NAFDAC explains position on claims for COVID-19 remedies
The National Agency for Food and Drug Administration and Control (NAFDAC) has said that the rush to mitigate the mortalities from the COVID-19 pandemic has resulted in acceleration of product development, repurposing of formulations for a vaccine to prevent COVID-19.
Amidst claims of discovering a cure for coronavirus by some bodies in Nigeria, NAFDAC noted that it has only received application from one company seeking approval for a product to treat people with symptoms of Covid-19 and not as the cure.
In a statement yesterday in Abuja, Director General of NAFDAC, Prof Mojisola Christianah Adeyeye stated that the public has witnessed quite a number of claims from different quarters – complementary and alternative medicines practitioners, traditional healers, and the academia but emphasized that these claims are domiciled in either the conventional news media or the social media.
She stated that a claim of a cure must be subjected to clinical evaluation through well controlled, randomized clinical trials and an approved clinical trial protocol.
The DG disclosed that the Nigerian Herbal Medicine Product Committee (HMPC) has met three times since March 15, 2019, September 6, 2019 and the most recent one being a virtual meeting on Thursday May 8, 2020 on issues around COVID-19.
She stressed that calls for expression of interest for the COVID-19 related medicines were made with several researchers and practitioners responding. But they are being guided to submit such medicines to NAFDAC for expedited review.
She encouraged all stakeholders to present the products of their research findings and allow these remedies go through internationally recognised process of approval through pre-clinical and where applicable, clinical trials.
Adeyeye pointed out that because no vaccine yet exists to stop the spread of the virus, the huge burden of developing a cure and treatment for the virus rests squarely on the shoulders of the medical world, of which Nigeria is no exception.
“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,” she said.
The NAFDAC boss noted that 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 after every two years of validity check.
She stressed that 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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