Oops, They’re In Trouble Again – Ranbaxy Labs Import Alert
September 16th, 2013 // 3:20 pm @ jmpickett
Latest FDA and cGMP Compliance News
In a massive setback for the embattled Ranbaxy Laboratories, FDA last week sent out an import alert on the products that are made at a plant in Mohali, India. This is one year after getting an F grade during an FDA cGMP inspection. This disclosure has sent the firm’s stock into a nose dive, because this particular plant is a very important producer of exported medicines to the United States.
FDA Import Alert for Ranbaxy for cGMP Problems
The FDA import alert states that Ranbaxy is not meeting cGMP practices, but no more details are offered at this time.
The import alert is four months after Ranbaxy settled with DOJ in the US to pay $500 million, as a settlement for civil and criminal charges that were related to its cGMP manufacturing scandal that went on for years. It involved two other Indian plants, and they continue to be under an FDA import alert. The company also entered into an FDA consent decree as part of its attempt to get back in the agency’s good graces.
FDA charged that Ranbaxy used raw ingredients from sources that were not FDA approved. It also stated that Ranbaxy Labs faked in house testing data, and concealed such activities from FDA auditors, by faking records. This episdoe really damaged confidence in Ranbaxy operations, and it raises many concerns about the safety of the global drug supply chain.
So, Ranbaxy basically engaged in a big cover up for almost 10 years to increase profits and to keep an edge as a maker of low cost generic drugs. Scientists apparently were told to fake and manipulate data, and employees were made to carry brand name drugs into India, and misleading statements were made by top Ranbaxy officials.
During the last months, more fall out has rained down on the company, as the Indian government ordered a top to bottom review of the firm’s operations. A big hospital in India banned its drug products. And, Daiichi Sankyo, which bought the firm for $4.5 billion, is now suing the founding family of the firm for not disclosing all of the cGMP problems.
The plant in Mohali is seen as very important in the turn around for the company, especially because the Dewas and Paonta Sahib plants that are in the consent decree are under import alert.
The Mohali facility has been expected to make valsartan, which is a generic form of Diovan, which is a heart drug made by Novartis. Ranbaxy won a 180 day exclusivity, and it had been thought to get approval a year ago.
