Changing scenario for promotion and development of Ayurveda – way forward

Journal of Ethnopharmacology 143 (2012) 424–434

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Review

Changing scenario for promotion and development of Ayurveda – way forward$ Pulok K. Mukherjee a,n, Neelesh K. Nema a, P. Venkatesh a, Pratip K. Debnath b a

School of Natural Product Studies, Department of Pharmaceutical Technology, Jadavpur University, Kolkata-700 032, India National Research Institute of Ayurveda for Drug Development (NRIADD) AYUSH, Ministry of Health and Family Welfare 4-CN Block, Sector V, Bhidan Nagar Kolkata-700091, India b

a r t i c l e i n f o

a b s t r a c t

Article history: Received 28 March 2011 Received in revised form 24 July 2012 Accepted 24 July 2012 Available online 2 August 2012

Ethnopharmacological relevance: Ayurveda, derives from the Sanskrit words Ayus (life) and Veda (knowledge) is the most ancient system of traditional medicine of the world. It has been practiced in Indian peninsula since 5000 BC to offer natural ways to treat diseases and to promote healthcare. Methodology: We reviewed the literature on the history, principles and current status of Ayurveda. The data have been presented systematically including the initiatives from Government of India. Several aspects of administrative management, education, teaching and related aspects for promotion and development of Ayurveda and other Indian systems of traditional medicine have been discussed. Results: This paper reviews on different aspects of development of Ayurveda. Presently, there are 2420 hospitals with about 42271 beds, 15017 dispensaries, 429246 registered practitioners, more than 320 educational institutions, 7699 drug-manufacturing units to promote Ayurveda into the health care delivery system in the country. Ayurvedic Pharmacopoeia of India is the official document for single Ayurvedic drugs (540 monographs) and different formulations (152 monographs). Several aspects in this regard for development of Ayurveda have been discussed. Conclusion: Considering the widespread use and popularity of Ayurveda worldwide, administrative management and infrastructure facilities, indigenous practices and standards for quality control and it’s evaluation have been highlighted. In India, all such efforts for integration of Ayurveda provide potential role in the health care benefits. & 2012 Elsevier Ireland Ltd. All rights reserved.

Keywords: Ayurveda Indian systems of medicine Vedic medicine Indian medicine Integrated approach Evidence based

Contents 1. 2. 3. 4.

5. 6. 7. 8.

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 425 History and description of Ayurveda. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 425 Principles of Ayurveda: the knowledge base . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 426 Initiatives of government of India for promotion of Ayurveda . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 427 4.1 Administrative bodies for development of traditional medicine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 427 4.2 Education and practices for expansion of Ayurveda . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 428 4.3 Ayurvedic pharmacopoeia of India and drug testing laboratories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 429 4.4 Regulatory assessment and legislature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 429 4.5 Traditional knowledge digital library (TKDL): knowledge substantiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 429 Ayurveda and its revitalization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 430 Product integrity – quality evaluation and standardization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 432 Pharmacovigilance study for Ayurvedic drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 432 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 433

$ This manuscript has been prepared based on the invited lecture delivered at the 11th Congress of the International Society for Ethnopharmacology; Castilla-La Manch, Albacete, Spain, September 20–25, 2010. n Corresponding author. Tel./fax:þ 91 33 24146046. E-mail addresses: [email protected], [email protected] (P.K. Mukherjee).

0378-8741/$ - see front matter & 2012 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.jep.2012.07.036

P.K. Mukherjee et al. / Journal of Ethnopharmacology 143 (2012) 424–434

425

Acknowledgment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 433 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 433

1. Introduction As per WHO estimates, traditional, complementary, alternative, or non-conventional medicines are used by 70–95% of global population particularly in developing countries for their healthcare (WHO, 2011). Traditional medicines vastly depend on the usage of plants, compared to other natural resources. India is one of the 12 mega bio-diversity zone covering 2.4% of world’s area but with 8% of global biodiversity. It includes 15 agro-climatic zones containing about 47,000 plant species including nearly 15,000 medicinal plants (WHO, 2007). These plant species are used in different systems of medicine like in folk wisdom (44%), Ayurveda (19%), Siddha (12%), Unani (10%), Homeopathy (8%), Tibetan (5%) and modern medicine (2%) (Mukherjee and Wahile, 2006). Wide spectrum of biodiversity and Indian habitats attracts global people. Several traditional healthcare systems exist in India from centuries and out of all the traditional practices, Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy are the official traditional systems of medicine. These systems are collectively known as Indian Systems of Medicine (ISM), and are currently called as an acronym for Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy (AYUSH, 2011) which collectively provides healthcare to the vast majority of people of India and neighboring countries (Mukherjee et al., 2010a). The word Ayurveda is derived from the Sanskrit word ‘Ayus’ (all aspects of life from birth to death) and ‘Veda’ (knowledge or science) science of long life (Mukherjee, 2001). Ayurveda, the most ancient system of traditional medicine of the world, has been practiced in Indian subcontinent since 5000 BC (Dasgupta, 1992; Mukherjee and Wahile, 2006). Ayurveda is a holistic approach towards life, health and disease management through medicinal herbs, minerals, diet, lifestyle and spirituality. Ayurveda was developed through daily experiences and mutual relationship between people and nature, and thus not only cure diseases but also prevent disease, maintaining health and promoting longevity (Fradwley and Ranade, 2001). This holistic system looks at the whole person as a combination of body, mind and soul (Atreya, 2002). Therefore, it is a comprehensive and integral medicinal systems, gift of Indian sages to mankind (Ninivaggi, 2008). Ayurveda is widely respected for its uniqueness and global acceptance as it offers natural ways to treat diseases and promote healthcare (Mukherjee and Houghton, 2009). Scientific studies on Ayurvedic medicaments unveil the cause and effect relationship of many plant based treatment in last few decades. Reserpine, an alkaloid from Rauwolfia serpentina Benth. (Apocynaceae) received international attention for the twin effect of lowering high blood pressure and as a tranquillizer (Woodson et al., 1957). Shatavarin-I a glycoside isolated from roots of Asparagus racemosus Willd. (Liliaceae) of Ayurvedic drug is now recommended for threatened abortion (Garg et al., 1971; Gaitunde and Jetmalani, 1969). Similarly ‘Triphala’ (‘Tri’-three and ‘Phala’-fruit) is a classical example of polyherbal formulation in Ayurveda having synergistic and counter balancing properties which contain dried fruits of Emblica officinalis Gaertn. (Euphorbiaceae), Terminalia belerica Roxb. (Combretaceae) and T. chebula Retz. (Combretaceae) in equal proportions (1:1:1), prescribed as laxative in chronic constipation, colon detoxifier, and as rejuvenator of the body due to its gallic acid content. These three fruits were mixed and the polyphenols of those plants

collectively produced synergistic effect (Ponnusankar et al., 2011; Mukherjee et al., 2011). In Ayurveda, pungent mixture of three spice known as trikatu (tri: ‘‘three’’; katu: ‘‘pungent’’), consisting of Piper longum L. (Piperaceae); P. nigrum L. (Piperaceae); and Zingiber officinale Rosc. (Zingiberaceae); in the ratio of 1:1:1, is used to promote digestion and assimilation (Premila, 2006; Gerson, 2009) due to their alkaloidal constituent piperine. This bioactive compound is having number of pharmacological properties including anti-inflammatory activity (Lee et al., 1984). These examples of Ayurvedic medicine make it more attractive to the researcher and scientific community for further research. This review aimed to highlight about Ayurveda and its basic principle in the changing scenario for their promotion and development through various initiatives of the Indian government.

2. History and description of Ayurveda In the Vedic time (5000 BC), curing of disease was dealt by specific person(s) called as ascetic people and later on, this enriched knowledge base was transferred to the next generations through scriptures, of two categories: Shruti (hearing) and Smriti (memory). Shruti refers to four Vedas while Smriti is the literature compiled by self realized sages based on their understanding of the Shruti. Shruti is composed in Vedic Sanskrit where words have accent and akin to converse in music with its own grammar. Nobody authorized to change even a single syllable of the shruti and hence these words have to be heard properly from the Guru (Teacher) in a disciplinary manner and hence Vedas are called Shruti (literature hearing). On the other hand Smriti is written in laukika, a Sanskrit language spoken by people, and was used to write on palm leaf parchments (Taalpatra) in the form of Shloka (Kapoor, 2002). Technically a ‘shloka’ in Ayurveda is a Sanskrit poem that follows a classical scheme, which describes a specific circumstances or situation (Fig. 1) Documentations of belief based Vedic medicines are described in all four Vedas—Rig-veda, Sam-veda, Yajur-veda, and Atharva-veda (Mukherjee, 2001). Rig-veda (2000 BC) is one of the oldest Vedas, which describes about diseases and medicinal herbs (Singh et al., 2003). The Rigveda, with 1028 hymns gives valuable information of about 67 medicinal plants (Heyn, 1990). There are 81 plants in Yajur-veda while 293 medicinal plants are mentioned in Atharvaveda (Samant et al., 2002). Ayurveda is said to be a Upaveda of Atharva-veda

Fig. 1. Sanskrit shloka from Sushruta Samhita.

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which contains 114 hymns related to formulations including plant and animal products, mineral, and metals for the treatment of different diseases. The concepts and practices, fully devoted to Ayurveda were described in text form by Agnivesha in his treatise the ‘‘Agnivesh tantra’’. It was later amended by Charaka (Anonymous, 2001a), and a group of scholars and was renamed as the Charaka Samhita [1000 BC–4th century] (Sharma, 2000). This ancient literature has been modified through different ages of editing process to its present form. It contains definite number of plants (341) and their systematic information (Ray and Gupta, 1965). Charaka represents the Atreya sampraday (School of physicians) founded by the great Scholar Punarvasu Atreya. Furthermore landmark in Ayurvedic literature was the Sushruta Samhita [1000 BC–5th century] (Sharma, 1999) compiled by Sushruta (Anonymous, 2001b), the ‘‘Father of Surgery’’, which has special emphasis on surgery and surgical techniques. It described 395 medicinal plants, 57 drugs of animal origin, and 64 minerals and metals as therapeutic agents (Mukherjee, 2002a). The next important authority after Charaka and Sushruta is Vagbhatta of Sindh, who flourished in the 7th century AD and described 902 plant species (Sharma, 1979). His treatise called the Ashtanga Hridya is considered unrivaled for the principles and practice of medicine. These three books are collectively called as the senior triad (vriddha traya) or ‘Brihat Trayees’ (Big or major three) which contain basic concepts of health and disease, disease management, anatomy and physiology, hygiene, pharmacology, therapeutics, herbal formulations etc (Mukherjee et al., 2010b). Ayurvedic text are much respected in India and neighboring countries and has been translated into Greek (300 BC), Tibetan and Chinese (300 AD), Persian and Arabic (700 AD) and several other languages (Mukherjee, 2001). Indian ‘Materia Medica’ provides plenty of information about ethnic folklore practices and the therapeutic uses of plants of Indian origin. This includes about 2000 drugs of natural origin. Out of these, 400 are of mineral and animal origin while the rest are of vegetable origin. Besides this, some un-codified information is being practiced in

rural areas as a folk medicine, which has not been documented till date (Mukherjee et al. 2007a).

3. Principles of Ayurveda: the knowledge base The roots of Ayurveda can be traced to the beginning of cosmic creation. In Universe, everything is composed of matter, and according to Ayurveda, all matters consist of five basic elements (panchamahabhutas) (Anonymous, 2001a): first element is space (aakash), and remaining four elements are earth (prithivi), air (vayu), water (jala), and fire (agni), exist within the space (Atreya, 2002). Both the systems, human (microcosm) and universe (macrocosm) are linked permanently, since both are built from the same elements. Thus human being is a replica of nature and everything which affects human being, also influence the macrocosm. Hence, the evolution of life and the creation of the universe can be concerned with Ayurveda (Heyn, 1990). Along with these panchamahabhutas, the functional aspect like movement, transformation and growth are governed by three biological humors, viz. vata (space and air), pitta (fire and water) and kapha (water and earth), respectively (Atreya, 2002). These three humors usually known as tridhatus regulate every physiological and psychological processes in the living organism. Additionally, ojaJeebaniya sakti (vital force) developed from tissue metabolism is also essential for healthy functioning of the body (Anonymous 2001b). It is believed that after intake of food/diet, it undergoes a process of digestion and ultimately forms two types of products – prasadas (nutritional products) and malas (excretory products). The prasada builds the seven dhatus (tissue) of the body, whereas malas become waste products. Body produces three types of waste products: feces (solid) and urine and sweat (liquid). Both prasada and mala are important and their presence in the right proportion in the body is indispensable for health and well being. Health is considered as balance between body, mind and consciousness along with three humors vata, pitta and kapha.

Fig. 2. Ayurvedic principle on the basic elements of human physiology.

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They work together to bring the balance (Fig. 2) with in. At birth, everyone is born in a state of balance with oja and the universal component panchamahabhuta. Later in life, this fragile balance is disrupted due to physical, emotional or spiritual disturbances. This imbalance, which might be an excess (vriddhi) or deficiency (kshaya), among doshas, dhatus, malas, agni and gunas, manifest as a sign and symptom of disease. Thus imbalance of the body and mind is responsible for physical and psychological pain (Lad, 2002; Jayasundar, 2010). For the treatment, there are two components in Ayurveda. First one is preventive, which includes personal hygiene, a regular daily routine, social behavior and use of rejuvenating materials. The other one is curative, consisting of drugs (aushadha), diets (anna) and exercise (vihara). While prescribing medicines to a person the practitioner considers other factors like the condition of body and mind, temperament, sex, age, metabolic profile, work & rest, sleep pattern and diet. Pharmacodynamically, body is made up of sapta dhatus viz. rasa (plasma), rakta (blood), mamsa (muscle), meda (fat), asthi (bone), marrow & nerve (majja) and shukra (reproductive component). When the sensory organs (panchajynedriya) are subjected to over activity, less activity or inactivity, the conscious mind (pragya–paradha) may lead to initiate pathogenesis in physical, mental and cellular levels. At last disease may occur in the variable sites and organs (Debnath, 2002; Lad, 2002). Ayurveda with eight major disciplines known as Ashtanga Ayurveda empowers every individual to take responsibility for his/her own well-being (Fig. 3). Presently, there are 16 specialties in Ayurveda viz. ayurveda sidhanta (fundamental principles of Ayurveda), ayurveda samhita, rachna sharira (anatomy), kriya sharira (physiology), dravya guna vigyan (materia medica and pharmacology), ras shashtra, (metal and minerals processing), bhaishajya kalpana (pharmaceuticals), kaumar bharitya (pediatrics), prasuti tantra (obstetrics and gynecology), swasth-vitta (social and preventive medicine), kayachikitsa (internal medicines), rog nidan (etio-pathology), shalya tantra (surgery), shalkya tantra (eye and ent), mano roga (psychiatry) and panchkarma (rejuvenation therapy) (Misra, 2007). General aspect of treatment of different animals and plants have also been described in Ayurveda e.g. treatment of cows (Gava Ayurveda),

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Table 1 Facilities available for the promotion of Ayurveda. Infrastructure facilities available in India

Quantitative fact for Total system in India

Registered practitioners 712121 Total number of Colleges 504 (Undergraduate) Admission capacity per annum for 25376 degree course Total number of colleges (post111 graduate) Admission capacity for post-graduate 2208 courses Exclusively colleges (post-graduate) 6 Admission capacity in exclusively 216 colleges Licensed drug-manufacturing units 8896 Hospitals 3193 Beds in hospitals 56842 Dispensaries 24280

Ayurveda system in India 429246 260 9927 65 1233 2 60 7699 2420 42271 15017

horses (Aswa Ayurveda) elephants (Gaja Ayurveda), bird’s inclusive poultry (Paksha Ayurveda), plants (Vriksha Ayurveda) and human (Ayurveda in itself) health (Debnath, 2002).

4. Initiatives of government of India for promotion of Ayurveda Indian people have a tremendous passion for medicinal plants and they use them for a wide range of health related applications from common colds to improve the memory, and from infection to the enhancement of general immunity. The ISM covers both the systems, which originated in India and abroad, or got adopted in India in course of time (Mukherjee et al., 2010c). An estimated 25,000 effective plant-based formulations are used in folk medicine and known to rural communities in India (Anonymous, 1998). There are over 1.5 million practitioners of traditional systems of medicine using medicinal plants for preventive, promotional and curative applications. There are over 7000 medicinal drug-manufacturing units in India (AYUSH, 2011), which consume about 2000 t of herbs annually. Each of these traditional systems has unique aspects, but use natural products, mostly herbs, for the care of ailing people is the common thread in all these systems. The encouraging features of Ayurveda includes its accessibility and affordability, broad acceptance, comparatively low cost, low level of technological input and growing economic value (Mukherjee et al., 2007b). Ayurveda has a vast infrastructure, which comprises of teaching institutions, government funded research institutes, registered medical practitioners, hospitals, dispensaries and drug-manufacturing units as presented in Table 1. Government has taken a number of initiatives for the promotion and development of the Ayurveda at different levels. Some of these aspects have been summarized here for better understanding. 4.1 Administrative bodies for development of traditional medicine

Fig. 3. Major disciplines prevail in the Ayurvedic science.

The Department of Indian Systems of Medicines and Homeopathy (ISM&H) was established in March, 1995 as a separate department in the Ministry of Health and Family Welfare, Govt. of India. It was re-named as Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) in November, 2003 with a vision to provide quality control and

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Table 2 Pre- and Post-independent initiatives on Indian system of medicine [ISM]. Pre-independent initiatives 1920 Indian National Congress adopted resolution for recognition 1943 Bhore Committee or Health survey and Development Committee recognized the past services of Indigenous medicine but failed to recommend its further development 1946 Chopra Committee had focused to harmonize the area of indigenous systems of medicine and western drugs for rendering of medical relief Post-independent initiatives 1947 Health Policy of Independent India, committee was constituted with Dr. B.C. Roy, Dr. G.V. Deshmukh and Dr. J.C. Roy headed by Colonel Solhey 1955 Dave Committee for uniform standard of Ayurvedic Education 1956 Indian Medical Council Act (IMC Act) 1956 Establishment of PGTRI, Gujarat Ayurveda University, Jamnagar 1964 Amendment of Drug and Cosmetic Act 1940 1970 Central Council of Indian Medicine Act for regulation and practice of Indian systems of Medicine and Homoeopathy 1989 Establishment of National Academy of Ayurveda 1995 Creation of Separate Department of Indian Systems of Medicine and Homoeopathy in the Ministry of Health and Family Welfare 1998 Involving 32 laboratories for Pharmacopeia Standards of Medicinal Plants and ISM formulation 1999 Information Education and Communication Schemes (IEC) for Non-governmental organizations to propagation and popularization of Ayurveda 2006 Mandatory Testing of heavy metals for export 2008 Guidelines of Pharmacovigilance on Ayurveda Siddha and Unani drugs 2009 International cooperation Council for Indian Systems of Medicine and Homoeopathy

standardization of traditional drugs, to make separate national policy and to generate awareness about these systems by upgrading educational standards at national and international levels. This department consists of: 1) Five central research councils, namely Central Council for Research in Ayurveda Science (CCRAS), New Delhi; Central Council for Research in Siddha (CCRS), New Delhi; Central Council for Research in Unani Medicines (CCRUM), New Delhi; Central Council for Research in Homoeopathy (CCRH), New Delhi; Central Council for Research in Yoga & Naturopathy (CCRYN), New Delhi. 2) Two statutory regulatory bodies, namely Central Council of Indian Medicine (CCIM) and Central Council of Homoeopathy (CCH). 3) Two laboratories known as Pharmacopoeial Laboratory for Indian Medicine (PLIM) and Homoeopathy Pharmacopoeia Laboratory (HPL). 4) Eleven national institutes for education. 5) One drug-manufacturing unit namely as Pharmacopoeial Laboratories, Indian Medicines Pharmaceutical Corporation Limited (IMPCL). They govern regulation, development and growth of AYUSH systems in the country and abroad. The department of AYUSH addresses the key issues relating to upgradation of the educational standards, strengthening the existing research institutions and ensuring a time-bound research program on identified diseases. Several schemes for promotion, cultivation and regeneration of medicinal plants have been made and also to develop pharmacopoeial standards. This department also takes all initiatives to ensure the status of Ayurvedic system in respect of policy support, infrastructure, legislation and regulation, research and development, courses of study, quality control and standardization at national and international levels. Central Council for Research in Ayurveda Science (CCRAS), an autonomous organization registered on March, 1978 under the Societies Registration Act, XXI of 1860 has started numerous schemes for the promotion of Ayurveda. Drug Control Cell is working in the AYUSH department to deal with the matters pertaining to quality control and the regulation of Ayurveda, Siddha and Unani drugs under the provisions of the Drugs and Cosmetics Act, 1940 and Rules, 1945 (Anonymous, 2005). This cell takes care of the activities of Ayurveda, Siddha and Unani Drug Technical Advisory Board (ASUDTAB), which is constituted by the Govt. of India [The Drugs

and Cosmetics (Amendment) Act, 1964, Chapter-IVA, Section33C)]. Ayurveda, Siddha and Unani Drugs Consultative Committee (ASUDCC) has also been constituted separately [Chapter-IVA, Section-33D)] to advise the ASUDTAB on herbal drug related technical matter. The National Medicinal Plant Board (NMPB) has been constituted to deal with different issues like conservation and cultivation, demand and supply, research and development, trade and export, quality control and standardization of medicinal plants (AYUSH, 2011). Several initiatives and committees have been developed for the improvement of traditional medicine from very long time, which has been shown in Table 2. 4.2 Education and practices for expansion of Ayurveda In early time of India, Indian education system, culture and traditional knowledge were much systematized. Taxila (UNESCO World Heritage Centre) was considered to be the most respected place of higher learning and education in India from 700 BC to 300 AD (Chakravorty, 1954). Nalanda near Patna (Bihar) was the foremost Buddhist monastery and an educational center during the 6th and 7th centuries AD. It had a rich stock of manuscripts on philosophy and religion and contained texts relating to grammar, logic, literature, the Vedas, Vedanta, Sankhya philosophy, Dharmasastras (religious book), Puranas (Old treatise), Astronomy, Astrology and Medicine (Mukherjee, 1969). Until 18th century, teaching and practice of medicine in India were based on Ayurveda, Unani or Arabic systems. During the British rule, several academics institutions were established by the East India Company, and by the Christian missionaries. The British founded the Banaras Sanskrit College in 1792 to support traditional knowledge and Sanskrit education. Hindu College (presently known as Presidency College) at Calcutta in 1816 and Raven Shaw College at Cuttack in 1816 immediately after passage of Charter Act at the British Parliament in 1813 were opened to promote Indian education (Ohdedar, 1969). During early 19th century, British rulers trained few of the Indians for diagnosis and treatment of diseases with allopathic medicine. First schooling system of medical education was started at Calcutta Sanskrit College in 1824 by the establishment of ‘‘Native Doctors’’ courses (the medical board issued a memorandum on 9th May, 1822, approved by Military Department letter Number, 362, dated 24th May, 1822, and passed as a general order, dated 21st June, 1822). In 1835, Medical College Calcutta (Kolkata) started functioning as the first medical college in Asia by British rulers, vide Notification GO No. 28 dated 28th January, 1835 (Anonymous, 1935). After

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independence, Institute of Post-Graduate Teaching and Research in Ayurveda (IPTRA) was established at Jamnagar (Gujarat) in 1956. In 1963, Banaras Hindu University started post-graduate education on Indian medicine, which later on merged with college of medical science and renamed as ‘‘Institute of Medical Sciences’’. National Institute of Ayurveda (NIA), Jaipur was established in 1976 by the Govt. of India, to develop the standards of teaching, training and research of Ayurvedic system of medicine. Guru–Shishya training through parampara (the traditional method of transfer of knowledge) was initiated by the Department of AYUSH, Ministry of Health and Family Welfare through Rastriya Ayurveda Vidyapith (National Academy of Ayurveda), New Delhi in 1988. In 2003, All India Institute of Ayurveda (AIIA) was established at New Delhi to set up benchmarks of post-graduate and post-doctoral education (MD/PhD.) in Ayurveda, and to promote Ayurveda at national and international levels. Department of AYUSH has taken initiative for the developments of education of traditional practices through 86 educational institutes/centers, out of them 11 are the national institutes and remaining are the regional institutes. Presently, Central Council of Indian Medicine (CCIM), established under parliamentary Act (Indian Medicine Central Council Act) 1970 is regulating the standard of education and practices of Ayurvedic, Siddha and Unani drugs (AYUSH, 2011).

4.3 Ayurvedic pharmacopoeia of India and drug testing laboratories In 1970, Ministry of Health & Family Welfare, Government of India, established the pharmacopoeial laboratory for Indian medicine (PLIM) at Ghaziabad (Uttar Pradesh) under the Drugs and Cosmetic Act, 1940. This approved laboratory monitors the pharmacopoeial standards, testing and quality control of Ayurveda, Unani and Siddha (ASU) drugs. They published monographs of single drugs as ‘Part I’ and compound formulations as ‘Part II’ in Ayurvedic Pharmacopoeia of India (API). So far, the seven volumes of ‘Part I’ consisting of 540 monographs on single drugs have been published, Out of them, 418 (80, 78, 100, 68, and 92) were published as first five volumes during 1990–2006. The sixth volume of Part I consisting of 101 monographs was published in 2008 while the seventh volume comprises the 21 minerals and metals in single drugs. The diseases that affect worldwide have been systematically enlisted in Sanskrit language (Table 3). Three Volumes of Part II have been published so far consisting of 101 monographs (50, 51) along with 51 monographs on formulations between 2007 and 2010. Ayurvedic formulary of India (AFI) was compiled to bring uniformity among the manufacturers and to follow the same formula of ingredients that meet to the standard norm of Drugs and Cosmetics Act. This book is separated into two parts as AFI Part I (published in 1978 with 144 formulations) and AFI Part II (published in 2000 with 191 formulations). Different laboratories of Central Council for Research in Ayurveda and Siddha (CCRAS), Central Council for Research in Unani Medicine (CCRUM), various laboratories of Council for Scientific and Industrial Research (CSIR) and public/private sector Universities, institutions and other laboratories are performing a commendable job in evolving and laying down safety and quality standards for polyherbal and herbo-mineral preparations, including the plant extracts. The Indian Pharmacopoeia (IP) 2007 includes pharmacopoeial specifications with monographs for 58 individual herbs used in therapy. The specifications include the name of the drug (along with its common name), its biological source (Latin name), the part of the plant under consideration, its description, identification, macroscopic and microscopic studies, several quality control parameters, and assay in respect to the phytochemical or botanical reference standards (Anonymous, 2007).

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Table 3 Diseases mentioned in Ayurvedic term (Sanskrit). Diseases

Sanskrit names in Ayurveda

Age related macular degeneration Aids/HIV

Jara janya Drshti Binduksaya Vyadhi Bala ksamata vriddhi kamaka Manodvega Manovikara Ekagratahani Svasanaka tantra anurajat Karkataka Prameha Medovriddhi Prambhika jirna vrkka pratighata Bhasmas rasa kalpas Vyanabala Utkshepa Raktagata Jirna kaphaja Atisara Kala azra Visam jvara Klevya and Vandhyata Rajonivrati kala janya vyadhiyaan Medovriddhi Alpasukrata Sandhigatavata Asthi kshya Kitibha kustha Krsna Mandala gata Netra roga Amavata Chittwatvega Srama-klama janya anidra Mutrashmari and Asthila

Anxiety neurosis Attention deficit, Hyperactive disorder Bronchial allergy Cancer Diabetes Dyslipidaema Early-chronic renal failure Herbo-mineral preparation Hypertension Irritable bowel syndrome Lieshmaniasis Malaria Male and female infertility Menopausal syndrome Obesity Oligospermia Osteo-arthritis Osteoporosis Psoriasis (skin diseases) Retinopathy Rheumatoid arthritis Stress adaptation Stress induced chronic insomnia Urolithiasis, Benign prostratic hypertrophy

4.4 Regulatory assessment and legislature The Drugs and Cosmetics Act, 1940 was enacted in India and rules were made under this Act known as Drugs and Cosmetics Rules, 1945. It is a central legislature which regulates the import, manufacture, distribution and sale of drugs and cosmetics. The Ayurvedic system of medicine was kept out of the preview of this legislation. This exemption continued upto 1964, when the act was amended as the Drugs and Cosmetics (Amendment) Act, 1964 (13 of 1964) effective from 15-9-1964, by which a definition of Ayurvedic drug and all necessary provisions for its control were introduced in chapter IV-A (Mukherjee et al., 2007a). The first schedule to the Act recorded 54 authoritative books of Ayurvedic system of medicine. The Act was amended in 1982 in which a definition of patent proprietary medicine of the Ayurvedic system was introduced; vide section 3(h). Recognizing the importance of Good Manufacturing Practice (GMP) in the manufacture of ISM, the Govt. of India further amended the Drug and Cosmetic Rules, 1945 called as drug and cosmetic (amendment) rules 2000. The Drug and Cosmetic 7th Amendment Rules, 2001 was introduced for the grant or renewal of approval for carrying out test on ASU Drugs. The Govt. of India has made mandatory for all ISM drugs manufacturing units to adopt GMP as per procedure detail to upgrade their standards for production and quality medicine (Mukherjee, 2003). The guideline emphasizes on several operational strategies for the production and evaluation of herbal medicinal products at large. The Drugs and Magic Remedies Act, 1954 provides several prohibition of advertisements of certain drugs and magic remedies for treatment of certain identified diseases and disorders and for prohibition of import and export of certain drugs that may mislead the public (Anonymous, 2005). 4.5 Traditional knowledge digital library (TKDL): knowledge substantiation Traditional knowledge digital library (TKDL) for Ayurveda, Unani, Siddha and Yoga is a collaborative project between CSIR,

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Ministry of Science and Technology and Department of AYUSH, Ministry of Health and Family Welfare. TKDL is an original proprietary database, which is fully protected under national and international law of intellectual property rights. About 2,12,000 medicinal formulations (Ayurveda: 82,900; Unani: 1,15,300; Siddha: 12,950) are documented in a patent compatible format in five international languages including English, French, German, Spanish and Japanese (TKDL-Dept of AYUSH, 2011) for easily accessible patent examination. The traditional medicinal knowledge exists in various local languages, such as Sanskrit, Urdu, Arabic, Persian and Tamil. TKDL is aimed to break these languages and format barrier with the help of information technology tools and a novel classification system i.e. traditional knowledge resource classification (TKRC). This is an innovative approach, which enables conversion to make the knowledge available for patent examiners in patent application format and in understandable language (Mukherjee et al., 2010b). In 2003, Inter governmental committee (IGC) of WIPO (World Intellectual

Fig. 4. Integrated approach for revitalization of ISM.

Property Organization) on intellectual property and genetic resources, traditional knowledge and expression of folklore has adopted international specifications and standards of traditional knowledge databases, in its fifth session. The TKDL access agreement was concluded with European patent office in February 2009, as a mutually beneficial agreement, since it enhances the quality of examination for traditional knowledge based patent applications for European patent office (EPO). It has been recognized by the director general of WIPO (AYUSH, 2011).

5. Ayurveda and its revitalization Department of AYUSH in its annual foreign trade report showed that the export of AYUSH products has increased from 22756.4 millions of Indian rupees (INR) in 2007–08 to 28870.1 million (INR) in 2009–10, with an average annual growth rate of 12.63%. In respect with total export of AYUSH products in 2009–10, 1184.6 and 5744.1 million (INR) of Ayurvedic products export was recorded for retail and without retail sale, respectively. The import of AYUSH products have increased 14.99% annually, from 2618.2 million (INR) in 2007–08 to 3462.2 million (INR) in 2009–10, in which the share of Ayurvedic products amounting to 187.6 and 125.7 million (INR) for retail and without retail sale, respectively (AYUSH, 2010). India has good trade value of AYUSH products, which includes a large share of Ayurvedic products. Presently, Drug discovery through different approaches (Fig. 4) is being considered to a high extent for revitalization of the Ayurveda. For the past 10 years, Govt. of India has started many policies and scheme such as extramural research project scheme; golden triangle partnership (GTP) scheme between Department of AYUSH, Council of Scientific and Industrial Research (CSIR) and Indian Council of Medical Research (ICMR); Scheme on home grown technology (HGT) through Technology Information Forecasting and Assessment Council (TIFAC); Drugs and Pharmaceutical Research Programme (DPRP) of Department of Science and Technology. The Ministry of Health and Family Welfare, Government of India in their national health policy (NHP) programme on ‘Drugs-2002’ had incorporated ‘Reverse Pharmacology’ strategies beside system biology approach, which concentrate on reversing routine approach from ‘laboratoryto-clinic’ to ‘clinics-to-laboratories’ for saving time and cost in drug

Fig. 5. Quality evaluation of Ayurvedic drugs.

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Table 4 Several Ayurvedic plant drugs used in traditional medicine for different ailments with their active marker compounds. Ayurvedic Plants

Parts used

Active constituent

Acorus calamus L. (Acoraceae)

Rhizomes

b-asarone H3C

O

H3C

Applications

Reference

CNS depressant, Anticonvulsant

Mukherjee et al., 2007c

Cardioactive, Antihyperglycemic, Antidislipidemic

Maity et al., 2009.

Anticonvulsant, Antiestrogenic

Kasture et al., 2000.

Prevent memory disability, Antiallergic

Subathra et al., 2005.

Anxiolytic, Antidepressant, Antipyretic, Antiinflammatory

Kumar et al., 2008.

CH3

O

O H3C

Aegle marmelos L. (Rutaceae)

Leaves

Agelin

OH NH H

H3CO Butea monosperma Lam. (Fabaceae)

O

Flowers

OH

Butein

H

H

O

OH

HO OH Centellia asiatica L. (Apiaceae)

Whole plant

Asiaticoside

OH O

HO

O

H

HO HO

O HO

H

OH O

O

O

H

OH

OH

OH

O OH

OH

OH Clitoria ternatea L. (Fabaceae)

Roots, seeds and leaves

CH3

H3C

Taraxerol

CH3 CH3 H

H

HO

Fruits

O

Gallic acid

CH3

CH3

H CH3

H3C

Emblica officinalis L. (Euphorbiaceae)

H

OH

HO

Antimutagenic, Cytoprotective, Gastro-protective

Ponnusankar et al., 2011

OH OH

Glycyrrhiza glabra L.(Fabaceae)

Roots

Glycyrrhizin

Expectorant, Antiallergy, Spasmolytic

H3C

H3C

O HO

HOOC

CH3

O

H

HO HOOC HO

O

HO

Gantait et al., 2010

COOH

CH3

CH3

CH3

O O H3C H3C H

OH Ocimum sanctum L. (Labiatae)

Leaves

Piper longum L. (Piperaceae)

Fruits

CH3

Carvacrol

H3C

Anticarcinogenic, Antibacterial, Antiseptic

OH

CH3 O

Piperine O

O

Chopra et al., 1941.

Antimetastatic, Antithyroid, Antidepressant N

Pathak and Khandelwal, 2007.

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Table 4 (continued ) Ayurvedic Plants

Parts used

Active constituent

Plantago ovata L. (Plantaginaceace)

Seed husk

D-xylose

O

Applications

Reference

Laxatives, Antidiarrheal

Karimzadeh and Omidbaigi, 2004.

Anxiolytic, Antiparkinsonian, Antivenom

Gupta and Rana, 2007.

OH HO OH OH

Withania somnifera L. (Solanaceae)

Roots and leaves

CH3

Withaferin A

OH H3C H3C O

OH

O

O

CH3

O

discovery programme (Vaidya, 2006; Patwardhan and Mashelkar, 2009). Moreover, Govt. of India initiated largest public–privatepartnership scheme name as New Millennium Indian Technology Leadership Initiative (NMITLI) in 2002, to promote industrial research and development (R&D) oriented work through existing science and technology in the country.

6. Product integrity – quality evaluation and standardization In traditional system of medicine, assessment of quality, safety and efficacy is most important. These issues have been considered by the ‘Rishis’, expert saints and later by the ‘Vaidyas’ and ‘Hakims’ (the physician), who used to prescribe these medications to patients for treatment. At present, there are well established regulatory guidelines of synthetic drugs for their global assessment, while for the botanicals the regulatory status differs between countries due to of poor documentation and improper scientific proofs (Mukherjee, 2002b). For marketing of herbal products/ botanicals, these regulatory guidelines are very essential to estimation of biochemical parameter and evaluation of therapeutic efficacy. Presently both traditional and modern parameters (Fig. 5), along with finger printing and marker compound analyses are being used for quality control and standardization of raw materials and finished products (Mukherjee et al., 2008). Marker compound analysis and estimation of secondary metabolites, not only helps in establishing the correct botanical identity but also in regulating the chemical sanctity of the herbs. Marker analysis also can be used in identification of chemical entities, detection of adulteration, quality control of mixtures and shelf life of herbal formulations with two type of fingerprinting implement. Chemical fingerprinting is an important tool used for the authentication of plant materials and products standardization, whereas biomarkers fingerprinting may be useful for the therapeutic evaluation. Some Ayurvedic plants and their active constituents for fingerprinting analyses have been highlighted in Table 4. Apart from marker analysis, different chromatographic techniques such as thin layer chromatography (TLC), high-performance thin layer chromatography (HPTLC), high-performance liquid chromatography (HPLC), gas chromatography (GC) etc. are most frequently used for the identification and quantifying the phyto-chemicals present in complex herbal mixtures. Ayurvedic pharmacopoeia of India has

specified several quality evaluation parameters for natural products, which includes morphological study, determination of quantitative data including extractive values, foreign matter, etc.; limit tests, and different physical tests including boiling range, refractive index, pH, etc (Anonymous, 1990). In order to reinforce traditional medicine in line with the modern medicine, various strategic areas in plant drug research are well thought-out in India. Indian systems of medicine are considering new methodology for development of existing traditional drugs such as pharmacokinetic properties of Ayurvedic formulations can be changed through novel drug delivery systems similar to polymeric nanoparticles, nanocapsules, liposomes, phytosomes, nanoemulsions, microsphere, transferosomes, and ethosomes etc. These are remarkable formulations over conventional systems, for e.g. the curcumin–phospholipid complex is a novel formulation, developed to overcome the limitation of absorption of free curcumin and to enhance its bioavailability in systemic circulation of the human body (Maiti et al., 2007). These efforts will benefit the studies of Ayurvedic medicine to accelerate the evidence-based pharmaceutical research and to revitalize traditional medicine.

7. Pharmacovigilance study for Ayurvedic drugs The Central Drugs Standard Control Organization (CDSCO) in collaboration with Indian Pharmacopeia Commission under control of Govt. of India has initiated a nation wide pharmacovigilance program for protecting the health of the patients. This program is to assure safety of drugs including herbals, which gives information on some specific criteria like detection of serious adverse reactions, quantification of their incidence, and identification of contributive or modifying factors (Mukherjee and Ponnusankar, 2010). The medical report suggests that the concomitant use of phyto-molecules along with prescription medicines/over the counter products may alter human drug metabolism or pharmacokinetics parameter, which may cause serious clinical adverse reactions, for e.g. assessment of the in vitro effect of ‘triphala’ revealed that, the herbs may inhibit drug metabolizing enzymes (Ponnusankar et al., 2011). In a different study, standardized extract of Acorus calamus L. (AC) (Acoraceae) showed ‘fluorescence product formation’ on

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individual isoforms such as CYP3A4 and CYP2D6 isozymes, in in vitro assay (Pandit et al., 2011). To carry out such type of studies and to monitor the adverse drug reactions on herbal products, Deparment of AYUSH has started national pharmacovigilance programme since August 2008. In this context, the department has setup a ‘National Pharmacovigilance Resource Center’ for Ayurveda, Siddha, and Unani drugs (NPRC-ASU) under the guidance of National Pharmacovigilance Consultative Committee, Govt. of India and has declared Institute for Post-Graduate Teaching and Research in Ayurveda (IPGT & RA), Jamnagar as national resource center for this programme. Regional and peripheral pharmacovigilance centers across the country are supporting organizations of NPRC-ASU, which are involved in collection of adverse drug reactions (ADR) data.

8. Conclusion Ayurveda practice continues today to treat human diseases and provides positive health benefits to the people. Considering the widespread use and popularity of Ayurveda, proper standardization and validation method are being developed for promoting Ayurvedic drugs. Documentation of their safety profiles and pharmacovigilance study are major areas to develop the standard procedures for Ayurvedic products. The existing knowledge of Ayurveda and ethnic medicines are being validated through newer guidelines of standardization, manufacture, quality control and modern techniques. In India, such efforts including administrative management and infrastructure facilities of AYUSH, standards for quality control and indigenous practices for integration of Ayurveda provide potential role in health care of the people.

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