By Doris Obinna
The National Agency for Food and Drug Administration and Control (NAFDAC) has said that it has placed emphasis on local herbal medicines by stepping down approval of imported herbal medicines that have equivalents in Nigeria.
Director-general of NAFDAC, Prof. Mojisola Adeyeye, disclosed this in Lagos during a press briefing at the launch of the International Narcotics Control Board’s Annual Report and Precursors Report.
According to her, it is to create a renaissance of Nigeria’s herbal medicines and mitigate falsification and counterfeiting.
“In this bid, NAFDAC inaugurated the Herbal Medicine Product Committee in March 2019 and has fostered collaboration between herbal researchers and local practitioners. This has led to joint submission of research proposals for funding for clinical trials of products that have been given listing approval by NAFDAC so that the product can be given full approval.
“The fact that something is herbal does not mean it does not kill. We were able to list about 42 products of herbal medicines during the (COVID-19) pandemic. We hope that, in 50 years’ time, NAFDA would be pioneers in terms of regulatory.”
She further stated that, over the years, the agency has evolved strategies to combat the ever-increasing challenge of regulated product counterfeiting and trafficking of substandard falsified medicines.
“While these strategies have yielded positive outcomes, the ever-innovative world of counterfeiting demands that new regulatory strategy is deployed to keep out these harmful products. This has led to the concept of building traceability and supply chain security into regulated products from plant to patient or from farm to fork.
“The launching of pharmaceutical traceability strategy document was done in October 2020 and it is the first step in positioning Nigeria to be a leader in driving traceability of pharmaceuticals in Africa. NAFDAC has developed a five-year traceability implementation plan in line with the objectives of the Nigeria Pharmaceutical Traceability Strategy to achieve supply chain visibility and strengthen its pharmacovigilance activities against the scourge of substandard and falsified medicines and medical devices by the end of the year 2024.”
She added that the agency has also established a Traceability Office (GS1 Desk) and a Technical Working Group to drive the activities in the five-year implementation plan: “NAFDAC is now using traceability to monitor distribution of vaccines across the country and the agency is now leading globally in the use of this technology to monitor the vaccines.
“Oxford University recognized what NAFDAC is doing and referred to it as the ‘Abuja Principles’ to mitigate falsification and counterfeiting of medical products.
“Also, NAFDAC has put a premium on local manufacturing of our regulated products to ensure that Nigeria will have drug security and turn the tide from 70 per cent imports to about 30 per cent imports by 2025. Part of the goal is to also mitigate SFs and counterfeiting, since ensuring the quality is much easier compared to an imported product.
“To enhance local production of pharmaceuticals in Nigeria, the agency reviewed and updated its five plus five-year validity policy. A product’s registration license is valid for five years and by the end of the fourth year of license validity, companies are required to submit draft blueprints of proposed partnerships with Nigerian companies or/and set up local manufacturing plant.
“Upon successful renewal for another five-year for companies with verifiable blueprints, NAFDAC will monitor the migration of the imported drugs to local production. At the end of year seven (first five years and two years into renewal), if there is no progress on migration to local manufacturing as detailed in the blueprint, an alert for de-registration will be sent to the company at the beginning of year.
“The migration to local manufacturing will be limited to products the local manufacturers have capacity to produce or that partnership would enhance the capacity to manufacture. This is with a view to reducing the number of registered imported products and encouraging local manufacturing and innovation.”