• MOH says investigations into both deaths ongoing, no conclusive link found yet

Despite reported quality failures in several batches of Indian-manufactured injectable medicines, no decision has been made to reconsider or ban their use, a senior official attached to the Ministry of Health (MOH) said.

Director General of Health Services Dr. Asela Gunawardena told The Sunday Morning that investigations had been launched into two deaths reported at the National Institute of Infectious Diseases (NIID). He stressed that it had not been conclusively established yet that the incidents were caused by the drug ondansetron.

“Investigations are currently underway to determine whether ondansetron had any direct connection to the two deaths,” he said, adding that parallel investigations were being conducted by the MOH and the National Medicines Regulatory Authority (NMRA).

“No definitive conclusion has been reached at this stage,” Dr. Gunawardena noted.

NMRA Chairman Dr. Ananda Wijewickrama said that on 12 December, following information indicating possible contamination, immediate steps were taken to temporarily withdraw all categories of the questionable drug ondansetron from patient use.

Addressing a special media briefing at the Department of Government Information last week, he reassured the public that there was no need to develop undue fear when seeking treatment from Government hospitals. “Sri Lanka’s public health system is supported by a well-trained and experienced workforce,” he emphasised.

Following further discussions with relevant authorities, concerns emerged regarding the production process of the medicine. As a result, the Health Ministry decided to temporarily suspend the use of all 10 injectable medicines manufactured by the Indian pharmaceutical company involved, until the safety and integrity of the manufacturing process could be fully verified.

Medical Supplies Division Director Dr. Dedunu Dias explained that ondansetron was a fully imported medicine. “The medicinal drug stocks were supplied through orders placed in 2021, which were received in 2022, and orders placed in 2024 for 2025 requirements. A total of 1,450,000 vials had been received, of which around 85,000 remaining units were withdrawn from use following the reported issue,” he said.

State Pharmaceuticals Corporation (SPC) Chairman Dr. Manuj Weerasinghe confirmed that the medicine had been procured in accordance with approved guidelines and procurement procedures and that a significant portion of the stock had already been used in treatment services. He further noted that the order for the coming year had been placed with a different supplier.

Health Ministry Secretary Dr. Anil Jasinghe said necessary steps were being taken to ensure that the country’s post-marketing surveillance system was strengthened to prevent similar incidents in the future.