President, Academy of Health Professionals, Ravi Kumudesh, yesterday (22), alleged that the National Medicines Regulatory Authority’s (NMRA) decision to suspend several batches of Ondansetron Injection USP 8 mg/4 mL (Batch Nos: OD24021E, OD25009E, OD25024E, OD25023E), following suspicions of patient complications, and a few reported deaths, seemed to be a bid to cover-up the latest public health sector crisis.
Kumudesh said so responding to The Island queries.
Kumudesh pointed out that the Chief Executive Officer of the NMRA, and other responsible officials of the Ministry of Health, were on record as having said that the alleged bacterial contamination in the medicine in question was based on laboratory test results generated at the Microbiology Laboratory of the National Hospital, Kandy.
He, however, emphasised that the Kandy facility lacked legally mandated facilities, validated systems, or regulatory accreditation required to conduct pharmaceutical sterility testing in accordance with internationally accepted regulatory standards.
“The Academy of Health Professionals is aware that the Microbiology Laboratory of the National Hospital, Kandy, does not possess the required facilities,” Kumudesh said, urging the government to come clean in this matter.
Kumudesh said the regulatory action taken by the political authority was aimed at deceiving the public, and theAcademy of Health Professionals had raised the issues with Health Minister Dr. Nalinda Jayatissa, Health Secretary Dr. Anil Jasinghe, NMRA head Dr. Ananda Wijewickrama and Director General Health Services (DGHS) Dr. Asela Gunawardena.
Kumudesh pointed out that the Kandy facility was meant to meet requirements within the Kandy National Hospital and not a world standard testing lab. Kumedesh sought an explanation as to how the suspended Ondansetron Injection had been administered on 13 December to a person warded at the hospital where NMRA head is based, a day after the NMRA decided to suspend it.
Public health sector trade union activist Kumudesh said that the Health Ministry couldn’t turn a blind eye to the disclosure that post-mortem reports of two persons, who allegedly died after being given the same medicine by the National Institute of Infectious Diseases, did not identify the medicine as the cause of death. According to him, the National Institute of Infectious Diseases administered the same medicine to patients, on multiple occasions, in the wake of the controversy.
Kumudesh said that it would be the responsibility of the government to ensure a comprehensive technical, legal, and administrative investigation into, what he called, Ondansetron affair. Having lambasted all previous governments of waste, corruption and irregularities, at the expense of the hapless public, the NPP couldn’t, under any circumstances, side-step the issue. “In the interest of transparency, regulatory credibility, and the protection of public health, this should be properly investigated,” Kumudesh said.
The crux of the matter was that the very basis of NMRA’s suspension of Ondansetron batches seemed to be irregular and questionable, Kumudesh said.
The Academy of Health Professionals, in its letter to Dr. Jayatissa, sought the Health Ministry’s response to the following questions: 1. Who requested the Microbiology Laboratory of the National Hospital, Kandy, to conduct sterility testing on this medicinal product?
2. Under what legal provisions was such a request made, and on what basis was the laboratory authorised to accept and perform such testing?
3. Who conducted the test, and who issued the report? Did those individuals possess the requisite professional qualifications, regulatory authorisation, and legal mandate to do so?
4. Did the laboratory possess the required infrastructure, validated testing systems, quality assurance mechanisms, and specialised training necessary to perform pharmaceutical sterility testing in compliance with regulatory standards?
5. If patient complications were attributed to microbial contamination, were all related materials—including syringes, IV lines, infusion fluids, and other associated devices—systematically tested? If not, on what scientific basis was it concluded that the contamination originated exclusively from the medicine?
6. Given that the NMRA is legally empowered to suspend a medicine as a precautionary measure, even without laboratory confirmation, when serious safety concerns arise, what was the justification for relying on an irregular and non-regulatory laboratory test instead?
Kumudesh stressed that Ondansetron, and nine other injectable medicines that had been suspended, were all ordered by the State Pharmaceutical Corporation (SPC) from an Indian manufacturer, Maan Pharmaceuticals.
By Shamindra Ferdinando
