NAFDAC URGES PHARMACEUTICAL COMPANIES TO TAKE ADVANTAGE OF AFcFTA WITH QUALITY PRODUCTS.
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, the Director General, National Agency for Food Administration and Control, NAFDAC, Prof Mojisola Adeyeye has said.
Prof. Mojisola 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 emphasized that Research and Development (R&D) is an important creativity and innovation that several companies will need to incorporate into the manufacturing environment.
Prof. Mojisola Adeyeye, in a statement signed by the NAFDAC Resident Media Consultant, Sayo Akintola, in Lagos on Sunday, 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.
Prof. Mojisola Adeyeye 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.
Knowing the strides that Daily-Need has made over the last 50 years, she expressed confidence 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.
She said 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”.
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Prof. Mojisola Adeyeye 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.
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 companys multi-billion Naira factory designed to NAFDAC, WHO & USFDA cGMP standards that has now positioned the company well for good manufacturing practices.
Prof. Adeyeye disclosed that 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.
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 Mojisola 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.
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.
Prof Mojisola Adeyeye stated that NAFDAC is committed to supporting 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.
She said creativity in manufacturing can be shown through targeted drive to achieve pre-qualification of the facility and product, noting that 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,’’ she said.
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