NAFDAC Insists On Clinical Trial For COVID-19 Herbal Medicine

National Agency for Food and Drug Administration and Control (NAFDAC) has emphasized that without clinical trial authorized by the Agency, nobody can claim that a product can cure COVID-19.

A statement signed by the NAFDAC Resident Media Consultant, Sayo Akintola in Abuja on Sunday, stated that the Director General of NAFDAC, Prof Mojisola Adeyeye, had set up an herbal medicine product committee in March 2019 before the pandemic broke out to advance research in herbal medicine.

“The goal for that was to make sure that the herbalist and the researcher are collaborating so that whatever the herbalist knows from ancestral history that does not have research to back it up, collaboration with researcher will enable that herbal medicine to be advanced to be listed by NAFDAC if its deemed safe.”

Adeyeye while explaining the reason why no locally made herbal remedy has not been approved by the Agency for the treatment of COVID 19 in Nigeria gave a stern warning to Nigerian Ivory Tower Researchers and other herbal medicine practitioners to refrain from promoting untested unverified medicinal products as suitable for the cure of COVID-19, without NAFDAC approval.

Adeyeye warned that such an act is a violation of the national regulatory authority’s regulations and protocols.

She insisted that no single drug has been found yet to cure COVID-19, noting that medicinal products available now can only help ease symptoms and up the odds of survival.

Adeyeye also warned Nigerians against excessive consumption of onions and garlic with a view to curing COVID–19, stressing that, “If you eat too much your breath will be smelling and nobody will want to stay by you.”

She admitted that onions or garlic or any of the natural fruits that we take have antioxidant and nutrients that can help us feel better.

“People might have been using it and they get better. But if it is not documented, it cannot be recognized by NAFDAC for COVID–19. They work on our cells to keep people healthier. But not to cure COVID–19. They help our body to function better. There is no cure for COVID-19 yet.”

“They may boost the immunity and the person may not be easily susceptible to infection, adding ‘’even with that you still have to protect yourself. If you eat Garlic and Onion and you don’t use mask you will get COVID -19. if you are in a very bad environment; If you dont watch your hands, you will get COVID -19. So, everything has to be put together.”

“University of Jos said that there was a herbal medicine, whether its tea or whatever, that can cure COVID 19. They linked it with treatment of COVID -19. They did the packaging.”

“We did a letter to warn them that they cannot claim something unless it has gone through our listing process. They were trying to sell it to their staff.”

“That is violation of our own regulatory policies. Nobody should say that this one can cure this or that without going through NAFDAC listing process.”

According to Adeyeye, the research into herbal medicine by the academia is normal however, added that It is now for the academia to also recognize the national regulatory authority established to safeguard the safety of the Nigerian populace by ensuring that the product that they are working on has to go through NAFDAC if they want to make it available for human consumption.

“There have been one or two cases where the product was being encouraged to be used by people without going through us.

“When that happens, we give the university a sanction because they are supposed to go through the national regulatory authority in order for us to declare it safe for consumption.”

Adeyeye made a stand that her Agency has to approve the clinical trial protocol, stressing that If they dont go through NHREC, if it is a new product; and if they dont go through NAFDAC before they start doing their clinical trial, that is violation of regulatory procedures.

She added that during the pandemic there were a lot of assertions that there were herbal medicines that could be used to treat symptoms of COVID-19.

There is no single medicine that has been identified today to cure COVID -19. But there are herbal medicines that could alleviate symptoms of COVID -19.

“NAFDAC has not granted registration approval for any medicine for that. NAFDAC approves such medicines for listing. It means that its been tested and is deemed safe to use.

“NAFDAC cannot say herbal medicine can treat COVID -19 until clinical trial is done. Right now, there is no single herbal medicine that has gone through full clinical trial the way clinical trial is supposed to be done.

“To do official clinical trial, you must write a protocol, pass it through the National Health Research Ethical Committee(NHREC) and NAFDAC and we have not received any like that.”

“Nonetheless, the Agency has approved some herbal medicines that they claim can alleviate some of the symptoms of COVID -19 and some of them are immune boosters that can increase the immune level of people.”

“When the immune level improves, it may prevent one from getting the disease, but as far as NAFDAC Is concerned, we have not approved any medicine to treat COVID -19. We have approved medicines that they said can alleviate symptoms and relieve people of some symptoms of COVID-19.