Safety Alert: Ambrose Ali University’s certificate to produce Glucozil for diabetes has expired –NAFDAC

*Prof. Mojisola Adeyeye, Director-General of Nigeria’s health regulatory agency, alerts consumers to disregard the ‘treatment, curative and preventive claims for diabetes, benign prostatic hyperplasia and detoxification were never approved for Glucozil’, as claimed by the University

Alexander Davis | ConsumerConnect

The National Agency for Food and Drug Administration and Control (NAFDAC) has disclosed the certificate earlier issued to Ambrose Alli University (AAU) Ekpoma, in Edo State, to produce Glucozil herbal capsules for control of diabetes has expired,

ConsumerConnect reports Prof. Mojisola Adeyeye, Director-General of NAFDAC, stated this Tuesday, August 29, 2023, in Abuja, FCT.

Adeyeye noted the attention of NAFDAC had been drawn to a news publication of August 24 this year, in which the University had claimed approval and lauded NAFDAC for approving AAU’s Glucozil herbal medicine for diabetes.

She, however, clarified that the health regulatory agency did not give approval of the drug, but only listed it November 10, 2020.

The Director-General of NAFDAC explained the drug was listed for the management of high blood sugar, as stated on the approved label and listing certificate issued to the university.

According to Adeyeye, the certificate so issued expired November 9, 2022.

What herbal medicine and related products regulations say

She also stated: “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.”

Adeyeye further said: “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.”

She equally recalled that  that the media publication claimed that Glucozil had been scientifically tested with safety established in both humans and animals.

What AAU ought to do before publicity

Adeyeye also said that the University’s research team ought to have verified the status of the herbal medicine certificate and the approved claim before going public with the information.

NAFDAC as well stressed that manufacturing, distribution or marketing of the product was not allowed until the renewal application had been submitted and approved by NAFDAC.

Adeyeye stated: “From our records, Ambrose Alli University was neither the manufacturer nor the applicant for approval of the said product.’