Sri Lanka’s drug regulator has ordered the immediate suspension of ten commonly used injectable medicines following reports of adverse reactions, including fatalities, triggering renewed concern over drug safety and regulatory oversight.
The National Medicines Regulatory Authority has instructed hospitals and healthcare providers to temporarily stop using ten medicinal products until their manufacturing processes are verified to meet required safety and quality standards, NMRA Chairman Dr. Ananda Wijewickrama confirmed.
Speaking to the Daily Mirror, Dr. Wijewickrama said an urgent circular had been issued to PTC Medical Pvt. Ltd., directing the company to withhold all parenteral products manufactured by Maan Pharmaceuticals Ltd. of India until further notice. The directive follows mounting safety concerns and multiple reports of adverse drug reactions linked to these products.
The decision was taken based on recommendations made by the NMRA’s Safety and Risk Evaluation Subcommittee on 16 December 2025. According to the NMRA, continuous reports of adverse reactions, including fatal cases, prompted immediate regulatory action. Preliminary investigations carried out by a consultant microbiologist at the National Hospital in Kandy also flagged potential safety risks associated with the affected medicines.
Under the circular, PTC Medical, which holds market authorization for the products, has confirmed that all affected medicines are being withheld across the private healthcare sector. Further laboratory testing is currently being conducted at the National Medicines Quality Assurance Laboratory to assess quality, safety, and efficacy before any decision on reintroduction is made.
Affected Products:
Ondansetron Injection USP 8 mg/4 mL (Ondanman 8)
Cefotaxime Sodium for Injection BP 1000 mg (Fotime 1000)
Co amoxiclav for Injection BP 1.2 g (Manoxclav 1200)
Co amoxiclav for Injection BP 600 mg (Manoxclav 600)
Haloperidol Injection BP 5 mg per mL (Mancalm 5)
Imipenem and Cilastatin for Injection 1 g (Cimi)
Iron Sucrose Injection USP 100 mg per 5 mL (Sofer Injection)
Meropenem for Injection USP 1 g (Manpen 1000)
Piperacillin and Tazobactam for Injection USP 4.5 g (Bacpac 4.5)
Sulbactam and Cefoperazone for Injection 1 g (Sulbactone 1)
PTC Medical described the withdrawal as a precautionary step and urged all private sector distributors and healthcare institutions to comply immediately with the NMRA directive.
Doctors Trade Union Alliance for Medical Civil Rights Chairman Dr. Chamal Sanjeewa said the suspended medicines include critical antibiotics, Ondansetron used for vomiting, Haloperidol prescribed for mental illnesses and febrile seizures, and Iron Sucrose for iron deficiency. He noted that most of these drugs were imported between 2024 and 2025.
Dr. Sanjeewa revealed that more than 100 batches of medicines imported from India have been temporarily or permanently withdrawn over the past two years due to quality concerns. He sharply criticized the Health Ministry, the Drug Regulatory Authority, and the State Pharmaceutical Corporation, claiming drug regulation had “collapsed” due to unsafe storage practices and persistent regulatory failures.
Calling for accountability, he urged responsible health officials to resign and advised the public to obtain medicines only under proper medical supervision. The latest withdrawal has intensified calls for urgent reform and stricter oversight in Sri Lanka’s drug procurement and regulatory system.
