Drug maker Ranbaxy Laboratories, which recently pleaded guilty of making fraudulent statements to the US Food and Drugs Administration and agreed to pay $500 million as penalty, now believes the worst is over and it is set to make a new beginning by re-establishing credibility among all its stakeholders and customers.
“I personally feel the worst is behind.
"My colleagues feel determined to deal with the situation,” Ranbaxy CEO & Managing Director Arun Sawhney told Business Standard in his first interview since the US penalty.
“If we do the right things, if we establish our credibility and if we stand by what we are saying, our credibility will only get stronger”.
The US FDA, during its inspection of Ranbaxy’s manufacturing facilities in India, between 2006 and 2008, had found violations, incomplete testing records and an inadequate stability programme, besides manufacturing practices that did not follow regulations.
Following such inspections, in September 2008, the regulator had imposed an import alert on Ranbaxy’s key Indian facilities at Paonta Sahib and Dewas, along with a ban on 30 products approved from these units.
In December 2011, the company signed a consent decree with the US FDA to undertake a series of corrective measures at these facilities.
According to Sawhney, the new management has introduced proper checks and balances in the system to ensure the issues of past are addressed and do not get repeated.
“I can stand behind every pill of Ranbaxy in any corner of the world and say these are in line with submissions made in those markets, they are of the standards that conform with the submissions made,” Sawhney emphasised.
“Never in future should there be a question on our compliance or quality. . . This is how I want the new culture of Ranbaxy to be built on.”
Sawhney, who took charge of Ranbaxy as MD in August 2010, says the company had already taken many corrective measures by then.
“The processes were very sound at that time. I think a lot of self assessment, a lot of introspection and correction that was required at that time had probably happened before I joined the company.
"When I came in and saw, the processes were all very right. . . for quality control, documentation, I did not see people wanting to flout.” Sawhney was re-designated CEO & MD of the company in August 2011.
Asked whether the company anticipated the impact of pleading guilty and whether it could have handled things differently, Sawhney said the move is in the best interest of all shareholders.
He said the company was confident of sailing through by putting in place best practices and processes.
Image: Arun Sawhney, Ranbaxy CEO and Managing Director | Photograph: Courtesy, Ranbaxy
