Clinical Trial : NAFDAC , NNMDA Chart Path For Safe, Effective Nigerian Herbal Medicines
By Winifred Bosa
The National Agency for Food and Drug Administration and Control (NAFDAC) is collaborating with the Nigeria Natural Medicine Development Agency (NNMDA) to develop scientifically proven, safe and effective herbal medicines that meet global standards through clinical trials.
According to a press release by Sayo Akintola , Resident Media Consultant, NAFDAC , the Director General of NAFDAC, Prof. Mojisola Adeyeye, who dropped the hint, disclosed that Nigerian herbal medicine practitioners have the capacity to formulate safe and effective indigenous natural remedies that meet international standards.
NAFDAC has two types of approval for herbal medicines. The first type is a listing (L) approval, and it is granted after the product has been evaluated in our laboratory for toxicology safety tests with satisfactory results. Products in this approval category are listed for a period of two years, with a NAFDAC number bearing the letter L at the end.
The second approval type requires that clinical trials be conducted on the product to prove the efficacy of such a product. If this is done (in a well-designed protocol) with proven efficacy, a full approval with five-year validity is given.
The Director General identified cost as a major obstacle preventing herbal medicine practitioners from subjecting their products to clinical trials.
‘If you have an herbal medicine that you cannot prove scientifically the extent to which it works without causing harm to the user by providing some data on the efficacy, then it cannot be fully registered by NAFDAC.
Prof Adeyeye disclosed that NAFDAC has listed thousands of herbal medicines, with only a few products that have gone through clinical trial outcomes, But we cannot give 5-year approval without passing the efficacy test through a clinical trial.
We know that herbal medicine works. It is how to ascertain through clinical trial the level it can be used below which patients will be safe, and above which there could be damage to the liver, the kidney, and other internal organs, she explained, emphasising that the fact that its natural doesnt mean that its all safe. Thats where NAFDAC regulation and control come in.
The DG recalled that NAFDAC launched the Herbal Medicine Products Committee just before the COVID-19 Pandemic, which brought the practitioners, the Ministry of Health, NAFDAC and researchers together. This collaborative effort is very important because the practitioners know what their forefathers have been using, while the researchers know the science.
According to her, the Agency is looking for funding to assist the practitioners in the conduct of clinical trials, which is highly capital-intensive.
She pointed out that the Agency is working assiduously with the NNMDA to ensure that clinical trial is conducted for the medicines that have met the regulatory requirements for listing.
She said that NAFDAC is working together with the NNMDA to use some selected listed herbal medicines to conduct clinical trials, so that we will prove beyond doubt that the medicine works well and those can now be registered fully.
Such medicines can be placed in a national formulary for herbal medicines, even if there are few.
She stated that NAFDAC has been educating the herbal medicine practitioners who intend to register products through stakeholders meetings.
The Agency even published a simple floor plan on the website as a guide for the practitioners.
She averred that it does not necessarily have to be a big place to use for production. She, however, maintained that the factory must be well-ordered to allow a good workflow so that there will not be contamination.
We are working with our practitioners. We are approving herbal medicines daily in NAFDAC, but we are working towards a phase where we will have a national formulary for those that have had clinical trials and have been proven to be very effective, she said.
The Director-General disclosed that before her appointment at NAFDAC, she was a professor in the United States. While at the university, she led a project that developed an anti-sickling polyherbal medicine.
This medicine, which NAFDAC had listed many years before her tenure, was tested in laboratory settings by incubating it with blood samples from children with sickle cell disease to prove its anti-sickling effect.
Two research papers were published, confirming both the anti-sickling and anti-infective properties of the medicine.
We conducted a clinical trial approved by the Ethics Committee of Bowen University and the Institutional Review Board of my University in the U.S on the polyherbal in July before my assumption of office in NAFDAC in November 2017.
She added that the trial showed that the product was efficacious but needed more data and funding for completion.
We are determined to assist our practitioners in the area of clinical trials and together with NNMDA we shall mobilise resources to get some herbal medicines fully registered after going through due process, she said.
