• Sunday, September 15, 2024
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How NAFDAC negotiates Nigeria’s new nexus for national economic transformation

How NAFDAC negotiates Nigeria’s new nexus for national economic transformation

L-R: Emmanuel Armon (l), deputy director; Muniru Adewale (l), deputy director; Uchenna Elemuwa, director, Pharmacovigilance, all NAFDAC; Marvis Oduogu, team lead, FMCG sector, Stren and Blan Partners; Moji Christianah Adeyeye, director-general, NAFDAC; Jason Ikegwu, partner, Digital Technology, Phillips Consulting; Augustine Oboli, deputy director, Human Resources Management, NAFDAC; Fagboyo Kayode (l), director, Lagos State office, NAFDAC; and Taye Awofiranye, managing partner, The Trusted Advisors.

BusinessDay recently hosted an instalment of its Policy Intervention Series, featuring the Director General of the National Agency for Food and Drug Administration and Control (NAFDAC), Professor Moji Christianah Adeyeye and other coordinating directors.

The event themed “NAFDAC as Agency for Economic Development and Transformation” at Radisson Blu Hotel, Victoria Island, Lagos was supported by NAFDAC and provided a platform for engaging dialogue between policymakers, regulators, and industry leaders.

Opening Remarks

Frank Aigbogun, publisher of BusinessDay, started the session with a warm welcome. He expressed gratitude for the presence of Professor Adeyeye and acknowledged her significant contributions to Nigeria’s industrialisation and economic development. Aigbogun highlighted the importance of such dialogues, especially in an era marked by misinformation, to foster a productive exchange of ideas among stakeholders.

Frank Aigbogun, publisher, of BusinessDay Media Limited, gives the opening remarks.

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Keynote Speech

Professor Adeyeye, who has been at the helm of NAFDAC since November 2017, shared her journey and the transformative changes she has implemented at the agency. Her speech centred on the vital role of a strong regulatory framework in driving economic development and ensuring public health and safety.

Strengthening NAFDAC’s Regulatory Framework

Upon assuming office, Professor Adeyeye was confronted with significant challenges, including substantial debt and outdated infrastructure. Through a commitment to quality management systems and international best practices, she has led NAFDAC from insolvency to a position of solvency. Key initiatives included:

● Implementation of Quality Management Systems: In January 2018, NAFDAC began training its staff on quality management systems, resulting in the attainment of ISO 9001:2015 certification by 2019. This process involved regular self-audits and continuous improvement to maintain high standards of transparency and accountability.

● Decentralisation for Efficiency: Recognising the inefficiencies of a centralised system, NAFDAC decentralised its food registration processes to regional offices. This move significantly improved the ease of doing business for manufacturers across Nigeria.

Infrastructure and Equipment Upgrades: NAFDAC has invested over six billion naira in upgrading its laboratories and purchasing essential equipment. These investments have not only enhanced operational efficiency but also led to international recognition, including World Health Organisation (WHO) prequalification for the Central Drug Laboratory in Yaba, Lagos State.

Professor Adeyeye highlighted the critical role of robust regulation in ensuring economic stability, emphasising that NAFDAC’s efforts to maintain food and drug quality are essential for public health and a productive workforce.

This regulatory rigour also fosters confidence among manufacturers and consumers, driving sustainable economic growth. NAFDAC has undergone significant organisational restructuring to improve governance and efficiency, increasing its directorates from 13 to 26 and streamlining decision-making processes with focus groups and coordinating directors.

Under Professor Adeyeye’s leadership, NAFDAC achieved WHO maturity level three in 2022, a distinction held by only 30 per cent of global regulatory agencies, and is now aiming for level four to enhance international trade capabilities. Despite operating with a smaller workforce than comparable agencies, NAFDAC has made substantial progress, with ongoing efforts to improve staff conditions and expand its facilities, reflecting its commitment to excellence.

Overview of NAFDAC’s Initiatives

NAFDAC has implemented several initiatives to strengthen Nigeria’s regulatory and economic landscape. The agency reorganised its zonal structure to align with the Presidential Enabling Business Environment Council (PEBEC), allowing local management of product registration, inspection, and pharmacovigilance while creating career advancement opportunities.

To support MSMEs, NAFDAC established local offices in all 36 states, focusing on product registration, sampling, and inspection, and promoted local manufacturing, particularly in therapeutic foods for children, reducing imports by 2023.

The “5+5 Initiative” was introduced to encourage local pharmaceutical production by limiting the renewal of licences for imported products. NAFDAC also conducts pre-shipment inspections to prevent substandard products from entering Nigeria, digitised the Port Inspection Directorate, and implemented the Mobile Authentication System (MAS) for consumers to verify product authenticity. The agency collaborates with security forces for enforcement and is transitioning open market sellers to controlled environments through Coordinated Wholesale Centers (CWC).

Economically, MSMEs, employing 80 per cent of Nigeria’s population and contributing 50 per cent to GDP, benefit from executive orders supporting local manufacturing. NAFDAC plans to outsource regulatory functions to licensed external labs, continue self-auditing, and facilitate global trade for Nigerian products. These initiatives have enhanced regulatory compliance and significantly contributed to Nigeria’s economic growth.

In addition, NAFDAC’s risk-based sampling and inspection strategies focus on high-risk areas for more effective oversight, though challenges like resource limitations and inconsistent risk assessments remain. The agency’s efforts are critical in maintaining quality standards, supporting local manufacturers, and fostering industrial growth by harmonising standards, building capacity, and encouraging innovation.

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Summary of presentations from coordination directors of NAFDAC

Coordinating directors for NAFDAC, delivered concise presentations on the agency’s inspection processes, emphasising the alignment with marketing authorisation and the critical role of inspections in ensuring compliance with regulatory standards.

They were: Victor Abiola, director, of Central Drug Control Laboratory; Rametu Momodu, director, of Veterinary Medicine and Allied Products; Yedunni Adenuga, director, of Narcotics and Control Substances; Eva Edwards, director, of Food Safety and Applied Nutrition.

Others were: Roseline Ajayi, director (Southwest Zone), Market Control & Trade; Leonard Omokpariola, director, Chemical Evaluation and Research; and Bello Muhamad, deputy director in charge of Legal Services.

NAFDAC has strengthened its regulatory and economic impact through several initiatives.

Marketing authorisation is followed by on-site inspections to ensure compliance with standards, including checks at distribution points for proper storage. The agency’s directorates under the Food and Feed Cluster play key roles in chemical evaluation, food safety, enforcement, narcotics control, and veterinary medicine regulation. Achievements include the implementation of an electronic portal for permits, risk-based inspections, and stakeholder education on banned substances.

NAFDAC’s zonal structure, as explained by Rosalyn Ajayi, director (Southwest Zone), decentralises the registration process, enhancing business operations and policy implementation at the grassroots level. The zones handle inspections, registrations, trade facilitation, and compliance monitoring, ensuring that products meet safety standards before reaching the market.

Market control activities, led by Leonard Omohomoh Pariola, director of Chemical Evaluation and Research, involve monitoring product quality, import control, and collaboration with customs to prevent substandard products from entering the market.

Legal challenges faced by NAFDAC include the slow judicial process and overlapping functions within government agencies, which can complicate regulatory enforcement. The Business Registration Act 2023 aims to streamline these processes and reduce regulatory burdens.

NAFDAC’s focus on risk-based inspections, stakeholder education, and market control is crucial for maintaining product safety and quality, despite challenges like limited resources and regulatory overlaps.

L-R: Rametu Momdu (l), director, of Veterinary Medicine and Allied Products; and Victor Abiola, director of Laboratory Services, Drugs; Roseline Ajayi, director, South-West Zone; and Eva Edwards, director, of Food Safety and Applied Nutrition, all of NAFDAC.

Two Panel Sessions collapsed into one

First panel – Driving Innovation: NAFDAC’s Impact on Economic Development.

Panellists: Ayanwande Ayangbenga, director, (Finance & Accounts); Taye Awofiranye, managing partner, The Trusted Advisor; Kayode Fagboyo, director (Lagos State Office); Jason Ikegwu, partner, Digital Technology, Phillips Consulting.

Second Panel – From Regulation to Growth: NAFDAC’s Economic Vision

Panelists: Marvis Oduogu, managing associate, Stren & Blan; Chike Obiano, director (Planning Research and Statistics); Uchenna Sonny-Afoekelu, director (Drug Registration and Regulatory Affairs); Uchenna Elemuwa, director, (Pharmacovigilance).

In a recent session of BusinessDay’s Policy Intervention Series, policymakers, industry regulators, and business leaders gathered to discuss the vital role of technology in enhancing regulatory frameworks.fmoji

Jason Ikegu, partner at Philips Consulting, opened the discussion by acknowledging the impressive strides made by the National Agency for Food and Drug Administration and Control (NAFDAC) under its current leadership. He emphasised the global trend of digital transformation and the importance of preparing for a future shaped by technological advancements.

Ikegu highlighted three key areas where technology can significantly impact regulatory practices: people, processes, and technology itself. He noted the importance of equipping individuals with the right skills to align with digital advancements, suggesting the implementation of a digital learning management system (LMS) to facilitate continuous learning across various devices. This, he argued, would empower organisations to remain agile in a rapidly evolving digital landscape.

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He also stressed the need for process optimisation before digitisation, warning against digitising faulty processes, which would only perpetuate inefficiencies. Ikegu praised NAFDAC’s efforts in aligning with international standards, such as ISO 9001 for quality management and ISO 27001 for information security, and urged the agency to continue refining its processes to fully leverage digital tools.

On the topic of technology, Ikegu pointed out the potential of virtual and augmented reality for remote inspections, which could revolutionise regulatory oversight in Nigeria. He also emphasized the need for robust data management systems to harness the wealth of data available to NAFDAC. By integrating artificial intelligence (AI) and data analytics, NAFDAC could gain valuable insights, anticipate market trends, and make informed decisions that would future-proof the agency’s regulatory practices.

Following Ikegu’s presentation, Pharmacist Obiano elaborated on how NAFDAC utilises data analysis to anticipate and respond to market challenges, particularly in identifying counterfeit and substandard products. He explained that through descriptive statistical analysis and stratified sampling, NAFDAC can make data-driven regulatory decisions that enhance product safety and quality.

The discussion then shifted to the challenges faced by small businesses in complying with NAFDAC’s registration processes. Mr. Kayode Faboyo, Director of NAFDAC’s Lagos State Office, addressed concerns about the complexity of the registration process for micro and small enterprises. He highlighted the agency’s efforts to streamline the process, including reduced tariffs and decentralised registration to regional offices, making it more accessible for small businesses to comply with regulatory requirements.

Faboyo also mentioned the introduction of shared facilities for businesses that lack their own manufacturing spaces, further lowering the barriers to entry. He emphasised NAFDAC’s commitment to supporting President Bola Tinubu’s job creation agenda by making regulatory compliance more achievable for small and medium enterprises (SMEs).

Pharmacist Uchina then discussed the importance of drug safety in maintaining public trust and its impact on economic development. She underscored NAFDAC’s role in pharmacovigilance—monitoring and ensuring the safety of medicines in the market. Uchina noted that drug safety is critical not only for public health but also for fostering confidence in the healthcare system, which in turn supports economic growth by attracting investment and reducing medical tourism.

The panellists concluded by reiterating the importance of international collaboration in maintaining high regulatory standards and ensuring that Nigerian products meet global safety benchmarks. They also emphasised the need for continuous innovation and adaptation to new technologies to keep pace with global trends in regulatory practices.

As the session came to a close, participants were reminded of the ongoing efforts to reform NAFDAC’s regulatory framework, including the revision of fines and the expansion of digital initiatives within the agency. The panellists expressed optimism about the future, emphasising that with the right strategies and technological tools, NAFDAC and similar agencies could significantly enhance their regulatory capabilities, ultimately contributing to Nigeria’s economic development.

Moji Christianah Adeyeye, director-general of, the National Agency for Food and Drug Administration and Control, giving her keynote speech.

Achievements and Economic Impact

Despite the challenges, NAFDAC has made significant strides in its regulatory activities. In the first half of 2024 alone, the agency recorded over 7,107 seizures and confiscations of substandard products, issued 2,300 import permits for raw materials and conducted 744 investigations and surveillance activities. These efforts have contributed to the empowerment of Nigerian entrepreneurs, particularly in the context of the African Continental Free Trade Agreement (AfCFTA), by ensuring that their products meet international quality standards.

The legal services team has also played a crucial role in reducing the agency’s reliance on external lawyers, handling 95 per cent of cases in-house. This has resulted in significant cost savings and improved the efficiency of NAFDAC’s legal operations.

Conclusion
The session highlighted the critical role of NAFDAC’s zonal operations and market control activities in safeguarding public health, promoting industrialisation, and facilitating trade in Nigeria. While challenges such as inadequate infrastructure, insecurity, and overlapping functions persist, the agency’s commitment to maintaining high standards and enforcing regulations remains unwavering. As NAFDAC continues to evolve and adapt to the changing regulatory landscape, its efforts will undoubtedly contribute to Nigeria’s economic growth and the well-being of its citizens.