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.

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past two years, more than 100 batches of medicines, imported from India, have been either temporarily, or permanently, withdrawn due to quality concerns,” he said.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.

NMRA Chairman Dr Ananda Wijewickrema said the decision followed recommendations made by the authority’s Safety and Risk Evaluation Subcommittee on 16 December, 2025, in response to continuing reports of adverse drug reactions, including fatal cases.

An urgent circular was issued to PTC Medical (Pvt.) Ltd.,

instructing the company to immediately withhold all parenteral products manufactured by MAAN Pharmaceuticals Ltd of India, pending further investigations. PTC Medical is the market authorisation holder for the products in question.

Dr Wijewickrema clarified that while the reported death at IDH occurred after the administration of Ondansetron, a direct causal link to the drug has not yet been conclusively established. However, he said the precautionary withdrawal was necessary in the interest of patient safety.

Further laboratory testing is currently underway at the National Medicines Quality Assurance Laboratory (NMQAL) to assess the quality, safety and efficacy of the affected products.

Dr Sanjeewa added that the drugs currently under suspension included essential medicines such as antibiotics, Ondansetron for vomiting, Haloperidol for psychiatric and seizure-related conditions, and Iron Sucrose for iron deficiency. Most of the affected products, he said, were imported between 2024 and 2025.

He also criticised the continued use of senior officials allegedly responsible for regulatory lapses, arguing that accountability must extend to the political leadership.

“The Minister says these medicines were imported under previous governments. But the same officials responsible for this criminal mishap are still in office. If he continues to be served by errant officials, the Minister, too, must bear responsibility,” Dr Sanjeewa said, calling for the resignation of Health and Mass Media Minister Dr Nalinda Jayatissa.

The MCRPA announced that it would lodge a formal complaint with the Criminal Investigation Department (CID) today (18), seeking a criminal probe into the matter.

Medical associations have also raised alarm over regulatory changes that allow medicines approved under Indian Pharmacopoeia (IP) standards to be used in Sri Lanka without mandatory local retesting.

Dr Sanjeewa said that after the current government assumed office, provisions were introduced permitting the direct use of IP-approved medicines in the state hospital system, bypassing additional local quality testing.

“This has created a dangerous loophole. Imported medicines must be retested locally before they are administered to patients,” he said, urging authorities to urgently reinstate local verification procedures.

Deputy Minister of Health Hansaka Wijemuni told the media that investigations were ongoing into the specific batch of Ondansetron under scrutiny, following reports of two deaths that raised safety concerns.

Suspicion intensified after a patient died on 12 November. A medical specialist at the National Hospital, Kandy, conducted laboratory tests and shared findings that prompted the NMRA to immediately suspend the relevant batch nationwide.

The Government Medical Officers’ Association (GMOA) confirmed that the use of the affected Ondansetron batch had been suspended across the country.

GMOA Spokesman Dr Chamil Wijesinghe said investigations at the National Hospital, Kandy, identified the drug as a quality failure after several patients developed adverse reactions.

Sri Lanka records between 80 and 100 cases of substandard or low-quality medicines annually, he said, stressing the need to determine whether such failures arise from manufacturing defects, poor storage and transportation, or inadequate regulatory screening at entry points.

“When medicines enter the country, NMRA laboratories are responsible for testing them. If quality failures are detected later, serious questions arise about whether proper checks were conducted in the first place,” Dr Wijesinghe said.

by Sujeewa Thathsara and Chaminda Silva