{UAH} Why NDA approved Covidex medicine
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Why NDA approved Covidex medicine
Wednesday June 30 2021
A customer buys Covidex from Pace Pharmacy in Ntinda, Kampala, yesterday after the National Drug Authority cleared it. PHOTO/STEPHEN OTAGE
Summary
- "A friend of mine got me Covidex. The drops are uncomfortable and intrusive but after 20 minutes, the congestion cleared," Tumushabe Sharon.
- "I was sceptical about this Covidex thing but it's actually working for me and my family… You have to be very careful where you get it from. There are a lot of fake ones on the market," Doreen Mbabazi.
- "Someone had flu but had tested negative for Covid. I gave him Covidex and he was fine within three days," Hillary Bamulinde
The National Drug Authority (NDA) yesterday gave Ugandans a green light to use Covidex, a locally-made herbal medicine, as a supporting treatment for Covid-19 and other viral infections.
This approval comes two weeks after NDA directed the manufacturer of the medicine to stop the sale until the authority approves it, citing safety concerns. The move triggered widespread public debate.
Addressing journalists at Uganda Media Centre in Kampala yesterday, Dr David Nahamya, the secretary to the authority, said after 14 days of engagement with the innovators and assessing the product, they decided to approve it.
"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 several diseases," Dr Nahamya said.
However, he added that the medicine does not cure Covid-19 but it can supplement the medicine health workers use to treat patients.
"We have advised the manufacturers to conduct random controlled clinical trials, which are the highest level of evidence to ascertain any claims of treatment," Dr Nahamya said.
He advised the public to only take the medication under guidance of a health personnel and report any side effects.
"We will continue to monitor the safety of Covidex through our post-market surveillance activities. We ask the public to immediately monitor any side effects of the product,' Dr Nahamya said.
Although the announcement attracted appreciation from Ugandans, a section of the public think approving the medicine was rush, and that this could have a serious consequence on Covid-19 response.
Mr Nshakira Rukundo, a researcher at the Institute for Food and Resource Economics at the University of Bonn in Germany, said it was wrong for the authority to bow to pressure and approve the medicine.
"How a drug pending clinical trials which haven't even begun is given authorisation for public use is beyond any sense of science and normalcy…. Here is what you [NDA] should have done: Stop the manufacturing of this medicine. Push the government to finance clinical trial independent of the manufacturers, conduct the study and wait for at least the first round of results," he tweeted.
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