The National Agency for Food and Drug Administration and Control (NAFDAC) is partnering with the Nigeria Natural Medicine Development Agency (NNMDA) to develop herbal medicines to ensure safety, efficacy, and global acceptance.
This is contained in a statement by NAFDAC resident media consultant, Mr Olusayo Akintola.
NAFDAC Director-General, Prof. 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.
Adeyeye said that products in this approval category are listed for a period of two years, with a NAFDAC number bearing the letter “L” at the end.
She said that the second approval type requires that clinical trials be conducted on the product to prove the efficacy of such a product, saying that if this is done in a well-designed protocol with proven efficacy, a full approval with five-year validity is given.
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 that have gone through clinical trial outcomes, but such cannot be given 5-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 comes in,” she stressed.
She recalled that the agency launched the herbal medicine products committee just before the COVID-19 pandemic, which brought the practitioners, Ministry of Health, NAFDAC and researchers together.
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 looking for funding to assist herbal medicine practitioners in the conduct of clinical trials, which is highly capital-intensive.
She equally noted that the agency is working assiduously with the NNMDA to ensure that clinical trial is conducted for the medicines that have met the regulatory requirements for listing.
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 published a simple floor plan on the website as a guide for the practitioners, while averting that it does not necessarily to have a big place to use for production.
The NAFDAC boss maintained that the factory must be well-ordered to allow a good workflow so that there will not be 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.
Adeyeye stated that before her appointment at NAFDAC, she was a professor in the United States, adding that at the university, she led a project that developed an anti-sickling polyherbal medicine.
“This medicine, which NAFDAC listed many years before my tenure, was tested in a laboratory settings by incubating it with blood samples from children with sickle cell disease to prove its anti-sickling effect.
“Two research papers were published, confirming both the anti-sickling and anti-infective properties of the medicine.
‘We conducted a clinical trial approved by the Ethics Committee of Bowen University and the Institutional Review Board of my University in the U.S on the polyherbal in July before my assumption of office in NAFDAC in November 2017’.
She added that the trial showed that the product was efficacious but needed more data and funding for completion.
NAFDAC, she said, is determined to assist herbal medicine practitioners, especially in the areas of clinical trials, adding that it will jointly mobilise resources with NNMDA to get some fully registered.
