NDA clears Covidex as a support drug in Covid treatment
Covidex has been cleared to be used as a supportive treatment in management of Viral infections but not as a cure of Cocid-19.
The NDA Executive Director while addressing journalists at the Uganda Media Center said “NDA has granted Covidex an approval based on initial assessment, published literature and safety studies by the innovator. The product has been formulated from herbal plants that have traditionally been used to alleviate symptoms of several disease.”
Covidex is a herbal medicine developed by Mbarara University scientist, Prof Patrick Ogwang, and manufactured by Jena Herbals Uganda.
Nahamya says after an engagement with the innovators, they filed for a notification and initial assessments were scientifically done and a response with further guidance was sent to the innovators with in three days.
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.
Nahamya says NDA received the answers on June 27 and a comprehensive was undertaken including a an inspection of the factory to assess compliance with good manufacturing practices to ensure that the product is of good quality safe and efficacious.
He says after engagement the innovator have removed unsubstantiated claims that the product treats and prevents cCobid-19 and revised it to supportive treatment in management of viral infections.
NDA will continue to monitor the safety of Covidex through post market surveillance activities.