The National Agency for Food and Drug Administration and Control has ramped up its efforts to combat the growing issue of substandard and falsified medicines across Nigeria.
This move follows a revealing investigation by PUNCH Healthwise, which highlighted the alarming influx of fake and unregistered Seretide inhalers in Nigerian markets, occurring just a year after British pharmaceutical giant GlaxoSmithKline exited the country.
In a statement sent to The PUNCH, NAFDAC’s Director General, Prof. Mojisola Adeyeye, outlined the agency’s comprehensive strategies aimed at regulating the manufacturing, importation, distribution, advertisement, and sale of food, drugs, and medical devices.
She emphasized the importance of heightened post-marketing surveillance through collaborations with various stakeholders and increased public education efforts.
Adeyeye reiterated NAFDAC’s multi-faceted approach to addressing the circulation of substandard medicines, which encompasses prevention, detection, and responsive measures.
Key initiatives include the formulation of National Drug Distribution Guidelines, advocacy for establishing centralized drug distribution centers, and improving access to advanced laboratory and screening technologies to thwart the proliferation of counterfeit products.
“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,” she stated.
The Director General also announced the agency’s phased implementation of a GS1-driven track and trace system, designed to enhance supply chain security for pharmaceuticals, building on a successful pilot involving COVID-19 vaccines.
NAFDAC has established a national pharmaceutical traceability strategy, initiated a steering committee for traceability, and is currently processing draft regulations for gazetting.
PUNCH Healthwise’s investigation, titled “Fake, unregistered asthma inhalers flood markets after GSK’s exit,” published on August 18, 2024, uncovered the pervasive availability of counterfeit inhalers in the open drug market in Church Street, Idumota, Lagos.
The investigation revealed that while many local pharmacies did not stock asthmatic inhalers, one recognized store was found selling an unregistered Seretide Diskus inhaler for N28,000.
Experts in pulmonology and pharmacy expressed serious concerns about the potential health risks posed by counterfeit inhalers to the over 13 million Nigerians suffering from asthma, highlighting the risk of increased morbidity and mortality.
The Nigerian Thoracic Society has urged regulatory bodies to take decisive action against this influx to safeguard patients.
In addition to these measures, Adeyeye noted that NAFDAC’s achievement of ISO 9001:2015 certification and WHO Maturity Level 3 status has further strengthened its regulatory framework.
The agency has established four ISO-17025 accredited laboratories dedicated to drug control and food safety, as well as a laboratory for vaccines, biologics, and medical devices.
Harnessing technology, NAFDAC has introduced the Med Safety App, designed for efficient monitoring and reporting of adverse drug reactions, replacing the outdated paper forms.
“This app enhances patient safety and facilitates monitoring of adverse effects associated with SF medicines in circulation,” Prof. Adeyeye explained.
Furthermore, NAFDAC has implemented a Mobile Authentication Service, allowing consumers to verify the authenticity of medicines at the point of purchase.
Through scratch codes and SMS verification, consumers can confirm whether a product is genuine or potentially counterfeit, empowering them in the fight against fraud.
Adeyeye highlighted the availability of the NAFDAC Greenbook, an online database of registered drugs in Nigeria, accessible at https://greenbook.nafdac.gov.ng, which serves as a primary resource for verifying the registration status of medicines.
The agency conducts regular grassroots awareness campaigns to educate the public on identifying and avoiding counterfeit and substandard medicines.
Adeyeye also noted ongoing collaboration with other national medicines regulatory authorities and INTERPOL to share intelligence on suspicious products found in Nigeria.
Looking towards the future, Adeyeye discussed NAFDAC’s regulatory directives, including the “Five Plus Five Validity” policy.
This initiative requires importers of drugs that can be manufactured locally to submit plans for local production or partnerships with local manufacturers during the renewal period.
She reported a growing trend of collaborations between importers and local manufacturers, along with new production facilities being established in Nigeria.
Moreover, NAFDAC is increasing the range of medical items covered by its ceiling from nine to 34, a move aimed at curbing the importation of drugs that can be produced locally to meet domestic needs. These initiatives are intended to bolster NAFDAC’s regulatory oversight and improve access to high-quality medicines in Nigeria.
