Regulators in the U.K. say they have inspected Ranbaxy Laboratories plants 6 times since getting a heads up in 2006 that U.S. regulators had uncovered shenanigans at the company. They have been there on their own, with the FDA as part of an international team and with regulators from Ireland and Australia. Generally inspectors have found nothing to be concerned with.
The statement from the Medicines and Healthcare Products Regulatory Agency (MHRA) came in response to Ranbaxy pleading guilty to charges in the U.S. that it had in the past manufactured subpar drugs and lied to regulators to hide evidence they didn't meet standards. But the MHRA assures patients that inspections have found no problems to suggest Ranbaxy is still doing that.
"We have no evidence that any of the products on the UK market manufactured by Ranbaxy are or have been of unacceptable quality," the MHRA said. "There is also no evidence that patients in the U.K. have been put at risk. Patients should continue to take their medicines as prescribed by their healthcare professional." It did say that in light of the admissions, it has been consulting with regulators in other countries to figure out if anything more needs to be done.
In May, Ranbaxy pleaded guilty to 7 felonies and agreed to pay $500 million to settle the matter. While the U.S. charges are related to problems the FDA uncovered years ago, there has been an outpouring of concern in India about the safety of Ranbaxy drugs since the May settlement. Some hospitals and the largest pharmacy chain there temporarily suspended use of the drugs, while officials collected information from the company that could reassure uncertain patients. A public interest lawsuit was also filed trying to close down the Ranbaxy plants involved in the U.S. case, but the Supreme Court refused to consider the case because it relied entirely on references to the U.S. case.
The MHRA document outlines inspections the U.K. did in 2006, 2008, 2009 and 2010 and says it continues to monitor operations there through inspections by other EU members. It points to a statement from the World Health Organization (WHO) that also says it has found no problems with drugs currently manufactured by Ranbaxy.
- see the MHRA statement
- here is the statement from the World Health Organization
- read more from The Economic Times