NAFDAC Faults Claim of Under Dosed Paracetamol in Market

The National Agency for Food and Drug Administration and Control (NAFDAC) has released the result of the investigation it carried out following reports(not by Concise News) of under dosed paracetamol in the market.

The agency said paracetamol tablets from 13 different local manufacturers were sampled from Lagos and Abuja pharmacy outlets.

It said 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 3.

“The assay test determines the amount of active pharmaceutical ingredient in each tablet,” NAFDAC said in a statement on Monday.

“The result of our test clearly showed that all the twenty tablets from each manufacturer met the stipulated dosage standards and specification. This includes adherence to both national and international regulatory requirements.

“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 for precise and reliable assessments of the dosage levels in the sampled paracetamol tablets.

“The assay results clearly contradict the results of the published report circulated on social media. The authors of the publication claimed that they used 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 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 British Pharmacopoeia, 2023, volume III. Page 1181.

“The following parameters that were not part of the subject in question were also tested: and found to meet the BP specifications.
Uniformity of mass
Average weight
Disintegration time

“We have many other grounds upon which the published research work is faulted and is unacceptable as stated below.

“The study in the publication lacks the necessary transparency in methodology, sample size, and selection criteria. Could the authors have a different objective? It is obvious that the researcher did not use the test method recommended in the British Pharmacopoeia. There is 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, about sample preparation, 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, 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.
The above are basic laboratory testing and scientific facts that those competent in pharmaceutical and regulatory science should know. These are the simplest of many rigorous tests that earned the NAFDAC Central Drug Control Laboratory the coveted Prequalification by WHO.

“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. This publication is a disservice to the pharmaceutical industry and the nation.”

NAFDAC emphasized the importance of evidence-based information to guide public discourse and urges stakeholders to rely on and check for accurate and comprehensive data.

“We just learnt that the article “Communication in Physical Sciences”, 2023, 9(2): 180-186 has been retracted.

“The mischief of placing the article in the social media on the background of World Health Organization logo is highly distasteful and illegal. That brings back the question, does the publisher has another agenda?

“As part of our commitment to public health and safety, NAFDAC will continue to ensure that 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,” the statement concluded.

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