Year : 2022 | Volume
: 5 | Issue : 1 | Page : 1--5
Quality and safety of Ayurvedic medicinal plants is it the key to the success of therapeutic management?
Tanuja Manoj Nesari
Director, All India Institute of Ayurveda, Sarita Vihar, New Delhi, India
Prof. Tanuja Manoj Nesari
All India Institute of Ayurveda, Sarita Vihar, New Delhi
|How to cite this article:|
Nesari TM. Quality and safety of Ayurvedic medicinal plants is it the key to the success of therapeutic management?.J Ayurveda Case Rep 2022;5:1-5
|How to cite this URL:|
Nesari TM. Quality and safety of Ayurvedic medicinal plants is it the key to the success of therapeutic management?. J Ayurveda Case Rep [serial online] 2022 [cited 2023 Mar 29 ];5:1-5
Available from: http://www.ayucare.org/text.asp?2022/5/1/1/343501
Safety is a fundamental principle in the provision of herbal medicines for health care, and a critical component of quality control. The drug, which is going to be administered into the human body, should be standard and should not produce any kind of untoward effects after its administration. Ancient seers of India too repeatedly stressed about these qualities in their respective classics. The long history of their successful usage in different pathological manifestations is the ultimate proof of their safe, efficacious, and nontoxic beneficial effects.
Herbal medicines form an important part of most traditional systems of medicine. It is estimated that 80% of the world's population living in the developing world rely on herbal medicinal products as a primary source of health care and traditional medical practice, which involves the use of herbs as an integral part of the culture in those communities. They are often used to provide first-line and basic health services to people living in remote and poor areas. Even in areas where modern medicine is available, the interest in herbal medicines has been increasing rapidly in recent years because of many reasons. The significant contribution made by herbal medicines to human health has led to increased official and commercial interest. The contribution of Ayurveda through its herbal remedies in global health care cannot be ignored by any science for its qualitative strength and clues provided in the field of therapeutics.
Very recently, the Centers for Disease Control and Prevention warned that the world is staring at a post-antibiotic era when common infections will no longer have a cure. In addition to drastic changes in lifestyle, increased pollution, and industrialization, the global population is affected by various kinds of lifestyle diseases. Unless addressed, the mortality and disease burden from these problems will continue to increase. Although the conventional systems of medicine have ample of drugs to treat such pathologies, these drugs have certain limitations, possibly considering which, emphasis on botanical sources for drug discovery and development of new effective molecules has been realized globally. Vinblastine, reserpine, atropine, artemisinin, morphine, codeine, curcumin, berberine, glycyrrhizin, digoxin, etc., are a few such molecules discovered by contemporary scientists and are being used in the conventional system of medicine. As most of the diseases have multifactorial causation, drugs as a whole (against extract of a herb) acting on a number of targets simultaneously is likely to be more effective. Traditional formulations are multicomponent, and thus have special relevance in such cases. Ayurveda with its armamentarium can provide promising results in many such situations.
According to Charaka, the substance that possesses Guna (~properties) and Karma (~action) in a state of coherence is called Dravya (~substance). All the Dravya can be used as “drug,” but the term drug or Bheshaja is applicable in specific conditions when used for a definite purpose and with logical thinking. The three main sources of drugs are herbal (~Audbhida dravya), animal (~Jangama dravya), and mineral (~Parthiva dravya) in origin, which have been advocated for use in different pathologies. In general, Ayurvedic drugs can be grouped into two, i.e., Kasthoushadhies (~herbal preparations) and Rasaoushadhies (~herbo-mineral/metallic preparations). Quality and safety of all these formulations at every level such as raw material, in process, and finished products is important. Classical Ayurvedic preparations have been developed following years of practical experience combining plants to get the optimal effect. Many formulations are a rich source of substances that have several therapeutic properties such as hepatoprotective, nephron protective, cardioprotective, chemopreventive, and other effects. They are reported to be potential for various systemic disorders of hepatic, cardiorespiratory, endocrinal, neuropsychiatric, and gastrointestinal systems. They are reported to increase the quality of life in individuals suffering from various pathologies. Such experiences provide a substantial basis for their safe and effective use. They also can be supplemented as an adjuvant to the mainstream of contemporary drugs in specified pathologies.
India is one of the richest countries in the world in terms of biodiversity and contributes about 7% of world biodiversity. India has 15 agro-climatic zones. In India, medicinal plants are found in Himalayan to marine and desert to rainforest ecosystems. Out of the 17,000–18,000 species of flowering plants, more than 7000 are estimated to have medicinal usage in folk and documented systems of medicine such as Ayurveda, Unani, Siddha, and Homoeopathy. Medicinal plants are not only a major resource base for the traditional medicine and herbal industry but also provide livelihood and health security to a large segment of the Indian population. About 1178 species of medicinal plants are estimated to be in trade, of which 242 species have annual consumption levels in excess of 100 metric tons/year. The global herbal trade of medicinal plants has been growing exponentially. With an annual growth rate of 15%, it is likely to touch a scale of five trillion US$ by 2050. The global interest in the Ayurveda system is evident from the inclusion of more than 100 Indian medicinal plants in the recent editions of US, European, and British Pharmacopoeias (BPs).
The World Health Organization (WHO) is fully aware of the importance of such medicines and supports the use of medicinal plants and their products in health care. In early 1978, the World Health Assembly adopted a resolution on drug policies and management of medicinal plants, which recognized the importance of medicinal plants in the health-care system. It passed a few resolutions emphasizing the identification, evaluation, preparation, cultivation, utilization, regulation, and conservation of herbal drugs. As many of the plants that provide traditional and modern drugs are threatened with extinction, the WHO endorses the call for international cooperation and coordination to establish programs for the conservation of medicinal plants, to ensure that adequate quantities are available for future generations.
Pioneers of Ayurveda have considered qualitative and quantitative aspects of Ayurvedic formulations and provided all guidelines to achieve and manufacture a quality product. They were fully conscious of the standards of quality, treatment schedules, and shelf life of formulations, which is reflected in many places of the classics. Charaka emphasized that an ideal drug should be available abundantly (~Bahuta), must be eligible for medicament (~Yogyatvam), should be available in various forms (~Aneka vidha kalpana), and should possess all qualities (~Sampat).
The rise in the demand for herbal products has parallelly given rise to various forms of abuse, leading to a bad reputation for the system. Concerns on Tinospora cordifolia (TC), a potential herb with multidimensional activities being used in AYUSH systems is an example to mention. TC is being used extensively even during the unprecedented COVID pandemic times across the country. However, this is not an over-the-counter herb/formulation and should always be used under the direction of registered AYUSH physicians. Self-medication or using these herbs without expert monitoring is not advisable. A drug can be a panacea or poison. Hence, quality control and standardization of herbal medicines become an essential aspect that needs to be addressed.
Each and every drug has some physical constants in its structure or unique features which can be standardized nowadays, and with the help of these parameters, the identification of raw drugs, in-process drugs, finished products of drugs, and its batch-to-batch consistency is possible. Raw drug evaluation includes pharmacognosy, phytochemistry, qualitative and quantitative evaluation with biomarkers, toxicity, pharmacological study including bioassays, screening for antibacterial and antifungal activities of bio constituents, fingerprinting, etc.
To attain a good requisite therapeutic result, it is mandatory to collect the drug bestowed with optimum Rasaveeryadi qualities. In Ayurvedic literature, specific parts of the plant collection have been advocated to be collected at specific timings. Such samples collected following the classical guidelines are said to possess the highest therapeutic potential. The temperature, rainfall, duration of daylight, altitude, methods of cultivation and collection, the effect of the lunar cycle, soil condition, processing, and storage have an impact on the secondary metabolites of the plant that affect the therapeutic quality.
The collected raw material should be kept in appropriate containers, which are free from contaminants such as water, smoke, dust, and pollen and should be protected from rats and quadrupeds. Before administration, all drugs should be examined for their nature (~Prakriti), qualities (~Guna), specific actions (~Prabhava), place of growth (~Desha), place of collection (~Grahana), method of preservation (~Nihita), method of processing (~Upaskrita), therapeutic dosage (~Matra), etc.
In modern science, a single pure chemical compound is used in different dosage forms, showing the same therapeutic effect as paracetamol used in injectable form, syrup, or in tablet form having the same effect. However, in holistic medicine, one plant is a factory of thousands of constituents. Based on the solvent nature, different phytoconstituents are extracted. Not only the drug but the drug delivery mechanism is also very important to maintain the quality and safety of Ayurveda herbs at each and every level. If a solvent system is changed, the therapeutic effect will also change. Like Guduchi (Tinospora cordifolia [Willd.] Miers) in Satva form has a different action, while its Ghana form shows different actions.
Immense medicinal applications of Guduchi in countering various pathologies, including hyperglycemia, hyperlipidemia, hepatic ailments, etc., are well known. T. cordifolia has been reported to prevent hepatotoxicity, whereas other species like Tinospora crispa may be associated with hepatotoxicity. Thus, consumers might develop hepatic injury without correctly identifying the plants that they are consuming. Having proper identification of the source plant becomes a mandate before its use. Despite having a wide range of therapeutic potentials, Guduchi is facing concerns that are unwarranted. It becomes the responsibility of every stakeholder to provide a quality drug to the consumers and contribute to global health care.
In Ayurveda, plants are named in Sanskrit, and at times, a single plant may have various biological sources. For example, Rasna (Pluchea lanceolata [DC.] Oliv. and Hiern) has multiple biological sources. Hence, proper identification of the drug is required to ensure the quality and therapeutic efficacy of the drug. Each plant has various varieties in terms of genera, species, and varieties. The action of the drug also changed in different species or varieties of the same plant. Therefore, proper authentication, pharmacognostical standardization, and quality assurance become very important.
Proper identification of the correct medicinal plants that go into the preparation of medicine is important in the Ayurvedic medicinal industry. The Botanical Survey of India has developed a National Database of Indian plants, including herbarium specimens, live specimens, botanical paintings, illustrations, etc., which helps in the identification and authentication of the herbal drugs. Centrally Sponsored Schemes of National AYUSH Mission is a flagship scheme of the Ministry of Ayush that supports the cultivation of medicinal plants, which is the key to integrity, quality, efficacy, and safety of the AYUSH systems of medicines by integrating medicinal plants into the farming systems. Cultivation following the Good Agricultural and Collection Practices (GACPs) is another objective to promote standardization and quality assurance and thereby enhance the acceptability of AYUSH systems globally and increase the development of value-added items such as herbal extracts, phytochemicals, dietary supplements, cosmeceuticals, and other AYUSH products. The scheme also aimed to encourage Good Field Collection Practices in medicinal plants and enhance the quality and safety of their produce. The Government of India has set up National Medicinal Plants Board (NMPB) under the Ministry of Ayush, Government of India, which is exclusively focusing on in situ and ex situ conservation and augmenting local medicinal plants and aromatic species of medical significance. NMPB also supports programs for quality assurance and standardization through the development of GACPs; development of monographs laying down standards of quality, safety, and efficacy; and the development of agro-techniques and credible institutions, a mechanism for certification of quality of raw drugs, seeds, and planting material. NMPB has also set up region-based Regional Raw Drug Repositories (RRDRs) in respect of raw drugs used in the Ayurveda, Siddha, Unani, and Homoeopathy (ASU and H) systems of medicine. RRDR units are mainly acting as a collection center of raw drugs available and used in each region. They are also acting as accredited reference libraries for authentication of raw drugs. They establish standard protocols and keys for authentication of raw drugs used in the herbal industries and thus ensure the quality of raw drugs.
Due to worldwide acceptance of herbal drugs, the WHO has framed guidelines for the standardization of herbal preparations to ensure the quality, safety, and efficacy of the drug, which is long lasting and the need of the hour. For this purpose, different countries, including India, prepared the Pharmacopoeias, which include monographs of drugs indicating quality parameters and high standards for the raw material and their products. The Government of India has prepared Ayurvedic Pharmacopoeia of India (API), a unique book of standards describing the quality, purity, and strength of the drugs. These published volumes will provide testing protocols for single as well as compound formulations. Biological Reference Standards (BRS) help to ensure the quality and consistency of biological treatments reaching patients globally. Phytochemical Reference Standards (PRS) have assumed a new significance and have become an integral part of the quality control of botanicals. Monographs in Indian Pharmacopoeia (IP), United States Pharmacopoeia, BP, and API now have assay sections employing chromatographic analysis using primary and secondary PRS.
According to Charaka, if a drug is not identified properly by its name, form, properties, and action may cause complications. In this respect, Charaka has emphasized that the physician should know the proper identification features of plants, and administration of these plants according to the individual constitution. The drugs should be studied in terms of name, morphology, properties, and therapeutic use, which is called Nama rupa gyana.
To further enhance the effectiveness and safety of the drug product, many regulatory agencies such as the United States Food and Drug Administration also require that the drug product be tested for its identity, strength, quality, purity, and stability before it can be released for use. For this reason, pharmaceutical validation and process controls are important despite the problems that may be countered. In-process quality control checks are carried out before the manufacturing process is completed. This may include control of equipment and environment too. In-process materials should be tested for identity, strength, quality, and purity as appropriate and approved or rejected by the quality control unit during the production process. In-process quality control may be performed at regular intervals during a process step (e.g., tableting or encapsulation) or at the end of a process step (e.g., granulation, blending). The tests give scientists security that the finished products fulfill all quality requirements.
Different techniques such as combination, purification, and variety of processes should be applied to increase the potency of a drug or to decrease the unwanted action of a drug. In the case of Rasaoushadhi, if the Shodhana (~purification/ bio-cleansing) process is not properly done, it affects the Marana (~incineration) process and ultimately, the quality and safety aspects of the finished products. Hence, in-process standardization is important. In schedule T, The good manufacturing practices are prescribed to ensure that raw materials used in the manufacture of drugs are authentic, of prescribed quality, and are free from contamination and the manufacturing process is as prescribed to maintain the standards.
In the case of Rasaoushadhi, the Siddhi-lakshana for every Kalpana (~form of medicine) is described in classical texts and specific tests for individual Kalpa are also mentioned.
Looking into the conditions prevailing in the present scenario, it is high time to deliberate regarding the concerns over traditional and classical Ayurvedic, Siddha, Unani, and Homoeopathy products and practices. Thus, the Ministry of Ayush, Government of India, New Delhi, has initiated the Pharmacovigilance Program for ASU and H drugs has been initiated to collect and collate data to establish evidence for the clinical safety of ASU and H drugs.
AYUSH has witnessed strong traction amid efforts to boost traditional medicines' global outreach. India's wellness market, valued at over US$10 billion, is expected to grow to US$21 billion by 2020. The exports of Ayush and herbal products were at $539.57 million during 2020–2021, as compared to $425.80 million during 2019–2020. To drive export growth, AYUSH Premium Mark, a quality certification scheme, ensures the efficacy of Indian herbal products.
To conclude, herbs as a potential source of therapeutics have attained a significant role in the health-care system all over the world, not only in the diseased condition but also as potential material for maintaining health. The efficiencies of herbal preparations in providing a rapid and long-lasting cure for specific diseases need to be compared, documented, and published in standard journals rather than obscure journals. In the case of the herbal products, the novel formulations developed are required to be standardized for safety, efficacy, and potency. It is required that various techniques should be used for the quality control examination of the herbs, which can be regulated to gain the required quality products by setting proper norms. We may link with the importance of ensuring authenticity and quality of medicines in clinical setup for achieving desired efficacy and recognition to the system. This, in turn, will provide the safer use, effective treatment, and required potency of the products, which will benefit humankind and society in achieving the desired clinical effect.
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