Ondansetron samples to be sent for global testing

By Sheain Fernandopulle 

Complying with the request made by the Indian company which manufactured Ondansetron injection in question, local health authorities have decided to send samples of the withdrawn injection batches to a World Health Organisation (WHO)-accredited laboratory for international testing, Daily Mirror learns. 

According to an informed source at the National Medicines Regulatory Authority (NMRA), communications with relevant parties are currently in progress, and the discussions are likely to conclude within this week. The NMRA ordered the withdrawal of four batches of the drug on December 13 following suspicions of possible contamination, after it was reportedly administered to two patients who later died. However, investigations are still ongoing to determine whether the deaths are directly linked to the injection.  

Against this backdrop, the manufacturer, Maan Pharmaceutical (Pvt) Ltd., had formally requested permission to send the withdrawn batches for independent testing at its own expense, which remained under consideration. 

After nearly a month, the authorities have decided to send the samples to a WHO-accredited laboratory while the local investigations are in progress. The company has also emphasised that the proper storage of samples prior to testing is the responsibility of Sri Lankan health authorities. 

The source added that the Medicines Evaluation Committee has not yet released its report, which is expected to play a key role in determining the next steps of the process. 

Meanwhile, NMRA Chairman Dr. Ananda Wijewickrama earlier said steps are being taken to upgrade existing local laboratory facilities to meet WHO accreditation standards.