***Says Herbal Medicine Works, But It Must Be Proven Scientifically
The National Agency for Food and Drug Administration and Control (NAFDAC) has entered into a landmark partnership with the Nigeria Natural Medicine Development Agency (NNMDA) to fast-track clinical trials and simplify the approval process for herbal medicines in Nigeria.
Announcing the collaboration in a statement signed by NAFDAC’s Resident Media Consultant, Sayo Akintola, the Director-General of the Agency, Prof. Mojisola Adeyeye, said the initiative aims to produce scientifically proven, safe, and effective herbal medicines that meet international standards.
According to her, Nigerian herbal medicine practitioners have the expertise and indigenous knowledge to formulate effective remedies but are often constrained by the high cost of conducting clinical trials a critical requirement for full registration.
“If you have a herbal medicine that you cannot prove scientifically the extent to which it works and the level at which it is safe then it cannot be fully registered by NAFDAC,” Prof. Adeyeye stated.
“We know herbal medicine works. What remains is to prove, through clinical trials, the level it can be used safely without causing harm to vital organs such as the liver and kidney.”
Prof. Adeyeye explained that NAFDAC operates a two-step approval process for herbal medicines. The first is a listing approval granted after laboratory safety evaluation and valid for two years identified by a NAFDAC number ending with the letter “L.”
The second is full approval, valid for five years, which can only be issued after successful clinical trials have proven the product’s efficacy.
“Thousands of herbal medicines have been listed by NAFDAC, but only a few have gone through clinical trials. We cannot grant five-year approval without efficacy data,” she said.
Prof. Adeyeye revealed that NAFDAC is intensifying collaboration with NNMDA to ensure selected listed herbal medicines undergo scientific validation through clinical trials.
“We are working with the NNMDA to use selected listed herbal medicines for clinical trials so that we can prove beyond doubt that the medicines work well. Such products can then be fully registered and included in a national formulary for herbal medicines,” she noted.
She added that NAFDAC has been holding stakeholder meetings with herbal practitioners and has published a simplified factory layout guide on its website to help them meet Good Manufacturing Practice (GMP) standards.
“It doesn’t have to be a big place,” she clarified, “but it must be well-organized to prevent contamination.”
The NAFDAC boss recalled that before the COVID-19 pandemic, the agency inaugurated the Herbal Medicine Products Committee a collaboration among NAFDAC, the Ministry of Health, researchers, and traditional practitioners aimed at integrating scientific research with indigenous medicinal knowledge.
She stressed that NAFDAC is currently seeking funding to support herbal practitioners in conducting clinical trials, describing the process as highly capital-intensive.
“We are approving herbal medicines daily in NAFDAC, but our goal is to build a national formulary for those that have undergone clinical trials and proven to be very effective,” she said.
Recounting her academic background, Prof. Adeyeye revealed that before her appointment at NAFDAC, she led a research project in the United States that developed an anti-sickling polyherbal medicine for sickle cell disease. The formulation, previously listed by NAFDAC, showed both anti-sickling and anti-infective properties in clinical studies conducted under ethical approval in Nigeria and the U.S.
“The trial confirmed the product’s efficacy but required more data and funding for completion. We are now determined to assist our local practitioners with clinical trials, and together with NNMDA, we will mobilize resources to ensure more herbal medicines are fully registered after due process,” she affirmed.
The partnership, according to experts, represents a critical milestone in the integration of traditional and modern medicine in Nigeria. It underscores NAFDAC’s resolve to ensure that herbal products are not only effective but also scientifically validated and safe for public use enhancing their credibility both at home and abroad.
