National Agency for Food and Drug Administration and Control (NAFDAC) has said that the agency is currently processing 21 herbal products for “Safe to use” or Listing status which it said most of the applicants claimed to be immune boosters and anti-infectives, and can be used to relief symptoms that could be associated with Coronavirus.
NAFDAC however warned that until a scientific clinical study is concluded, no herbal medicine manufacturer can claim effectiveness to treat coronavirus associated symptoms.
This was contained In a statement, yesterday, in Abuja, by the Director General of NAFDAC, Prof. Mojisola Adeyeye, who described as inaccurate, the reports circulating in the social media that NAFDAC has approved Pax herbal product specifically for treating symptoms associated with Coronavirus.
She explained that no clinical study has been done yet on any of the products to prove their claim of efficacy adding 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.
She added that listing of a herbal product is not a requirement for the conduct of Clinical Trials.
According to Adeyeye, “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.
“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.
“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.”
