NAFDAC to Re-certify Paracetamol Tablets Sold in Nigeria

Pat Stevens/

The National Agency for Food and Drug Administration (NAFDAC) said it has commenced the process of sampling and testing all paracetamol tablets sold in Nigeria.

The agency made this known today against the backdrop of a report making the rounds, which alleges that paracetamol tablets sold in Nigeria are underdosed.

A medicine is said to be underdosed when it shows lower concentrations than the expected limit, which may be due to errors in its calculation or formulation. This automatically deprives patients of the full dose of their prescription.

NAFDAC in a statement signed by its Director General, Professor Moji Adeyeye, questioned the authenticity of the claim but said it would reexamine the paracetamol tablets currently being sold in the country to reassure the citizens of their safety.

The statement reads, “The National Agency for Food and Drug Administration (NAFDAC) is aware of a recent story presently being circulated on social media alleging that nearly all paracetamol tablets sold in Nigeria are under dosed. We have received a copy of the publication of the research finding of the subject and we wish to state categorically that the report is misleading, and the science is questionable.  As the quality culture of NAFDAC demands, as soon as the Agency became aware of the news, the Director General, had meetings with the respective Directors and gave a directive that a survey of the market should be done to sample and test. The DG has also met with the leadership of the Pharmaceutical Manufacturing Group of the Manufacturing Association of Nigeria to inform them of the Agency’s intent.  

“NAFDAC’s laboratories are ISO 17025-certified every year to ensure that the procedures used for testing are based on international standards and the equipment or instruments used are qualified similarly.  We do yearly post-marketing survey of medicines to ensure that the quality and safety are maintained.  Where there is a deviation from this, i.e., whenever we find any regulated product to be substandard or falsified, NAFDAC regularly issues public alerts or do recalls. In the last two years we have issued eighty-eight (88) public alerts and ordered thirty-two (32) recalls for medicines and foods.

“We are using this medium to assure the public that NAFDAC is using international standards and scientific method to survey the paracetamol product where samples are collected from different parts of the country in the right amount and will be tested using well calibrated, and qualified state-of-the-art equipment or instruments. 

“This is part of our routine regulatory post marketing surveillance among others throughout the life cycle of a medicine. We want to reiterate that NAFDAC has five ISO-17025 Laboratories across the country, and a WHO Prequalified Laboratory at Yaba Lagos where medicines are tested for quality and safety.  The laboratories test medicines using official monographs of British Pharmacopeia, United States Pharmacopoeia, and International Pharmacopoeia.

“As soon as we finish the laboratory testing, we will update the public. NAFDAC wishes to reassure the public that the Agency is very vigilant in her responsibilities in safeguarding the health of the nation.  It is on this basis that NAFDAC has been recognized by WHO as a stable, well-functioning agency, and by other international partners as an organisation that places premium on the quality, safety and efficacy of medicines, food, and other regulated products.”