NAFDAC Director General Reaffirms Agency's Dedication to Supporting Local Manufacturers
The Director General of the National Agency for Food and Drug Administration and Control (NAFDAC), Professor Christiana Mojoshola Adeyeye, has emphatically stated that the agency under her leadership remains steadfastly committed to encouraging and empowering local manufacturers across Nigeria. She made this declaration during a significant event in Lagos, where she commissioned the new facilities of Sam Pharmaceutical Limited, describing the occasion as a powerful testament to the transformative impact of collaboration and innovation within the nation's pharmaceutical sector.
Five Plus Five Policy Drives Significant Growth in Local Production
Professor Adeyeye highlighted that her administration has been instrumental in shaping the robust growth of the pharmaceutical industry, particularly through the strategic introduction of the Five Plus Five policy. She explained that this bold and innovative initiative has effectively motivated local manufacturers to strive for excellence, resulting in a remarkable and substantial increase in local production capacity. According to the DG, local production has now surged to an impressive 50 per cent, a significant leap from the previous figure of 30 per cent, showcasing the tangible success of NAFDAC's regulatory and supportive frameworks.
The impact of these progressive policies is clearly evident in the impressive strides made by pioneering companies such as Sam Pharmaceuticals. Adeyeye emphasized that the commissioning event was not merely a celebration of a new facility's opening but represents a critical milestone in Nigeria's ongoing pharmaceutical journey towards greater self-reliance and industrial development.
Shift Towards Self-Sufficiency and Enhanced Medicine Accessibility
"With more local manufacturing outfits emerging, we are witnessing a definitive shift towards self-sufficiency, which is making essential medicines more accessible and affordable for all Nigerians," Professor Adeyeye added. She elaborated that NAFDAC's Five Plus Five policy is meticulously designed to drive foreign investment while simultaneously strengthening and fortifying local pharmaceutical production capabilities within the country.
The DG provided detailed insights into the policy's operational mechanisms, stating, "Upon successful renewal for another five years for companies with verifiable and actionable blueprints, NAFDAC will rigorously monitor the migration of imported drugs to local production. At the end of year seven, which encompasses the first five years plus two years into the renewal period, if there is no demonstrable progress on migration to local manufacturing as detailed in the submitted blueprint, an alert for de-registration will be formally sent to the company at the beginning of year nine."
Strict Compliance and Continuous Regulatory Improvement
For products that have already enjoyed more than two cycles of renewals, Adeyeye clarified that such companies are now required to submit immediate and concrete blueprints outlining their migration plans to local manufacturing. "Where a manufacturer has more than one product, a verifiable blueprint for the local production of at least one product will be deemed acceptable and allowed," she noted, underscoring the agency's flexible yet firm approach to regulatory compliance.
Furthermore, Professor Adeyeye highlighted NAFDAC's unwavering commitment to continuous improvement in its regulatory maturity levels since the first World Health Organization (WHO) Audit in June 2019. "NAFDAC has worked assiduously and diligently towards attaining maturity level three (ML3) to enable Nigeria to strengthen its systems and manufacture vaccines domestically. This achievement is also firmly based on continuous self-audit in all regulatory processes that could enhance the agency's image and that of Nigeria on the global stage," she explained.
The WHO re-benchmarked the agency between February 21 and 25, 2022, and the prestigious ML3 rating signifies that NAFDAC has been officially recognized as attaining a stable, well-functioning, and fully integrated regulatory system under Professor Adeyeye's visionary leadership, further solidifying its role in fostering a thriving local manufacturing ecosystem.
