Glucometer: NAFDAC Confirms First Locally Made Device
The National Agency for Food and Drug Administration and Control (NAFDAC) has confirmed the manufacture of a locally made glucometer used in testing and measuring blood sugar levels by Colexa Biosensor Limited, a subsidiary of Codix Pharma Limited, in Lagos.
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 and 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.
A statement by the NAFDAC Consultant on Media, Sayo Akintola quoted the DG of the agency, Prof Mojisola Adeyeye, as having disclosed this during a facility tour of the first In-vitro Diagnostics (IVD) manufacturing site of a health technology company, Colexa Biosensor Limited in Lagos.
She said that although there are different methods of testing and measuring blood sugar levels, one of which is the use of blood glucose meters, 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, emphasized the need for the continuous availability of high-quality products that meet world-class standards to be able to strive favorably with competition from Europe and the United States at relatively affordable prices.
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The DG said that NAFDAC will be looking at FDA standards as accepted anywhere in the world, adding that the Agency would work with the company for the necessary assistance in their regulatory compliance.
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.
Adeyeye 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 UAE and UK.
She further told the firm that 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.
The NAFDAC boss, however, urged the company to constitute a research team that will go all out to monitor the selectivity and sensitivity rate once it enters the market in Nigeria, adding that this should go hand in hand with the marketing.
The results of this study must be guided by and shared with NAFDAC.
According to her, it will be a lot easier when NAFDAC attains WHO Maturity Level 4, adding that at that point, there will little time spent for pre-qualification for applications submitted post attainment.
As a leading manufacturer of medical devices and in-vitro diagnostics in Sub-Saharan Africa, Adeyeye commended the company for achieving firsts in several endeavors of its operations, being the first to introduce Malaria Rapid Diagnostic Test (RDT) kits to the national malaria elimination program, which has accelerated the ability to test and treat malaria in a timely manner.
