The National Agency for Food and Drug Administration and Control (NAFDAC), mandated for safeguarding public health by ensuring that food and drug products made available to the public are safe, effective, and of good quality, is proud to announce the significant strides it has made in enhancing the safety and quality of pharmaceutical products in Nigeria. This has been through the implementation of pharmaceutical traceability, pharmacovigilance, post marketing on the field checking for substandard falsified medicines, and other system strengthening interventions. This endeavour has been made possible through vital support from the Global Fund’s Resilient and Sustainable Systems for Health (GF-RSSH) grant, with the National Agency for the Control of AIDS (NACA) as the principal recipient. The Global Fund is an international financing institution dedicated to combating HIV/AIDS, Tuberculosis, and Malaria. It provides support to countries in their efforts to address these global health challenges and strengthen health systems. For more information. The National Agency for the Control of AIDS (NACA) is Nigeria’s main organization for the control of HIV and AIDS. NACA is responsible for coordinating the country’s response to HIV and AIDS and provides strategic guidance for the national response.
Under the GF-RSSH grant, several budget lines were implemented by NAFDAC during Grant Cycle 6, totalling $2,305,695.03, as outlined below:
- Strengthening NAFDAC role and capacity in pharmacovigilance and ADR monitoring and reporting ($36,965.00): Over the years, NAFDAC has invested in the capacity building of staff in Pharmacovigilance (PV). However, in ensuring sustained delivery of its mandate, the skills and competence of its staff require continuous capacity strengthening and advancement. The BL33 under the RSSH 2 grant was used to support the capacity strengthening of PV officers in recent development and advances in PV and Adverse Drug Reaction (ADR) reporting in Nigeria in line with the newly revised Nigerian National Pharmacovigilance Policy and Implementation Framework 2020 document. NAFDAC has successfully built the capacity of 76 staff members across 36+1 states on Pharmacovigilance of AIDS, Tuberculosis, and Malaria (ATM) commodities.
- In addition, GF (BL 106) supported NAFDAC to acquire a mobile app for ADR reporting and monitoring Pharmacovigilance activity for three years ending in 2023 ($8,684.21): The implementation of a mobile app has streamlined the reporting and monitoring of adverse drug reactions (ADR) and improving the overall responsiveness of the healthcare system.
- To ensure that the medicinal product is the right medicine which the label carries, Global Fund (BL36) supported three NAFDAC state offices with three field devices (Truscan®) for rapid on the spot check for product quality ($184,112.00): NAFDAC’s state offices have been further equipped with some devices for rapid screening of product quality, ensuring that unsafe and substandard products are swiftly identified and removed from circulation. Alongside this is the funding of the Yaba Central Drug Control Laboratory (CDCL).
- Strengthening one of the NAFDAC ISO 17025 laboratories (CDCL, Yaba) to conduct comprehensive analysis of ATM and other disease program medicines ($944,605.00) was another huge contribution of Global Fund (BL38): The purpose is to support and strengthen existing NAFDAC existing Laboratories to sustain their ISO-17025 Accreditation and to get WHO Prequalification. This initiative has enhanced NAFDAC’s laboratory capabilities, enabling comprehensive analysis of many medicinal products. Significant procurement included Liquid Chromatography, Dissolution Apparatus, Disintegration Apparatus, HPLC (with chiller), FTIR, UV Spectrophotometer, Top load balance, Ultra-Low Freezers, Polarimeter, Incubator, Digital Stopwatches, Digital Thermometers, PH Meters, and NIR Spectrophotometric Scanners.
It is good to share success story that the Central Drug Control Laboratory, Yaba has attained World Health Organisation Prequalification, partly because of the GF support. The implication of this is that many more medicines will be tested for quality in our laboratory, and this will ensure access to quality medicines by our citizens.
- Another impactful support from GF was the support to NAFDAC for phased implementation of traceability of health products ($1,131,328.82 – BL136): This budget line has been instrumental in rolling out a phased implementation of traceability for health products in Nigeria. This budget line supported:
- Training a total of 1,561 stakeholders trained across 36 states and the FCT comprising 832 in the Public Sector and 729 in the Private Sector.
- Deployment of 435 android-enabled mobile android scanners and 315 internet routers to support traceability of ATM commodities.
- Raising awareness among health sector stakeholders about the Nigeria traceability initiative and the engagement of stakeholders in the development of the Pharmaceutical Traceability Regulation.
- Strengthening market control of NAFDAC’s regulated products – medicines and vaccines. All the above have contributed to supply chain visibility, mitigation of substandard falsified medicines and strengthening of the health systems.
This support from the Global Fund has had a profound impact on NAFDAC’s goals of ensuring the availability of safe and high-quality ATM health products to Nigerians.
Through improved pharmacovigilance, product quality screening, laboratory analysis, and traceability, NAFDAC can proactively identify and mitigate potential risks associated with pharmaceutical products. This not only safeguards public health but also contributes to the overall trust and confidence in the healthcare system.
Sustainability and Next Steps:
Looking ahead, NAFDAC is committed to ensuring the sustainability of these efforts. We plan to continue building on the progress made through the GF-RSSH grant by:
- Enhancing Regulatory Frameworks: NAFDAC will work on strengthening regulatory frameworks to ensure long-term traceability and quality assurance of health products.
- Capacity Building: Continued training and capacity building for NAFDAC staff and stakeholders will be a priority to maintain and further improve the quality of health products in Nigeria.
- Public Awareness: NAFDAC will engage in public awareness campaigns to educate consumers and healthcare providers about the importance of pharmaceutical traceability and quality assurance.
- Partnerships: NAFDAC will continue to collaborate with all our partners, including the Global Fund, World Health Organization (WHO) Nigeria, USAID, the Bill and Melinda Gates Foundation (BMGF), and UNICEF, to advance traceability initiatives and support ongoing efforts.
We plan to enhance the capability of the Agulu and Kaduna NAFDAC laboratories that routinely used risk-based approach for ascertaining the quality of medicinal products. We look for support from Global Fund to strengthen the laboratories toward WHO Prequalification.
Acknowledging Other Partners: – USAID, WHO, Bill Melinda Gates Foundation, and UNICEF
NAFDAC extends its heartfelt gratitude to its partners for their invaluable contributions to these initiatives. The WHO Nigeria has donated scanners and supported training for traceability of vaccines, USAID has donated scanners and supported training as well as in-country serialization efforts, BMGF has supported scanners and monitoring, and UNICEF has donated scanners to support traceability in selected states in Nigeria. More of these announcements will be made in another Press forum.
Together with these partners, NAFDAC is committed to a future where Nigerians have access to safe and high-quality health products, promoting better health outcomes for all. Thank you.
NAFDAC………safeguarding the health of the Nation!!!
Director General
