Ayurveda is at a crossroads of sorts. In taking the bridge to modernity, the Ayurvedic community has gifted itself a thorny dilemma. How exactly to make the transition? One of the conceptual struggles relates to pharmacology: the actual medical substances to be used, and their form and dosage. ‘New’ Ayurvedic medicines fill our shop shelves, but how are they to be accounted for? Are they research-backed? What are the terms of such research? Are they truly ‘Ayurvedic’ in the sense of following the essential tenets? It’s not a black-and-white question, one that should provoke instant judgement on either side; the dilemmas run deep.
Take two partly competing nuances, both inherently valid. One, even when there is a call for having rigorous scientific data to back Ayurvedic formulations—all meticulously documented, as in the case of modern medicines — researchers in the Ayurvedic pharmaceutical industry do not believe all new formulations in Ayurveda could be strictly brought under the purview of such a methodology. For, the very nature of empiricism involved here is different. At the same time, opinion is also divided on whether all new Ayurvedic medicines actually satisfy an Ayurvedic rationale.
Now, classical formulations continue to be the mainstay in Ayurvedic treatments; new medicines are seen by practitioners as supportive care. But new formulations are emerging from various pharmaceutical companies like never before—claiming newer, perhaps even better formulas, as happens with modern medicines, or rather, in the manner of fast-moving consumer goods (FMCG)! How does one deal with this? We need to get a grasp on the old first.
“The composition of classical drugs used in Ayurveda treatments has not changed for over 3,000 years,” says Dr S. Gopakumar, head, Roganidana (Aetiology), Government Ayurveda Medical College (GAMC), Thiruvananthapuram. “Even though many things in our daily use, our ideas and concepts get outdated in our lifetime, classical drugs have stood the test of time.”
This is different from how modern medicine works. Many modern medicines used today are the result of constant improvements on earlier formulations; sometimes they do not even resemble the original molecule in many aspects. The first antibiotic, Penicillin, is an example. Its derivatives are far removed from the original. But classical Ayurvedic formulations — like the widely used Triphala or, say, Amritothari kashayam or Dasamularishtam — have been in prevalence over millennia without undergoing any change in composition. The fact that these formulations continue to be made as written in the ancient texts show the nature of their complete, near-eternal value, says Dr Gopakumar. Classical drugs have outlived all the technological advances made by mankind, he says.
Actually, a handful of classical medications are enough to manage a wide range of diseases, says Dr K. Murali, chief editor, Publication Division, Kottakkal Arya Vaidya Sala. Even presuming an exalted range of medical formulations, a practitioner would require not more than 25-30 formulations, says Dr Murali, who’s also the former superintendent of GAMC, Tripunithura.
Dr Remya Krishnan, associate professor, Ayurvedic Clinical Pharmacology, Rajiv Gandhi Ayurveda Medical College, Mahe, agrees. She concedes that it may sound unbelievable, but says all diseases in the world could be handled with just about 15 classical formulations.
The Sarangdhara Samhita, known as the pharmaceutical treatise which describes the making of classical formulations, is part of the Laghutrayee (The Lesser Trio) that also includes Madhava Nidana and Bhavaprakasa. These texts are of course besides the Brihatrayee (The Greater Trio)—Charaka Samhita, Sushruta Samhita and Vagbhatacharya’s Ashtanga Hridaya/Sangraha—which provide the foundation for the Ayurveda system.
Besides these texts, there are quite a few regional texts too that provide formulae for classical drug compositions. Sahasrayogam is an important compendium of over a thousand drugs from the Kerala tradition, popular across South India. The formulations have been picked up by many practitioners and pharmacologists in the North too.
The modern dilemma, firstly, relates to this. With thousands of Ayurvedic formulations mentioned across these various texts, there are quite a few practitioners who wonder whether there is a need at all for new drugs. The debate in the community is whether such innovation is the way forward for Ayurveda in its tryst with modernity. That notwithstanding, Ayurvedic pharmaceutical companies have come out with over 500-600 new medicines. How to fit them into the canon, if at all?
Now, any modification to classical medication is considered a proprietary drug. Dr Sarala Karalam, pharmaceutical industrial researcher at Vaidyaratnam Oushadhasala, Ollur, Kerala, says even classical medicines that have been changed only in the dosage/form are called proprietary.
One of the major problems people have faced in the modern age while taking Ayurvedic treatment is consuming classical medicines in the prescribed form/dosage as mentioned in the text. This is where the proprietary medicines have gained, says Dr P. Rammanohar, director, Research, Amrita Advanced Centre for Ayurveda Research. So, the kashayams/kwath/kaada have become tablets, lehyams have become granules, and thailams (oils) have become capsules. Compared to their earlier forms, these set off a revolution that helped Ayurveda make a comeback into the court of public health, says Dr Rammanohar.
Illustrating how a classical medication could be converted into a proprietary dosage, Dr Karalam says Nagaradilepa choornam, a classical drug, if made into a hydrogel form, would constitute a new dosage, enabling it to become a proprietary drug. If the classical Amritothari kashayam, used in managing fevers, is modified into a suppository, it is a new drug delivery system. Hence, again, proprietary. Just the change in the presentation of a classical drug formulation, in a user-friendly dosage form, makes it a new entity — owned by a pharmaceutical company.
The medicines that remain within the precincts of their classical origin too have become proprietary medicines of the generic category, which have been standardised over the years. These are made by most pharmaceutical companies as their mainstay. There are about 55 books listing the classical drugs of Ayurveda under the Drugs and Cosmetic Act 1940, Schedule 1, as per the Ayurvedic Pharmacopoeia of India. Different pharmaceutical companies making any drug from the list in their own drug delivery form could be considered proprietary of the generic category. Just like the same paracetamol molecule can be marketed through innumerable brands.
For all that, Ayurveda is not a fixed canon. It does allow new drug formulation. New medicines had evolved earlier too and entered popular usage locally, but their numbers were very small. It’s the consumer-friendly approach towards dosage delivery, however, that has brought in a whole plethora of new medicines.
There’s an interesting aspect to Ayurveda’s inner capacity for innovation. Some drugs that have come up through physicians’ clinical experience have shown good results, Dr Rammanohar says. That’s because, as Dr Karalam points out, experiential wisdom matters a lot in drug development in Ayurveda. Instead of drugs going from laboratory to clinic, it’s the other way round. The rationale for new drug development here comes from clinical experience and is then tested in the laboratory for results.
Designing new drug delivery systems may have bred a market revolution, but it also brought a new paradigm into Ayurveda itself. New medicines had emerged that do not have any reference in the classical texts at all. Quite a few Ayurvedic practitioners have a hard time deciding whether these new medications, categorised as Patent and Proprietary (P&P) drugs, are trustworthy enough to be included in their prescriptions. For, new drug innovations must at least sync with the basic Ayurvedic rationale. Do they? That partly explains why such drugs are still accorded only a supporting role, if any. The main treatment line is provided by the classical drugs, affirms Dr Rammanohar.
Dr Pavana J., the specialist at District Ayurveda Hospital, Kollam, and a strong votary of classical drugs, agrees. She says she does prescribe P&P medicines, but only in a supportive role in certain limited cases. She also warns that patients should not be buying them over the counter as many of these contain traditional pharmacological elements that come with restrictions and should not be taken beyond a stipulated period.
Harilal Madhavan, faculty member of, Indian Institute of Scientific Education and Research, Thiruvananthapuram, describes this new mutation in Ayurveda as a “reformulatory” regime. A development economist who specialises in Asian Indigenous Medicine, Health and Pharmaceutical policies, Dr Madhavan says “reformulation” means merely giving the classical formulation a twist. It could mean taking out one ingredient or replacing an ingredient, adding another, or increasing or decreasing the quantity of any, thus yielding a “new” formulation on which the company can have a proprietary claim.
Though these formulations are categorised as Patent and Proprietary drugs, these are not actually patented per se, says Dr Madhavan. These drugs require only marketing authenticity and that needs licencing by the Drug Control authorities. Hence, they are marketed under the label “Ayurvedic proprietary medicine”.
Compared to getting an actual patent, with the requisite three phases of clinical trials, it is much easier to get a licence for these drugs, he says. Instead of rigorous scientific data to back a patent, the companies need to establish only a rationale of the combination and follow certain procedures, adds Dr Madhavan. But it breeds a kind of public credulity. Ayurvedic drug manufacturers, especially those with large-scale production, getting new products on the shop shelf is by itself looked upon as an indicator of their growth into modernity, with proper research techniques. Even most companies in Kerala are happy with this “reformulatory” regime, which can create a brand without going in for actual patents, says Dr Madhavan.
Of the 700-odd units in Kerala, there are only 19 firms which are into large-scale production, most others come under the small-scale sector. As per the rules, all companies must follow good manufacturing practices (GMP). Though abiding by GMP is not really a surety for quality on all counts, it could perhaps make for some minimal process qualities.
A new trend in Ayurveda drug manufacturing is to isolate different active alkaloids from a plant and categorise it under the Ayurveda label. Dr Karalam, who spent 20 years at Oushadhi, the Pharmaceutical Corporation (Indian Medicine) Kerala Ltd, and had been part of developing and modifying 28 drugs, says the Ayurveda methodology is fundamentally different from that. It takes a plant or plant part as a whole, not merely its active ingredient. “In Ayurveda, we consider turmeric as a whole, not curcumin. Curcumin may be the active ingredient in turmeric, but turmeric as a whole is used in making kashayams according to the ancient principles for creating water-soluble medicines. What is the status of curcumin? Is it water-soluble?” she asks. Besides, how a plant’s active ingredient acts in a polyherbal preparation could be different from how it could behave when isolated, she adds.
Outside Kerala, several companies are involved in making Ayurvedic medicines that seem to be based on biomolecules, in the Western way, and backed up by several research papers, says Dr Madhavan. These companies manufacture medicines under the Ayurvedic proprietary drug label the same way that modern medicine is manufactured, catering to a section of consumers who are looking at the scientific value of the products, he adds. “A scientific research base is created to satisfy a particular section that may not be a legal entity at all.” Quoting Prof Madhulika Bannerjee of Delhi University, who has written extensively on Ayurveda, Dr Madhavan says: “Modernisation of Ayurveda should not be confused with the modernisation of its products.”
Kerala is still an outlier. “Despite such a parameter for growth, Kerala has a different image compared to the rest of the country. Here most firms still produce more generic drugs and not much of innovation has taken place by way of new drug-making, apart from the reformulatory approach,” he says. This is probably why Kerala continues to claim a bit of authenticity in the Ayurveda system, he adds, “for being a service-oriented market and not just a product market”.
(The writer is an independent journalist based in Kochi, and covered health for The Hindu for 20 years. This report was supported by a grant from the Thakur Family Foundation. The foundation did not exercise any editorial control over the contents of this report. This is the first of a series of four articles that will cover various aspects of Ayurveda.)