The Food and Drugs Authority has approved a herbal medicine known as Cryptolepis sanguinolenta locally known as Nibima for clinical trials for the treatment of COVID-19.
The Authority made this revelation known via a press statement issued on Monday, February 1, 2021, and signed by Chief Executive Officer of FDA, Mrs. Delese A.A. Darko.
Mrs. Darko disclosed that the approval of the herbal medicine comes on the back of laboratory studies conducted by the Kwame Nkrumah University of Science and Technology (KNUST) research team which proves the efficacy of the medicine against the novel coronavirus.
“The Food and Drugs Authority (FDA), The National Medicine Regulatory Agency (NMRA) in Ghana, has approved a herbal medicine, Cryptolepis sanguinolenta, locally known as Nibima for clinical trials in January 2021.
“In the search for a treatment for the ongoing COVID-19 pandemic, researchers from the School of Public Health at the Kwame Nkrumah University of Science and Technology, (KNUST), submitted a clinical trial application in September 2020 to assess the safety and efficacy of Cryptolepis sanguinolenta as a potential treatment for COVID-19. This follows results from laboratory studies conducted by the KNUST research team which points in the direction of possible clinical benefits.”
The Authority added that it gave the authorization after “detailed assessment.” It insisted that it did so under (Section 150-166) of the Public Health Act 2012 (Act 851).
“The FDA after a detailed assessment of the application gave the requisite regulatory authority for the conduct of the trial as per the mandate outlined under Part 8 (Section 150-166) of the Public Health Act 2012 (Act 851), which gives the Authority the legal mandate to regulate clinical trials of drugs, herbal medicinal products, cosmetics or medical devices. The trial will be at two sites.”
Additionally, the FDA boss also noted that trial of the medicine will be conducted at two sites, further assuring the general public that the Authority remains committed to protecting the health and safety of consumers.
The statement further admonished citizens to report any suspicious activities on FDA regulated products to the Authority.
Prior to the approval, the FDA in a statement issued on January 12, 2021 urged the general public to desist from buying any COVID-19 vaccine from health facilities.
According to the Authority, its attention has been drawn to the fact that “some unscrupulous members of the business community are peddling information on the sale of COVID-19 vaccines to hospitals and other health facilities”.
“The information is ostensibly to inform the general public of the availability of these vaccines from well-known pharmaceutical brands indicating their price ranges.
“The general public is hereby cautioned against the patronage of such vaccines since the FDA has not yet approved any COVID-19 vaccine for use in Ghana. In view of the above, the FDA wishes to inform all health facilities and the general public that, peddling of such information contravenes Section 118 of the Public Health Act 2012, Act 851 and constitutes a very serious offence.”
The statement further stressed that “anyone caught dealing with unregistered COVID-19 vaccine will be sanctioned in accordance with the provisions of Section 129 of Act 851, which includes a fine of up to GHC180,000 or to a term of imprisonment of up to 25 years or both”.
