The World Health Organization has expressed concern about Uganda's approval of a locally made herbal treatment for COVID-19 amid a third wave of cases.
The WHO has not approved the substance for COVID-19 treatment, but Ugandan pharmacists say they have little choice because drugs authorized for emergency use in developed countries are not available.
Uganda’s drug authority said Tuesday that it had approved the herbal medicine, Covidex.
Dr. David Nahamya, executive director of Uganda’s drug authority, said the approval followed a two-week scientific evaluation of the medicine's safety and efficacy.
“Covidex has been notified to be sold in licensed drug outlets for supportive treatment in management of viral infections but not as a cure of COVID-19,” Nahamya said.
The WHO consulted researchers from nine African countries, including Uganda, in March about the use of traditional medicine to treat COVID-19, the disease caused by the coronavirus.
Dr. Solome Okware of the WHO’s Uganda office said Covidex wasn’t among the traditional medicines that were evaluated.
“WHO has not received any information about this product,” Okware said.
Bases for approval
Nahamya reassured Ugandans that the manufacturer, Jena Herbals Uganda, had increased production and that the herb would be available for all who needed it, under medical supervision.
He added that the approval was based on initial assessments, published literature and safety studies conducted by the innovator.
“The product has been formulated from herbal plants that have been traditionally used to alleviate symptoms of several diseases," Nahamya said. "To further the efficacy of the drug for other uses, NDA [Uganda's National Drug Authority] has advised the manufacturer to conduct random controlled clinical trials, which are the highest level of evidence to ascertain any claims of treatment.”
Okware said that in collaboration with the Africa Centre for Disease Control and Prevention, the WHO developed master and generic protocols to provide guidance to members for developing clinical trials to assess claims of effective treatment for COVID-19.
“Many plants and substances are being proposed without the minimum requirements and evidence of quality, safety and efficacy," Okware said. "The use of products to treat COVID-19 which have not yet been robustly investigated can be harmful if the due process is not followed.”
Dr. Samuel Opio, secretary of the Pharmaceutical Society of Uganda, said that while there were concerns about misuse of Covidex by the public, its approval was a positive step.
"Whatever is currently being approved [for] emergency use in the U.S. are not available in Uganda," Opio said. "So the issue of lack of a treatment, the issue of inaccessibility to even what is approved for emergency use, means that we need to also look for local solutions to the global challenges, and herbal treatment is one area.”
Uganda recently received 175,000 doses of AstraZeneca vaccine but is inoculating only frontline workers. With just 856,025 people vaccinated in the country, many members of the public have resorted to using Covidex to treat COVID-19 symptoms.