|ONE NATION, ONE HEALTH SYSTEM - SPECIAL ISSUE
|Year : 2023 | Volume
| Issue : 1 | Page : 59-64
Integration of Ayush within national health care systems: Challenges and the way forward
Research and Development Cell, Avinashilingam Institute for Home Science and Higher Education for Women, Coimbatore, Tamil Nadu, India
|Date of Submission||28-Oct-2022|
|Date of Acceptance||15-Nov-2022|
|Date of Web Publication||08-Dec-2022|
Prof. S P Thyagarajan
Research and Development Cell, Avinashilingam Institute for Home Science and Higher Education for Women, Coimbatore 641043, Tamil Nadu
Source of Support: None, Conflict of Interest: None
The utilization of traditional knowledge is crucial for achieving universal healthcare, according to the World Health Organization (WHO) Traditional Medicine Strategy 2014–23. The Indian systems of Medicine—Ayurveda, Yoga, Unani, Siddha, and homeopathy (Ayush)—have been projected to play a significant role in universal healthcare due to the emphasis placed on preventive and promotive health, their reasonable cost, low level of technological input, and the rising popularity of naturally derived plant-based products. These systems are being recommended for inclusion in national public health policy. Traditional Medicine (TM) is being used more frequently, which has raised questions regarding its safety and toxicity potential, such as hepatotoxicity. Thus, under the Department of Ayush’s vision and mission-2030, it is intended to develop scientific evidence in Ayurvedic principles and drug therapies by integrating ancient wisdom with modern technology and to bring Ayurveda to the people through innovations related to diagnostics, preventive, promotive as well as treatment methods and introduce scientific research for sustained availability of quality natural resources, to translate them into practical applications as modern science solutions for ensuring international acceptance of Ayush systems and their integration into National Health System and Modern Medicine, achieving the goal of One Nation, One Health System. Ayurvedic biology, standardization through chemobiological fingerprinting, chemobiological assays, and Pharmacovigilance studies of herbal medicines are suggested.
Keywords: Integration of Ayush, metals and minerals in ayush medicines, national public health system, standardisation
|How to cite this article:|
Thyagarajan S P. Integration of Ayush within national health care systems: Challenges and the way forward. J Res Ayurvedic Sci 2023;7:59-64
|How to cite this URL:|
Thyagarajan S P. Integration of Ayush within national health care systems: Challenges and the way forward. J Res Ayurvedic Sci [serial online] 2023 [cited 2023 Feb 2];7:59-64. Available from: http://www.jrasccras.com/text.asp?2023/7/1/59/362946
| Introduction and Rationale|| |
Non-communicable diseases (NCDs), often known as chronic diseases, are responsible for 41 million deaths worldwide each year, or 71% of all deaths. In India, NCDs caused 5.9 million deaths in 2018 (or 60% of all deaths), surpassing infectious diseases for the first time. The National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases, and Stroke (NPCDCS) was introduced by the Government of India (GoI) in October 2010. NCDs (such as cardiovascular illnesses, stroke, malignancies, and respiratory diseases) result in a considerable loss of years of life that could have been spent working. The majority of NCDs have a strong correlation with critical unhealthy lifestyle choices and risk factors such as alcohol and tobacco use, inactivity, sedentary behavior, and poor diet (high intake of sugar, salt, and trans fats) and low intake of fruits and vegetables).
Using traditional knowledge is crucial for achieving universal healthcare, according to the WHO Traditional Medicine Strategy 2014–23. The Indian systems of Medicine—Ayurveda, Yoga, Unani, Siddha, and Homoeopathy (Ayush)—have been projected to play a significant role in providing universal healthcare under the broad auspices of the National Health Framework. These systems are appealing for inclusion in and implementation of National public health policy due to inherent advantages of Ayush, such as diversity, the emphasis placed on promotive health and preventive health, modest cost, low level of technological input, and the growing popularity of natural plant-based products.
| Review of Literature|| |
Both developing and industrialized nations have seen an upsurge in the use of traditional Medicine (TM), and around 80% of people in Asia and Africa use TM as part of their primary healthcare., Natural treatments have been taken at least once by 48% of people in Australia, 31% of people in Belgium, 70% of people in Canada, 49% of people in France, 50% of people in Germany, 47% of people in the UK, and 42% of people in the USA.
More than US$83 billion are sold each year globally in TMs. Trade in TM is considered worth $3.12 billion, $83 billion, $7.4 billion, and $33.9 billion in Australia, China, the Republic of Korea, and the United States, respectively. TM, including Ayurvedic medicine, nutraceuticals, and traditional Chinese medicine, is gaining popularity, possibly because of the assumption that natural is a healthier alternative to non-traditional medicines.
Issues concerning TM’s safety and potential for hepatotoxicity have grown along with its use. Although prescription medications are a significant contributor to liver damage, reports of herbal and botanical medication-induced liver damage have grown over time and have significantly varied around the world, with rates ranging from 17% in Japan, 20% in the USA, 31% in China, and 70% in Korea. Additionally, from 12.4% during the past ten years to 21%, severe TM-induced liver injury has nearly doubled in the USA. The reports mentioned above must be supported by the literature from the Indian systems of medicine, currently referred to as Ayush systems of medicine and including Ayurveda, Siddha, Unani, and Homeopathy. These are essentially herbal remedies with the inclusion of metals and animal sources, and they have been successfully used for many years in India. The Ayurvedic medical system has withstood the test of time for at least four millennia. The ancient seers discovered that rules of conduct and dietary guidelines, along with medications of various origins (herbal, metal, or animal), are valuable tools for preserving health in healthy individuals and curing diseases in the sick.
This system has no other counterparts in using metallic preparations in healthcare. Processed metals, such as mercury, gold, silver, lead, zinc, and copper, were frequently and effectively employed in various illness situations by seers of the Indian tradition. The widely held belief is that these metals undergo detoxification during the intricate manufacturing processes detailed in Ayurvedic scriptures, particularly the Rasashastra. There are several references to the use of metals for various reasons in the Charaka Samhita, one of the official scriptures of Ayurveda. They have recommended specific processing methods (such as Shodhana, Marana, pudam, detoxification treatments, etc.) based on this understanding, which will eliminate the harmful qualities of these medications. They have also recommended testing procedures (like Bhasma Pariksha) to let the maker know whether the medicine has been transformed into a form that won’t be hazardous when administered by a physician. The resultant metals or minerals are referred to as Bahamas.
The Government of India’s National Initiative on Metal-Based Drugs Program, which ran from 2012 to 2016, launched national-level lab-participated projects to scientifically validate the therapeutic and toxicological qualities of some of the typical metal-containing “sastric” Ayurvedic and Siddha preparations that have been used for centuries to treat chronic non-communicable diseases. Our team of researchers at Sri Ramachandra Institute of Higher Education and Research (Deemed University), Porur, Chennai, received funding for a project titled “Scientific evaluation of copper-containing Herbo mineral formulation for the management of Ulcers.” The research showed that the “Pudam technique” was effective at detoxifying and quenching, which made the “Thamiraparpam” concoction useful for treating duodenal and stomach ulcers.
One of the most crucial concerns relating to Ayush formulations is the concept of stability, as there are no defined criteria for it. Although the shelf life of Ayurvedic formulations was revealed in the Ayurvedic lexicon and a Government of India Gazette notification published on November 26, 2005. More recent advances in packaging and storage technology have necessitated a modification of this information. The International Conference on Harmonization (ICH) and the World Health Organization are the two primary standards that provide information about the parameters for a stability assessment of pharmaceutical goods, but Q1 through Q11 of the ICH guidelines are typically followed. It is essential to take into account a well-designed stability protocol that includes information on the choice of batches and samples, test characteristics, analytical processes, acceptance criteria, storage conditions and period, testing frequency, sampling plan, container closure systematic, and different types of stability studies and stability testing methods. Pharmaceutical products are typically tested using a validated stability-indicating analytical method, and an expiration date is marked based on the anticipated time frame following the date of manufacture at which the pharmaceutical product would exhibit more than 10% deterioration in the active molecule. These recommendations can be used in Ayurvedic formulations, where the percentage of deterioration can be measured while the product is stored under various temperature and humidity settings.,
| The Way Forward|| |
Because of the significant analytical reports on quality and standardization aspects of Indian Systems of Medicine, the policy document of the Department of Ayush, Government of India, the “Vision- 2030 Statement” projects the following:
To create scientific proof for Ayurvedic principles and pharmacological therapies by fusing modern technology with ancient knowledge and to popularise Ayurveda through advancements in diagnostic, preventive, promotional, and therapeutic techniques.
Introducing scientific research for the continued availability of high-quality natural resources, translating it into goods and procedures, and introducing these innovations in collaboration with concerned organizations into public health systems.
| Sustainable Development Goals (SDGs) for vision 2030 (15 years) for Ayush|| |
- ❖ Translation of research outcomes into clinical practice through commercialization of new drugs developed by CCRAS through translational research to make them accessible to the public.
- ❖ Main streaming of Ayurveda therapies through integration and including them in a National Health Programme.
- ❖ Development of new drugs/combinations based on the leads from classical literature and local health traditions on different conditions to meet the demand of unmet medical needs.
- ❖ Development of safe /effective products for diseases of national and global importance as add-on/ adjuvant therapies and standalone management for improving quality of life.
- ❖ Generation of scientific evidence on the safety of Ayurvedic formulations and therapies.
- ❖ Revalidation of specific Classical formulations for evidence of safety and efficacy.
- ❖ Dissemination of research outcomes through appropriate media for sustainable utilization by medical practitioners and the public;
- ❖ RandD infrastructure development to improve the quality of research.
To achieve the above SDGs of Ayush-Vision 2030, the understanding and implementation of Translational Research in Ayush are essential.
| Characteristics of Translational medical (Ayush) research are|| |
- i. Basic studies to define biological effects of therapeutics in humans;
- ii. Human studies for the biology of disease and basis for new/ improved therapies and their mechanism of action;
- iii. Non-human-non clinical studies for safety/toxicity and efficacy to advance therapeutics to clinics;
- iv. Initial Phases of clinical trials for dosage/efficacy
- v. Appropriate product development for Phase III clinical trials as required by the Regulators.
- vi. Adoption of Best Practices that link medical learning with patient outcomes.
| Challenges in Implementing Translational Research in Ayush|| |
Correlating Ayurvedic notions with those of contemporary biology is the first and most crucial stage, after which it is necessary to create suitable experimental models to rigorously evaluate Ayurvedic claims. To do translational research and experimental work that is epistemologically informed, the top scientists and Ayurvedic practitioners must work together. The assignment entails translating Ayurvedic systemic notions into scientific theoretical frameworks. Translational and cross-disciplinary research on top national public health issues needs critical and ongoing support from this program. It requires visionary, and missionary leadership spread over a network of institutions to carry it out in a coordinated manner.
| Newer Frontiers of Research and Development to Globalize Ayush|| |
Innovative research findings from the newly emerging transdisciplinary subject known as “Ayurvedic biology,” which connects concepts and systemic theories of Ayurveda with structural theories of biology, may have a national and international influence.
| Ayush Drugs and Systems Biology|| |
Combination therapy was developed because a single modern medicine molecule may not efficiently modulate several targets when multiple cell types and pathways contribute to human disease. Herbal extracts used in Ayush medications work through nature’s combinatorial chemistry with a wide range of chemical components that address several targets at once, creating the impact of a synergistic system. Since macromolecules create complex networks and get arranged into systems with qualities that go beyond individual functions, we need to give predictive models of the behavior of varied molecular systems to find functional relationships to confirm this concept. To comprehend function at many levels of the biomolecular organization, systems biology enables the computational integration of data produced by genomic, transcriptomic, proteomic, and metabolomic platforms. A system biology infrastructure and knowledge are required to elucidate the functional and mechanistic properties of Ayush medications. Systems biology of evaluating herbal drugs using microarrays is the new informational paradigm fusing genomics, proteomics, and metabolomics sciences.
| Phytochemistry and Chemo Biology to Fingerprint Mechanisms of Plant Bioactivity and Biological Diversity|| |
The search for the molecular mechanisms underlying plant bioactivity was a crucial task. Due to the complexity of the processes involved in the creation, expression, and control of natural products, this job has proven to be highly challenging and has thus far produced no appreciable outcomes. This needed using “Chemo-biological fingerprinting” to identify evolutionary chemical patterns similar to the evolutionary Ethno botanical patterns. The combination of chemical (structural) and biological (functional) terms is necessary to build a model that can be used as a reference for comparing the features of medicinal plants, can only be accomplished by a “coherent language.”
As a result, our main objective is to replace the conventional and narrative approach with a comprehensive and scientifically based quantitative methodology. This comprehensive strategy would revitalize research into the long-debated problem of plant bioactivity. The main obstacle to achieving this goal is the clash between traditional knowledge and scientific methods, which necessitates adopting a new coding system for biological processes expressed in chemo-biological language.
Chemo-Biology is a novel interdisciplinary endeavor to comprehend life, whereas Physical Chemistry emerged as a multidisciplinary method necessary to characterize matter. Chemobiological fingerprinting must be used to combine chemical (structural) and biological (functional) information into a “coherent language” for this endeavor. Because of the steadily expanding interest in medications with natural sources, these “Fingerprint structures” have developed into a significant quality control tool for herbal samples.
The WHO has approved fingerprinting as a technology for the quality control of herbal medication samples. It is used to recognize closely similar plant species, spot forgeries, manage the extraction process, or assess the caliber of a final goods. Herbal medications’ biological activity—rather than their chemical composition—is thought to be a key factor. The only information available from traditional chromatographic fingerprint analysis is qualitative and quantitative. The fact that substances may exert more decisive biological action when present in low concentrations as opposed to being present in higher concentrations is a crucial issue. Therefore, it is crucial to incorporate biological activity screening into studying chromatographic fingerprints. Examining the natural samples’ biological fingerprints has been presented to check for the presence of the most active substances. The idea of biological fingerprinting was initially created to ensure the high quality of sophisticated traditional Chinese medicines. A set of chromatographic and/or spectroscopic signals that provide the identification of the active substances contained in a complex herbal sample is known as a biological fingerprint or “Bio-fingerprint.” Bio-fingerprints integrate the data collected in conventional chromatographic fingerprints (qualitative and quantitative) with biological activity; these Quality Assurance and Standardization laboratories are another impending demand in Ayush Translational Research.
According to WHO, “herbal medications” must also include specific excipients, such as solvents, diluents, or preservatives, in addition to plants or plant materials in their raw or processed form as active ingredients. According to international terminology, phytotherapeutic agents, often known as phytomedicines, are complex mixes of one or more plants that are utilized in most nations to treat various disorders. There are now several drug regulatory models for herbal medications, including prescription drugs, over-the-counter drugs, traditional medicines, and nutritional supplements. The majority of herbal products are sold as “dietary supplements” and “nutraceuticals” under the Dietary Supplement Health and Education Act (DSHEA) of 1994 due to the strict standards of standardization for quality and efficacy.
The idea of holistic standardization is put out to meet the requirements of the worldwide community. This is characterized as a process integrated into production and quality control procedures to obtain a constant and repeatable quantity of active components in each dose of herbal medicine. The following procedures are recognized as a consensus methodology to accomplish holistic standardization of a traditional medicine product out of the several phases.
Herbal medicinal products are always a complex mixture of different plants and thus different compounds that may act agonistic, synergistic, complementary, antagonistic, or toxic. The traditional medicine concept of “biological synergism” of balancing the above properties resulting in the holistic outcome of patients’ well-being has to be synchronized with the present-day efforts of standardization of herbal drugs with permissible limits of ‘batch-to-batch variation.’ There is a specific challenge in developing methods to prove the bioequivalence of herbal drug preparations. If the constituents responsible for therapeutic activity are known, the concept of essential similarity used with chemically defined substances can be fully applied. For extracts with unknown active markers, as in many Indian systems of Medicines, data on defined chemical constituents are helpful for control purposes called “charge-conformity” but not sufficient to prove bioequivalence. Hence methods to assess the type of bioequivalence parameters may vary depending upon (a) what is the disease or condition for which the drug is being used? (b) what is the proposed mechanism of action, if known already? (c) what is the purported benefit to the patient? and (d) what the risks are? Depending on the above, the preparations in Traditional systems of medicine, in general, and Indian systems of medicine, in particular, are to be standardized using:
- (i) Pharmacological bioequivalence assays.
- (ii) Microbiological bioequivalence assays.
- (iii) Pharmaceutical bioequivalence assays.
- (iv) Toxicological bioequivalence assays.
- (v) Clinical reproducibility studies.
Such a protocol shall not only add the modem scientific concept into traditional medicines but also make these medicines easily protectable under the existing Intellectual Property Rights (IPR) norms. The protection of IPR is equally essential in herbal medicines since the concern and difficulties related to the patenting of herbal medicines have precluded the financial incentives that could be provided to pharmaceutical industries.
Fundamental questions about the effectiveness, safety, appropriate clinical applications, meaningful outcomes, and authentication of bio reproducibility for all medical therapies, including those regarded as alternative medicine, must ultimately be evaluated critically and objectively using well-established scientific principles and strict criteria for the assessment of scientific evidence. There can be no other option for patients, doctors, and all practitioners of alternative medicine—indeed, for everyone who shares the goal of enhancing individual and societal health.
While the Vision-2030 of the Department of Ayush parallelly undertakes the above global concepts of Research and Development, the Ayush systems of medicine advocate a holistic wellness approach aiming at the prevention of diseases and promotion of health and well-being. On January 30, 2019, a decision was taken that at least 12,500 Health and Wellness Centres (HWCs) under Ayushman Bharat will be upgraded by the Ministry of Ayush. The Union Cabinet, during its meeting on March 20, 2020, has approved the proposal to operationalize these 12,500 Ayush HWCs through States/UTs in Centrally Sponsored Scheme mode and under the broad umbrella of National Ayush Mission (NAM) in a phased manner by 2023–24.
An essential component of the National Health Plan 2017 was ‘Integration with Ayush’ for mainstreaming Ayush and promoting pluralism in healthcare through cross-referrals across all systems of medicine. To strengthen the impact of existing NPCDCS, the Ministry of Health and Family Welfare (MoHFW) and the Ministry of Ayush (MoA) collaboratively implemented the pilot project to integrate Ayush with NPCDCS in 2015–16. The project was implemented in six districts and six states. The pilot project implementation underwent third-party evaluation by NIHFW, which revealed that the Ayurveda/ Unani/ Homeopathy integration was a successful low-cost working model. The study concluded that strengthening the healthcare network by utilizing the services of Ayush doctors can be adopted to prevent and control NCDs through primary healthcare networks. The objective may be fulfilled with the intervention, and the services may be co-located in the facilities. This program also boosted the referrals and cross-referrals of patients among conventional and various Ayush systems.
The implementation was jointly reviewed by the Hon’ble Minister of Health and Family Welfare and MOS, MoA, in the meeting held on 26.10.2020. In the meeting, it was decided to continue the program beyond 31.10.2020, to constitute a Committee to find out the modalities for further continuation of NPCDCS-Ayush Integration, and the program should be implemented in service delivery mode by utilizing the existing resources. The program can be taken forward through two verticals. The two verticals are Ayushman Bharat- Health and Wellness Centres (AB-HWCs) (through NHM and NAM by integrating the outcomes of a pilot study in the package of NCDs) and integrating NPCDCS-Ayush with NCD clinics (through central sector theme). NHSRC will extend all support for modeling the operational guidelines and implementing the program in consultation with MoA; NHSRC might support Ayush experts to facilitate and support expanding the scope of Ayush in national programs.
| Conclusion|| |
The National Health Policy 2017 emphasizes "One Nation, One Health System" by developing protocols for mainstreaming Ayush as integrated healthcare. This has a considerable potential for effective prevention and therapy that is safe and cost-effective. Mainstreaming of Ayush systems with modern medicine and healthy lifestyle measures has a great potential to facilitate primary healthcare to achieve better outcomes and universal health coverage.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Anonymous. Taskforce report of Ministry Health Family Welfare and Ministry of Ayush, on “AYUSH implementation at Ayushman Bharat – Health and welfares centre for NCDs”, August,2022. Available at http://220.127.116.11/loksabhaquestions/annex/179/AU3435.pdf
[last accessed on 02 Nov 2022]
Anonymous. World Health Organization, Traditional Medicine Strategy - 2014–20. Available at https://www.who.int/publications/i/item/9789241506096
[last accessed on 01 Nov 2022]
Oyebode O, Kandala NB, Chilton PJ, Lilford RJ Use of traditional medicine in middle-income countries: A WHO-SAGE study. Health Policy Plan 2016;31:984-91.
Jones WB Alternative medicine -learning from the past, examining the present, advancing to the future. J Ame Med Asso 1998;280:1616-8.
Fontanarosa PB, Lundberg GD Alternative medicine meets science. J Ame Med Asso 1998;280:1618-9.
Gyamfi1 ET Metals and metalloids in traditional medicines (Ayurvedic medicines, nutraceuticals and traditional Chinese medicines). Environmental Science and Pollution Research 2019;26:15767-78.
Luo L, Wang B, Jiang J, Fitzgerald M, Huang Q, Yu Z, et al
. Heavy metal contaminations in herbal medicines: Determination,comprehensive risk assessments,and solutions. Frontiers in Pharmacology 2021;11:1-14.
Devarbhavi H Ayurvedic and herbal medicine – Induced liver injury: It is time to wake up and take notice. Indian J Gastroenterology 2018;37:5-7
Barve M, Mashru M, Jagtap C, Patgiri BJ, Prajapati PK Therapeutic potentials of metals in ancient India: A review through charaka samhita. Journal of Ayurveda and Integrative Medicine 2011;2: 55-63
Thyagarajan SP, Chamundeeswari D, Unni Nair B Scientific evaluation of copper-containing herbo mineral formulation for the management of Ulcers (2008–2013) -National initiative on metal based drugs - SERC-DST, Govt of India.
Royapuram Parthasarathy P, Manikandamathavan VM, Chandronitha C, Vasanthi HR, Mohan VK, Vijayakumar V, et al
. Synthesis, characterization, and in V ivo toxicological evaluation of copper (II) oxide containing herbometallic siddha nanocomplex “thamira parpam”. Front Bioeng Biotechnol 2022;10:849441.
Anonymous, World Health Organisation. WHO guidelines for quality assessment of herbal medicines with reference to contaminants and residues 2007. Available at: https://apps.who.int/iris/handle/10665/43510
[last accessed on 02 Nov 2022].
Calixto JB Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents). Braz J Med Biol Res 2000;33:179-89.
Goyal C, Khemchand S, Arunkumar G Stability testing ayurvedic formulations: Exigency of today’s world. International J Green Pharmacy 2017;11:338.
Anonymous. Ministry of Ayush, "Vision". 2022. Available at: https://namayush.gov.in/content/vision
[last accessed on 02 Nov 2022].
Xiong H,Yu LX, Qu H Batch to batch quality consistency evaluation of botanical drug products using multivariate statistical analysis of the chromatographic finger print. AAPs Pharm Sci Tech 2013;14:802-9
Loew D, Kaszkin M Approaching the problem of bioequivalence of herbal medicinal products. Phytother Res 2002;16: 705-11.
Sharma AK, Kumar R, Mishra A, Gupta R Problems associated with clinical trials of ayurvedic medicines. Brazilian J Pharmacognosy 2010;20:276-81.