Sri Lanka's Minister of Health, Keheliya Rambukwella, has escalated a critical matter involving Isolez Biotech Pharma AG Ltd and the procurement of Immunoglobulin supplies for state hospitals to the Attorney General's Department, as the issue continues to stir public outrage.
In a letter addressed to the Attorney General, Minister Rambukwella highlighted the importance of safeguarding the safety, efficacy, and availability of pharmaceuticals to protect citizens' health. Central to the issue is a substantial order of Immunoglobulin IV 5g Vials, totaling 22,500 vials, placed with Isolez Biotech Pharma AG Ltd by the State Pharmaceuticals Corporation (SPC). A portion of the order had been delivered to the Medical Supplies Division (MSD). However, complications and adverse events associated with using the drug in hospitals prompted a comprehensive investigation.
During this inquiry, it was revealed that Isolez Biotech Pharma AG Ltd lacked the necessary waiver of registration (WOR) from the National Medicines Regulatory Authority (NMRA). The NMRA's CEO found no record or evidence of a WOR issued to the supplier, raising suspicions of forgery and fraudulent practices.
Minister Rambukwella formally filed a complaint with the Criminal Investigation Department (CID) to conduct a comprehensive inquiry into the matter, which is currently under active investigation by the CID.
One of the significant concerns surrounding this situation is the lack of a purchase order from the SPC, a standard requirement preceding pharmaceutical procurement. Despite this anomaly, the MSD acknowledged and accepted the delivered goods, raising questions about internal processes and stakeholders involved in this situation.
In his letter to the Attorney General, Minister Rambukwella emphasized the gravity of the situation and the potential breach of regulatory and legal standards. He sought guidance on how to proceed to hold accountable those responsible for wrongdoing, emphasizing the government's commitment to upholding the rule of law and ensuring accountability.
The issue has generated considerable public outrage as Sri Lankan citizens express concern about transparency and integrity within the healthcare system, demanding that all parties involved be held accountable for any breaches of regulatory and legal standards.