- Regulator plans WHO-accredited labs by 2027
The National Medicines Regulatory Authority (NMRA) is awaiting responses from overseas laboratories regarding whether they can conduct the necessary tests on ondansetron, the expected timelines for such reports, and other relevant details, following a request from an Indian pharmaceutical company, The Sunday Morning learns.
This, amidst the NMRA’s attempt to establish World Health Organization (WHO)-accredited laboratory facilities to improve sovereign testing capacity in the coming years.
Citing suspected issues with quality and adverse medicinal drug reactions, the NMRA had suspended four batches of the drug ondansetron on 12 December, before withdrawing the product the day after.
Maan Pharmaceuticals Ltd., the manufacturer of the controversial batches which were withdrawn from use by the local regulator, had sought to test its products which were withdrawn at an accredited international laboratory to verify concerns about the product.
When contacted by The Sunday Morning, NMRA Chairman Dr. Ananda Wijewickrama stated that the medicinal drug was being tested at the authority’s laboratory as they awaited responses from global laboratories on whether the necessary testing could be carried out by them, how long reports would take, and other relevant details.
Sri Lanka at present does not possess a laboratory that meets WHO accreditation standards, with systemic neglect of capacity building leading to dependence on external laboratories for internationally recognised medicinal drug testing.
Dr. Wijewickrama said that the NMRA was currently working towards improving the authority’s own laboratory to meet WHO standards. “It is a long process that will take time, but we are planning to receive WHO accreditation by 2027,” he said.
The NMRA Chairman stated that the plan in place was to acquire funding from the Asian Development Bank for this endeavour.
Ondansetron is a drug used to prevent nausea and vomiting that is caused by cancer medicines (chemotherapy) or radiation therapy, as well as to prevent nausea and vomiting that may occur after surgery.
At present, investigations are ongoing to determine the possibility of harmful substances contaminating the vaccine.