NAFDAC Certifies Paracetamol Tablets in Nigeria

NAFDAC has officially certified that paracetamol tablets in Nigeria adhere to the stipulated dosage standards and specifications, meeting both national and international regulatory requirements.
The Director General of National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye
The Director General of National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola AdeyeyeGuardian

The National Agency for Food and Drug Administration and Control (NAFDAC) officially certified that paracetamol tablets available for sale in Nigeria adhere to the stipulated dosage standards and specifications, meeting both national and international regulatory requirements.

During a briefing to announce the results of the comprehensive laboratory tests conducted on paracetamol tablets in NAFDAC's WHO-prequalified laboratory in Lagos, the Director General, Prof Christianah Adeyeye, vehemently dismissed a recent report claiming that almost all paracetamol tablets in Nigeria were potentially underdosed, labeling it as 'false and unscientific.'

Prof Adeyeye emphasized NAFDAC's commitment to taking action against the researchers responsible for the misleading report. She stated, "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 contradicted the results of the published report circulated on social media, adding that the authors of the publication claimed 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.

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