NAFDAC certifies Paracetamol tablets in Nigeria
The National Agency for Food and Drug Administration and Control, NAFDAC, yesterday certified that paracetamol tablets on sale in Nigeria met stipulated dosage standards and specifications in adherence with both national and international regulatory requirements.
Disclosing this at a briefing to make public the findings from the comprehensive laboratory tests of paracetamol tablets in its WHO-prequalified laboratory in Lagos, the Director General, Prof Christianah Adeyeye, described a recent report that nearly all paracetamol tablets in Nigeria were possibly underdosed as ‘false and unscientific.’
Adeyeye, who said NAFDAC would be taking action against the researchers, said: “This is a 100 per cent 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 for precise and reliable assessments of the dosage levels in the sampled paracetamol tablets.”
Giving insight into how the tests were conducted, Adeyeye explained that “Paracetamol tablets from 13 different local manufacturers were sampled from Lagos and Abuja pharmacy outlets.
“A minimum of 20 tablets from each manufacturer were used for the assay analysis by regulatory officers with verifiable analytical skills and competencies using the British Pharmacopoeia monograph 2023 edition volume. The assay test determines the amount of active pharmaceutical ingredient in each tablet.”
The DG, who said she was worried about the recent false publication as a scientist and a professor of pharmaceutical manufacturing and drug evaluation for 30 years, explained that the assay was validated using British Pharmacopoeia testing methodologies for precise and reliable assessments of the dosage levels in the sampled paracetamol tablets.
She said the assay results contradicted the results of the published report circulated on social media, adding that the authors of the publication claimed they used the British Pharmacopoeia test procedure to carry out the tests.
“We fault this grim publication in totality. The current edition of British Pharmacopoeia, 2023, volume III, states that paracetamol tablets can be tested using the Ultraviolet (UV) spectrophotometric method by setting the absorbance at 257nm wavelength.
‘’The authors claimed in the publication to have set the absorbance at 700 nm wavelength. This can be fact-checked in the current edition of British Pharmacopoeia, 2023, volume III. Page 1181,’’ the NAFDAC boss said.
Adeyeye added that other parameters not part of the subject in question were also tested and found to meet the BP specifications, including, uniformity of mass, average weight, friability, hardness, disintegration time, and identification.
Stating that the alleged research work was unacceptable, she argued that the study in the publication lacks the necessary transparency in methodology, sample size, and selection criteria. Querying if the authors have a different objective, she said they did not use the test method recommended in the British Pharmacopoeia and there was no evidence whatsoever that the test method used was validated and accepted.
She said the pharmaceutical manufacturing sector in Nigeria strives to maintain and enhance the quality of pharmaceutical products in Nigeria to align with NAFDAC’s quality culture.
