As forex scarcity bites hard on the economy, including on prices of medical devices and drugs, users of glucometer may soon heave a sigh of relief.
A glucometer is a medical device for monitoring of blood sugar, early diagnosis of diabetes, HIV and malaria.
Prof Mojisola Adeyeye, the Director General of the National Agency for Food and Drug Administration and Control (NAFDAC), says the agency is excited by the news of a Nigerian company manufacturing glucometre.
She said the manufacture of blood glucose metres and strips in Nigeria would revolutionise healthcare and make a significant impact on the lives of people living with diabetes in Africa and beyond,
Adeyeye said this in Lagos during a facility tour of the site of the first In-vitro Diagnostics (IVD) manufacturing company, Colexa Biosensor Limited, a subsidiary of Codix Pharma Limited, in Lagos.
The NAFDAC DG said as a regulatory body, NAFDAC would continue to monitor the progress of the company and ensure that it remained compliant with good manufacturing practice (GMP) and other global best practices.
She promised that NAFDAC would help the company with the necessary assistance in their regulatory compliance as it had done with others.
Adeyeye said that 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.
She advised the company to focus more attention on the local market by making quality products that would be readily available to Nigerians before venturing into the global market with its 12 locations in Africa, including UAE and UK.
NAFDAC boss, however, said that the Agency would only allow the export of quality products with proven safety and efficacy.
She urged the company to constitute a research team that would 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 be little time spent for pre-qualification for applications submitted post-attainment.
She commended the company for achieving firsts in several endeavours 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.
Samson Ogunjimi, the Chairman of Colexa Biosensor Limited, said the company had provided over five million tests of HIV/Syphilis Combo tests to the HIV programme, helping to increase testing in pregnant women and saving lives.
He said 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. He said over 15 million test kits were distributed in Nigeria.
Ogunjimi said the factory would be equipped with cutting-edge technology following a technology transfer from a reputable global health organization with an estimated production capacity of 60 million tests of RDTs to be distributed across Africa.
He said the company would have installed capacity (1 line 3 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.
Ogunjimi said this could serve the country’s needs for strips i.e. 10.75 m packs at 5% prevalence of the total population should each obtain 1 pack (50 tests) of strips in 1 year with job opportunities for over 1,000 Nigerians from the manufacturer and sales of Blood Glucose Monitoring System (BGMS).
He said Nigeria could be a hub in Sub-Sahara Africa for the supply of BGMS and related consumables like lancets, alcohol swabs, lancet devices, packaging, etc. with opportunities for research and development of other tests using the same technology.
