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Standards: NAFDAC affirms paracetamol tablets, syrups in Nigeria meet international regulatory requirements

Prof. Mojisola Adeyeye, Director-General of NAFDAC

*Prof. Mojisola Adeyeye, Director-General of the National Agency for Food and Drug Administration and Control explains how the Nigerian health regulator conducted a ‘comprehensive testing’ of over 20 paracetamol brands from 13 different local manufacturers in Lagos and Abuja pharmacy outlets to confirm their authenticity and potency

Isola Moses | ConsumerConnect

The National Agency for Food and Drug Administration and Control (NAFDAC) says the health regulatory agency has verified the authenticity of paracetamol tablets and syrups in the Nigerian market after thorough laboratory testing.

It is recalled that recently, there were reactions, especially in the social media space resulting from a publication, titled: “Nearly all paracetamol tablets in Nigeria are possibly underdosed”.

Paracetamol tablets

ConsumerConnect reports NAFDAC, however, in a response to the widespread allegation, said it had conducted a comprehensive testing of over 20 paracetamol brands from 13 different local manufacturers in Lagos and Abuja pharmacy outlets to investigate these claims.

In a verdict after the investigation, Prof. Mojisola Adeyeye, Director-General of NAFDAC, at a media briefing held Monday, January 22, 2024, in Lagos, disclosed the findings of the study are positive.

Adeyeye said the health regulatory agency’s findings indicated that “all 20 tablets from each manufacturer met the stipulated dosage standards and specification.”

How NAFDAC conducted laboratory testing on 20 local brands, by Director-General

Prof. Adeyeye also stated that minimum of 20 tablets from each paracetamol drug manufacturer in Nigeria were used for the assay analysis by regulatory officers with verifiable analytical skills and competencies, using the British Pharmacopoeia monograph 2023 Edition Volume 3.

According to her, the assay test determines the amount of active pharmaceutical ingredient in each tablet.

The verdict? The Director-General of NAFDAC declared that “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. This is a 100 percent pass rate for the full compendia tests result for the 20 samples of paracetamol tablets tested.

“The 20 tablets also met the BP specifications; uniformity of mass; average weight; friability; hardness; disintegration time and identification.”

Adeyeye further stated that the study 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,” she declared.

The agency as well faulted and pooh-poohed the so-called published research work that had hitherto raised safety concerns among the Nigerian consumers.

Adeyeye: Publication ‘lacks the necessary transparency in methodology, sample size and selection criteria’

Underscoring the authenticity of the NAFDAC findings in line with global standards, Adeyeye said: “The study in the publication lacks the necessary transparency in methodology, sample size and selection criteria.

“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.

She noted the test sample size of two tablets used for analysis as stated in the journal is far below the recommended sample size for analysis and grossly unscientific and unprofessional.

The Director-General stated: “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.”

Adeyeye also explained: “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 (World Health Organisation).”

Nigeria’s pharmaceutical manufacturing sector maintains quality culture, says NAFDAC

Meanwhile, the West African country’s health sector regulatory agency has said that the pharmaceutical manufacturing sector in Nigeria strives to maintain and enhance the quality of pharmaceutical products to align with NAFDAC’s quality culture.

Adeyeye posited, again, that the publication in question “is a disservice to the pharmaceutical industry and the nation.”

She restated that NAFDAC places emphasis on the importance of “evidence-based information” to guide public discourse, while urging stakeholders to rely on and check for accurate and comprehensive data.

Prof. Adeyeye added: “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.”

Additional reporting by Gbenga Kayode.

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