The Food and Drugs Authority (FDA) has approved the first herbal medicine, Cryptolepis sanguinolenta, locally known as Nibima, for Covid-19 clinical trials.
The medicine, developed by researchers from the School of Public Health at the Kwame Nkrumah University of Science and Technology (KNUST) as a potential treatment for Covid-19, was given the approval after detailed assessment by the regulatory agency.
The FDA, in a release signed by its Chief Executive Officer (CEO), Delese Darko, said, “The FDA after detailed assessment of the application gave the requisite regulatory authorization for the conduct of the trial as per the mandate outlined under Part 8 (Section150-116) of the Public Health Act 2012 (Acct 851).”
The authority, which has the legal mandate to regulate clinical trials of drugs, herbal products, cosmetics or medical devices, said initial laboratory studies conducted on the medicine by the KNUST research team pointed in the direction of possible clinical benefits for Covid-19 treatment.
The institution thus submitted a clinical trial application in September 2020 to access the safety and efficacy of Cryptolepis sanguinolenta as a potential treatment for Covid-19 which had been approved.
According to the FDA, the trial will be conducted at two sites that have adequate capacity to ensure the safety of participants as well as produce credible scientific data.
“The research team has over the years been involved in FDA’s stakeholder engagements and capacity building activities and has an in-depth experience as well as the knowledge in international and national regulatory requirements requisite for the effective conduct of clinical trials,” the release said.
The FDA further assured the public that it remained committed to protecting the health and safety of consumers. “It is hoped that data from this study may be useful to inform policy to be used for scientific judgments and opinions in relation to Covid-19,” it stated.
By Jamila Akweley Okertchiri