COVID-19: NAFDAC clears the air on alleged approval of Paxherbal product

Posted by News Express | 11 July 2020 | 1,464 times

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By NKECHI ONYEDIKA-UGOEZE, Abuja

The National Agency for Food and Drug Administration and Control (NAFDAC) Sunday said it has not approved any herbal mixture for the treatment of COVID-19.

The director-general of NAFDAC, Prof Mojisola Adeyeye described as inaccurate, the reports that the agency NAFDAC has approved a Paxherbal product “specifically for treating symptoms associated with Coronavirus.”

Adeyeye explained that no clinical study has been done on any of the products to prove claims of efficacy, that until a clinical study is done in a scientific manner, no herbal medicine manufacturer can claim effectiveness to treat COVID-19 associated symptoms.

“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,” Adeyeye said.

“The applicant can arrange for clinical trials that will involve the 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 the 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.” (Text, excluding headline, courtesy Saturday Guardian)


Source: News Express

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