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The National Agency for Food and Drug Administration and Control (NAFDAC) is pleased to announce that Afrimedical Manufacturing and Supplies Ltd, Ogun State has achieved WHO Prequalification of a medical device 0.5 ml auto disable syringe after an arduous process, guided by NAFDAC and heavy investment that was made by Afrimedical to achieve this feat.
NAFDAC has the mandate to regulate and control the importation, exportation, manufacture, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, packaged water and chemicals. Since its inception, NAFDAC has thus been regulating medical devices including in vitro diagnostics.
NAFDAC in keeping with its vision of transformational leadership to be a world class regulator that ensures only quality and safe regulated products are imported, exported, manufactured, distributed, sold and used, has embraced global best practices in all its regulatory functions of medical products. The Agency started laying a foundational policy in 2019 for local manufacturing of medicines such as 5+5 regulatory 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.
Following the country’s unfortunate experience during the pandemic, when supply of imported medical devices including in vitro diagnostics was disrupted and the nation struggled to access these commodities, NAFDAC re-focused its strategies.
To ensure access, the Agency assiduously encouraged local manufacturing of quality medical devices such as syringes and in vitro diagnostics.
As of 2023, only three of the seven indigenous syringe manufacturers were functional. The three functional facilities have a combined installed capacity of over 2.5 billion syringes per annum. However, they were functioning below 20% capacity as they could not compete with imported syringes.
Upon discovering the available local capacity for manufacturing standard syringes, NAFDAC commissioned a performance evaluation of locally manufactured syringes to assess their quality and performance and gain insight into why they were less preferred than imported syringes.
The survey (which included field investigation, sampling, and testing in NAFDAC’s laboratory) revealed that the locally manufactured syringes were comparable to some of the imported ones but slightly more expensive. It was also discovered that some of the imported ones were of poorer quality.
However, in the spirit of continual improvement for the locally manufactured products, the laboratory evaluation results were shared with the manufacturers, and this served as a basis for handholding until they improved the quality of their syringes to the highest standards.
This handholding project involved:
- Conducting announced and unannounced Good Manufacturing Practice (GMP) Inspections to assess compliance to ensure that manufacturers maintain consistent quality standards in their production processes. Non-compliant facilities were guided on necessary corrective actions to improve the quality of their products and safeguard public health.
- Continual and close engagement with manufacturers to address identified gaps and provide technical support to facilitate swift resolution of non-conformances, ensuring continuous improvement in production quality.
- Random sampling of syringes from production sites and markets for quality testing with identified gaps addressed through guidance from NAFDAC.
- Regular engagements with manufacturers, industry associations, and other stakeholders to discuss regulatory updates, challenges, and best practices. These meetings fostered a better understanding of NAFDAC’s requirements, build their capacity through training programs and encourage voluntary compliance.
- Successful efforts by the manufacturers to attain ISO 13485 and improved compliance of local manufacturers with international manufacturing standards, enhanced product quality.
- NAFDAC submission of a brief on the efforts being made to ascertain progress and use of international standards to guide the manufacturers and consequent emphasis by the Coordinating Ministers of Health and Social Welfare to development partners of the importance of procuring NAFDAC-certified locally made syringes
In view of the foregoing, Afrimedical Manufacturing and Supplies Limited, 1b, Westerner Industrial Avenue, Isheri, Karameh Industrial City, Ifo, Ogun State, having satisfied national regulatory requirements for registration of its syringes, opted to challenge itself further to initiate the process for WHO Prequalification of its 0.5ml Auto-Disable (AD) syringes.
Therefore, 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 the company, that WHO has prequalified Afriject 0.5ml AD Syringes from Afrimedical Manufacturing and Supplies Limited. The Afriject 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 organizations.
This has not only made Afrimedical Manufacturing and Supplies Limited the first local manufacturer of syringes in Nigeria to achieve this laudable feat, but also the first in West and Central Africa region.
This is undoubtedly the outcome of meaningful collaboration between Afrimedical Manufacturing and Supplies Limited and NAFDAC, and the systematic implementation of NAFDAC policies mentioned earlier. With this achievement, Afrimedical Manufacturing and Supplies Limited has become the first manufacturer of syringes to be recognized by the WHO as operating at an acceptable level of compliance with GMP requirements in West Africa.
NAFDAC provided immense technical support throughout the prequalification process, including several meetings with key personnel of Afrimedical Manufacturing and Supplies Limited.
This achievement has strengthened NAFDAC’s drive for more collaboration, synergy, and appropriate policies to support Nigeria’s manufacturing Industries and make them more competitive regionally, continentally and globally.
The Agency also appreciates the technical guidance provided to Afrimedical Manufacturing and Supplies Limited by the United Nations Children’s Fund (UNICEF). UNICEF has keyed into NAFDAC’s vision and has also supported the Nigerian Federal Government’s agenda to produce high-quality health commodities.
NAFDAC hereby encourages 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 as we can achieve more together as a team.
NAFDAC is open to supporting more local manufacturers who have over the years shown a history of continued compliance with our extant regulations. At a time like this in our Nation’s history when the Federal Government is poised to support indigenization of medical product manufacturing, we can together replicate this achievement and propel more local manufacturers to attain similar global recognition.
It is expected that priority in procurement will be given to companies such as Afrimedical to underscore President Bola Ahmed Tinubu’s industrialization policy of strengthening domestic economy and promoting local manufacturing of quality products.
Prof. Mojisola Christianah Adeyeye, FAS
Director General/CEO
NAFDAC………Safeguarding the Health of the Nation!!!
