Government policies and initiatives for development of Ayurveda

Government policies and initiatives for development of Ayurveda

Author’s Accepted Manuscript Government Policies and Development of Ayurveda Initiatives for Dinesh Katoch, Jitendra S Sharma, Subhadip Banerjee, R...

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Dinesh Katoch, Jitendra S Sharma, Subhadip Banerjee, Rajarshi Biswas, Bhaskar Das, Debayan Goswami, Ranjit K. Harwansh, C. K Katiyar, Pulok K Mukherjee www.elsevier.com/locate/jep

PII: DOI: Reference:

S0378-8741(16)30544-X http://dx.doi.org/10.1016/j.jep.2016.08.018 JEP10365

To appear in: Journal of Ethnopharmacology Received date: 15 February 2016 Revised date: 25 July 2016 Accepted date: 16 August 2016 Cite this article as: Dinesh Katoch, Jitendra S Sharma, Subhadip Banerjee, Rajarshi Biswas, Bhaskar Das, Debayan Goswami, Ranjit K. Harwansh, C. K Katiyar and Pulok K Mukherjee, Government Policies and Initiatives for Development of Ayurveda, Journal of Ethnopharmacology, http://dx.doi.org/10.1016/j.jep.2016.08.018 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting galley proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

Government Policies and Initiatives for Development of Ayurveda Dinesh Katoch1, Jitendra S Sharma1. Subhadip Banerjee2, Rajarshi Biswas2, Bhaskar Das2, Debayan Goswami2, Ranjit K. Harwansh2, C. K Katiyar3, Pulok K Mukherjee2* 1

Ministry of AYUSH, Government of India, AYUSH Bhawan, B Block, GPO Complex, INA, New Delhi- 110023 2

School of Natural Product Studies, Department of Pharmaceutical Technology, Jadavpur University, Kolkata-700032, India. 3

Research & Development Center, Healthcare Division, Emami Limited 13, BT Road, Kolkata - 700056, India

*Corresponding author: Pulok K. Mukherjee, PhD, FRSC School of Natural Product Studies Department of Pharmaceutical Technology Jadavpur University, Kolkata -700 032, India Telefax: +91-33-24146046 E-mail: [email protected]

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Abstract Ethnopharmacological relevance: Ayurveda (Sanskrit: Ayus - life + Veda - knowledge) means the “True knowledge of life”. Ayurveda deals with a complete self-sustainable system of medicine. The Government of India through its Ministry of AYUSH is responsible for policy formulation, development and implementation of programs for the growth, development and propagation of Ayurveda. Aim of the study: This review aimed to highlight the various aspects of government policies and initiatives for development of Ayurveda. Materials and methods: We critically reviewed various books, annual reports, policy documents and various ancient Ayurvedic literatures. Besides the websites of Ministry of AYUSH, National Medicinal Plant Board, Central Council for Research on Ayurvedic Sciences (CCRAS) and AYUSH research portal have been searched and data was recorded. Results: The vision of the ministry is to position AYUSH systems as the preferred systems of living and practice for attaining healthy nation. The ministry has identified its mission in terms of seven broad thematic functional areas of AYUSH activities. These are information, education and communication; drug administration, human resource development, medicinal plants, research and development, international collaborations, AYUSH services. Different programs have been taken up towards increasing visibility, acceptability and usage of Ayurveda vis-a vis its integration in the health system. Strategies to globalize and promote Ayurveda are being taken up through AYUSH clusters focusing its safety-efficacy-quality aspects and rational use of Ayurveda Conclusion:

The government policies are taking firm steps towards promotion and

development of Ayurveda. Research and development towards validation of Ayurveda is being projected as the thrust area.

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Keywords: Ministry of AYUSH, National AYUSH Mission, Center for Excellence, Traditional Knowledge Digital Library, Industrial Clusters

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Contents 1. Introduction 1.1. Ministry of AYUSH 2. National policy of AYUSH 2.1. Vision and mission 3. Promotion of Ayurveda in education and practice 3.1. Education policy of Ayurveda 4. Industrial Initiatives- Ayurvedic drugs and pharmaceuticals 4.1. Development of formulations and ensuring quality standards 4.2. Medicinal Plants: conservation, development and sustainable management 4.3. Information, education and communication 4.4. Initiatives to promote Ayurvedic drug industry 4.5. AYUSH industrial clusters 5. Regulatory affairs of Ayurveda 5.1. Regulatory mechanism for Ayurvedic education and practice 5.2. Regulation and quality control of Ayurvedic drugs 5.2.1 Good clinical practice guidelines 6. Development Initiatives 6.1. Center for excellence, AYUSH 6.2. Traditional knowledge digital library (TKDL) 6.3. Central council for research in Ayurvedic sciences (CCRAS) 7. National AYUSH mission 8. International cooperation and promotion 9. Conclusion

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1. Introduction Ayurveda is an ancient healthcare system originated at the dawn of human civilization.

The ancient Vedic text Atharva-veda documented around 5000 years back

contains various references to Ayurvedic medicine and allied aspects of healthcare. The Sanskrit word "Ayurveda" consists of two words- ‘Ayus’ means life and ‘Veda’ means knowledge or science. Thus "Ayurveda’ in totality means ‘Science of life’. It integrates every facet of existence including physical, psychological, spiritual and social. It explains what is beneficial and what is harmful to live, how happy life can be achieved and miserable life thawed; all these important queries and lifespan allied issues are opulently and ardently conferred in Ayurveda (Mukherjee et al., 2012). The main classical texts for reference of Ayurvedic principles comprise of ‘Charak Samhita’, ‘Susrut Samhita’, ‘Ashtanga Hridaya’, ‘Sharangdhar Samhita’, ‘Madhav Nidan’, ‘Kashyap Samhita’, ‘Bhavprakash’ and ‘Bhaisajya Ratnavali’, etc. Ayurveda presents an extensive knowledge of prevention of disease, promotion of health and its preservation and management of diseases as well in holistic terms. Lifestyle management or Swasthyavritta is a major area of focus mentioned in Ayurvedic texts, which on regular practice helps to sustain healthy status. Ayurveda can efficiently manage lifestyle associated diseases, drug abuse, degenerative diseases, autoimmune diseases and metabolic and allergic disorders with its unique therapies, body-mind constitution based lifestyle guidelines and medicaments. It has the multidimensional range of treatment efficacy in disease conditions like migraine, Parkinsonism, neurological disorders, musculoskeletal diseases, which are not so effectively manageable with conventional treatment (Mukherjee et al., 2010). A plethora of medicinal herbs mentioned in Ayurveda have been scientifically validated for their purported effects as anti-convulsant, anti-cancer and anti-ageing agents. Ayurveda way is known as efficient mode of treatment of most of the diseases relating to various systems of the body with its

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novel therapies known as Panchakarma (Debnath et al., 2015). Holistic approach and affordability of Ayurvedic healthcare has been established in a manner that people have started using it as an adjuvant with the ongoing treatment and for individualized lifestyle modulation.

In India, Ayurveda is the widely practiced and culture bound tradition of

healthcare and its knowledge is available in both codified and non-codified forms. Huge literature and institutional network is the testimony of communities’ adoption and preference for pursuing Ayurveda-based healthy life and healthcare. This article highlights on different aspects of development and promotion of Ayurveda as being highlighted in different sections with principle emphasis on the Ministry of AYUSH and other Government initiatives being taken in India. 1.1. Ministry of AYUSH In order to accord focused attention for the growth and development of Ayurveda and other systems of Indian Medicine, Government of India established Department of Indian Systems of Medicine and Homoeopathy (ISM&H) established under the Ministry of Health & Family Welfare in March 1995. It was re-named as Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy with an acronym as AYUSH in November 2003. Each letter of the acronym ‘AYUSH’ represents officially recognized systems of medicine other than allopathic medicine.

With the change of Government in 2014, a

conscious decision was taken to upgrade the Department to full-fledged Ministry of AYUSH with independent Minister and mandate for systematic development in all spheres of Indian Medicine and to bridge the prevailing gaps in healthcare delivery and outreach of health services. The Ministry is responsible for policy formulation, planning and implementation of schemes and programs for augmenting the domain, quality and outcomes of AYUSH sector in inclusive terms. Sowa Rigpa, traditional medical system of the people of Himalayan region has also been given recognition and added recently in the family of AYUSH. Objectives of

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the Ministry of AYUSH are multifaceted and inter alia include (1) Up-gradation of educational standards of teaching & training institutions; (2) Strengthening of research and development institutions and time-bound execution of prioritized research programs; Implementation

of

schemes

for

promotion,

cultivation,

conservation,

sustainable

development and resource augmentation of medicinal plants used in AYUSH systems; (4) Standardization and Quality Control of drugs as per global trends; (5) Mainstreaming and Integration of AYUSH services in the national health delivery network; and (6) Awareness building and propagation of AYUSH through information, education and communication (Ministry of Health and Family Welfare, 2012-17). 2. National policy of AYUSH 2.1. Vision and mission The vision of the Ministry is to position AYUSH systems as the preferred systems of living and practice for attaining a healthy India [Ministry of Ayurveda, Yoga, Unani, Siddha, Homeopathy (AYUSH), 2014-2015]. The Ministry has identified its mission in terms of seven broad thematic functional areas to undertake and support activities of public information, education and communication; drug administration; human resource development, development of medicinal plants; research and development; international collaboration; and enhancement of AYUSH- based health services. The significance of Indian Systems of Medicine and Homoeopathy was first brought in the National Health Policy-1983 and later emphasized in the National Population Policy-2000 and National Health Policy, 2002 and ultimately in comprehensive terms in National AYUSH Policy, 2002. It was envisaged in the policy statements that Ayurveda, have a substantial role because of its advantages, such as diversity, modest cost, low level of technological input and the growing popularity of natural plant based products, especially in the under-served, remote and tribal areas (National Health Policy, 2002). The policy envisaged the consolidation of

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documentary knowledge of Ayurveda to protect it from commercial exploitation, piracy and misappropriation by foreign entities. It promotes measures to ensure affordable health services and drugs which are safe and efficacious. Integration of AYUSH in the healthcare delivery system and national programs to ensure optimal use of the vast infrastructure of hospitals, dispensaries and physicians were focused in the policy (Samal, 2015). Reorientation and prioritization of research in Ayurveda to validate drugs and therapies to address in particular the chronic and new emerging lifestyle related diseases was given importance in the policy. Optimal utilization of Ayurveda has been taken up for the mainstreaming of its services through National Rural Health Mission, which is now upgraded into flagship program called National Health Mission (Shrivastava et al., 2015). As a result of this initiative, the public perception is evolving and increased opportunities are emerging in AYUSH including development of Ayurveda in various aspects. All this is poised to be achieved through the utilization of the potentiality, strength and revival of Ayurveda (Patwardhan, 2015). 3. Promotion of Ayurveda in education and practice 3.1. Education policy of Ayurveda The educational system and professional practice of Ayurveda are controlled by the Central Council of Indian Medicine (CCIM), which is a statutory body set up under the provisions of Indian Medicine Central Council (IMCC) Act, 1970. The Central Government has adopted stringent regulatory provisions for granting permission to establish new colleges, increase in admission capacity in any course of study or training, and for starting a higher or new course of study in existing Ayurveda colleges and to maintain uniform standards of education across the country. There are 265 Ayurveda colleges including 117 with postgraduate courses of study both in public and private sectors. World Health Organization (WHO) recognizes Ayurveda since it adopted traditional medicine to achieve the objective of

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"health for all" due to its potential role in rendering primary health care services to the people. Ayurveda enjoys a better place in respect of prevention and cure of the disease in comparison to several other medical systems (Chaudhary and Singh, 2011). The current status of manpower and institutional profile of Ayurveda in India are as follows: (i) registered Medical Practitioners – 438721, (ii) dispensaries – 15193, (iii) hospitals – 753, (iv) bed strength – 35182 and (v) teaching institutions – 219. Ayurveda doctors with degree or equivalent qualifications are considered as recognized medical practitioners as mentioned in the schedules of Indian Medicine Central Council Act, 1970. The recognized qualifications for the purpose of registration and to engage in clinical practice of Ayurvedic Medicine are Bachelor of Ayurvedic Medicine and Surgery (BAMS) and MD/MS (Ayurveda) master’s degrees in 22 specialties and equivalent qualifications. 4. Industrial initiatives- Ayurvedic drugs and pharmaceuticals 4.1. Development of formulations and ensuring quality standards Legally Ayurvedic medicines can be manufactured under license from the formulae or the natural raw materials of plant, animal, mineral or marine origin mentioned in the authoritative books listed in a schedule of the Drugs & Cosmetics Act, 1940. Different kinds of formulations are accordingly manufactured and administered as Ayurvedic drugs. Considering their method of preparation, palatability, bioavailability and therapeutic values formulations are grouped in various dosage forms as shown in Table 1 viz Avleh, churna, Asava, Bhasma, Ghrita, Taila, Kupipakva, Gutika, Guggulu Modaka, Louha, Pisti, etc. as described in the Ayurvedic Formulary of India published by the Government. In persuasion of standardization of Ayurvedic drugs for the purpose of effective quality control, 265 standardized formulations from classical texts are published in four volumes of the National Ayurvedic Formulary and 645 monographs of quality standards of single drugs and 252 monographs of quality standards of multi-ingredient formulations are published in two parts

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of Ayurvedic Pharmacopoeia in thirteen volumes. Pharmacopoeial standards of Ayurvedic drugs are developed on the basis of twelve assessment parameters of identity, purity and strength including confirmed identification, chemical constituents and permissible limits of heavy metals, pesticide residue, aflatoxins and microbial load. Similarly, in order to ensure supply of quality Ayurvedic medicines to the health facilities across the country, an Essential Drug List containing more than 250 medicines is published and the states are supported to procure such medicines for free public distribution to patients through dispensaries and other medical centers. The work of development and revision of standards of Ayurveda drugs is done under the supervision of Pharmacopoeia Commission of Indian Medicine & Homoeopathy and with the responsibility of Ayurvedic Pharmacopoeia Committee of interdisciplinary experts. Various scientific laboratories and Pharmacopoeial Laboratory for Indian Medicine (PLIM), which is an appellate laboratory under the provisions of Drugs & Cosmetics rules, 1945, are engaged in the work of standardization and SOPs of Ayurvedic drugs using sophisticated equipment and analytical tools. Although, significant achievements have been made by the existing pharmacopoeia set up, a unified pharmacopoeial infrastructure is intended for better coordination and outcomes. For this purpose, development of pharmacopoeial standards is proposed to be augmented through studies conducted by laboratories or institutions accredited by Government. This effort will substantiate the existing pharmacopoeial standards of single and multi-ingredient drugs of plant, mineral, metal and animal origin (Mukherjee. et al., 2010).

Standard Operating

Procedures (SOP) of manufacturing processes of formulations, assays, atlas of chromatography, Pharmacognosy atlas etc are being appended to the quality standards of drugs to facilitate the testing procedures and estimation of marker compounds and phytochemical standard materials. Parameters like DNA barcoding or fingerprinting of medicinal plant materials are combined within the framework for quality control of

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Ayurvedic drugs (Fig. 1). Drug Control Cell in the Ministry of AYUSH looks after regulatory and quality control matters of Ayurvedic drugs under the provisions of Drugs and Cosmetics Act, 1940 and rules there under. Drug Control Cell coordinates with the State Licensing Authorities, Drug Controllers and Drug Testing Laboratories for the purpose of enforcement of legal provisions of quality control of Ayurvedic and other traditional medicines. Amendment of regulatory provisions is a continuous process and it is taken up in accordance with the felt needs and emerging trends in the quality control of natural medicinal products. Lot of thrust has been given to check manufacturing companies for compliance to Good Manufacturing Practices, prescribed Shelf-life and evidence of safety and effectiveness of drugs. Government has sanctioned additional senior level posts of regulatory positions and steps taken to set up a vertical structure for AYUSH drugs in the Central Drug Standards Control Organization headed by Drugs Controller General. Financial support is provided to the states to strengthen infrastructural and functional capacities for production, testing and quality enforcement of Ayurvedic and other traditional medicines. 4.2. Medicinal plants its conservation, development and sustainable management India is endowed with 15 agro-climatic zones and 17000-18000 species of flowering plants. Out of which 6000-7000 are estimated to have medicinal usage in folk and Ayurveda like documented systems of medicine. There are about 960 species of medicinal plants which are estimated to be in the trade. 178 species of them have annual consumption levels more than 100 metric tons. Cultivation and conservation of medicinal plants through the development of sustainable management strategies is an absolute requirement. To address these issues the National Medicinal Plants Board (NMPB) under Ministry of AYUSH was set-up in November 2000 by the Government of India. The board support policies and programs for the growth of trade, export, conservation, and cultivation of medicinal plants. The NMPB provides support for survey, inventorization, in-situ conservation, ex-situ

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conservation, herbal gardens and linkage with joint forest management programs, research, and development, etc. This project aims at delivering Ayurvedic health care by medicinal plants to the rural and tribal population of India, at their doorstep, where the conventional modes of treatment don't reach. Department of Biotechnology and Department of Forests undertakes biodiversity conservation projects including cultivation, post-harvest processing and storage of medicinal herbs through various assistances.

Threatened, endangered,

vulnerable medicinal plants species are being protected in different ways. Restrictions are enforced for rampant deforestation for the collection of raw materials of medicinal value from the wild sources. 4.3. Information, education and communication The Ministry of AYUSH has been focused towards implementing promotional programs of information, education and communication (IEC) to develop awareness amongst the masses about the efficacy of Ayurveda, their cost effectiveness and dissemination of proven results on research and development work. The AYUSH Ministry provides funding for the organization of national and state level Arogya Fairs. Health fairs or melas or exhibitions organized by government departments, state governments and other reputed organizations and participations therein. Promotional incentives are provided to Ayurveda industry to participate in Arogya and other fairs/ melas/ exhibitions/ conferences/ seminars etc. 4.4. Initiatives to promote Ayurvedic drug industry The market demand for Ayurvedic medicine has been part of India’s socio- cultural heritage and the market is increasing steadily, the world over. Although the Ayurvedic industry is the most traditional form of industry, the emerging market opportunities remain underexploited. In order to address that problem initiatives are taken up by Department of Science & Technology to start the Drugs & Pharmaceuticals Research Programme (DPRP) in

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1994-95 for promotion of industry-institutional collaboration in the development of new drugs in pharmaceuticals sector (Ministry of Health & Family Welfare, 2011). Pharmacy courses like B. Pharm (Ayurveda) and M. Pharm (Ayurveda) in different parts of the country. Emphasis has been laid on Ayurveda in some specific development of herbal drugs. Research regarding process validation and biological evaluation of formulations is made a major thrust area. Pharmaceutical Export Promotion Council (Pharmexcil) constituted a National committee in the field of Ayurvedic medicines to guide the industry to march ahead with the basic objective of promoting exports to developed countries. 4.5. AYUSH industrial clusters The Ayurvedic industry is dominated by micro, small and medium enterprises (MSMEs). These account for more than 80% of the enterprises that are located in identifiable geographical clusters. To exploit the emerging market opportunities, and overcome the constraints explained above AYUSH cluster program has been taken up. Cluster based approach is being highly recognized as an efficient and sustainable strategy for competitiveness augmentation of MSMEs. An approach like this which leverages the geographical proximity of the MSMEs on ‘collaborating while competing’ principle is participatory, cost efficient which provides crucial mass for customization of interventions (Anonymous, 2015). Testing facilities such as analytical lab, toxicology centre, process & product validation laboratory, raw material testing, standardization laboratory, etc. which will enable better quality assurance & control are the mandatory component of the project. The testing laboratory should be according to the standard of National Accreditation Board for Testing and Calibration of Laboratories (NABL). 5. Regulatory affairs of Ayurveda 5.1. Regulatory mechanism for Ayurvedic i.e., education and practice

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The Central Council of Indian Medicine (CCIM) is a Statutory Body constituted under the Indian Medicine Central Council Act, 1970. The Council is envisioned to be a dynamic regulatory body which will regulate the practice of Ayurveda and also guide, develop and sustain a network of ‘institutions of excellence’ in education to meet the national needs considering the global trends. The mission of the council is to establish, guide, develop and sustain for the conservation of standards and quality of academic study programmes as well as practice of Ayurveda to meet national as well as global standards through resource allocation, good governance and management. The CCIM maintains central register of practitioners of Ayurveda and for dealing with matters connected therein with. The council is responsible for maintaining the minimum standards for education. This council as per the provisions introduced the following courses or degrees delivered in Ayurveda.

For degree course Ayurvedacharya (BAMS), then

Ayurved Vachaspati (MD Ayurved) at Post Graduate level and Ayurved Varidhi for Ph. D in Ayurveda. Specialised courses like B. Pharm (Ayurveda), M. Pharm (Ayurveda) have been started in Gujarat Ayurveda University, Jamnagar; Jadavpur University, Kolkata; Banaras Hindu University, Varanasi. Moreover PG Diploma courses on Ksharsutra and Panchakarma are also started. 5.2. Regulation and quality control of Ayurvedic drugs For globalizing the system and its products, the Ministry of AYUSH has focused its attention on standardization and quality control of Ayurvedic drugs. Good Manufacturing Practices (GMP) have been notified under ‘Schedule T’ of the Drugs & Cosmetics Rules, 1945 and testing for heavy metals, viz. mercury, arsenic, lead and cadmium, in all purely herbal Ayurvedic drugs is made mandatory for export purposes (Anonymous 2013). All these measures have been introduced to give greater impetus to consumer awareness, consumer and

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doctor benefit, acceptance in the globalized markets and to ensure safety which is of utmost concern while using Ayurveda medicines. 5.2.2. Good clinical practice guidelines Clinical safety and efficacy documentation proof of Ayurvedic medicine had been a persistent and increasing demand globally (Singh, 2010). The history of GCP statute traces back to one of the oldest enduring traditions in the history of medicine that is Ayurveda. Therefore clinical trials in Ayurveda, need to be guided by the principle of ‘Good Clinical Practice’ (GCP). Safety and therapeutic efficacy of the ASU drugs can be readdressed to assure their quality. Thus clinical research in these lines helps us to generate quality data, which are acceptable to regulatory authorities. The importance for which are directly concerned with product registration or approval for marketing especially for products based on non-classical or non-generic formulations. It has focused much on ethical guidelines while treating a patient with medical/surgical interventions. The requirement of proof for effectiveness of licensing on the patent or proprietary ASU medicine for the enactment of Drugs & Cosmetics Rule 158 B since August 2010 has necessitated the development of present guidelines of GCP. These guidelines have been prepared by a comprehensive consultative process and are fine-tuned to the best interest of Ayurveda. 6. Development Initiatives 6.1 Center for excellence, AYUSH The Ministry is aimed towards achieving excellence concerning creative and innovative research in Ayurveda. There is a growing acceptance of Ayurveda among consumers in the domestic and global market. It is growing as a crucial component of pluralistic healthcare system in India and throughout the world. The Ministry has decided to identify and promote through reputed Ayurvedic knowledge centres engaged in drug development & research, education, clinical research etc. in government or non-government, non-profit to support them to enhance their functions and facilities to the levels of excellence. 15

These Centers of Excellence (COE) are projected as institutions and organizations specializing in one or more of the thrust areas of clinical research, hospitals, nursing homes, research based on the fundamentals of Ayurveda. It may be engaged in interdisciplinary research in pharmacology, pharmacy or product development, which will bridge Ayurveda and modern science or in any other specialized area of AYUSH.

Adding new global

functions and making significant qualitative improvements in the existing services including support for human resources, adding infrastructure and equipment. The Government is supporting the current facilities of the COE organization will be upgraded to NABH, NABL, GLP, GMP level which are acceptable to the Department to achieve higher standards. 6.2. Traditional knowledge digital library (TKDL) The TKDL program deals with the documentation of this existing knowledge on Ayurvedic systems of medicine. It is imperative to safe guard the sovereignty of traditional Ayurvedic knowledge to protect them from being misused in patenting on non-patentable inventions. Although this knowledge is in the public domain, the patent office does not have a mechanism to access this information to deny patenting rights. Obtaining patents for all such medicinal uses is impossible. It is also extremely costly and time-consuming to fight patents granted to others. Thus, bringing such knowledge into an easily accessible format to forestall wrongful patents was actualised through the Traditional Knowledge Digital Library (TKDL) (http://www.tkdl.res.in). It is an original proprietary database, which is fully protected by national and international laws of intellectual property rights. The core of the project is the innovative approach in the form of Traditional Knowledge Resource Classification (TKRC) that enables conversion of 140,000 pages of information, containing 36,000 formulations described in 14 texts of Ayurveda, into the patent-compatible format in various languages, viz. translation of Sanskrit shlokas not only in Hindi but also in English, French, German, Spanish, and Japanese etc. The information includes names of plants,

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Ayurvedic description of diseases under their modern names, therapeutic formulations, and so on (Mukherjee et al., 2010).

6.3. Central council for research in Ayurvedic sciences (CCRAS) The Central Council for Research in Ayurvedic Sciences (CCRAS) is an autonomous body under Ministry of AYUSH, Govt. of India which is undertaking for coordinating, formulating, developing and promoting research on scientific lines in Ayurveda. The main activity of the Council includes clinical research, drug research, and literary research in Ayurvedic Sciences. The research activities are carried out through its 30 Institutes/Centers/ Units located all over India (Table 2) and also through collaborative studies with various universities, hospitals and institutes. Different clinical projects on the topics like hemorrhoids, Rasayana (Immunomodulation) and osteoarthritis have been successfully completed under CCRAS research program (Annual Report 2014-15). Intra Mural Research (IMR) projects have been initiated in drug standardization and pharmacological research (Annual Report 2013-14). 7. National AYUSH mission About 30% of the Indian populations were using traditional medicines because they are convinced about its therapeutic effectiveness, however, creating awareness and improving access to traditional medical systems in India is needed (Srinivasan and Sugumar, 2015). The Ministry of AYUSH, Government of India, has launched National AYUSH Mission (NAM) during 12th Plan for implementing through States/UTs notified on 29.09.2014. It envisages better access to services, strengthening educational institutions, enforcement of quality control of drugs and continuous availability of raw materials in the States/UTs during 12th Plan (Anonymous, 2015). The new initiatives under NAM include school health programme

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through AYUSH. The public health outreach activity has been taken up to focus on increasing awareness regarding the strength of Ayurveda in managing community health problems. The adoption of villages for propagating Swasthyavritya that is "Ayurvedic way of life" together with interventions of health care is termed as AYUSH Gram project. An integrated approach converging with the principles and practices of AYUSH systems with Yoga and Naturopathy wellness centres which will facilitate early prevention of noncommunicable diseases and promotion of health care by way of Behaviour Change Communication (BCC).

The scheme envisages flexibility of implementation of the

programmes which will lead to substantial participation of the State Governments/UT. 8. International cooperation and promotion

Global promotion and propagation of Ayurveda has been an important thrust area of the Department of Ministry since past few years. It has adopted a strategy for the signing of Country to Country Memorandum of Understanding (MoU) on cooperation in Traditional Medicine. It has set AYUSH Academic chairs in Foreign Universities and Institutes. The AYUSH Information Cell has been opened in the premises of the India Missions / ICCR Cultural Centre to disseminate authentic information about AYUSH. The significant achievements of international cooperation have been tremendous which have resulted Ayurveda to emerge at the global level. Globally traditional medicine has regained its prestige when Traditional Chinese Medicine (TCM) earned the Nobel Prize in Medicine for the discovery of anti-malarial drug in 2015 and the UN decided to celebrate International day of Yoga on June 21 as World Yoga Day. It is a matter of triumph when “Traditional Medicine: Delhi Declaration”

was adopted as the resolution of the WHO Regional

Committee for South-East Asia SEA/RC67/R3 as proposed by AYUSH, Govt. of India and now adopted by the countries of whole South-East Asia region. 9. Conclusion 18

The people bear a strong faith in AYUSH and are also convinced by its effectiveness. However it requires genuine need for developing awareness and ease of access to traditional medical systems in India. Interdisciplinary research, standardization, quality control and validation of the Ayurvedic medicine is needed to establish a knowledge base to meet the global standards. AYUSH industry also needs mentoring from the government to flourish in India and abroad. The Ministry of AYUSH is taking a huge step towards for the promotion and development of Ayurveda nationally and internationally. However there are more to be done to mainstream Ayurveda and validate to make it acceptable worldwide as a scientific system of healthcare to regain its glory. Acknowledgement The authors wish to acknowledge the Ministry of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy (AYUSH), Government of India, for the systematic information provided in their web portal.

Conflict of interest The authors declare that they have no conflict of interest.

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References Annual Report, 2013-14. Central Council of Research Ayurvedic Sciences. Department of AYUSH (Drug Control Cell), Ministry of Health & Family Welfare, Government of India, New Delhi. Annual Report, 2014-15. Government of India, Ministry of Ayurveda, Yoga, Unani, Sidha, Homeopathy (AYUSH). Anonymous, 2013. Good Clinical Practice (GCP-ASU). Department of AYUSH, Ministry of Health & Family Welfare, Government of India, New Delhi. Anonymous, 2015. Framework for Implementation of National AYUSH Mission (NAM), Department of AYUSH, Ministry of Health and Family Welfare, Government of India. Accessed from www.indianmedicine.nic.in as on 12.12.2015. Anonymous, 2003. The Ayurvedic Formulary of India, Part 1, 2nd ed.; The Controller of Publications: Delhi. Anonymous, 2012. Ayurveda the science of Life Department of AYUSH, Ministry of Health and Family Welfare, Government of India, New Delhi. Anonymous, 2013. Manual for Inspectors Procedural Guidelines For Inspection of Ayurveda, Sidha and Unani Drug Testing Laboratories. Department of AYUSH (Drug Control Cell), Ministry of Health & Family Welfare, Government of India, New Delhi. Anonymous, 2015. International Cooperation achievements, 2012-13, 2013-14 and 2014-15. Accessed from www.indianmedicine.nic.in as on 12.12.2015. Anonymous, 2015. Scheme for Development of AYUSH Clusters, Department of AYUSH, Ministry of Health and Family Welfare, Government of India. Accessed from www.indianmedicine.nic.in as on 12.12.2015. Chaudhary, A., Singh, N., 2011. Contribution of world health organization in the global acceptance of ayurveda. J Ayurveda Integr Med. 2, 179-86.

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Debnath, P.K., Banerjee, S., Debnath, P., Mitra A., Mukherjee, P.K., 2015. Ayurveda – opportunities for developing safe and effective treatment choices for the future, in: Mukherjee, P.K. (Eds.), Evidence-Based Validation of Herbal Medicines. Elsevier, Amsterdam, pp. 427-454. Janmejaya, S., 2015. Situational analysis and future directions of AYUSH: An assessment through 5-year plans of India. J Intercult. Ethnopharmacol. 4, 348-54. Ministry of Health & Family Welfare, 2011. Central Scheme for Evolving Pharmacopoeial Standards for Ayurveda, Siddha, Unani and Homoeopathy drugs and Standardized Operating Procedures (SOPs) of Manufacturing Processes of ASU&H drugs. Department of AYUSH (Drug Control Cell), Ministry of Health & Family Welfare, Government of India, New Delhi. Accessed from www.indianmedicine.nic.in as on 12.12.2015. Ministry of Health and Family Welfare, 2012-17. Report of working group on AYUSH for 12th five year plan (Available from: http://planningcommission.nic.in). Accessed 04.07.16. Mukherjee, P.K., Bahadur, S., Chaudhary, S.K., Kar, A., Mukherjee, K., 2015. Quality related safety issue-evidence-based validation of herbal medicine farm to pharma, in: Mukherjee, P.K. (Eds.), Evidence Based Validation of Herbal Medicines, Elsevier, Amsterdam, pp. 1-28. Mukherjee, P.K., 2002. Quality Control of Herbal Drugs, 1st ed.; Eastern Publishers (Business Horizons Ltd.): New Delhi, Mukherjee, P.K., Nema, N.K., Venkatesh, P., Debnath, P.K., 2012. Changing scenario for promotion and development of Ayurveda way forward. J. Ethnopharmacol.143, 424-34. Mukherjee, P.K., Venkatesh, M., Gantait, A., 2010. In Comprehensive Natural Products II Chemistry and Biology, Mander, L., Lui, H.W., (Eds.), Elsevier, Oxford, pp. 479-507.

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Mukherjee, P.K., Venkatesh, P., Ponnusankar, S., 2010. Ethnopharmacology and integrative medicine Let the history tell the future. J. Ayurveda Integr. Med.1, 100. National Health Policy, 1983. Accessed from www.mohfw.nic.in National Health Policy, 2002. Accessed from www.mohfw.nic.in Patwardhan, B., 2015. Public perception of AYUSH. J. Ayurveda. Integr. Med. 6, 147-9. Samal, J., 2015. Role of AYUSH workforce, therapeutics, and principles in health care delivery with special reference to National Rural Health Mission. Ayu. 36, 5-9. Shrivastava, S.R., Shrivastava, P.S, Ramasamy, J., 2015. Mainstreaming of Ayurveda, Yoga, Naturopathy, Unani, Siddha, and Homeopathy with the health care delivery system in India. J. Tradit. Complement. Med. 5, 116-118 Singh, R.H., 2010. Exploring larger evidence-base for contemporary Ayurveda. Int. J. Ayurveda Res. 1(2), 65–66. Srinivasan, R., Sugumar, V.R., 2015. Spread of Traditional Medicines in India: Results of National Sample Survey Organization’s Perception Survey on Use of AYUSH. J. Evid. Based Complementary Altern. Med. 1-11.

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Figure legend: Fig. 1. Framework for quality control of Ayurvedic drugs by the Ministry of AYUSH

Table legend: Table 1. Formulations available in the Ayurvedic Formulary of India (AFI) Table 2. CCRAS Research Institutes/Units state wise

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Fig. 1. Framework for quality control of Ayurvedic drugs by the Ministry of AYUSH

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Table 1. Formulations available in the Ayurvedic Formulary of India (AFI) S. No. Ayurvedic Name (Sanskrit Name)

Explanation

Major constituents with Applications

1.

Asavas and Aristas

Fermented self generated alcoholic formulation made by soaking the herb in sugar solution or jiggery with Madhuka Pushpa (Madhuca longifolia (J.Konig) J.F.Macbr.) for a specified period of time.

Draksharista -Vitis vinifera Linn. as major ingredient. Urakshata – useful in chest injury

2.

Arka

A liquid preparation obtained by distillation of certain liquids or herbs soaked in water using the distillation apparatus.

Ajamodarka- Apium graveolens as the main ingredient, which is used as a digestive, contains

3.

Avaleha or leha and paka

These are semisolid preparations, prepared with the addition of jaggery, sugar, or sugar candy and boiled with prescribed juice of the herbs or its decoction.

Kutajavaleha-Major ingredient is Holarrhena antidysenterica, used to treat hyperacidity, anemia, and diarrhea.

4.

Churna

Powder of herb(s), where a single herb or combinations of herbs are made into a coarse powder

Narasimha Churna Contains Tinospora cordifolia Miers and Semecarpus anacardium Linn. as the main ingredients, used in the treatment of cough, pthisis, and fever.

5.

Guggulu

An exudate obtained from the plant Commiphora weightii. Preparation having the exudate as the main effective ingredient is known as ‘guggulu’.

kaisora guggulu (contains mainly T. cordifolian Miers) and kancanara guggulu (contains mainly Bauhinia variegata Linn.).

6.

Ghritas (snehakalpa):

asoka ghrita is used in the treatment of pelvic pain, lower backache, and anemia and contains Saraca asoca de Wilde as the major herb.

7.

Taila

Preparation in which ghee (clarified butter derived from milk) is boiled with prescribed decoction of drugs according to the formula as prescribed in Ayurvedic text. This process ensures absorption of the active therapeutic principles of the ingredients used. Preparations in which oil is boiled with prescribed decoction of drugs according to the formula. This process ensures absorption of the active therapeutic principles of the 25

prasarini taila (major ingredient, Paederia foetida Linn.) and bhringaraja taila (major ingredient, Eclipta alba

ingredients of the plant.

Linn.).

Liquid preparations obtained from lavanas (rock salts) and ksaras by distillation process with or without any addition of fluids. Ksaras are alkaline substances obtained from the ash of drugs. The drugs are cut into small pieces, dried, kept in an earthen pot, and burnt to ash. Topical applications in the form of a paste. The drugs are made into a fine powder. Before use on the body, it is mixed with some liquid or other medium indicated in each preparation and made into a soft paste. Water, cow’s urine, oil, and ghee are some of the media used for mixing. Medicinal preparations in the form of tablets or pills. They are made of one or more drugs of plant, animal, or mineral origin.

Sankha dravaka is used in treating diseases of the abdomen and spleen and contains Calotropis procera R.Br. and Euphorbia nerrifolia Linn. along with other ingredients. Avalgujadi lepa (contains Psoralea corylifolia Linn.) and pathyadi lepa (contains Terminalia chebula Retz. along with other ingredients) are some of the examples of this category. Khadiradi gutika is an example to mention. It contains Acacia catechu Willd. and is used in the treatment of halitosis, diseases of the teeth, and dental cavities (caries). Nalikeranjana (containing Berberis aristata DC and Glycyrrhiza glabra Linn.) and tamradi gutika (containing Glycyrrhiza glabra Linn. and Saussurea lappa C.B. Clarke along with other ingredients) are examples of this category. Louha bhasma (ash made from iron) is the main ingredient of preparations like ‘lauha kalpas’.

8.

Dravakas

9.

Lepa

10.

Vati and Gutika

11.

Vartti, Netrabindu, and Anjana

Preparations used externally for the eye.

12.

Bhasma and Pishti

13.

Rasa Yoga:

Bhasma -residue after incineration–calcined preparation Pishti-(powdered gem or metal) along with appropriate herbs is recommended for treatment of critical ailments. Contains mineral drugs as main ‘Amlapittantaka rasa’ ingredients, and it may be in pill or (contains T. chebula Retz.) powder form. and ‘Anandabhairava rasa’ (contains Piper nigrum Linn. and Piper longum Linn.).

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Table 2. CCRAS Research Institutes/Units state wise State Andaman Andhra Pradesh

Arunachal Pradesh Assam Jammu & Kashmir Karnataka

Kerala

Madhya Pradesh Maharashtra

Nagaland Odisha Punjab Rajasthan Sikkim Tamil Nadu

Uttar Pradesh Uttarakhand West Bengal

Name of Institute Ayurveda Tribal Health Care Research Project, Port Blair National Institute of Indian Medical Heritage, Hyderabad National Ayurveda Research Institute for Vector Borne Diseases, Vijayawada Ayurveda Regional Research Institute, Itanagar North East India Ayurveda Research Institute, Guwahati Ayurveda Regional Research Institute, Jammu National Ayurveda Dietetics Research Institute, Bangalore Advanced Center for Ayurveda in Mental Health & Neurosciences, Bangalore Ayurveda Research Institute for Mother and Child Health Care, Trivandrum. National Research Institute for Panchakarma, Cheruthuruthy National Research Institute for Ayurveda - Siddha Human Resource Development, Gwalior. National Research institute of Basic Ayurvedic Sciences, Pune. Ayurveda Cancer Research Institute, Mumbai Ayurveda Mental Health Research Institute, Nagpur Herbal Ayurveda Research Centre, Nagaland National Research Institute for Ayurveda Drug Development, Bhubaneswar National Institute of Ayurvedic Pharmaceutical Research, Patiala Ayurveda Central Research Institute, Jaipur Ayurveda Regional Research Institute, Gangtok Captain Srinivasa Murthy Research Institute for Ayurveda and Siddha Drug Development,Chennai. Dr. Achanta Lakshmipati Research Centre for Ayurveda, Chennai National Veterinary Ayurveda Research Institute, Lucknow National Vriksha Ayurveda Research Institute, Jhansi Regional Research Institute of Himalayan Flora, Tarikhet, Ranikhet National Research Institute for Ayurveda Drug Development, Kolkata

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Graphical Abstract

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