Allexer Namundjembo
The Namibia Medicines Regulatory Council (NMRC) has confirmed that Fabu-Paracetamol meets required safety and quality standards following an independent assessment prompted by public concerns.
In a public notice dated 20 May 2026, former Registrar of Medicines Fransina Nambahu said the NMRC commissioned independent laboratory testing on samples collected from various health facilities, including Central Medical Stores, to ensure a representative evaluation of the product available on the market.
“A comprehensive number of batches were sampled and subjected to analytical testing. The results indicate that all batches complied with the required quality specifications and contained the correct quantities of active pharmaceutical ingredient (API) and preservative,” the notice read.
The NMRC further revealed that its Quality Surveillance Laboratory conducted targeted screening for toxic contaminants, including diethylene glycol and ethylene glycol.
“The results were negative, confirming that none of the tested batches contained these harmful substances. No such contaminants were detected in any of the batches analysed. The results conclusively demonstrate that the products are fit for their intended therapeutic use,” Nambahu said.
She advised the public to report any suspected adverse reactions related to paediatric products through healthcare professionals, who can submit reports to the Therapeutic Information and Pharmacovigilance Centre using the safety “yellow form”.
The findings follow a prolonged dispute involving manufacturer Fabupharm and the ministry of health and social services over the safety of the children’s paracetamol syrup.
Last year, Fabupharm released results from its own independently commissioned tests, claiming the product met all safety and regulatory standards.
However, health minister Dr. Esperance Luvindao rejected the report, citing a conflict of interest.
Responding to questions in Parliament from Affirmative Repositioning leader Job Amupanda, Luvindao said the ministry had made it clear that it would not accept findings commissioned by the company itself.
“We don’t self-regulate,” Amupanda said, questioning the legal basis of the company’s so-called independent verification.
Luvindao reiterated that the ministry’s position remains unchanged, adding that Fabupharm would not be allowed to proceed with the product until all outstanding concerns were addressed.
“We clearly stated that there was a conflict of interest, and for that reason, we could not accept their report as legitimate,” she said.
Fabupharm has maintained that its product is safe, stating that it commissioned two certified laboratories, including the Quality Services Laboratory, to conduct a full assessment.
The company said both internal and external tests confirmed compliance with international standards and dismissed allegations against it as lacking scientific basis.
“The allegations were made without supporting evidence or scientific evaluation,” the company said, adding that it remains committed to upholding high pharmaceutical standards.
