Stakeholders consulted on Andrographis removal from permitted medicines
Summary
TGA proposes removing Andrographis from permitted medicines
What changed
TGA has opened consultation on removing Andrographis paniculata from the Permissible Ingredients Determination, which lists low-risk ingredients permitted in listed medicines. The proposal follows documented cases of anaphylaxis, including rapid-onset reactions occurring within 30 minutes that can happen on first use or after previous uneventful use, even in individuals with no allergy history. The agency published updated safety data covering adverse events through December 2025.
Affected parties include medicine sponsors, manufacturers, and retailers of Andrographis-containing herbal products marketed for cold and flu relief. If finalized, the removal would prohibit these products from being sold as listed medicines in Australia. Stakeholders including consumer associations, health professionals, industry peak bodies, and medicine sponsors are invited to provide feedback before any decision is made.
What to do next
- Review TGA's safety review and supplementary report on Andrographis anaphylaxis cases
- Submit feedback to TGA on the proposed removal before the comment deadline
- Assess product portfolio for Andrographis-containing medicines and plan alternative formulations
Archived snapshot
Apr 8, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Stakeholders to be consulted on proposal to remove Andrographis paniculata as a low-risk ingredient
Published
8 April 2026
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- Email 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 Topics
- Safety monitoring and information
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