12 October 2023 01:39 pm Views - 1539
The Health Ministry has sought the advice of the Attorney General over the concerns associated with the pharmaceutical company, Isolez Biotech Pharma AG Ltd, which has raised significant legal and regulatory issues in the healthcare sector.
The essence of the issue revolves around a substantial order of Immunoglobulin IV 5g vials, totaling 22,500 vials, placed with lsolez Biotech Pharma AG Ltd by the SPC of which a portion has already been delivered to the Medical Supplies Division (MSD).
However, a thorough investigation was required due to the subsequent complications and adverse events associated with the use of this drug in hospitals.
During this inquiry, it came to light that lsolez Biotech Pharma AG Ltd, the supplier in question, did not possess the necessary waiver of registration (WOR) from NMRA, a critical requirement for engaging in pharmaceutical procurements and distribution within Sri Lanka at this juncture.
Furthermore, NMRA's CEO, has clarified that a WOR had not been issued to lsolez Biotech Pharma AG Ltd, raising suspicions of forgery and fraudulent practices by the supplier.
In light of these concerns, the Health Minister filed a formal complaint with the Criminal Investigation Department (CID) to conduct a comprehensive inquiry into this matter.
Meanwhile, the MSD has also acknowledged the delivered goods, further complicating matters and raising questions about the internal processes and stakeholders involved.
Given the gravity of this situation and the potential breach of regulatory and legal standards, the Health Minister has sought the advice of the Attorney General.