ANTA Submission to the TGA Regarding Andrographis Paniculata

ANTA has formally responded and provided a submission to the Therapeutic Goods Administration (TGA) consultation regarding the proposal to remove Andrographis Paniculata from the list of permitted ingredients for listed medicines. 

As a national professional association representing practitioners across Naturopathy, Western Herbal Medicine, Chinese Herbal Medicine and Ayurvedic Medicine, ANTA recognises the seriousness of anaphylaxis and the important role of the TGA in protecting public safety. 

At the same time, ANTA does not support the immediate blanket removal of Andrographis from the permitted ingredients list at this stage. Instead, ANTA has called for a staged, proportionate and evidence-informed regulatory response that strengthens consumer safety while maintaining appropriate access through regulated channels. 

ANTA’s Position 

In its submission, ANTA acknowledges that adverse reactions associated with Andrographis must be taken seriously. However, ANTA has expressed concern that immediate removal may be disproportionate without further analysis of where and how risks are arising, including whether concerns relate to specific formulations, combinations, labelling practices or patterns of use. 

ANTA has advocated for a graduated approach that includes: 

  • stronger warning statements and clearer front-of-pack advisory language 
  • improved sponsor compliance and pharmacovigilance obligations 
  • enhanced practitioner and consumer education 
  • closer investigation of formulation-specific risks 
  • a measured review process before considering full removal of the ingredient. 

Supporting Public Safety and Regulatory Balance 

ANTA’s submission highlights the importance of balancing public protection with practical regulatory outcomes. Noting, that removing Andrographis entirely from regulated listed medicines may unintentionally reduce visibility of warnings, weaken traceability and encourage sourcing through less regulated pathways. 

The submission also recognises the implications for qualified practitioners who currently utilise herbal medicines within lawful clinical practice settings. ANTA has encouraged the TGA to carefully consider both consumer safety and the broader operation of the existing regulatory framework before making a final decision. 

Continuing Engagement 

ANTA remains committed to evidence-informed regulation, professional standards and public safety. ANTA has welcomed ongoing engagement with the TGA as the consultation process continues and will continue advocating for regulatory approaches that are both protective and workable for practitioners, consumers and the broader natural healthcare sector. 

ANTA Members can access and download the full PDF via the ANTA Member Portal.