NAFDAC faults report on substandard paracetamol tablets

Says report misleading, questionable
National Agency for Food, Drug Administration and Control (NAFDAC) has faulted a recent report that nearly all paracetamol tablets sold in Nigeria are below standard, describing the report as misleading and questionable.

However, the Director General of NAFDAC, Prof. Mojisola Adeyeye, said the agency has directed that a survey of the market be done to sample and test various paracetamol brands.

A recent study on paracetamol tablets in Nigeria had claimed that nearly all the brands fell below standards set by British Pharmacopoeia and World Health Organisation.


The study, titled ‘Comparative Analysis of Five Different Brands of Paracetamol Sold in Nigeria with the British Pharmacopoeia Standards,’ which was published in the journal, Communication in Physical Science (Journalcps.com),  stated that samples from five different paracetamol brands, each claiming to contain 500mg, were tested and analysed, using the spectrophotometric method.

Search by The Guardian showed that the report was received on December 19, 2022 and accepted on May 19, 2023.

Adeyeye, in a statement, yesterday, in Abuja, observed that as the quality culture of NAFDAC demands, as soon as the agency became aware of the report, she held meetings with respective directors and gave a directive that a survey of the market be done to sample and test.

She noted that she had 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 said: “This is part of our routine regulatory post marketing surveillance 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.”

Adeyeye said that as soon as laboratory testing is completed, the agency would update the public, stressing 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 recognised 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’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,” she added.

Author

Don't Miss