Regulation of herbal medicines not inadequate says TGA


The TGA has hit back at claims the regulation of traditional herbal  medicines is inadequate in Australia.

The criticisms come from a paper published in this week’s MJA that says the “light touch” regulation of the herbal and complementary medicines industry means “dosages can be inconsistent, contents inaccurately listed, and toxic and pharmaceutical contaminants and adulterants may be present in herbal medicines”.

This was an unsatisfactory situation which the government and regulatory bodies, including the TGA, should respond to with “great urgency” say the authors from Adelaide and Perth.

However a spokeswoman for the TGA said the paper largely referred to examples from overseas.

“Australia has an internationally well regarded regulatory system for all medicines, including herbal and other complementary medicines.”

“Only ingredients that are known to be safe can be used in herbal medicines,” she said.

Referring to an overseas example cited in the paper where Stephania tetrandra was substitued by Aristolochia fangchi containing the nephrotoxin aristolochic acid, the TGA said it banned the use of all aristolochia species and any herb that could be mistaken for aristolochia.

“Any species that might contain the substance aristolochic acid must undergo TGA pre-approval process. Every single batch of a product that is at risk of being inadvertently contaminated with aristolochic acid must be tested using TGA approved methods before it can be sold here,” the spokeswoman confirmed.

“The thrust of the MJA paper, that regulation of complementary medicines in Australia is inadequate, is contrary to the finding of the recent independent review – Medicines and Medical Devices Review – which found that most submissions to the review were generally supportive of the current regulatory framework but that there were opportunities to improve consumer confidence in the efficacy of complementary medicines”.

“Importantly, there were no negative findings in relation to the current regulatory arrangements in relation to the oversight of quality matters, which is the issue raised by the MJA article” she added.

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