The National Agency for Food and Drug Administration and Control is partnering with the Nigeria Natural Medicine Development Agency to develop herbal medicines to ensure safety, efficacy, and global acceptance.
This was disclosed in a statement by NAFDAC resident media consultant, Olusayo Akintola.
NAFDAC director-general Mojisola Adeyeye said Nigerian herbal medicine practitioners have the capacity to formulate safe and effective indigenous natural remedies that meet international standards.
She said that NAFDAC has two types of approval for herbal medicines, adding that the first type is a ‘listing’ (L) approval, which is granted after the product has been evaluated in the agency laboratory for toxicology safety tests and with satisfactory results.
Ms Adeyeye said that products in this approval category are listed for a period of two years, with a NAFDAC number ending with the letter ‘L’.
She said that the second approval type requires clinical trials to prove the product’s efficacy. She explained that if these trials are conducted in a well-designed protocol with proven efficacy, a full approval with five-year validity is granted.
The NAFDAC boss identified cost as a major obstacle preventing herbal medicine practitioners from subjecting their products to clinical trials.
She said that NAFDAC has listed thousands of herbal medicines, with only a few products having undergone clinical trials outcomes. However, such products cannot receive a five-year approval without passing the efficacy test through a clinical trial.
“We know that herbal medicine works. It is how to ascertain through clinical trial the level it can be used that patients will be safe, and above which there could be no damage to the liver, the kidney, and other internal organs. The fact that it is natural doesn’t mean that it is all safe. ‘That is where NAFDAC regulation and control come in,” she stressed.
She recalled that the agency launched the herbal medicine products committee just before the COVID-19 pandemic, which brought the practitioners, the Ministry of Health, NAFDAC, and researchers together.
Ms Adeyeye said that this partnership effort is very important because the practitioners know what their forefathers have been using, while the researchers know the science.
According to her, NAFDAC is seeking funding to assist herbal medicine practitioners in conducting clinical trials, which are highly capital-intensive.
She also noted that the agency is working assiduously with the NNMDA to ensure that clinical trials are conducted for the medicines that have met the regulatory requirements for listing.
Ms Adeyeye said that NAFDAC has been educating the herbal medicine practitioners who intend to register products through stakeholders’ meetings.
She said that the agency has gone ahead to publish a simple floor plan on the website as a guide for the practitioners, while averting that it does not necessarily require a big space to use for production.
The NAFDAC boss maintained that the factory must be well-ordered to ensure a smooth workflow and prevent contamination.
‘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,’ she said.
Ms Adeyeye stated that before her appointment at NAFDAC, she was a professor in the U.S., adding that at the university, she led a project that developed an anti-sickling polyherbal medicine.
She added that the trial showed that the product was efficacious but needed more data and funding for completion.
