As the debate over the efficacy and safety of a local herbal drug, Covidex in the treatment of Covid-19 rages on, the Pharmaceutical Society of Uganda and herbal medicine experts have given their nod of approval despite objections from National Drug Authority (NDA).
NDA mid this month banned the use of Covidex, saying the developer, Prof Patrick Ogwang had not subjected it to the required trials and approvals. For a locally manufactured drug to be approved by NDA, it has to go through clinical trials among other requirements.
But Pamela Achii, the president of the Uganda Pharmaceutical Society, and Dr. Grace Nambatya, the director of research at the Natural Chemotherapeutics Research Institute say that while the herbal-based treatment has not been approved by the NDA, it has some ingredients to treat Covid-related infections and should not be wholly dismissed.
Achii said Saturday that the remedy has the berberine plant as an active ingredient and its effectiveness has been proven in Covid-19 studies done elsewhere. Berberine has also been used in treatments for diabetes and liver disease. As the Pharmaceutical society, she adds that they are supporting clinical trials of the drug to quickly start.
She added that on Friday they finished the required protocols to have authentication processes start since Prof Ogwang the innovator of the formulation has already applied for emergency use authorization.
"We have this herbal formulation called Covidex which of course we see that it has berberine, and berberine is active against Covid. The product has been formulated but for lack of a better word, this product we found it in the market and those who have used it have said they are getting healed in the situation where we don't have alternative medicine to cure this disease. So we had a moral dilemma and moral obligation; should you stop the manufacturer and use of this medicine because you have not had all the clinical trial processes done while there are people who are benefiting from this formulation?" said Acci.
Dr Nambatya said she had a 79-year-old patient battling Covid-19 in the Intensive Care Unit (ICU) and when she was given Covidex she suddenly and greatly improved. She however recommends that the remedy shouldn't be administered in the nose but rather through the mouth to throat since another herb known as Warburgia ugandensis in the formulation is sensitive to the membranes in the nose especially when someone is sick.
"We have a relative who has been in ICU and we're a big family, so people come with interventions and one of them came with Covidex. The proprietor [Prof Ogwang] was my staff member, I know him very well and I respect him, he has published, he has put things on the market and on the label at least one of the ingredients is Warburgia and I know it very well. Of course, there are some other plants, but once I saw Warburgia, I knew this must be effective. But now for me on this patient, what I noted this was a patient in ICU when it was put in the nose for this 79-year patient, it was really bad," said Nambatya.
She says there's inflammation in Covid-19 where remedies with peppery taste can be challenging especially if administered in the nose.
"In Covidex, there is inflammation and dryness, people talk of Covid but when you have been near a patient and your own there is that dryness of membranes, and I think if something has Warbugia and it is dosed into the membrane, Warbugia has a peppery taste for those who know the plant, you chew the plant and it has chilli. In the mouth, the patient felt fine and the patient improved. Maybe this dosage form should not be administered in the nose because of the dryness there," added Nambatya.
A 2018 paper titled A review on the botanical aspects, phytochemical contents and pharmacological activities of Warburgia ugandensis notes that the Warbugia has been for long been used as herbal treatment for stomachache, cough, toothache, fever, malaria, oral thrush, measles and diarrhea in African communities where the plant occurs including Malawi, Tanzania, South Africa, Uganda.
An updated 2019 paper notes that Warbugia has also been used in the management of pneumonia, asthma, malaria, candidiasis, skin infections, human immunodeficiency virus (HIV) opportunistic infections, diarrhea, and measles given the common use in the management of these diseases.
The South African Journal of Botany notes Warbugia is widely used in traditional medicine to treat coughs, colds, bronchial infections, oral thrush, cystitis and many other ailments.
NDA says that Prof Ogwang has submitted his application for the remedy to be notified, a process that can allow the product to be used under emergency use categorization even as clinical trials have not yet been done. He says so far, no natural product has been authorized to be used as a Covid-19 cure.
"The reason why NDA is in between the producer and the user is to ensure safety and if NDA has not come out to tell you this product now is verified for use in Uganda then you're using a product whose safety has not been ascertained by a body that is responsible for doing that. We have teams out there and I think if you went out there and said I want Covidex, you may not find ut on the shelf or you may not find it in pharmacies, it is on the black market and there are teams out there to ensure that this product is controlled," said NDA's Brain Sekayomba.
Sekayomba adds that Ogwang was asked to submit additional documents to support his innovation ten days ago but they since got no feedback from him. Normally, the product notification process takes about three months to be completed. Once this process is completed and no red flags are noted in the formulation, it will be allowed for use by the general public.
The experts were speaking during the launch of findings by Regional NGO Twaweza in their Sauti Za Wananchi, a mobile phone survey in which they captured Kampala residents' experiences and opinions on the use of herbal remedies.
In the surveys conducted from July to August 2020, and December to January 2021, they found close to half of the residents in Kampala believe drinking herbal combinations can cure Covid-19. Also, the findings show that three out of ten people believe steam inhalation cures Covid-19 whereas four out of ten believe that taking Vitamin C, a drug whose use among those on homecare for Covid-19 can actually cure the disease.
Overall, 50 per cent of the people surveyed wrongly believe that a person who doesn't show symptoms even when positive doesn't spread the disease, while 46 per cent believe hot climates prevent spread.
With such wide misconceptions and the fact that study findings show even in Twaweza surveys that are still being done that use of herbal remedies are on the increase, experts urged the regulators to expedite the process of its approval as it's very important especially now that there is no known cure yet for the viral respiratory disease.
According to data currently being collected in Kampala and Kyotera, Twaweza says already they are seeing herbal medicine use to shoot up to 31 per cent from 17 per cent last year.
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