AMS raises concerns over adverse drug reactions to IVIG

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The Association of Medical Specialists (AMS) has expressed deep concerns following the shocking revelations in a recent press release issued by the National Medicines Regulatory Authority over the adverse drug reactions to a brand of intravenous immunoglobulin (IVIG) distributed to state hospitals.

IVIG is a critical and expensive medication used to treat seriously ill and immunocompromised patients. It undergoes stringent quality control measures during the manufacturing process to ensure it is free from infections such as HIV and hepatitis B and C.

According to the press release of NMRA, two patients from DGH Matale experienced life-threatening allergic reactions, known as anaphylaxis, after receiving the IVIG.

The IVIG was procured under a Waiver of Registration (WOR) certificate, allegedly issued by the CEO of the NMRA. The manufacturer, Livealth Bio Pharma Pvt Limited, located in Khambhat, Dist. Gujarat, India, has officially stated that they do not produce IVIG. The local agent involved in the distribution is Isolez Biotech Pharma AG.

"What is particularly alarming is that the NMRA and Ministry of Health (MOH) only became aware of these facts after multiple patients had already been administered the fraudulent IVIG, resulting in adverse reactions, including deaths," the AMS stressed.

The NMRA has taken the matter seriously and filed a complaint with the Criminal Investigations Department (CID) regarding the fraudulent importation using the forged WOR certificate.

The AMS has raised several crucial questions that remain unanswered. Firstly, they are seeking clarity on who ordered the purchase of IVIG from Livealth Bio Pharma Pvt Limited and whether there was a genuine need for an emergency purchase. Besides, the AMS wants to know which officers were responsible for verifying the authenticity of the WOR certificate and whether a thorough assessment of the manufacturing company's product profile was conducted.

Furthermore, the AMS is calling for transparency regarding the amount paid by the MOH to Isolez Biotech Pharma AG for the procured IVIG. They also question whether there was a scarcity of IVIG in Sri Lanka at the time of the order, which may have contributed to the decision to import from an unregistered source.

However, if the IVIG administered to over 1,000 patients was not subjected to these necessary testing and screening procedures, there is a significant risk of contamination and potential infections. The AMS is urging the MOH to promptly identify and screen all patients who received the fraudulent IVIG for possible HIV and hepatitis B and C infections. They are also calling for thorough testing of the vials from this consignment to determine if they contain any viral components.

Moreover, the AMS emphasizes the importance of evaluating the effectiveness of the IVIG in treating the patients' underlying diseases and offering further treatment from a properly registered source if necessary. This incident raises serious concerns about the quality of medicines available in state hospitals and the potential impact on patient safety.

The AMS insists that only properly registered medicines should be supplied to patients and that rigorous quality checking procedures should be implemented during procurement. The AMS strongly believes that those responsible for this fraudulent importation must face appropriate legal consequences for endangering the lives of numerous patients. They are calling on the MOH to take immediate action to identify and monitor all individuals who received the fraudulent IVIG.

Thus, the AMS emphasizes the need for a robust and reliable health system that prioritizes patient safety and ensures the provision of properly registered medicines.