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NMRA decision to ‘withhold’ antibiotic jabs under fire
View(s):- Sri Lanka needs an accredited state-of-the-art lab for tests, urge many, as drug authority responds to alleged contaminated anti-nausea medicine Ondansetron
By Kumudini Hettiarachchi
A growing debate has emerged over the “blanket” withholding of several antibiotic medications from an Indian pharmaceutical company in Gujarat this week, over suspicions of one non-antibiotic medication being contaminated.
This is as many in health circles also reiterated the need for Sri Lanka to have its own accredited state-of-the-art laboratory to test medications coming into the country, in the light of drug failures being reported over the years.
The issues surround the Ondansetron injection USP 8mg/4mL (Ondanman 8), a non-antibiotic medicine given for nausea and vomiting.
Manufactured by the Indian company, MAAN Pharmaceuticals Ltd., Ondansetron is imported in ampoules to Sri Lanka. The local agent is PTC Medical (Private) Limited, based in Colombo. (See box for other withheld injections.)
The National Medicines Regulatory Authority (NMRA) initially decided to withhold four batches of Ondansetron, after alleged pathogen contamination of the intravenous preparation, reportedly caused adverse effects at the Kandy National Hospital. This was followed by a subsequent decision to withhold all stocks after “continuous adverse drug reaction reports (including fatal reactions),” at the National Institute of Infectious Diseases (NIID), Angoda.
The Sunday Times reliably learns that several patients in the Kandy Hospital’s Neuro-Intensive Care Unit (NICU) had been unusually severely ill after surgery. Their blood specimens had clearly indicated the pathogen Rhizobium radiobacter (a soil-living, gram-negative, motile rod-shaped bacterium). Exhaustive testing had been carried out of the environment the patients were in and the medications they had been administered.
Sources said the same pathogen found in the patients’ blood specimens was “without a doubt” found in two ampoules in two batches of Ondansetron. The tests had been on the intravenous-preparation which was in sealed ampoules.
A senior medical specialist, along with many others, told the Sunday Times that there were a few technical issues with regard to the ‘blanket withholding’ of antibiotics in a low-resource setting. There was no problem with withholding Ondansetron due to contamination suspicions.
While medicines such as Ondansetron should have an ultra-clean production line, the specialist pointed out that intravenously-administered antibiotics have an absolutely ‘sterile’ manufacturing process. This starts from the point of getting the raw material (the Active Pharmaceutical Ingredient – API) to the point of final production.
A basic principle in medicine manufacture is that the antibiotic production line is exclusively for a specific antibiotic and no other, the specialist said, pointing out that as such cross-contamination would be highly improbable.
Moving onto quality maintenance and functionality involving Good Manufacturing Practices (GMP) certification, this specialist explained that there are ‘Strict Regulatory Authorities’ such as the US Food & Drug Administration (FDA) and the European Medicines Agency (EMA). This certification is costly. Then there are the other individual country regulators such as in India and Sri Lanka. Bridging these two levels is the World Health Organization (WHO) GMP certification, which is inching towards the standards of the ‘Strict Regulatory Authorities’.
When contacted, NMRA Chairperson Dr. Ananda Wijewickrama told the Sunday Times that Ondansetron is being tested at the National Medicines Quality Assurance Laboratory (NMQAL) and further investigations have been initiated to ensure product quality, safety and efficacy.
Asked how long it would take to get the results, he said it would be difficult to give a time period.
The NMRA’s Safety & Risk Evaluation Sub-committee had taken the decision to withhold all medications manufactured and supplied to the country by MAAN Pharmaceuticals as a precautionary measure as they originated from one plant. This is until testing proves one way or the other.
Giving the sequence of events, Dr. Wijewickrama said that a complaint from the Kandy Hospital had stated that when blood samples of two patients with continuing fever were tested, an organism, a somewhat unusual bacteria, was found. The same germ was found in two Ondansetron injections. He did not name the pathogen.
Based on that information, the Safety and Risk Evaluation Sub-committee decided on Friday (December 12th) to withhold four batches, informing the Medical Supplies Division (MSD) as well as the local agent of this decision.
The batches were: OD24021E; OD25009E; OD25024E; and OD25023E. The agent had also been instructed to furnish an explanation from the manufacturer within 28 days to the NMRA.
Then, on December 15th (Monday), the NMRA had been informed of a similar incident at the NIID with regard to Ondansetron and orders had been issued by the NMRA to withhold all stocks of this product due to “adverse drug reactions and suspected quality defects”.
This was followed by a decision on December 16th (Tuesday) to withhold all products from MAAN Pharmaceuticals until further investigations, citing continuous adverse drug reaction reports including fatal reactions. Both NMRA orders of December 15 and 16, state that “as the market authorization holder, you must ensure that the product is withheld in the entire private sector immediately”.
According to Dr. Wijewickrama, with suspicions that there may be an issue or defect at the manufacturing plant, all injection varieties being imported from that plant have been withheld.
On December 17, while reiterating that there should be no undue fear when seeking treatment from the government hospital system, the Director General of Health Services, Dr. Asela Gunawardena had told the media that currently the Health Ministry and NMRA are conducting two investigations to determine whether this drug was the cause of death of the two NIID patients.
MAAN Pharmaceuticals had got registration in 2019 and Sri Lanka has imported 1.3 million Ondansetron injections since then, without any issues among the 1.2m used up to now, said Dr. Wijewickrama. Referring to “unnecessary’ issues raised by some groups with this incident as the focus, the NMRA Chairperson said they were about the NMRA approving the Indian Pharmacopoeia (an official book containing a list of medicines and drugs and instructions for their use). He explained that a pharmacopoeia is a standardized method adopted by a specific country, whether it is the US, Britain, Japan or China. “We have been accepting drugs under the Indian Pharmacopoeia for over 15 years. There is no need to spread fear.” Meanwhile, a Director of MAAN Pharmaceuticals’ local agent – PTC Medical (Private) Limited, Gihan Beneragama told the Sunday Times that they have followed due processes with regard to securing NMRA registration as well as in the procurement procedures.
“All registration protocols have been followed in Sri Lanka – with provisional registration being received in December 2019, then renewed as full registration in December 2022, valid till December 2027. An NMRA pre-requirement was WHO-GMP standards, which MAAN Pharmaceuticals had, in addition to the audit certification by the Indian authorities,” he said.
Mr. Beneragama said that MAAN Pharmaceuticals has supplied nearly 1.5 million Ondansetron injections as ampoules (small, sealed, full glass containers) and not as vials (small, cylindrical glass containers with stoppers made of rubber).
The stocks were imported under two tenders, awarded by the State Pharmaceuticals Corporation (SPC) – 1.2m in 2021 and 250,000 in 2024, totalling 1.45m, delivered as per a schedule set by the SPC. The stocks were brought by sea.
Mr. Beneragama says that under the pre-shipment sample testing, samples were taken from each batch and tested according to the USP. The other testing included those from Oasis Test House, accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL), accepted by Sri Lanka’s SPC and also Sipra Labs Ltd., a WHO pre-qualified laboratory in India.
The stocks in question are in four batches, he says. They are:
- OD-24021E – a stock of 67,600 ampoules manufactured in November 2024 and supplied in February 2025
- OD-25009E – a stock of 67,600 ampules manufactured in May 2025 and supplied in July 2025
- OD-25024E & OD-25023E – a stock of 67,600 each, manufactured in August 2025 and supplied in September 2025 respectively. “The Ondansetron injections have USP on their label and are manufactured according to the US Pharmacopoeia. So, they need to be tested according to those standards,” he said. The company has supplied the product only via SPC tenders and not stocked it in the private sector, he said, adding that while the company is testing samples from its retained stocks, it has also requested the NMRA to get samples from the withheld stocks tested at a WHO-certified laboratory and it would pay for such testing
| The nine other ‘withheld’ medications The other medications, all in injection-form too imported from MAAN Pharmaceuticals Ltd., and withheld under further notice are: Antibiotics –
Antibiotics in combination with others –
Anti-psychotic medication – Haloperidol BP 5mg/mL (Mancalm 5). An iron supplement – Iron Sucrose USP 100mg/5mL (Sofer). This intravenous iron replacement medication is used to treat iron deficiency anaemia in patients with chronic kidney disease (CKD). Antibiotic or antibiotic combination injections are administered in the treatment of bacterial infections. | |
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