COVID-19: NAFDAC processing 21 Herbal medicinal products

By Chioma Obinna, Vanguard, Nigeria

The National Agency for Food and Drug Administration and Control, NAFDAC, on Saturday, disclosed that 21 herbal medicinal products which their manufacturers claim to be an immune booster against symptoms of COVID-19 were under processing for listing status.

The Director-General of the Agency, Prof Mojisola Adeyeye, in a press statement made available to Vanguard said the herbal products if meet the agency’s requirements would be granted safety approval.

Adeyeye who further dismissed media reports that the agency has approved Pax Herbal CUGZIN capsule for COVID-19 treatment said it only listed it as being safe for consumers and not based on efficacy against the pandemic.

She said many manufacturers, including Paxherbal seeking for listing, had claimed that their products were immune boosters and anti-infectives useful for relief of symptoms that could be associated with COVID-19.

She warned that no clinical study has been done yet on any of the products to prove their claim of efficacy, adding that, NAFDAC was yet to evaluate them.

The agency further explained that NAFDAC only approves drugs to ensure that it is not injurious to consumers and not based on efficacy.

She said: “The listing status involves the review of the composition of the formulation, the labelling of the product, the process of manufacture and ‘Safe to use’

“NAFDAC 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 the 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.

“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.”

“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 the use of human subjects in order to prove efficacy or claim for treatment following laid-down procedures and with the approval of NAFDAC.”

She noted that listing a herbal product was not a requirement for the conduct of the clinical trials.

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.

Collaborating with Adeyeye, Pax Herbals confirmed that its drug, CUGZIN has been issued a NAFDAC number as an ‘immune booster and anti-infective.’

The manufacturer, posted on its Facebook account; “The drug, CVD PLUS renamed CUGZIN will help to boost body immunity, as there is yet no officially approved drug for the cure of COVID-19.

“We ask our followers to look out on our Facebook page for official statements and be wary of different claims and stories or images on social media about our products. This page remains the only authentic place for news about the activities if Pax Herbals.”