Again. NAFDAC denies approving Paxherbal product for COVID-19 treatment

The National Agency for Food and Drug Administration and Control says there is no truth to statements circulating in the social media that it has approved a Pax Herbal product for the treatment of symptoms associated with the COVID-19 global pandemic.

This is the second time in less than three months that the regulatory agency will be denying granting approval for alleged COVID-19 drugs made by Pax Herbal.

Last May, PUNCH HealthWise had reported that Pax Herbal had issues with NAFDAC over its herbal formulation, Pax CVD Plus, which it said was a likely COVID-19 cure.

In this latest case, Cugzin, a Pax Herbal medication, is being touted as approved by the regulatory agency for the management of COVID-19 symptoms.

Pax Herbal is a Nigerian alternative medicine product manufacturing company founded by Fr. Adodo Anselm in 1996 at Ewu Monastery, situated in Esan Central Local Government area of Edo State.

The controversial information, wildly circulated via the cross-platform messaging app WhatsApp, states, “Cugzin: Nafdac number: A7-4358L Fr Anselm: After a series of screening spanning 8 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. PAXHERBAL CUGZIN: Nafdac number: A7-4358L.”

When contacted, NAFDAC emailed a Press release denying the Pax Herbal claim.

The statement, signed by NAFDAC’s Director General, Prof. Mojisola Adeyeye, states, “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.”

Explaining the steps involved in listing products for approval, NAFDAC states, “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 a herbal product is not a requirement for the conduct of clinical trials.”

The federal agency said 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.

Zeroing in on Pax Herbal, the agency said, “Pax Herbal 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 Pax Herbal 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.”

Concerning Pax Herbal’s claim for its Pax CVD Plus as a likely COVID-19 cure, NAFDAC had also issued a disclaimer that it had neither registered nor approved Pax CVD Plus or any drug whatsoever, for the treatment of COVID-19.

A Press release signed by Adeyeye denied every claim made in an advertorial by Pax Herbal Clinic and Research Laboratories.

Adeyeye said the advertorial made a claim that Pax Herbal had developed a herbal drug called Pax CVD Plus for the treatment of COVID-19 and was working with NAFDAC to speed up approval for its use.

“The same advertorial claimed that I appointed experts to work with Pax Herbal on what the company has described as a special project.

“I wish to inform the public that Pax CVD Plus has not been registered or listed for treatment of COVD-19; neither have we registered nor listed any other remedy for COVID-19.

“The clinical trial has not taken place. It is, therefore, unfortunate that Pax Herbal has made claims that are not backed up by facts.

“This response is intended to correct the erroneous impression created by the advertorial,” Adeyeye said in the Press release.

When contacted, Director of Pax Herbal Clinic and Research Laboratories, Rev Fr. Anselm Adodo, denied telling the regulatory agency that his firm had a drug or cure for COVID-19.

“What we said was that we have a herbal formulation that has the potential to treat COVID-19, just like the type Prof. Maurice Iwu came up with.

“We did not say it was a ‘drug,’ but a formulation we had worked on.

“As a regulator, it is only fair we bring it to NAFDAC’s attention for evaluation and subsequent registration if it meets the requirements,” he said.

The priest, however, noted that perhaps the “only mistake” Pax Herbals made was to share the story on its Facebook wall, which subsequently went viral.

He said the reactions that greeted the post must have put pressure on the agency.

“Such reactions are expected, though, because people have come to trust Pax Herbal products over the years and probably felt the formulation was a good herbal initiative both NAFDAC and NCDC could consider in the fight against the novel coronavirus.

“However, NAFDAC warned that they didn’t like being put on the spot and asked us to pull down the post and correct the impression we painted.

“We went back to Pax Herbal Facebook [page] and did what they requested” Adodo said.

He said the company had also been told not to continue with the formulation, despite being reassured that it was subjected to observatory trial.

“NAFDAC asked us not to go further with the herbal formulation until a proper clinical trial has been concluded.

“We have so far complied with the directive, until this recent public disclaimer and media trial we are still trying to understand.

“As it stands, there is little or nothing we can do. We leave this case to the media and the Nigerian people to judge,” he said. (Healhwise)