Special issue with the Sunday Magazine
From the publishers of THE HINDU

Indian health traditions: October 08, 2000

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Need for friendly interaction

Dr. G. G. Gangadharan

The author is executive director of the Lok Swasthya Parampara Samvardhan Samithi, Coimbatore.

The Ayurvedic industry in India is around 100 years old. The earliest players were Dabur in the East, Dodh Pappaswer in the West, Kottakkal in the South, and Vaidya Nath in the North. All these groups were founded between 1890 and 1910. Before that the Ayurvedic industry was confined to the physicians and was more a service than a profession. The knowledge was considered sacred and was believed to have spiritual origins. In the process of westernisation and consequent commercialisation of healing, Ayurveda also had to become a part of this process.

There were intrinsic problems in the commercialisation of ayurvedic products, because Ayurveda basically is a science which does not treat a disease but the patient. The formulations given in classical texts are more than 20,000 in number. It is said that there are over 1,00,000 manuscripts lying in different parts of the country and abroad on indigenous health tradition in different languages and scripts. The permutation-combinations permitted in Ayurveda is infinitive but each combination has its own limitations and restrictions for use.

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There is a wide range of plant parts used in medicine such as the stem, seeds, as well as roots, fruits, fruit rind, resin, bulbs and rhizomes.

So selecting widely active and comprehensive formulations for large-scale preparation was the first task in industrialisation of ayurvedic medicine preparation. This was achieved by the founders of ayurvedic industries through their experience, using a wide spectrum of formulations for varieties of diseases for all personality types. So a pharmacy would prepare 400-600 medicines which cover almost all possible diseases that usually occur in tropical countries. And the flexibility of Ayurveda in allowing permutation-combinations of formulations for a given condition helps vaidyas use this for different conditions.

All the major traditional ayurvedic medicines in the South are prepared following this pattern. In Kerala, the contribution of traditional pharmaceuticals to tribal health and industry is more than 80 per cent and is promoted by physicians. The other herbal industries which evolved, especially after the 1970s, are the ones who do not have such vision, but focus on few formulations which are of wide use and are based on simple formulations. This sector is fast growing and, today, though there are around 7,000 registered manufacturers of herbal medicines in the country only a few make the wide range of classical preparations.

Dosage from development and improving shelf life were the two challenges that these industries met with support from modern science. The Indian medical heritage flows through two streams - oral and written. The oral tradition of the folk stream is represented by millions of housewives, folk practitioners and bone setters and makes use of thousands of species of medicinal plants and other natural materials. This stream addresses the local health needs and depends upon immediately available resources.

Complementing this are codified systems represented by sciences like Ayurveda, Siddha, Unani and Tibia. These systems are evolved with well established scientific and theoretical explanations of therapeutic aspects of natural materials and biological changes. These systems are contained in leaf manuscripts and have more than 4.5 lakh registered practitioners. They address a range of problems from those of a primary nature to complex diseases like paraplegia and arthritis. These two streams are mutually nourishing and connected in terms of their practical approach to health and diseases. The primary health care needs of the country have been met by these streams for thousands of years.

In spite of their potential, these streams are in a weak state today due to many socio-historical reasons. The challenge is to see how these systems can be put into operation to take care of the health needs of our people.

There is a wide gap between the health care delivery systems created and nurtured by the Government and the health needs of the people. The infrastructure under primary health care is very impressive to the extent of a health worker per 1000 people, a community health centre per 10,000 people, a primary health centre per 30,000 people and taluk hositals, district hospitals at secondary and tertiary level and we spend every year about 95 per cent of health budget for this system to operate. The Planning Commission, during the Eighth Plan, noted with great cocern that the official health care serves only 20 per cent of the population. It is only three per cent in hilly terrains where transport is difficult and maximum coverage is 33 per cent in urban areas. It also observed that there is no possibility of filling this big gap between the need and available resources as it invites huge infrastructural expenditure, technology input and manpower disbursement.

In 1974, WHO recognised the potential and scope of traditional medicines and made the Alma Ata declaration accepting traditional medicines as an important tool to achieve health for all by 2000 and requested member-countries to improve the service and availablity of traditional systems of medicine.

Among the codified streams, Ayurveda is not widely practised in India and is well knit into the social fabric as it is culturally linked with the lifestyle of the local communities.

Ayurveda is rooted in the darshanic principles of the Indian thought process and has its own foundational principles, concepts, categories and methodologies to explain and validate universal phenomena and biological changes which are holistic in nature. This is diagonally opposite to the analytical approach of modern medicine, which as a rule always tries to dominate all other knowledge systems by taking a position that science is universal with an affirmation of "Western Science." This political and cultural arrogance perpetuated by modern science looks at all other knowledge systems through its own ethnocentric world view. This has isolated modern science from other sasthras of oriental countries.

There are two ways for the development and appropriation of traditional systems of medicines (TSM) into contemporary health needs and futuristic medicine.

The Western View

Modern science as a whole, due to its global acceptance especially after the post industrial era, has taken the position that all knowledge systems evolved from different cultural roots have to be reviewed systematically by modern scientific parameters. So the theoretical basis of systems like Ayurveda is not acceptable to them because, by their criteria, it is based on unmeasurable or subjective parameters. So they consider only its pharmacopoeia. They find many useful formulations and single drugs based on natural flora, fauna and minerals in TSM. The whole effort is to separate the drugs from the entire theory.

Here the research and development is directed at isolating biomolecules, alkaloids and other active principles in the secondary metabolites of a plant system. The concept of synergy, which is central to TSM, is not taken into account and any product developed out of this effort no more belongs to Ayurveda. The trend is to add new products to the pharmacopoea of modern medicines. Many a time, these efforts become counter productive as active principles alone cannot bring about the same effect as the whole extract and also the formulations in the crude form is indicated in a bio-dynamic condition with or without the disease per se. The side effects and the drug resistance also will be a problem. Once an active principle or a biomolecule is isolated from an extract without its synergical colleagues to support and balance its action, it loses its character as explained in TSM. However, this is the kind of research carried out in many governmental and non governmental centres.

The Indian View

This is a small group especially from the non-governmental sector supported by very senior scientists of Ayurveda. This group has become active only after the 1970s and holds the view that development of this system should begin from the roots and should be comprehensive in approach. It does not accept the view that TSM is a cluster of crude formulations and plant medicines. It believes that modernisation does not mean westernisation but taking stock of its own inherent resources to develop based on the local needs and realities. It means that there is need to change the form without distorting the principle.

Thus, while accepting the changes and improvements offered to herbal preparations in the form of modern dosage form and packaging technology, they resist any effort to isolate biomolecules.

It is here the importance of pharmacy comes to play. Ayurveda describes different dosage forms, both internal and topical and some are highly sophisticated in comparison to modern dosage forms in terms of their application and bio-availability. For example, asawas and arishtas have a better penetration quality and speedy action than any other oral form. Experts like D.B.A. Narayanan have said that many of the modern dosage forms have their roots in Ayurveda (EP:XL:477).

a) The five basic ways to make a decoction from the extract which is known as Panchakashya Kalpana is unique to Ayurveda.

b) Aqueous and oil enema as a rectal nutritional roots as practised in Ayurveda was understood only recently by modern science.

c) Rehydration of dehydrated infants by application of breast milk soaked in cotton through frontenelle is a unique feature of Ayurveda.

d) Preservation through fat and oil and self-generated alcohol is another feature of Ayuvedic pharmacy.

e) Potentiation of medicines by repeated processing of the same ingredient again is another feature. For example Ksheerabala (101) and Dhanwantharam (101)

f) The concept of atomisation or micro-pulverisation of material to improve the bio-availability is yet another feature of ayurvedic pharmacy. For example, Vilwadi tablet for treatment of poisonous bites.

g) The concept of the "smiliars increases," is very well developed in Ayurvedic pharmacy and the need for iron in bio available form was understood and documented at least 2000 years back by Charaka and Vagbhata.

These are all but some examples to show the richness, diversity and sophistication of ayurvedic pharmacy. There is a lot to gain if modern pharmacy and ayurvedic bhaishaiyakalpaha come together to tackle today's needs. So far the approach has been the reverse, modern science taking a position that "we know everything and tell us your problems." This approach should change into a friendly interaction where both parties interact from an equal status and concern.

The outcome of this can be two-fold. Ayurveda will benefit in modernising some of its dosage forms like:

a) Decoction, tablets and choornams, where modern pharmacy inputs will be very valuable.

b) Encapsulation of low dose high potential oils (avarthy) preparation.

c) Using total extracts of crude materials.

d) Standardisation of secondary metabolites for quality control purpose.

e) Time bound drug release inside systems.

Modern medicine can benefit by getting:

a) More preparations from the clues received from Ayurveda.

b) It can even make a paradigm shift from isolating biomolecules to using total or fractional herbal extracts as a whole for specific conditions.

c) This will help complement allopathic medicines.

d) There are more than 10,000 species of plants which are used as medicines in TSM. If only one per cent of these preparations are made available to modern medicine through research, it will be a great contribution.

e) There are also plant materials with antioxidants digesting free radicals circulating in the body causing a lot of chronic and degenerative diseases. These can be made available for therapeutic use in appropriate dosage forms.

f) In areas of neuromuscular regeneration, there are many herbs which can be developed into therapeutically active medicine if TSM principles are properly understood by modern pharmacy.

There are many areas which can be worked out by experts in the field. There is an urgent need to open comparative schools by experts from both the fields before integration. Because integration can take place only when both parties understand each other from the other's own perspective.

Some of the immediate areas where modern science and particularly modern pharmacy can play a role are given below.

Raw Material:a) Authenticity; b) Continued, sustained and sustainable availability; c) Adulteration; d) Controversial drugs; e) Sastrically permitted substitutes; f) Sastrically unallowed adultrants; g) Seasonal availability vs. storage/ preservation for unseasonal use vs. retention of full potency over the period; h) Development of fungi, microbes over the period. A partial solution can be by making standardised extracts. Standardisation - validation to confirm to Good Medical Practices (GMP).

Process: Ayurvedic preparations fall into many categories - Kashayams, choornams, gulikas, lehyams, arishtas, medicated fats and medicinal ghees, oils and kuzhumbus and mineral preparations (bhasmas, sindooras) require different methods of processing. Some of these are time consuming extending upto 3-6 months for a single preparation like 101 aavarti thailam.

Problems to be resolved: The problem awaiting satisfactory solution are:

a) Better and more effective extraction in Kashayams. Often the partly extracted expensive raw materials are thrown away. Perhaps here standardised extracts have a role to play.

b) The fine grinding of gulikas even with mechanical flat wet grinders can be time consuming. Shortening the time without adversely affecting potency is desirable.

c) The preservation aspects - use of permitted preservatives.

d) Arishtas and Asavas: excise restrictions, drug controllers' restrictions. Also the occurrence of further fermentation leading to souring.

e) Lehyams: Regulating final moisture and preventing fungal growth.

f) Medicated oils and ghees: As per old sastric way, prolonged heating and stirring over a low fire was stipulated. Can this be achieved with the present day quick processing (with steam)?

g) Foaming problems: Loss of considerable expensive oil/ghee with kalkan - problems with Kuzhambu are similar.

h) Satadhoutha ghritham (for wound healing): In the classical method, the ghee has to be extensively purifieds. How it can be replaced by modern methods?

i) Minerals: The classical way - Uncontrolled temperature of incineration of bhasmas.

Packaging: Cost vs. improving aesthetic acceptability. Shelf Life: More systematic studies/ observations desirbaly for all dosage form. Standardisation: To confirm to GMP?

Classical Sashtric Ayurvedic Preparations vs the Proprietary "Herbal" Formulations: Can the latter enjoy the benefits of classical preparations in terms of licensing, drug regulation laws, guaranteed safety from toxic effects? Once the latter is popularised in a free for all way, real Ayurveda is going to be in jeopardy. The latter need the marketing support. Are we falling into the trap of consumerism with respect to health care?

Drug Regulatory Laws and possible adverse effects on the tiny Ayurvedic sector to the Vaidya who prepares his own medicine for patients?

Statistics: (if possible) of the small and tiny sector Ayurvedic Manufacturers. The village doctors do have an important role especially in rural health care. Their interests will have to be protected to ensure their survival for their important contribution to the rural to semi-urban areas? Competition with organised modern pharmaceutical sector, many of these giants are entering the so-called herbal field.

Waste disposal and environmental protection aspects, availability/ conservation of raw materials and survival and multiplication of endagered species are also important problems.

I have pointed out the problem areas in Ayurveda, where help and support from other systems are desirable. If we look into the richness of Ayurveda, in terms of its economic potential it is tremendous. The world herbal market according to a report published by U.K. based consultancy McAlpine Thorpe and Warrier, stands at $14.2 billions or Rs. 51,210 crore (Business India, November 17-30, 1997). This presents a big opportunity since India's share is currently only around Rs. 280 crores, against China's figure of Rs. 18,000 crores. So apart from tapping domestic needs, the traditional systems can bring in much need foreign exchange if properly developed. This is apart from the fact that Indian health care expenditure and quality of life can be further improved if traditional systems and natural health care programmes are tapped in implementing of national health programmes.

Apart from the technical support, what is urgently needed is potential will for policy changes to revitalise Traditional Systems of Health Care to contribute to the contemporary health needs not only in India but also globally.

The growth of the Ayurvedic industry, especially of the major vendors, are in three different, but mutually complementing, directions.

1. The pure classical traditions as followed by Arya Vaidya Sala Kottakkal, Arya Vaidya Pharmacy, Coimbatore which revolve around a physician and his/ her prescription. The growth of this sector is very slow but steady.

2. The growth pattern using classical as well as patent and proprietary medicines (PP) and OTC (over the counter products). Probably Dabur is the best example. Their classical side is rather slow in growth and expansion where as their PP products are popular.

3. The growth pattern of PP and OTC alone with a focus on the modern medicine practitioner as well as new Ayurvedic generation physicians. Himalaya drug company makes such preparations and perhaps its fast growth in the last few decades is an indicative of this trend.

The domestic market is fast growing for traditional medicine and the need is not properly exploited by these sectors yet.

Paradoxically while the demand for herbal medicine is growing the resource base of these, the medicinal plants, is fast disappearing.

According to a Conservation Analysis and Management Process (Camp) study conducted by FRLHT, a Bangalore based NGO as per the IUCN norms, around 59 species are coming under the Rare Endangered and Threatened Species (RET) and the Ministry of Environment has to ban export of the produce of these herbs in 1998. However, due to pressure from the industry as well as export promotion councils the Government of India had to lift the ban for the time being. Consequently the list was brought down to 28.

The Government has now come with many new regulations to control and direct the herbal industry. The following are being implemented from this year i.e. 2000.

Good Manufacturing Practices (GMP)

As per the June 23 Gazette of India all the existing herbal industries should follow the GMP pattern for production and a grace period of two years is given for existing units. This means at least a million rupee investment and documentation work. Most of the small players of the 7,000 units will have to stop their operation.

National Bio Diversity Act - 2000

This Act which will be placed in the Parliament in the coming session and is a major step in controlling the use of medicinal plants and limiting the benefit of IPR to India as well as helping conservation by sustainable utilisation. Under this Act even the collection of wild plants needs the consent from the State Bio-diversity board. Also collaboration with agencies abroad will require permission from this Board.

New Drugs Act

Another act which may change the Drug and Cosmetic Act related to herbal industry is the new categories being brought to Ayurvedic drugs. So all Ayurvedic drugs were either classical preparations as per the text (no dosage improvement, also no excise duty) or patent proprietary (excisable but less than its modern counterpart).

The amended Drug & Cosmetics Act comes with four categories of herbal preparations which will be specified in the drug licence issued.

1. Classical

2. Patent and proprietary

3. Herbal cosmetics

4. Industrial supplements

Even in the herbal cosmetic category soaps herbal and shampoos, etc., are not included. That means another category may have to be adopted for them.

Many leading pharmaceutical concerns have already ventured into Ayurveda or other herbal industries. GUFIC-Bombay is said to have only herbal products. Their allopathic units no longer interest them.

All these efforts makes sense because it is not just the domestic market one is looking into. The global market, especially the American and European markets, are said to be growing at a rate of 35 per cent a year (a record growth for last three years continuously). America is literally undergoing a herbal and natural product revolution.

So a time may come when the affluent, educated and sophisticated will use the costly and highly evolved, free-from-side effects, herbal products and the poor and less informed in the developing countries will use the chemical-based, cheap and easily available conventional medicine.