FDA approves first herbal medicine for Covid-19 clinical trial

The Food and Drugs Authority(FDA) has ratified a herbal medicine known as Cryptolepis Sanguinolenta for a clinical trial on Covid-19.

This was made known through a statement released by the FDA. It indicated that the medicine locally known as Nibima has been tested in the laboratories of Kwame Nkrumah University of Science and Technology(KNUST) and has some “clinical benefits” hence its approval.

Read the statement below;

“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 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 FDA Ghana is listed as a WHO “Maturity Level 3” Regulatory Agency, the second
country in the WHO African Region to attain this level in the four-tier WHO classification
of National Medicines Regulatory Systems. This level, the second within this
classification, indicates that Ghana’s medicines regulatory system is well functioning and
integrates all required elements to guarantee its stable performance, thereby ensuring
the safety, quality and efficacy of all medical products imported, exported, manufactured
or distributed in the country including the regulation of the conduct of clinical trials.

“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
(Sections 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 conducted at two sites.

“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 sites have adequate capacity to ensure the safety of participants as
well as produce credible scientific data.

“It is hoped that data from this study may be useful to inform policy or be used for scientific judgments and opinions in relation to COVID-19”.

FDA approves first herbal medicine for Covid-19 clinical trial