Findings on Substandard Paracetamol Tablets, Misleading, Says NAFDAC

pharmacy

The National Agency for Food and Drug Administration (NAFDAC) has dismissed recent research finding, which indicated that all paracetamol brands sold in Nigeria are below the approved standards of World Health Organisation (WHO) and British Pharmacopeia.

Director General, NAFDAC, Prof. Moji Adeyeye, in a statement made available to Pharmanewonline, categorically countered the report, which has gone viral on social media as misleading, with questionable science.

Paracetamol is one of the most consumed over-the-counter (OTC) analgesics in Nigeria, due to its basic function of relieving pain from different conditions.

Findings from the study, published in the journal, Communication in Physical Sciences, claimed  that paracetamol concentrations in five different samples of tablets were 358, 185, 320, 250 and 285mg, respectively, below 500mg, the recommended standards by BP and WHO.

Prof. Adeyeye disclosed that the agency’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.

She revealed that upon receiving the report, the agency has commenced international standards and scientific method survey on the paracetamol products from different parts of the country, where samples were collected in the right amount and will be tested using well calibrated, and qualified state-of-the-art equipment or instruments.

She said “We are using this medium to assure the public that NAFDAC is aware of a recent story presently being circulated on social media alleging that nearly all paracetamol tablets sold in Nigeria are under dosed. 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”.

The NAFDAC boss further explained the annual post-marketing survey of medicines by the agency, where they ensure that the quality and safety of drugs are maintained.  Where there is a deviation, she said, from this, i.e., whenever we find any regulated product to be substandard or falsified, NAFDAC regularly issues public alerts or do recalls.

She asserted that the agency in the last two years has issued eighty-eight (88) public alerts and ordered thirty-two (32) recalls for medicines and foods.

Adeyeye, therefore assured the public of NAFDAC’s vigilance in safeguarding the health of the nation, while expressing the agency’s readiness to update citizens on the outcome of the laboratory testing when concluded.