New York: According to the statement of Justice Department, a cancer drug-maker in India has admitted to destroying and concealing records before an inspection of its plant in West Bengal by US authorities and agreed to pay USD 50 million in fines and forfeitures. The admission made by Fresenius Kabi Oncology Limited (FKOL) was made public in the federal court in Las Vegas, Nevada, on Tuesday, the Department said.

The company admitted that it was guilty of the charge of violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to US Food and Drug Administration (FDA) investigators and would pay a criminal fine of USD30 million and USD20 million in forfeitures, according to the Department. Acting Assistant Attorney General Brian Boynton said: "FKOL's conduct put vulnerable patients at risk.

"By hiding and deleting manufacturing records, FKOL sought to obstruct the FDA's regulatory authority and prevent the FDA from doing its job of ensuring the purity and potency of drugs intended for US consumers." The Department acknowledged the help of India's Central Bureau of Investigation, saying it "provided invaluable assistance to US authorities in the investigation of this matter".

Just before an FDA inspection of its manufacturing facility in Kalyani, West Bengal, in 2013, the drugmaker "management directed employees to remove certain records from the premises and delete other records from computers that would have revealed FKOL was manufacturing drug ingredients in contravention of FDA requirements", according to court documents.

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