The Therapeutic Goods Administration (TGA) continues to receive reports of lead poisoning linked to imported or unregistered Ayurvedic medicines contaminated with heavy metals. Laboratory testing by state health organisations prior to referral to us confirmed the presence of lead, mercury and arsenic in several products.
These include:
- Haidyanath Sundary Sakhi tablets - lead, arsenic, mercury
- Sharmayu Som Pushpa - lead, arsenic
- Unjiha Pushpadhanva Rasa - lead, arsenic, mercury
- Baidyanath Rajahprawartini Bati - lead, arsenic, mercury
- Acineutra tablets - lead, mercury
- Flexy tablets - lead, mercury.
If high levels of lead are present in products, taking them could result in lead poisoning. Lead poisoning is a serious condition that can cause long-term health effects up to and including organ damage and death. Pregnant women and children are at a great level of risk of lead poisoning.
Two additional products were associated with reported adverse events but were not subject to laboratory testing. Both were determined to likely have elevated heavy metal content based on product labelling or listed ingredients:
- SG Phyto Pharma Palsinurion - label declares ingredients containing naga bhasma (lead) and/or shuddha parada (mercury).
- Kamini (brand unknown) tablets - often labelled with shuddha parada or shuddha hingula (purified cinnabar/mercury); previously subject to a safety advisory.
Some substances found in Kamini and similar products are also prohibited imports under the Customs (Prohibited Imports) Regulations 1956. Importing these substances without the appropriate license or permit may result in infringement notices, or civil or criminal penalties.
In addition to these findings, the TGA has:
- continued to intercept unregistered Ayurvedic medicines at the border
- removed online advertisements for products containing ingredients that may indicate the presence of heavy metals.
Several intercepted products also contain ingredients that are within Schedule 10 to the Poisons Standard, which are prohibited for supply and use in Australia due to their associated health risks. Examples include:
- Acorus calamus - also known as calamus, vacha, sweet flag
- Azadirachta indica - also known as neem
- Note: debitterised neem seed oil is regulated differently.
- Melia azedarach - also known as white cedar, Persian lilac, chinaberry, umbrella tree.
Regulation of Ayurvedic medicines in Australia
In Australia, Ayurvedic medicines are regulated as listed medicines (also known as complementary medicines) and must meet the same safety and quality standards as other medicines. They must not contain dangerous substances or heavy metals at levels that pose a risk to health.
Why choose regulated medicines
To confirm if a product is on the Australian Register of Therapeutic Goods (ARTG), check for an AUST R or AUST L number on the packaging. This number confirms that the medicine is included on the ARTG and meets Australian standards including:
- the ingredients listed on the label are accurate
- the claims made are not misleading
- the product was manufactured under strict safety and quality standards.
Products without an AUST R or AUST L may not meet Australian standards and pose potential health risks. Whether purchased online or from local retailers, they may be unsafe, ineffective or a waste of money.
For further information on how we regulate registered and listed medicines, visit the TGA website.
Information for consumers
These risks highlight the importance of making informed choices when purchasing medicines. We advise consumers to exercise extreme caution when purchasing medicines from unknown overseas websites.
Products purchased over the internet:
- may be fake
- may contain incorrect or undisclosed and harmful ingredients
- may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia.
If you are considering purchasing medicines from overseas, watch this short video on the risks associated with buying medicines and medical devices online. For your safety, always buy medicines from reputable sources and consult your healthcare provider or local registered pharmacy if you have any questions.
Importing and supplying any unregistered Ayurvedic products is illegal, even if they don’t contain prescription-only ingredients.
If you, or someone you care for, has any of the products listed above, do not use them and take any remaining product to your local pharmacy for safe disposal.
If you have already taken any of these medicines, seek medical advice from your doctor or contact the Poisons Information Centre on 13 11 26.
If you suspect you have had a side effect (adverse event) to this or other products, please contact the TGA on 1800 020 653 or make a report via our website.
Information for health professionals
Health professionals also play a key role in identifying and managing these risks. Please be aware of the risks associated with unregistered Ayurvedic medicines and advise patients accordingly. Health professionals are encouraged to report adverse events involving medicines, including unapproved medicines. These reports assist the TGA in identifying previously unknown side effects and other safety issues.
In January 2025, the Victorian Department of Health also published an updated health advisory in relation to Ayurvedic medicines containing lead, other heavy metals and scheduled poisons.
Action we are taking
The TGA continues to monitor signals relating to harmful unregistered products and will notify the Australian Border Force (ABF) to seize and destroy any of these products intercepted at the border.
Reporting problems
Consumers are advised that the TGA cannot provide advice about individual medical conditions. If you are concerned about a possible side effect associated with a medicine or vaccine, please speak with a health professional.
You are also encouraged to report the side effect to the TGA as this helps us monitor and respond to emerging safety concerns.
If you suspect non-compliance in relation to therapeutic goods, you can report a perceived breach or questionable practice online to the TGA.
We also encourage the reporting of non-compliant advertising.
| Phone: | 1800 020 653 |
| Online: | Report a problem or side effect |
| Email: | info@tga.gov.au |