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Immunoglobulin scandal: German lab backs MRI findings
View(s):By Namini Wijedasa
Germany’s largest official medicines control laboratory, InphA GmbH, has confirmed what the Medical Research Institute (MRI) in Sri Lanka found in late 2023: there was barely any human immunoglobulin in the stock purchased by the Health Ministry that year and that it contained bacteria.
The foreign lab analysed six sample solutions from different bottles using “high performance size exclusion chromatography with diode array detection”. They were sent for testing by Sri Lanka’s National Medicines Regulatory Authority (NMRA).
“The estimated value for the IgG content is less than 1% of the declared value,” state the lab reports presented to the Maligakanda Magistrate. IgG is immunoglobulin G.
The most IgG that was found in the bottles was between 0.02 milligrams (mg) per millilitre (mL) and 0.4 mg/mL. Another screening method showed that pharmaceutically active ingredients were not identified.
Separately, a sterility test of the IgG samples resulted in “strong bacterial growth” being observed after three days using both media (thioglycolate and trypsin-soy broth). The identified microorganism was Enterobacter hormaechei.
“The sample is not free of visible particles,” the reports state. “Sodium chloride could be identified with chemical analysis.” Sodium chloride is salt or saline.
Human immunoglobulin (Ig), also known as immune globulin or IVIG (intravenous immunoglobulin), is a medication used to treat a variety of immune system disorders.
The Court was also informed of the results of tests by InphA GmbH on rituximab samples. Rituximab is a prescription medication, specifically a monoclonal antibody, used to treat certain types of cancer and autoimmune diseases.
The lab could not isolate any pharmaceutically active components in the rituximab samples: “Only sodium chloride could be identified.”
In 2023, the Sunday Times reported how the MRI had found no “detectable levels” of immunoglobulin in the counterfeit immunoglobulin consignment purchased and paid for by the Health Ministry; and that the medication, some of which was administered to patients in government hospitals, was not sterile and contained bacterial endotoxins.
The Health Ministry had paid an advance of Rs. 36,381,875.40 to the Seeduwa-based supplier Isolez Biotech Pharma AG for an initial 900 vials of injection, which contained, as one medical expert termed it, “literally no drug”.
The full awarded contract was for 22,500 vials at a total value of US$ 2,925,000 (more than Rs. 960 million). It only failed to go through because the so-called medication, once injected, caused adverse reactions in patients in several hospitals and triggered an investigation. (the Sunday Times first reported these side effects on September 24, 2023).
The Health Ministry awarded contracts to Isolez for six separate medications. Limited numbers of just two products, purported to be human immunoglobulin and rituximab, arrived before the controversy halted any further stocks. Four out of the six medications were intended for cancer patients.
On the orders of the Maligakanda Magistrate, to whom the Criminal Investigation Department (CID) is reporting evidence regarding this case, the NMRA sent vials from three batches of counterfeit immunoglobulin for testing to the MRI, the National Blood Transfusion Service (NBTS) and the National Medicines Quality Assurance Laboratory (NMQAL).
NBTS said it was incapable of testing the product. However, the MRI laboratory found that the vials contained “IgG below detectable levels”.
The MRI report also states that it tested three patients with “inborn errors of immunity” (immunological disorders characterised by variable susceptibility to infections, immune dysregulation and/or malignancies) who were administered the Isolez product.
Two of them had developed anaphylaxis during the infusion. The immunoglobulin levels of the patients were “inadequate following infusions: and, therefore, “these patients were at risk of infections”.
Separately, the NMQAL checked the samples for microbes. According to its reports, all three failed the sterility and bacterial endotoxin (agents of pathogenicity of Gram-negative bacteria) tests, leading to the conclusion that they contained harmful microorganisms.
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