Urges stakeholders to present products of their research findings for validation

The National Agency for Food and Drug Administration and Control (NAFDAC) has said that 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.

The agency however noted that it 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.

In a statement yesterday in Abuja, Director General of NAFDAC, Prof Mojisola Christianah Adeyeye stated that in a bid to discover a cure for Covid-19 disease, the public has witnessed quite a number of claims from different quarters, Complementary & 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 observed that a claim of a cure must be subjected to clinical evaluation through well controlled, randomized clinical trials following an approved clinical trial protocol.

The DG disclosed that the Nigerian Herbal Medicine Product Committee (HMPC) 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, stressing that call for expression of interest for the COVID-19 related medicines was made and several researchers and practitioners have responded and 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 recognized process of approval through pre-clinical and where applicable, clinical trials.

Adeyeye pointed out that 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.

She s, “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”.

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 adding that the listing status is valid for two years and is renewable.

According to her, “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”.

Adeyeye explained that 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 and 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.

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.