NAFDAC set to standardise local herbal medicine

September 7, 2020
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The Director-General (DG) of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof Mojisola Adeyeye has reiterated the need for traditional medicines practitioners in Nigeria to collaborate with researchers with a view to making herbal products internationally acceptable after clinical trials.

This was said in a statement released to Tribune Online by NAFDAC’s Resident Media Consultant, Mr Sayo Akintola on Monday.

The statement reads: “Speaking on the occasion of the 2020 edition of the African Traditional Medicines day that holds every August 31st of each year, she posited that the event should be a daily reflection of who we are as Africans. “African Traditional Medicines Day in Nigeria lives with us every day. This is what many Nigerians use every day.”

“NAFDAC has been focused on making traditional herbal medicines prominent with regards to the activities of the Agency. To this end, in March 2019, long before the advent of COVID -19 in Nigeria, the DG called for a meeting of all stakeholders including academia, herbal medicine practitioners and legal practitioners. The essence of the meeting was to engender a culture of collaborative effort aimed at promoting research, discovery and production of herbal products.

“The DG, in a goodwill message on the occasion, noted that herbal medicines renaissance in Nigeria has already begun. She stressed that the nation has the biodiversity and complementary human capital to sustain herbal medicines production.

“Moreover, the Federal Government through the Central Bank of Nigeria (CBN) is making loans available to qualified manufacturers of pharmaceutical products. The CBN has also launched the Health Sector Research and Development Intervention Scheme to fund successful proposals on translational R&D and manufacturing of therapeutics, herbal medicines and medical devices for infectious diseases, including COVID-19. In addition, the Tertiary Education Trust Fund (TETFund) is funding COVID-19 related herbal medicines clinical trial research through NAFDAC’s administrative oversight. The Agency currently has about 40 applications on COVID-19 related herbal medicines submitted by interested parties, many of these are for listing while only very few are for clinical trials.

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“It is important to note that while the listing of a herbal product guarantees safety, and it is for two years at the first instance, a herbal product that has successfully gone through clinical trials would receive NAFDAC‘s full registration and the claims of efficacy and cure can then be made by applicants.

“A further step to enhance collaborative efforts between the various stakeholders in the herbal medicines industry is the institutionalization of the confidentiality agreement between parties. NAFDAC’s Legal Services Directorate developed the document and will broker the agreement. This is necessary to assure traditional practitioners that intellectual property will not be lost in the process of collaboration.

“In this same vein, the Ministry of Industry, Trade and Investment, Trade Mark Office, National Office for Technology Acquisition and Promotion (NOTAP), and patent legal practitioners in the area of protection of intellectual property were brought into discussions with the researchers and practitioners by the Agency. She added that NAFDAC’s development of modalities for registration of herbal products is to encourage the growth and standardization of the sector.

“The Director-General stated that the ultimate goal, with regards to traditional herbal medicines, is to come up with products that are not only marketable in the country but also acceptable globally.

“This can only happen, however, when NAFDAC as the regulatory authority subjects products that are submitted for approval to global standards.

“She, therefore, encouraged everyone or party with products to bring their applications forward. Registration procedures are already made simple through the published template of required documentation, guidance on registration and clinical trials and the Agency’s online NAPAMS (NAFDAC Automated Product Administration and Monitoring System) platform.

“The Agency has the mandate to safeguard the health of the nation, and this would continue to be done by making sure that all herbal products are subjected to the required safety and/or efficacy test(s),” she assured.

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