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Ayurvedic medicines

27 April 2005

The Therapeutic Goods Administration (TGA) is aware of recent research into the toxic heavy metal content of some Ayurvedic herbal medicine products from India and Pakistan that are available in the United States.

Firstly, it should be noted that the United States system for regulating these types of products is very different to the Australian system.

In Australia, medicines such as Ayurvedic and traditional Chinese medicines are classified as 'complementary medicines', and are generally required to meet the same standards of quality and safety as other medicines. In the United States, these products are regulated as 'dietary supplements', and are not required to meet such standards.

Complementary medicines available in Australia must be included in a central database maintained by the TGA. All manufacturers of complementary medicines must be licensed by the TGA.

Sponsors of complementary medicines supplied in Australia are required to ensure that their products contain safe amounts of incidental metals and non-metals that may be potentially hazardous, but whose presence is unavoidable. This includes heavy metals in herbal and other ingredients. The presence of such components should not represent an unacceptable risk to public health and safety.

As part of providing assurance that medicines are of high quality and safety, the TGA has a post-market monitoring program for monitoring the safety of complementary medicines supplied in Australia. This includes monitoring reports of suspected adverse reactions, and testing of complementary medicines for quality, including heavy metal content.

However, certain medicines do not come under the control of the TGA. Individuals are able to import certain medicines into Australia for personal use or by a member of their immediate family. Medicines imported for personal use may not be approved for supply in Australia, and this means that the TGA cannot provide assurances about their safety, quality or effectiveness.

The TGA considers the use of medicines that are not approved for supply in Australia to be experimental. People wishing to use these products should bear in mind that no assurance can be given regarding their quality, safety or effectiveness. Patients should discuss the use of any unapproved medicines with their health practitioner to determine whether such a medicine is suitable for them.

In May 2003, the Australian Government established the Expert Committee on Complementary Medicines in the Health System to review the regulatory, health system and industry structures related to complementary medicines. The Expert Committee's Report was released on 31 October 2003.

The expert committee made 49 recommendations on a range if issues related to complementary medicines, including that a communication strategy be developed to better inform consumers of the potential risks associated with the personal importation of complementary medicines that may not be manufactured to the same standards of medicines available in Australia.

The Australian Government's Response to the Expert Committee's recommendations was released on 9 March 2005.

The Government will work in an active and consultative way with stakeholders to determine the specific enhancements required and to enable effective implementation of the recommendations agreed upon.