The National Agency for Food and Drug Administration and Control (NAFDAC) has approved two herbal drugs for COVID-19 clinical trials.
NAFDAC Director-General, Prof. Mojisola Adeyeye, in a statement Sunday, said three herbal formulations were approved for clinical trial studies during the COVID-19 pandemic.
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She said while two studies had commenced, including the IHP Detox Tea; the third clinical trial study was yet to start.
She denounced the claims of efficacy of IHP Detox Tea for the cure of COVID-19 patients purportedly made by the Chief Executive Officer of Bioresources Development and Cosnservative Programme, Prof. Maurice Iwu, in a national daily.
She said it was worrisome that “such unguided statement was made without the stated fact that no product can be approved by NAFDAC without satisfactory clinical evidence.”
She said the IHP Detox Tea clinical trial study at CMU/LUTH and NAUTH approved for Iwu’s company, was only a pilot study with a small sample size inadequate to make pronouncement on safety and efficacy of the product.
Adeyeye said the World Health Organisation team and other well-meaning individuals in the research space had found the claim on the efficacy of the IHP Detox Tea misleading.
She said preparatory to the WHO team’s visit to Nigeria for the study, NAFDAC officials, on inspection of the clinical trial site of IHP Detox Tea, had found some lapses.
“We discovered some 17 lapses during our inspection visit. We passed the lapses to them as compliance directive to address.’’, she said, adding that the company was yet to respond to the identified lapses by the regulatory authority before making pronouncement that the product is efficacious for the treatment of COVID-19 patients.
She asked Iwu to retract the statement in the same newspapers and any other platform used for such improper and misleading representation of the IHP Detox Tea study within 48 hours from the receipt of the letter and inform the agency on the action to avoid further regulatory sanctions.
Iwu, in his response, said being an unsolicited and independent editorial decision of the newspaper, ‘’we are not in a position to compel the newspaper to retract its story nor retract a story not published by us or at our instance’’.
