Ondansetron controversy: Sri Lanka weighs Indian company’s request for global testing of its drug

By Sheain Fernandopulle   

Amid the ongoing probe into the withdrawn batches of the Ondansetron and request of the relevant Indian company to send samples for global testing, fresh concerns have been raised over Sri Lanka’s continued absence of a World Health Organization (WHO)-accredited laboratory for drug testing.   

Speaking to the Daily Mirror, Dr. Ananda Wijewickrama, Chairman of the National Medicines Regulatory Authority (NMRA) said steps are now underway to upgrade existing laboratory facilities to meet WHO accreditation standards. However, he stressed that former authorities had failed to take timely action over the years to establish or upgrade such a facility resulting in the current dependency on external laboratories for international-level testing.   Meanwhile, he said Sri Lanka is still considering a request made by Indian pharmaceutical company Maan Pharmaceutical (Pvt) Ltd. which has manufactured Ondansetron in question, to refer the withdrawn batches of the drug to an internationally recognised laboratory for independent testing. The company has informed the Ministry of Health that it is willing to bear the full cost of the tests.   

Dr. Wijewickrama said the request is currently being considered by the Medicines Evaluation Committee. He said a final decision would be taken based on the committee’s recommendations.   

The NMRA on December 13 ordered the immediate withdrawal of four batches of the Ondansetron injection manufactured by Maan Pharmaceutical from use in both state and private hospitals following suspicions of possible contamination.   

The drug had reportedly been administered to two patients who later died, though investigations are still underway to determine whether the deaths are directly linked to the injection.   

In its communication to the Ministry of Health, Maan Pharmaceutical reiterated its request for international testing and emphasised that the proper storage of samples prior to testing is the responsibility of Sri Lankan health authorities.