Indian drugmaker to pay $50mn fine, forfeiture in US for irregularities

A cancer drugmaker 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 50 million in fines and forfeitures according to the Justice DepartmentThe admission made by Fresenius Kabi Oncology Limited FKOL was made public in the federal court in Las Vegas Nevada on Tuesday the Department saidThe 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 30 million and 20 million in forfeitures according to the DepartmentActing Assistant Attorney General Brian Boynton said FKOLs conduct put vulnerable patients at riskBy hiding and deleting manufacturing records FKOL sought to obstruct the FDAs regulatory authority and prevent the FDA from doing its job of ensuring the purity and potency of drugs intended for US consumersThe Department acknowledged the help of Indias Central Bureau of Investigation saying it provided invaluable assistance to US authorities in the investigation of this matterJust 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 documentsIts employees removed computers hardcopy documents and other materials from the premises and deleted spreadsheets that had evidence of the plants violations according to court documentsThe Department said that at the Kalyani plant FKOL made active pharmaceutical ingredients APIs used in various cancer drug products distributed in the USFKOL appears to have connections to a German multinational company although it is listed on the National Stock Exchange in IndiaA warning letter was sent by the FDA on December 4 2017 about the findings f an FDA inspection that year of the FKOLs Kalyani plant to Mats Henrikkson the CEO of Fresenius Kabi in Bad Homburg GermanyAccording to the company history on FKOLs website it began as a part of Dabur Pharma and in 2008 the Burman family promoters of the Dabur Pharma Group divested its entire stake in Dabur Pharma Ltd to Fresenius Kabi a business segment of Fresenius SE amp Co KGaA a German Multinational with business interests across the globeThis story has been sourced from a third party syndicated feed agencies Midday accepts no responsibility or liability for its dependability trustworthiness reliability and data of the text Midday managementmiddaycom reserves the sole right to alter delete or remove without notice the content in its absolute discretion for any reason whatsoever