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NSW company KL4 Pty Ltd (Medcure) fined $106,560 for alleged unlawful importation of Ayurvedic medicines

1 December 2021

The Therapeutic Goods Administration (TGA) has issued eight infringement notices totalling $106,560 to KL4 Pty Ltd (trading as Medcure), for the alleged importation of Ayurvedic medicines in breach of the Therapeutic Goods Act 1989 (the Act).

The company allegedly imported Ayurvedic medicines that were not entered in the Australian Register of Therapeutic Goods (ARTG) at the time of importation, including Ayurvedic medicines containing Schedule 10 substances in the current Poisons Standard. These medicines are of such danger to health they are banned from sale, supply and use in Australia.

Under the Act, therapeutic goods must be entered in the ARTG before they can be lawfully imported into Australia unless a specific exemption, approval or authority applies.

In Australia, Ayurvedic medicines (sometimes known as traditional medicine) are a type of complementary medicine that are generally required to meet the same standards of quality and safety as other medicines. Ayurvedic medicines must not contain dangerous substances or heavy metals at levels that pose an unacceptable risk to the health and safety of Australian consumers.

Banned substances declared in recent importations of Ayurvedic medicines include:

  • Acorus calamus - also known as calamus, Vacha, sweet flag
  • Azadirachta indica - also known as neem, including its active components, in preparations for human internal use (except for debitterised neem seed oil)
  • Melia azedarach - also known as White Cedar, Persian Lilac, Chinaberry and Umbrella Tree.

If you suspect non-compliance in relation to therapeutic goods, you can report illegal or questionable practices online to the TGA.

The TGA also encourages the reporting of suspected non-compliant advertising.