It has been six years since the Director General of National Agency for Food and Drug Administration and Control (NAFDAC) started the reforms and transformation of the Agency to a well-functioning, strong and stable regulatory Organization. Today we can look back at the Executive Order that I am forwarding to you (see below), and say that THE EFFORTS ARE PAYING OFF!!!.

On this path, we carried the local manufacturers along with our new  Quality Management culture and WHO Global Benchmarking. NAFDAC became accredited for ISO-9001-2015 in 2019, recognized as Maturity Level 3 Agency in Medicines and the Central Drug Control Laboratory in Yaba, Lagos, and became a WHO Prequalified Laboratory.

Along this path, NAFDAC started placing  Regulatory Directives (RD) in place to strengthen local manufacturing:

1) GMP Road Map in 2018, to ensure our manufacturers are compliant with international standards,

2) Five-Plus-Five RD in 2019, to ensure that the capacity of local manufacturers are maximized by limiting import renewals of medicines that our manufacturers have the capacity to manufacture locally,

3) Pharma Operations Division created in 2019 to ensure better oversight and compliance with regulatory requirements by local manufacturers

4) Layout Review RD in 2021 to ensure that that from inception when the architectural blueprint is being designed, NAFDAC is part of the design for proper guidance to the manufacturer so that quality is built into the facility design.

5) Ceiling 34 Regulatory Directive in 2021 to increase the number of medicinal products that cannot be imported into the country because of our local capacity.

6) Hand Holding and Targeted Inspection and Testing of of local manufactured medical devices and in-vitro diagnostics (IVDs) in 2023 to ensure the devices and IVDs conform with international standards.

Along this path, importers started migrating to local manufacturing or forming partnerships with local manufacturers, thus resulting in a 30% increase in new facilities being built. Confidence continued to build among local manufacturers and they started responding by re-designing their facilities, especially during the pandemic with some intervention of funds from the President Buhari Administration for infrastructural development.

However, the perennial and persistent costly challenge of importation of ALL materials needed for manufacturing (except water) by local manufacturers became an open sore. As Director General, my professional heart ached for local manufacturers considering the import duties they have to pay for ALL materials, some packaging materials and equipment.  I have advocated for zero tariffs since my assumption of office with a limited moratorium to give local manufacturers industrial breathing space to do what they know how to do best – manufacturing quality medical products.

Then came the Tinubu Administration, and then the administration of the cerebral Coordinating Minister of Health and Social Welfare, Prof Mohammed Ali Pate, and Coordinating Minister of State for Health and Social Welfare, Dr. Tunji Alausa, who put the interest of the 200 million plus Nigerians before their own interest.  Then the unimaginable started happening –  giving local manufacturers a chance to excel and be competitive. Then came the Executive Order below as published from the Coordinating Minister of Health and Social Welfare Office in quote.

“Revitalizing Nigerias Healthcare: President Tinubus Bold New Executive Order

President Tinubu, GCFR, has signed an Executive Order (EO) to transform Nigerias healthcare sector by increasing local production of healthcare products, reducing costs of healthcare equipment and consumables, and promoting local investments. This initiative, part of the Nigeria Health Sector Renewal Investment Initiative (NHSRII), addresses longstanding challenges and aims to improve health outcomes for Nigerians.

Key Provisions

The EO includes several measures:

1. Zero Tariffs and Excise Duties: Exempting specified pharmaceutical machinery, equipment, goods, and accessories from tariffs and excise duties to reduce production costs and make healthcare products more affordable.

2. Special Waivers on Pharmaceutical Inputs: APIs, excipients, and other essential raw materials, including those for Long-lasting Insecticidal Nets (LLINs) and Rapid Diagnostic Kits, will benefit from zero tariffs, excise duties, and VAT, lowering the price of essential medicines and medical supplies.

3. Market Shaping: Establishing framework contracts and volume guarantees to stabilize the local manufacturing market.

4. Regulatory Harmonization and Expedited Approvals: Developing a Harmonized Implementation Framework to guide regulatory agencies in streamlining approval processes.

5. Implementation and Compliance: Agencies like the Nigeria Customs Service, NAFDAC, SON, and FIRS are mandated to ensure swift implementation. The waivers and exemptions are valid for two years from the effective date.

Relevance to the Nigeria Health Sector Renewal Investment Initiative (NHSRII)

The EO is vital for the NHSRIIs success, addressing key issues:

 Reducing the High Cost of Medicines: By lowering tariffs and providing special waivers, the EO aims to reduce the prohibitive costs of medicines and other pharmaceutical products, making healthcare more affordable for Nigerians.

 Boosting Local Industry: Encouraging local manufacturing will create jobs, stimulate economic growth, and reduce dependence on imports, ensuring a reliable supply of essential healthcare products.

 Enhancing Quality and Innovation: Regulatory harmonization and market shaping will drive innovation and quality improvement in the local healthcare industry.

 Strengthening Health Systems: By addressing underinvestment and regulatory challenges, the EO will strengthen Nigerias health system, improving service delivery and health outcomes, and enhancing resilience to future health crises.

Conclusion

The Presidents EO underscores his administrations commitment to transforming Nigerias health sector. It aligns with the broader objectives of the NHSRII and the Presidential Initiative on Healthcare Value Chain (PVAC), approved in October 2023. By addressing core challenges and providing a clear path for improvement, this EO sets the stage for a sustainable and high-quality healthcare system for all Nigerians”.

Prof. Mojisola Adeyeye

Director General, NAFDAC