The National Agency for Food and Drug Administration and Control says it has intensified its efforts to combat the proliferation of substandard and falsified medicines across different parts of the country.
This development is in response to an investigation by PUNCH Healthwise, which exposed how fake and unregistered Seretide inhalers flooded Nigerian markets one year after British pharmaceutical giant, GlaxoSmithKline exited Nigeria.
NAFDAC’s Director General, Prof Mojisola Adeyeye, in a statement exclusively sent to PUNCH Healthwise on the matter, noted that the agency has implemented various measures to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale, and use of food, drugs, cosmetics, medical devices, packaged water, chemicals, and detergents.
She further noted that the agency had strengthened its post-marketing surveillance through multi-stakeholder engagement, education, and awareness.
The DG re-emphasised NAFDAC’s current strategy for tackling the circulation of SF medicines to include prevention, detection, and response mechanisms.
She further emphasised the development of National Drug Distribution Guidelines, advocacy for the establishment of coordinated drug distribution centres, and access to laboratory and screening technologies as measures to curb the tide of fake and unregistered medicines.
According to her, “NAFDAC has strengthened its Investigation and Enforcement directorate/Federal Task Force on Counterfeit and Fake Drug and Unwholesome Processed Food to carry out investigation and enforcement activities to deter the circulation of SF medicine.”
Adeyeye also said, “We have commenced phased implementation of a GS1-driven track and trace system, with in-country serialisation capability, to secure the supply chain for pharmaceuticals, following a successful pilot study with Covid-19 vaccines.
“NAFDAC successfully developed and launched the national pharmaceutical traceability strategy, inaugurated the national traceability steering committee and published the guidelines for master data requirements. The Agency also published the draft national traceability regulation that is being processed for gazetting.”
PUNCH Healthwise’s report with the headline, ‘Fake, unregistered asthma inhalers flood markets after GSK’s exit’, was published on Sunday, August 18, 2024.
In the report, our correspondent embarked on a fact-finding mission to the open drug market in Church Street, Idumota, Lagos State where it was discovered that fake and unregistered, Seretide inhalers, had flooded the market.
To further investigate the extent to which the unregistered inhalers have flooded the pharmaceutical shops, our correspondent visited some local and popular dispensing pharmacies.
PUNCH Healthwise found out that although most local dispensing drug stores do not sell asthmatic inhalers, a recognised drug store openly displayed and sold the unregistered Seretide Diskus inhaler for N28,000.
Pulmunologists and leading pharmacists, who spoke to PUNCH Healthwise, expressed concerns that counterfeit Seretide inhalers could worsen the condition of over 13 million Nigerians living with asthma, leading to increased morbidity and mortality.
The Nigerian Thoracic Society urged regulatory agencies to tackle this influx and protect patients.
Continuing, Adeyeye stated that the agency’s attainment of ISO 9001:2015 certification and WHO Maturity Level 3 has further strengthened the agency’s regulatory system.
The NAFDAC DG also said the agency established four ISO-17025 re-certified drug control and food laboratories, as well as a Vaccines, Biologics, and Medical Devices laboratory, to ensure the quality of regulated products.