The certificate issued to Ambrose Alli University (AAU) Ekpoma, Edo, to produce Glucozil herbal capsules for the control of diabetes has expired, NAFDAC declared in Abuja on Tuesday.
Its Director-General, Prof. Mojisola Adeyeye, stated that NAFDAC did not give approval of the drug, but only listed it on Nov. 10, 2020.
She explained that the drug was listed for the management of high blood sugar as stated on the approved label and listing certificate issued to the university.
The certificate, she added, expired on Nov. 9, 2022.
“Treatment, curative and preventive claims for diabetes, benign prostatic hyperplasia and detoxification were never approved for Glucozil as claimed by the university and should be disregarded by the public.
“As specified in the Herbal Medicine and Related Products Labelling Regulations (2021), the listing was subject to the inclusion of the mandatory disclaimer.
“This is the regular disclaimer that is used and required for other listed herbal products which have not undergone clinical trials that NAFDAC deem satisfactory.
“The claims on the product’s label have not been evaluated by NAFDAC,’’ Adeyeye stated.
She added that the attention of NAFDAC had been drawn to a news publication of Aug. 24 that NAFDAC had approved AAU’s Glucozil herbal medicine for diabetes.
She noted that the media publication claimed that Glucozil had been scientifically tested with safety established in both humans and animals.
Adeyeye stated that the university ought to have verified the status of the herbal medicine certificate and the approved claim.
She stressed that manufacturing, distribution or marketing of the product was not allowed until the renewal application had been submitted and approved by NAFDAC.
“From our records, Ambrose Alli University was neither the manufacturer nor the applicant for approval of the said product,’’ Adeyeye stressed. (NAN)