Director-General of the National Agency for Food and Drug Administration and Control, NAFDAC, agency, Mojisola Adeyeye, says that it has received only
Director-General of the National Agency for Food and Drug Administration and Control, NAFDAC, agency, Mojisola Adeyeye, says that it has received only one application from a company for a product which it presented for approval for the treatment of symptoms of COVID-19, and not cure of the disease.
In a statement, the agency said, “The rush to mitigate the mortality and morbidity resulting from the COVID-19 pandemic has resulted in acceleration of product development, repurposing of formulations, off label use of therapeutics and the search for a vaccine to prevent COVID-19. Because no vaccine yet exists to prevent further spread of the virus, the huge burden of developing a cure or at best, a treatment for this deadly virus rests squarely on the shoulders of the medical world, of which Nigeria is no exception.
“In a bid to discover a cure, therefore, the public has witnessed quite a number of claims from different quotas – Complementary and Alternative Medicines Practitioners, Traditional healers, and the Academia. It is pertinent to note, however, that these claims are domiciled in either the conventional news media or the social media. The National Agency for Food and Drug Administration and Control, NAFDAC, as at the time of this press release has only received application from one company for a product the company is 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. That Africa as a continent is blessed with diverse plants and herbs that constitute a source of food and medicine is incontrovertible. The drugs of today’s modern society are products of research and development by major pharmaceutical companies. Among the most important raw materials researched and developed are naturally occurring materials obtained especially from plants.
“It should be mentioned also, however, that many plants are similarly very poisonous. 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. At present, the agency lists herbal medicines based on 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 production of herbal remedies from the country’s rich diversity of plants.
