COVID-19 Drug: Only One Researcher Has Submitted Request For Approval, Says NAFDAC

The National Agency for Food and Drug Administration and Control (NAFDAC) on Wednesday said that it has received only one application for approval of a product for the treatment of COVID-19 symptoms and not a cure for a disease.

This was in spite of NAFDAC’s call for expression of interest for the COVID-19 related medicines, and efforts of the Agency to guide researchers and practitioners on how best to submit such medicines to NAFDAC for expedited review.

NAFDAC Director-General Prof Mojisola Adeyeye in a statement on Wednesday explained that the essence of passing through a thorough and strict test process of the herbal products was because of the harmful nature of some of the herbs.

“That Africa as a continent is blessed with diverse plants and herbs that constitute a source of food and medicine is incontrovertible. But a claim of a cure for any disease must be subjected to clinical evaluation through well-controlled, randomised clinical trials following an approved clinical trial protocol.

“Many of these plants are very poisonous. However, NAFDAC as the agency with the mandate of safeguarding the health of Nigerians will continue to ensure that only medicinal products, including herbal remedies, that have proven safety data would be approved for use by the public.

“Presently, the Agency lists herbal medicines based on a 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 for human consumption. The listing status is valid for two years and is renewable,” Prof Adeyeye said.

The NAFDAC boss said the agency is committed to the advancement of herbal products, hence the decision to set up the Nigerian Herbal Medicine Product Committee (HMPC) which brings together manufacturers, academia, researchers and relevant stakeholders to bridge the gap often created between traditional medicine practitioners (possible patent holders) and drug manufacturers, whose responsibility it would be to formulate the products.

She said the aim was to translate the research into herbs into commercial products with proven safety and efficacy, promising that the agency will continue to encourage all stakeholders to present the products of their research findings and allow them to go through the internationally-recognised process of approval through pre-clinical and, where applicable, clinical trials.

She, however, reaffirmed NAFDAC’s commitment to encouraging and supporting sponsors with appropriate guidance to expedite the development of effective interventions to treat or prevent COVID-19.