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We received only one application for endorsement of product treating Covid-19 symptoms, not cure – NAFDAC

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NAFDAC water factory



The National Agency for Food and Drug Administration and Control [NAFDAC] says it has received only one application from a firm for the endorsement of a product to treat the symptoms of Covid-19 and not the virus itself.

The NAFDAC DG, Prof. Moji Adeyeye, in a statement on Wednesday also added that all other claims about a possible cure for Covid-19 in Nigeria only exist on social media and the pages of newspapers.

The agency admitted that Africa is indeed blessed with herbs but stated that all possible cures must pass all scientific testing before approval.

It noted that the rush to mitigate the mortality and morbidity from the COVID-19 pandemic had resulted in acceleration of product development, repurposing of formulations, off-label use of therapeutics and the search for a vaccine to prevent the virus.

She said,

“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.

“NAFDAC, as of 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.”

Adeyeye explained that a claim of a cure must be subjected to clinical evaluation through well-controlled, randomised clinical trials, following an approved clinical trial protocol.

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She said,

“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.”

According to her, the agency currently lists herbal medicines based on historical perspectives 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.

She added that the listing status was valid for two years and was 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.

“Part of the efforts to advance herbal products development informed the setting up of the Nigerian Herbal Medicine Product Committee by the DG, NAFDAC.

“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,” the NAFDAC boss said.

Adeyeye added that the committee had met three times since inception, including on March 15, 2019, September 6, 2019 and May 8, 2020.

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