BREAKING: NAFDAC’s Reaction To Alleged Underdozing Of Paracetamol Tablets

It was a thing of concern recently when allegations of underdozing of paracetamol tablets in Nigeria appeared in the social media. In a situation where it remains the first tablet of reference for most people seeking relief from basic illnesses in Nigeria, the issue of underdozing of paracetamol tablets is indeed a cause for concern....CONTINUE READING

The allegation as serious as it is immediately caught the attention of the regulatory agency the National Agency for Food Drugs Administration and Control (NAFDAC).

The Eagle also reports that Medical Negligence Team, an online medical advisory concern.

It states that: “Avoidable errors of incorrect dosage can have serious effects on a patient”.

It adds: “You may suffer further illness, internal injuries, and lifelong psychological trauma”.

This and the general wellbeing of the Nigerian public have heightened our correspondent’s interest in following through this issue.

However, the National Agency for Food Drugs Administration and Control (NAFDAC) has indeed responded to the issue of overdozing of paracetamol tablets, The Eagle reports.

in its submission of January 24, 2024, titled: RE: PUBLICATION – “NEARLY ALL PARACETAMOL TABLETS IN NIGERIA ARE POSSIBLY UNDERDOSED”, the agency described the publication asserting the above as false, adding that it actually issued a press release on the matter on January 14, 2024.

“The National Agency for Food and Drug Administration and Control (NAFDAC) issued a press release on Monday 14/01/2024 as an initial response to the above subject concerning a story circulating on the social media that paracetamol tablets in circulation in Nigeria are under dosed.

“In a scientific response to the recent reports suggesting widespread under dosing of paracetamol tablets in Nigeria, NAFDAC conducted a comprehensive testing of the tablets, sampled from different pharmacy outlets to investigate these claims.

“As a scientist and a Professor of Pharmaceutical Manufacturing and Drug Evaluation for thirty years, the publication has given the Director General a grave concern on the non-quality of this publication and lack of responsibility regarding the impact of the unscientific release on the Nigerian society.

“It is surprising that the publication was accepted by a journal”, the agency said.

It advised Nigerians to disregard the issue underdozing of Paracetamol tablets in the country, adding that it would make a publication immediately it finished concluding testing in the Agency World Health Organisation (WHO) Prequalified Laboratory.

“The results of the Laboratory testing are ready, and we are pleased to inform the public of the outcome as follows:

Paracetamol tablets from thirteen different local manufacturers were sampled from Lagos and Abuja pharmacy outlets.

Minimum of twenty 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 twenty 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% 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”, NAFDAC said.

According to it, the conclusions from its independent investigation on the issue of overdozing of paracetamol tablets in the country, had nullified the allegations and circulation in the social media.

It added: “The authors of the publication claimed that they used 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 Ultraviolet (UV) spectrophotometric method by setting the absorbance at 257nm wavelength.

“The authors claimed in the publication to have set the absorbance at 700 nm wavelength. This can be fact checked in the current edition British Pharmacopoeia, 2023, volume III. Page 1181”.