Officials of NMRA, SPC, and Health Minister under pressure to resign as drug safety concerns mount

Mounting concerns over drug safety and regulatory oversight have triggered strong calls from medical professionals and trade unions for the resignation of senior officials at the National Medicines Regulatory Authority (NMRA) and the State Pharmaceutical Corporation (SPC), following patient deaths, allegedly linked to the administration of Ondansetron injections.

- BY SUJEEWA THATHSARA AND CHAMINDA SILVA

Medical and civil rights groups say the incident has exposed deep systemic failures in Sri Lanka's drug regulatory framework, with critics warning that the collapse of quality assurance mechanisms is placing patients' lives at risk.

The Medical and Civil Rights Professional Association of Doctors (MCRPA), and allied trade unions have accused health authorities of gross negligence and demanded the immediate resignation of senior NMRA and SPC officials.

MCRPA President Dr Chamal Sanjeewa said the Health Ministry, NMRA and SPC had collectively failed to ensure patient safety, citing, what he described as, a failed drug regulatory system.

"These are not isolated incidents. Over the past two years, more than 100 batches of medicines, imported from India, have been either temporarily, or permanently withdrawn due to quality concerns," he said.

The controversy intensified after the NMRA announced the temporary withdrawal of several batches of Ondansetron Injection USP 8 mg/4 ml (Ondanman 8), manufactured by Maan Pharmaceuticals Ltd., India, following reports of serious adverse reactions and at least one confirmed death at the Infectious Diseases Hospital (IDH). Social media reports have also claimed two deaths at the National Hospital, Kandy, though these have not been officially confirmed.

The NMRA subsequently ordered hospitals nationwide to suspend the use of 10 injectable medicinal products until their manufacturing processes are verified to meet required safety and quality standards.