Manufacturer Sends Letter Regarding Ondansetron Injection

Dr. Ananda Wijewickrama, Chairman of the National Medicines Regulatory Authority (NMRA), stated that Mann Pharmaceuticals, the manufacturer of the Ondansetron injection, has informed in writing that the withdrawn batches of the injection should be immediately tested at an internationally recognized laboratory.

The Chairman added that the letter further states that the company is prepared to bear all expenses incurred for these tests.

Meanwhile, Dr. Ananda Wijewickrama emphasized that while Mann Pharmaceuticals had requested that the withdrawn batches of Ondansetron injection be stored according to proper standards, it is not a matter requiring special mention that storing any drug batch withdrawn from hospitals according to standards is a normal procedure.

The Chairman also mentioned that an investigation has been launched by an expert committee regarding the deaths of two patients who received this injection at the Colombo IDH Hospital. He said that this investigation would determine whether there is a direct link between the injection and the patients' deaths.

Dr. Wijewickrama revealed that Mann Pharmaceuticals obtained full registration in the country in 2022. One order for Ondansetron was placed in 2022, and that stock arrived in the country in 2024. He further stated that another order was placed in 2023.