Govt blocks Gulu varsity Covid drug

The National Drug Authority (NDA) has ordered Gulu University to cease production of Covilyce-1, a herbal medicine that the varsity developed to treat Covid-19, saying it has not yet been approved.

The statutory regulator’s directive comes a few days after the university scientists led by Dr Alice Veronica Lamwaka announced that 100 Covid-19 patients who used Covilyce-1 had recovered.

Dr Lamwaka reportedly made an appeal for Shs200m support to increase production due to soaring demand for the herbal medicine several of whose users testify that it works to treat the pandemic.

Nevertheless, Mr Abiaz Rwamwiri, the NDA spokesman, told Daily Monitor that the Authority had dispatched a team of its experts to northern Uganda to stop Gulu University from producing the medicine, citing safety and efficacy concerns.

“Our team is on the ground to stop the production of the drug and also to investigate where it is being produced because the university does not have a factory to produce the drug but they only have a laboratory,” Mr Rwamwiri said.

He said the NDA initially agreed with the university that after developing the formulation, samples should be submitted to the authority for scientific assessment.

Mr Rwamwiri said they were shocked to see the university declaring that the product was efficacious and could be used even before NDA approval.

“What we don’t agree with the university is that this product is used on anyone without [following scientific] study [protocol] because there are guidelines for trying the drug and we have not given any approval for the drug to be used outside the laboratory,” he said.

The spokesman added: “Ugandans should not be allowed to be used on a drug study without guidance since we can’t guarantee that (the drug) is safe. We are wondering how they did it because no one, not even the NDA authorized them to do that.”

Other stand-off

This is not the first stand-off between the regulator and a local Covid drug manufacturer.

NDA was last month entangled in a contest with Mbarara University lecturer, Prof Patrick Ogwang, the maker of Covidex, whom it accused of prematurely releasing onto the market his herbal cocktail that he, based on users’ testimonies, proclaimed as safe and efficacious in Covid treatment.  

 The statutory regulator argued that the scientist had not followed the protocol for drug development and approval, provided no supporting data, done no clinical trial and not disclosed the formulation of the medicine.

After days of Ping Pong, NDA issued a notification – a formal and tentative authorisation for use of the herbal medicine as supportive treatment – following President Museveni’s direct intervention, dramatically altering Covidex price from a pocket-friendly Shs3,000 to Shs10,000 before it jumped to Shs50,000 and Shs100,000 upwards.  

Like Prof Ogwang did in June, Gulu University’s Dr Lamwaka yesterday argued that there are clear testimonies from users that the medicine is safe and effective. She said she couldn’t see people dying of Covid-19 yet she has a remedy that works.

“As a university of research, our duty is to look at the efficacy and safety of herbs. There is a huge demand for herbs; so, we could not deny those who wanted to take the medicine. When the people know that something works, you cannot stop them,” she added.

Dr Lamwaka revealed that since January, the 300 herbalists they trained at the University’s Pharmaceutical Biotechnology and Traditional Medicine Centre of Excellence have been offering supportive therapy for Covid-19 in northern Uganda communities.

“The patients are the ones who are declaring it [testifying about their cure] and we still want to do clinical trials and more phytochemical analysis,” she said.

She, however, said although they have evidence that the medicine heals Covid-19 patients within 72 hours, the university has not come out officially to declare that they made a cure for the virus.

In the past several months, President Museveni has severally hinted that Uganda scientists, whom he did not name, were closer to finding a vaccine as well as treatment for the pandemic that has claimed millions of lives and disrupted livelihoods worldwide.

Mr Museveni imposed a second lockdown on June 18 following a steep increase in infections and deaths, which triggered an oxygen crisis at quickly overwhelmed hospitals, before the reported drop.

NDA faulted

In yesterday’s interview, Dr Lamwaka, who is also the principal of Pharmaceutical Biotechnology and Traditional Medicine Centre of Excellence at Gulu University, said the directive to stop production of Covilyce-1 was perplexing.

“NDA already knows we are using these herbs because they came to launch these products more than a month ago,” she said.

Uganda government’s main approach to the pandemic, besides locking down country as a way of dispersing populations and trumpeting public health messages, is to vaccinate some 21.9 million citizens with vaccines it does not currently have.

The dilemma has given appeal to discoveries by Uganda scientists who have positioned to solve a complex problem using local solutions instead of solely relying on jabs whose arrival in the country, amid stiff global competition, depends on manufacturers far off in Europe, China and the United States.

Dr Lamwaka yesterday said that NDA official are “aware and these (Covilyce-1) are products which are not harmful”.

“We know that chlorophyll is a very strong antioxidant, they also have macromolecule C, which is very good for lacing infections, causing it to collapse. Once it has collapsed, it means it can no longer continue multiplying in the person,” she added.

While opening the Makerere University-hosted World Health Summit Africa at Commonwealth Speke Resort Munyonyo in Kampala, President Museveni, in a diversion from his written speech, explained that many of Uganda’s notable scientists grew up upcountry where parents treated them using various herbs, some of which they are integrating to make supportive Covid treatment combinations.  

In a separate interview, Mr Michael Mutyaba, the head of the Traditional Medicines Division at NDA, when asked about the claims by Dr Lamwaka that the regulator was aware about Covilyce-1, denied any knowledge.

“I’m not aware of the packing or anything. But all medicines that should be sold to the public need to be approved by the NDA,” Mr Mutyaba said.

The university started packaging the herbs three weeks ago. However, the institution lacks a factory for mass production and it is short on finances too, officials said.

Meeting Museveni

Dr Lamwaka, who said she met President Museveni on Monday, revealed that they are facing financial challenges which are affecting their production to cover the whole country.

“We need about Shs200 million to carry out mass production. When the demand became high, we got some little money that we used for buying containers because some orders are coming from other districts,” she said.

Highly-placed sources intimated to this newspaper that the President, for unstated reason, asked Dr Lamwaka to stop media engagement.

Following a week of media blitz, security abruptly restrained Prof Ogwang from granting more interview.

About Covilyce-1

A group of more than 10 scientists at Gulu University have formulated Covilyce-1, an assortment of four different herbal medicines they claim cure Covid-19.

The drug comes in four formulas; Linctus (made from four plants), Covilyce-1 Powder (a combination of eight plants), Covilyce-1 Suppository (made from 3 plants) and Covilyce-1 Nasal drops (made from 6 herbs).

The researchers started using the concoctions of eight different herbs in January 2021, after doing phytochemical analysis on the herbs, to find out what active ingredients are present in them and what they could cure.

Covid-19 patients with mild symptoms enrolled on the nasal drops (in the mouth, ears and nose) recovered between 12-72 hours while those with nasal congestion and chest pain use the Linctus.

Patients with co-morbidities like hypertension, asthma, ulcers and diabetes, use a combination of Covilyce-1 powder, Linctus and Nasal drops that clears the infection in approximately 12 hours.

What it takes to get herbal medicine approved

Dr Grace Nambatya, the director of research at Natural Chemotherapeutic Research Institute of the Ministry of Health, said initial approval of herbal medicine takes three months.

“When you have a product [herbal medicine], you should bring the samples to us [NCRI which is at Wandegeya) for assessment on safety” she said.

Mr Joseph Muyanja, one of the government scientists who does assessment of herbal products before getting National Drug Authority Board (NDA) approval, said they test for specific plant chemicals which kill bacteria, fungi and 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 said.

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

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

She said a product can only be declared as a cure after completing clinical trials which used to take up to six years, but with the advent of Covid-19, trials for vaccines have been done in just about 1 year. 

Additional reporting by Abet Tonny