Coronavirus herbal medicine : We have a mandate to authorise clinical trials - FDA

The Food and Drugs Authority (FDA) boss, Mrs Delese Mimi Darko has stated that as a Regulatory body, the Authority has the mandate to authorize the clinical trials of all medications when necessary.

This comes after the Ghana Federation for Traditional Medicine Practitioners said the association is unaware of the herbal medicine that has been approved by the FDA for a clinical trial on the coronavirus treatment in Ghana.

Herbal medicine, Cryptolepis sanguinolenta, locally known as Nibima has been approved by the FDA and the National Medicine Regulatory Agency (NMRA) in Ghana for clinical trials.

Speaking on Atinka TV’s morning show, Ghana Nie, hosted by Ekourba Gyasi Simpremu, Mrs. Delese Mimi Darko admitted that the FDA has authorized a pre-trial of the medications locally manufactured for the treatment of COVID-19.

Reacting to allegations by Ghana Federation for Traditional Medicine Practitioners that it is unaware of the herbal medicine that has been approved by the FDA, Mrs. Delese Mimi Darko said it has the power to investigate and approve all kinds of medicines per the Constitution.

“We have approved of a clinical trial pending research by Researchers from KNUST to know if we can use the medicine to treat covid-19. Authorization of the clinical trial is solely the mandate of the regulatory authority, and so they don’t have to know of any clinical trials. Clinical trials has a lot of confidential information, but if they need an information they can go to the researcher and ask for that information,” she said.

Mrs Delese Mimi Darko added,” But as a regulatory authority, our mandate under part 8 of the Public Health Act, Section 150 to 166 gives us the power to authorize clinical trials. And so we are not at liberty to inform any other body except the researcher and ethics to know about this…”