U.S. regulator prohibited manufacture of drugs from Ranbaxy’s Mohali plant
The U.S. Food and Drug Administration (FDA) has issued an import alert on drugs made at the Mohali plant of troubled India-based pharmaceuticals giant Ranbaxy following reports that during an inspection, a tablet was found to contain an embedded black fibre that could have been a hair from an employee’s arm or tape fragments.
In a statement posted on its website this week, the U.S. regulator said it subsequently prohibited the manufacture of drugs from Ranbaxy’s Mohali plant so far as U.S. supplies were concerned, and that Ranbaxy would remain on the import alert until it complied with standard U.S. drug manufacturing requirements.
Earlier this year, Ranbaxy made headlines after the U.S. Department of Justice announced that the firm had pled guilty to felony charges relating to selling adulterated drugs and agreed to pay $500 million in a settlement to resolve allegations of false claims, quality violations and false statements to the FDA.
The settlement came after a series of investigations of Ranbaxy plants in Dewas and Paonta Sahib beginning in 2006, that did not see however lead to the FDA pulling back drugs already on the market. In February 2009, the FDA imposed an Application Integrity Policy that effectively closed down further drug applications from Ranbaxy.
This week reports, including by Reuters, said that documents suggested that the black fibre embedded in the tablet was likely either “tape remnants on the nozzle head of the machine or a hair from an employee's arm that could be exposed on loading the machine.” The FDA’s latest decree saw Ranbaxy shares crash 35 per cent at one point on Monday’s trading.
Ranbaxy was quoted saying that it would review the details of the FDA import alert and take “all necessary steps to resolve the concerns,” at the earliest, adding that the FDA conducted inspections at Mohali in 2012 and that since then “the company believes that it has made further improvements at its Mohali facility.”
Even as recently as June 2013 Ranbaxy CEO Arun Sawhney’s had assured that the Mohali plant was meeting regulatory standards, saying on one occasion, “We will resume supplies of atorvastatin for U.S. pharmacies and retail market, manufactured at the Mohali facility over the next few months. We have not done so [till now] because of commercial reasons.”
Neither the U.S. nor the Indian regulators have prosecuted top Ranbaxy officials, including the former owners of the company, brothers Malvinder and Shivinder Singh, who sold the company to Japanese Daiichi Sankyo Co in 2008 for $2 billion.
U.S. regulator says Ranbaxy will remain on the import alert until it complied with standard U.S. drug manufacturing requirements