Challenges and opportunities in the advancement of herbal medicine: India’s position and role in a global context

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JOURNAL OF HERBAL MEDICINE

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journal homepage: http://www.elsevier.com/locate/hermed

Review

Challenges and opportunities in the advancement of herbal medicine: India’s position and role in a global context Saikat Sen a b

a,* ,

Raja Chakraborty a, Biplab De

b

C.E.S. College of Pharmacy, Kurnool, Andhra Pradesh 518 218, India Regional Institute of Pharmaceutical Science and Technology, Agartala, Tripura 799 005, India

A R T I C L E I N F O

A B S T R A C T

Article history:

In the last few decades eco-friendly, bio-friendly, cost-effective and relatively safe herbal

Received 15 June 2011

medicines have moved from the fringe to the mainstream with increased research in the

Accepted 2 November 2011

field of traditional medicine. Medicinal plants are an integral component of alternative

Available online 22 December 2011

medical care. For millennia, Indian people traditionally played an important role in the management of biological resources and were custodians of related knowledge that they

Keywords:

acquired through trial and error over centuries. India has a rich wealth of medicinal plants

Herbal medicine

and the potential to accept the challenge to meet the global demand for them. Ayurveda,

Traditional knowledge

Naturopathy, Unani, Siddha and folk medicine are the major healthcare systems in Indian

India

society, which fully depend upon natural resources. The market for herbal drugs has grown

Healthcare

at an impressive rate due to a global resurgence in traditional and alternative healthcare

Economy

systems, and therefore medicinal plants have great economic importance. However loss

Conservation

of biodiversity, over-exploitation and unscientific use of medicinal plants, industrialization, biopiracy, together with lack of regulation and infrastructure are the major impediments to the growth of herbal medicine. Conservation, proper research based on traditional knowledge, quality control of herbal medicine and proper documentation are essential in the 21st century for the growth of herbal medicine usage. Ó 2011 Elsevier GmbH. All rights reserved.

Contents 1. 2. 3. 4.

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Medicinal plants in the Indian healthcare system . . . . . . . . . . . The herbal medicine scenario in India . . . . . . . . . . . . . . . . . . . . The economic importance of herbal plants and India’s position

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* Corresponding author. Address: Dept. of Pharmacology, Creative Educational Society’s College of Pharmacy, NH 7, Chinnatekur, Kurnool, Andhra Pradesh 518 218, India. Mobile: +91 9032011182, +91 9494222701. E-mail address: [email protected] (S. Sen). Abbreviations: WHO, World Health Organization; GMP, good manufacturing practices; NMPB, National Medicinal Plants Board; AYUSH, Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy; TKDL, Traditional Knowledge Digital Library; EPO, European Patent Office; Assochem, Associated Chambers of Commerce and Industry of India; IUCN, International Union for Conservation of Nature 2210-8033/$ - see front matter Ó 2011 Elsevier GmbH. All rights reserved. doi:10.1016/j.hermed.2011.11.001

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5. 6. 7. 8.

1.

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JOURNAL OF HERBAL MEDICINE

Impediments to the advancement of herbal medicine use. Quality and regulatory challenges . . . . . . . . . . . . . . . . . . . . Initiatives in Indian herbal medicine. . . . . . . . . . . . . . . . . . India’s role and future perspectives. . . . . . . . . . . . . . . . . . . References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Introduction

Since time immemorial nature has bestowed its benefits on mankind as it provides food, shelter, medicine and other resources according to our needs (Cragg and Newman, 2005). The interrelationship between society and nature, and the importance of herbal medicine to human health has recently become widely acknowledged, which has drawn attention to the fact that loss of biodiversity, destruction or unscientific use of medicinal plants can have direct and indirect effects on the well-being of humans. Disruption of biodiversity, and loss of forest and plant resources cause our ecosystem to be less resilient, and more vulnerable to shocks and disturbances. Human health cannot be considered alone, as it is extremely dependent on the quality of the environment in which we live; for people to be healthy, they need healthy environments and a proper medical care system that provides eco-friendly, bio-friendly, cost effective and relatively safe treatments (Alves and Rosa, 2007; Cragg and Newman, 2005; Sen et al., 2009). The quest of mankind coupled with modern technological and scientific advancements making progress in the discovery of synthetic medicines has helped greatly in the treatment or prevention of several acute/chronic/lifethreatening diseases. But over-use and prolonged use of these drugs can lead to toxic side effects, becoming a major threat in the modern era. Increases in pollution, unhealthy lifestyles, stress, loss of traditional medicinal practices and loss in plant biodiversity has increased in recent times leading to an alarming disturbance in the structure and function of nature (Alves and Rosa, 2007; Dubey et al., 2004). In the 21st century, medicinal herbs are gaining importance in mainstream healthcare as greater numbers of people seek relatively safe remedies and approaches to healthcare. The demand for herbal medicines, herbal health products, herbal pharmaceuticals, nutraceuticals, food supplements and herbal cosmetics etc. is increasing globally due to the growing recognition of these products as mainly non-toxic, having in the main less side effects, better compatibility with physiological flora, and availability at affordable prices (Dubey et al., 2004; Sharma et al., 2008). Medicinal plants are an integral component of traditional medicinal systems. Earliest records suggest that herbal medicines have been used and documented in Indian, Chinese, Egyptian, Greek, and Roman medicinal systems for about 5000 years. Traditional herbal medicine has also been practised from ancient times in American and Arabian countries, and Japan. The transcripts of classical traditional medicine systems in India include Rigveda, Atherveda, Charak Samhita and Sushruta Samhita. Folk (tribal) medicines are also important sources for the indigenous healthcare system. India has been known to be a rich repository of medicinal plants from ancient civilizations. The forests of India are the principal source of large number of medicinal and aromatic plants (De et al., 2010;

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Kamboj, 2000; Mukherjee, 2008). Research into medicinal plants, isolation of bioactive constituents and pharmacological screening can help us to find new therapeutically active drugs. It is estimated that there are more than 6000 higher plant species included in codified systems such as Ayurveda, Siddha and Unani traditions and in folk medicine of India, consisting of about 40% of the total higher plant diversity of the country (Ved and Goraya, 2008). With its rich wealth of herbs, India is on the threshold of an herbal revolution and is able to supply medicinal plant resources to meet the increasing global demand. Medicinal plants are not only important for the healthcare system but also important to boost the economy and can impart a significant role in economic development. Many valuable medicinal plants are on the verge of extinction due to degradation of biodiversity (Alves and Rosa, 2007). Thus maintaining plant biodiversity and their sustainable use can help to build a healthy and great economic society and India can play a major role in this aspect.

2. Medicinal plants in the Indian healthcare system Plants have been a source of medicinal agents for thousands of years and continue to be an abundant source of novel therapeutic agents. It was estimated that approximately 5–15% of the total 250,000 species of higher plants have been systematically investigated, and yet the potential of many plants that can be a good source of novel bioactive compounds has barely been tapped (Cragg and Newman, 2005). Plant products and herbal medicine play a vital role in the healthcare system, mainly in rural areas of developing countries. Medicinal plants have a great history as the source of potential therapeutic agents, for example reserpine, deserpidine, rescinnamine, vinblastine, vincristine, codeine, morphine, etoposide, guggulsterone, teniposide, nabilone, plaunotol, z-guggulsterone, lectinan, artemisinin and ginkgolides, which have been incorporated into modern medicine (Kamboj, 2000; Mukherjee et al., 2010; Verma and Singh, 2008). Plant-derived products became a primary choice for biological and pharmacological research and served as leads for the development of synthetic drugs. It is estimated that nearly 75% of the herbal drugs used worldwide were incorporated from indigenous medicine (Verma and Singh, 2008). In India, nearly about 70% of modern medicines are derived from natural resources and several other synthetic analogues have been made from prototype compounds isolated from plants (Sharma et al., 2008). About 6% of all described species have been investigated chemically and among them only a small fraction has been investigated pharmacologically. Demand for a slim body and fair skin is growing considerably and a major factor in the herbal product business. According to Polshettiwar (2006), out of the USD 2446.5 million (INR. 12,000 crores) herbal product

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Fig. 1 – Percent use of herbal medicine for primary health care is extensive in some developing countries [Figure compiled from data published by the World Health Organization, 2002].

industry, USD 142.7 million (INR. 700 crores) belongs to skincare products and USD 20.4 million (INR. 100 crores) to general cosmetics. Herbal drugs used in cardiovascular conditions account for 27% of the herbal product industry, respiratory for 15.3%, digestive for 14.4%, hypnotics and sedatives for 9.3%, and miscellaneous for 12% approximately. In the USA, discovery, research and development of a synthetic drug require an average period of 12 years with a huge investment of USD 230 million. It was seen that investigation and modification of herbal drugs takes comparatively much less time and expenses than synthetic drugs (Wakdikar, 2004). The main problem with the use of synthetic drugs is the unwanted and sometimes unpredictable side effects which certainly can on occasions be more dangerous than the diseases they claim to treat. Though some of the drugs from plant sources also possess some serious adverse effects (like vincristine), generally natural drugs are less toxic and produce less side effects than synthetic drugs. So in contrast with synthetic medicine, herbal medicines are based upon the premise that they contain natural substances that can support health and alleviate illness; we believe that herbal products are relatively safer, possess better patient tolerance, are relatively less expensive and globally competitive. The use of plants as food or herbal products as dietary supplements has also proved effective to keep the body healthy and free from disease (Sen et al., 2010a, 2010b). According to the WHO, most people of the developing countries from Asia and Africa still use herbal medicine for primary healthcare. Recently, use of traditional or complementary alternative medicine in developed countries has also increased rapidly. Dietary supplements from plant sources are now gaining importance. The demand for herbal products is predicted to increase rapidly as the use of herbal supplements and medicines in developed countries is increasing sharply. The percentage uses of traditional medicine for primary healthcare in some developing countries are given in Fig. 1 (World Health Organization, 2002).

3.

logical wealth. More than 45,000 plant species, 15,000–18,000 flowering plants, 23,000 fungi, 2500 algae, 1600 lichens, 1800 bryophytes and 30 million micro-organisms exist in India (Bharucha, 2006; Kamboj, 2000). About 7500 species of higher plants out of 17,000 species are known for their medicinal value, and surveys have suggested that among 45,000 different plant species 15,000–20,000 plants have good medicinal value (Kala et al., 2006; Mukherjee, 2008; Sharma et al., 2008). India enjoys the benefits of diverse climate and conditions, from alpine in the Himalaya to tropical wet in the south, arid in Rajasthan to North-eastern states with diverse physiography, plains, plateaus and mountains with associated valleys. Such favourable climatic conditions (soil, temperature, rainfall etc.) have given rise to rich and varied flora in the Indian subcontinent. Traditionally, India has a very long history of safe and continuous usage of many herbal drugs. The alternative systems of health, Ayurveda, Yoga, Unani, Siddha, Homeopathy and Naturopathy play an important role in the Indian healthcare system. About 70% of the Indian population uses plants or plant products for their healthcare (Vaidya and Devasagayam, 2007). In 1995, the Ministry of Environment and Forests in India estimated that over 7500 plant species are used by 4635 ethnic communities for human and veterinary healthcare across the country, and about 25,000 effective plant-based formulations are known among rural communities in India. Over 1.5 million practitioners of traditional medicinal systems use medicinal plants in daily practice for their preventative, promotional and curative applications. More than 500,000 non-allopathic practitioners are trained in the (>400) medical colleges for their respective healthcare systems (Government of India, 2009a; Vaidya and Devasagayam, 2007; Verma and Singh, 2008). Since the Indian subcontinent is well known for its traditional knowledge and diversity of forest, there is an urgent need to cherish these in both the national and international perspectives for benefit of mankind. Apart from healthcare, medicinal plant trade is an important alternative incomegenerating source for under-privileged communities.

The herbal medicine scenario in India

India is one of the 12 mega biodiversity zones in the world; the biodiversity of India is unmatched due to the existence of 16 different agro-climatic zones and ten vegetative zones. The presence of two ‘biodiversity hotspots’ make India rich in bio-

4. The economic importance of herbal plants and India’s position Due to the global resurgence in traditional and alternative healthcare systems, the market for herbal drugs has grown

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at an impressive rate. The global market for herbal drugs is lucrative and therefore the world herbal trade is expected to reach USD 7 trillion by 2050. The Indian share of this world trade at present is quite low (Vaidya and Devasagayam, 2007). According to available data, the value of the herbal medicine market in European countries in 1991 was about USD 6 billion, which became USD 10 billion in 1996, and was expected to exceed USD 20 billion by 2000. The contribution to the world herbal medicine market from the USA in 1996 was about USD 4 million and in other countries was USD 5 billion. Herbal sales increased in the USA by 101% in mainstream markets between May 1996 and May 1998 (Hasan, 2010; Kamboj, 2000). A recent publication by WHO on Traditional medicine showed that, In Japan spending on traditional medicine was just over USD 1 billion in 2006, while in 2004–2005 Australia spent a total of USD 1.86 billion on herbal medicine. Traditional medicinal preparations in China constitute between 30% and 50% of the total consumption of medicine, equating to a sale value of USD 14 billion in 2005 (up more than 28% from the previous year).though expenditure in UK and brazil in 2007 was relatively less, only USD 230 million and USD 160 million respectively. Among the European nations, the value of the known market sales of herbal medicine in 2003 was estimated to be USD 5 billion, though it may not represent an accurate figure as the total was based on the manufacturers’ prices to wholesalers, and such does not reflect the actual cost to the end user (Rabinson and Zhang, 2011). Traditional medicine accounts for around 40% of all healthcare provided in China. In 2002, it was estimated that Malaysia spent USD 500 million annually on traditional medicine/complementary alternative medicine compared with USD 300 million on allopathic medicine (World Health Organization, 2002). Another report on ‘Traditional Medicine’ by WHO estimated that the global market for traditional medicine was USD 83 billion annually in 2008, which is increasing exponentially. The growth rate of traditional medicine product sales amounts to between 5% and 18% per annum (Robinson and Zhang, 2011).

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Although interest in the use of herbal medicine is increasing worldwide, there is comparatively less interest in India despite its vast resources. India and China are the two biggest countries of Asia in population and natural resources. According to Wakdikar (2004), China contains about 4941 medicinal plant species out of a total 26,092 species, while India contains 3000 out of 15,000 plant species. Indonesia, Malaysia and Nepal also have a lot of plant species but less in comparison with China and India. The total number of plants and medicinal plants worldwide are given in Fig. 2. India has a very small share (1.6%) in this fast-growing global trade of herbal medicine (Wakdikar, 2004). Other data suggest that traditional Chinese medicine includes nearly 5000 plant species, whereas India includes about 7000, though globally India’s share in medicinal plant exports is very low at about 8.13% against 28% from China. Between 1991 and 2002, the Indian share of world export grew by 4.95%, whereas China’s growth rate was reported to be 7.38% (Singh and Vadera, 2010; Verma and Singh, 2008). According to AYUSH, India ranks as the world’s second largest exporter of medicinal plants after China in 2009 (Dhanabalan, 2011). Between 1991 and 1998, 36,750 tonnes of medicinal plants were exported from India, compared with China’s 139,750 tonnes. Exports of herbs from India during the year of 2007– 08 were worth USD 96 million (INR. 470.73 crore) whereas in 2006–07 they were worth USD 76.9 million (INR. 377.02 crore) (Government of India, 2009a; Schippmann et al., 2002). According to an Indian Government press release in December 2010, exports of herbal products from India were worth USD 62.4 million (INR. 306.3 crore) in 2005–06 and USD 116.4 million (INR. 570.8 crore) in 2009–10. So the data show that export of herbal products increased at a compound annual growth rate of 16.80% (Government of India, 2010a). The demand for herbal supplements also increased tremendously; the global market for herbal supplements exceeded USD 15 billion in 1991, with a USD 7 billion market in Europe, USD 2.4 billion in Japan, USD 2.7 in the rest of the Asian countries

Fig. 2 – Total number of plant species and plants used medicinally in selected countries worldwide [Figure compiled from the data published by Wakdikar, 2004].

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and USD 3 billion in North America (Wakdikar, 2004), by observing the trends it may be predicted that the market will increase a few fold in the next few years. Currently about 960 species of Indian medicinal plants are estimated to be traded of which only 178 species will have an annual consumption of 100 metric tonnes (Medicinal Plant Board of India, 2010). The total annual demand for herbal raw drugs in India was 319,500 metric tonnes from 2005 to 2006. From this, the demand from the Indian herbal industry was 17,000 metric tonnes and for households it was 86,000 metric tonnes. An annual (2005–06) trade of 319,500 metric tonnes of botanical raw drugs in India is worth about USD 217.9 million (INR. 1069 crores) [the trade value of the herbal industry and rural household are INR. 627.90 and 86.00 crores, respectively]. The annual turnover of the herbal industry in the country has been estimated at USD 1794.1 million (INR. 8800 crores) for the year 2005–06 (Ved and Goraya, 2008). Demand for herbal medicines is increasing. In 2010 the production of Indian herbal drugs was worth around USD 815.5 million (INR. 4000 crores) and about 1650 herbal formulations were available on the Indian market. The number of major plants involved in their formulation was 540 (Polshettiwar, 2006). According to the Government of India Export Import Data Bank of the Department of Commerce, the total share of exports of traditional medicines from India is quite low but is increasing rapidly. The details are provided in Table 1 (Government of India, 2011). Sales of medicinal plants grew by nearly 25% in India between 1987 and 1996, and in 2004, the market for ayurvedic medicines was expanding by 20% annually (Wakdikar, 2004). Emblica officinalis Gaertn. (family Phyllanthaceae; amla) is the highest consumed botanical raw drug by the domestic herbal industry in India, whereas exports of isabgol (Psyllium husk), senna (leaves and pods), henna (leaves and powder) and myrobalans account for almost 70% of total exports of plant raw drugs by volume (Ved and Goraya, 2008). Opium alkaloids, senna derivatives, vinca extract, cinchona alkaloids, ipecac root alkaloids, solasodine, diosgenine/16DPA, menthol, gudmar herb and mehdi are some major pharmaceuticals exported from India (Sharma et al., 2008). Other commercially important medicinal plants grown in India are listed in Table 2. India dominates the world market in the production and export of Psyllium husk and seeds, as 80% of the psyllium available in the world market is exported by India (Singh and Vadera, 2010). A survey of those 178 species with an annual consumption of 100 metric tonnes reveals that 21 species

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(12%) are obtained from temperate forests, 70 species (40%) are obtained from tropical forests, 36 species (20%) are obtained largely or wholly from cultivations/plantations, 46 species (25%) are acquired mostly from road sides and other waste land and the remaining five species (3%), Aquilaria agallocha (agar), Commiphora wightii (guggul), Glycyrrhiza glabra, Piper chaba and Quercus infectoria need to be imported from other countries. Although agar and guggul are available in tropical India, their wild population is not sufficient to fulfill total domestic requirements (Ved and Goraya, 2008). A survey suggested that three of the ten most widely selling herbal medicines in developed countries (specifically preparations of Allium sativum, Aloe barbedensis and Panax species) are available in India (Dubey et al., 2004). Nearly 9500 registered herbal industries and a multitude of unregistered cottage industries in India depend upon the continuous supply of medicinal plants for manufacturing herbal formulations (Ved and Goraya, 2008). In India, it is estimated that there are about 25,000 Indian government licensed pharmacies of the Indian system of medicine. In 2008, it was estimated that about 1000 single herbal drugs and about 3000 compound herbal formulations were registered. About 8000 medicinal plants are currently used by the industry (Sharma et al., 2008). Some of the major traditional herbal industries in India include, Himalaya, Zandu, Dabur, Hamdard, Maharishi, Baidyanath, Charak and Madona, and modern pharmaceutical companies, such as Ranbaxy, Lupin and Allembic, are also involved in the manufacturing of herbal formulations.

5. Impediments to the advancement of herbal medicine use Degradation of forests is one of the main threats to medicinal plants. Rapid rises in population, pollution, modern civilization, industrialization and unsustainable resource use are also key reasons for degradation of plant biodiversity. Overexploitation of forests is responsible for the extermination of numerous medicinal plant species around the globe (De et al., 2010). Forests are the primary source of India’s medicinal plants, while only about 10% of known medicinal plants are restricted to non-forest habitats (Wakdikar, 2004), though cultivation of several plant species found mainly in the forest has started to address the demand. Another nationwide survey in India carried out by the National Medicinal Plants Board (NMPB) found that about 77% of medicinal plants used in the country are sourced from forests and wastelands

Table 1 – The export of Ayurvedic, Unani and Siddha products during the years 2009–10 and 2010–11 (Apr–Sep) [Data obtained from: Government of India. Export Import Data Bank, Department of Commerce, Ministry of Commerce and Industry, Govt. of India, New Delhi. 2011]. Name of product

2009–10 (USD Million)

% Share

2010–11(Apr–Sep) (USD Million)

% Share

Medicants of Ayurvedic system Medicaments of Ayurvedic system Medicants of Unani system Medicaments of Unani system Medicants of Siddha system Medicaments of Siddha system India’s total export

25.00 117.15 0.02 0.07 0.01 0.08 178,751.43

0.0140 0.0655 0.0000 0.0000 0.0000 0.0000

23.73 48.11 0.01 0.08 0.04 0.23 105,063.92

0.0226 0.0458 0.0000 0.0001 0.0000 0.0002

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Table 2 – List of some commercially important medicinal plants grown in India [Table complied from the data published by Ved and Goraya, 2008]. Common name in hindi

Latin name

Plant family

Chirata Kalmegh Safed musali Ashok Daru haldi Kokum Sarpagandha Ashwagandha Giloe Kuth Atees Gudmar kutki Shatavari Bael Guggul Makoy Tulsi Bhumi amla Mulethi Vai vidang Brahmi Jatamansi Patharchur Vatsnabh Chandan Kalihari Pippal

Swertia chirata Buch.Ham. Andrographis paniculata (Burm.f.) Wall. ex Nees Chlorophytum borivilianum Sant. et Fernand. Saraca indica L. Berberis aristata DC Garcinia indica Choisy Rauvolfia serpentina (L.) Benth. ex Kurz Withania somnifera L. Tinospora cordifolia (Willd.) Miers ex Hook. F. & Thoms Saussurea lappa (Decne.) C.B. Clarke Aconitum heterophyllum Wall Gymnema sylvester R. Br. Asparagus racemosus Wild Aegle marmelos (L.) Corr.Serr. Commiphora mukul (Stocks) Hook. Solanum nigrum L. Ocimum sanctum L. Phyllanthus niruri L. Glycyrrhiza glabra L. Embelia robusta Roxb. Bacopa monnieri L. Pennell Nardostachys grandiflor DC Coleus barbatus B Aconitum heterophyllum Wall Santalum album L. Gloriosa superba L. Ficus religiosa L.

Gentianaceae Acanthaceae Liliaceae Leguminosae Berberidaceae Clusiaceae Apocynaceae Solanaceae Menispermaceae Asteraceae Ranunculaceae Asclepiadaceae Asparagaceae Rutaceae Burseraceae Solanaceae Lamiaceae Phyllanthaceae Fabaceae Myrsinaceae Scrophulariaceae Valerianaceae Laminaceae Ranunculaceae Santalaceae Lilaceae Moraceae

(Government of India, 2009b). Open access to the forest resources and their over-exploitation has led to the existence of certain medicinal plants being in grave danger. To protect medicinal plants and to grow them for our needs is the major challenge and necessity at this time. Unfortunately, due to rapid depletion of forests, many valuable plants are being lost at an alarming rate. About 50% of the tropical forests have already been destroyed. Forests in India are disappearing at an annual rate of 1.5 million hectares per year and only 8% forest area is remaining against a mandatory 33% (as per National Forest Policy of India, 1988) of total geographical area (Joy et al., 1998). Many valuable medicinal plants of India are on the verge of extinction. According to the International Union for Conservation of Nature (IUCN) species survival commission, in India 19 species of plant are extinct, 43 species are considered to be extinct/endangered, 149 species are endangered, two species are endangered/vulnerable, 108 species are vulnerable and 256 species are rare plants (Baillie et al., 2004; Verma and Singh, 2008). The availability of forest resources is a major requirement for establishing medicinal and aromatic plant-based industries. Conservation of medicinal plants and their sustainable use are necessary for the growth of herbal medicine. Initiation of systematic cultivation programmes and sustainable use of natural resources will help to grow the herbal industry as well as the economy. Cultivation of wild medicinal plants is an important approach in this regard. Both cultivated and wild plants can be used for drug formulation, although temperature, rainfall, day length and soil characteristics are some

important factors affecting the effectiveness of some medicinal plants. However, in many cases, properly cultivated plants show improved quality compared with wild plants. Mass propagation is necessary to meet the demand for medicinal plants. Plant cell or tissue culture, biochemical conversions and clonal propagation of indigenous medicinal plants is another potential strategy (Dubey et al., 2004).

6.

Quality and regulatory challenges

Although herbal medicines are widely used for the prevention, diagnosis, treatment and management of disease, quality control and proper regulation worldwide are still a big challenge. Widespread and growing use of botanicals has created a global health challenge in terms of quality, safety and efficacy. Scientific validation and technological standardization of herbal medicine is needed for the future advancement of traditional medicine. Proper use of products of assured quality could also do much to reduce any risks associated with herbal medicine. However, regulation and legislation of herbal medicines has been enacted in very few countries; most countries do not have any proper regulation of botanicals, and the quality of herbal products sold is generally not guaranteed (World Health Organization, 2002; Warude and Patwardhan, 2005). Recently several European countries adopted The European Directive on Traditional Herbal Medicinal Products (formally The Directive 2004/24/EC amending) which aims to assure the quality and regulation of herbal products. In the United Kingdom this is implemented by the

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Medicines and Healthcare products Regulatory Agency (MHRA) formed in April 2003 by the merger of the Medicines Control Agency and Medical Device Agency. The MHRA is responsible for the quality and safety of all types of medicines. Many other countries particularly in Africa and some parts of Asia do not have such regulation, thus developing such regulations worldwide is urgently needed. Research into herbal products is also inadequate; although a lot of research is carried out on natural products, very few trials produce satisfactory results that are included in the healthcare system. Therefore, it is perhaps not surprising that clinical trials that have been carried out for isolated active phytoconstituents are few, small and inadequately controlled. Evaluation of herbal medicines is generally difficult; accuracy of plant identification and isolation of active ingredients is the key challenge in this regard. The latter is complex and needs special precautions, because a single medicinal plant can contain hundreds of natural constituents and medicinal plant properties are influenced by the time of collection, area of plant origin, and environmental conditions. Therefore, policies regarding various issues are urgently needed, including: legislation and regulation for herbal products and practice of therapies; education, training and licensing of providers; research and development; and allocation of financial and other resources (Kamboj, 2000; World Health Organization, 2002). Challenges in education and training regarding herbal medicine are high. Ensuring the knowledge, qualifications and training of traditional medicine providers is the first challenge. Training to ensure that traditional medicine providers and allopathic practitioners understand and appreciate the complementary nature of this type of healthcare is important. Although there are varying degrees to which it is recognized by governments, the lack of sound scientific evidence of the efficacy of many traditional herbal medicine systems, difficulties relating to the protection of indigenous traditional knowledge and problems in ensuring its proper use need to be focused on urgently. Attention should also be paid to intellectual property issues to stop biopiracy of indigenous traditional knowledge and/or natural resources that are used in traditional medicinal products (World Health Organization, 2002). A report by Associated Chambers of Commerce and Industry of India (Assochem) revealed that of the 700 plant species commonly used in India, only 20% were being cultivated on a commercial scale and 90% of medicinal plants used are collected from wild resources (Sharma, 2008). Overexploitation or unscientific collection results in the destruction of medicinal plants. According to Assocham, over 70% of plant collection involves destructive harvesting due to use of roots, bark, wood, stem or the whole plant, which particularly in the case of herbs, causes obliteration of that plant. This poses a specific threat to genetic stocks and medicinal plant diversity, therefore sustainable use of natural products is necessary (Sharma, 2008). Regulations and standardization of crude drugs and herbal medicines are another challenge for the growth of herbal medicine. Improper regulation and facilities of small-scale industries, and lack of rigid quality controls for herbal material and formulations are the limitations for standardization of herbal medicine (Verma and Singh, 2008). The quality control/standardization of herbal formulations and

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crude drugs are the principal important factor in justifying their acceptability in modern medicine. There is an urgent need for Good Manufacturing Practices (GMP) to ensure the high quality of herbal drugs. In order for a drug regulatory agency to meet the high expectations of the public, there is a need for well-designed, randomized, double-blind, and placebo-controlled clinical trials to establish the safety and efficacy of herbal medicines together with allopathic drugs. Systematic clinical trials will provide new opportunities for basic and applied research in the areas of herbal products and Ayurvedic remedies used in India. GMP for Ayurvedic, Siddha and Unani medicine came into force in the year 2000, the Indian Pharmacopoeia 2007 included 59 monographs on herbs and herbal Products, while the Indian Pharmacopoeia 2010 included 89 (Indian Pharmacopeia, 2010; Narayana, 2009). In 2005, the Ayurvedic Pharmacopoeia of India included 258 different drugs, and the Indian Herbal Pharmacopoeia included 52 monographs of widely used medicinal plant (Warude and Patwardhan, 2005).

7.

Initiatives in Indian herbal medicine

A pressing need exists in India for rigorous research into agropharming, plant-biotechnology and the pharmaceutical sectors to increase the production of medicinal plants as well as their active medicinal ingredients by using modern genomic and biotechnological methods. Though a number of universities/colleges are present in India, the research in this area is not sufficient and is comparatively less than in China, Japan, Europe, and Israel. The agricultural and medicinal/pharmaceutical colleges/universities and plant and forest research institutes should be encouraged to undertake such basic research ventures. Biopiracy is another problem that prevents growth of Indian herbal medicine worldwide. Unfortunately, there is a huge gap between developed and developing nations such as India on patenting the products (Kala et al., 2006). The limiting factors for the growth of herbal medicine include degradation of biodiversity, aggressive modernization, and industrialization. In modern times, peoples are loath or unable to avail themselves of the traditional knowledge from their ancestors in regard to vegetation, medication etc., which causes a shortage of trained people in the area of traditional/ folk medicine (Ved and Goraya, 2008). Therefore, proper documentation of indigenous knowledge, work on patenting, and research based on literature is necessary for the growth of Indian herbal medicine. The Indian Government has taken a different initiative for conservation of forests and medicinal plants. The Department of Indian Systems of Medicine and Homoeopathy (established in 1995) was re-named in November 2003 as Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy (AYUSH), with a view that our ancient and holistic medicinal systems can make a difference towards better healthcare. The department lays the emphasis on Indian traditional medicinal education standards, quality control and standardization of drugs, improving the availability of medicinal plant material, research and development and generating awareness of the efficacy of the systems domestically and internationally. About USD 158 million (INR. 775 crore) has been allocated to the AYUSH Depart-

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ment during its 10th five-year plan (Government of India, 2010b). The NMPB was set up in November 2000 by the Government of India to work towards all matters relating to medicinal plants and support policies and programs for growth of trade, export, conservation and cultivation of medicinal plants. NMPB have undertaken various programs/schemes for conservation of rare, endangered and threatened plant species for development and sustainable management of medicinal plants, which has an outlay of USD 65.2 million (INR. 320 crores) during the 11th- 5 year plan (2007–2012) (Government of India, 2009b). Research support into documentation of indigenous knowledge is another important approach in addressing the patent and intellectual property right issues. Protection and preservation of traditional knowledge from biopiracy has been a matter of concern to India, particularly due to certain incidents. The Traditional Knowledge Digital Library (TKDL) is the first Indian effort and is a proprietary and original database of traditional knowledge based on medicinal plants. TKDL is a collaborative project between Council of Scientific and Industrial Research and Department of AYUSH of Government of India, which was initiated at 2001. Documentation of traditional knowledge that is available in the public domain from existing literature related to Ayurveda, Unani and Siddha is the prime focus of TKDL. The TKDL incorporates about 212,000 medicinal formulations (Ayurveda: 82900; Unani: 115300; Siddha: 12950) from 148 books available in the public domain. Government of India has signed TKDL access agreements and approved to provide the access of TKDL database to International Patent Offices, European Patent Office (35 member state), German Patent Office, Indian Patent Office and United State Patent and Trademark Offices, which are unique in nature and have inbuilt safeguards on non-disclosure to protect India’s interest. The European Patent Office (EPO) set aside three patents as of September 2010 and twenty-three patents have been withdrawn by EPO based on TKDL database. There has been a sharp decline (44%) in the filing of patent applications concerning Indian systems of medicine at the EPO (Government of India, 2010c). Thus TKDL is proving to be an effective deterrent against biopiracy. India has also set up a global biopiracy watch system under TKDL in respect of patent applications related to Indian Systems of Medicine (Goyal and Arora, 2009; Singh, 2006).

8.

India’s role and future perspectives

Demand and growth for herbal medicines will continue to flourish, and promises a bright future. Sustained globalization of trade markets for medicinal plants and herbal drugs along with ethnobotanical exploration can be projected to continue to bring awareness and utilization of new plant materials for home, medicinal, and industrial use (Janick and Whipkey, 2007; Sen et al., 2009). It is also evident that potential growth of herbal medicine is important for India’s economic growth. Adequate quality assurance for herbal medicine should be guaranteed and should be a prime focus so that customers can buy unadulterated products. The growth of herbal medicine provides people an alternative healthcare system which

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is important for better, cost-effective treatments for the world community. The surge in global demand for herbal medicines/supplements has been followed by a belated growth in global alertness about the dwindling supply of the world’s medicinal plants. The prevalence of diversity in climatic conditions puts India in a supreme position with respect to the richness of its medicinal plants. The art of Indian traditional knowledge regarding herbal medicine has a long history and can be considered as a potential source of new medicine. India has great potential in the market for herbal medicine, which is evident by the fact that medicinal plants required to prepare 50% of the drugs mentioned in the British Pharmacopoeia are reported to be present in the Western Himalayan region alone and India has approximately 8% of the world’s biodiversity, including plant genetic diversity with medicinal properties (Singh, 2006). We now urgently need to integrate modern knowledge with traditional knowledge. In the past, many modern drugs were discovered from plants, and were then synthesized chemically by the pharmaceutical industry; therefore isolation and identification of therapeutically safe active ingredients from plant materials and their subsequent chemical synthesis would be helpful to the sustainability of precious plants that are excessively harvested and are quickly disappearing from the Indian subcontinent. Cultivation of economically important medicinal plants in wasteland areas can be an important source of income in rural areas, for example cultivation of several medicinal plants in North-Eastern India has changed the socio-economic status of the rural people (Shankar and Rawat, 2006). Therefore, the Government should also encourage individual people to grow medicinal plants to provide a steady supply, which will be useful for economic sustainability by generating new jobs and employment in rural areas. To harness the potential of this sector, realistic policies with economic outlook and effective planning strategies are required (Kamboj, 2000; Singh, 2006). The increased use of traditional herbal medicines, and exploring the possibilities that will ensure their successful integration into a public health framework is essential in this modern age. This potential has been tapped since India has a diversity of medicinal plants with great demand in the overseas market. India should fuel research into natural products, agrotechnology, standardization, and quality control of herbal drugs; understanding the socio-economic background and policies that favour research is needed to ensure development of this sector in a sustainable manner. Conservation of the biodiversity of medicinal plants and preventing biopiracy are also essential to maintain the growth of this sector. Now is the time to compile and document available traditional knowledge on our precious plant resources and prove their efficacy scientifically through detailed phytochemical, biological and pharmacological investigation.

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