Ramchandre Damle, of Southall, Middlesex, pleaded guilty to three counts of selling and supplying ‘DBCare’, ‘BControl’ and ‘SX Power’, which were deemed to be unauthorized diabetic medicines.
The Medicines and Healthcare products Regulatory Agency (MHRA) had issued a public warning about DBCare and pursued the action after seeing a local newspaper ad for the three products marketed by Ace Continental Exports Ltd.
It ordered the company to withdraw the products, and took further action after it became apparent its order had been ignored.
Damle is estimated to have sold about £70,000 (€82,000) worth of the products between 2005 and 2008.
Ill-gotten financial gain
MHRA Head of Herbal Medicine Policy, Richard Woodfield said: “This case is an example of very poor practice in part of the unlicensed herbal sector and shows the risk that can arise where serious unauthorised claims are made for unlicensed herbal products.”
“In contrast, the public can be assured that herbal medicines registered under the Traditional Herbal Registration scheme meet the assured standards of safety and manufacture, and that they come with authorised information for consumers about the safe use of the product."
MHRA Head of Operations, Danny Lee-Frost added: “The conscious supply of dangerous products such as these proves that some individuals and companies will blatantly flout regulations in order to make money. They have no consideration for their customer’s health nor are they healthcare professionals. Their only motivation is financial gain.”
Other region compliance?
However, while DBCare may not have approval for sale in the UK, it is freely sold in many places on the internet with one website boasting of its US Food and Drug Administration (FDA) and Indian Food and Drug Control Administration (FDCA)-authorisation as an ayurvedic medicine.
“All Our Products are in Compliance with all FDA Rules & Regulations, USA and are Approved by the FDCA, India,” the website states.
It goes on to claim: “Helps you to lower your blood sugar levels naturally with our ayurvedic formula.”
And then: “We promise that DBCare :
- Will naturally help you drop 60 Points in 30 Days
- Will naturally help control blood sugar levels
- Will naturally give you more energy
- Will naturally lead to an active lifestyle
- Will naturally help you lose weight
- Will naturally improve bladder control
- Will naturally alleviate any tingling sensations
- Will naturally clear up blurred vision
- DBCare has no side effects”
While the product formulation may be approved for sale by the FDA and FDCA, recent FDA warning letter activity indicate the agency would consider such claims medicinal, and demand they be amended or removed.