The National Agency for Food and Drug Administration and Control (NAFDAC) is partnering with the Nigeria Natural Medicine Development Agency (NNMDA) to conduct clinical trials on herbal medicines before approval.
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 the agency’s 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.
A statement on Sunday by Mojisola Adeyeye, NAFDAC director-general, said Nigerian herbal medicine practitioners have the capacity to formulate safe and effective indigenous natural remedies that meet international standards.
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Adeyeye, however, said cost is 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,” she said.
Adeyeye said NAFDAC has listed thousands of herbal medicines, with only a few products that have gone through clinical trial outcomes,
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“But we cannot give 5-year approval without passing the efficacy test through a clinical trial,” she said.
“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 it’s natural doesn’t mean that it’s all safe. That’s where NAFDAC regulation and control come in.”
She said the agency is working with the NNMDA to ensure that clinical trial is conducted for the medicines that have met the regulatory requirements for listing.
“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 said.
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“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.”
