NDA, public split over Covidex herbal medicine

With vaccines in short supply and Covid-19 infections soaring daily, and hundreds being hospitalised or killed by the virus, the public is frantically searching for remedies to boost immunity or fend off the mass killer disease.

But there is sharp split of opinion on whether herbal medicine is the best option to quickly fix the infections and deaths.

While scientists say the best option to stop the pandemic remains a vaccine, enough of it won’t be available soon to save the 21.9 million Ugandans who the government says need it.

In light of this scarcity, many have come to see Covidex, marketed as a novel ‘Covid cure’, as a quick treatment to stop their panic and death from Covid-19.

The drug, made by Mbarara University scientists led by Prof Patrick Ogwang, had filled up drug stores and are selling out so quickly and in large quantities.

However, on June 14, both the National Drug Authority (NDA) and Mbarara University of Science and Technologhy (MUST) issued statements banning the use of the drug.

Each of the small 20mls bottle was being snatched up at between Shs20,000 and Shs30,000, but soon after the ban, the prices soared to Shs50,000.

Covidex was being touted as both curative and preventive treatment for Covid-19.

Currently, lucky buyers can only secure supplies by contacting someone who knows another who had bought off some good quantities of the drugs.

But lists of drug stores in Kampala, Entebbe, Wakiso and Mukono stocking the throat and nasal drops are being widely shared on social media.

Quick supplies of the drug upcountry also still continues.

But as the quick-fix drug became more popular, NDA, MUST, and the Pharmaceutical Society of Uganda, were drawn into a fight over production and sale of Covidex.

So why should these entities fight over what the users say is an effective drug that is saving them from Covid-19 infections and deaths?

Why are the entities feuding instead of collaborating to quickly evaluate and improve the home-grown herbal medicine to stop Covid?

NDA was the first to move, stopping the drug outright on June 14, with the national drugs regulator saying it had not yet approved the Covidex herbal medicine.

It warned the public “against use of products [including Covidex] on the markets purporting to treat Covid-19 that are not authorised by NDA.”

Then followed Mbarara University through Vice Chancellor, Prof Celestino Obua, who issued the statement, terming as “illegal production, distribution, and sale of Covidex.”

The university claimed the drug was its own, and not of Dr Ogwang. It said “the product was leaked to the market before going through all the required procedures.”

The university then asked the public “to be patient and allow this product undergo all necessary procedures ….lab tests, animal tests, clinical trials, production agreements, certification, registration and licensing before it can be put on the market for sale.”

The university said it had absolute rights over Covidex and warned that no one should deal with anyone, except the university, regarding the drug.

Finally, the university warned Jena Herbals Ltd “to stop any production, distribution or sale of Covidex without permission of Mbarara University.”

Prof Ogwang is the proprietor of Jena Herbals Uganda Ltd.

Perhaps bowing to pressure, Prof Ogwang, on the same day, wrote that he had met with NDA and “agreed that no treatment claims be made on [Covidex] until the clinical trials results are obtained. NDA also advised me to change the product name to avoid using a word related [to] ‘Covid’, and I have taken their advice positively.”

But the Pharmaceutical Society of Uganda were clear that Covidex was being developed by Dr Ogwang in the management of Covid-19.

It said “efforts by Prof Ogwang to develop Covidex for the management of Covid-19 need to be applauded considering that no proven cure for Covid-19 has yet been established globally.”

The society praised Prof Ogwang as a renowned researcher in herbal medicine, who has served them with distinction, both as treasurer and president.

The society also argued that many of the current conventional drugs were originally sourced from plants, in effect saying just as is Covidex.

In sum, the society said there is no proven cure for Covid-19, implying herbal medicines deserve being given equal treatment and chances as are other biomedical drugs, since all are being used on trial basis.

But the restrictive actions by NDA and Mbarara University have triggered mixed reactions, with many Ugandans saying halting production and sale of Covidex is depriving them access to life-saving natural product for Covid-19 treatment.

Indeed, the developers claim Covidex had successfully undergone laboratory tests, and was being sold across the country as a novel “Covid cure” from locally available medicinal plants. The developers also say many Covid-19 patients have since recovered after using Covidex.

But since being put under pressure by NDA and Mbarara University, Dr Ogwang has since said: “Only a few people have used it [Covidex] so far to relieve their symptoms of Covid-19. This, therefore, needs more proof that it works against Covid-19.”

But the mixed reactions from the public are unsurprising given that between 70 and 80 per cent of Ugandans rely on herbal medicine for healthcare, according to World Health Organisation (WHO).

But many cases of adulteration of herbal medicine have also increased safety concerns among some users.

Some Ugandans think blocking Covidex is a manifestation of centuries of monopoly of healthcare sector by large pharmaceutical companies which will do everything to suppress small developers of alternative medicines.

“What is happening to Covidex is a battle of science, economics and politics,” Mr Lawrence Taremwa, a pharmacist wrote on Twitter on June 14, after NDA halted production of Covidex.

Dr Anthony Kakooza, an intellectual property law expert, says herbal medicines developers in Uganda such as Covidex cannot go far because of century-long agenda by petrochemical dealers to destroy the traditional medicines industry.

He says suppression of traditional medicines dates back to the early 20th Century when the brain behind America’s pharmaceutical industry, Mr John D. Rockeffeller, set out to undermine herbal medicines.

He says Mr Rockeffeller’s agenda has persisted to date and that he achieved it by winning loyalty of medical institutions and hospitals.

“His intention was to grow commercial support for his petrochemicals (oil) which could be patented and sold for high profits in the pharmaceutical industry....Rockefeller’s plan, therefore, in outwitting competition from traditional medicine, was to financially influence medical colleges and hospitals away from following traditional medicines to following patented drugs [pharmaceuticals],” he said in a write up.

To achieve this, Dr Kakooza argues that Mr Rockefeller channelled money to universities to study special chemicals in medicinal plants that kill infectious agents.

“The big and powerful institutions that control the pharmaceutical market globally may not warm up to Covidex,” he warns.

But Dr Grace Nambatya, the head of research at Natural Chemotherapeutics Research Laboratory (NCRL) of Ministry of Health, who is also an NDA board member for herbal medicines, says complains about suppression from major pharmaceutical companies are only excuses.

She says Prof Ogwang receives support from both the government and World Bank to do his research on herbal medicine.

Dr Nambatya is the lead developer of UBV-01N, another Covid-19 herbal medicine whose clinical trial at Mulago hospital was launched by President Museveni in January.

The trial was affected by low numbers of patients to be tested between January and April, according to information from Mulago hospital.

But President Museveni, while announcing the new lockdown measures to contain the second wave of Covid-19 last week, said: “We’re working on our own vaccines, which will be better than all these [Western vaccines]. I also have my own line of therapeutics …but now the patients are plenty, and 70 have been tried on, and 58 have recovered. They [Ugandan scientists] now say by [June] 25, they will have covered the number required [for human trial]. We shall get our own solutions.”

It was not clear whether President Museveni was referring to Covidex or the other lines of drugs being developed.

But Prof Ogwang, following NDA and Mbarara University statements, said in a public statement: “Clinical trials that prove a medicine is effective [against a disease] has not yet been done [for Covidex] due to funding limitations, but President Museveni talked to me and [has] given me all the support we need to do more work on Covidex. I have linked up with the Pharmaceutical Society of Uganda and other scientists at MUST to carry out clinical trials so that we may know whether it is beneficial or not.”

Dr Nambatya, however, admits that support for developers of herbal medicines in the country has largely been low until the onset of Covid-19 pandemic.

But other Ugandans think the action by NDA against developers of Covidex is because the government does not trust locally developed products.

“Can NDA avail evidence of clinical [efficacy] of Covid vaccines because it looks like a failed scheme as those who got vaccinated still suffer severely from the disease. African governments can back up anything forwarded by foreigners but they cannot rely on their own innovations,” another netizen who identifies himself as Fred wrote on twitter on June 14.

Dr Juuko Ndawula, the director of the International Institute of Alternative and Complementary Medicine in Uganda, who holds a PhD in natural medicine, says there is clear evidence that herbal medicines work.

He says since the outbreak of the coronavirus pandemic, he has been treating many Covid-19 patients in Uganda, Rwanda, Tanzania and other African countries.

Dr Juuko, who accepts that herbal medicines should undergo clinical trial, says up to 90 per cent of Covid-19 patients he has treated got cured. However, he says it does not make sense for government to ask herbalists to do clinical trials for herbal medicines obtained from ginger, tea and other medicinal plants that people have been using for ages.

He argues that a clinical trial is meant to determine safety and efficacy of a drug.

“We have known about the viruses, bacteria and fungi that cause diseases to people. The medicines we have for treating other viral diseases are very effective against Covid-19. You just have to use a combination because Covid-19 is a bit hard to treat,” he said.

The natural medicine expert says they face opposition from large pharmaceutical companies who want to keep Africa on the market side of the pharmaceutical economy and not the production side.

But Dr Jane Ruth Aceng, the Health minister said on Friday that the action against Prof Ogwang was to protect public health.

She, however, acknowledged that “all our drugs come from herbs and plants,” but that before a medicine is availed to the market, it must be approved.

But some Ugandans also applauded the move by NDA, saying the drugs regulatory authority was simply executing its mandate.

Mr Nimrod Kimmanje, a pharmacist, says it was unthinkable that Prof Ogwang, a former head of Pharmaceutical Society of Uganda, would start advertising a product [Covidex], which is not yet approved.

“I think the professor undermined the pharmacy profession. How can a pharmacist put a product on market yet it is not registered by NDA? What happened to following the National Drug Policy and Authority Act? And how is that a good example to other herbalists (non-pharmacists) who make claims about their product?” he wonders.

But NDA in its June 14 statement also said they will work with Prof Ogwang and his team to make sure the approval processes are followed.

“This morning, NDA met with a team from Jena Herbals (U) Ltd led by Prof Ogwang and have agreed to follow the necessary processes as per NDA Act cap 206,” NDA said in its June 14 statement.

The Pharmaceutical Society of Uganda said they have set up a special taskforce to help Prof Ogwang fulfill technical requirements so that the medicine can be approved.

Prof Ogwang is pharmacist by profession and he has majored in herbal medicines research, a field where he developed several other herbal medicines which were approved by NDA and are being sold in the country.

Prof Ogwang’s other products include Artavol and Artavolplus for malaria prevention, Jenacof for coughs and flu, and jenacid for ulcers, among others.

Many herbalists and herbal researchers, including those at Makerere University and Gulu University, have said they have developed or are developing a medicine for Covid-19.

Mr Joseph Muyanja, an ethnobotanist at the Department of Plant Sciences at Makerere University, says they have developed medicines to support or protect people from Covid-19.

He says they have products such as immune-plus, eucalyptus oil for steaming and cough cure for chest decongestion.

“Steaming with water that contains eucalyptus oil clears airways and removes excess mucus. The product has proven anti-bacterial and anti-viral effects,” Mr Muyanja, who is undertaking a Master’s degree in medicinal plants at the university, says.

But many medical experts are decampaigning steaming, citing complications that can arise, especially when people use very hot water.

Procedure

What it takes to validate herbal medicine in Uganda

Dr Grace Nambatya, the head of research at Natural Chemotherapeutics Research Laboratory (NCRL), who is also on the NDA board, says for a product to be validated and allowed on the market, it must complete the approval process, which takes about three months.

“When you have a product [herbal medicine], you should bring the samples to us (Natural Chemotherapeutics Research Laboratory) for assessment on safety,” she says.

Mr Joseph Muyanja, an ethnobotanist at the Department of Plant Sciences at Makerere University, who also assesses herbal products, says they analyse the herbal medicine for specific plant chemicals, which kill bacteria, fungi or viruses.

“The phytochemical tests [assessing plant chemicals of medicinal value] costs around Shs100,000. After this, the toxicity tests are done to ensure the product is not harmful. This requires around Shs150,000, the developer should buy laboratory animals [guineas pigs or rats] where the product is tested on,” he says.

Dr Nambatya says after successfully completing the steps, NDA verifies the results and validates the product so that the developer can proceed to do mass manufacturing and sales.

She, however, warns the developers not to use the word “cure” but talk about their products as “supplements” as the law requires.

Prof Celestino Obua (Mbarara University Vice Chancellor)

The product [Covidex] was leaked to the market before going through all the required procedures. The public should be patient and allow this product undergo all necessary procedures, including lab tests, animal tests, clinical trials ... before it can be put on the market for sale.

Dr Anthony Kakooza (Intellectual property law expert)

Herbal medicines developers in Uganda cannot go far because of century-long agenda by petrochemical dealers to destroy the traditional medicines industry. Prof Ogwang has a multiplicity of barriers to deal with in pursuit of intellectual property rights for Covidex.

Dr Grace Nambatya (Head of research at Natural Chemotherapeutics Research Laboratory)

The issue of suppression [of herbal medicine] is an excuse. We are funded by government to do the work. Prof Ogwang receives support from both the government and World Bank to do his research on herbal medicine.

Dr Juuko Ndawula  (director, International Institute of Alternative and Complementary Medicine in Uganda)

...it does not make sense for government to ask herbalists to do clinical trials for herbal medicines obtained from medicinal plants that people have been using for ages. A clinical trial is meant to determine safety and efficacy of a drug.

Dr Jane Ruth Aceng (Health minister)

We appreciate such innovations [like the one by Prof Ogwang’s Covidex herbal medicine] that are coming up. The innovation needs to follow approval process to the dot so that by the time the medicine is coming to the market, we are sure we are not putting anyone’s life in danger.

Nimrod Kimmanje,  (Pharmacist)

I think the professor undermined the pharmacy profession. How can a pharmacist put a product on market before it is registered by NDA? What happened to following the law? And how is that a good example to other herbalists (non-pharmacists) who make claims about their product?”

Anthony Mugisha, (Professor of Veterinary Sciences & Socio-economics at Makerere University)

I can attest he is an accomplished research scientist in natural products. I think Prof Ogwang should by now be under [State] protection. He is a national asset. He could be one of the solutions to Covid and also an avenue to rake into the forex we badly need”

Social media user Fred wrote on twitter on June 14 

Can NDA avail evidence of clinical [efficacy] of Covid vaccines because it looks like a failed scheme as those who got vaccinated still suffer severely from the disease. African governments can back up anything forwarded by foreigners but they cannot rely on their own innovations.”

Background

Patrick Ogwang: Professor in the eye of Covidex storm

Prof Patrick Engeu Ogwang is a senior lecturer in the Department of Pharmacy at Mbarara University of Science and Technology (MUST).

He is a practising pharmacist who formerly served as president of the Pharmaceutical Society of Uganda. 

Upon graduating with a Bachelor of Pharmacy, Ogwang worked with the Natural Chemotherapeutics Research Institute (NCRI), Ministry of Health, where he progressed to the level of research officer.

Ogwang continued onto PhD under a regional multi-institutional project on Natural Products called ARISE-AFNET where colleges of Health Science and that of Veterinary Medicine, Animal Resources and Biosecurity- Makerere University and other institutions in Tanzania were active partners.

Ogwang’s research project for PhD was on using Artemesia (a medicinal plant) as a preventive measure against malaria among the workers on one of the flower farms on Entebbe Road.

Ogwang left NCRI to work as a lecturer at MUST, where he, along with other experts, started Pharm-Biotechnology and Traditional Medicine (PHARMBIOTRAC) to further research and development of herbal medicines in Uganda. The initiative has received huge support from the World Bank and the government of Uganda.