- Claims one of the two IVIG batches banned during investigation are being cleared for reuse
The Medical and Civil Rights Professional Association of Doctors (MCPA) has called for an urgent explanation from the Ministry of Health over the alleged decision to reintroduce a batch of human intravenous immunoglobulin (IVIG) that was previously banned due to safety issues.
Speaking to The Daily Morning, MCPA President Dr. Chamal Sanjeewa said that during investigations into a batch of substandard IVIG imported by a particular company during the tenure of former Health Minister during which a controversy over import of substandard medicines occurred, a second company’s IVIG was also flagged, prompting a separate probe by the Criminal Investigation Department (CID). He claimed that the CID investigation confirmed that a patient in Trincomalee had died after being treated with that IVIG.
"The Health Ministry’s Drug Risk Assessment Subcommittee then tested four samples of this IVIG, and the results confirmed the presence of bacterial toxins and other visible contaminants. This led to a formal and permanent ban of the stock on 23 October 2024, as stated in circular 2024/41 issued by the Medical Supplies Division (MSD). However, according to the drug database maintained by the MSD, the hospitals have now been instructed to re-use it." he alleged.
Dr. Sanjeewa charged that this is not the first time a drug that had been banned by the National Medicines Regulatory Authority (NMRA) has made its way back into the system. “Some of these drugs have been re-approved based on foreign lab reports paid for by the same pharmaceutical companies that imported them. This has shattered public trust in the system. How can the Health Ministry justify this move? They must immediately reveal on what basis the decision to allow hospitals to re-use it was made," Sanjeewa pointed out.
Multiple attempts to contact the Minister for Health Dr. Nalinda Jayathissa, Deputy Minister of Health, Dr. Hansaka Wijemuni, Secretary to the Ministry Dr. Anil Jasinghe, and the GMOA for comment on the allegations levelled by the MCPA, proved futile.