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22,500 vials of Indian-made antibodies withdrawn after adverse reactions
View(s):A batch of immunoglobulin imported on a waiver of registration (WoR) issued by the National Medicines Regulatory Authority (NMRA) has caused adverse reactions in patients in four hospitals around the country, documents show.
The waiver to import the 22,500 vials of human immunoglobulin—antibodies produced by blood plasma cells—was granted in February this year by the NMRA.
The product is manufactured by Livealth Biopharma Pvt Ltd of India, and its local agent is Isolez Biotech Pharma Ag Ltd.
Reports of adverse reactions, including anaphylaxis, have been lodged by doctors at the National Hospital in Colombo, the National Hospital (Teaching) in Kandy, and hospitals in Matale and Matara.
“Immunoglobulin is extracted from human donors, and it’s particularly important to ensure that a good manufacturing process has been followed,” a senior pharmacist said, requesting anonymity. “If not, there could be a transfer of certain infections. Drug regulatory authorities around the world are particularly strict where immunoglobulin is concerned.
However, the NMRA CEO on February 12 this year issued a WoR for the batch. As a standard disclaimer in each WoR, the CEO writes to the Health Ministry’s Director of Medical Supplies that, “This medicine was not evaluated by the NMRA. Therefore, please note that quality, safety and efficacies of these projects are responsibility [sic] of yours.”
Meanwhile, two medical devices manufactured and imported from India on WoRs have been withdrawn and withheld this month by the Health Ministry’s Medical Supplies Division (MSD) after defects were reported.
A batch of disposable IV giving sets manufactured by Hi-Tech Medics Private Ltd of India, has been ordered to be withdrawn on the basis of: “Malfunctioning of the device and foreign particles were observed inside the intact pack”.
A separate batch of peritoneal dialysis catheter kits from Manish Medi Innovation of India has been withheld from use on the basis of: “Rusty knife, malfunctioning discoloured guided wire, introducer is not strong and has a sharp end, adapter is not connecting well to the catheter peel off sheets was [sic] already broken”.
Two other batches of peritoneal dialysis catheter kits from Manish Medi Innovation were withdrawn in August.
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