The National Agency for Food and Drug Administration and Control (NAFDAC) has denied granting recognition to the herbal drug developed by the Afe Babalola University, Ado-Ekiti ((ABUA) for the treatment of COVID-19.
The agency’s Director General, Prof. Mojishola Adeyeye who stated this during an interview on ‘The Morning Show’ monitored on Arise News Channel yesterday, explained that what NAFDAC granted the university was approval for listing.
According to her, “What NAFDAC does is to do a listing approval first. The listing approval is about safety of the medicine not its efficacy. This means that if a patient takes the medicine, there will not be toxicity that would threaten the life of the patient.
“So when we got the application in May last year, we sent what we call compliance directive, meaning what you should do and should not do.”
She further explained that in the case of Afe Babalola University, the agency got an application from the university authorities in May, 2021 in relation to its drug and after subjecting it to pre-clinical stage test, approved it for listing as safe for consumption.
She said one of the things that NAFDAC usually pays attention to for herbal medicines was the claim of efficacy.
“So what we did was to say remove treatment or cure of coronavirus from the label. We told the university that the herbal drug can only be effective as an antioxidant and immune booster.
“We also said they should remove anti-inflammatory problem and they complied because they corrected all the areas and in December, we then approved,” she said.
She said the university has complied with NAFDAC’s directive and has re-submitted it application.
Adeyeye, however stressed not labelling the herbal medicine with a claim of efficacy against COVID-19 does not mean that it cannot be active against the virus.
The DG said the listing approval was considered by all the members of the technical committee before granting it approval.
Adeyeye said drug development passes five stages of approvals – the preclinical, then three phases of clinical trials and the then the post-marketing phase, saying, “which is what we have now for COVID-19 vaccines.”
She added that for herbal medicine which has been in use locally for decades, phases one and two were collapsed together so that instead of going through many phases, it will just move to phase two.
Adeyeye further said anyone seeking to carry out clinical trials in Nigeria must submit an application to NAFDAC and to the National Ethics Committee domiciled in the Federal Ministry of Health for approval. – Thisday.
