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Friday, July 12, 2024

Ambrose Alli varsity-made Glucozil not approved for treatment of diabetes, others -NAFDAC

The National Agency for Food and Drug Administration and Control has refuted the claim that it granted approval for the use of “Glucozil,” a local herbal medicine said to be indicated for the treatment and cure of diabetes and Benign Prostatic Hyperplasia.

Researchers at Ambrose Alli University in Ekpoma, Edo State said they had developed Glucozil, adding that the purported herbal medicine underwent scientific testing and that it was safe for both humans and animals.

Reacting to the viral information on Tuesday [today], the Director-General of NAFDAC, Mojisola Adeyeye, explained that the product was listed by the agency on November 10, 2020, specifically for managing high blood sugar.

“The agency listed Glucozil capsule on November 10, 2020, for the “MANAGEMENT OF HIGH BLOOD SUGAR” (as captured on the approved label and Listing Certificate issued to the applicant) which was valid till 9th November 2022. Therefore, the herbal medicine certificate has expired,” it said.

It added, “As specified in the Herbal Medicine & Related Products Labelling Regulations 2021, this listing was subject to the inclusion of the mandatory Disclaimer “These claims have not been evaluated by NAFDAC” on the product label. This is the regular disclaimer that is used and required for other listed herbal products which have not undergone Clinical Trials that the Agency deemed satisfactory.”

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The statement made it clear that claims of Glucozil being capable of treating, curing, or preventing diabetes, BPH, or detoxification were never approved by NAFDAC and should be disregarded by the public.

“Treatment, Curative and Preventive Claims for Diabetes, Benign prostatic hyperplasia and detoxification were never approved for Glucozil as claimed in the publication and hence should be disregarded by the public.”

The NAFDAC DG further clarified that AAU was neither the manufacturer nor the applicant for the product, rendering the listing invalid. She emphasized that the university should have verified the status of the herbal medicine certificate and its approved claims.

“From our records, Ambrose Alli University was neither the manufacturer nor the applicant of the said product for which the Listing is no longer valid. The University should have verified the status of the herbal medicine certificate and the approved claim.

“Manufacturing, Distribution or Marketing of this product is not allowed until the renewal application has been submitted and approved by the agency.”

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She, however, assured Nigerians that NAFDAC is committed to ensuring public health and safety through stringent regulatory oversight remains steadfast.

“It is crucial to exercise caution when interpreting health-related claims therefore we encourage the public to refer to NAFDAC’s official communications channels for accurate updates and information.”

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