The Director General of the National Agency for Food Administration and Control (NAFDAC), Prof Mojisola Adeyeye has said that Nigerian pharmaceutical companies must be ready to trade quality products approvable in the different countries through continental reliance among regulators.
Adeyeye said this has become imperative as a result of the African Free Trade Agreement (AfcFTA) that allows free trade among African countries.
Speaking on From Green to Gold: Operational Realities in the 21st Century at the 50th Anniversary of Daily-Need Industries Limited in Lagos, the NAFDAC boss emphasised that Research and Development is an important creativity and innovation that several companies would need to incorporate into the manufacturing environment.
A statement signed by the NAFDAC Resident Media Consultant, Sayo Akintola in Lagos on Sunday quoted Adeyeye as saying that that would encourage research and clinical trials of new molecules, immune-modulators, complementary alternative medicines, especially for some non-communicable diseases such as cancer, diabetes, amongst others.
The NAFDAC DG pointed out that an innovation that COVID-19 pandemic taught Nigeria is that of embracing the manufacturing of vaccines, active pharmaceutical ingredients, and excipients, stressing that until the country has at least five companies making these pharmaceutical ingredients, and one or two companies manufacturing vaccines, Nigeria would remain insecure.
Given the strides that Daily-Need made over the last 50 years, Adeyeye expressed confidence that the diligence, strategic leadership, and response to challenges through improvement in the manufacturing premise with continuous quality monitoring, would bring about a future where innovation and creativity would be embraced for drug security, health security and subsequently universal health coverage.
She said Daily-Need had sown a seed using one product, the Penicillin Ointment, while the company had grown to over 20 products categories.
She cited Ecclesiastes 11:6: “Sow your seed in the morning, and at evening let your hands not be idle, for you do not know which will succeed, whether this or that, or whether both will do equally well”.
Adeyeye explained that that passage shed light on operational realities in any century, especially in the 21st Century as she identified The Sower, The Soil, and Creativity and Innovation of the Sower as the three operational realities in pharmaceutical development.
She described the Sower as the Founder, the Managing Director or Leader, and further said: “The question can be asked, what are the characteristics of the Sower as it relates to the ‘green to gold’ concept. These attributes of the Sower should include the following: Diligence (not be idle) strategic, and a good manager of time. Adopt business continuity plan in case there are unexpected issues that may lead to ‘change’ in the original plan and being progressive in continuous quality monitoring”.
Having read through the history of Daily-Need, she asserted that these attributes have been used in various ways as shown in the successful completion of the company’s multi-billion Naira factory designed to the standards of NAFDAC and the World Health Organisation, and US Food and Drug Administration that has now positioned the company well for good manufacturing practices.
Adeyeye enthused: ‘’It is good to reminisce about the Seed that was sown decades before and how tendering of the green has led to the growth and the golden fruit that it has yielded’’, adding that in the pharmaceutical industry or the regulatory world, there is no one-off.
“The tendering of the fruit is a continuous endeavor. Therefore, the Sower must be progressive in continuous quality monitoring. Many of our pharmaceutical companies, including Daily-Need have kept up with this quality monitoring’”.
According to the NAFDAC boss, the proactiveness of a company would reduce the risk of failures of operation. ‘”As an example, adopting a business continuity plan due to unexpected changes. I will give two practical situations; during a pandemic, a company will ensure that the needs and expectation of the customers are met, and the institution keeps functioning optimally during such times. Another example is the change in the format of submission of drug registration application that NAFDAC started enforcing about three years ago’’.
She further that when NAFDAC move from Maturity Level 3 to ML4 and World Listed Authority, Nigerian companies would be able to trade their products globally through the regulatory collaborative registration and reliance among national medicine regulatory agencies world-wide.
According to Adeyeye, the second operational reality, which is the Soil on which the seed is planted, includes the organisation, staff, and regulatory space. “Where the Sower plants the seed will determine the outcomes. Daily-Need started with less than 30 staff to more than 700 over the past 50 years. The operational realities for this aspect include training to increase the level of competence of the staff. The second is strong organisational structure, a needed strength of any company. The workforce must be well motivated and disciplined”.
She said NAFDAC has been part and parcel of this reality, adding that Good Manufacturing Practices culture, which is the bedrock on which quality pharmaceutical products are produced, has been given rapt attention by pharmaceutical companies in Nigeria through the GMP Road Map that was done on 25 companies by NAFDAC/UNIDO and the second Road Map that involved 145 companies.
She said Daily Need was an active participant in the Road Map and has proven to be able to live up to the regulatory expectation.
Adeyeye stated that NAFDAC is committed to supporting innovation and recognise the pharmaceutical industry through the Five-year Exclusivity that was introduced to local manufacturers in 2019 for manufacturing and marketing if the company can meet in-country market demand.
She said creativity in manufacturing could be shown through targeted drive to achieve pre-qualification of the facility and product, noting that that could also be done with the goal to get certification from WHO, or as part of preparation for global trade through collaborative registration and reliance among regulators.
“This is being underscored today because of AfcFTA that allows free trade among African countries. Nigerian pharmaceutical companies must be ready for trading their products across the continent with quality products that can be approved in the different countries through continental reliance among regulators”, she said.
