NAFDAC asks researchers to submit products for COVID-19 cure for clinical tests

The National Agency for Food and Drug Administration and Control (NAFDAC), has called on researchers claiming to have found drugs for the treatment of Coronavirus to come forward with them.

The agency said it was necessary they submitted their products believed could cure the virus so that they could be subjected to internationally recognized process of approval through pre-clinical and where applicable, clinical trials.

This was contained in a statement the agency released on Wednesday.

In the statement by its Director-General, Professor. Mojisola Adeyeye, the agency said it was encouraging “all stakeholders to present the products of their research findings and allow these remedies go through internationally recognized process of approval through pre-clinical and where applicable, clinical trials.”

Below is the full text of the statement:

“The rush to mitigate the mortality and morbidly 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 & 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.

“Presently 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.

“Part of the efforts to advance herbal products development informed the setting up of the Nigerian Herbal Medicine Product Committee (HMPC) by the Director-General, 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.

“This collaboration, brokered by the Agency, aims at translating research of herbs into products of commerce with proven safety & efficacy.

“The committee has met three times since inception, on March 15, 2019, September 6, 2019 and the most recent one being a virtual meeting on Thursday May 8, 2020.

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“Call for expression of interest for the COVID-19 related medicines was made; several researchers and practitioners have responded and are being guided to submit such medicines to NAFDAC for expedited review.

“The Agency continues to encourage all stakeholders to present the products of their research findings and allow these remedies go through internationally recognized process of approval through pre-clinical and where applicable, clinical trials.

“Finally, as the body with the mandate to regulate the conduct of clinical trials in the country, NAFDAC is committed to encouraging and supporting sponsors with appropriate guidance to expedite the development of effective interventions to treat or prevent COVID-19.”

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