The Health Ministry of Sri Lanka has turned to the Attorney General for guidance regarding the issues surrounding Isolez Biotech Pharma AG Ltd, a pharmaceutical company that has raised significant legal and regulatory concerns within the healthcare sector.
At the center of the problem is a large order of Immunoglobulin IV 5g vials, totaling 22,500 vials, that was placed with Isolez Biotech Pharma AG Ltd by the SPC. A portion of this order has already been delivered to the Medical Supplies Division (MSD).
However, complications and adverse events related to the use of this drug in hospitals have prompted a thorough investigation. During this inquiry, it was discovered that Isolez Biotech Pharma AG Ltd, the supplier in question, did not possess the necessary waiver of registration (WOR) from NMRA, which is a crucial requirement for engaging in pharmaceutical procurements and distribution in Sri Lanka.
The CEO of NMRA has confirmed that no WOR was issued to Isolez Biotech Pharma AG Ltd, raising suspicions of forgery and fraudulent practices by the supplier.
In response to these concerns, the Health Minister has filed a formal complaint with the Criminal Investigation Department (CID) to conduct a comprehensive inquiry into the matter.
Meanwhile, the MSD has acknowledged the receipt of the delivered goods, further complicating the situation and raising questions about the internal processes and stakeholders involved.
Given the seriousness of the situation and the potential violation of regulatory and legal standards, the Health Minister has sought the advice of the Attorney General.
