11th July, 2020
By Abankula
Professor Moji Adeyeye, director-general of NAFDAC has debunked the claim that a Nigerian herbal medicine has been approved to treat or cure COVID-19 cases.
“There is no cure for COVID-19 at the moment”, she told P.M.News on phone.
NAFDAC, spelled as National Agency for Food and Drug Administration and Control is the regulatory authority for all food and medicine in Nigeria.
Adeyeye was reacting to a viral claim by the Director of the PaxHerbal Clinic and Research Laboratories, Ewu in Edo State, Rev. Fr. Anslem Adodo, that his herbal remedy, Paxherbal Cugzin has been approved for the treatment of symptoms associated with COVID-19.
“After a series of screening, spanning eight weeks, NAFDAC has today approved our PaxHerbal COVID-19 herbal drug, PaxHerbal Cugzin, for public use.
“It is the first to be so approved and presently the only one. The drug is specifically for treating the symptoms associated with the coronavirus.”
He said NAFDAC had earlier given approval for the drug to be used, even though the body was yet to make that approval official; hence the initial packs of the herbal remedy bore the disclaimer, “these claims have not yet been verified by NAFDAC.”
But with that hurdle crossed, PaxHerbal Cugzin now has the NAFDAC number: A7-4358L.”, Adodo claimed.
NAFDAC issued a rebuttal on Saturday, describing the claim as ”wrong and inaccurate”.
“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”, Adeyeye said.
Read the full statement:
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. 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”. 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.
*Prof Mojisola Adeyeye, Director General NAFDAC
However, Listing of a herbal product is not a requirement for the conduct of Clinical Trials.
The applicant claimed that it is an immune booster and an anti- infective.