• 10 more injectables suspended nationwide
• Kandy, IDH, other hospitals report alleged reactions to contaminated meds

The Government Medical Officers’ Association (GMOA) yesterday (20) demanded that the Cabinet take responsibility for the importation of contaminated medicines from India, following serious safety concerns and reports of deaths linked to injectable medicinal drugs supplied by one supplier.

GMOA Spokesman Dr. Chamil Wijesinghe told The Sunday Morning that several patients at the National Hospital, Kandy had developed similar patterns of infection after receiving ondansetron, supplied by a company based in Ahmedabad, India, with production plants reportedly in Gujarat as well.

“Hospital microbiologists, anaesthesiologists, ICU teams, and consultant doctors jointly observed these cases and initiated investigations. Samples of the medicine were cultured at the hospital’s microbiology laboratory, where bacterial contamination was detected,” he said.

“The organism identified was described as one that typically affects immunocompromised patients. Hospital laboratories are capable of conducting culture tests, and the investigation involved qualified specialists and the full microbiology team,” he added.

Dr. Wijesinghe explained that following these findings, ondansetron had been immediately suspended at the National Hospital, Kandy. The National Medicines Regulatory Authority (NMRA) then decided to withhold not only ondansetron but also 10 other parenteral medications from the same manufacturer, citing quality failures.

“Investigations have now revealed that all 10 medicinal drugs from the same manufacturer had either failed quality tests or were suspected to be contaminated, raising concerns about possible issues at the manufacturing plant itself,” he said.

The affected products include both vials and ampoules.

Commenting on deaths at the National Institute of Infectious Diseases (NIID), Dr. Wijesinghe said investigations were ongoing and the exact causes had not been concluded yet.

“While both patients had reportedly received the same medicinal drug, post-mortem examinations are still under review. One patient had a platelet count of around 140,000 and died within 24 hours, making dengue an unlikely – but still possible – cause, based on the clinical presentation,” he said.

Dr. Wijesinghe also confirmed that adverse reactions had been reported earlier at the Sri Jayewardenepura General Hospital and that the NMRA had received multiple complaints regarding such reactions.

He criticised the NMRA’s limited testing capacity, stating: “While the authority has its own laboratory, it lacks sufficient capacity to conduct comprehensive quality testing. As a result, medicinal drug testing in Sri Lanka is often carried out only after complications or complaints arise, rather than through routine pre- and post-market surveillance, which is standard practice internationally.”

Addressing concerns about imports, he clarified that the affected medicines were imported through the State Pharmaceuticals Corporation (SPC) via a registered local agent, in line with standard procedures. Dr. Wijesinghe stressed that medicinal drug regulation was a collective responsibility involving the entire health administration and political leadership.

Responding to claims that Indian-manufactured medicinal drugs were allegedly substandard, Dr. Wijesinghe said India was one of the world’s largest pharmaceutical producers, with many factories maintaining standards comparable to those in the US and the UK. 

However, he emphasised that regulatory authorities must regularly inspect manufacturing plants and questioned whether such inspections were being carried out effectively. 

The GMOA Spokesman also referred to a letter circulated on social media in which the manufacturer reportedly challenged Sri Lanka’s testing capacity and requested that samples be sent to internationally accredited laboratories. “If contamination across multiple medicinal drugs from the same plant is confirmed, the factory should be sealed,” he said.

The Medical Supplies Division (MSD) of the Ministry of Health has instructed all Government health institutions to immediately suspend the use of several injectable medicines manufactured by Maan Pharmaceuticals Ltd., India. The suspension follows reports of failed quality samples and adverse medicinal drug reactions, including fatal cases.

An official circular issued by the MSD stated that the decision was based on recommendations by the NMRA and the Safety and Risk Evaluation Subcommittee (SAFRESC), which met on Tuesday (16). Preliminary investigations by consultant microbiologists at the National Hospital, Kandy informed the decision.

This was confirmed by Ministry of Health Secretary Dr. Anil Jasinghe yesterday (20), when The Sunday Morning sought clarification. However, MSD Director Dr. Dedunu Dias, who signed the relevant letter, declined to comment and directed inquiries to the NMRA.

The suspension applies to all batches of the affected products, regardless of whether they were supplied through the MSD, donations, or local purchases.

The medicines withdrawn from use include several widely used injectable antibiotics and other critical medicinal drugs: imipenem with cilastatin, meropenem, piperacillin with tazobactam, cefotaxime, co-amoxiclav injections, iron sucrose, ondansetron, haloperidol, and sulbactam with cefoperazone.

Health institutions have been instructed to immediately stop using these medicines, secure existing stocks, and report batch details to the National Medicines Quality Assurance Laboratory (NMQAL) in Colombo for further testing. Samples may be requested by the NMRA as part of the ongoing investigation.

The MSD has warned hospital authorities to remain vigilant and ensure that no injectable products manufactured by Maan Pharmaceuticals are used until further notice, irrespective of procurement method.

Provincial and regional directors of health services have been directed to circulate the notice among all institutions under their jurisdiction and ensure full compliance. The Health Ministry stressed that these measures were being taken in the interest of patient safety and in accordance with existing health sector circulars.