The National Drug Authority has approved the use of Covidex as a supportive treatment in the management of viral infections.
Mid this month, the NDA banned the use of the drug saying the developer, Professor Patrick Ogwang had not subjected it to the required approvals. For a locally manufactured drug to be approved by the NDA, it has to go through clinical trials among other requirements.
The approval comes days after the drug authority cautioned the public against using the drug since it had not yet undergone necessary testing.
Dr David Nahamya, the Secretary NDA now says that the herbal drug is safe following an assessment of the drug and inspections of the production facilities.
He however emphasized that the drug as of now should not be sold as a treatment for COVID-19 since more clinical trials are needed to substantiate claims that it can treat the disease.
“NDA has granted C ovidex an approval based on initial assessment, 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 severe diseases. To further support the efficacy of the drug for other uses, the manufacturer is advised to conduct random controlled clinical trials to ascertain any claims of treatment,” Dr Nahamya said.
Prof Ogwang says his drug works and he is willing to follow all NDA recommendations.
According to Prof Ogwang, his product has been used by over 40 people both in the first and second waves.
The approval of the drug will most likely lead to an increase in the price. While Ogwang manufactured the drug so that it is easily accessible at 3,000 Shillings at retail, the drug on the open market costs 50,000 Shillings.
If the drug undergoes randomised clinical trials and is tested on over 120 people, it could be a big breakthrough for the country as far management of COVID-19 is concerned, especially during this second wave where the country have registered over 37,000 infections and 400 deaths.
On Saturday, Pamela Achii, the President of the Uganda Pharmaceutical Society and Dr Grace Nambatya, the Director of Research at the Natural Chemotherapeutics Research Laboratory said that while the herbal-based treatment has not been approved by the NDA, it has some ingredients to treat COVID-related infections and should not be wholly dismissed.
Achii said that the remedy has the berberine plant as an active ingredient and its effectiveness has been proven in COVID-19 studies done elsewhere. Berberine has also been used in treatments for diabetes and liver disease. She also said that as a society, she adds that they are supporting clinical trials of the drug to quickly start.