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 achieved World Health Organisation (WHO) prequalification.
NAFDAC Director-General, 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.
According to Adeyeye, 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.”
Adeyeye added that Afrimedical was 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.
She emphasised that NAFDAC, in its drive to become a world-class regulator, embraced global best practices in all aspects of medical product regulation.
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 revealed.
Adeyeye 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.
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, Mr Gabi Al-Aridi, described the WHO prequalification as a major milestone for the company, NAFDAC, and Nigeria as a whole.
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.
The National Agency for Food and Drug Administration and Control (NAFDAC), says a medical device, 0.5ml Auto Disable Syringe produced by Afrimedical Manufacturing and Supplies Ltd, has achieved WHO Prequalification.
Prof. Mojisola Adeyeye, the Director-General of NAFDAC disclosed this at a news conference in Lagos on Wednesday.
Adeyeye said the company located in Ogun State is the first st local manufacturer of syringes in Nigeria and also in West and Central Africa region to achieve the laudable feat.
She said the company was able to achieve the feat after a thorough arduous process, heavy investment and technical support and guardians by NAFDAC.
The D-G noted that the feat also align with the agenda of the President Bola Tinubu led administration to support local production of medical products in the country.
“it is with great joy and delight that I have the privilege of informing our stakeholders and the public that, after a rigorous process and a lot of investment by Afrimedical, the WHO has prequalified 0.5ml AD Syringes.
“The syringes have now been added to the WHO list of prequalified syringes and are therefore eligible for national and international procurement by relevant agencies and organisations.
“This is undoubtedly the outcome of meaningful collaboration between the company and NAFDAC, and the systematic implementation of NAFDAC policies over the years.
“Afrimedical has become the first manufacturer of syringes to be recognised by the WHO as operating at an acceptable level of compliance with GMP requirements in West Africa,” he said.
Adeyeye said in line with NAFDAC vision to be a world class regulator that ensures only quality and safe regulated products are used in the country, the agency embraced global best practices in all its regulatory functions of medical products.
She added that only three out of the seven indigenous syringe manufacturer were functional in the country in 2023 and they have a combine installed capacity of over 2.5 billion syringes per annum, while functioning below 20 per cent capacity.
She said:”The Agency started laying a foundational policy in 2019 for local manufacturing of medicines such as 5+5 regulatory.
“This directive which ensures that products that were previously imported with five-year registration validity and that can be manufactured in Nigeria are given the last renewal of five years and thereafter prevented from being imported.
“In 2023, after the attainment of WHO Maturity Level 3, NAFDAC engaged UNICEF supply chain in Copenhagen and at a workshop in Lagos to patronize locally manufactured medical products including syringes.
The Director-General, however, encourage other well-meaning local manufacturers of medical products to emulate this feat through harmonization of collective aspiration and synergy of effort with NAFDAC’s relevant directorates.
Speaking also, the General Manager of Afrimedical Manufacturing and Supplies Limited, Mr. Gabi Al-Aridi described the feat as a major milestone for the company, NAFDAC and Nigeria at large.
Al-Aridi, who commended the federal government for promoting local production of pharmaceutical products said the company producing about 1.8 billion syringes per annum.
He reiterated the company dedication to providing high-quality, locally manufactured syringes, while urging Nigerians to embraced locally made syringes to boost the nation’s economy.
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