The National Agency for Food and Drug Administration and Control, has certified that paracetamol tablets on sale in Nigeria meet specified dosage standards and specifications in compliance with national and international regulatory requirements.
The Director General of NAFDAC, Prof Christianah Adeyeye, made this known a press conference on the findings from the laboratory tests of paracetamol tablets in Lagos on Monday.
She described a recent report that nearly all paracetamol tablets in Nigeria are possibly underdosed as ‘false and unscientific’.
Adeyeye said NAFDAC will be taking action against the researchers.
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.”
Speaking on 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.”
The NAFDAC boss expressed worries about the recent false publication as a scientist and a Professor of Pharmaceutical Manufacturing and Drug Evaluation for 30 years.
She noted that the assay results contradict the results of the published report circulated on social media.
Adeyeye stated further that the authors of the publication claimed that they used the British Pharmacopoeia test procedure to carry out the tests.
She said, “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.”
Adeyeye equally pointed out that other parameters that were not part of the subject in question were also tested. And they were found to meet the BP specifications, identifying these to include uniformity of mass, average weight, friability, hardness, disintegration time, and identification.
She insisted that the study in the publication does not have the necessary transparency in methodology, sample size, and selection criteria, querying if the authors have a different objective.
The DG stressed that 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.”
Adeyeye disclosed that the pharmaceutical manufacturing sector in Nigeria strives to maintain and boost the quality of pharmaceutical products to align with NAFDAC’s quality culture.
She also said that the publication was a disservice to the pharmaceutical industry and the nation, adding the agency will take action against the researchers.
NAFDAC highlighted the importance of evidence-based information to guide public discourse, urginvy 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?”
Adeyeye added that NAFDAC will continue to ensure that the quality of the products is assured and collaborate work with stakeholders to maintain and enhance the quality of pharmaceutical products.
