The National Agency for Food and Drug Administration and Control, NAFDAC, on Monday, verified that paracetamol pills on sale in Nigeria fulfil mandated dose levels and specifications in adherence with national and international regulatory criteria.
Furthermore, Prof Christianah Adeyeye, Director General of NAFDAC, characterised a recent allegation that nearly all paracetamol tablets in Nigeria are potentially underdosed as ‘false and unscientific’.
Adeyeye said NAFDAC will be taking action against the researchers.
She spoke at a press conference on the findings from the laboratory tests of paracetamol tablets in Lagos.
According to Adeyeye, said: “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. It is for precise and reliable assessments of the dosage levels in the sampled paracetamol tablets.”
The test
Adeyeye explained that “Paracetamol tablets from 13 different manufacturers in Nigeria were sampled from Lagos and Abuja.
“A minimum of 20 tablets from each manufacturer were used for the assay analysis. The analysis was done by regulatory officers with verifiable analytical skills and competencies. They used the British Pharmacopoeia monograph 2023 Edition Volume.
“The assay test determines the amount of active pharmaceutical ingredient in each tablet.”
Meanwhile, the DG said she was worried about the recent false publication as a scientist and a Professor of Pharmaceutical Manufacturing and Drug Evaluation for 30 years.
She said the assay results contradict the results of the published report circulated on social media.
Adeyeye added that the authors of the publication claimed that they used the British Pharmacopoeia test procedure to carry out the tests.
Her words: “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 they were found to meet the BP specifications. These include uniformity of mass, average weight, friability, hardness, disintegration time, and identification.
She argued that the study in the publication lacks the necessary transparency in methodology, sample size, and selection criteria. She queries if the authors have a different objective.
Faults social media report
According to the NAFADAC boss, the authors 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 two tablets used for analysis as stated in the journal is far below the recommended sample size. And it is grossly unscientific and unprofessional.
“Aside from using unrecommended 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. This is because the anticipated test solution concentration should fall within the calibration concentration range.”
Threatens action
She said the pharmaceutical manufacturing sector in Nigeria strives to maintain and enhance the quality of pharmaceutical products to align with NAFDAC’s quality culture.
Adeyeye added that the publication was a disservice to the pharmaceutical industry and the nation. She said the agency will take action against the researchers.
NAFDAC emphasised the importance of evidence-based information to guide public discourse. Also, she urged stakeholders to rely on, and check for, accurate and comprehensive data.
However, Adeyeye 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 WHO logo is highly distasteful and illegal.
“That brings back the question, does the publisher have another agenda?”
Furthermore, she said NAFDAC will continue to ensure that the quality of the products is assured. Also, they will continue to work with stakeholders to maintain and enhance the quality of pharmaceutical products.