NMRA orders temporary withdrawal of 10 medicines until safety checks completed

Colombo, Dec 17 (Daily Mirror) - The National Medicines Regulatory Authority (NMRA) has directed local hospitals to temporarily stop using ten medicinal products until their manufacturing processes are verified to meet required standards, NMRA Chairman Dr. Ananda Wijewickrama said.

Dr. Wijewickrama told the Daily Mirror that an urgent circular has been issued to PTC Medical Pvt. Ltd., instructing the company to withhold all parenteral products manufactured by Maan Pharmaceuticals Ltd., India, until further notice, following safety concerns and reports of adverse drug reactions.

The decision, based on the Safety and Risk Evaluation Subcommittee’s recommendation on 16 December 2025, follows continuous reports of adverse reactions, including fatal cases. Preliminary investigations by a consultant microbiologist at National Hospital, Kandy, also highlighted potential safety risks.

According to the circular, PTC Medical, the market authorization holder, confirmed that the affected products are being withheld across the entire private sector. Further testing is underway at the National Medicines Quality Assurance Laboratory (NMQAL) to ensure their quality, safety, and efficacy.

Affected Products:

1. Ondansetron Injection USP 8 mg/4 mL (Ondanman 8)
2. Cefotaxime Sodium for Injection BP 1000 mg (Fotime 1000)
3. Co‑amoxiclav for Injection BP 1.2 g (Manoxclav 1200)
4. Co‑amoxiclav for Injection BP 600 mg (Manoxclav 600)
5. Haloperidol Injection BP 5 mg/mL (Mancalm 5)
6. Imipenem and Cilastatin for Injection 1 g (Cimi)
7. Iron Sucrose Injection USP 100 mg/5 mL (Sofer Injection)
8. Meropenem for Injection USP 1 g (Manpen 1000)
9. Piperacillin and Tazobactam for Injection USP 4.5 g (Bacpac 4.5)
10. Sulbactam and Cefoperazone for Injection 1 g (Sulbactone 1)

PTC Medical said that the withdrawal is a precautionary measure and urged all private sector distributors and healthcare providers to comply immediately.

Doctors' Trade Union Alliance for Medical Civil Rights Chairman Dr. Chamal Sanjeewa said the drugs include antibiotics, Ondansetron for vomiting, Haloperidol for mental illnesses and febrile seizures, and Iron Sucrose for deficiency. Most were imported between 2024 and 2025.

Dr. Sanjeewa noted that over 100 batches of medicines from India have been temporarily or permanently withdrawn in the past two years due to quality concerns. He criticized the Health Ministry, Drug Regulatory Authority, and State Pharmaceutical Corporation (SPC) for “collapsed” drug regulation, citing unsafe storage of imported medicines and ongoing regulatory failures.

He called for responsible health administrators to resign and urged the public to obtain medicines only under professional supervision.

This historic withdrawal highlights the urgent need for stricter oversight and reform in the country’s drug regulation and procurement system.