NAFDAC announces WHO prequalification of locally made syringe

The National Agency for Food and Drug Administration and Control (NAFDAC), has said a 0.5ml Auto Disable Syringe produced by Afrimedical Manufacturing and Supplies Ltd, has achieved the World Health Organisation (WHO) prequalification.

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NAFDAC Director-General, Mojisola Adeyeye, disclosed this at a news conference on Wednesday in Lagos, describing it as a significant milestone for Nigeria and the West and Central Africa region.

Mrs Adeyeye, a professor, said Afrimedical, located in Ogun, is the first indigenous syringe manufacturer in Nigeria—and the entire West and Central Africa—to receive WHO prequalification for its syringes.

She noted that the achievement followed a rigorous process, substantial investment, and technical support and guidance provided by NAFDAC.

“This milestone aligns with the agenda of the President Bola Tinubu-led administration to promote local production of medical products,” she said.

“It is with great joy that I announce that, after a rigorous process, the WHO has prequalified Afrimedical’s 0.5ml AD Syringes. They are now eligible for national and international procurement by relevant agencies and organisations.”

Mrs Adeyeye added that Afrimedical is now the first manufacturer in West Africa to be recognised by WHO as operating at an acceptable level of compliance with Good Manufacturing Practice (GMP) requirements.

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She emphasised that NAFDAC, in its drive to become a world-class regulator, embraced global best practices in all aspects of medical product regulation.

Mrs Adeyeye disclosed that in 2023, only three out of seven indigenous syringe manufacturers in Nigeria were functional, collectively operating at less than 20 per cent of their combined installed capacity of 2.5 billion syringes per year.

She highlighted NAFDAC’s “5+5” policy, introduced in 2019, which restricted the importation of medicines and devices that could be produced locally.
“Products with five-year registration validity that can be manufactured in Nigeria will be granted one final five-year renewal, after which importation will no longer be allowed,” she explained.

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Local manufacturing

Following NAFDAC’s attainment of WHO Maturity Level 3 in 2023, the agency began engaging international procurement bodies, such as UNICEF’s supply division in Copenhagen, to promote patronage of locally manufactured medical products, including syringes.

The Director-General urged other indigenous manufacturers to emulate Afrimedical’s achievement through collaboration and alignment with NAFDAC’s regulatory goals.
Also speaking at the event, Afrimedical General Manager, Gabi Al-Aridi, described the WHO prequalification as a major milestone for the company, NAFDAC, and Nigeria as a whole.

Mr Al-Aridi praised the federal government’s efforts to support local production and stated that “Afrimedical currently produces about 1.8 billion syringes annually.”
He reaffirmed the company’s commitment to high-quality, locally made medical products and encouraged Nigerians to embrace them to help boost the nation’s economy.
(NAN)