The National Agency for Food and Drug Administration and Control said Afrimedical Manufacturing and Supplies Ltd, Ogun State, has achieved a major milestone in West Africa as its Afriject 0.5ml Auto-Disable Syringes have been prequalified by the World Health Organisation.
According to NAFDAC, this achievement marks the first time a Nigerian manufacturer and indeed any manufacturer in West and Central Africa has attained WHO prequalification for syringes, positioning the country on the global map for quality medical device production.
Speaking on Wednesday at the NAFDAC Lagos office, Director General of NAFDAC, Prof. Mojisola Adeyeye, described the development as “a landmark achievement for Nigeria’s medical manufacturing industry.”
This is undoubtedly the outcome of meaningful collaboration between Afrimedical Manufacturing and Supplies Limited and NAFDAC.
It demonstrates the effectiveness of our regulatory reforms and the potential of local manufacturers when given the right support.”
According to her, the journey to this milestone was made possible through NAFDAC’s commitment to building a strong, local manufacturing base and reducing over-dependence on imports.
NAFDAC’s vision is to be a world-class regulator that ensures only quality and safe regulated products are imported, exported, manufactured, distributed, sold and used.
We began laying the foundation for this in 2019 with policies such as the 5+5 regulatory directive.”
The agency noted that Nigeria’s challenges during the COVID-19 pandemic, when supply chains for imported medical devices were disrupted, inspired renewed focus on building local capacity.
She maintained that at that time, only three of the seven indigenous syringe manufacturers were functional, collectively operating at less than 20 per cent of their combined 2.5 billion syringe capacity.
To address this, NAFDAC unveiled a series of interventions, including product quality evaluations, industry engagement, and technical assistance to improve local standards.
Adeyeye revealed that many of the locally produced syringes were of good quality, but were facing market resistance due to misconceptions and pricing challenges.
She said, “Our laboratory evaluations revealed that some imported syringes were actually of poorer quality.
“We guided the manufacturers on improving their processes and conducted GMP inspections to ensure compliance.”
Adeyeye revealed that Afrimedical Manufacturing and Supplies Ltd was one of the companies that responded positively, adding that after fulfilling national regulatory requirements, it chose to pursue WHO prequalification, a rigorous international process that examines product safety, quality, and manufacturing practices.
She said, “We are proud to announce that Afriject 0.5ml Auto-Disable Syringes have now been added to the WHO list of prequalified syringes.
This means they are now eligible for both national and international procurement by organisations such as UNICEF.”
She added that this accomplishment represents “the first time a syringe manufacturer in Nigeria, and indeed in West and Central Africa, has been recognised by WHO as operating at an acceptable level of compliance with global GMP standards.”
The NAFDAC boss also expressed gratitude to the United Nations Children’s Fund for its technical support to Afrimedical during the prequalification process.
UNICEF has keyed into NAFDAC’s vision and supported the Federal Government’s agenda to produce high-quality health commodities locally,” said Prof. Adeyeye.
She urged other Nigerian manufacturers to emulate Afrimedical’s dedication and work in close synergy with NAFDAC to achieve similar global recognition.
Adeyeye added, “At a time like this in our nation’s history, when the Federal Government is strongly promoting industrialisation and self-sufficiency, we must rally around and encourage local manufacturers.
“NAFDAC is open and ready to support compliant manufacturers on this journey.”
Adeyeye called on government ministries and procurement agencies to prioritise companies like Afrimedical, in line with President Bola Tinubu’s industrialisation policy.
She said, “This achievement is not just Afrimedical’s victory, it is Nigeria’s victory. It proves that when we believe in ourselves and support local innovation, we can compete and thrive on the global stage.”
