NAFDAC Validates First-Ever Locally Produced Glucometer For Diabetes, HIV, And Malaria

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The National Agency for Food and Drug Administration and Control (NAFDAC) has officially given its stamp of approval to the locally manufactured glucometer by Colexa Biosensor Limited, a subsidiary of Codix Pharma Limited based in Lagos. This device, designed for testing blood sugar levels, particularly in diabetes management, marks a significant stride of development for In-vitro Diagnostics (IVD).

The glucometer, also known as a blood glucose meter, plays a crucial role in home blood glucose monitoring—an essential aspect of managing diabetes. NAFDAC’s confirmation of the glucometer’s production came during a comprehensive facility tour led by Prof Mojisola Adeyeye, the Director-General of NAFDAC, at the first-ever In-vitro Diagnostics (IVD) manufacturing site of Colexa Biosensor Limited in Lagos.

Prof Adeyeye, in a statement delivered by the NAFDAC Consultant on Media, Sayo Akintola, emphasised the potential transformative impact of locally producing blood glucose meters and strips. She highlighted the positive implications for healthcare, particularly for individuals living with diabetes, not only in Nigeria but across the African continent and beyond.

While acknowledging various methods of testing blood sugar levels, Adeyeye underscored the critical need for consistently providing high-quality products that meet global standards. She emphasised the necessity for competitiveness against counterparts in Europe and the United States, all the while ensuring affordability. Adeyeye confirmed NAFDAC’s commitment to collaborating with Colexa Biosensor Limited to ensure regulatory compliance based on FDA standards.

The Director-General urged the company to focus on the local market, emphasising the creation of readily available, top-quality products for Nigerians before venturing into the global market. She stressed NAFDAC’s commitment to only allowing the export of products with proven safety and efficacy, stressing the role of quality, especially with the upcoming plant in Shagamu expected to commence operations in October next year.

In anticipation of international procurement, Adeyeye recommended that the company establish a research team to monitor the glucometer’s performance and efficacy in the Nigerian market. She highlighted the importance of transparency, urging the company to share findings with NAFDAC. Adeyeye projected that NAFDAC reaching WHO Maturity Level 4 would streamline pre-qualification processes for future submissions.

Commending Colexa Biosensor Limited as a leading medical device manufacturer in Sub-Saharan Africa, Adeyeye applauded the company’s pioneering efforts, including being the first to introduce Malaria Rapid Diagnostic Test (RDT) kits to the national malaria elimination program. This groundbreaking innovation has significantly enhanced the ability to promptly test and treat malaria cases, showcasing the company’s commitment to advancing healthcare solutions in the region.

 

 

 

 

 

 

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