The Food and Drugs Authority (FDA), and the National Medicine Regulatory Agency (NMRA) have approved a herbal medicine Cryptolepis Sanguinolenta, locally known as Nibima for clinical trial as a potential treatment for coronavirus disease (COVID-19) in January 2021.
According to the FDA, in search of a treatment for the COVID-19 pandemic, a research team 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 was contained in a press release signed and issued by the Chief Executive Officer of the FDA, Mrs Delese Darko, who said the trial followed a result from laboratory studies conducted by the KNUST research team which points in the direction of possible clinical benefits.
She said the FDA Ghana is listed as a World Health Organisation (WHO) “Maturity Level 3” Regulatory Agency, the Second country in WHO Africa 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 medicine regulatory system is well functioning and integrates all required elements to guarantee its stable performance thereby ensuring safety, quality and efficacy of all medicinal products imported, exported, manufactured or distributed in the country, including regulation of the conduct of clinical trials,” she added.
The CEO stated that the FDA, after detailed assessment of the application, gave requisite regulatory authorisation for the conduct of the trial 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 medicines products, cosmetics or medical devices.
She said the trial would be conducted at two sites.
Mrs Darko said the research team has over the years been involved in the FDA’s stakeholder engagements and capacity building activities and has an in-depth experience as well as the knowledge in international and national regulatory requirement requisite for effective conduct of clinical trials.
She said the sites had adequate capacity to ensure the safety of participants as well as produce credible scientific data.
“It is hoped that data from this study be useful to inform policy or be used for scientific judgement and opinions in relations to COVID-19,” she added.
She assured the public of FDA continuous commitment to protect the health and safety of consumers, adding that the public should report any suspicious activity on FDA regulated products to the Authority.
