The National Agency For Food and Drugs Administration and Control (NAFDAC) has revealed that , the country now officially has one drug that has been submitted to the regulatory agency for approval in treating the novel Covid-19 virus, which has claimed over 290,000 lives worldwide.
The agency in a statement tracked by Apple’s Bite Int’l Magazine on Wednesday, May 13, said it has received only one application from a company that presented for approval in the treatment of the symptoms of Covid-19, stressing it is 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,” read the statement signed by Mojisola Adeyeye, director general of NAFDAC.
Following a series of meetings organized by NAFDAC by setting up the Nigerian Herbal Medicine Product Committee (HMPC) with attendance of Manufacturers, Academia, Researchers and relevant stakeholders, it says call for expression of interest for the COVID-19 related medicines was made. This has led to several researchers and practitioners responding and 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,” said Adeyeye.
It was noted that in production of even modern medicines, among the most important raw materials researched and developed are naturally occurring materials obtained especially from plants. Perhaps fortunately, the statement reiterates that the African continent is blessed with diverse plants and herbs that constitute a source of food and medicine that could help in combating the coronavirus pandemic.
However, considering that many plants are similarly very poisonous, NAFDAC as the Agency saddled with the mandate of safeguarding the health of the citizenry, pledged in the statement to continue to make sure that only medicinal products (including herbal remedies) that have proven safety data will be approved for use by the public.
The Agency says it presently 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.
NAFDAC stressed that this listing 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,” said Adeyeye.