In 2014, the TGA examined cases of allergy and anaphylaxis regarding Andrographis paniculata ('Andrographis'), and published a safety alert in 2015. At that time, industry supported the introduction of a warning statement for this herb with adequate transition time, however, a warning statement was not implemented by the TGA.

Additional cases of allergy and anaphylaxis have been reported since 2015, and the TGA have signalled that they are intending to require a new allergy and anaphylaxis label warning statement for immediate implementation in mid-October (2019), for any Andrographis medicine that is 'released for supply' from the date of the upcoming October Permissible Ingredients Determination. 

If you are a sponsor with an Andrographis product, please be aware of an upcoming announcement. CMA are examining whether there are possibilities to minimise impacts.