laboratories (Ranbaxy) could affect its reputation yet again with US FDA. This time, Ranbaxy fell foul of an Indian state regulator, the Maharashtra FDA (FDA, Maharashtra State, India). The Indian crack-down on Ranbaxy follows in the wake of a consent decree issued by US FDA in January 2012 which tightens scrutiny of Ranbaxy’s quality control and reporting measures.

Ranbaxy, whose best-selling generic product is a version of Pfizer’s blockbuster cholesterol-lowering drug Lipitor (atorvastatin), had its operations suspended for four days from 18 to 21 June 2012 with a ban on selling, manufacturing or marketing its products in Maharashtra State. According to reports from India, Ranbaxy was in breach of regulations for ‘not maintaining proper storage conditions’.

But this penalty ‘was not enough punishment rendered for such a gross violation of law’, according to Mr Narendra Jain, General Secretary of the Maharashtra Chemists & Distributors Federation.

This is not good news for Ranbaxy, with the news of yet another run in with regulators likely to be taken as a sign that Ranbaxy continues to have difficulty adhering to regulations.

In January 2012, US FDA took the unprecedented step of filing for a consent decree of permanent injunction against Ranbaxy after a series of misdemeanours, including falsification of data and failure to maintain good manufacturing standards at three facilities in India and one US facility at Gloversville, New York, USA [1]. Ranbaxy paid a hefty US$500 million fine, and had to agree to new measures to ensure the validity of data contained in new applications made to FDA, including the appointment of an independent authority to review and audit data relating to the facilities in question.

FDA issued advice to patients in the US that they‘should not be concerned that any drugs from those facilities are currently in the US market.’

Ranbaxy has reaped US$600 million in revenue from the sale of generic atorvastatin since Pfizer’s patent expired in November 2011. However, its market share could sink as other generics manufacturers enter the scene following the end of Ranbaxy’s 180-day marketing exclusivity on 30 May 2012.

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1.  GaBI Online - Generics and Biosimilars Initiative. Ranbaxy consent decree with FDA submitted to court [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Jun 29]. Available from: www.gabionline.net/Generics/News/Ranbaxy-consent-decree-with-FDA-submitted-to-court

Source: Business Standard, FDA, Pharmabiz, The Economic Times

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