For years, regulators around the globe have been touting the challenges and benefits of globalization, explaining that a globally diverse product supply chain means needing to rely on regulatory partners to ensure that products are safe for consumption. Now UK regulators are learning a related lesson: A scandal that affects products intended for one country may well affect more than just one regulatory authority.
On 13 May 2013, Ranbaxy Laboratories pled guilty in US court to three felony charges: making false claims about its products, manufacturing products not in conformity with current good manufacturing practices (CGMPs), and making false statements to the US Food and Drug Administration (FDA).
The fine was notable for both its size and topic: $500 million, the largest-ever fine paid by a generic pharmaceutical company, and the largest false claims case ever prosecuted in the state of Maryland, where FDA is headquartered.
Details about the violations were scarce at the time of the settlement's announcement, but it was clear that the company had been forced to withdraw dozens of generic drug applications as a result of the case, and that the problems had been chiefly related to data quality issues.
Those problems, however, were put on full display in an investigation published by Fortune magazine, which revealed that the problems at Ranbaxy were more extensive than anyone had previously revealed. In particular, the investigation revealed that the company had systematically buried or falsified test results regarding the quality of their generic drug products, in some cases distributing drugs that did not work as intended.
And that fraud, the investigation alleged, was far more widespread and affected many more products than just those distributed to the US.
MHRA: 'No Evidence' of Quality Failures
While US regulators have been largely spared from additional questioning, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has found itself forced to put out a statement regarding the allegations made therein, and in particular to defend its regulatory oversight record.
"We have no evidence that any of the products on the UK market manufactured by Ranbaxy are or have been of unacceptable quality," the agency said in a statement. They added that they have worked with other regulators to review the allegations made against Ranbaxy and to conduct on-site inspections and sample products produced at the plants. The results from these inspections have been "satisfactory," it said.
However, MHRA added that it is currently reviewing whether "any further action is deemed appropriate." The regulator explained that its investigations had not found any products manufactured by the company to be of "unacceptable quality" outside of some non-compliance issues related to current good manufacturing practices (CGMPs).
Critically, MHRA said it had tested samples of the company's products found in the market in the UK. The Fortune investigation had alleged that the company had routinely offered regulators samples of the innovative manufacturer's own product, which was smuggled back to India from sources around the world. This testing method would seem to be a more reliable barometer of the true quality of the product.
MHRA added that no patients taking drugs manufactured by Ranbaxy should stop taking their medicines unless directed to do so by their prescribing physician.
MHRA Statement on Ranbaxy