Prof. Mojisola Christianah Adeyeye, Director General of the National Agency for Food and Drug Administration and Control (NAFDAC), has stated why the Agency is yet to approve a locally created herbal medicine for COVID 19 treatment in Nigeria.
She does, however, encourage Nigerian ivory tower researchers and other herbal medicine practitioners to avoid marketing unproven, unverified medicinal remedies as COVID 19 cures without first getting approval from NAFDAC.
Adeyeye warned that such an act is a violation of the national regulatory authority’s norms and processes, according to a statement made by NAFDAC resident media consultant Sayo Akintola in Abuja on Sunday.
She claimed that no one treatment has yet been discovered to cure COVID -19, and that current medical items can only aid to alleviate symptoms and increase the chances of survival.
In order to cure COVID–19, Adeyeye cautioned Nigerians from overeating onions and garlic, adding, “If you eat too much, your breath will be smelly, and nobody would want to stay by you.”
She stated that onions, garlic, and any other natural fruits we consume have antioxidants and minerals that can make 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’’, she insists.
She added that 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, she said.
She added: 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 her, the research into herbal medicine by the academia is normal. She however, quickly 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.
The NAFDAC DG insists 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.
Without clinical trial authorized by NAFDAC nobody can claim that a product can cure COVID 19. Of course, some people might have been using it and they got better, but without being approved scientifically and documented, we may not be able to guarantee that its safe for human consumption
Prof Adeyeye recalled that NAFDAC set up an herbal medicine product committee in 2019 March 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.
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.
However, 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, she maintains, adding that 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, she said you must write a protocol, you must pass it through the National Health Research Ethical Committee, NHREC you have to pass it through NAFDAC. We have not received any like that, she said,
Nonetheless, she said the Agency has approved some herbal medicines that they claim can alleviate some of the symptoms of COVID -19, stressing that some of them are immune boosters that can increase the immune level of people.
When the immune level improves, Prof. Adeyeye pointed out that it may prevent one from getting the disease, adding that 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.
When the product is listed then clinical trial may start. I used may because its expensive; it takes a lot of money to do clinical trial, she said. She further disclosed that University of Jos has been given approval for its product, Silymarin to commence clinical trial. She however, disclosed that this is yet to commence.
The NAFDAC DG, further disclosed that many herbal products have been submitted for federal government grants because most of the herbal practitioners lack the required wherewithal to do clinical trial.
As we speak many of these herbal products are being subjected to review by different agencies of government in the country. In terms of going through clinical trial official protocols, none has come through yet. That doesnt mean they will not because the process is still on, she said.
Before a herbal product can be used to investigate whether it could be effective for COVID -19, she insists that that herbal medicine must be listed first.
According to her, listing involves submission of information about the herbal medicine, the toxicology study of it, the microbial limit test of it. Prof Adeyeye added that ‘’when they submit all these to us, we will confirm in our laboratory whether the product is safe to use; meaning it’s not toxic, whether it has tendency for microbial growth, we will test that in our lab’’.
The NAFDAC DG further explained that ‘’we will also do some physical testing, some piezochemical testing. We will find out whether it has other components that may be used to alleviate some symptoms. We will also go to the manufacturing site to establish its level of Good Manufacturing Practice GMP compliance. If it does, then we take samples’’.
Adeyeye however, disclosed that the product is approved as listed If everything goes well, adding that ‘Listed’ means temporary approval for two years and renewable as a prelude to the clinical trial process.