Director General, National Agency for Food Administration and Control, NAFDAC, Prof. Mojisola Adeyeye has urged Nigerian pharmaceutical to get ready for trading their products across the continent with quality products that can be approved in the different countries through continental reliance among regulators.
Adeyeye said this is being underscored because 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 (R&D) is an important creativity and innovation that several companies will need to incorporate into the manufacturing environment.
In a statement signed by the NAFDAC Resident Media Consultant, Sayo Akintola, in Lagos on Sunday, Adeyeye stated that this will 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.
She pointed out that an innovation that COVID-19 pandemic has taught us in Nigeria is embracing as long overdue the manufacturing of vaccines, active pharmaceutical ingredients, and excipients, stressing that until we have at least five companies as a starter, making these pharmaceutical ingredients, and one or two companies manufacturing vaccines, Nigeria will remain insecure.
The NAFDAC boss said this sheds light on operational realities in any century, especially 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, Leader, etc.; 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, Good Manager of time. Adopt business continuity plan in case there are unexpected issues that may lead to “change” in original plan and being Progressive in continuous quality monitoring.
She 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’’.
The proactiveness of a company in the above stated attributes, she added, will reduce 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 commended the leadership of many pharmaceutical companies in Nigeria for rising to the occasion and increased improvement in the submission has been witnessed by NAFDAC, stressing that this is part of change management that is intricately linked to continuous quality monitoring.
She further stated that it is also a preparation for when NAFDAC will move from Maturity Level 3 to ML4 and World Listed Authority; when our companies will be able to trade their products globally through the regulatory collaborative registration and reliance among national medicine regulatory agencies world-wide.
The second operational reality, according to Prof. Adeyeye, the Soil on which the seed is planted includes the organization, staff, and regulatory space.
‘’Where the Sower plants the seed will determine the outcomes. Daily-Need started with less than thirty (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 organizational structure, a needed strength of any company. The workforce must be well motivated and disciplined.’’
Part of the Soil as mentioned is the regulatory ecosystem. 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.