Nigeria to test ‘COVID-19 cures’ for safety, not efficacy

Some 'COVID-19 cures' may soon get NAFDAC approvals but it doesn't mean they are effective

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The Nigerian has announced plans to subject medicines claimed to possibly prevent and/or cure COVID-19 to testing to ascertain their safety and not efficacy, according to the regulator in charge of drug administration in the country.

In a statement gotten by HealthNews.NG, the Director General of Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC), Prof Mojisola Christianah Adeyeye, said the agency has issued a Call for expression of interest for COVID-19 related medicines.

“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,” the DG said.

She noted the establishment of the Nigerian Herbal Medicine Product Committee (HMPC) that 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 DG stated.

Safety, not efficacy

In her statement, Adeyeye said NAFDAC’s priority is not to ascertain the efficacy of the treatment agents but to ensure their safety for use.

“Presently the Agency lists herbal medicines…after carrying out toxicological and microbiological evaluations…to ensure that they are, at the minimum, safe. [NAFDAC] does not validate the efficacy claims being made for the products,” Adeyeye said.

She noted that the labels must bear a disclaimer informing the consumer “The claims have not been evaluated by NAFDAC”.

The agency said: “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.”

According to the DG of NAFDAC, 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.

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.”

While admitting that that has been quite a number of claims from different quotas – Complementary & Alternative Medicines Practitioners, Traditional healers, and the Academia, regarding possible cures for COVID-19, Adeyeye noted that it is pertinent to note, however, that these claims are domiciled in either the conventional news media or the social media.

“NAFDAC 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.”

The agency stressed that a claim of a cure must be subjected to clinical evaluation through well controlled, randomized clinical trials following an approved clinical trial protocol.

“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,” Adeyeye said.

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