Therapeutic Goods Administration issues warnings over heavy metals in Ayurvedic tablets

Australia's medicine watchdog has issued another safety warning for three unapproved Ayurvedic medicines found with "extremely high" amounts of heavy metals.

The Therapeutic Goods Administration issued the warnings after finding unsafe levels of mercury, lead, arsenic and cadmium in them.

The TGA urges anyone taking Brahmi Vati tablets or Kumar Kalyan Rasa tablets manufactured by Unjha Ayurvedic Pharmacy to stop and dispose of any remaining pills at their local pharmacy.

The same advice has been issued for Manasamitra Vadakam tablets manufactured by SKM Siddha and Ayurvedha after it was also found to contain a prohibited herb on the TGA's poisons list.

While it is illegal to import and supply unapproved Ayurvedic medicines in Australia, individuals can purchase them from overseas for limited personal use.

There have been several consumer warnings issues for unregistered Ayurvedic medicines in recent years.

Earlier this year, the Victorian health department reported cases of lead poisoning from consuming imported Ayurvedic medicines with high levels of heavy metals. 

Lead poisoning can cause long-term health effects like organ damage and death, with pregnant women and children most at risk.

While exposure to even small amounts of mercury can be toxic to organs and the nervous, digestive and immune systems.

What is Ayurvedic medicine?

Ayurveda is a type of traditional complementary medicine system that supports conventional medicine and is increasing in popularity.

The Australian Ayurvedic herbal market is expected to grow 11 per cent annually over the next decade taking its worth from $174m to $529m by 2034, according to Research and Markets. 

Ayurvedic medicine originated from ancient India where it remains a widely used traditional medicine system.

Naveen Shukla, president of the Australasian Association of Ayurveda, said Ayurveda was a "time-tested … complete system of medicine" that combined ancient and modern knowledge and practices.

Ayurveda seeks to rebalance the energies of the mind, body and sprit through tailored diets, yoga, breathing exercises, physical therapy and herbal medicine.

Ayurvedic medicines refer to the therapeutic products like pills, powders and ointments used in this system.

But medical experts say evidence supporting the therapeutics benefits of many Ayurvedic medicines is limited because they have not undergone rigorous clinical trials required in Western medicine.

What are these tablets?

The Brahmi Vati tablets flagged by the TGA are often used to support memory, Kumar Kalyan Rasa tablets claim to help immune function in children, and Manasamitra Vadakam tablets are used to support mental wellbeing.

Dr Shukla is a qualified Ayurvedic practitioner in India and Australia and has been practising for more than 28 years.

He said most Ayurvedic medicines consisted of herbs and minerals.

But a small, specialised class of medicines were made up of minerals and metals like nanoparticles of gold, ash, or ash of iron which he said were banned in Australia.

Dr Shukla said the TGA-flagged Kumar Kalyan Rasa medicine from India was an example of this metallic class of medicine.

Besides being made of metallic compounds, another reason why high levels of heavy metals could be found in imported Ayurvedic medicines was because heavy metals were often used during the extraction process of some herbs.

These levels of heavy metals while permitted in India, exceeded Australian limits for what was considered safe.

Dr Shukla recommended people only get Ayurvedic medicines from fully insured and registered practitioners qualified with an Advanced Diploma in Ayurveda.

How do these medicines get into Australia?

While it is illegal to import and supply unregistered Ayurvedic medicines, individuals can legally order medicines online for personal use if they have a prescription or it was less than a three-month supply.

Since most Ayurvedic medicines found in India were not approved for Australian distribution, many individuals were ordering them online, Dr Shukla said.

He said people also preferred to be treated by familiar practitioners from their home countries out of habit, a shared language, or the perception they were more knowledgeable, like a well-trusted family GP.

"But [those practitioners] were not equipped to know what was available here or have the knowledge to know what medicines are allowed in Australia."

Overseas medicines were also cheaper because TGA-approved ones had to undergo strict testing regimes and tended to be Australian-made, he said.

"When it comes to our health, we should not compromise."

Dr Shukla wanted more people to understand that there were many qualified practitioners in Australia who knew how to substitute unavailable medicines in line with TGA regulations.

"Half of the problems will be solved if people contacted an Australian practitioner instead of someone back home."

How are complementary medicines regulated?

All therapeutic goods sold and supplied in Australia including complementary medicines and traditional medicines must be tested by the TGA unless they are exempt.

Adjunct Associate Professor Jennifer Hunter from the University of Sydney said Australia had one of the best regulatory frameworks for complementary medicines but there were still gaps.

Dr Hunter is on the TGA's Advisory Committee for Complementary Medicines and said herbs used for therapeutic purposes could also fall under the food standards which made them tricky to regulate.

For example, a traditional Chinese medicine, Ayurvedic or naturopathic practitioner can compound and dispense raw herbs regulated as foods without needing to meet TGA standards for complementary medicine, because their accreditation allowed them to do so.

Asian supermarkets also stocked packaged combinations of raw medicinal herbs as "functional foods", she said.

As a GP, Dr Hunter said these store-bought foods were traditionally consumed to support mothers after childbirth, or to support energy or digestion.

So long as no therapeutic claims were made, these pre-packaged herbs were legal to sell.

She said ginseng was a well-known herb consumed to improve energy, memory, focus and general wellbeing.

"You can buy a lot of very potent ginseng products and extracts that are regulated as foods and not as medicines, yet they definitely have therapeutic doses in them that can interact with some medications."

She advised people taking or planning to take complementary medicines or functional foods at high doses to seek professional advice from a doctor, pharmacist or health practitioner trained in herbal medicine.

Is my complementary medicine safe?

Consumers should look for an AUST R or L number on the product which meant the medicine met Australian standards and was safe to use.

An R number indicated the medicine was "registered" on the Australian Register of Therapeutic Goods (ARTG) and underwent a more comprehensive evaluation for higher risk ingredients and therapeutical indications.

Lower risk medicines that have their ingredients and indications approved are "listed" on the ARTG and have an L number.

Without these numbers the TGA warned the medicine could be unsafe, ineffective or a waste of money.

But Dr Shukla advised against self-prescribing Ayurvedic medicines even with AUST numbers.

"When you are having it for therapeutic purpose, you need proper guidance."