Second Term Resumption Speech – Continuation Of Transformative Leadership Of NAFDAC

(An Agency Strictly Guided by International Standards)

Doing the right things makes a nation great or, simply stated, Righteousness exalts a nation. On the contrary, not doing the right things brings setbacks.

I would like to thank the President and Commander-in-Chief of the Nigerian Armed Forces, President Muhammadu Buhari (GCFR) for my reappointment for a second term as Director General of NAFDAC.  I am immensely grateful for the Presidency and the efforts made to ensure that I got the second term. In the process of the renewal of the term, I have discovered senior Nigerians from different parts of the country that love the country with passion and who worked very hard to ensure that the transformative leadership that started in NAFDAC on November 30, 2017, is sustained. I am eternally grateful to my living mentor who has believed in me before I joined NAFDAC.  He visited me in my university in the USA more than 15 years ago and saw what I was doing in building of quality into medicine development and training of students for such purpose could benefit Nigeria.  I am indeed grateful to the National Assembly, The Leadership of the Federal Ministry of Health, NAFDAC Council, Sister Agencies with which we collaborate and other Stakeholders. My first tenure wouldn’t have been successful without the dedicated NAFDAC staff who placed the Agency and the country first, above themselves, and worked hard for the international recognition that NAFDAC now enjoys in both food and drug administration, and control. I appreciate them very much.

My appreciation also goes to African Medicines Regulatory Harmonization (AMRH) of African Union Development-Agency-New Partnership for Africa’s Development or AUDA-NEPAD (whose Steering Committee I chaired for almost five years) and WAHO/ECOWAS-MRH for their understanding during the wait for the second term. I am also grateful to the Pharmaceutical Manufacturing Group of Manufacturing Association of Nigeria that had been in the tunnel with me since 2017, and especially over the last few weeks in ensuring that the industry is strengthened and becomes competitive globally. NAFDAC (as Maturity Level 3 regulatory agency) is now guided by international standards to ensure that the regulated products are of quality, safe and efficacious, thus safeguarding the health of consumers. 

Our activities are global, and our regulated products are traded on an international platform, thus underscoring the need for use of international standards.

That brings up our international partners who since 2017 have worked very closely with NAFDAC to ensure that the Agency is strengthened and becomes recognized as an international player in the global arena. I am very grateful for their support and waiting during the last six weeks before the announcement of my reappointment. These partners include AUDA-NEPAD, WHO, World Bank, Global Fund, USAID, UNICEF, FAO, and Codex Alimentarius; IAEA, GAIN, Alive & Thrive, International Coalition of Medicine Regulatory Authorities (ICMRA), International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and Organisation For The Prohibition Of Chemical Weapons (OPCW).

LOOKING BACK 2017-2022

Upon my assumption of duty on November 30, 2017, I listed the following cardinal points as the goals to be achieved:

• Maintaining a well disciplined and motivated workforce
• Working towards eliminating substandard and falsified medicines (SFs), unsafe or illicit drugs, unwholesome foods, chemicals and other products
• Aligning NAFDAC with international standards in food, drugs and other regulated products regulation
• Reconstruction of NAFDAC web presence and streamlining the submission and approval of dossiers for registration of drugs, food, and water.
• Working towards eliminating overlaps among sister agencies, such as FCCPC, SON, NESREA, NAQS and PCN
• Engagement of Micro, Small and Medium Enterprises (MSMEs)
• Providing much needed Transportation and logistics to inspection sites as part of concerted efforts to strengthen our enforcement activities.

I thank God that all these and much more have been achieved as stated below.  For these, I wish to thank again His Excellency, President Muhammadu Buhari (GCFR) and his Advisers for the wisdom in appointing me as the Director General of NAFDAC in the first instance.

You may please recall; I met an Agency with glaring symptoms of sundry administrative and procedural lapses such as shown below.

• A huge debt of 3.2 billion naira,
• Dismally low Internally Generated Revenues (IGR) of 700 million naira and a collection of 7 billion naira as user fees. Furthermore, adherence to Budget was most irregular or absent altogether. 
• Essential physical facilities and laboratory infrastructures had fallen into terrible states of disrepair. Indeed, some NAFDAC laboratories were almost non-functional
• No Scheme or Condition of Service, and payment of staff allowances was very irregular.
• The skewness of nominal roll revealed a disregard for the requirements for Federal Character.
• No Post-marketing Good Distribution Practice (GDP) Surveillance

It is with gratitude to God, and for the immeasurable support of President Muhammadu Buhari that I report that most of these problems were assiduously confronted and solved as listed below.:

A.     Governance (WHO GLOBAL BENCHMARKING TOOL (GBT) – REGULATORY SYSTEM)

• Capitalized on competence-based HUMAN CAPITAL
• 3.02 billion naira inherited debt was paid off within my first year in office. The sum of about 180 million naira were discovered to be fictitious
• Better financial management. The IGR have tripled to 2.5 billion naira. User fees have more than doubled to 15 billion naira.
• 2019-Date: International Partners funding (Cash and Technical Support) received – amounted to $3,927,186.00. These funds are currently being utilized for specified purposes.
• NAFDAC was reorganized and more directorates created (from 13 to 27) for effective management
• Established a continuous training culture in customer-centric Quality Management System (QMS) for all NAFDAC mandates
• Accreditation on QMS (ISO 8001-2015) in 2019 and yearly re-accreditation since that time
• More motivated staff through trainings and better emoluments
• The better financial management enabled improvement of infrastructures and building of State offices and laboratories:
  • Sokoto, Kebbi, Yobe, Ogun, Kwara, Osun and Ebonyi; plus, Ports Inspection Directorate Airport NAHCO Office and Yaba Drug Laboratory are completed or near completion respectively to meet WHO specifications.
  • Over 140 New Utility Vehicles were procured for Inspection and other activities.
  • Over 5 billion naira worth of laboratory equipment.
• Scheme and Condition of Service were instituted for the first time in the history of the Agency – currently awaiting approval by The Head of Service.
• Lopsidedness in hiring of new staff was remedied – FCC Compliance Certificate on File.
• Established palpable and sustained collaborations with sister agencies (e.g., PCN, NHREC, NCDC, NPHCDA, FCCPC, SON, etc.), with some supported with Memorandum of Understanding
• Aligning NAFDAC with international standards in food, drugs and other regulated products regulation
• Re-accreditation (ISO 17025-2017) of four laboratories since 2018, and accreditation and continual re-accreditation (ISO 17025-2017) of Biologics/Vaccines laboratories in 2019
• All the above are part of WHO Requirements for Maturity Level 3 that were met.

B.     Public Communications

• Transparency
  • Basis for Global Benchmarking (Information shared with WHO via SharePoint)
  • Most information can be obtained from the website
  • Open communication with staff and Union
  • Digitalization of regulatory processes
  • Procurement and Finance/Account/Human Resources becoming more transparent through SAP platform
  • Open communication with international partners
  • Continuous improvement

• Scheduled stakeholders’ awareness meeting for different sectors (Examples)
  • NAFDAC-MAN (Manufacturers Association of Nigeria) Quarterly Interactive Dialogue
  • Pharmaceutical Manufacturers Group of MAN – engendered better understanding
  • Association of Food, Beverage & Tobacco Employers (AFBTE) – for control of consumption of alcohol among children
  • National Association of Supermarket Operators of Nigeria (NASON) – for tariff reduction and other pending issues
  • Small and Medium Enterprises Development (SMEDAN) – encouraging small businesses in registration facilitation using the online NAPAMS platform
  • Association of Table Water Association. Master Bakers Association, Patent & Proprietary Medicine Vendors Association – for self-regulation aside from NAFDAC regulation, and for market collaboration
  • Chemical Stakeholders – proper handling, storage and moving of certain chemicals
  • Food Manufacturers Association on hygienic and safe handling of foods in restaurant or other facilities
  • Agro-Allied Sectors on Use of Pesticides
  • Herbal Medicines Product Committee of Practitioners and Researchers
  • Micro Small Medium Size Enterprises (MSMEs)
  • TV Media weekly show on NAFDAC and Your Health (NTA&TVC)
  • NAFDAC and Your Health (NTA&TVC) Radio weekly program on FRCN in English, Yoruba, Igbo, and Hausa
  • Inter-Agency Meetings to Foster Quality of Product-driven Exportation of NAFDAC Regulated Products
• Social Media coverage of NAFDAC Activities (Moved Desk to DG’s Office in October 2022 for better management)
• Quarterly Media Parley
• News from the Zones and States

C.     NAFDAC Regulations

• Gazetted twenty-eight regulations for food, drug, and Cosmetics (Part of WHO GBT ML3 – Regulatory System)
• More regulations on Foods, Drugs, Vaccines, and Traceability in the pipeline for gazetting
• National Assembly Member-Sponsored Amendment of NAFDAC CAP N1 and C34 Bill
• Developed Traceability of the Supply Chain Regulation – in process for gazetting
• Developed Vaccine Lot Release Regulation – in process for gazetting

D.    Information and Communication Technology (IMPACTED ALL WHO GBT FUNCTIONS)

Reconstruction of NAFDAC web presence and digitalization of many regulatory activities such as:

• E-Registration using NAFDAC Automated Product Administration and Monitoring System (NAPAMS) –WHO Global Benchmarking Tool (GBT) – MARKET AUTHORIZATION
• Single Portal Window for Ports Inspection, E-Clinical Trial Application – WHO GBT Clinical Trials
• Ports Inspection Data Capture and Risk Management System (PIDCARMS). (WHO GBT MARKET CONTROL)
• E-database for registered drug products Green Book
• E-portal for dossier submission and review – App to be launched in Q1 2023

E.    Training of Staff (Continuous and Agency-wide) – WHO GBT Regulatory System Function

• Dedicated budget for staff training
• Technical areas such as Common Technical Document Formatting, Good Manufacturing Practices (Food, Chemical and Drugs), Good Clinical Practice, Good Distribution Practice,
• Leadership and Anti-corruption
• Emotional Intelligence
• Knowledge Management

F.   Substandard and Falsified (SFs), Counterfeit Medicines, Narcotics & Unwholesome Foods through different means and continual regulatory efforts such as listed below. WHO GBT VIGILANCE, (VT) MARKET CONTROL (MC)

• Restoration of NAFDAC’s presence at the ports was restored in 2018 after absence since 2011
• Tighter pre-shipment testing and control through Clean Report and Inspection Analysis (CRIA) in India & China since 2019
• Instituted Good Distribution Practices Inspection for the first time since 1993 as part of supply chain monitoring and mitigating SFs
• Good Manufacturing Practices Road Map that involved 165 companies and resulted in risk-based categorization and monitoring of GMP Compliance
• Instituted in 2021 for the first time in the Agency history, Good Distribution Practice Post-Market Inspection
  • Inspected over 550 distribution sites to ensure quality of that medical products
• Blacklisting of erring companies
• Public enlightenments
• Provision for on-the-spot detection of SFs using detection devices
• increased enforcement activities.
• Creation of the Traceability (Track and Trace) system that has been successfully used for the distribution and tracking of COVID-19 vaccines during the pandemic.

G.    Strict testing of Covid-19 vaccines and Issuance of over 120 Lot Release Certificates

• First African Regulatory Agency to develop Guidance on Regulatory Preparedness for Licensing and Accessing COVID-19 Vaccines
• Developed Guidance to Sponsors of Clinical Trials in Nigeria Including COVID-19 Related Trials
• Testing and issuance of over 140 quality/safety-based Lot Release certificates for ALL COVID-19 vaccines used in Nigeria during the pandemic
• Track and Trace monitoring of all COVID-19 vaccines
• Science-driven rejection of a vaccine consignment that did not meet international standards
• Staff training on Testing and Bio-manufacturing

H.     Strengthening Local Pharmaceutical Industry through regulatory policies or mediation with the government (WHO GBT MARKET CONTROL AND REGULATORY INSPECTION)

• Good Manufacturing Practice (GMP) Inspection Road Map – Inspected over 165 companies GMP compliance that resulted in risk-based categorization
• Instituted Five Plus Five Policy
• NAFDAC Ceiling for medicines with large in-country manufacturing capacity
• Partnership of multi-nationals with local manufacturers are being formed based on good manufacturing practices compliance: Examples – GSK-Fidson Healthcare Plc and Sanofi-May & Baker Nigeria Plc
• Choice of Nigeria as a country that can manufacture vaccines – facilitated by Director General and enhanced by attainment of ML3

I.     Herbal Medicine and Medical Devices Regulation

• New Guidance and Guidelines
• New Technical Information Submission Template
• Inaugurated Herbal Medicine Product Committee
• Organized many stakeholders/practitioners/researchers’ meetings
• Paired and mediated practitioners/researchers’ collaboration
• Registered more than forty (40) COVID-19 related herbal medicinal products during the pandemic
• Registered the first Nigerian-made medical mask during the pandemic, and was exported/sold in the USA

J.    International Collaboration and Reliance

• NAFDAC received support from the following international partners – World Bank, World Health Organization (WHO), United States Pharmacopeia (USP), Bill and Melinda Gates Foundation (BMGF), Global Fund (GF), United States Agency for International Development (USAID), United Nations Industrial Development Organization (UNIDO). These various supports contributed to respective global benchmarking functions and attainment of ML3.
• Training on Food Safety: The Agency has been amply supported in various aspects of Food Safety by the Danish Government through the Royal Danish Consulate General in Nigeria
• Support from Organization for Prohibition of Chemical Weapons (OPCW) in Lab Analysis/Validation and Chemical Management
• Partnership with Global Alliance for Improving Nutrition (GAIN)
• Technical support from USP on Vaccines and Biologics in some aspects of laboratory analysis and Lot Release
• Support from Family Health International (FHI) 360-Alive & Thrive for Breastmilk Substitute (BMS) Code Compliance
• Support from FAO on Total Diet Study that focuses on contaminants including mycotoxins in food as eaten and assessing the risks to the consumers.
• TRANSFORMATIONS IN SECTIONS A-J LISTED ABOVE RESULTED IN ATTAINMENT OF WHO MATURITY LEVEL 3. NAFDAC BECAME ONE OF THE 30% OF ALL REGULATORY AGENCIES GLOBALLY TO ATTAIN ML3
• THE ATTAINMENT MADE NIGERIA TO BE RECOGNIZED AS ONE OF THE SIX AFRICAN COUNTRIES THAT CAN MANUFACTURE VACCINES

K.    Food Safety Assurance

• Stricter regulatory Inspection or regulated foods and bottled water
  • Shutting down of many food companies and water companies
  • Baseline inspection of food handling facilities – eateries/restaurants
• Faster time for approval (90 working days)
• Re-equipment of Food Laboratories for analysis of food components trace nutrients
• Monitoring of micronutrients in specific food items such as Fats/Oils, Sugar, Milk, etc.
• Training of staff in food safety and certification in ISO 22000
• Improvement on National Total Diet Study Activities to reduce contaminants such as mycotoxins or aflatoxins in foods that are consumed daily or slated for exports
• Risk-based regulatory inspection of food industry
• Better attention paid to products under global listing
• Continuous training in various aspects of food safety

L.    Proactive interaction and delivery of services to Micro, Small and Medium Enterprises (MSMEs) – Herbal Medicines and Cosmetics – WHO GBT Market Authorization (MA) and Market Control (MC)

• Effective management of MSMEs through decentralization of Food Registration to Zones plus FCT and Lagos Offices headed by Directors (six +2 Directors) for effective management
• NAFDAC was Recognized as most-improved MDA by MSME in 2020
• Continuous improvement in surveillance of food, herbal medicines, and cosmetics

M.    Chemical Safety

• Continuous engagement of stakeholders in the chemical industry
• Strict guidance on Chemical Good Manufacturing and Distribution Practices
• Close collaboration with Office of National Security Adviser on Distribution of Certain Chemicals
• Training of staff

N.    Establishment of Organization for Prohibition of Chemical Weapons (OPCW) Laboratory

• President Buhari Intervention Fund in 2018/2019 jump-started the OPCW Lab
• Training and Capacity Building of Kaduna and Oshodi Laboratory Staff
• Continuous proficiency Testing for qualification

O.    Veterinary Medicine and Allied Products

• Capacity building of staff
• Awareness and sensitization Programs for Stakeholders
• Banning of Dichlorvos (100 ml)
• Phase-out banning of Paraquat and other unsafe agrochemicals
• Enhancement in GMP Inspection of veterinary medicine and agrochemical facilities
• Post-marketing monitoring of regulated products

STRATEGIC GOALS FOR 2023-2028

A.      Governance, Financial Management and Publicity

• Governance
  • Continuation of meaningful deployment use of human capital
  • Sustain Strong Governance – Expansion of Directorates for greater and impactful management
  • Obtain approval of Hazard and Regulatory Allowance (To be funded from NAFDAC Generated User Fees)
  • Secure approval of Scheme and Condition of Service
• Sustain Strong Financial Management – Continuity and Consolidation
  • Ensure well-trained staff on SAP Account Software
  • Increase IGR and User Fees by 20% from the current levels based on availability of more infrastructure and tools stated
  • More accountability
• Publicity
  • Use additional media outlets to disseminate noteworthy NAFDAC’s activities
    • Initiated in October 2022 by deploying Social Media Staff to DG’s Office
    • Use of Twitter, Facebook, Linkedin, etc.
    • Use of drama and comedy artists to convey importance of quality, safe, efficacious, and wholesome regulated products
    • Make the Media parley more structured

B.     New Initiatives

• Attain WHO ML4 and World Listed Authority (WLA) Status – Attainment will enable:
  • Global trade of Nigerian-made pharmaceuticals through collaborative registration with other regulatory agencies
  • Local Pharma manufacturers to be more competitive in AFCTA
• Attain Vaccine Lot Release ML4 to position Nigeria strategically for vaccine manufacturing
  • Ensures Good Manufacturing Practice of Nigeria Vaccine Company
  • Assures quality, safety and efficacy of vaccines manufactured in Nigeria or imported
  • Establishes Vaccine Clinical Trial Research and Service Pipeline for the Local Manufacturer
• Create Office of Women’s Health Office
  • Understudy drug, cosmetics, and food products that affect women, the unborn and the child
  • Emphasize misuse or abuse of drug among women and impact on the child
  • More focus on maternal and child mortality and morbidity rate

C.    Newer Initiatives

• Supply Chain Monitoring
  • Continual sanitization of the Supply Chain Units to mitigate counterfeits and SFs
    • Scale up Track and Trace of Imported and locally Manufactured Pharmaceuticals
      • Establish Structured and Active Tracking and Tracing through Solution Providers
      • Initiate Track and Trace of Foods
    • Continual vigilance to Reduce SFs, Counterfeit Medicines, and Narcotics
      • Enhancing Local Manufacturing (including Vaccines) Quality and Trade
      • Training on Active Pharmaceutical Ingredients (API) Regulation
      • Develop NAFDAC-Industry API Manufacturing Regulation
      • Enhance Research and Development Training Platforms with the Pharmaceutical Industry

• Expand Post Marketing Surveillance (PMS)
• Recruit more staff and provide more tools
• Provide capacity building
• Make Enforcement nimbler for sustained response
• Increase collaboration with Academia
  • Regulatory science training
  • Drug, food, and herbal medicines regulation-oriented research

D.    Continuous Strengthening Regulatory Activities

• Creative Engagement of Micro, Small and Medium Enterprises (MSMEs)
  • More proactive interaction with different sectors of MSMEs at the State Level
  • Better Engagement on Exportation of Regulated Products
  • Establish evidenced-based facilitation of export of quality NAFDAC regulated products
  • Expand the role of the NAFDAC Office of Trade and International Relations
• Investigation and Enforcement and work collaboratively with NDLEA in mitigating substances or drugs of abuse
• Increase vigilance on cosmetic products
• Maintain Food Safety
• Ensure Chemicals and Agrochemicals Safety
• Establish well-structured Pharmacovigilance Inspection
• Continuation of improvement in ICT Functions
  • Enhance Digitalization of More Regulatory Processes for better management and transparency
  • Improve the website for better navigation

• Continuation of Infrastructural Development
• Build NAFDAC Headquarters in Abuja
• Continuation of Nation-wide Improvement of working environment – Adding more Laboratories, Zonal and State Office Infrastructures

CONCLUDING REMARKS:

To the glory of God Almighty, and through the relentless efforts of a hard-working staff, the Agency has achieved much success under my leadership in the last five years. We look forward to building on these achievements while working even harder to record more achievements and successes in the coming years.

Thank you and God bless.

NAFDAC………safeguarding the health of the Nation!!!

Director General