Since taking over the helms of affairs as the director-general of the National Agency for Food and Drug Administration and Control (NAFDAC), Moji Adeyeye – a pharmacist and professor has given the regulatory agency a new lease of life.
Moji who became the DG on November 3, 2017, has sharpened the agency 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 the 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 also encouraging the Pharmaceutical Industry to imbibe similar quality 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 of self – 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.”
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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 a local manufacturing 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 is no 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.
Adeyeye further said that special attention is now being given to 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 inline with the provisions of Executive Order No. 001,” she added.
The Agency has 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 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 percent 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.
Adeyey said that 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 the 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 granted Administrative approvals to 185 alcohol-based sanitizers, three face coverings/non-medical mask, and one medical mask,” she said.
The DG stated that she 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,” she said.
Considering the rich plant biodiversity in Nigeria, from which medicinal preparations are derived, and the upsurge in the use of herbal medicines, 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 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.
