TGA tightens rules for Andrographis medicines
25 Sep 2026
Andrographis is a herbal ingredient used in medicines for conditions such as colds and flu. Products containing it have been available from pharmacies, supermarkets and health food stores without a prescription.
The change took effect on 17 September 2026. New medicines containing Andrographis can no longer be listed in the Australian Register of Therapeutic Goods (ARTG) as listed medicines.
The TGA said the risk of severe allergic reactions, including anaphylaxis, could not be managed well enough under the listed medicines pathway.
The regulator has continued to receive reports of anaphylaxis linked to Andrographis-containing medicines. A fatal case was reported in June 2024. By 31 December 2025, the TGA had received 287 reports of anaphylaxis linked to these medicines.
Medicines already listed in the ARTG will not be removed immediately. Some products may therefore remain available while sponsors consider voluntary action, including cancelling their listings or recalling products.
If sponsors do not take timely action, the TGA may consider stronger regulatory measures from mid-October 2026, including compulsory recalls or cancellation of ARTG listings.
The TGA said the decision does not mean Andrographis will no longer be available in Australia. Medicines containing the ingredient may instead need to go through the registered medicines pathway, where individual products are assessed for safety, quality and effectiveness before registration.
Warnings about allergic reactions have been required on Andrographis-containing medicines since 2020. The TGA also issued a safety alert in 2024, while one sponsor introduced a stronger warning. However, reports of anaphylaxis have continued.
The TGA says reactions can occur the first time a person takes Andrographis or after previous use without problems. Symptoms usually appear within 30 minutes.
Health professionals are encouraged to consider patients' individual circumstances, discuss the potential allergy and anaphylaxis risk, and report suspected problems with medicines to the TGA.
TGA tightens rules for Andrographis medicines
Source: Therapeutic Goods Administration (TGA).