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NAFDAC rejects WHO’s claims of substandard paracetamol in Nigeria


The National Agency for Food and Drug Administration and Control has refuted assertions that the majority of paracetamol drugs in Nigeria are below recommended doses.

NAFDAC’s Director-General, Prof. Mojisola Adeyeye, addressed the media on Monday, providing insights into the agency’s findings following a publication alleging under-dosed paracetamol tablets.

To address the claims, NAFDAC conducted extensive testing on paracetamol tablets sourced from various pharmacy outlets in Lagos and Abuja.

Samples from thirteen local manufacturers underwent assay analysis, meeting the stipulated dosage standards and adhering to both national and international regulatory requirements, resulting in a 100% pass rate.

Adeyeye stated, “As a Scientist and Professor of Pharmaceutical Manufacturing and Drug Evaluation for 30 years, the publication gave me a great concern on the lack of responsibility regarding the impact of the unscientific release on the Nigerian society.

“The results of the laboratory testing are ready after paracetamol tablets from 13 different local manufacturers were sampled from Lagos and Abuja pharmacy outlets,” she said.

NAFDAC criticized the methodology used in the published report, citing discrepancies in the wavelength setting for absorbance during testing.

The agency highlighted that the British Pharmacopoeia recommends testing paracetamol tablets using Ultraviolet spectrophotometric method at 257nm, while the authors claimed to have set the absorbance at 700nm.

In addition to the subject in question, NAFDAC tested various parameters such as uniformity of mass, average weight, friability, hardness, disintegration time, and identification, all meeting the British Pharmacopoeia specifications.

Adeyeye added“Basic scientific facts such as the range of the concentrations of the standard curve solutions (0.01 to 0.05) being lower than the solution test samples (0.1) further invalidates all the analysis because the anticipated test solution concentration should fall within the calibration concentration range.”

The agency identified shortcomings in the published research, questioning transparency in methodology, sample size, and selection criteria.

NAFDAC stressed the importance of evidence-based information and urged stakeholders to rely on accurate and comprehensive data.

The agency condemned the unauthorized use of the World Health Organization logo in the social media dissemination of the article and confirmed that the article had been retracted.

Emphasizing their commitment to public health and safety, NAFDAC affirmed its dedication to ensuring the quality of pharmaceutical products in Nigeria, describing the publication as a disservice to the pharmaceutical industry and the nation.

The agency pledged to continue collaborating with manufacturers and stakeholders to maintain and enhance product quality, emphasizing its role in upholding a quality culture in the pharmaceutical manufacturing sector.