One-Year Anniversary Speech By Prof. Mojisola Christianah Adeyeye, Phd, Fas

Speech By Prof. Adeyeye C. M

Director General NAFDAC

One-year Anniversary Speech

NAFDAC Headquarters, Abuja

30^th November, 2018.

Protocol

I wish to begin this one-year-on-the-job speech by thanking His Excellency, the President and the Commander-in-Chief of the Armed Forces, Federal Republic of Nigeria, President Muhammadu Buhari, GCFR, who gave me the opportunity to take NAFDAC to the next level, and the responsibility to ensure that the health of Nigerians is safeguarded. Mr. President, you will be glad to know that your aspirations are being realized. I also wish to thank His Excellency, the Vice-President, Prof. Yemi Osinbajo, SAN, GCON, for his passionate leadership role to drive all the activities of the Presidential Enabling Business Environment Council (PEBEC), either through the micro, small and medium size enterprises (MSMEs) initiative, or the proactive engagement with NAFDAC as he does with all MDAs.  I thank the National Assembly, Honourable Minister of Health and the Governing Council of NAFDAC for provision of enabling environment to function and their unquantifiable support.

I would like to thank the about 2,300 staff of NAFDAC’s 14 directorates located in Lagos and Abuja, in the 6 zonal offices plus the FCT and Lagos State Office who have been part of the ongoing changes and progress that are taking place. Some of the changes within the Agency have been difficult and inconveniencing due to the outright turn around approach to running of NAFDAC’s businesses. However, to have a gain that leads to progress, there must be some painful decisions.  The changes are intended to make NAFDAC stronger and credible as an Agency that is aligned with international standards in food and medical product regulation to ensure safety, efficacy and quality.

I wish to thank the USP, USAID, WHO, FDA, IAEA, Global Fund, as well as other partners for their efforts and support of NAFDAC in the assurance of quality food, medicines and medical devices for all Nigerians.  I acknowledge many embassies, trade groups and organizations that paid me courtesy visits.

In my resumption speech last year, I enumerated many challenges in the Agency that I hoped to address and solve. I have pulled those challenges into the following categories:

• Maintaining a well disciplined and motivated workforce
• Work toward 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 streamline the submission and approval of dossiers for registration of drugs, food and water.
• Working toward eliminating overlaps among sister agencies such as CPC, SON and PCN
• Engagement of Micro, Small and Medium Enterprises (MSMEs)
• Transportation and logistics to inspection sites as part of concerted efforts to strengthen our enforcement activities

 I will intersperse the highlighted challenges and the accompanied positive outcomes with other challenges I did not know a year ago and how those have been turned into positive fundamental changes in NAFDAC

1. Ensuring Disciplined and Motivated workforce:

Staff Welfare: For the first time in the history of the Agency, the following have been made reality for our staff:

1. Reviewed and approved through the Governing Council, NAFDAC’s Conditions of Service that included:
   1. Hazard Allowance. Our staff risk their lives everyday on the job and an allowance is the least that can be given to them
   2. Severance package for retiring staff
   3. Upward review of Laboratory Allowance.
2. Approval of Schemes of Service for the Agency
3. Vigorous pursuit towards the realization of a new salary structure for NAFDAC backed by the NAFDAC’s Council and supported by the Federal Ministry of Health
4. Created seven Director positions; this is for effective oversight of the six geo-political zones plus the Lagos State Office and for career advancement.
5. Placed premium on staff development through training in international quality standards.

Disciplined workforce:  I have established a transparent, and quality-driven work environment that is expected of a regulatory agency. This aligns with our pursuit of global benchmarking and in compliance with global best practices. To achieve this, an Agency-wide Quality Management System (QMS) training, (partly funded by West African Health organization  (WAHO) Medicines Regulatory Harmonization Group) was instituted.

Quality Management System (ISO 9000-2018):  The goals for the QMS training are to:

• Meet or exceed customer satisfaction through a set of quality objectives and necessary operational processes
• Focus always on conformance by working to prevent non-conformance through internal auditing of all aspects of NAFDAC’s formations, thus avoiding failures in our deliverables to the customers
• Be Agency-minded, i.e., do all things right that will make Safeguarding the health of Nigerians the priority

NAFDAC now has a new motto – Customer-focused and Agency-minded.

Our staff members are embracing a Standard Operating Procedures (SOPs)-driven culture for all the processes of the directorates in line with QMS requirements.

The process started with training of top management on March 05-06, 2018 and then continued with training of our 2,300 staff in a cascading manner, starting from top management and trained quality managers to the directorates in Lagos and Abuja and onward to the six zones and then to the thirty-six states. This can be used as a model for other MDAs as a process to bring the concerns of the average Nigerian to fore.

What I did not know:  No Budgeting, and Large Debt

I did not know that there was no directorate-focused budgeting before my assumption and that the Agency had 3.2-billion naira debt

I met this big challenge with great resolve as part of quality management system that included fiscal and financial responsibility. I had to work with Finance and Accounts Directorate for about three months from January-March 2018. The following have been achieved

• Bringing of financial sanity to the Agency by stepping down all fictitious claims.
• Introducing budget discipline to all financial activities in NAFDAC.
• Reducing the Debt Profile of N3.2 billion naira of the Agency to zero as of November 20 2018.
• Introducing cost effective measures thereby steadily increasing the Agency’s cash position in TSA.
• We have put both human and material resources in place that have resulted in boosting the Agency’s internally generated revenue significantly and also reduced recurrent expenditure drastically
• Payment of N14,246,499.00 Severance Allowance for the first time in the history of the Agency to the staff who retired from NAFDAC between July and September 2018
• Discovery and recovery of N106,590,298.52 erroneously credited to another MDA in 2015 as a result of deep reconciliation exercise carried out in Final Account unit.
• Recovery of 533 million naira up to date, by the Ports Inspection Directorate, of evaded administrative charges (2014 to 2017) from stakeholders
• Completion of Management Account for year 2016 for audit exercise.
• Putting machinery in place to ensure that all statutory deductions are remitted in due course while contractors and staff claims no longer suffer unnecessary delay.
• Maintaining all Books of Accounts in compliance with International Public Sector Accounting Standards and Generally Accepted Accounting Principles
• Demanding regular financial information for guidance in decision-making.

1. Eliminating substandard and falsified medicines (SFs), unsafe or illicit drugs, unwholesome foods, chemicals and other products

 This is the crux of our regulatory activities and involves almost all the technical directorates.  It starts from the Ports Inspection through Laboratory Services to Pharmacovigilance and to Investigation and Enforcement.

NAFDAC’s Presence at the Ports and Borders: Removal of NAFDAC from the Ports from 2011 to 2018 worsened the problem of SFs, illicit drugs and unwholesome foods in the country and portended real danger to the populace.

• Through the support of the Presidency, Office of the National Security Adviser and my incessant awareness campaign about the implications of absence of NAFDAC at the Ports, NAFDAC was returned to the Ports in May 2018 and was also included on the inspecting MDAs in the Kaduna dry port in August 2018.
• The Agency has seized and destroyed SFs worth over 3 billion naira that included unwholesome foods and other unregulated products within the last one year.

Staff Training and Use of SF Detection Devices: To step up the prevention, detection and response toward eliminating SFs and unwholesome foods, several trainings of our staff had taken place over the past year.  These included the WHO workshop held in Lagos in April 2018 and staff training at the WHO headquarters in Geneva in May/June 2018, as well as the workshop on Medicine Quality and Public Health workshop in Oxford, England.  The PV/PMS Directorate has undertaken the following:

• Pharmacovigilance Africa (PAVIA) program in which NAFDAC’s PV/PMS Directorate is highly involved has received funding and training in strengthening functional regulatory and organizational structures towards ensuring the safety of medicines through detection and monitoring and prevention of SFs.
• In the continued efforts toward eliminating SFs, zonal directors from the six geo-political zones in NAFDAC were trained in October 2018 on the use of technological tools such as TRUSCAN in the detection of SFs.
• The Agency is in the process of procuring more detection gadgets to monitor SFs at the zonal/state levels, thus reducing SFs, and protecting the health of the populace.

Reducing SFs through Emphasis on Local Manufacturing:  Promotion of local manufacturing has been on my priority list. This is to reverse the trend of 30% locally manufactured drug products toward 70%. It has been documented that most of the SFs are imported due to the fact that access and fastness to inspect local companies are quite spontaneous.

Local manufacturing also ensures drug security, reduces unemployment and increases contribution of the pharmaceutical industry to the nation’s GDP. The achievements in this area include:

• Engagement of trade groups such as PMG-MAN, Association of Pharmaceutical Importers of Nigeria (APIN) and NIROPHARM in working on a roadmap toward improving local manufacturing.
• Talks with the Honourable Ministers of Health and of Industry, Trade and Investment
• Discussion with international companies and Chambers of Commerce to invest in Nigeria pharmaceutical industry through partnership and local manufacturing of drug products especially raw APIs and non-active pharmaceutical components
• Reinstatement of enforcement of Five-Plus-Five Year validity for drugs that can be manufactured in Nigeria. This was promoted many years ago but abandoned.
• Presently conducting survey on the capacity of all local manufacturers in order to know the needed therapeutics that can be locally produced and biosimilars that may need to be imported
• Talks underway to encourage innovation for first-in-the market local manufacturers through exclusivity incentives

What I did not Know – High Prevalence of Unsafe and Illicit Drugs – Codeine and Tramadol

Little did I know that aside from SFs issue, the unsafe and illicit drugs would become a significant part of my role as the Director-General of NAFDAC in safeguarding the health of the nation.

Since my assumption of duty the new director of Ports Inspection Directorate and his team have intercepted 86 containers containing tramadol and other unregulated drug products.

• These include twenty-three (23) 40ft containers recently examined and found to have been loaded with Tramadol of various strengths from 120mg to 250mg Tramadol and other unregistered Pharmaceutical Products that are known to be injurious to the health of the public, most importantly our youth.
• The tramadol is estimated to be Six billion, four hundred and forty-six million and one hundred thousand (6,446,100,000) tablets. The worth of tramadol alone on the street is estimated to be at about One Hundred and ninety-three billion, three hundred and eight-three million Naira (N193,383,000,000.00) on an average cost of one million, five hundred thousand naira per carton (N1,500,000.00).
• In addition, three hundred and twenty-one thousand, one hundred and forty-six (321,146) cartons of other unregistered pharmaceutical products that could be worth hundreds of millions of naira. Prevention of these dangerous drugs from entering into the Nigerian markets would protect millions of youths from hazards of drug addiction that can pose threat to families, Nigerian workforce and the security of the nation at large. This would have increased the number of casualties from insurgency, armed robbery and other social vices that are known to be the aftermath effect of use of illicit drugs.

1. Aligning NAFDAC with international Regulation Standards in Food, Drugs and Other Regulated Products

This involved training of our staff, updating our laboratories equipment, replenishing the inventory of needed laboratory supplies, accreditation of the four previously accredited laboratories, updating the regulations and guidelines, using global best practices in registration, inspection and enforcement, planning toward obtaining a pre-qualification status by the World Health Organization and demonstration of global benchmarking, improved maturity level and international reliance and collaboration.

1. Training: A lot of our staff have received training in various aspects of regulatory controls of food, medical products and chemicals and other related products. The following are included in our achievements since my assumption of duty

• Over the past year, hundreds of staff have been trained in the area of their specialties at the national and international levels.
• In-kind training support that is worth 30 million naira was received from partners such as USP, Organization for the Prohibition of Chemical Weapons (OPCW), Pharmacovigilance Africa. NAFDAC on its own has spent about 48 million naira directly on various staff development training
• Over the past year, NAFDAC has collaborated with international partners in the training of our staff. Examples are included below:
• Chemical Evaluation and Research Directorate collaborated in March and October 2018 with Major Development Partners such as United States Department of State Chemical Security Program and their implementing partner, Oakridge National Laboratory, The Organization for the Prohibition of Chemical Weapons (OPCW) and other MDAs (Office of the National Security Adviser) to train our staff and other stakeholders to enhance chemical security in the country.
• Food Safety and Applied Nutrition Directorate collaborated with the Global Fortification Data exchange (GFDx) USA, on training for staff and stakeholders on improving food fortification information collection, sharing, analysis and usage
• Regulations and Regulatory Affairs Directorate collaborated with USP in Dossier Evaluation training
• Drug Evaluation and Research Directorate collaborated with USP in Good Manufacturing Practice training
• Veterinary Medicine and Allied Products Directorate organized training of NAFDAC staff across the thirty-six (36) and FCT Abuja, on regulatory activities with emphasis on Pesticides, Agrochemicals and Animal feeds

Several challenges were met with regard to the laboratories in equipment and supplies Procurement.  A lot of our equipment pieces and instruments needed upgrading.  The laboratories were short of supplies needed for testing of products for approval and registration Re-equipping the laboratories became a priority.

2. Re-equipment of the Laboratories: The improvements that have taken place included:

• Direct purchase of equipment from manufacturers instead of going through a third party in order to save money and receive good maintenance agreement
  • Signed Memorandum of Understanding with Merck KGAA of Germany
  • Agreed with Agilent for direct purchase and maintenance of equipment
  • Initiated direct purchase of equipment with Thermo-Fischer Scientific
• Ordered more than 500 million Euros worth of supplies from Merck KGaA Germany. This is made possible due to our new fiscal management and QMS culture
• Ordered for the first time drug standards worth 20 million naira from USP
• Purchased a 500 kV generators for the Yaba laboratories
• Ordered few pieces of equipment
• Efforts are underway to re-equip our laboratories with upgraded pieces through efforts being made for government intervention or international partners support

ISO 17025 Reaccreditation of Laboratories

• Reaccreditation of the Kaduna, Agulu and Yaba laboratories in May and October 2018

Pre-Qualification of the Yaba Drug Control and the Biological and Vaccine

Laboratories

• World Health organization informed NAFDAC in October 2018 that the labs have been scheduled for Prequalification status (PreQ) based on previous self and assisted audit
• Preparation of the laboratories are progressing for the 2019 visit by the WHO

Upgrading of Zonal/State Offices and Laboratories

Following visits to several state offices and laboratories and feedback from the outstations, I realized that attention must be given to the zones and state offices. This is more so because we have decentralized registration of some products to the zones and facility upgrading becomes necessary. Actions taken include:

• Gave a directive that the office furniture, supplies and laboratory accessories be upgraded or replaced at respective offices across the country.
• Several outstations now have new furniture, generators and with plans underway for upgrading Maiduguri laboratory.

3. Registration and Regulatory Affairs:

• Clearing of 6000 backlog of applications by April 09, 2018
• Updating the Regulations and Guidelines that have not been revised for thirteen years in June 2018
• Enforcing submission of applications for drug product approval using common technical document (CTD). This was supposed to be the practice but it was never enforced
• Use of CTD will now be the format for submission of new applications and renewal of old applications in compliance minimally with best global practices.
• Reducing registration to for product approval or compliance directive to 90 days for food, simple cosmetics and water and 120 days for drugs and some cosmetics
• Online registration for drug or food approvals is almost ready and will be launched by December 15, 2018

4. The Drug Evaluation and Research (DER) Directorate: Under my directive, DER has sharpened their focus on increasing access to quality and efficacious medicines through local manufacture. Some of the successes in this area include:

• Development of guidelines for Active Pharmaceutical Ingredient (API). Knowing API governs the final quality of drugs and for better quality standards, the guidelines are needed addition to the Agency’s drug evaluation platform
• At present, a nationwide inspection is ongoing for Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) at pharmaceutical sites and clinical trial sites respectively. The outcome will enable NAFDAC to advise companies on the path of GMP certification.
  • We share inspection reports (which are submitted within stipulated timelines) with stakeholders in line with global best practice to increase transparency
  • The Agency helps companies make informed decision on CAPA implementation and improve understanding of relevant GMP concepts.
• Within the context of our regulations and in line with the ease of doing business we have scaled down many of our requirements in order to accommodate micro and small manufacturers of herbal medicines and cosmetics
• Kitchen Scale Production for cosmetics was introduced for the micro/small manufacturers, i.e., individuals can make certain products in their kitchens as long as the kitchens are not shared.

5. Ports Inspection: Over the past year, the Ports Inspection has aligned the Directorate with international standards.  In addition to the significant achievements in interception of illegal and other unregulated products, other successes are stated below:

• Development and deployment of the Ports Inspection Data Capture and Risk Management System (PIDCARMS) as a web-based online application that provides electronic endorsement and inspection reporting, real-time risk profiling of transactions and notification of declarations to all PID formations nationwide.
  • This has led to an effective blockage of leakages of revenue of the Agency.
  • Discovery and blockage of avenue at falsifying the Agency’s security documents
  • Over half a billion Naira of evaded payments have been recovered.
  • Restoration of sanity and professionalism into Port operations

6. Investigation and Enforcement: The achievements are as follows.

• Interception and destruction of twenty-five (25) containers of Tramadol worth one billion, seven hundred and eight million, seven hundred and fifty thousand naira (N1,708,750,000).
• Plan underway to destroy more than thirty containers of tramadol and other unregistered products worth more than 198 billion naira on the street
• Three persons involved in the distribution of the banned Tramadol have been arraigned at the Federal High Court, Lagos.
• The Agency secured the conviction of one of the distributors and the court ordered the destruction of the seized consignment.
• Shut down of three pharmaceutical companies over poor distribution practice of codeine-containing syrup
• The Agency arraigned the distributor of Codeine cough mixture exposed in a BBC documentary on Codeine abuse aired in May 2018 at the Federal High Court, Lagos. Prior to this, other persons had been arraigned for the sale and distribution of counterfeit Codeine-containing cough mixture.
• The Agency in an unprecedented move initiated the prosecution of an unrepentant advertiser of fake medicines with spurious and unsubstantiated claims in a National daily after a vigorous campaign against such illegal and dangerous activities.
• To further protect the health of consumers, the Agency destroyed fake, adulterated, counterfeit, banned and unwholesome NAFDAC Regulated Products worth four billion, two hundred and sixty thousand naira (N4,000,260,000) in exercises across the nation, while also clearing its Apapa warehouses that had been filled to the brim since 2013.

7. Pharmacovigilance and Post-marketing Surveillance (PV/PMS): The activities have been drastically improved through high alertness culture that has been fostered between PV/PMS and other Directorates such as FSAN, DER, R&R, PID and I&E.

• Successful PMS was done for three food products
  • On cold meat from South Africa that could cause listeriosis: PMS and enforcement activities were carried out at Shoprite stores throughout the nation by our zonal and state officers.
  • “Plastic fish” panic: PV/PMS FSAN, R&R and Lab Services swung into action and quickly did the regulatory controls including post-marketing mystery shopping and laboratory testing for the authenticity and safety of the fish.
  • On the margarine spread that would not melt: Appropriate regulatory controls including inspection of the company, several meetings with the executive, and sanction too place.

8. Effective Regulatory Controls and Transportation: For all the stated regulated controls, successes that were highlighted above, the need for utility vehicles or transportation cannot be over-emphasized. The vehicles are urgently needed for inspection and Investigation. Other activities include enforcement, laboratory services, pharmacovigilance and post-marketing surveillance and enhancement of MSMEs across the nation. NAFDAC needs at least 50 pick up vans urgently.

• With our fiscal management we have bought few vehicles in the third quarter but we still need the 50 vehicles.

9. Global Benchmarking:

• Based on the quality management system, we have imbibed the culture of self-audit as part of our benchmarking, in compliance to WHO and improving our maturity level as stipulated by WHO.
• Since my assumption of duty, our maturity level had doubled and we are working toward doubling the current maturity level in preparation for the official audit during the second quarter of 2019.

10. Global Collaboration and Reliance:

Some of the international collaborations and partnership which have developed over the past year included:

• The African Medicines Regulation Harmonization (AMRH), which elected me as NAFDAC DG in April 2018 as the Steering Committee Chair. AMRH is the precursor organization for the African Medicines Agency
• World Health Organization global benchmarking
• Medicine Quality and Public Health
• International Conference of Drug Regulatory Authorities (ICDRA)
• International Coalition of Medicines Regulatory Authorities(ICMRA) – an invitation only organization. NAFDAC was one of the two African countries invited and the only one that attended the last meeting in September 2018
• United States Pharmacopeia Convention (USP)

1. Revamping of the Information Communication Technology (ICT) Unit: Although ICT was mentioned at this point in the speech, it is actually a unit that drives most of our processes in NAFDAC. Since assumption of duty the following have been achieved:

• Aligning staff to using government backed mail system to improve security in communication
• Significant improvement in communication among staff via email –
• Introduced videoconferencing between Abuja and Lagos and purchase of the equipment. This has reduced travel cost between the two cities and contributes to reduction in overall expenditure
• Reconstruction of NAFDAC web site and populating it with needed information that is accessible to stakeholders and for imminent online registration
• Increased transparency in compliance to global regulatory practices
• In the process of purchasing software to further improve communication and ensure proper documentation needed for QMS
• Gradual provision of laptops and desktops to staff through budgeting and donations. This is one of the needs I did not know a year ago.

1. Community Engagement and Enlightenment

Part of safeguarding the heath of Nigerians is engaging and enlightening the public on NAFDAC’s activities and their health. Since resumption, we have engaged eighteen media partners that include four TV houses and the FRCN.  Health issues such antimicrobial resistance and the link with incomplete use of antibiotics, carbide use in fruit ripening, dangers of abuse of codeine and tramadol, recalls and alerts of drugs that are not safe to use have been discussed through these media and on social media. We have also created transparency with the stakeholders through stakeholders meeting, roundtables in order to make our regulatory controls and relevant.

NAFDAC is very active at the grass roots regarding drug abuse. Our staff, both from the center and at zonal levels have taken the awareness campaign on the road into mosques, churches and the entertainment industry. In a few days, we will do a flag off of a pilot national awareness campaign in Kano that will be followed by sustained awareness and education campaign on drug abuse in the other five geographical zones.

Moving Forward:

The successes realized over the past year have become a template for building on the fundamental changes that had taken place. We will provide more training opportunities for the staff, work with our local manufacturers to ensure medical products security, wholesome foods and secured chemicals. There are many challenges that we have and these include the re-equipping of our laboratories, providing utility vehicles for inspection of drug markets, pharmaceutical companies, ports and borders and incinerators for destruction exercises. The computers needed for registration of regulated products and approval, data gathering is another challenge that we hope to overcome in the coming year.  Having scaled through the first year, we strongly believe and have demonstrated in NAFDAC is Customer-focused and Agency minded and poised to continue to Safeguard the health of the Nation.

Thank You and God bless