Umamageswari Maruthappan
Fresenius Kabi Oncology Limited (FKOL), an Indian Drug Manufacturer admitted of its guilty of destroying and concealment of records during an inspection. The admission was made before the Federal Court in Las Vegas, Nevada on 9th February 2021.
According to the charge, the company has violated the requirements of Federal Food, Drug and Cosmetic Act by concealing records to the US Food and Drug Administration (FDA) investigators. The CBI in India had also assisted the Department during investigation.
“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,” said the Justice Department. FKOL has to now pay Rs. 50 Million as fine and for forfeitures.
US Attorney Nicholas A. Trutanich for the District of Nevada said that “Pharmaceutical companies that obstruct FDA inspections jeopardise patient safety.”
FKOL’s plant in Kalyani, West Bengal makes Active Pharmaceutical Ingredients (APIs) for cancer drug products which are distributed in the US. However, during an US FDA in 2013, the company allegedly hided all the necessary reports and also have destroyed some relevant information.