A local herbal clinic and laboratory based in Edo tried to evade NAFDAC label and subtly planted in the media that its herbal product Paxherbal Cugzin has been certified by the federal government as safe for use for treating Covdi-19 symptoms.
But the National Agency for Food and Drug Administration has denied approving the herbal product by Pax Herbal Clinic and Laboratory.
According to a disclaimer by NAFDAC, the drug is only one of the 20 applicants who seek approval for their drugs, mostly immune boosters anti-infectives, they have not tested clinically—drugs which the agency categorises under Listing.
However, no clinical study has been done yet on any of the products to prove theIr claim of efficacy, according to a statement by NAFDAC.
Listing status, which Paxherbal Cugzin belongs, involves the review of the composition of the formulation, the labelling of the product, the process of manufacture and “Safe to use” testing.
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.
But, Listing of a herbal product is not a requirement for the conduct of Clinical Trials, the statement added.
Paxherbal, in other words, is not approved.
It only applied for Listing which was approved by NAFDAC and Listed as “Safe to use”.
“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,” the agency said.