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Ayur drugs at crossroads
Dr T S Muraleedharan | Thursday, December 11, 2008, 08:00 Hrs  [IST]

The ayurvedic drug manufacturing activity, as an organised industrial endeavour, has come off age. Some of the pioneers like Dabur and Arya Vaidya Sala have crossed a century of their operations, while there are several other majors like Zandu, Baidyanath, etc who will reach that milestone soon. From historical angle, it is interesting to note that most of the contemporary major ayurvedic institutions of the country were founded in the early decades of the last century, when the British rule was at its pinnacle. It was, indeed, the pioneering efforts of some renaissance personalities of the time that paved the way for such an esoteric and individualistic activity like ayurvedic drug preparation to enter the industrial arena at that point in history.

Presently, there are several thousand individual units that produce ayurvedic drugs in the country. They represent a wide spectrum of organisational structures, right from individual efforts in very limited environs upto huge business corporations doing multi-crore business having their presence even across the national boundaries. They cumulatively present a rather bewildering picture. There is, perhaps, no other industrial sector which is more heterogeneous in every aspect of operational characters. This poly-character pertains to financial, organisational, administrative, technical and commercial components of industrial functioning. As a natural consequence, the important environmental conditions like, regulatory controls, market forces, financial management and technological upgradation, have all got to be uniquely tuned to match with sectarian needs.

It is in this veritable background that the scope and reach of ayurveda as a health-care system needs to be viewed. Added to this typical Indian scenario, there exists the new confounding factor of the present global economic pressures. One should start by taking a comprehensive look at the current status of the industry. Before that, it may be in place here to make a reference to certain assumptions which are often found quoted in the media.

The first one among them is that about 80% of the Indian population still relies on traditional medicines for its health care needs. This number has remained so static for the past several decades that one starts doubting its veracity. We know that the national population is increasing fast. We also know that the market size of herbal medicines in the country, which was Rs 1500 crores in 1995, has now reached Rs. 4000 crores. But, this increase should be compared with the spectacular growth in the market size of modern medicine from Rs 15000 crores to Rs 45000 crores during the same period. This apparent discrepancy in the growth rate between the two markets does not support the assumption that ayurveda continues to be the primary health care provider for the common populace. May be, that was a reason for the government to recently plan to proactively enter into chosen areas of primary health care programme. Similarly, the projection of $ 62 billion as the worth of global market for herbal products and its annual average growth rate of 35% are all numbers which need to be objectively validated before they can be used as effective inputs for the growth of ayurvedic industry.

Even after 3000 years since it took shape as a personalise health care system, ayurveda has stood the test of time and it still continues to provide succour to many ailing people. This, in itself, amply demonstrates its ruggedness and resourcefulness. Formulations mentioned in Charakasamhita, written in 1500 BC are still in vogue as effective medicaments. Moreover, those classical formulations have allowed themselves to be modified in their presentation forms as a necessary act of improving user compliance. And this traditional wisdom continues to enthuse modern scientists by offering new insights into the nature's healing capability. These are all very convincing strengths of ayurveda.

But there is a flip side too. The industry, which provides the ayurvedic armamentarium, faces several critical issues which have the potential to throttle its organic growth. The most important one among them is the threat that its resource-base is facing. The very growth of the industry seems to prove detrimental to its foundation. Eighty percent of the raw materials the industry uses comes from the vegetable kingdom. They are collected from both the wild and the cultivated sources.

The famous CITES negative list categorically prohibits the use of about 50 medicinal plant species for being under threat of extinction. At least 11 of them are crucial in drug preparation. The fact that important items like Rauvolifia serpentina, Swertia chirata, Nardostachys jatamamsi, Berberis aristata and similar others are cited in this list is an unnerving information for the industry. How will the industry ensure fidelity of its products in the absence of essential raw herbs?

The central and state medicinal plant boards are confronted with this issue. Yet another equally important issue is the unorganised nature of resource management. There is no organised system to procure, value add, store and supply ayurvedic raw herbs. The quality, the quantity and the cost all suffer in this scenario. The case of Acomitum heterophyllum is a typical example. It is an essential ingredient in several important anti-arthritic formulations. Its cost shot up from Rs 1500 for a kg to more than Rs 4200 in the last two years. A manufacturer like Arya Vaidya Sala (AVS) uses over 20000 kg of the item in an year. The annual cost impact due to the cost escalation of a single ingredient works out to more than Rs 5 crores. This makes the end product costlier. Temptation to adulterate at various stages of material handling is yet another casualty.

Making available ingredients of right quality in right quantity is an essential requirement for the sustained growth of ayurvedic industry. Several options are put forth by stake holders.

● Can cultivated herbs replace wild ones?
● Can benign parts like flowers, leaves or bark replace the roots?
● Can some easily available alternative plants substitute for the difficult ones?
● Can chemical extraction of plant species be a solution?

It is evident that all these options offer limited solutions. There are reports that the chemical profiles of medicinal plants like Aegle marmelos and Saraca asoca collected from the wild and the cultivated are similar. But the equivalance between their biological activity may have to be ascertained. There are research data indicating higher anti-oxidant activity (because of higher gallic acid content) in cultivated variety of Phyllanthus emblica compared to its wild variety, whereas, the trend is vice-versa in the case of vitamin-C content. The question of equivalance between the root of a plant and its flower or leaf is still more difficult.

Very often the soil interaction of root and ambient reaction of leaf as well as plant metabolism give rise to apparently different secondary metabolites. The question of appropriate substitutes for endangered species has been considered by the ayurvedic seers themselves.

The fourth option is fraught with many complicating issues. It is not quite clear how the use of extracts is going to frugalise the use of med-plants. If the formulator sticks to the ingredient ratio of the original formula while designing a new formula with extracts, then he has to go by the extractiveness value. That is, he has to keep in mind the herb-to-extract ratio. It obviously means that the original quantity of raw herb will still have to be consumed, if not by him but by the extractor.

Thus, there is no real saving of herb. The other possibility is to use a chemical molecule of the plant as a marker and then to use a solvent system which extracts this marker preferentially and more efficiently. Then he can afford to reduce the consumption of original herb by maintaining equivalence of maker molecule. But there are two relevant questions here. Are we sure that it is the marker molecule which is responsible for the biological activity of the plant?

But, from the ayurvedic point of view, the formulation is envisaged to contain only that much of activity which gets extracted in water. If one goes by the herb-to-extract ratio as a deciding factor while designing the formulation, then one may end up with a molecular ratio which is disproportionate with the original formula, because many minor and other molecules might have got extracted differentially. Will it not tamper with the safety profile of the original formula? Piperine, for example, when administered in higher doses may cause ulcer unlike the original formulation. Then, there is the all important question of the toxicity of organic solvent. Even the rare instances of the organic solvent finding its way to the final formula, in whatever trace level, will cause very serious damage to the image of the product.

Strengthening the textual base, innovating in the area of technology and upgrading standardisation methods are other segments deserving appropriate inputs. These predicaments before the contemporary ayurvedic industry are presented for the purpose of highlighting the importance of initiating very serious discussions on the matter. The purpose is definitely not to sound pessimistic before the newly evolving trends of change.

(The author is chief (R&D), Arya Vaidya Sala, Kottakkal.)

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