Andrographis paniculata (andrographis), also known as green chiretta, has been barred from new medicines entering the Australian market, the Therapeutic Goods Administration announced on Monday.
Existing medicines containing andrographis will not be removed from the market immediately, but the TGA has encouraged suppliers to recall products containing the herb.
Native to India and Sri Lanka, andrographis is commonly used in Ayurvedic and Chinese traditional medicine to support immunity and combat cold and flu symptoms.
Around 80 products containing andrographis are listed on the Australian market, some of which are available from supermarkets, health food stores and pharmacies.
The ingredient has attracted growing industry concern in recent years following reports of anaphylactic reactions and one fatality in June 2024.
"We have continued to receive reports of anaphylaxis linked to medicines containing andrographis," the TGA said.
"The TGA has decided to remove andrographis from the Permissible Ingredients Determination on the basis that the risk of severe allergic reactions (including anaphylaxis) is not adequately mitigable within the listed medicines framework."
The decision follows a safety review in April, which found the medicine was responsible for 1368 reactions up to December 2025, including almost 300 cases of anaphylaxis.
Allergic reactions to andrographis are unpredictable and can happen the first time someone takes it, or after taking it previously without any issue, the TGA said.
Little is known about why andrographis causes anaphylaxis and most people affected have no known history of allergies or asthma.
The sector's peak advocacy body, Complementary Medicines Australia, criticised the ban, calling for andrographis to be managed with warnings, like other medicines including paracetamol and antibiotics.
"A blanket ban that denies hundreds of thousands of Australians access to a product they have used safely is not the right approach, and there is strong evidence to show a significant number of consumers will turn to online products that do not contain any warning at all," it said in a statement.
Suppliers are strongly encouraged to take voluntary action to stop manufacturing supplements containing the ingredient and undertake a consumer-level recall.
The TGA will take regulatory action from mid-October to remove the medicine from supply if companies fail to voluntarily recall their products and stop manufacturing.
Australian company BioCeuticals said it has stopped releasing stock for its ArmaForce and Clinical ImmuneForce supplements, which both contain the ingredient, and are engaging with the TGA.
"The health and safety of consumers is our highest priority," the company said in a statement.
Consumers are currently advised to check whether their medicines contain andrographis and consider whether to continue using it.
The ingredient is expected to be diverted to the registered medicines pathway, which requires more vigilant regulation and consumer medicine information.
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