The Government Medical Officers’ Association (GMOA) has called on the Cabinet to take responsibility for the importation of contaminated medicines from India, following reports of bacterial contamination and deaths linked to injectable drugs supplied by a single manufacturer.
GMOA spokesman Dr. Chamil Wijesinghe said several patients at the National Hospital, Kandy, developed similar infections after receiving ondansetron from Maan Pharmaceuticals Ltd., based in Ahmedabad, India, with production reportedly in Gujarat.
Laboratory tests at the hospital confirmed bacterial contamination, particularly in immunocompromised patients.
“Hospital microbiologists, anaesthesiologists, ICU teams, and consultant doctors jointly observed these cases and initiated investigations. Following these findings, ondansetron was immediately suspended at the National Hospital, Kandy,” he said.
The National Medicines Regulatory Authority (NMRA) subsequently recommended suspending not only ondansetron but also 10 other injectable drugs from the same manufacturer, citing failed quality tests or suspected contamination.
The affected medicines include widely used antibiotics, iron sucrose, haloperidol, and other critical injections.
Dr. Wijesinghe said adverse reactions had previously been reported at Sri Jayewardenepura General Hospital and said multiple complaints were filed with the NMRA.
He criticized the authority’s limited testing capacity, noting that drug testing in Sri Lanka often occurs only after complaints rather than through routine surveillance, a standard practice internationally.
While deaths at the National Institute of Infectious Diseases are under investigation, Dr. Wijesinghe said post-mortem examinations are still ongoing, and causes have not yet been confirmed.
The Medical Supplies Division (MSD) of the Health Ministry instructed all government health institutions to immediately suspend the use of injectable medicines from Maan Pharmaceuticals, following recommendations from the NMRA and the Safety and Risk Evaluation Subcommittee (SAFRESC).
Health facilities have been told to secure existing stocks, report batch details to the National Medicines Quality Assurance Laboratory in Colombo, and refrain from using any affected products until further notice.
The suspension applies to all batches of the affected medicines, regardless of whether they were supplied through the MSD, donations, or local purchases.
Provincial and regional health directors have been instructed to circulate the notice widely and ensure full compliance.
Dr. Wijesinghe stressed that while India produces medicines of standards comparable to the U.S. and the U.K., regular inspections of manufacturing plants are essential.
He also noted that if contamination across multiple drugs from the same plant is confirmed, the factory should be sealed.
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