Imagine a world where ancient herbal remedies, trusted for centuries, are scientifically validated and recognized on a global scale. This is the ambitious vision of Nigeria's National Agency for Food and Drug Administration and Control (NAFDAC) and the Nigeria Natural Medicine Development Agency (NNMDA).
But here's where it gets controversial...
In a bold move, NAFDAC, led by its Director-General, Prof. Mojisola Adeyeye, is partnering with NNMDA to bring herbal medicines into the spotlight of scientific scrutiny. Adeyeye believes that Nigerian herbal practitioners possess the skills to create natural remedies that rival international standards. However, she emphasizes the need for scientific validation through clinical trials to ensure these remedies are not just effective but also safe.
The World Health Organization estimates that up to 80% of Africa's population relies on herbal remedies for primary healthcare. NAFDAC's initiative aims to bridge the gap between traditional knowledge and modern scientific standards, ensuring that local herbal products meet global benchmarks.
And this is the part most people miss...
NAFDAC currently offers two types of approval for herbal medicines. The first, a listing (L) approval, is granted after toxicological safety tests with satisfactory results. These products are listed for two years and bear a NAFDAC number ending with the letter 'L'. The second approval type requires clinical trials to prove efficacy, and if successful, the product receives full approval valid for five years.
Adeyeye highlights the high cost of clinical trials as a major challenge, deterring many herbal medicine practitioners from scientifically validating their products. She disclosed that while NAFDAC has listed thousands of herbal medicines, only a few have undergone rigorous clinical trials with verifiable outcomes.
So, what's the catch?
Adeyeye stresses the importance of determining safe dosage levels scientifically. She explains, "Below a certain level, patients will be safe, but above it, there could be damage to vital organs such as the liver and kidneys. Just because a product is natural doesn't mean it's completely safe. This is where NAFDAC's regulation and control are crucial."
NAFDAC launched the Herbal Medicine Products Committee shortly before the COVID-19 pandemic, bringing together practitioners, researchers, and government agencies, including the Ministry of Health, to collaborate on advancing traditional medicine research and regulation.
NAFDAC is also seeking funding support to help practitioners conduct clinical trials, which are highly capital-intensive. The ongoing partnership between NAFDAC and NNMDA aims to identify selected herbal medicines that have met regulatory requirements and subject them to clinical trials.
The Bottom Line:
Adeyeye emphasizes the need to prove beyond doubt that these medicines are effective and safe for human use. Once confirmed, they can be fully registered and potentially included in the national formulary for herbal medicines. 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.
This initiative promises to revolutionize the herbal medicine industry in Nigeria, but it also raises questions. Do you think scientific validation is necessary for traditional remedies? Is there a risk of losing the essence of traditional knowledge in the process? Share your thoughts in the comments below!
