Six-month suspended sentence for selling and supplying herbal medicines without a marketing authorisation

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A 48-year-old man was sentenced yesterday to six months’ imprisonment suspended for two years and 200 hours of unpaid work for selling and supplying herbal medicines to the public without a marketing authorisation.

Ramchandre Damle of Southall, Middlesex, pleaded guilty to three counts of selling and supplying the medicinal products, ‘DBCare’, ‘BControl’ and ‘SX Power’.

The Medicines and Healthcare products Regulatory Agency (MHRA) issued a warning to the public about DBCare in 2008 as it claimed it could allow patients to stop taking their prescribed diabetic medication.

This case came to the attention of the MHRA after it received a complaint concerning an advertisement in the publication, ‘Pravasi Times’, which contained a website operated by Ace Continental Exports Ltd.

The MHRA reviewed the three medicines in question to determine they were relevant medicinal products, then ordered the company to withdraw them from sale. However, further investigation revealed that they had not been withdrawn and the company was in possession of quantities of all three drugs which were intended to be placed on the market.

Invoices provided by Mr Damle disclosed that the income received by the company for unauthorised sales of each product from 2005 to 2008, totalled approximately £70,000. The court has been invited to consider making a confiscation order against Mr Damle.

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 said, “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 customers’ health nor are they healthcare professionals. Their only motivation is financial gain.”

For Assistance with Obtaining Herbal Marketing Authorisation and THMP Registration Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Drug Regulators, MHRA, publish updated guidance on advertising traditional herbal medicines.

The guidance is intended for advertisers of traditional herbal medicinal products (THMs) holding a registration certificate granted by the MHRA under the Traditional Herbal Medicines Registration Scheme. This is the Scheme that implements the requirements of the Traditional Herbal Medicines Directive (Directive 2004/24/EC). Products registered under this Scheme must meet established standards of safety and quality for medicines but, instead of the recognised efficacy standards required for a marketing authorisation, the product must have been used for at least 30 years (at least 15 of which must normally have been within the EU) to demonstrate long-standing traditional use in the specified conditions of use.

General Statement

It is a central feature of the traditional herbal medicine registration scheme that the products concerned do not fulfil the requirement to demonstrate efficacy for a marketing authorisation. In particular, such products will not fulfil the efficacy requirements for a well-established medicinal use. There is one additional requirement for advertising of these products, to include a specified form of wording to inform the consumer that the efficacy of the product for the stated indications is not scientifically supported but is based exclusively on evidence of long-standing use.

“Traditional herbal medicinal product for use in [specify one or more indications for the product consistent with the terms of the registration] exclusively based upon long-standing use as a traditional remedy”.

The exact wording above must be used (with the italic section completed with appropriate indication(s) for use of the product).

Indication Statement

Advertisements must include at least one indication for use of the product. Wordings that imply efficacy has been demonstrated such as “clinically proven”, “effective for …” or “works fast to relieve …” are unlikely to be acceptable.

Reference to Clinical Trials

In order to ensure that consumers are not misled when presenting the results of limited clinical studies, it is important to make clear the basis on which the product was registered, i.e. that there were insufficient clinical data to demonstrate the efficacy of the product. In practice, given the nature of the traditional herbal scheme, it would be particularly difficult, in brief advertisements, to make reference to clinical trial data without misleading consumers. In principle it may be more feasible that compliance with the regulatory requirements may be achievable in a longer, more narrative type of advertisement (‘advertorial’), but the practicalities of this would need careful consideration.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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