Made In Nigerian Syringe Attains WHO Prequalification – NAFDAC

The National Agency for Food and Drug Administration and Control (NAFDAC) says a 0.5ml auto-disable syringe, produced by Afrimedical Manufacturing and Supplies Ltd, has been prequalified by the World Health Organisation (WHO).

NAFDAC Director-General (DG) Prof. 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.

Adeyeye said Afrimedical, located in Ogun, is the first indigenous syringe manufacturer in Nigeria and the first in all of West and Central Africa to receive WHO prequalification for its syringes.

According to her, the achievement followed a rigorous process, substantial investment, 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. 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,” she said.

The NAFDAC boss 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 requirements.

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

Adeyeye also highlighted NAFDAC’s “5+5” policy, introduced in 2019, which restricted the importation of medicines and devices that could be produced locally. She explained that 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.

Adeyeye noted that with 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.

She 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 Mr Gabi Al-Aridi described the WHO prequalification as a major milestone for the company, NAFDAC, and Nigeria as a whole.

Al-Aridi lauded the federal government’s efforts to support local production and stated that Afrimedical currently produces about 1.8 billion syringes annually.

Made In Nigerian Syringe Attains WHO Prequalification – NAFDAC is first published on The Whistler Newspaper