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AAU’s Certificate To Produce Herbal Drug For Diabetes Has Expired – NAFDAC Speaks
AAU’s Certificate To Produce Herbal Drug For Diabetes Has Expired – NAFDAC Speaks
In Abuja on Tuesday, the National Agency for Food and Drug Administration and Control (NAFDAC) announced that the certification granted to Ambrose Alli University (AAU), Ekpoma, Edo State, for the production of Glucozil herbal capsules for diabetes management has expired.
According to Prof. Mojisola Adeyeye, the Director-General of NAFDAC, the agency did not provide approval for the drug; rather, it was included on the list of products on November 10, 2020.
This inclusion was solely for the purpose of managing high blood sugar, as indicated on the authorized label and listing certificate given to the university.
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The certificate, she elaborated, officially lapsed on November 9, 2022.
Adeyeye underscored that the claims made by the university regarding Glucozil, particularly regarding its efficacy for treating diabetes, benign prostatic hyperplasia, and detoxification, were never sanctioned by NAFDAC and should be disregarded by the public.
As stipulated in the Herbal Medicine and Related Products Labelling Regulations (2021), the listing necessitated the inclusion of a mandatory disclaimer. This disclaimer is a standard requirement for other listed herbal products that haven’t undergone clinical trials that meet NAFDAC’s standards.
“The statements on the product’s label have not undergone evaluation by NAFDAC,” stated Mrs. Adeyeye.
She brought attention to a news article published on August 24, which erroneously claimed that NAFDAC had granted approval to AAU’s Glucozil herbal medicine for diabetes. The article asserted that Glucozil had been subjected to scientific testing with confirmed safety for both humans and animals.
Adeyeye stressed that the university should have confirmed the status of the herbal medicine certificate and the approved claims before making such declarations.
Furthermore, Adeyeye emphasized that any manufacturing, distribution, or marketing of the product is prohibited until a renewal application is submitted and approved by NAFDAC.
Contrary to the claims made, Ambrose Alli University was neither the manufacturer nor the applicant seeking approval for the mentioned product, according to Mrs. Adeyeye.
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