Alleged Substandard PCM Report: NAFDAC Probes Quality Of Paracetamol Brands In The Country

Following viral reports of research alleging that nearly all of the paracetamol tablets sold in Nigeria are possibly under-dosed, the National Agency for Food and Drug and Administration and Control, NAFDAC, has said it is investigating the presence of fake and substandard paracetamol brands in the open market in Nigeria.

Director-General of NAFDAC, Prof Mojisola Adeyeye, in a statement on Monday, said the agency has ordered a market survey to sample and test paracetamol brands sold across the country.

Adeyeye, who debunked the accuracy of the research described the report as misleading, even as she described the science as questionable.

She stated that NAFDAC had met with the leadership of the Pharmaceutical Manufacturing Group of the Manufacturing Association of Nigeria, PMG-MAN to inform them of the Agency’s intent.

In the statement titled, “Nearly all paracetamol tablets in Nigeria are possibly under-dosed: Initial NAFDAC response” Adeyeye confirmed that the agency had received a copy of the publication of the research findings of the subject.

“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,” she affirmed.

Further, the D-G assured that 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 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,” she remarked.