COVID-19:NAFDAC, Herbalists, Scientists Disagree Over Herbal Medicines Registration Procedures

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Towards the production of safe natural medicines for the treatment of COVID-19, and other ailments in Nigeria, herbal medicine practitioners, under the umbrella of National Association of Nigerian Traditional Medicine Practitioners (NANTMP) have objected to the subjection of their formulations to the same clinical trial procedures as of orthodox medicines, claiming most of their active ingredients are food items.

The herbal practitioners and researchers, among whom were Prof. Maurice Iwu, professor of Pharmacognosy and CEO Bioresources Development Group; Dr Robert Uzu, CEO Ruzu Herbal Medicines; Dr Akintunde Ayeni, CEO Yemkem Int’l, Dr Ben Amodu, herbal farmer and researcher; Pharm.(Hajiya) Zainab Sheriff, former CEO of Nigerian Medicinal Plants Development Company, NMPDC, and others bared their minds during a virtual stakeholders meeting organised by the National Agency for Food and Drug, Administration and Control (NAFDAC) on Thursday.

NAFDAC DG, Professor Moji Adeyeye, the convener of the conference had expressed the concerns of the agency towards various claims put forth by herbal practitioners regarding the efficacy of their products, especially during the COVID-19 pandemic, saying that an herbal preparation can treat symptoms, does not mean it can cure the ailment.

Adeyeye, who maintained the position of the agency on safety of the populace, said for any herbal preparation to be listed as a treatment for Coronavirus, it must past some tests such as the “toxicity, expiration date, microbial content, trademark test, and others, while it also has to undergo clinical trials”.

She said: “Anyone that claims to have a preparation for COVID-19 must have got his product listed by NAFDAC. When it comes to medicines efficacy, we don’t want to subject people to undue danger, unless the herbalist can proof beyond doubt that the product is very safe.

“We have guided the Lagos State Government a great deal, as it regards to clinical trials, as they had to get guidelines from the hospitals they were using for treatment”, she stressed.

In his own contribution, the Director General, National Office of Technology Acquisition and Promotion (NOTAP) Engr. Umar Buba Bindir, stated that the interest of his institution is to have safe products, that are not limited to use in Nigeria alone, but that can be sent abroad for the verification of its efficacy.

And for this to take place, he said, it requires the collaboration of everyone including herbalists, scientists, regulatory agencies, and governments at all levels.

Reacting to the NAFDAC DG’s point on clinical trials for natural medicines, Dr Amodu raised an observation on the need to boycott protocols and safe lives, as many are in need of their formulations in the country and even African to overcome COVID-19. “We need to cut off protocols at this time and safe lives. Many people need our help in Nigeria, African and the world”.

Also speaking in the same vein, Prof. Iwu said the situation in the country and in the world calls for special attention, as it is a warlike scenario. “We are in a war situation, registration guidelines can be abridged, and clinical trials are very expensive for herbal medicine practitioners to conduct”.

For Dr Uzu, who claimed his listed product is already being used to treat patients with positive results, the NAFDAC boss told him he is already in the clinic trial process, but he will need to get ethical clearance from the facilities he is using for the trial.

The NAFDAC Director of Drug Evaluation and Research, (D/DER) Dr Nwankwo highlighted the procedures for clinical trials stating that the use of one to three centres must obtain ethical clearance from institutions ethics committee, while trials that will be conducted at more than three centres will require clearance from National Health Research Ethics Committee.

She said NAFDAC can grants authorisation and expedited review process for trials in emergency situation, but candidates will obtain NAFDAC clinical trial form, while the duly completed form with other relevant documents are to be submitted to the D/DER.

In a related development, the Department of Traditional Complimentary and Alternative Medicine (TCAM) of the Federal Ministry of Health had craved the indulgence of the NAFDAC DG for the listing of a natural cough medicine, it described as “Cov-herbal cough mixture, a formulation intended for the management of cough in COVID-19 and other cough related infections.

The FMoH claimed the medicinal plants used for preparation of Cov-herbal “have documented scientific evidence of long use for the management of cough and other respiratory infections, with medicinal properties of mucolytic, antitussive, expectorant, soothing, demulcent, anti-inflammatory and antiviral effects”.

However, the agency is yet to respond to the mail, saying they will perform their regulatory duty accordingly.