Lagos – NAFDAC on Saturday said it is currently processing 21 herbal medicinal products for ‘Safe to use’ or Listing status, which their manufacturers claim to be effective as immune booster against symptoms of COVID-19.
According to Prof Mojisola Adeyeye, Director General, if the drugs meet the agency requirements, they will be accorded safety listing or listing status.
Adeyeye who disclosed this in a statement made available to Daily Independent, said that the agency only listed Pax Herbal CUGZIN capsule, contrary to reports making rounds that her agency approved the drug.
Adeyeye explained that many manufacturers, including Paxherbal seeking for listing claim that their products are immune boosters and anti-infectives useful for relief of symptoms that could be associated with COVID-19.
However, she said that no clinical study has been done yet on any of the products to prove their claim of efficacy, noting, “NAFDAC is yet to evaluate them.”
The agency further explained that NAFDAC only approve drug to ensure that it is not injurious to consumers and not based on efficacy.
The NAFDAC boss further explained that listing status involves the review of the composition of the formulation, the labelling of the product, the process of manufacture and ‘Safe to use’ testing.
The statement partly reads; “NAFDAC is currently processing 21 herbal medicinal products for ‘Safe to use’ or Listing status. Many of the applicants claim that their products are immune boosters and anti-infectives useful for relief of symptoms that could be associated with COVID-19.
“However, no clinical study has been done yet on any of the products to prove their claim of efficacy.
“Listing status involves the review of the composition of the formulation, the labelling of the product, the process of manufacture and ‘Safe to use’ testing.
“Most of the applicants that submitted herbal medicines that are currently undergoing processing have been issued compliance directives to provide additional information or/and evidence of Good Manufacturing Practice or environment fit for production of the medicines.
It added; “Paxherbal applied for Listing of Pax Herbal CUGZIN capsule 290mg which was approved by NAFDAC and Listed as ‘Safe to use.’ The applicant claimed that it is an immune booster and an anti- infective.
“However, as part of the labelling of the product, and in line with global practice, a Disclaimer is on the product label which clearly states that the claims have not been evaluated by NAFDAC.”
The statement also said; “Once the product is able to meet all requirements, a listing status is granted with a clear Disclaimer that states clearly that claims have not been evaluated by NAFDAC.
“The applicant can arrange for clinical trials that will involve use of human subjects in order to prove efficacy or claim for treatment following laid-down procedures and with the approval of NAFDAC.”
However, listing of an herbal product is not a requirement for the conduct of clinical trials, the Director General stressed.
Therefore, the statements circulating in the social media that NAFDAC has approved Paxherbal product ‘specifically for treating symptoms associated with Coronavirus’ is ‘Wrong’ and ‘Inaccurate.’ Until a clinical study is done in a scientific manner, no herbal medicine manufacturer can claim effectiveness to treat COVID-19 associated symptoms.
Collaborating with Adeyeye, Pax Herbals confirmed that its drug, CUGZIN has been issued a NAFDAC number as an ‘immune booster and anti-infective.’
The manufacturer, posted on its Facebook account; “The drug, CVD PLUS renamed CUGZIN will help to boost body immunity, as there is yet no officially approved drug for the cure of COVID-19.
“We ask our followers to look out on our Facebook page for official statements and be wary of different claims and stories or images on social media about our products. This page remains the only authentic place for news about the activities if Pax Herbals.”