Australia widens kalmegh (andrographis) recalls as regulator moves to enforcement

Australia's medicines regulator, the Therapeutic Goods Administration (TGA), has moved into the enforcement stage of its crackdown on andrographis, the bitter herb known in India as kalmegh. The TGA removed Andrographis paniculata from the list of ingredients allowed in low-risk "listed" medicines with effect from September 17, 2026, after linking it to serious allergic reactions, including anaphylaxis. It asked companies to recall or cancel existing products voluntarily and said it would begin regulatory action from mid-October 2026 against those that had not. Recalls are now spreading: six product lines had been recalled by October 8, and further popular immune-support supplements have since been pulled from shelves.

Andrographis has been one of the best-selling herbal ingredients in Australian cold and flu remedies, usually sold as an immune supplement taken at the first sign of a sore throat. For years the TGA tried warnings and label changes. It has now concluded that those steps did not bring down the number of anaphylaxis reports, and that the herb no longer belongs in the category of medicines that can be sold after a company simply certifies its own product. Listed medicines in Australia are not individually checked for safety before sale; registered medicines are. Moving andrographis out of the listed pathway means any future product with the herb would need a full pre-market assessment of safety, quality and effectiveness.

For readers in India the story is close to home. Kalmegh is a familiar plant in Ayurveda. The Indian Council of Agricultural Research describes it as widely used in Ayurveda for conditions such as fever, jaundice, bronchitis, diabetes and skin disease, and its leaves are recognised in Indian pharmacopoeial standards. The Australian decision does not say the herb has no use. It says that, at the doses and forms sold in Australian supplements, the risk of a sudden, severe allergic reaction is too high for a product category that skips individual review.

The case is a clear example of where tradition meets evidence. A plant with a long history of use in one system can still produce new safety signals when it is concentrated into tablets, taken widely by the public, and monitored through a modern adverse-event reporting system. Regulators elsewhere watch such decisions closely, and companies that export herbal products to Australia now face a stricter path.

Australia's andrographis rules at a glance Stage | Date | What it means Ingredient removed from listed medicines | September 17, 2026 | No new low-risk listed products with andrographis Voluntary recalls and cancellations | September to mid-October 2026 | Companies asked to withdraw existing products Regulatory action | From mid-October 2026 | TGA may order recalls or cancel listings Registered pathway | Ongoing | Products allowed only after full TGA assessment

Short-term: Australian shoppers will find fewer andrographis immune products on pharmacy and supermarket shelves as more brands recall stock or cancel listings. Some brands are reformulating, with other botanicals and probiotics under consideration as replacements, according to industry reports. Consumers are advised to check labels and think about whether to keep using products containing the herb.

Long-term: The decision may shape how other regulators view andrographis and similar concentrated herbal extracts. It also raises the bar for Indian and other exporters of kalmegh-based supplements, who would need full registration data to sell in Australia. The TGA has also asked sponsors of export-only products made in Australia to review the safety findings.

Who is affected: Australian consumers who use herbal cold and flu remedies, supplement companies and pharmacies in Australia, exporters of andrographis extracts, and Ayurveda practitioners and manufacturers who follow international regulatory trends on traditional herbs.

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