US fines Indian pharmaceutical company Rs 364 crore, poses risk to patients

- The company admitted to destroying the record

New delhi date. Wednesday, February 10, 2021

The US has slapped a fine of Rs 364 crore on an Indian pharmaceutical company. FKOL has pleaded guilty to concealing information and destroying records, according to a U.S. Justice Department report. The company was accused of destroying several records in 2013 when a US Food and Drug Administration (FDA) team arrived at the company's office to investigate.

According to a report by the US Department of Justice, the company has pleaded guilty and agreed to pay a fine of Rs 364 crore. The case was filed in federal court in Nevada. The FKOL company was accused of violating the US Federal Food, Drug and Cosmetics Act.

According to the U.S. Department of Justice, some information was withheld from the FDA and records were deleted during drug investigations for U.S. consumers. This posed a risk to the patients.

According to documents submitted to the court, FKOL manufactures drugs at Kalyani in West Bengal. The company manufactures materials for cancer drugs. According to the US allegations against the company, management officials asked staff to remove some records before the FDA team arrived. The records show that the company manufactures drugs against FDA rules.

According to the US Department of Justice, FKOL staff deleted data from the computer and also lost hardcopies of several documents. The U.S. government has said it will continue to prosecute companies that violate FDA rules.