The National Medicines Regulatory Authority (NMRA) has temporarily banned the use of all injections manufactured by Mann Pharmaceuticals Private Limited of India, the producer of the controversial Ondansetron injection, following reports of serious complications, including two alleged deaths.
NMRA Chairman Dr. Ananda Wijewickrama said the decision was taken amid suspicions that the reported complications may have been caused by an error during the manufacturing process of the vaccine.
Meanwhile, Health Minister Dr. Nalinda Jayatissa stated at the Cabinet Decisions Media Conference yesterday that a formal investigation has been launched into the Ondansetron injection, which has now been suspended.
Several batches of the vaccine were withdrawn after concerns were raised that they may be contaminated. Complaints were also received from a number of hospitals regarding adverse reactions.
Ondansetron is a drug administered to patients to control nausea and vomiting and is widely used in hospitals across the country.
On December 12, the NMRA issued a written directive to the private company importing the drug, ordering the immediate recall of four batches of Ondansetron from all hospitals nationwide.
The suspension order followed reports of complications and a study conducted by the Microbiology Department of the Kandy National Hospital, which found that a sample contained a suspected pathogen.
The vaccine was subjected to special testing after several patients at the Kandy National Hospital developed fever following its administration. Preliminary reports of similar reactions were also received from several other hospitals, the NMRA said.
Meanwhile, national newspapers reported yesterday that two patients at the Colombo Infectious Diseases Hospital (IDH) had died after receiving the drug. Responding to these reports, Dr. Wijewickrama said approximately 270,000 doses of the drug had been imported into the country.
He added that steps were taken to remove the vaccine from hospitals starting last Friday; however, about 220,000 doses had already been administered before the recall was implemented.
The NMRA also confirmed that a separate investigation has been launched into the reported deaths of the two patients at the Colombo IDH Hospital who had received the vaccine.
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