The National Agency for Food and Drug Administration and Control, or NAFDAC, has launched an investigation into the existence of counterfeit and inferior paracetamol brands on the open market in Nigeria in response to widely circulated research reports suggesting that almost all of the tablets sold there may be underdosed.
Prof. Mojisola Adeyeye, the Director-General of NAFDAC, stated in a statement on Monday that the organisation has mandated a market study to sample and test paracetamol brands that are marketed all across the nation.
While describing the science as dubious, Adeyeye refuted the accuracy of the research findings and said that NAFDAC had met with PMG-MAN, the leadership of the Pharmaceutical Manufacturing Group of the Manufacturing Association of Nigeria, to explain the Agency’s intentions.
In the press release headed “Nearly all paracetamol tablets in Nigeria are possibly under-dosed: Initial NAFDAC response,” Adeyeye attested to the fact that the organisation had obtained a copy of the publication containing the subject’s study findings.
She said:
“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. As soon as we finish the laboratory testing, we will update the public.
“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. 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.
“NAFDAC wishes to reassure the public that the Agency is very vigilant in her responsibilities in safeguarding the health of the nation. 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 88 public alerts and ordered 32 recalls for medicines and foods.”
cc: Vanguard Ng
