The National Agency for Food and Drug Administration and Control, NAFDAC, has certified that paracetamol tablets on sale in Nigeria meet stipulated dosage standards and specifications in adherence with both national and international regulatory requirements.
Disclosing this during a press conference 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 states nearly all paracetamol tablets in Nigeria are possibly underdosed as ‘false and unscientific.’
Adeyeye who said NAFDAC will 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 contradict the results of the published report circulated on social media.
Adeyeye said the authors of the publication claimed that 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.”
Continuing, Adeyeye added that other parameters that were 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.
“The test sample size of 2 tablets used for analysis as stated in the journal is far below the recommended sample size for analysis and grossly unscientific and unprofessional. Aside from using un-recommended ultraviolet absorbance max, no mention of the solvent used to prepare the samples vs. standard solution, sample preparation, or equipment used (model, year) for the analysis.
“Does the equipment have Installation Qualification, Operational Qualification Performance Qualification certificates? Facts such as instrument calibration, the last calibration date, and the environmental condition in terms of temperature and humidity of the testing laboratory were missing in the publication.
“Other 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.”
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.
She added that the publication was a disservice to the pharmaceutical industry and the nation, and stated that the agency will take action against the researchers.
She emphasised the importance of evidence-based information to guide public discourse and urged stakeholders to rely on and check for accurate and comprehensive data.
Adeyeye however, announced that the article “Communication in Physical Sciences”, 2023, 9(2): 180-186 has been retracted.
“The mischief of placing the article in social media on the background of the World Health Organisation logo is highly distasteful and illegal. That brings back the question, does the publisher have another agenda?
She said NAFDAC will continue to ensure that the quality of the products is assured and continue to work with manufacturers, and other stakeholders to maintain and enhance the quality of pharmaceutical products in Nigeria.
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