Enforcement news

Recent prosecutions

140,000 illegally imported diet patch treatments
seized by TGA investigators in Sydney

Recent prosecutions by the Surveillance Unit have resulted in the convictions of:

• A Melbourne man in relation to the importation of alarge quantity of herbal ecstasy tablets; and
• A Sydney company in relation to several importations of medical devices used in the termination of pregnancy.

Prohibited claims

The marketing of products, often by mail order or at exhibitions, that promise a "miracle cure" is of particular interest to the TGA Surveillance Unit. These products are being promoted for indications which are prohibited under Schedule 2 to the Regulations in relation to what they can cure. Such claims have included cancer, AIDS, arthritis, leprosy, multiple sclerosis and diabetes. In other cases the claims have been of a more cosmetic nature and have included cures for baldness, obesity and ageing.

21 pallets of illegally imported traditional
Chinese medicine drug products seized by
TGA investigators in Sydney

The promotion of these products is designed to appeal to persons who are long term sufferers, often of incurable diseases, who may be enticed into the use of a "miracle cure".

Such promotion to the public is unlawful under Australian legislation and is often associated with unregistered products and unlicensed manufacturers. The Surveillance Unit pays particular attention to the sponsors of goods not included in the Australian Register of Therapeutic Goods (ARTG). The unit also provides support to the co-regulatory activities of the APMA, PMAA and the NFAA in relation to breaches of the Therapeutic Goods Advertising Code.

Counterfeit drugs

At a recent international workshop on counterfeit drugs hosted by the World Health Organization (WHO) in Geneva, the WHO reported that of the 751 cases of counterfeit drugs detected over the past eight years, 25% came from industrialised countries.

TGA Surveillance Unit statistics disclose that of the 577 criminal offences charged by the unit in Australia over the past five years, 87 or 15%, involved counterfeit drugs.

The counterfeiting of both prescription and over the counter medicines has been detected by the TGA with offences including the complete manufacture of counterfeit product; the substitution of ingredients; the production of counterfeit labels and packaging and the fraudulent production of documentation.

The WHO workshop recommended the development of close national collaboration between drug regulatory authorities, customs, police and the industry. The Surveillance Unit enjoys strong operational cooperation with customs, police and overseas regulatory authorities. The unit also acknowledges and encourages strong liaison with industry in combatting the threat posed by the distribution of counterfeit product to both public health and the integrity of the industry.

TGA publications

There is a large variety of TGA publications. Those available to the public can be found in the TGA Publications List available from the TGA Publications Office (1800 020 653 or 02 6232 8610) and on our Internet site. Most publications are available from this Office, but a number (especially TGA Acts and Regulations) are only available from Government Info Shops.

Apart from TGA News the TGA also publishes the Australian Adverse Drug Reactions Bulletin <http://www.tga.gov.au/adr/aadrb.htm>, the Australian Therapeutic Device Bulletin <http://www.tga.gov.au/docs/html/atdb/tdbindex.htm>, the GMP Newsletter, the Laboratory Information Bulletin <http://www.tga.gov.au/docs/html/lib/libindex.htm> (all free) and Australian Recalls and Cancellations ($60.00 per year).