The National Drug Authority (NDA) has cleared the use of covidex, a local herbal medicine, in the treatment of viral infections, including COVID-19. 

NDA’s chief executive David Nahamya described their latest move in favour of covidex as partial clearance for treatment of viral infections.  
“Covidex has been notifi ed to be sold in licensed drug outlets for supportive treatment and management of viral infections, but not as a cure of COVID-19,” Nahamya said. 
He was speaking during a press conference at the Uganda Media Centre in Kampala yesterday.  

BRAIN BEHIND COVIDEX

Prof. Patrick Ogwang is the brain behind the innovation of covidex, a local herbal product that has proved to be controversial until it was cleared by NDA yesterday. 
Ogwang’s research is funded by the Government of Uganda and undertaken by Mbarara University of Science and Technology. 
The partial clearance follows back-and-forth measures against covidex, which somehow got onto the market before clearance from Uganda’s topmost authority on the use of medicine in the country.  

GIVING GO-AHEAD
Two weeks ago, NDA released a statement indicating that it had not authorised the production, sale, and use of covidex (manufactured by Jena Herbals Uganda Ltd).  
NDA subsequently engaged the innovators and an application for notifi cation was submitted on June 15, the initial assessments were scientifically done and response with further guidance was sent to the innovators within three days.  
On June 27, NDA received the answers from the innovators and a comprehensive assessment was undertaken, including inspection of the factory to assess compliance  with good manufacturing practices to ensure that the product is of good quality, safe and efficacious (effective). 
“After engagements, the innovators have removed unsubstantiated claims that the product treats and prevents COVID-19. It provides supportive treatment in management of viral infections,” Nahamya said.   
He also warned against self-medication, pointing out that herbal medicine should only be accessed through pharmacies and that it can only be used with guidance from medical professionals.
 NDA has granted covidex an approval based on initial assessment, published literature, and safety studies conducted by the innovator, according to Nahamya.  
“The product has been formulated from plants that have been traditionally used to alleviate symptoms of several diseases,” he explained.
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 claims of treatment.
As a standard procedure, NDA will continue to monitor the safety of covidex through post-market surveillance activities. NDA also appealed to the public to report any side-effects regarding the use of covidex on NDA’s toll-free line 0800 101 999.  
Nahamya also dispelled claims that NDA was frustrating local innovators dealing in herbal medicine by pointing out that NDA has in the last three years authorised over 190 local herbal products. 
NDA has also provided technical support through over 70 inspection of local herbal medicine manufacturers, according to Nahamya.   
He appealed to manufacturers, whose products have not been notifi ed, to engage NDA for assistance to have their products assessed. 
Nahamya also urged the public to follow the health ministry COVID-19 guidelines and standard operating procedures (SOPs) and always seek treatment from licensed health facilities.
According to NDA’s director, covidex does not cure COVID-19 but has been cleared for supportive treatment of viral infections.

“Covidex has been notified to be sold in licensed drug outlets for supportive treatment and management of viral infections, but not as a cure of COVID-19,” he said.  

Nahamya added that notifi cation is an initial approval granted to herbal medicines based on an evaluation of scientifi c data to confi rm the quality, safety, and efficacy of the drugs.  
Nahamya said covidex treats symptoms of COVID-19, such as flu and cough. 

“What we can evidently say is that we are approving the product as a supportive drug. We need further evidence. It can alleviate certain symptoms, such as fl u and cough,” he explained. 

About people who are exploiting others by selling the herbal medicine exorbitantly, Nahamya said the manufacturer has increased the capacity of manufacturing and that intending clients should not be worried about price. 

WHAT OTHERS SAY

In a meeting over the weekend, organised by Twaweza East Africa and the Ministry of Health at Hotel Africana in Kampala, covidex remained the elephant in the room.
  
Pamela Achii, the president of Uganda Pharmaceutical Association of Uganda, said covidex is a local innovation that should be supported and that the promoter should follow the necessary protocols.

Dr Grace Nambatya, the director of Research at the Natural Chemotherapeutics Research Institute, said the name covidex creates an impression that it is a cure for COVID-19. 

She also pointed out that one of the ingredients, Warbugia Ugandensis, is a known medicinal tree in covidex. 

However, she warned that there is a need to know how much of it is effective and for safe application.     

Abiaz Rwamwiri, NDA’s public relations manager, said an impression had been created that NDA is blocking local innovations, including covidex. “It is not true that we are blocking local developers. We have made attempts to engage Prof. Ogwang,” he said. 
 
DEMAND SHOOTS UP 

Meanwhile, moments after it was cleared, the demand for covidex shot up countrywide. 

Several people flocked pharmacies in search of herbal medicine, which is still scarce. In some parts of Kampala, a dose had shot up from sh3,000 a few weeks ago to sh50,000.

Eseza Olato, one of the drug sellers in Soroti,  said they stocked about 600 doses of covidex last week and these run out within three days.

She said although they were selling each piece at  sh12,000, one person was taking more than five. Some pharmacies had limited stocks and were selling it above the recommended sh10,000.

Additional reporting by Emmy Alomu