Andrographis is out of the listed medicines framework: what sponsors should do now
The TGA has removed Andrographis from the permitted ingredients for new listed medicines. If it is in your range, here is the sequence to work through.
In short. From 17 September 2026, new medicines containing Andrographis paniculata can no longer be listed on the ARTG. Medicines already listed are not cancelled automatically, but the TGA has said it expects sponsors to act, and that it will start regulatory action from mid-October 2026 if they do not.
What the TGA decided
The TGA removed Andrographis from the Permissible Ingredients Determination after continuing reports of anaphylaxis, including a fatal case reported in June 2024. It concluded the risk of severe allergic reactions cannot be managed well enough under the listed medicines pathway, which is designed for lower risk products.
What it means for products already on the market
Existing listings stay on the ARTG for now, so Andrographis products are still on shelves. The TGA is asking sponsors to cancel the ARTG entry voluntarily or to recall where appropriate. If sponsors do not act in good time, it has flagged stronger action, including compulsory recalls and ARTG cancellations. A recall notice for Andrographis products has already been published on the TGA site.
A sensible order of work
1. Find every product. Check every ARTG entry you sponsor for Andrographis, including blends and products where it is a minor herbal component, and check what is in stock, in transit and in production.
2. Stop the pipeline. Pause manufacture and hold the release of stock for supply while you decide what to do.
3. Decide: cancel or reformulate. You can cancel the entry voluntarily. A reformulated product without Andrographis is a different product and needs to be assessed against the current rules before it is listed or varied.
4. Recall properly if you need to. The TGA asks sponsors to follow its recall process and to agree the approach with the TGA before contacting customers. Do not email your customer list first.
5. Check your advertising. Take down or update website pages, listings, social posts and wholesaler materials that promote the product while you work through the above.
6. Keep the record. Note what you decided, when and why. If the TGA asks, a clear timeline is your best answer.
Export only products
The TGA notes that sponsors of export only listed medicines containing Andrographis should also review their products and consider what its safety findings mean for continued supply.
The wider lesson
A permitted ingredient today is not a permanent one. Build a regular check of the Permissible Ingredients Determination into your product calendar, and read the TGA's update notices when they land.
This article is general information, not legal advice. Check the current TGA notices for your products.
- TGA, Andrographis removed from listed medicines framework because of allergy risk, 21 September 2026: tga.gov.au.
- TGA, High-moderate risk changes to permissible ingredients: Andrographis paniculata 2026, 18 September 2026: tga.gov.au.
- TGA, Andrographis recalls: Concerns over allergy risk, 1 October 2026: tga.gov.au.
- Therapeutic Goods (Permissible Ingredients) Determination, as in force.
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