The National Agency for Food and Drug Administration and Control (NAFDAC) has officially certified that paracetamol tablets available in Nigeria adhere to specified dosage standards and meet regulatory requirements both nationally and internationally. The announcement was made by NAFDAC’s Director General, Prof Christianah Adeyeye, during a press conference in Lagos on Monday.
Addressing recent claims suggesting underdosing in nearly all paracetamol tablets in Nigeria, Adeyeye dismissed the allegations as “false and unscientific.” She clarified that NAFDAC had conducted thorough laboratory tests on 20 samples of paracetamol tablets, achieving a 100% pass rate for the full compendia tests.
Adeyeye emphasized the reliability of the assay, which was validated using British Pharmacopoeia testing methodologies to ensure precise assessments of dosage levels. The tablets, sourced from 13 different manufacturers in Nigeria, underwent analysis in accordance with regulatory standards.
The NAFDAC boss expressed concern about the misinformation, stating that the published report contradicted the results of the assay tests conducted by the agency. She particularly criticized the authors of the report for using an incorrect test procedure, noting that the British Pharmacopoeia recommends the Ultraviolet (UV) spectrophotometric method with a specific wavelength, contrary to the authors’ claim of using 700 nm instead of the specified 257 nm.
Adeyeye highlighted the absence of transparency in the methodology, sample size, and selection criteria of the published study. She questioned the authors’ motives and stressed that the study lacked necessary scientific rigor and professionalism.
Furthermore, Adeyeye disclosed that other parameters, such as uniformity of mass, average weight, friability, hardness, disintegration time, and identification, were tested and found to meet British Pharmacopoeia specifications.
The Director General assured the public that the pharmaceutical manufacturing sector in Nigeria is committed to maintaining and improving the quality of pharmaceutical products in alignment with NAFDAC’s quality standards. She stated that the agency would take action against the researchers responsible for the misleading report.
NAFDAC underscored the importance of evidence-based information for accurate public discourse and urged stakeholders to rely on and verify accurate and comprehensive data. Additionally, Adeyeye announced the retraction of the article in question and condemned the act of placing the article on social media with the World Health Organization (WHO) logo, describing it as distasteful and illegal.