Director General of National Agency for Food and Drug Administration and Control (NAF- DAC), Prof Mojisola Adeyeye, has said the manufacture of blood glucose meters and strips in Nigeria will revolutionise healthcare and make a significant impact in the lives of people living with diabetes in Africa and beyond. She, however, emphasised the need for the continuous availability of high-quality products that meet world-class standards to be able to strive favourably with competition from Europe and the United States (U.S) at relatively affordable prices.
Adeyeye made the assertions recently in Lagos during a facility tour of the first In-vitro Diagnostics (IVD) manufacturing site of a health technology company, Colexa Biosensor Limited, a subsidiary of Codix Pharma Limited, in Lagos. According to a statement from NAFDAC’s Resident Media Consultant, Sayo Akintola, the director general 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 practice (GMP) and other global best practices.
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. A persistent elevation in blood glucose leads to glucose toxicity, which contributes to cell dysfunction and the pathology grouped together as complications of diabetes.
Diabetes mellitus is characterised by persistent hyperglycemia from a variety of causes, and it is the most prominent disease related to the failure of blood sugar regulation. There are different methods of testing and measuring blood sugar levels, one of which is the use of blood glucose meters. Speaking further during the tour, Adeyeye said, ‘’I will in addition be looking at United States Food & Drug Administration (FDA) standards because It’s accepted anywhere in the world,’’ adding that the Agency would 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, she said 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. Prof Adeyeye, however, advised 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 the United Arab Emirate (UAE) and the United Kingdom (UK).
NAFDAC will only allow export of quality products with proven safety and efficacy. According to the company, the introduction of a new plant in Shagamu, things will be a lot easier when that plant becomes operational in October next year. “Regarding procurement by international partners, it is quality that is going to sell the product. NAFDAC has the tiered categorisation scheme where the Agency has risk-categorised 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 director general remarked. Earlier in his speech, the Chairman of Colexa Biosensor Limited, Mr. Samson Ogunjimi disclosed that the company had provided over five million tests of HIV/Syphilis Combo test to the HIV programme, help- ing to increase testing in pregnant women and saving lives.
He added that the company was also the first to introduce the COV- ID-19 rapid antigen test in Nigeria and provided various platforms for Point-of-Care (POC) COVID testing. Over 15 million test kits were distributed in Nigeria. Mr. Ogunjimi explained further that the factory is equipped with cutting-edge technology following a technology transfer from a reputable global health organisation with an estimated production capacity of 60 million tests of rapid diagnostic tests (RDTs) to be distributed across Africa.
Striving for equitable access to its diagnostics in Nigeria and across Africa, the chairman said the company has an installed capacity (one line three shifts) of 3.6m packs of strips and can be scaled up to three lines to enable a maximum total capacity of 10.8m packs of strips per annum. He noted that this can serve the country’s needs for strips i.e. 10.75 m packs at five per cent prevalence of the total population should each obtain one pack (50 tests) of strips in one year with job opportunities for over 1,000 Nigerians from the manufacture and sales of Blood Glucose Monitoring System (BGMS).