The National Agency for Food and Drug Administration and Control is partnering with the Nigeria Natural Medicine Development Agency to develop scientifically proven, safe, and effective herbal medicines that meet international standards through properly designed clinical trials.
In a statement signed by NAFDAC’s media consultant, Sayo Akintola, on Sunday, the Director-General of NAFDAC, Prof. Mojisola Adeyeye, revealed that Nigerian herbal medicine practitioners possess the capacity to formulate safe and effective indigenous natural remedies comparable to international standards.
She, however, emphasised the need for scientific validation through clinical research to ensure the safety and efficacy of such products.
According to the World Health Organisation, up to 80 per cent of Africa’s population relies on herbal remedies for primary healthcare.
NAFDAC’s initiative aims to bridge this gap by ensuring that local herbal products are not only effective but also meet global scientific and regulatory benchmarks.
According to the statement, NAFDAC currently offers two categories of approval for herbal medicines.
“The first type is a listing (L) approval, granted after the product has undergone toxicological safety tests in our laboratory with satisfactory results. Products under this category are listed for a period of two years, bearing a NAFDAC number ending with the letter ‘L’,” Adeyeye explained.
“The second approval type requires that clinical trials be conducted to prove the product’s efficacy. If such trials are carried out under a well-designed protocol and the results confirm efficacy, the product receives full approval, which is valid for five years,” she added.
Adeyeye identified the high cost of clinical trials as a major challenge, discouraging many herbal medicine practitioners from validating their products scientifically.
“If you have a herbal medicine but cannot scientifically prove its efficacy and safety, NAFDAC cannot grant it full registration,” she said.
The NAFDAC DG disclosed that while the agency has listed thousands of herbal medicines, only a few have undergone clinical trials with verifiable outcomes.
“We know that herbal medicine works, but we must determine scientifically the safe dosage levels. Below a certain level, patients will be safe, but above it, there could be damage to vital organs such as the liver and kidneys. The fact that a product is natural doesn’t mean it’s completely safe—that’s where NAFDAC regulation and control come in,” she stressed.
Adeyeye recalled that NAFDAC launched the Herbal Medicine Products Committee shortly before the COVID-19 pandemic. The committee brings together practitioners, researchers, and government agencies, including the Ministry of Health, to collaborate on advancing traditional medicine research and regulation.
She further revealed that NAFDAC is seeking funding support to help practitioners conduct clinical trials, which are highly capital-intensive.
According to her, the ongoing partnership between NAFDAC and the NNMDA aims to identify selected herbal medicines that have met regulatory requirements and subject them to clinical trials.
“We need to prove beyond doubt that these medicines are effective and safe for human use. Once confirmed, they can be fully registered and possibly included in the national formulary for herbal medicines,” she stated.
Adeyeye also noted that NAFDAC has been engaging herbal medicine practitioners through stakeholder meetings to educate them on product registration requirements and best practices for ensuring safety and efficacy.
Credit: punchng.com
