Ranbaxy Laboratories Ltd, which recently settled the long-pending case with USFDA by agreeing to pay USD 500 million, has now landed into a fresh trouble with health ministry ordering a probe into company's documents.
According to a media report, health ministry had ordered Drugs Controller General of India (DCGI) to examine all the documents of Ranbaxy on the basis of which it had received approvals in the past and sources in health ministry revealed that company could face severe penalty if found guilty.
Business Standard on Wednesday quoted a health ministry official as saying that "We have to look at the whole thing very comprehensively. DCGI has been asked to go through the US order in detail and then examine the documents, dossiers and approvals to Ranbaxy in India. The regulator will evaluate all documents to see whether there has been any compromise in safety, quality, efficacy, or even in submitting data for seeking approvals."
Last week Ranbaxy, which pleaded guilty to making fraudulent statements to the USFDA about how it tested drugs at two of its Indian plants, agreed to pay a criminal fine and forfeiture totalling USD 150 million and USD 350 million for civil claims in order to resolve fraud allegations made in a whistle-blower's lawsuit and federal criminal charges.