The TGA said it has removed Andrographis paniculata (Andrographis) from the Permissible Ingredients Determination in an announcement today (September 18).
The move comes after the TGA’s safety review consultation with targeted industry stakeholders in April this year, where the regulator raised concerns about anaphylaxis associated with Andrographis supplement use.
As of December 31, 2025, the TGA had received 287 reports of anaphylaxis associated with Andrographis-containing medicines.
Andrographis is used in Indian and Chinese traditional medicine for conditions such as the common cold, flu and liver support. In supplements, it has been used to relieve common cold, flu and mild URTI symptoms. The ingredient is also often combined with other herbal ingredients, including Echinacea.
“Adverse 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. “Most people affected had no history of allergies or asthma and symptoms usually appear within 30 minutes of consuming Andrographis.”
“The TGA considers that delaying implementation of this change would likely pose an imminent or serious risk of injury to consumers,” it added. “Accordingly, an amendment made under section 26BC of the Act to remove the ingredient Andrographis from the Permissible Ingredients Determination commenced on 17 September 2026.”
The Permissible Ingredients Determination consists of ingredients that the TGA recognizes as low-risk and can be used in all assessed listed medicines and most listed medicines.
In Australia, health supplements are regulated as listed medicines, assessed listed or registered medicines, based on their level of risk to consumers, which is determined by the ingredients they contain and their intended use.
All listed medicines, assessed listed or registered medicines must be listed in the Australian Register of Therapeutic Goods before they can be sold in Australia.
“Removing the ingredient from the Permissible Ingredients Determination means that from 17 September 2026, new medicines containing Andrographis are no longer eligible to be included in the Australian Register of Therapeutic Goods (ARTG) as listed medicines,” the TGA added.
What about existing products?
Current ARTG-listed medicines containing Andrographis can continue to be supplied.
However, the TGA also said that it would be in touch with sponsors shortly and it would “strongly recommend” that sponsors either cancel their Andrographis products’ ARTG listings or recall these products.
While sponsors can voluntarily cancel or recall their products, the TGA also said that it would, from mid-October, assess whether any of these medicines needed to be compulsorily recalled, or their listing in the ARTG cancelled, if sponsors did not take “timely voluntary action”.
“Consequently, some or all listed medicines containing Andrographis may become unavailable in Australia,” the regulator said.
The alternative pathway
Although Andrographis can no longer be used in listed and assessed listed medicines in Australia, it can still be available to consumers through the registered medicines pathway, the TGA said.
The registered medicines pathway is designed for health supplements and OTC medicines considered as relatively higher risk than listed and assessed listed medicines.
All registered medicines are assessed by the TGA for quality, safety and efficacy before they are sold in the Australian market. The product sponsors, in this case, must also provide high-quality evidence to support the medicine, such as data from human clinical trials.
Registered complementary medicines that have successfully undergone the pathway may also apply to use the ‘TGA assessed’ claim on their products.
“The removal of Andrographis does not mean removing consumers’ access to Andrographis altogether,” the TGA said. “This is only to ensure that medicines containing Andrographis are regulated in a way that better matches its safety risks. This can be done via the registered medicines pathway.”
What about export-only products?
For sponsors of export-only (EO) listed medicines containing Andrographis, the TGA said that they should review their products and consider the implications of the TGA’s safety findings for continued export.
For instance, sponsors should consider the safety concerns identified by the TGA, regulatory requirements of the importing country and whether continued inclusion in the ARTG as an EO-listed medicine remains appropriate.
“The TGA may consider further regulatory action in relation to individual EO-listed medicines where safety concerns are identified,” said the TGA. “Any such action would be considered on a case-by-case basis, considering the circumstances of the medicine, available evidence and the relevant legislative framework.”
“Regulatory action may include ARTG cancellation or notification to relevant overseas regulatory authorities where considered appropriate. Any decision to take regulatory action would be made following consideration by the Secretary or their delegate,” the TGA added.
