NAFDAC faults publication on under dose Paracetamol
The National Agency for Food and Drug Administration and Control (NAFDAC), based on its scientific findings, faults claims that nearly all paracetamol drugs in the country are under the recommended doses.
Prof. Mojisola Adeyeye, the Director-General of NAFDAC, made this known on Monday while briefing newsmen on findings carried out by the agency due to a publication’s claim of under dose paracetamol tablets in the country.
Adeyeye said that based on a scientific response to recent reports suggesting widespread under dosing of paracetamol tablets in Nigeria, NAFDAC conducted a comprehensive testing of tablets, sampled from different pharmacy outlets to investigate these claims.
“As a Scientist and Professor of Pharmaceutical Manufacturing and Drug Evaluation for 30 years, the publication gave me a great concern on the lack of responsibility regarding the impact of the unscientific release on the Nigerian society.
“The results of the laboratory testing are ready after paracetamol tablets from 13 different local manufacturers were sampled from Lagos and Abuja pharmacy outlets.
“We assured the public that we will publish the result of our own investigation of the paracetamol tablets in Nigeria immediately we conclude testing in the agency’s WHO pre-qualified laboratory.
“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 3.
“The result of our test clearly showed that all the 20 tablets from each manufacturer met the stipulated dosage standards and specification.
“This includes adherence to both national and international regulatory requirements”.
She said: “This is a 100 per cent pass rate for the full compendia tests result for the 20 samples of paracetamol tablets tested.
“While 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 and we fault this grim publication in totality,” she said.
She added that parameters including uniformity of mass, average weight, friability, hardness, identification and disintegration time that were not part of the subject in question were also tested.
They were found to have met the BP specifications, she said.
“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.
“These 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 Pre-qualification by World Health Organisation (WHO),” she said.
According to Adeyeye, the pharmaceutical manufacturing sector in the country strives to maintain and enhance the quality of pharmaceutical products to align with NAFDAC’s quality culture.
“This publication that has now been retracted is a disservice to the pharmaceutical industry and the nation.
“The mischief of placing the article in the social media on the background of World Health Organisation logo is highly distasteful and illegal.
“NAFDAC emphasises the importance of evidence-based information to guide public discourse and urges stakeholders to rely on and check for accurate and comprehensive data”.
The Director-General reassured Nigerians of the agency’s commitment to public health and safety.
