The National Agency for Food and Drug Administration and Control (NAFDAC) has reacted to claims of the herbal COVID-19 remedies.
The agency said that all claims of local remedies for COVID-19 are domiciled in either the conventional news media or social media.
In a statement by the Director-General of the agency, Mojisola Adeyeye said that they only received an application from one company for a product it’s presenting (for approval) to the agency for the treatment of the symptoms of COVID-19, and not for the cure of COVID-19 as a disease.
“A claim of a cure must be subjected to clinical evaluation through well-controlled, randomized clinical trials following an approved clinical trial protocol”.
While acknowledging that drugs are products of research and development from plants, the NAFDAC DG noted that many plants are also very poisonous.
She said, “As the agency that has been saddled with the mandate of safeguarding the health of the citizenry, NAFDAC will continue to make sure that only medicinal product (including herbal remedies) that have proven safety data will be approved for use by the public.
The NAFDAC boss says that any claim of a cure must follow an approved clinical trial protocol, and subjected to clinical evaluation through well-controlled, randomized clinical trials.
“Presently the Agency lists herbal medicines based on a historical perspective on the use of the products after carrying out toxicological and microbiological evaluations in the laboratories to ensure that they are, at the minimum, safe. The listing status is valid for two years and is renewable.
“It does not validate the efficacy claims being made for the products hence, the labels must bear a disclaimer informing the consumer.
“The claims have not been evaluated by NAFDAC, this minimum requirement of ‘proof of safety’ is the Agency’s way of encouraging the production of herbal remedies from the country’s rich diversity of plants.
“Part of the efforts to advance herbal product development informed the setting up of the Nigerian Herbal Medicine Product Committee (HMPC) by the Director-General, NAFDAC”.
The agency further explained that the platform brings together Manufacturers, Academia, Researchers, and relevant stakeholders by bridging the gap often created between traditional medicine practitioners (possible patent holders) and drug manufacturers, whose responsibility it would be to formulate the products.
“This collaboration, brokered by the Agency, aims at translating the research of herbs into products of commerce with proven safety & efficacy”.