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NAFDAC approves paracetamol tablets

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National Agency for Food, Drug Administration and Control (NAFDAC) has declared recent report claiming that paracetamol tablets sold in Nigeria are below standard as “false and unscientific”.

The agency’s Director General, Prof. Mojisola Adeyeye, made the declaration at a press briefing held, yesterday, in Lagos, to announce the results of tests carried out on Nigerian paracetamols.

NAFDAC’s response followed a publication claiming that “nearly all” paracetamol tablets in Nigeria were substandard, leading to ineffective treatment.
Adeyeye expressed surprise that the publication was accepted by a journal.

The results of NAFDAC’s investigation presented at the conference showed a 100 per cent pass rate for the compendia tests conducted on paracetamol tablets from 13 different local manufacturers.

The testing, performed in NAFDAC’s WHO Prequalified Laboratory, adhered to both national and international regulatory requirements. She said: “The results of the Laboratory testing are ready, and we are pleased to inform the public of the outcome as follows: Paracetamol tablets from 13 different local manufacturers were sampled from Lagos and Abuja pharmacy outlets.

“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 result of our test clearly showed that all 20 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 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”.

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