The National Drug Authority (NDA) informs the public that after a record time of 14 days of engagements with the innovators and assessments of the product information, 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.
The product should be used under the guidance of a professional health worker. Notification is an initial approval granted to herbal medicines based on evaluation of scientific data to confirm the quality, safety and efficacy of the drug and inspection of the factory for good manufacturing practices.
As you are all aware, on June 14th 2021, NDA released a statement notifying the public that it had not authorized the production, sell and use of Covidex (manufactured by Jena Herbals Uganda Ltd) that had claims of preventing and treating COVID-19. NDA engaged with innovators and an application for notification was submitted on June 15th, initial assessments were scientifically done and a response with further guidance was sent to the innovators within three days!
NDA received the answers on June 27th and a comprehensive assessment was undertaken including an inspection of the factory to assess compliance with good manufacturing practices to ensure that the product is of good quality, safe and efficacious. After engagements, the innovators have removed unsubstantiated claims that the product treats and prevents COVID-19 and revised it to supportive treatment in management of viral infections.
The National Drug Authority 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 several diseases. To further support the efficacy of the drug for other uses, NDA has advised the manufacturer to conduct random controlled clinical trials.
