The certificate issued to Ambrose Alli University, AAU, Ekpoma, Edo, to produce Glucozil herbal capsules for the management of diabetes has expired, NAFDAC declared in Abuja on Tuesday.
Its Director-General, Prof. Mojisola Adeyeye, said that NAFDAC didn’t give approval of the drug, however solely listed it on Nov. 10, 2020.
She defined that the drug was listed for the administration of excessive blood sugar as said on the permitted label and itemizing certificate issued to the college.
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,” Mrs Adeyeye said.
She added that the eye of NAFDAC had been drawn to a information publication of Aug. 24 that NAFDAC had permitted AAU’s Glucozil herbal medication for diabetes.
She famous that the media publication claimed that Glucozil had been scientifically examined with security established in each people and animals.
Mrs Adeyeye said that the college ought to have verified the standing of the herbal medication certificate and the permitted declare.
She confused that manufacturing, distribution or advertising and marketing of the product was not allowed till the renewal utility had been submitted and permitted by NAFDAC.
“From our records, Ambrose Alli University was neither the manufacturer nor the applicant for approval of the said product,” Mrs Adeyeye confused.
NAN