Politics
NAFDAC Grants Approval For Paracetamol Tablets In Nigeria
NAFDAC Grants Approval For Paracetamol Tablets In Nigeria....KINDLY READ THE FULL STORY HERE▶
The National Agency for Food and Drug Administration and Control (NAFDAC) officially affirmed on Monday that paracetamol tablets available in Nigeria adhere to prescribed dosage standards and specifications in compliance with national and international regulatory standards…….CONTINUE READING
Addressing a press conference on the outcomes of laboratory tests conducted on paracetamol tablets in Lagos, Prof Christianah Adeyeye, the Director General of NAFDAC, refuted recent claims suggesting that almost all paracetamol tablets in Nigeria may be underdosed, dismissing them as “false and unscientific.”
Prof Adeyeye emphasized the agency’s commitment to taking action against the researchers responsible for the contested report. She revealed that the laboratory tests, conducted on samples from 13 different manufacturers in Nigeria, resulted in a 100% pass rate for the compendia tests, using British Pharmacopoeia testing methodologies for precise and reliable assessments of dosage levels.
The assay analysis involved a minimum of 20 tablets from each manufacturer, and the active pharmaceutical ingredient in each tablet was determined through the assay test. Adeyeye highlighted the thoroughness of the regulatory officers’ analytical skills and competencies in carrying out the assessment.
Expressing concern over the false publication as both a scientist and a Professor of Pharmaceutical Manufacturing and Drug Evaluation, Adeyeye noted discrepancies between the published report and the British Pharmacopoeia test procedure. She pointed out that the authors set the absorbance at 700 nm wavelength, contrary to the recommended 257nm wavelength stated in the current edition of the British Pharmacopoeia, 2023, Volume III.
Adeyeye criticized the lack of transparency in the study’s methodology, sample size, and selection criteria, questioning the authors’ objectives. She asserted that the publication was misleading, as it did not adhere to recommended test methods and lacked evidence of validation.
The NAFDAC Director General underscored the pharmaceutical industry’s efforts to maintain and enhance product quality in alignment with NAFDAC’s quality culture. She declared that the agency would take action against the researchers responsible for the misleading publication.
In an effort to stress the importance of evidence-based information in public discourse, Adeyeye urged stakeholders to rely on accurate and comprehensive data. Additionally, she announced the retraction of the article from the “Communication in Physical Sciences,” 2023, 9(2): 180-186, labeling the placement of the article on social media with the WHO logo as distasteful and illegal, prompting questions about the publisher’s motives. NAFDAC affirmed its commitment to ensuring the quality of pharmaceutical products and collaboration with stakeholders for ongoing quality improvement.
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