The article in Medical Republic brings attention to a case of lead poisoning in a Canadian woman attributed to Ayurvedic medicine, raising concerns about similar issues with complementary medicines in Australia. The study from the University of Queensland demonstrates that only five reported cases of lead poisoning from complementary medicines in Australia were reported in the 15 years between 2005 and 2020, mostly due to unregistered (illegal) products.
While addressing the potential health risks of any medicine is essential, it's crucial to acknowledge that in Australia, all legal herbal and nutritional medicines including Ayurvedic products have strict lead limits and are subject to ongoing regulations to ensure that lead does not enter the product supply chain here.
Regulated Products and Unregistered, Illegally Imported Products
The Therapeutic Goods Administration (TGA) regulates Ayurvedic products in Australia as complementary medicines and has the most robust measures for these products compared to any other country in the world. Ayurvedic medicine, originating in India has a rich history and is globally embraced; many individuals experience benefits from these practices.
To prevent risks, the distinction between properly regulated Ayurvedic products and illegally imported ones is critical. In addition to responding to high-risk allegations of non compliance regarding products, theAustralian Government will: gather and use intelligence to identify higher-risk products and trends, share information with other health and law enforcement agencies to enhance understanding of supply chains and usage patterns and target advertising of unapproved products on digital platforms.
The TGA's regulatory system also effectively protects public health by addressing potentially dangerous illegal products, as demonstrated by the investigations and warnings on the illegal products mentioned in the article. Since 2008, the TGA has worked with Australian Border Force as part of Operation Pangea to prevent illegal products entering the country and have prevented 307,000 units of unlawfully imported therapeutic goods entering the country. Complementary Medicines Australia has actively supported the TGA in taking actions against illegally imported complementary medicines.
Strict Regulatory Limits in Australia
Australian-made complementary medicines are committed to quality and safety, adhering to strict legal limits on contaminants. The TGA's regulatory framework ensures that products entered onto the Australian Register of Therapeutic Goods (ARTG) meet safety standards and that any adverse events are thoroughly investigated.
The TGA requires manufacturers to follow testing procedures for materials including herbs and other ingredients used in Ayurvedic products. The TGA has legal standards that set strict limits on lead and other heavy metals, which are determined by internationally harmonised standards developed by the European Medicines Agency. Although these standards do not apply to herbal medicines in other countries, they do in Australia.Products that do not meet legal safety standards are required to be recalled.
Dr Moses incorrectly states in the article that Australian complementary medicines are under no obligation to warn people about potential side effects or drug interactions; this is untrue. Regulated medicines have significant safety reporting requirements and must apply a host of label warning statements where determined necessary by the TGA. Important drug interactions are also mandated to be included on product labels.
The TGA regularly inspects manufacturing sites, ensuring compliance with Good Manufacturing Practice (GMP) pharmaceutical-level standards, and routinely conducts tests and audits of products within the Australian marketplace to monitor risk and compliance actively; this shows that Australian regulated herbal medicines are safer and more reliable than anywhere in the world.
Enhancing Public Awareness
While valid concerns are raised by Dr Geraldine Moses including the use of products that are not on the ARTG, it's necessary to consider that the complementary medicine industry, including Ayurvedic products, contributes to overall wellness for many individuals, and that there are safe, regulated products available. Consumers and practitioners must look for products that contain an ‘AUST L’ ‘AUST LA’ or ‘AUST R’ number on the label.
Engaging in respectful discussions and ongoing education with clinicians, patients, academia, and industry is essential for understanding the benefits and risks of complementary medicine through best practices and only using regulated products must not be understated.
