From 17 September 2026, the Therapeutic Goods Administration (TGA) removed Andrographis paniculata (andrographis) from the ingredients permitted in new Australian listed medicines.
TGA: Andrographis removed from the listed medicines framework
Why does this matter?
Andrographis is commonly found in products marketed for colds, flu and immune support, including products sold through pharmacies and health-food retailers.
The TGA’s decision follows concerns about severe allergic reactions, including anaphylaxis, which it says cannot be adequately managed through label warnings alone. The TGA reports that a fatal case was reported in June 2024 and that reactions can occur unpredictably, including in people who have previously tolerated andrographis.
What happens to existing products?
Existing products are not automatically removed. Sponsors are being encouraged to voluntarily cancel listings or recall products. If voluntary action does not occur, the TGA says it may consider stronger regulatory action.
What does the evidence show?
The evidence comes largely from post-market adverse-event reports, safety reviews, specialist input and international case information rather than randomised trials designed to measure allergy risk. This means the exact incidence remains uncertain, and some reports involve multi-ingredient products, making attribution more difficult.
However, the TGA concluded that the pattern and severity of reported reactions were not compatible with the low-risk listed-medicine pathway.
What remains unclear?
It is still unclear which formulations or co-ingredients may contribute most to the risk, and whether future andrographis products could meet the higher evidence and oversight requirements of the registered-medicine pathway.
Australian action point:
Check labels for andrographis, Andrographis paniculata, king of bitters, kalmegh or green chiretta.
For signs of a severe allergic reaction — including difficulty breathing, throat or tongue swelling, wheezing, collapse or rapidly worsening symptoms — call 000 immediately.
