NAFDAC faults study claiming paracetamol under-dosed in Nigeria

The National Agency for Food and Drug Administration and Control (NAFDAC) has faulted a report alleging that nearly all paracetamol tablets sold in Nigeria are under-dosed.

In a 2023 study titled: ‘Comparative Analysis of Five Different Brands of Paracetamol Sold in Nigeria with British Pharmacopoeia Standards’, samples from five different paracetamol brands, each claiming to contain 500mg paracetamol as its active ingredient, were said to have been tested and analysed using the spectrophotometric method.

But the paracetamol concentrations were reportedly found to range from 185mg to 358mg, which is less than the recommended 500mg.

The study’s researchers raised concerns about the possibility of treatment failure due to under-dosed paracetamol tablets.

Reacting in a statement on Monday signed by Mojisola Adeyeye, its director-general, the agency said the report “is misleading, and the science is questionable”.

NAFDAC said as soon as it became aware of the news, Adeyeye held meetings with the respective directors and gave a directive that a survey of the market should be done to sample and test.

The statement said the DG also met with the leadership of the pharmaceutical manufacturing group 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,” the statement reads.

“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. ”