- Says Pax Herbal not approved for treating COVID-19
The National Agency for Food and Drug Administration and Control (NAFDAC) on Saturday debunked rumours that it has approved Pax Herbal, to treat COVID-19.Reacting to news that Pax Herbal has been approved to treat COVID-19 as wrong and inaccurate because it only listed and approved the product as ‘safe to use’ and not for its efficacy in treating COVID-19.
The agency explained further that although it is currently evaluating twenty-one (21) herbal medicines to determine how safe they are to consume, no herbal medicine in the country has been approved to treat COVID-19 associated symptoms because none have gone through clinical trials with humans.
The Director-General of NAFDAC, Prof. Mojisola Adeyeye, made this known in a statement in Abuja.
She said, “NAFDAC is currently processing twenty-one (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.
“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.”
Adeyeye added, “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.
“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.”