National Drug Authority in Uganda has licensed Covidex as supportive treatment in management of viral infections including Covid 19 in the country.
Abiaz Rwamwiri National Drug Authority Public Relations Manager confirmed to media at Uganda Media Centre in Kampala.
“National Drug Authority informs the public that after a record time of 14 days of engagement with the innovators and assessment of the product information, Covidex has been licensed and should be sold in drug outlets. The product should be used under the guidance of professional health worker,”Rwamwiri said.
Rwamwiri however says NDA has granted Covidex an approval based on trial assessment, published literature and safety studies conducted by the innovators.
” The product has been formulated from herbal plants that have been traditionally used to alleviate symptoms to several diseases. To further support the efficacy of the drug for other uses. NDA has advised the manufacturer to conduct random controlled clinical trials which are the highest level of evidence to ascertain any claims of treatment, “he explained.
NDA however will continue to monitor the safety of Covidex through post market surveillance activities.
” NDA remains committed to ensuring that all drugs imported, produced and sold in Uganda are of good quality, safe and efficacious as way of safe guarding public health as empowered by the National Drug Policy and Authority Act cap 206,” he added.
NDA introduced comprehensive herbal medicines guidelines for local herbal medicine manufacturers to improve the quality of their products. So far NDA has authorised over 190 local herbal products and provided technical support through over 70 inspection of local medicine manufacturers.
On 14th June NDA released a statement notifying the public that it had not authorized the production, sell and use of Covidex manufactured by Jena Herbals Uganda limited.
He said NDA engaged with innovators and an application for notification was submitted on June 15th while Initial assessment 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 efficious.
After engagement, 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.
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