The use of herbal medicines including Ayurveda, Siddha, Unani (ASU), phytonutrients or nutraceuticals have been continuously expanding across the world. The world is, now, increasingly relying on herbal food supplements as a primary source of healthcare. Unfortunately, the regulation norms for the herbals are not as strict as compared to the synthetic drugs, which further lead to decrease in the quality standards of the supplements. Hence, it has become very essential that the quality of ayurveda-based supplements should be controlled and regulated.
The biggest challenge facing the Ayurveda industry is the supply disruption of the ingredients. The supply of ingredients used in ayurveda-based food supplements has outpaced the availability of methods to analyse them. From COVID-19 to supply chain disruptions, the ingredients used for these supplements has become a major challenge for the manufacturing of ASU drugs.
Dr Smita Naram, Co-Founder, Ayushakti, stated, “The only challenge faced by the system of Ayurveda is that it is not well structured like Allopathy and there isn’t sufficient data and analysis on current Ayurvedic herbal medicines.”
Standardisation of raw materials
ASU drugs which are mainly based on the plants and plant products besides animal products metal/minerals and products of marine origin have different chemical constituents which may vary in same species of plant due to influence of climatic condition under which they grow, geographical distribution, age of the plant, altitude and period of harvesting and storage conditions. Henceforth, controlling the quality of raw plant material with reference to chemical constituents becomes challenging.
Therefore, the biggest challenge faced by the ayurveda industry in the manufacturing of ayurvedic supplements is the standardisation of raw materials. It further depends on components like authentication of the raw material and signs of contamination in the medicinal plant like insects, moulds and other animal contamination.
Giving insights on the raw materials, Dr Smita said, “In the concept of Ayurveda, there is nothing in nature that can’t be used as medicines because everything is made out of five elements of nature that is air, fire, water, ether, and earth including the body, and accordingly the medicines are derived from natural sources of raw material like plants, minerals, metal, animals and marine products.”
She added, “While all of the above natural sources are available, manufacturing Ayurvedic drugs is an extensive process where challenges like the quality of herbs, spurious raw materials, and fluctuating demand of herb cultivation are a few hurdles.”
Issues like adulteration, misidentification of plant, faulty preparation, lack of Good Manufacturing Practices (GMP), lack of implementation and regulation of the guideline, incorrect formulation process are the main problems that reduces the effectiveness of herbal preparation and can be considered as key factors affecting quality and purity of herbal food supplements.
There are many aspects in determining quality of plant ingredients in herbal formulations such as place of origin, method of cultivation, time, season, methods of collection and storage. All these parameters play important roles in final plant quality and should therefore be listed among a given plant’s attributes and applied to all herbal ingredients. Many plants, though grown with great care and nourishment, are not found to be effective, because they lack the necessary Veerya (potency or active property of a substance). For instance, for an ingredient like turmeric; smaller specimens of Haridra (Haldi, Turmeric), grown under demanding, dry conditions in Tamil Nadu are far more potent, with greater concentration of curcumin, than the same variety grown in damp conditions. Some plant ingredients like Piper longum in milk need to be processed in particular materials to obtain their full efficacy.
Dr Anand Gudivada, Advisor, Ministry of AYUSH, in a webinar on ‘Issues and challenges in Quality Standards of ASU Sector’ held on November 25, 2021, stated, “It is time to bring the quality control standards from other countries into the Indian AYUSH sector and with strong and efficient licensing framework that ensures regularities.” He further mentioned that several steps have been taken in India to promote ASU medicine and to integrate them into clinical practice.
Ayurveda’s flagship herb Ashwagandha has faced most supply chain disruptions globally. The supplies of ashwagandha from India have tightened, because of the novel coronavirus.
Apart from supply disruptions, India’s Ministry of AYUSH has even released a statement that advised against the use of ashwagandha leaves in Ayurveda and products for therapeutic purposes.
The ministry has decided to re-examine the matter relating to the use of Ashwagandha (Withania somnifera) leaves in ASU drugs by constituting an expert group. The expert group will make appropriate recommendations to the Government of India on the use of ashwagandha leaves in ASU products based on scientific evidence.
Turmeric, which is the leading source in India, has experienced a great fluctuation in its price and supply due to the pandemic. Concerns like adulteration, fraudulent suppliers, duplicating turmeric has become another major cause for turmeric supply.
Furthermore, research by Bill Chioffi for the Sustainable Herbs Programme, highlighted upon synthetic curcumin in the Indian market, stated, “A large foreign manufacturing company had opened a plant in India and was selling concentrated curcumin extract made from Indian turmeric at a quarter of the current market price. My sources manufacture turmeric extract and are well aware of all the various associated operating costs in the country. They find it impossible to produce and sell extracts for the prices they were offered.”
Since, safety continues to be a foremost issue with the use of herbal remedies therefore, clinical trials are necessary to understand the safety and efficacy of these supplements before they are introduced in the industry.
Cinnamon, a spice obtained from the inner bark of several tree species from the genus Cinnamomum, is commonly known for its very high risk of fraudulent adulteration, substitution with Cassia. Cassia is a common diluent and a cheap, but toxic substitute for cinnamon. Cinnamon-cassia contains high levels of coumarin, whereas true cinnamon has a minimal amount of coumarin. Coumarin is toxic to some animals and certain sensitive humans causing liver and kidney damage.
In recent years, the Food Safety and Standards Authority of India (FSSAI) has even issued guidelines on the distinguishing features of both the spices. The note was released with reference to several representations received by the apex regulator for cassia.
Furthermore, in recent years, cinnamon has also been adulterated with coffee husks and even lead. Several factors are responsible for adulteration of ingredients used in ayurveda-based supplements which are sold in the market. The main reason may be due to scarcity of the genuine raw material causing high prices of the material in the market.
The food industry is constantly working on various ayurvedic food innovations and technologies to scale up businesses. Leading companies like Dabur has been witnessing a huge surge in demand for its flagship immunity booster Dabur Chyawanprash and Dabur Honey.
With companies launching many ayurveda-based food supplements, it becomes important to ensure the scientific knowledge of the ingredients used in these supplements.
Speaking about scientific knowledge, Dr E T Krishna Mooss, Executive Director, Vaidyaratnam Group, Thrissur, revealed, “In Ayurvedic pharmacopoeia of India (API), there are certain scientific standards explained for new drugs or already existing classical formulations. For a new formulation, the scientific parameters for quality check include 6-month stability test, toxicology analysis, pilot study etc. Only after these parameters are fulfilled, the sanction is being given to any formulation. For a classical formulation, the Quality Check (QC) and Quality Analysis (QA) parameters are explained while preparing the medicines.”
All these parameters play an important role in the final quality and processing of the ASU drugs, where identifying the ingredients becomes the first step in characterising the supplements.
Therefore, problems like ingredient misidentification, supply disruption, safety concerns, and quality assurance/control continue to affect the industry and consumers, alike.