Warning: Trying to access array offset on value of type bool in /usr/www/users/urnnet/a/story.php on line 43 Researchers Want Drug Regulators to Relax Approval Process for Covid-19 Herbal Treatments :: Uganda Radionetwork
According to the researchers, the time needed to carry out trials to get approvals is too long given the ongoing COVID-19 global pandemic. They argue herbs are part and partial of the African lifestyle and are safe.
Researchers
in herbal medicine want medicine regulators to relax approval requirements for
medicines being developed to manage COVID-19.
Before the National Drug
Authority-NDA approves a herbal drug for use, the manufacturer needs to present
at least two samples of the drug to the World Health Organization-WHO for
testing.
The researcher
also needs to provide a list of all used plants and during the trials, they
need to provide evidence that the drug is effective and does not lead to
life-threatening side effects. Normally, this process can take months or even
years to complete.
According to the
researchers, the time needed to carry out trials to get approvals is too long
given the ongoing COVID-19 global pandemic. They argue herbs are part and
partial of the African lifestyle and are safe.
Prof
Motlalepula Matsabisa, a South African based researcher on herbal medicine says
it is unrealistic for drug regulators to ask for many detailed research outcomes.
//Cue in;
"We need expedited...
Cue out...similar
pandemics."//
He says preliminary
research shows that herbal medicines produced locally on the market are
effective in managing COVID-19. Matsabiba says instead of frustrating ongoing
works, drug authorities should expedite approvals.
At the moment, 14
ongoing COVID-19 herbal remedies types of research are ongoing in Africa. These researches are taking place in Botswana,
Congo, Ghana, South Africa, Benin, Burkina Faso, DRC, Guinea, Madagascar,
Nigeria, Togo, Uganda and Ghana.
Uganda currently has
three products that are currently being used in the management of COVID-19.
Only one of the products, UVB-01N a proposed treatment is undergoing clinical
trials while the trials for Covidex and Covylice are yet to start.
Prof Patrick Ogwang, the
developer of Covidex says that the fees needed make it almost impossible for scientists
and researchers to carry out studies.
"Herbal medicine
works but when drug regulators start asking you for clinical trial data it
becomes hard because it is too expensive to carry out clinical trials. Many
herbalists can't carry them out because they do not have money. Over two
billion shillings is needed for someone to start a trial," he said.
However,
drug regulators insist that herbal medicines need to undergo all stages of drug
approvals like efficacy and safety studies to ensure that the products are not
adulterated or harmful to consumers.
Dr Michael
Mutyaba, the head of herbal medicines at the National Drug Authority-NDA says
it is important for all stages to be followed in the approval of drugs to
ensure they work and are not harmful to consumers.
"NDA has the
mandate to protect all Ugandans to make sure that the drugs they are using are
safe and will not cause them harm. We have streamlined this process to make it
easy for everyone," he said.
In June, the WHO expressed
concern over the use of herbal remedies such as COVIDEX to treat COVID-19 due
to a lack of safety and efficacy data. The NDA also issued warnings advising
Ugandans not to use the remedy because no studies had been carried out to show
how safe it was for clinical use.