A study published in the Journal of Pharmaceutical and Biomedical Analysis
, highlights that inappropriate substances were found in several herbal medicines purchased from Australian pharmacies and other outlets. Again, Complementary Medicines Australia (CMA) wishes to share the facts about this world-leading complementary medicines industry in Australia. And why Australians can be confident in the Therapeutics Goods Administration (TGA) listed and registered products which have been subjected to the highest standards of quality control and testing in the world.
“The Complementary Medicine (CM) industry expected to be worth an estimated US$180 billion by 2020,” say the authors and this is an Australian success story. An increasing number of jobs in Australia rely on this exemplary industry. And, worldwide, discerning companies and consumers have done their research and want to purchase complementary medicines from our highly regulated industry.
“It is of zero benefit for the industry to intentionally adulterate products and damage this important and blossoming industry in this country. Our quality control is world-class. Our reputation relies on it,” says Carl Gibson CEO of Complementary Medicines Australia (CMA).
Australian standards = the global benchmark
Australia has the most highly regulated environment in the world for complementary medicines. These are manufactured to a pharmaceutical standard under principles of Good Manufacturing Practice (GMP). Products meet strict guidelines set by the TGA. For Australian products, what you read on the label is what you get inside.
Widely, vociferously and repeatedly stated
Products in the study were purchased in Australian capital cities; pharmacies, health food stores, traditional herbal retailers and online. It has been widely, vociferously and repeatedly stated that the CMA does not recommend products from overseas be purchased online or in person.
Regulation and testing
Stringent regulations are applied when Australian products are manufactured and distributed. And, the TGA also conducts post-market control to monitor the continuing quality, safety and efficacy of CMs via:
· Auditing good manufacturing practices
· Selected and random audits of Listed products, laboratory testing of products and surveillance in the marketplace
· A strong pharmacovigilance program, which involves the assessment of adverse events that are reported to the TGA by consumers
· Implementation of an effective, responsive and timely recalls procedure
· The placement of controls for the advertising of therapeutic goods.
· Batch testing of finished products (tablets /capsules) that verifies the consistency and quality of the active ingredients within the label claim. To enhance consumer safety and confidence in Australian products and ensure compliance post-market and prevent potentially dangerous products from being sold in the first place.
To be a listed medicine on the Australian Register of Therapeutic Goods (ARTG) a product:
• can only contain certain low risk ingredients in acceptable amounts that are permitted for use in listed medicines by the TGA
• must be manufactured in accordance with the principles of Good Manufacturing Practice (GMP)
• can only make indications (for therapeutic use) for health maintenance and health enhancement or certain indications for non-serious, self-limiting conditions.
Along with the requirement to comply with the TGA’s mandated standards, Carl Gibson stresses that many factors determine the overall quality of ingredients in complementary medicine including their design, development, in-process controls, GMP controls, and process validation plus by specifications applied to them throughout development and manufacture.
“The compositional guidelines, specifications, and monographs are an important component of quality assurance, but these aren’t the only important factors. All of these considerations are necessary to ensure consistent production of high-quality complementary medicines,” says Carl Gibson.
He adds: “Be assured, where complementary medicine products, including herbal medicines are concerned if you see a product in your pharmacy which is registered on the Australian Register of Therapeutic Goods (ARTG) the accurate identification of medicinal herbs is a legal requirement. It would not be possible to meet consumer expectations without it.”
Complementary medicines in Australia are more strictly regulated than products from the USA and even the UK, complementary medicines, including finished product herbal medicines. DNA barcoding is not considered to be the most appropriate testing method for authenticating products, especially those that contain herbal medicines and botanical extracts.
Those complementary medicines sold legally in Australia must be entered on the ARTG. They are subject to assessments and requirements related to quality and safety, including:
• Verification and identification testing methods include botanical taxonomy, macroscopic and microscopic examination, and chemical methods.
• The utilisation of ingredients assessed as safe and allowed at safe levels by the TGA.
• Stability studies to ensure that the product remains effective and safe throughout its shelf life.
• Product quality reviews to ensure that quality data is aggregated and tracked over time, allowing the industry to identify and act on any emerging trends.
• The rigorous capturing and monitoring of adverse events by the TGA so that any emerging issues can be identified and addressed promptly. Labels of Australian products state that consumers should seek the advice of their healthcare practitioner.
The anti-natural medicine lobby
The minority group, Friends of Science in Medicine (FSM) is an anti-natural medicine lobby group. One of the researchers of this study, Dr Ian Musgrave, is an active member of this anti-complementary medicines group. Among many activities, they attempt to sully the term traditional medicine. But research is increasingly showing the reason why certain traditional medicines have stood the test of time and has even saved millions of lives. (reference http://www.cmaustralia.org.au/Media-Releases/7860867)
Look at the Australian label
“Just look at the label,” Says Carl Gibson. The Department of Health’s Therapeutic Goods Administration requires that several compulsory statements are made on Australian complementary medicines labels.
Combatting intentional and unintentional adulteration
Regarding the suggestion that Australian products are contaminated, Carl Gibson points to the GMP followed by Australian manufacturers. “And to help ensure that the Australian complementary medicines industry is informed and forewarned about any possible quality issues with raw materials. CMA and the Australian complementary medicines industry support the work of the American Botanical Council (ABC)” says Carl Gibson.
ABC Founder and Executive Director, Mark Blumenthal said: “The Botanical Adulterants Program informs the industry worldwide about the most common causes of both intentional and unintentional adulteration. It provides the tools for product sponsors to combat those causes of unintentional adulteration when developing or reviewing strategies for minimising risk.”
Consumers of Australian made CM products can be confident that they are manufactured according to the highest standards. However, this confidence does not extend to products that are not regulated as medicines or bought online or from overseas.
Products from overseas or purchased online outside of Australian domain sites are not subject to such tight controls including those to ingredients, warnings, recommendations, contraindications and therapeutic claims. “The stringent regulations enforced in Australia don’t apply to these products,” says Carl Gibson.
Online purchases should only be made on the recommendation of a qualified healthcare professional or bought from a known and reputable source.
For more information, please contact Ravinder Lilly on Ravinder.firstname.lastname@example.org