NAFDAC begins testing as fake paracetamol floods market

Mojisola Adeyeye, the Director General of the National Agency for Food and Drug and Administration and Control (NAFDAC) has ordered a market survey to sample and test paracetamol brands in Nigeria.

This is in response to a recent investigation which found that nearly all of the paracetamol tablets sold in Nigeria are possibly underdosed, falling short of the requirements specified by the British Pharmacopoeia and the World Health Organization (WHO).

A 2023 study, titled ‘Comparative Analysis of Five Different Brands of Paracetamol Sold in Nigeria with British Pharmacopoeia Standards,’ exposed variations in the claimed and actual dosage of paracetamol tablets. Samples from five different brands, all purportedly containing 500mg, were found to have concentrations ranging from 185mg to 358mg, significantly below the recommended limit

The NAFDAC boss in a statement on Monday disputed the accuracy of the research, labeling it as misleading and questioning the scientific methodology. Adeyeye consequently directed a market survey to sample and carry out a laboratory test of paracetamol brands across the country.

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.

The DG assured 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.

She emphasized 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 do yearly post-marketing survey of medicines to ensure that the quality and safety are maintained. 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”, she stated.

“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”, the DG stated.