The Lady Helen Child Health Foundation (LHCHF) has  been at the forefront of advocating for improved health outcomes for vulnerable populations, particularly children and mothers. As part of our efforts to ensure access to essential medications, we submitted a Freedom of Information (FOI) request to the National Agency for Food and Drug Administration and Control (NAFDAC) on January 31, 2025. The request sought to clarify the regulatory and approval status of Multi-Drug Therapy (MDT) medications used in the treatment of leprosy in Nigeria.

Key Points from NAFDAC’s Response

NAFDAC’s prompt response provided critical insights into the current state of leprosy drug regulation and availability in the country:

1. Approval of MDT Medications:

• NAFDAC confirmed the registration of approximately seven Dapsone and eight Rifampicin Finished Pharmaceutical Products, demonstrating the agency’s commitment to ensuring the availability of essential medications.
  
  2. Streamlined Regulatory Systems:
• The agency highlighted the introduction of Version 3 of the NAFDAC Automated Product Administration and Monitoring System (NAPAMS). This system enhances the efficiency of product registration processes.
• Additionally, the Dossier Management System (DMS) was implemented to facilitate the submission of Dossiers for new product registrations.
  
  3. Availability of Donated MDT Medications:
• On January 31, 2025, NAFDAC approved an import permit for donated MDT products, including Multi-Drug Therapy Combi MB Adult (Rifampicin, Dapsone, and Clofazimine) and Multi-Drug Therapy Combi MB Child (Rifampicin, Dapsone, and Clofazimine). These donations, facilitated through the World Health Organization (WHO) Nigeria Office, are vital in supporting Nigeria’s healthcare delivery system.
  
  4. Resource Accessibility:
• NAFDAC’s official website (www.nafdac.gov.ng) serves as a comprehensive resource for updates on regulated products, safety recalls, guidelines, and gazette regulations. Stakeholders are encouraged to utilize this platform for further information.

Recent Developments

1. WHO Shipment of Leprosy Drugs:
   • Following a year-long delay caused by bureaucratic bottlenecks and new testing regulations, WHO announced the shipment of leprosy drugs to Nigeria. These medications were approved in December 2024 but faced further delays due to systemic vulnerabilities.
2. Nigeria’s Leprosy Crisis:
   • Nigeria ranks fourth globally in leprosy burden, with over 1,000 reported cases annually. The absence of MDT drugs since early 2024 exacerbated patient suffering, leading to irreversible damage for many

Implications for Healthcare Advocacy

The response from NAFDAC underscores the agency’s proactive approach in ensuring the availability of critical medications for leprosy treatment. However, it also highlights areas for continued advocacy and collaboration:

1. Ensuring Consistent Supply:

• While the approval of donated MDT products is commendable, LHCHF will monitor their distribution and usage to ensure they reach the intended beneficiaries, particularly in underserved communities.
  
  2. Addressing Bottlenecks:
• Despite the streamlined regulatory systems, challenges in accessibility and awareness about these advancements remain. LHCHF plans to educate healthcare providers and the public on leveraging NAFDAC’s e-services for improved healthcare delivery.
  
  3. Strengthening Partnerships:
• The collaboration between NAFDAC and WHO to secure donated medications demonstrates the value of partnerships in addressing healthcare gaps. LHCHF will explore similar avenues to support the availability of essential medicines.

The recent BBC article (“Nigeria’s Health Struggles: Accessibility of Essential Medications”) highlights the broader challenges in accessing critical medications in the country. It underscores systemic issues such as supply chain inefficiencies, regulatory bottlenecks, and limited public awareness, which align with the findings from our FOI request.

The article also draws attention to the urgent need for multisectoral collaboration in overcoming these barriers. NAFDAC’s initiatives, as detailed in their response, reflect a step in the right direction. However, sustained efforts are required to address underlying gaps and ensure equitable access to essential medicines like MDT for leprosy treatment.

Conclusion

NAFDAC’s response to Lady Helen’s  FOI request highlights significant strides in improving access to leprosy medications in Nigeria. Coupled with the insights from the BBC article, it is evident that there is still much work to be done in ensuring a robust healthcare delivery system. LHCHF remains committed to advocating for efficient healthcare systems and ensuring that vulnerable populations benefit from these advancements. We encourage stakeholders to stay informed and work collectively towards eradicating leprosy and other preventable diseases in Nigeria.

References

Lady Helen Child Health Foundation. (2025, January 31). Freedom of Information Review: Approval Status of Leprosy Drugs in Nigeria. Retrieved from NAFDAC.

World Health Organization. (2025, March 8). WHO announces shipment of leprosy drugs to Nigeria. Retrieved from WHO Nigeria Office.

BBC News. (2025). Nigeria’s Health Struggles: Accessibility of Essential Medications. Retrieved from BBC.

National Agency for Food and Drug Administration and Control (NAFDAC). (2025). Updates on MDT medication approval and importation. Retrieved from www.nafdac.gov.ng.

Author’s note; Please note that when using any part of this write up, cite the authorship of the lady Helen child health foundation.

Corresponding Author: Dr Benjamin Odeka mbbs dch ma frcp frcpch  www.ben@ladyhelenchildfoundation.com