No Efficacy Test, No Full Registration – NAFDAC Warns Herbal Practitioners
The National Agency for Food and Drug Administration and Control (NAFDAC) has reaffirmed its commitment to ensuring that only scientifically proven, safe, and effective herbal medicines are fully registered for use in Nigeria.
The Agency said it is working with the Nigeria Natural Medicine Development Agency (NNMDA) to standardize herbal products through clinical trials that meet global benchmarks.
NAFDAC Director-General, Prof. Mojisola Adeyeye, disclosed this in a statement, stressing that Nigerian herbal medicine practitioners possess the capacity to develop effective indigenous remedies that can meet international standards.
However, she noted that the high cost of clinical trials remains a major obstacle for many practitioners.
According to Prof. Adeyeye, “If a herbal medicine cannot be scientifically proven to work without causing harm and lacks data on its efficacy, it cannot be fully registered by NAFDAC.”
She revealed that while thousands of herbal medicines have been listed by the Agency, only a few have undergone successful clinical trials.
The DG explained that NAFDAC operates two approval categories for herbal medicines. The first, known as listing approval and marked with an “L” on the NAFDAC number, is granted for two years after laboratory evaluation for safety.
The second is full approval, which requires clinical trials to prove efficacy before a five-year registration can be issued.
Prof. Adeyeye emphasized that the Agency’s Herbal Medicine Products Committee—comprising NAFDAC, the Ministry of Health, researchers, and practitioners—was created to promote collaboration and scientific validation of herbal products.
She added that NAFDAC is seeking funding support to help practitioners conduct the capital-intensive clinical trials.
To guide manufacturers, Adeyeye said NAFDAC has published a simplified production plan on its website and stressed that factories must maintain good workflow and hygiene to avoid contamination.
“We are approving herbal medicines daily, but our goal is to have a national formulary containing those that have passed clinical trials and proven highly effective,” she stated.
The NAFDAC boss assured Nigerians that the Agency, in collaboration with NNMDA, is already conducting clinical trials on selected herbal medicines to verify their effectiveness.
She said successful products will receive full registration and inclusion in a forthcoming National Herbal Medicine Formulary.
Reporting by Julie Ekong