Ranbaxy CEO Arun Sawhney says stringent steps taken to meet USFDA concerns:

Leading pharmaceutical company Ranbaxy has been in the news for all the wrong reasons for many months now. Products from three of its manufacturing units - at Paonta Sahib, Dewas and most recently, Mohali - have drawn the ire of the US Food and Drugs Administration (US FDA). Business Today has been exhaustively covering the developments. Ranbaxy CEO Arun Sawhney has now written a detailed mail to editors providing his perspective on the matter and outlining the road ahead.

"I would like to assure you that the issues that were raised by the US FDA in 2012 have been addressed and we have taken stringent steps to ensure that we meet all US FDA concerns," says the letter. "Since the last inspection by the US FDA at Mohali in 2012, Ranbaxy has strengthened its management, manufacturing and monitoring systems and processes, to ensure quality and compliance in all areas."

The letter goes into some detail about the background of the controversy. "As you would know, on September 16, 2013, Ranbaxy received a communication from the US FDA about an import alert on its Mohali plant. The US FDA also advised that the Mohali plant will be subject to certain terms of the consent decree (CD), filed in late January 2012 for Ranbaxy's Paonta Sahib and Dewas plants. We are assessing the terms and practical applications of this CD... We will continue to work closely with the US FDA on remediating the issues at our Mohali facility and will take all necessary measures to keep our facilities in full compliance to all global regulations. We are focusing on resuming submissions and supplies to the US from our Mohali plant once we satisfy the US FDA stipulations."

What about the other two plants? "In terms of the CD with the US FDA for its Paonta Sahib and Dewas plants, we are committed to further strengthen procedures and policies to ensure data integrity and to comply with current good manufacturing practices (cGMP). So far we have met all obligations under the CD and are making good progress in its implementation. We will continue to invest in R&D to enrich our global product pipeline and install state-of-the-art technologies at our manufacturing facilities. We have a pipeline of new products including First-To-File (FTF) product exclusivities and the Company will seek to maintain the value of its product portfolio," the letter says.

Sawhney reminds that Ranbaxy is far from having been barred from the US market due to the controversies. "In the last two years, Ranbaxy has launched several products in the US including Atorvastatin, AbsoricaTM, Desvenlafaxine, Cevimeline (Evoxac) and continues to market to the US Federal Government," he says. So too, the company has had significant developments in India and elsewhere. "In India, we launched the first New Chemical Entity (NCE), SynriamTM for the treatment of malaria and we are now working towards taking this product to other developing countries. In the emerging markets of Africa, Latin America, CIS and Asia, Ranbaxy continues to provide a wide range of World Health Organisation prequalified (WHO PQ) ARVs in addition to supplying high quality generic medicines. About 1 million patients worldwide use Ranbaxy's ARV products for their daily treatment needs."

On the products sold by the company, he says that he wants to reassure "that all Ranbaxy products being supplied in India and globally are safe and efficacious. Ranbaxy remains strongly committed to providing high quality, affordable drugs to patients in India and other parts of the world. We are guided by our philosophy of 'Quality and Patients First', and will uphold the highest quality standards that patients, prescribers, government and all other stakeholders expect from Ranbaxy."