NMRA temporarily withdraws Ondansetron injections amid safety concerns

 The National Medicines Regulatory Authority (NMRA) has temporarily withdrawn four batches of the Ondansetron injection, a critical medicine used to prevent vomiting and nausea in young children, pregnant women, and patients undergoing surgery or anesthesia, with immediate effect.

According to an official letter (NMRA/PA/I/ADR/04/2025) dated December 12, 2025, issued by the Executive Director of the NMRA, the withdrawal follows reports of complications and adverse reactions linked to the use of the drug. The manufacturer has been instructed to provide an explanation within 28 days.

Dr. Chamal Sanjeewa, Chairman of the Doctors' Trade Union Alliance for Medical and Civil Rights, highlighted ongoing concerns about Indian Pharmacopoeia (IP) approved drugs, noting that similar imports in the past were repeatedly withdrawn due to poor quality. He criticized the Ministry of Health for approving such drugs for hospital use without additional testing, calling attention to the economic and health risks caused by inferior medicines.

This latest withdrawal has reignited public debate over the safety and quality of imported drugs, underscoring the need for stricter regulatory oversight to protect patients.