The Sri Lankan Health Ministry is once again in questionable action. It has allowed the import of drugs with the use of forged documents. The same company that supplied the government health supplies with counterfeit human immunoglobulin in March 2023 have repeated their performance. It is highly suspected that the fraudulent purchase has been carried out with insider assistance.
The company, Isolez Biotech Pharma AG, has used forged waivers of registration (WoR) containing the forged signature and stamp of the chief executive officer of the National Medicines Regulatory Authority (NMRA) to secure these tenders.
One of the medications is a monoclonal antibody called Rituximab, which is used to treat certain autoimmune diseases and types of cancer. It was immediately withheld from use when a hospital reported the batch to the NMRA after noticing that the information printed on the box was similar to that on the immunoglobulin packages. The other medication has not yet been supplied.
The NMRA is now expeditiously limiting the issuance of WoRs, which allows medicines and devices to be imported with minimal or no regulatory oversight. The regulator says that WoRs became common due to last year’s economic collapse, which led to a lack of funds to secure medications, necessitating quick approval to avoid shortages.
However, the recent incidents of counterfeit drugs have raised concerns about the safety of the country’s drug supply.