Nigeria: NAFDAC Certifies Paracetamol Tablets in Nigeria, Dispelling Misinformation

Nigeria: NAFDAC Certifies Paracetamol Tablets in Nigeria, Dispelling Misinformation

By Ahmad Hadizat Omayoza, Mamos Nigeria

In a recent development, the National Agency for Food and Drug Administration and Control (NAFDAC) has officially certified that paracetamol tablets available in Nigeria adhere to stipulated dosage standards and specifications in accordance with both national and international regulatory requirements. This certification comes in response to a widely circulated report suggesting potential underdosing of paracetamol tablets in the country.

During a press conference held in Lagos, Prof Christianah Adeyeye, the Director General of NAFDAC, emphatically dismissed the aforementioned report as ‘false and unscientific.’ She announced that the agency would be taking action against the researchers responsible for the misleading information.

The certification process involved rigorous laboratory tests conducted on paracetamol tablets from 13 different manufacturers in Nigeria, sourced from both Lagos and Abuja. A total of 20 tablets from each manufacturer were subjected to assay analysis, employing the British Pharmacopoeia monograph 2023 Edition Volume for precise and reliable assessments of the dosage levels.

Adeyeye clarified, “This is a 100% pass rate for the full compendia tests result for the 20 samples of paracetamol tablets tested. The assay was validated using British Pharmacopoeia testing methodologies.”

Addressing specific concerns raised in the report, Adeyeye highlighted discrepancies in the test methodology employed by the authors. She pointed out that the authors claimed to have used the British Pharmacopoeia test procedure but set the absorbance at 700 nm wavelength, whereas the current edition recommends 257nm wavelength for the Ultraviolet (UV) spectrophotometric method.

Moreover, the DG underscored that other essential parameters, such as uniformity of mass, average weight, friability, hardness, disintegration time, and identification, were rigorously tested and found to meet the British Pharmacopoeia specifications.

Expressing her concern as a scientist and a Professor of Pharmaceutical Manufacturing and Drug Evaluation, Adeyeye criticized the lack of transparency in the study’s methodology, sample size, and selection criteria. She questioned the authors’ objectives and emphasized the need for evidence-based information to guide public discourse.

In response to the misleading publication, NAFDAC announced the retraction of the article titled “Communication in Physical Sciences,” published in 2023, 9(2): 180-186. Adeyeye condemned the publication’s use of the WHO logo on social media as highly distasteful and illegal, raising suspicions about the publisher’s agenda.

In conclusion, NAFDAC reiterated its commitment to ensuring the quality of pharmaceutical products and pledged to take action against those responsible for spreading misinformation. The agency emphasized the importance of relying on accurate and comprehensive data, urging stakeholders to contribute to evidence-based information for the benefit of public health.

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