Gulu varsity rejects NDA conditions on Covid drug

Gulu University has rejected the National Drug Authority (NDA)’s demand for full disclosure of botanical names of plants used in making Covilyce-1 as one of the requirements for approval.

Covilyce-1 is a new herbal medicine developed by a group of scientists from Gulu University and is said to be effective in the management of Covid-19. 

The scientist say their medicine has so far “cured” 100 people before clinical trials.

A highly placed source at the university, who attended the closed-door meeting between NDA officials and the university scientists on Tuesday, but requested not to be named, said NDA asked the Covilyce-1 developers to disclose the plants they used to make the medicine,  and the formulation process.

According to the sources, NDA wants the university to declare the contents of the drug by naming the details of each plant, as well as declare how they formulate it so that they are sure of the product being made.

Another source told Daily Monitor that the NDA team also queried the packaging and production process of the drug and asked the university to make amendments before they can formalise production.

When contacted, Dr Alice Lamwaka, the lead developer of Covilyce-1, confirmed that NDA has set for them those conditions.
“But we told the team we cannot name the plants because Covilyce-1 is still a lab-based product, which is not officially in the market,” Dr Lamwaka said.

“We withheld the botanical names of plants used in formulating Covilyce-1 but we accepted to only name the active ingredients and what parts of the plants have been used to develop Covilyce-1,” Dr Lamwaka added.

However, Mr James Onono, the university spokesperson, who also attended the meeting, said they agreed to submit the application to NDA for Covylice-1 approval but that they will not reveal names of the plants.

NDA said the university has confirmed to them that the product was still under lab research and tests, and that “before we notify a product, it shouldn’t be used as we can’t guarantee its safety.”

On Tuesday, the authority stopped the innovators from trading in the drug on grounds that it was still under research and development.

Mr David Kaggwa, the NDA regional manager for northern Uganda, said they are hopeful the university will adhere to the directives from NDA.

He said the intervention by the authority was not to block the scientists at the university from progressing with their research but help them produce a better and safer product.

“We went with instructions to guide them to formalise the process of making the herb. The university is an institution which is reputable and recognised with experts and they have the raw materials. So, we believe they can do the right thing and work with the NDA,” he said.

Covidex case
Mr Abiaz Rwamwiri, the NDA spokesperson last month also complained that Associate Prof Patrick Ogwang, the developer of another Covid-19 drug, Covidex, had not given them some important information in the application for medicine approval that he had submitted.

Although Mr Rwamwiri didn’t specify what Prof Ogwang left out, people close to Prof Ogwang said NDA wanted Prof Ogwang to disclose deep details about his product including plants used. 

The Covidex developer said he sought President Museveni intervention at some point before his product was approved.
Covilyce-1 was developed by a group of more than 10 scientists from the faculty of Biotechnology and Pharmaceutical Studies (Pharm-Biotech). They started production of four different concoctions, which they said they have been administering to Covid-19 patients in the community since January.

Background
Early this week, Dr Alice Lamwaka, the faculty’s dean appeared in the media to declare that the university had successfully made a herbal drug that can cure Covid-19 in 72 hours.

However, the declaration sparked a quick reaction from the country’s drug regulator (NDA), who said Covilyce-1 was being traded illegally and ordered the university to cease production pending formal approval.