The Director-General of National Agency for Food and Drug Administration and Control, Prof. Mojisola Adeyeye, has asserted that the agency will not compromise the standards its commit to protecting nd promoting the global competitiveness of Nigerian indigenous manufacturing companies.
Pof Adeyeye made this declaration in a statement on Sunday by the agency’s Resident Media Consultant, Sayo Akintola, following a facility tour of the first In-vitro Diagnostics manufacturing site of a health technology company, Colexa Biosensor Limited, in Lagos.
The company is the first to produce glucometer, and medical devices for early diagnosis and management of diabetes.
A glucometer, also known as a blood glucose meter or blood sugar meter is a medical device, In-vitro diagnostic, used to measure the approximate concentration of glucose in the blood. It is a key element for home blood glucose monitoring.
The agency’s Director-Genetal stated that the manufacture of blood glucose meters and strips in Nigeria will revolutionize healthcare and make a significant impact in the lives of people living with diabetes in Africa and beyond.
She however, identified the need for the continuous availability of high-quality products that meet world-class standards to be able to strive favorably with compete with Europe and the United States at relatively affordable prices.
In the statement, the DG said that as a regulatory body, NAFDAC would continue to monitor the progress of the company and ensure that it remains compliant with good manufacturing practices (GMP) and other global best practices.‘
She said, “I will in addition be looking at FDA standards because it’s accepted anywhere in the world’’, she said, adding that the agency would collaborate with the company for the necessary assistance in their regulatory compliance, as it does with others to provide the needed guidance.
“For an African medical device company, the feat would go a long way in improving the health of nations through access to quality, innovative, technology-enabled healthcare solutions for the prevention, early diagnosis, and management of diseases.
“NAFDAC will only allow the export of quality products with proven safety and efficacy.
“Regarding procurement by international partners, it is quality that is going to sell the product. NAFDAC has a tiered categorization scheme where the Agency has risk-categorized companies into Low, Medium, and High categories.
“The Agency is working with international partners such as UNICEF to understand and use this approach for procurement of some medical products and ready-to-use-therapeutic foods from our local manufacturers’’, the DG remarked.
She then admonished the company to focus more attention on the local market by making quality products that are readily available to Nigerians before venturing into the global market with its 12 locations in Africa, including UAE and UK
She called on the company to constitute a research team that will move around to monitor the selectivity and sensitivity rate once it enters the market in Nigeria.
Speaking on the step should go hand in hand with the marketing, the DG said, “The results of this study must be guided by and shared with NAFDAC.
Adeyeye gave the assurance that the there would be a remarkable improvement when NAFDAC attains WHO Maturity Level 4, noting that at that point, there will be little time spent for pre-qualification for applications submitted post-attainment.
The Chairman of Colexa Biosensor Limited, Samson Ogunjimi, had earlier revealed that the company had provided over 5 million tests of HIV/Syphilis Combo tests to the HIV program, helping to increase testing in pregnant women and saving lives.
He stated further that the company was also the first to introduce the COVID-19 rapid antigen test in Nigeria and provided various platforms for Point-of-Care (POC) COVID testing.
