The Sri Lankan Ministry of Health is currently investigating the sale of counterfeit drugs to the government by a company called Isolez Biotech Pharma AG. This has raised serious concerns about the quality of medicines available to patients in the country.
The investigation began after hospitals reported receiving batches of immunoglobulin that appeared to be fake. Further investigation revealed that Isolez had also sold counterfeit Rituximab, a monoclonal antibody used to treat certain autoimmune diseases and types of cancer.
The NMRA’s former CEO has also referred to a third medication that was bought from Isolez based on a fake waiver of registration. This suggests that the problem may be more widespread than previously thought.
Isolez owner Hewage Sudath Janaka Fernando is currently in remand and has reportedly told the CID that his company manufactured the immunoglobulin locally with plasma from the NTBS. This is despite stating in documents submitted to—and endorsed by—the Health Ministry that the raw materials would be imported from India.
Health Ministry officials ;
No action has been taken against health officials who made the payments to the company, either for the immunoglobulin or the Ritumaxib. It also remains unclear whether the Indian Credit Line was used for the purchases.
The Health Ministry is also investigating how many waivers were issued by the NMRA since last year, when its board delegated sole authority for issuing waivers to the CEO. This decision has been questioned by some, as it may have made it easier for companies like Isolez to obtain approval for fake drugs.