Suspicions have arisen over the State Pharmaceuticals Corporation (SPC) opening Letters of Credit (LCs) to import a large stock of Human immunoglobulin IV from an Indian company, when the vaccines imported earlier from the same company have allegedly reacted to HIV antibodies and investigations into the matter are still on-going This vaccine is used to treat patients who have a weak immunity. Patients who have heart and kidney diseases and eye conditions are given this vaccine as a treatment. The National Medicine Regulatory Authority (NMRA) had decided to suspend the stock of vaccines on 23 April 2021.
After that the NMRA Safety and Risk Evaluation Subcommittee has also seconded that decision on 27 April 2021. However, some batches of this vaccine have been allowed on several occasions but permission had not been granted to use the full stock as some batches are still under suspension. In such a backdrop, the SPC has opened LCs to order the same type of vaccine.
In 2020, the SPC had ordered the vaccine at USD 112 per jab under Serial No. DHA/C/ PS/133/2020. But this time, the SPC has ordered 112,500 vials from the Indian company at USD 123 per jab. It is estimated that Rs 2.7 billion would have to be spent for ordering the new vaccine stock. The NMRA has sent the explanation received from the Indian manufacturer, upon being informed that importing vaccines would be halted, as the vaccine was reacting to HIV as discovered by 4th Generation HIV Test (ELISA), to the local agent of Indian manufacturer on 28 April 2021.
The letter was copied to Health Ministry, Secretary to the Health Ministry, SPC Chairman and Head of the Medical Supply Division. Even though the NMRA Safety and Risk Evaluation Subcommittee lifted the restriction on importing the vaccines on 30 April 2021, three vaccine batches, which bear numbers ID05G20028, ID05G20030 and ID 05G20033 had showed reactions when they were subjected to ELISA test.
As a result, Director of Medical Supply Division Dr. H.M.K. Wickramanayake issued a circular, under serial number MSD/SCU/(s)/Cir/2020, to Hospital Directors and health authorities, that the NMRA’s suspension on the vaccine would continue until foreign experts’ opinion regarding the matter is received.
When contacted, SPC CEO Dr. Kamal Jayasinghe said the NMRA took steps to suspend the use of a medicine if there is a suspicion or a complaint received against it. Then, laboratory tests will be conducted and further steps regarding the medicine would be taken after seeking experts’ opinions on the matter.
“We suspend the use of the Human Immunoglobulin 1v when we received a complaint against it. However, laboratory test results showed that there is no problem with the vaccine. We release batches by batches according to the laboratory test results.
We released three batches this week too,” he added. Speaking further, Dr. Jayasinghe said none of the batches were discovered to consist of HIV antibodies. “So we cannot say that anyone was harmed because of the vaccine,” he claimed. “The decision to release batches would be taken after obtaining opinion of four foreign experts about the laboratory reports.
Many batches of the vaccine have been tested by now. We have released 13 batches and only a few batches are to be tested at the moment. The research about this particular medicine is being done by the laboratory of the National STD/ AIDS control programme,” Dr. Jayasingeh further said.
It was confirmed that the laboratory of the National STD/ AIDS Control Programme conducted research on this particular vaccine upon the request by the NMRA and no problem was detected in the batches which were already screened. However, attempts to contact the SPC Chairman, to find out why they ordered a large stock of the vaccine from the same Indian company, failed.
