Sun Pharmaceutical Industries’ subsidiary in the US has reached a resolution with the Department of Justice (DOJ) on the promotion of Levulan Kerastick (aminolevulinic acid HCL) and BLU-U®.
Under the civil settlement agreements signed with the DOJ, Sun’s subsidiary DUSA Pharmaceuticals Inc will pay $20.75 million (over ₹150 crore) to resolve allegations related to the promotion of these products, the company told the Bombay Stock Exchange. In fact, Sun Pharma had made a provision of ₹156.36 crore in its consolidated financial statement for the three months ended March-2020 for the settlement, the company said.
This was a fallout of a complaint filed by a former employee in September 2016. “DUSA had already made a provision towards this in its Q4 financials for the year ended March 31. The settlement does not constitute any admission by DUSA of any liability or wrongdoing,” the statement added.
As part of the resolution, DUSA and Sun Pharmaceutical Industries Inc have entered into a corporate integrity agreement with the Office of Inspector General of the US Department of Health and Human Services. The agreement supplements SPII’s existing compliance program, which is based on established best practices and industry standards as well as the company’s global code of conduct.
Under the settlement agreement, the DOJ has agreed not to bring any action seeking to exclude DUSA or SPII from participating in Federal health care programs, the company said. In a separate agreement, DUSA also fully resolved all allegations made by the former employee.