The Uganda National Drug Authority (NDA) has approved the use of a local herbal drug, Covidex as a supportive treatment in the management of viral infections including coronavirus disease (Covid-19).
Mid this month, NDA banned the use of Covidex, saying the developer, Prof Patrick Ogwang had not subjected it to the required approvals. For a locally manufactured drug to be approved by 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. NDA has been under intense pressure on social media - with several users giving 'testimonies' about how the treatment helped their Covid patients including those in the intensive care unit (ICU) to suddenly recover just moments after taking in a few doses.
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.
"NDA has granted Covidex 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.
Ogwang says his drug works and he is willing to follow all NDA recommendations. According to Ogwang, his product has been used by over 40 people both in the first and second waves who have fully recovered.
NDA says it will continue monitoring the use of the drug on the market. Dr Nahamya encourages users of the drug to get in touch with the authority in case they experience any side effects on their tool-free number 0800101999.
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 affordable at Shs 3,000 at retail, the drug on the open market now costs Shs 50,000 and Shs 25,000 on the black market.
If the drug undergoes randomized clinical trials and is tested on over 120 people, it could be a big breakthrough for Uganda as far as management of Covid-19 is concerned, especially during this second wave in which the country has 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.
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