• Adverse reactions and quality concerns cited
• Doctors raise regulatory oversight concerns

The National Medicines Regulatory Authority (NMRA) has temporarily withdrawn four batches of Ondansetron Injection with immediate effect, citing adverse drug reactions and suspected quality issues.

Ondansetron Injection is used to prevent nausea and vomiting associated with surgical procedures, anaesthesia, cancer chemotherapy, and radiation therapy.

According to a letter issued by the NMRA, seen by The Daily Morning, batches OD24021E, OD25009E, and OD25023E were withdrawn on 12 December following reports of adverse reactions. The affected batches were manufactured by an Indian pharmaceutical company and marketed by a pharmaceutical firm located in Colombo 10.

The NMRA stated that the decision followed a safety risk evaluation based on adverse drug reaction reports received by the Authority, as well as recommendations contained in a preliminary investigation report by a Consultant Microbiologist at the National Hospital, Kandy. The Authority has also instructed the relevant company to submit an explanation from the manufacturer within 28 days from the date of the notice.

Confirming the withdrawal, NMRA Chairperson Dr. Ananda Wijewickrema told The Daily Morning that instructions had been issued to withhold the use of the injection after adverse reactions were reported among some patients. He added that further laboratory tests are being carried out following reports of a germ detected in the drug.

Meanwhile, President of the Medical and Civil Rights Professional Association of Doctors (MCPA), Dr. Chamal Sanjeewa, said that after the current Government assumed office, regulatory provisions were introduced to allow medicines approved by the Indian drug regulatory authority to be used in Sri Lanka’s hospital system without additional local testing. He claimed that despite objections raised, the NMRA proceeded with such approvals, amounting to a failure in its regulatory responsibilities, and said the Ministry of Health bears direct responsibility for the financial losses arising from substandard medicines.