THE TGA has provided a detailed response to its consultation on the newly implemented "list of permitted indications" (PD 08 Mar), detailing the reasoning behind the outcome which has seen more than 1,000 indications, including some using traditional Chinese or Ayurvedic terminology.
During the consultation process several groups, including Friends of Science in Medicine, scoffed at some of the proposed indications as "bizarre" and "not supported by scientific evidence" (PD 09 Feb).
The TGA has provided feedback on the process, saying its approach of using Traditional Chinese Medicine (TCM) and Ayurvedic specific indications and supporting terminology is "consistent with international developments".
In particular the agency pointed out that the World Health Organization's Traditional Medicine Strategy "recommends member states appropriately use traditional medicine terms in their regulatory, legislative and policy initiatives around traditional and complementary medicine products and practices".
In addition, the TGA has accepted advice from the Advisory Committee on Complementary Medicines to mandate the addition of a label advisory statement on medicines using Ayurvedic and TCM indications stating: 'Please seek the advice of a traditional Chinese (or Ayurvedic) medicine practitioner if you are unsure if this medicine is right for you'.
Such complementary medicines must also now state that the indication is based on traditional evidence, and specify the paradigm e.g. 'Traditionally used in Chinese herbal medicine'.
The TGA noted that almost 3,000 additional indications were proposed for inclusion in the list.
Last year's consultation period saw over 100 submissions received.
The above article was sent to subscribers in Pharmacy Daily's issue from 10 May 18
To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 10 May 18
