By Chioma Obinna

The National Agency for Food and Drug Administration and Control, NAFDAC, has announced the World Health Organisation, WHO, pre-qualification of AFRI Medical Manufacturing and Supplies Limited’s 0.5ml auto-disabled syringes making it the first Nigerian company and the first in West and Central Africa to earn such certification for syringes.

Speaking during a press briefing at NAFDAC’s Isolo office in Lagos, Director General, Prof. Mojisola Adeyeye, hailed the achievement as a “testament to the success of NAFDAC’s strategies to promote local manufacturing of quality medical products.”

“This feat was not achieved overnight,” Adeyeye said. “It is the result of a rigorous process, heavy investment by AFRI Medical, and consistent guidance and support from NAFDAC. Today, their product is on the WHO list of pre-qualified medical devices, making it eligible for international procurement by UNICEF and other global bodies.”

She noted that the WHO pre-qualification would allow AFRI Medical to export high-quality syringes globally, significantly enhancing Nigeria’s presence in the global medical device market.

The NAFDAC boss emphasised that this milestone aligns with the Federal Government’s industrialization agenda and President Bola Ahmed Tinubu’s policy to strengthen the domestic economy through local production.

“In keeping with our vision to be a world-class regulator, NAFDAC has embraced global best practices in ensuring that only quality and safe regulated products are imported, exported, manufactured, distributed, sold, and used,” she said.

Adeyeye further encouraged other local manufacturers to intensify efforts to meet global standards, disclosing that NAFDAC had started laying policy foundations since 2019. One such initiative is the “5+5” regulatory directive that discourages the continued importation of products that can be locally produced after an initial five-year registration cycle.

“We discovered during the COVID-19 pandemic how fragile our reliance on imported medical devices can be,” she explained.

“This prompted us to refocus our strategy and commission evaluations of locally manufactured syringes to assess their performance.”

The agency’s evaluation, which included field investigation and laboratory testing, found that while some locally made syringes were of good quality, others fell short. NAFDAC responded by launching a “hand-holding” initiative with manufacturers to guide them towards compliance with international standards.

This included unannounced inspections and technical support.

“The results of these evaluations were shared with manufacturers. With our continued collaboration, we have seen improvements, and today, AFRI Medical is the shining example of what is possible,” she added.

Also speaking, General Manager of AFRI Medical, Mr. Gabi Al-Aridi, described the WHO pre-qualification as “a milestone achievement,” noting that the certification enables the company to supply best-quality syringes to international organisations, including UNICEF.

“This means that AFRImedical Nigeria can now export syringes with the highest level of WHO certification, as well as ISO and market clearance certifications,” he said.

Speaking, former NAFDAC Director and current staff of AFRI Medical, Mr. Sheriff Olagunju also applauded the collaboration between the agency and the company.

“It’s been a very tedious journey with WHO and its technical team. But the prequalification is proof of AFRI Medical’s competence and commitment to global standards.”

Present at the briefing were directors from various NAFDAC departments and representatives of AFRI Medical, all of whom echoed the need for increased investment in local manufacturing.

Adeyeye urged other manufacturers to take advantage of NAFDAC’s regulatory support, saying, “We are open to working with any local manufacturer committed to compliance and excellence.”