Stakeholders to be consulted on proposal to remove Andrographis paniculata as a low-risk ingredient

The Therapeutic Goods Administration (TGA) has begun consultation on a proposal to remove Andrographis paniculata (Andrographis) from the list of permitted ingredients in listed medicines. The Permissible Ingredients Determination is a list of low-risk ingredients that are permitted in listed medicines.

Andrographis is found in a range of herbal medicines that are intended for relief of cold and flu and can be purchased at pharmacies, supermarkets and health food stores without a prescription. 

The proposal to remove Andrographis from the permitted ingredients list follows a number of reports of anaphylaxis. Anaphylaxis can be a life‑threatening allergic reaction requiring immediate emergency medical treatment.

Anaphylaxis associated with Andrographis can be rapid and unpredictable. It can occur on first use or after previous uneventful use, even in people with no history of allergies. Symptoms can appear within 30 minutes of taking the medicine and often require urgent medical treatment.

The TGA has invited stakeholders, including consumer associations, health professionals, medicine sponsors and industry peak bodies, to provide feedback on the proposed removal of Andrographis from the permitted ingredients list. All responses will be considered before any final decision is made.

The TGA has also published an updated safety review of Andrographis, with in depth analysis of adverse event data up to 31 December 2024, and a supplementary report considering adverse event data up to 31 December 2025. For more information, visit our webpage Andrographis paniculata (Andrographis) and anaphylaxis - updated safety review and supplementary report.

Consumers are advised to refer to the updated safety review and supplementary report webpage for information on what they should consider before taking Andrographis.

Contact for members of the media:

• Email: news@health.gov.au
• Phone: 02 6289 7400