This comes after a report published in the journal Communication in Physical Sciences, saying that samples from five different paracetamol brands, each claiming to contain 500mg, were tested and analysed using the spectrophotometric method, on the 2023 study titled ‘Comparative Analysis of Five Different Brands of Paracetamol Sold in Nigeria with British Pharmacopoeia Standards’.
The National Agency for Food and Drug Administration (NAFDAC) has begun surveying and testing of paracetamol tablets in the Nigerian market.
This comes after a report published in the journal Communication in Physical Sciences, saying that samples from five different paracetamol brands, each claiming to contain 500mg, were tested and analysed using the spectrophotometric method, on the 2023 study titled ‘Comparative Analysis of Five Different Brands of Paracetamol Sold in Nigeria with British Pharmacopoeia Standards’.
According to the investigation, the concentrations range from 185mg to 358mg, which was much lower than the suggested 500mg limit.
But reacting to the report, the Director General of NAFDAC, Prof Moji Adeyeye said the agency was aware of a recent story presently being circulated on social media alleging that nearly all paracetamol tablets sold in Nigeria are under dosed.
It described the report as misleading but said a directive had been given to the surveying and testing of samples in the market.
It said, “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,” it said.
The agency reiterated 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”.
It said, “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.”