Keynote Speech By Prof. Adeyeye C. M
Director General NAFDAC
From Green to Gold: Operational Realities in the 21st Century
50th Anniversary of Daily-Need Industries Limited
21st July, 2022.
The Sower and the Soil:
Pharmaceutical Industry Operational Realities in the 21st Century
It is a great pleasure and honour for me to give this Keynote Speech on the 50th Anniversary of Daily-Need Industries Limited. The topic of this address, “From Green to Gold: Operational Realities in the 21st Century” is very apt considering the pharmaceutical farm on which Daily-Need has been planting. I would like to thank the Founder/Chairman of Daily-Need, Otunba (Dr.) Matthew Oyin-Jolayemi, OFR, JP.
I would like to thank Daily-Need and the entire organization, other pharmaceutical manufacturers and associated partners for the courage to continue their passion to make medicines accessible and affordable for our population. I am very thankful for importers that are now looking to migrate to local manufacturing through contract manufacturing opportunities with local manufacturers in response to the NAFDAC 5+5 validity program and the expanded “Ceiling” that mandate local manufacturing. I appreciate other importers and multi-national companies that bring in quality products for which the country does not yet have capacity. This is a day to remember because of the legacy that we are celebrating with Daily-Need Industries Limited.
As the daughter of a farmer, I can relate to Otunba in terms of the time it takes to plant and harvest. As a regulator, I understand even more the plant-to-harvest time and efforts, and I congratulate Daily-Need for this great milestone.
Daily-Need has sown a seed using one product, the Penicillin Ointment, and the company has grown to over 20 products categories. The Bible stated in 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”.
This sheds light on operational realities in any century, especially 21st Century. What are the operational realities in pharmaceutical development? Some of the realities I will consider includes:
1) The Sower: The Sower is 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
- Progressive in continuous quality monitoring
Having read through the history of Daily-Need, I know these attributes have been used in various ways as shown in the successful completion of the company’s multi-billion Naira factory designed to NAFDAC, WHO & USFDA cGMP standards that has now positioned the company well for good manufacturing practices. Daily-Need was one of the companies that was inspected under the NAFDAC/UNIDO cGMP Road Map using international standards, and some of the indicators for that inspection included three for the manufacturing site – premise, equipment, and utilities. 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. 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 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.
The leadership of many pharmaceutical companies in Nigeria rose to the occasion and increased improvement in the submission has been witnessed by NAFDAC. This is part of change management that is intricately linked to continuous quality monitoring. 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.
2) The Soil: The second operational reality, 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. According to the published data, this is the best resource of Daily-Need. The Board and Management have consistently put the emotion and psyche of their staff and stakeholders as top priority. The outcomes are therefore not surprising as the good Soil, is yielding a hundred, sixty or thirty times what was sown.
The Soil from the regulatory perspectives is likened to the quality management system ((QMS) platform in NAFDAC’s regulatory inspection of pharmaceutical companies. The inspection related QMS has about 14 indicators for cGMP compliance. These indicators include the staff and what the staff are expected to do – quality assurance, sanitation and hygienic environment of the premise, qualification and validation of equipment, handling of complaints, training, personnel, documentation, etc.
Part of the Soil as mentioned is the regulatory ecosystem. NAFDAC has been part and parcel of this reality. 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. Daily Need was an active participant in the Road Map and has proven to be able to live up to the regulatory expectation.
3) Creativity and Innovation of the Sower: The third reality is creativity and innovation. These two attributes of the Sower or the Leader of an establishment are needed to birth new concepts and to implement such ideas as the green has now yielded golden opportunities. Daily-Need has been innovative and is encouraged to continue to be. The company has demonstrated this through the development of the Damoxen 125mg Dispersible Tablets (Amoxicillin) before my tenure. Some of our companies are also becoming more creative. NAFDAC is committed to support innovation and recognize 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.
Creativity in manufacturing can be shown through targeted drive to achieve pre-qualification of the facility and product. This can 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 the African Free Trade Agreement (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.
Research and Development (R&D) is an important creativity and innovation that several companies will need to incorporate into the manufacturing environment. 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, etc.
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. 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. I knowingly place this creativity/innovation last so that it can leave an after taste following this golden jubilee celebration of Daily-Need as actionable urgent actions for the immediate future.
Knowing the strides that Daily-Need has made over the last 50 years, I am confident that the diligence, strategic leadership, and the response to challenges through improvement in the manufacturing premise with continuous quality monitoring, will generate into a future where innovation and creativity will be embraced for drug security, health security and subsequently universal health coverage.
I would like to congratulate Daily-Need for the Golden-Jubilee Anniversary and wish Otunba and the entire governance structure of the company decades of successes for the current and future Green to Gold initiatives.
God bless.
