Monday, November 30, 2020 12:27 am
By Sayo Akintola
When Prof Mojisola Adeyeye was appointed Director Generalof the National Agency for Food and Drug Administration and Control (NAFDAC) in Nov 2017, little did she know that the Agency was under the weight of a debt profile of N3.2 billion. She neither knew nor was told that some of the internal processes were also broken down and not performing as they should. In addition, staff morale was at its lowest ebb as they were largely dis-incentivised due to a narrow pathway to career progression and inadequate renumerations. There were no operational vehicles at the 36 NAFDAC offices across the Federation and at the various nation’s border posts. The Laboratories were mere shadows of themselves as the required equipment were in short supply.
She never knew that there was no directorate-focused budgeting before her assumption. She met this big challenge with great resolve as part of quality management system that included fiscal and financial responsibility. Prof. Adeyeye had to work with Finance and Accounts Directorate for about three months from January-March 2018 to achieve
Fiscal and Financial Responsibility.
The NAFDAC DG was able to bring financial sanity to the Agency by stepping down all fictitious claims. She introducedbudget 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 in the process.Approximately N3.01 billion–naira debt was paid. The balance from the stated N3.2 billion-naira debt (about N200,000,000.00 naira) was said to be for fictitious claims and were written off. The paid debts are as follows: Unpaid Taxes and VAT owed and paid to FIRS was N1,590,990,110.00. Debt owed to Contractors stood atN399,293,490.50 while N484,956,344.43 was debt owed staff(for Good Manufacturing Inspection Travels).
2015-2017 missed unpaid operating surplus paid to the government stood at N548,026,195.07, leaving us with the sum total debt paid in 2018 at N3,002,266,080.00, out of which N2,141.016,305.07 was paid to the Federal Government in 2018. As a result of deep reconciliation exercise carried out in Final Account unit, Prof. Adeyeye was able to discover and recover in 2018 N106,590,298.52 erroneously credited to another MDA in 2015 as a result of deep reconciliation exercise carried out in Final Account unit.
In 2018, N533 million was recovered up to date, by the Ports Inspection Directorate, of evaded administrative charges (2014 to 2017) from stakeholders. Thanks to Prof. Adeyeye’s eagle eye at the helm of affairs at the nation’s key regulatory institution.
But for a woman who had already achieved several career highs at global institutions abroad before her return home, the situation Prof. Adeyeye met at NAFDAC was a challenge she turned into opportunity to put into use the experience garnered over the years. In fact, the challenge provided by NAFDACwas part of the reasons she took the job: her goal was to make the ailing whole again.
Starting out, she added a new motto “Customer-focused and Agency-minded” to the Agency’s vision of ‘Safeguarding the health of the nation.’
“This change became necessary to always remind us of our approach to “safeguarding the health of the nation,” she said.These and many other measures she introduced brought financial sanity to the Agency and has improved NAFDAC’s cash position in the Treasury Single Account (TSA), thereby enabling her to pay off the inherited debt of N3.01 billion within one year. NAFDAC has continued to maintain a zero-debt profile. This is unprecedented!”
On assumption, Prof Adeyeye restructured and expanded the Agency’s structure from 13 Directorates and FCT Office to eighteen Directorates. The five newly created Directorates are Legal Services, Laboratory Services: Yaba Central Drug, Biologics and Vaccines Laboratory, Kaduna Area Laboratory, Agulu Zonal Laboratory and Food Registration and Regulatory Affairs.
In addition, the six (6) Zonal Offices, plus the FCT and Lagos Offices are now headed by Directors, thereby creating more vacancies and enhancing career progression at the directorate cadre.
What the expanded directorates means, apart from a more functional organisation, is that staff now have better opportunities for promotion as vacancies opened and newopportunities for progression and responsibilities are created. This was done alongside staff capacity development.
Under Prof Adeyeye’s leadership, staff training received great priority. A total of 3,525 staff have been trained and retrained in the last three years. Similarly, staff are encouraged to undertake postgraduate programmes locally to improve their expertise on the job, provided it does not interfere with their official assignments.
With a transparent and quality-driven work environment that is expected of a regulatory agency, our staff are now well motivated, disciplined and more dedicated.
Her leadership also boosted the Agency’s ICT department to move most of its E-operations online. This led to significant improvement in communication among staff and between the Agency and the general public, especially its interested parties. The NAFDAC web site was redesigned and populated with needed information that is accessible to stakeholders and for imminent online registration. Over 150 computers were procured and 500 more are under procurement to improve the regulatory services and Ease of Doing Business for thousands of Micro Small Medium Enterprises (MSMEs).
The email system was also aligned to the use of government backed mail system using the Microsoft 365 platform for improved documentation and security in communication. As early as the first quarter of 2018, the Director General introduced and established videoconferencing with new audio-visual equipment, which has led to reduced travel cost and contributed to reduction in overall expenditure. This tool has become invaluable for regulatory activities during the Covid-19 pandemic.
To ensure that the public is abreast of happenings within the Agency, and most importantly to sensitize the citizenry on the importance of healthy living, the Agency boosted its community engagement and enlightenment operations. In the past three years, the Agency has engaged eighteen media partners and a robust social media presence, through which health issues such as antimicrobial resistance and its link to inappropriate 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. It holds regular stakeholder engagements through stakeholders’ meetings and roundtables in order to make its regulatory controls more transparent and convenient.
NAFDAC is very active at the grassroots regarding drug abuse, including through the NAFDAC-YADA (Youth Against Drug Abuse) project fully funded by NAFDAC. The members of Young Pharmacists Group (YPG) of thePharmaceutical Society of Nigeria (PSN) who came up with the initiative are using the project to sensitize the general public on the public health implications of the abuse of psychoactive drugs in Nigeria.
The campaign, which has an in-built data collection component, is piloted in six schools each in Osun, Anambra, Adamawa, Kwara, Delta, Kano and Lagos states.
Based on its mandate to protect public health by ensuring thatright quality food and drugs are manufactured, distributed, sold and used in Nigeria, NAFDAC is taking other steps necessary to curb the menace of substance abuse, including alcohol, in the country. Under her leadership and guidance from the Ministry of Health, policies were made to curb underage drinking of alcohol.
These include (1) all facilities producing unregistered alcoholic products shall be closed down and all unregistered products shall be eliminated from circulation; (2) no new products in sachet and small volume PET bottles above 30%ABVV will be registered by NAFDAC; (3) manufacturers will effect a reduction of the total volume of sachets and small volume PET bottles from current levels of 85% to 50% of total production capacity by 31st January 2020and (4) the production and importation of sachets and small volume PET bottles will cease by 31st January 2024.
Of course, the Agency has been proactive and vigilant in the areas of Detection and Elimination of Substandard and Falsified Medicines (SFs), Unsafe or Illicit Drugs, Unwholesome Foods, Chemicals and other Regulated Products.
This is the crux of its regulatory activities and involves almost all the technical Directorates, namely: Investigation and Enforcement, Ports Inspection, Pharmacovigilance and Post Market Surveillance, Laboratory Services, Chemical Inspections, Food Safety and Applied Nutrition, Narcotics and Controlled Substances as well as Veterinary Medicines and Allied Products Directorate.
Prof Adeyeye said: “In our determined effort to combat SFs, Illicit Drugs and chemicals as well as unwholesome foods; the Agency has deployed multifaceted measures or strategies...The Pre-Shipment Clean Report of Inspection and Analysis of Imported Medicines and other NAFDAC Regulated Products from India and China has been overhauled to prevent sub-standard and falsified products from getting into the country.Rather than running after fake drug importers here in Nigeria, NAFDAC has made it difficult if not impossible for them to ship fake drugs into Nigeria without being caught at the country of export. This has lessened the hues and cries over arrests of fake medicine importers in Nigeria by NAFDAC as the Agency has taken the battle to the countries where the products are being manufactured.
The Agency, on October 9, 2020 blacklisted Mars Remedies PVT Limited, India for the manufacture of falsified Ciprofloxacin Tablets BP 500mg (NAFDAC REG. NO C4-0498) for Pinnacle Health Pharmaceutical Ltd, 16/18. Nuru Oniwo Street, Surulere, Lagos.
In view of the unprofessional practice, the Agency stated that all products manufactured by the Mars Remedies PVT LTD, 635, GIDC Estate Waghodia, Vadodara, Gujurat, India, wouldno longer be allowed into Nigeria.
In a letter dated October 9, 2020 addressed to the ManagingDirector of Mars Remedies PVT Limited, Prof. Adeyeyereiterated the Agency’s position of zero tolerance for substandard and falsified medicines preponderance in Nigeria in fulfillment of the regulatory obligation of safeguarding the health of the nation.
Other measures include deployment of Cutting-Edge Monitoring Technologies; Risk-based laboratory testing; Public Enlightenment on SFs, Inter-Agency, Inter-Professional Collaboration and Community Efforts and continuous Post-Marketing monitoring of quality of medicines.
The Agency is in the process of procuring detection devices to monitor SFs at the Zonal/State levels in addition to the several trainings our staff have undertaken over the past years.
A major achievement in the direction of reducing theincidence of Substandard and Falsified medicines in the country was the hosting of the second Africa GSI TraceabilityConference on Healthcare in Lagos in September 2019.
The Conference attracted Medicines Regulatory Agencies from about twenty-five countries in Africa, as well as other stakeholder partners from the Americas and Europe. The Agency is already on a five-year roadmap to establishing a culture of Track & Trace with regards to pharmaceutical products. With this, medicines and medical devices can be monitored throughout the supply chain from manufacturing to the end user, the patient. Accordingly, the Agency has developed a roadmap to this effect which has been approved by the Honourable Minister of Health.
On November 2nd, at the inaugural meeting of the Traceability Steering Committee, (a committee that was recently inaugurated earlier by the Honorable Minister of Health, Dr Osagie Ehanire, for the governance and implementation of the traceability strategy), held its inaugural meeting. Prof Adeyeye stated at the meeting that the traceability strategy document is the outcome of two years’ work by NAFDAC in collaboration with Ministry of Health, international partners such as World Bank, USAID, Global Fund, GS1 Technologies to develop Traceability Desk in NAFDAC, i.e., an enabling environment for the implementation of the track and trace of medical commodities by using global standards.
Describing the gains of implementing pharmaceutical traceability as enormous, Prof Adeyeye said traceability would provide visibility of medicines from plant to patient to promote trust in the pharmaceutical sector and healthcare system.
NAFDAC laboratories are changing rapidly with improvement in new laboratory equipment and supplies. The National Control Laboratory for Vaccines and Biologics got ISO-17025 accreditation in February 2019 while the other laboratories have successfully been re-accredited yearly for ISO-17025. The Yaba laboratory complex was renovated and refurbished. An expansion of the complex is underprocurement.
Maintaining a National Quality Control Laboratory (NQCL),for ensuring that drug or medical products that are being registered are of quality at the post-marketing level, was the emphasis made at the African Medicines Quality Forum -AMQF – (a technical working group of African Medicine Regulatory Agency (AMRH) that often convenes for capacity building and information sharing among NQCLs.
Led by the DG, the Agency hosted the third annual African Medicines Quality Forum (AMQF) international meeting from February 24 to February 28, 2020 in Abuja. Thirty-four countries were represented at the meeting. There were also representatives from African Union Development Agency-New Partnership for Africa’s Development (AUDA-NEPAD), three Regional Economic Communities (ECOWAS, West Africa Health Organization (WAHO) and The West African Monetary and Economic Union – EUMOA), Intergovernmental Authority on Development (IGAD) and Southern African Development Community (SADC), the United States Pharmacopeial Convention (USP), Bill and Melinda Gates Foundation (BMGF), the World Bank and the World Health Organisation (WHO).
The theme of the 2020 meeting was 2020: Perfect Vision for Quality Medicines in Africa. The meeting achieved all its set objectives and deliverables in ensuring quality of medicines.
A major achievement of Prof Adeyeye’s leadership, following her relentless efforts, was the return of the Agency back to the Ports in May 2018 (all thanks to the Office of the National Security Adviser); coupled with rigorous inspection and enforcement activities. Because of this, the Agency has, in collaboration with Nigeria Customs Service, seized and destroyed SFs, unwholesome foods and other unregulated products worth over N4b in exercises across the nation and Tramadol seizures with estimated street value of N1. 7trillion.
To effectively detect Adverse Drug Reactions (ADRs) as well as identify and mop up substandard regulatory products in circulation, the agency adopted electronic reporting of ADRs for International Drug Monitoring and it is maintained by Uppsala Monitoring Centre in Uppsala, Sweden. E-reporting allows the National Pharmacovigilance Centre to capture Individual Case Safety Reports (ICSRs) directly from patients into Vigiflow (Database). It can also be accessed through the NAFDAC website.
ON November 4, Prof Adeyeye oversaw the launch of the Med Safety Mobile Application for reporting of Adverse Drug Reactions (ADRs) in Nigeria. This application would enhance the promotion of awareness and increased reporting of ADRs amongst healthcare professionals, healthcare providers and members of the public
The app, which launch was done virtually, would be one of the tools that would be used for Covid-19 vaccines in collaboration with other sister agencies in Nigeria whenever the vaccines are available and deemed fit on quality, safety and efficacy by NAFDAC.
The App would ensure safety of the end-users of medicines and improve on health outcomes of the patients, noting that it would directly reach out to over 10,000,000 pharmacovigilance stakeholders with the use of conventional and social media platforms.
The National Pharmacovigilance Centre (NPC) domiciled in NAFDAC is charged with the responsibility of coordination of all pharmacovigilance activities in Nigeria.
Despite the availability of these pharmacovigilance reporting tools, ADRs and other drug-related problems remain under-reported in Nigeria and generally within the WHO region of Africa.
The provision of the Med Safety App which is available to download for free on android or apple smartphone devices provides a medium for users to seamlessly report incidences of ADRs from the comfort of their mobile phone devices.
The registration of applications process is undergoing continuous improvement; from 6000 backlog of registration applications in 2017 that were cleared by April 2018 to the now digitalized processing. To make things easier for businesses, the Agency digitalized its registration processes to allow its clients to register online through NAPAMS V2.0. It is also implementing assisted E-registration of regulated products and palliative program for MSMEs. In addition, NAFDAC is also now enforcing submission of applications for Drug Product Approval using Common Technical Document (CTD) which was not always the case.
Under the leadership of the DG, the Agency has sharpened its focus on increasing access to quality and efficacious medicines through local manufacturing. Some of the successes in this area include the development of guidelines for Active Pharmaceutical Ingredient (API). The Agency, through the support of its development partners [United States for International Development (USAID) and United States Pharmacopeia (USP)], carried out assessments of 165 local Pharmaceutical Manufacturers in Nigeria with a view to developing a Good Manufacturing Practice (GMP) Roadmap for NAFDAC and the pharmaceutical industry.
It is gratifying to see several multi-national Pharma forming partnerships with local companies as a result of strengthening of the local companies. Local manufacturing will improve drug security, reduce SFs, improve the GDP and reduce unemployment.
As a result of the Agency-wide training in QMS, NAFDAC was ISO 9001:2015 Certified in June 2019. The agency is alsoencouraging the Pharmaceutical Industry to imbibe similarquality management systems in their operations through training and capacity building.
“The WHO Benchmarking Programme commenced in Nigeria in January 2018 and since then we have imbibed a culture ofself – audit as part of WHO-Global Benchmarking requirements and in line with International Best Practices. We have continued to improve our maturity level since the first WHO Audit in June 2019. Currently, we are working towards attaining Maturity Level 3 to enable the production of vaccines in the country,” the DG said.
“The ultimate goal, however, is to achieve Maturity Level 4,which will make Pharmaceutical Companies in Nigeria attain WHO Prequalification.”
To enhance local production of pharmaceuticals in Nigeria, the Agency reviewed and updated its Five Plus Five-Year Validity policy. A product registration license is valid for 5 years and by the end of the 4th year of license validity, companies are required to submit draft blueprints of proposed partnerships with Nigerian companies or/and set up localmanufacturing plant.
Upon successful renewal for another 5 years for companies with verifiable blueprints, NAFDAC will monitor the migration of the imported drugs to local production. At the end of Year 7 (First 5 years + 2 years into renewal), if there isno progress on migration to local manufacturing as detailed in the blueprint, an alert for de-registration will be sent to the company at the beginning of ninth year.
Special attention is now being given the Micro Small and Medium Enterprises MSMEs by the Agency through proffering possible solutions to the teething problems associated with registration and securing approval for locally manufactured products. NAFDAC is now in partnership with private sector-driven bodies like Lagos Chamber of Commerce and Industry (LCCI), National Association of Chambers of Commerce and Industry, Mines and Agriculture(NACCIMA) to create public awareness leveraging on the bodies’ sectoral event platforms.
NAFDAC, being an active member of the Presidential Enabling Environment Council (PEBEC), has continued to support the job creation agenda of the present administration in line with the provisions of Executive Order No. 001.
The Agency carried out a lot of reforms of its activities to create an enabling environment for MSMEs businesses to thrive, focusing on micro and small companies. According to Prof. Adeyeye however, the Agency ensures that only quality products that are safe, efficacious and wholesome reach the market and ultimately, the consuming public.
She has enhanced the processing of all NAFDAC licenses (Approvals, Certificates and Permits) to ensure efficiency and elimination of person to person contact, leading to the availability of end-to-end online automated processing platforms with outputs being digitized electronic licenses.
To further encourage the sector, on the 15th May 2020, NAFDAC launched the assisted registration through NAFDAC Automated Product Administration and Monitoring System (NAPAMS) for MSMEs as a means in easing their registration processes. The launch ran concurrently in the six geo-political zones plus FCT and Lagos state.
It is worthy to state here that during this COVID 19 Pandemic; the Agency instituted the following palliative programs for micro and small Enterprises (MSEs): Zero tariffs for first 200 MSEs, within a time lag; 80% reduction in tariffs for registration of MSEs products for a period of 6 months; waivers on administrative charges for renewal of expired licenses for products of MSEs for the same period.
Some of the international collaborations and partnership the Agency has developed over the past years included: World Health Organization Global Benchmarking; Swiss Medic Marketing Authorisation for Global Health Products and the African Medicines Regulation Harmonization (AMRH), which elected the NAFDAC DG in April 2018 as the Steering Committee Chair.
Others include Medicine Quality and Public Health International Conference of Drug Regulatory Authorities (ICDRA) and International Coalition of Medicines Regulatory Authorities (ICMRA) and Paediatric Regulatory Network (PRN). NAFDAC was one of the two African countries invited to the ICMRA and the only one that attended the last meeting in September 2018 at the United States Food and Drug Administration.
As part of her mandate on regulatory control on foods, the Agency advocates the importance of infant and young child feeding (IYCF) and the continued protection, promotion, and support of breastfeeding during the COVID-19 pandemic that cannot be over-emphasized. During the 2020 Breastfeeding Week, the DG restated that “breastmilk is a natural and renewable food which requires no preparation, no packaging, no storage, and no transportation, and therefore is environmentally friendly and sustainable. Breastfeeding is a win-win situation for the infant, the mother, the environment, and the planet. Breastfeeding is the right of all infants and young children’’.
The Director General has also supported food fortification with Vitamin A and other micronutrients as a means of keeping healthy in the general public and improving development of children.
The Agency remained functional even during the COVID-19 pandemic, though it activated alternative pathways to ensure that GMP Inspections continue, nevertheless. Digitalization of its registration processes also afforded its clients continuous registration of their products during Federal Government COVID-19 lockdown. Expedited pathways were developed to handle COVID-19 related products to ensure processing of requests that met set standards and to assure quality of products. Consequently, the Agency to date has grantedAdministrative approvals to 185 alcohol-based sanitizers, three face coverings/non-medical mask and One medical mask.
It also intensified surveillance to ensure that only NAFDAC registered Hand Sanitizers and Chloroquine Tablets which are of good quality are distributed and sold to the members of the public. Despite the pandemic restrictions, the Agency was able to analyse 3,712 medical product samples (between January and June 2020) some of which are COVID-19 related products.
Considering the rich plant biodiversity in Nigeria, from which medicinal preparations are derived, and the upsurge in the use of herbal medicines, Prof Adeyeye led the Agency to establish the National Herbal Medicinal Products Committee (HMPC).
What gets done, no doubt, gets counted. The positive changes at NAFDAC have not gone unnoticed, and the agency has been recognised by various partners for its responsiveness to the needs of its stakeholders.
“I am proud to inform you that, within the period I’ve led the Agency, NAFDAC has received the Most Improved MDAAward during the 2nd MSMEs Awards Ceremony.
The Agency has also received award of the Nigeria Public Sector Productivity Award for Excellence in Effective Use of ICT To Propel the Productivity Frontier,” Prof Adeyeye enthused.
The COVID-19 pandemic has gingered the Federal Government to put up intervention funds for the health sector. The pharmaceutical industry and other health related institutions are receiving intervention funds for infrastructure improvement and research and development. The Director General served as the broker between the Central Bank of Nigeria (CBN) and the pharmaceutical companies in Nigeria. She is also leading the Body of Experts in the CBN Health Sector research and development (R&D) Intervention Scheme in the development of funding mechanisms for translational research in the development of COVID-19 related therapeutics, vaccines and medical devices for infectious diseases and some non-communicable diseases.
-Sayo Akintola, Resident Media Consultant