Updated on 17 October 2013
Tangles related to drug regulation are not new for Indian drug makers. Although drug giants in India have received more than 100 generic drug approvals from the FDA in 2013, this year will be remembered for Ranbaxy Laboratories' $500 million legal settlement with the US Department of Justice and the US FDA.
In May, the Indian generic drug major pleaded guilty to over seven US felony charges and made, what has come to be known as, one of the biggest pharmaceutical settlements. The company acknowledged that it had held back data from the US drug regulator and sold adulterated drugs in the US market.
Further inspections by the US FDA then led to an import letter being issued to Ranbaxy's two major manufacturing units in India including, Dewas in Madhya Pradesh and Paonta Sahib in Himachal Pradesh. The company's CEO, Mr Arun Sawhney, had then said, "When you are a major player for the US market, you will also have larger number of inspections."
The company, which clocked over $1 billion in US sales alone in 2012, probably didn't foresee any trouble. Even as imports remain banned from two of Ranbaxy's units, late during September 2013, the US FDA blacklisted Ranbaxy Laboratories' Mohali plant for quality issues. The FDA suspected that a black fiber, which was found embedded in a Ranbaxy tablet, could have been an employee's arm hair.
Daiichi Sankyo, the Japanese majority stakeholder of Ranbaxy Laboratories, has for the first time come forth to address the issue. The company said that it will work with the US FDA to resolve drugs quality issues.