High-moderate risk changes to permissible ingredients - Andrographis paniculata 2026

The Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2026 (the Permissible Ingredients Determination) is a legislative instrument made under section 26BB of the Therapeutic Goods Act 1989 (the Act). This instrument specifies all of the ingredients that may be used in all assessed listed medicines and most other listed medicines, and their associated requirements for use. The Permissible Ingredients Determination is continually reviewed by the Therapeutic Goods Administration (TGA) to ensure that all ingredients and their requirements are appropriate for use in low-risk medicines.

Following the publication of an updated safety review and supplementary report in April 2026, and consideration of submissions received through a targeted consultation (see below), the TGA has decided to remove Andrographis paniculata (Andrographis) from the Permissible Ingredients Determination.

The TGA considers that delaying implementation of this change would likely pose an imminent or serious risk of injury to consumers (see High-moderate risk changes). 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.

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.

Consumers may continue to see and buy listed medicines containing Andrographis, as this change will not immediately affect medicines containing Andrographis that are already listed in the ARTG. The TGA will shortly recommend that sponsors take voluntary action, such as the cancellation of ARTG listings or the recall of their medicines that contain Andrographis. If sponsors do not take timely voluntary action, the TGA will assess whether any of these medicines need to be compulsorily recalled, or their listing in the ARTG cancelled. Consequently, some or all listed medicines containing Andrographis may become unavailable in Australia.

The removal of Andrographis does not mean removing consumers’ access to Andrographis altogether. 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. Under this pathway, individual medicines are assessed by the TGA for safety, quality and effectiveness before they are registered in the ARTG. Registered medicines may be accompanied with consumer medicine information and product information for consumers and health professionals.

Background

Prior to the amendment to the Permissible Ingredients Determination, the ingredient Andrographis was permitted for use in listed medicines and assessed listed medicines by way of its inclusion in the Permissible Ingredients Determination.

The TGA first reviewed Andrographis following concerns about anaphylaxis in 2008 and published a safety review and alert in 2015, with ongoing adverse event monitoring. Since 2020, following High-moderate risk changes to permissible ingredients, all listed medicines containing Andrographis have been required to carry the following label warning about the risk of allergic reactions (including anaphylaxis):

'Andrographis may cause allergic reactions in some people. If you have a severe reaction (such as anaphylaxis), stop use and seek immediate medical attention.' (or words to that effect).

Following a large increase in the number of reports of anaphylaxis in 2019, the TGA has continued to receive a sustained high number of reports of anaphylaxis associated with Andrographis‑containing medicines, which is inconsistent with a listed medicine that would be considered a low-risk medicine. A fatal case was reported in June 2024.

In April 2026, the TGA finalised and published an updated safety review with adverse event data to 31 December 2024 and a supplementary report with updated adverse event figures to 31 December 2025 evaluating the current evidence as to the safety of Andrographis, the effectiveness of current risk-mitigation strategies, and regulatory options for further measures to address the risk. Current evidence regarding the safety of Andrographis considered in the updated safety review and supplementary report included expert advice from a clinical immunology and allergy specialist, advice from the Advisory Committee on Complementary Medicines (ACCM), reported adverse events in Australia and internationally, the formulations of the medicines involved in the Australian adverse events, available published literature since November 2011 and a toxicological review of non-clinical studies.

Decision

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. 

In making the Decision, the TGA considered information which included the following:

• the background to the use of Andrographis in listed medicines in Australia by way of inclusion in the Permissible Ingredients Determination;
• the evidence presented in the updated safety review and supplementary report; and
• the submissions received in response to the consultation.

An amendment to the Permissible Ingredients Determination commenced on 17 September 2026. Removing the ingredient from the Permissible Ingredients Determination means that new medicines containing Andrographis are no longer eligible to be included in the ARTG as listed medicines. Consumers may continue to see and buy listed medicines containing Andrographis, as this change will not immediately affect medicines containing Andrographis that are already listed in the ARTG or present on store shelves. The TGA will shortly recommend that sponsors take voluntary action, such as the cancellation of ARTG listings or the recall of their medicines that contain Andrographis.

Consultation

The TGA invited stakeholders, including consumer associations, health professional associations including complementary medicine health professional associations, affected medicine sponsors and industry peak bodies, to provide feedback on the proposed removal of Andrographis from the Permissible Ingredients Determination under section 26BC of the Act. The targeted consultation commenced on 8 April 2026 and ended 8 May 2026.

All invited responders to this consultation were encouraged to refer to the published updated safety review and supplementary report prior to providing their submissions.

Analyses to the responses submitted to this consultation and the TGA’s comments can be accessed below:

What consumers need to know

From 17 September 2026, Andrographis is no longer included in the list of ingredients that are permitted for use in 'low-risk' listed medicines.

Consumers may continue to see and buy listed medicines containing Andrographis, as this change does not immediately affect medicines containing Andrographis that are currently available for supply in Australia. However, the TGA will shortly recommend that sponsors take voluntary action, such as the cancellation of ARTG listings or the recall of their medicines which contain Andrographis. If sponsors do not take timely voluntary action, the TGA will assess whether any of these medicines need to be compulsorily recalled, or their listing on the ARTG cancelled.

If cancellation or recall action is undertaken, some or all products containing Andrographis may no longer be available for sale in Australia.

In the meantime, consumers should reconsider their need to take products that contain Andrographis given the unpredictable and potentially fatal risk of anaphylaxis associated with its use.

The TGA anticipates that some consumers will continue to take Andrographis-containing products. For those consumers, please keep the following in mind:

• Be aware of the signs of anaphylaxis, which is a severe allergic reaction that can be unpredictable and may be triggered by Andrographis.
• If you or someone else you know is taking or considering taking Andrographis, consider how timely medical care could be accessed should an allergic reaction occur.
• If you or someone else is suspected of having anaphylaxis, seek emergency medical help immediately by calling '000'.
• Always speak to a health practitioner about your individual clinical circumstances.
• Always read medicine labels carefully before using a product.
• If you experience any symptoms of an allergic reaction after taking a product containing Andrographis, stop taking the product and seek immediate medical advice.Severe symptoms require urgent medical attention. These symptoms may include difficult or noisy breathing; swelling of tongue; swelling or tightness in throat; wheeze or persistent cough; difficulty talking or hoarse voice; persistent dizziness or collapse; becoming pale and floppy (in young children); stomach pain or vomiting. 

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

What should consumers do if a medicine is recalled?

If a medicine you use is recalled, you should follow the recall instructions, which may ask you to for example stop taking it, dispose of the product, return it to the place of purchase, or contact the sponsor of the medicine to arrange the product's return.

You are strongly encouraged to speak with a health professional if you have any concerns about a recalled product.

When a recall occurs, we publish information on the TGA's website and social media channels, including the details of the product and what you need to do.

Learn more about what to do if your medicine or medical device is recalled.

What healthcare professionals need to know

Andrographis is used in Indian and Chinese traditional medicine for conditions such as the common cold, flu and liver support. It is often combined with other herbal ingredients, including Echinacea. Andrographis-containing products have historically been available from supermarkets, health food stores and pharmacies for self-selection.

Adverse reactions to Andrographis are unpredictable and can happen the first time someone takes it, or after taking it previously without any issue. Most people affected had no history of allergies or asthma and symptoms usually appear within 30 minutes of consuming Andrographis.

Little is known about why Andrographis causes anaphylaxis. However, general factors that may increase the likelihood or severity of allergic reactions include viral infections, taking anti‑inflammatory medicines (such as ibuprofen), alcohol consumption, or exercising around the time of exposure to the allergen.

Health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

What sponsors and/or manufacturers of existing listed medicines supplied in Australia need to do

The removal of Andrographis from the Permissible Ingredients Determination due to associated safety concerns came into effect on 17 September 2026. This means that new medicines for supply in Australia that contain this ingredient will no longer be eligible for listing in the ARTG.

Unless or until the sponsor takes voluntary action or the TGA takes regulatory action, current ARTG listed medicines containing Andrographis can continue to be supplied. Sponsors of listed medicines containing Andrographis are strongly recommended to take voluntary action in the first instance. For affected medicines, this may include voluntarily cancelling the listing from the ARTG, liaising with your manufacturer(s) to cease manufacturing and releasing stock for supply, and undertaking a consumer-level recall.

Manufacturers should discuss the effect of these changes with relevant sponsors when considering whether to cease manufacturing and releasing stock for supply. Domestic manufacturers are reminded that they may not manufacture and release a medicine unless it is listed or registered on the ARTG, or is the subject of an applicable exemption, approval or authority.

How do I cancel my ARTG entry?

Cancellation requests can be submitted through the TGA Business Services (TBS) portal. Please refer to Request to cancel an ARTG entry for further information.

Once a medicine is cancelled from the ARTG, its sponsor and/or manufacturer can no longer release it for supply.

How do I undertake a recall?

Sponsors should refer to the Procedure for recalls, product alerts and product corrections (PRAC) and submit a draft recall notification through the TGA Business Services (TBS) portal (Business Services > Applications > Market actions) for assessment by the TGA Recalls Section. Do not begin contacting your customers until we have assessed your notification and sent you the TGA agreement letter.

Questions regarding recall notifications can be directed to recalls@health.gov.au.

What happens if I don't take timely voluntary action?

Where sponsors do not take appropriate and timely voluntary action, the TGA will start taking regulatory action from mid-October 2026.

Regulatory action can include ARTG cancellation and/or consumer level recall given that the TGA continues to receive reports of anaphylaxis associated with the use of Andrographis. However, any decision to cancel, recall or take other regulatory action will be specific to each medicine, and will only be made after consideration by the Secretary or their delegate.

What retailers with existing stock need to do

Retailers are encouraged to work with the sponsors of products regarding specific actions, such as removal of affected product from shelves, to be taken during the voluntary action period.

What sponsors of existing listed export-only medicines need to do

Export‑only (EO) listed medicines are included in the ARTG under section 26 of the Act. While EO medicines must meet similar listing criteria to Australian supplied listed medicines, they are not supplied in Australia and must primarily meet the regulatory requirements of the importing foreign country.

EO medicines are not required to exclusively use ingredients included in the Permissible Ingredients Determination. However, inclusion has historically been relied upon as assurance that the ingredient has been assessed as low risk.

Following the removal of Andrographis from the Permissible Ingredients Determination due to identified safety concerns, effective from 17 September 2026, sponsors of EO listed medicines containing Andrographis should review their products and consider the implications of the TGA's safety findings for continued export. In undertaking that review, sponsors should consider:

• the safety concerns identified by the TGA;
• the 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. 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.