Paracetamol Drugs Meet International Specification – NAFDAC

National Agency for Food and Drug Administration and Control (NAFDAC) has verified the authenticity of paracetamol tablets in the Nigerian market, after thorough laboratory testing.
Recall that social media platforms were awash with reports from a publication titled: “Nearly all paracetamol tablets in Nigeria are possibly underdosed.“

In a response, NAFDAC conducted a comprehensive testing of more than 20 brands from 13 different local manufacturers of paracetamol in Lagos and Abuja pharmacy outlets, to investigate these claims.
The director-general, NAFDAC, Prof. Mojisola Adeyeye, in a press briefing, yesterday, in Lagos, disclosed that findings of the study showed that all 20 tablets from each manufacturer met the stipulated dosage standards and specification.

Adeyeye 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.

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,“ she said.

The DG asserted that the study was validated using British Pharmacopoeia testing methodologies for precise and reliable assessments of the dosage levels in the sampled paracetamol tablets, adding that, „The assay results clearly contradict the results of the published report circulated on social media.“
She faulted the published research work, while adding that, „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.
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. 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, Adeyeye posited, even as she stated that the publication is a disservice to the pharmaceutical industry and the nation.

She affirmed 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.
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,“ she assured.