At last, the National Administration for Drugs and Food Control is said to have approved herbal remedy for the treatment of COVID-19 that has killed thousands globally.
Recall that NAFDAC had given tacit approval for the use of the drug, resulting in the initial packs of the herbal remedy bearing the disclaimer, “these claims have not yet been verified by NAFDAC.”
The Director of the Pax Herbal Clinic and Research Laboratories, Ewu, Edo State, Nigeria, Rev. Fr. Anslem Adodo, OSB, who broke the news said: “after a series of screening, spanning eight weeks, NAFDAC has today approved our PAXHERBAL Covid-19 herbal drug, PAXHERBAL CUGZIN, for public use.”
In their internal memo, Fr Anselm Adodo said, “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.”
This as is as NAFDAC in a statement described as wrong and inaccurate the statements circulating in the social media that NAFDAC has approved Paxherbal product “specifically for treating symptoms associated with Coronavirus.
The drug- PAXHERBAL CUGZIN with NAFDAC number A7-4358L, had earlier been produced under the brand name of “CVD PLUS” before it was rebranded to “PAX HERBAL CUGZIN”. The novel drug is in capsules form and is packaged in a container of eighty 290mg capsules, each containing Garcinia Kola, Curcuma Longa, and Zingiber officinale.
In an interaction with Fakaday, an online publication, Rev. Fr. Dr. Jerome Ejim, OSB, said the drug has undergone NAFDAC serious NAFDAC screening through animal testing and clinical trials before approval was given for distribution.
According to him, the drug meant for curative and preventive serves as an immunity booster, and an anti-infective drug, warning pregnant women and children under 11 years old not to use it.
On April 29, 2020, the Pax Herbal Clinic and Research Laboratories, in a press statement on its official Facebook Page, wrote “ABOUT CURE FOR COVID-19,” though the claim was really about the “TREATMENT” of COVID-19.”
Earlier in an interview with Catholic Herald, Rev. Fr. Dr. Anselm Adodo, whose doctoral degrees are in Management of Technology and Innovation, and Medical Sociology, had said, “we have herbal medicines for many of the diseases that plague our people.
“For more than 25 years, we have been producing herbal medicines for diabetes, hypertension, asthma, malaria, prostrate problem, male and female infertility and others. For those 25 years, we have strived to maintain the same high standard and consistency. The only thing is that we are poor at making noise about what we do. Those who use the products make noise for us.”
Meanwhile, NAFDAC says it is currently processing 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.
Professor Mojisola Adeyeye, Director-General, NAFDAC in a statement said 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.”
According to her, “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 herbal product is not a requirement for the conduct of Clinical Trials.
“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.
“Until a clinical study is done in a scientific manner, no herbal medicine manufacturer can claim effectiveness to treat COVID-19 associated symptoms,” she noted.
