Abstract
Ayurveda is one of the oldest systems of medicine in the world, but the growing commercial interest in Ayurveda based products has increased the incentive for adulteration and substitution within this herbal market. Fraudulent practices such as the use of undeclared fillers and use of other species of inferior quality is driven both by the increased as well as insufficient supply capacity of especially wild plant species. Developing novel strategies to exhaustively assess and monitor both the quality of raw materials and final marketed herbal products is a challenge in herbal pharmacovigilance. Seventy-nine Ayurvedic herbal products sold as tablets, capsules, powders, and extracts were randomly purchased via e-commerce and pharmacies across Europe, and DNA metabarcoding was used to assess the ability of this method to authenticate these products. Our analysis reveals that only two out of 12 single ingredient products contained only one species as labeled, eight out of 27 multiple ingredient products contained none of the species listed on the label, and the remaining 19 products contained 1 to 5 of the species listed on the label along with many other species not specified on the label. The fidelity for single ingredient products was 67%, the overall ingredient fidelity for multi ingredient products was 21%, and for all products 24%. The low level of fidelity raises concerns about the reliability of the products, and detection of threatened species raises further concerns about illegal plant trade. The study highlights the necessity for quality control of the marketed herbal products and shows that DNA metabarcoding is an effective analytical approach to authenticate complex multi ingredient herbal products. However, effort needs to be done to standardize the protocols for DNA metabarcoding before this approach can be implemented as routine analytical approaches for plant identification, and approved for use in regulated procedures.
Highlights
Ayurveda, or Ayurvedic medicine, is one of the oldest systems of traditional medicine (TM), with origins in India more than 3,000 years ago
Seventy-nine Ayurvedic herbal products sold as tablets (n = 30), capsules (n = 30), powders (n = 16), and extracts (n = 3) were purchased via e-commerce (n = 53) and pharmacies (n = 26), from Norway (n = 21), Romania (n = 26), and Sweden (n = 32)
Interpretation of incongruences should focus on the detected species in the products, and less on the failure to detect species as there are many steps in manufacturing processes that could lead to degradation or loss of DNA beyond detectable limits, e.g., alcoholic extraction, decoction and drying of material at high temperatures
Summary
Ayurvedic medicine, is one of the oldest systems of traditional medicine (TM), with origins in India more than 3,000 years ago. About 7,000 plant species are used for medicinal purposes in India, from which, about 1,200 species have been reported to be actively traded (Goraya and Ved, 2017). The total commercial demand for herbal material in India, in 2014 and 2015, was estimated to be in excess of 512,000 tons, with a market value of 1 billion USD (Goraya and Ved, 2017). India has more than 8,000 licensed manufacturing units for medicinal products and the increasing level of consumption of herbal products exceed the supply capacity for some plant species (Goraya and Ved, 2017). In order to ensure a level of uniformity of the therapeutic formula and the ingredients used, the Ayurvedic formulary and Ayurvedic Pharmacopeia of India was published by the Government of India as a legally binding document describing the quality, purity, and strength of selected drugs that are manufactured, distributed and sold by the licensed manufacturers in India (Joshi et al, 2017)
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