Ayurveda is at a kind of crossroads. In taking the bridge to modernity, the Ayurvedic community has faced a thorny dilemma. How exactly do you transition? One of the conceptual struggles relates to pharmacology: the actual medical substances to be used and their form and dosage. Ayurvedic "new" medicines fill our store shelves, but how should they be accounted for? Are they backed by research? What are the terms of that investigation? Are they really "Ayurvedic" in the sense of following the essential principles? It is not a black and white question, one that should elicit instant judgment on both sides; the dilemmas are profound.
Take two competing nuances, both inherently valid. One, even when there is a call for rigorous scientific data to support Ayurvedic formulations, all meticulously documented, as in the case of modern medicines, researchers in the Ayurvedic pharmaceutical industry do not believe that all new formulations in Ayurveda can be strictly included in the scope of said methodology. Because the very nature of the empiricism involved here is different. At the same time, opinion is also divided on whether all the new Ayurvedic medicines actually satisfy an Ayurvedic foundation.
Now, classic formulations continue to be the mainstay of Ayurvedic treatments; Doctors consider new drugs to be supportive care. But new formulations are emerging from various pharmaceutical companies like never before, calling for newer, perhaps even better, formulas as is the case with modern medicines, or rather, in the form of fast moving consumer goods (FMCG)! How do you deal with this? First we have to understand the old.
Classical ayurveda
"The composition of classical drugs used in Ayurveda treatments has not changed for more than 3,000 years," says Dr. S. Gopakumar, Director, Roganidana (Etiology), Government Ayurveda Medical College (GAMC), Thiruvananthapuram. "Although many things in our daily use, our ideas and concepts become obsolete in our life, the classic drugs have withstood the test of time."
This is different from how modern medicine works. Many modern medicines used today are the result of constant improvements in previous formulations; sometimes they don't even look like the original molecule in many ways. The first antibiotic, penicillin, is an example. Its derivatives are very far from the original. But classical Ayurvedic formulations, such as the widely used Triphala or, say, Amritothari kashayam or Dasamularishtam, have prevailed for millennia without undergoing any change in composition. The fact that these formulations are still being elaborated as written in ancient texts shows the nature of their complete and almost eternal value, says Dr. Gopakumar. Classic drugs have outlived all the technological advances made by mankind, he says.
Actually, a handful of ayurvedic products online is enough to control a wide range of diseases, says Dr. K. Murali, Editor-in-Chief, Publications Division, Kottakkal Arya Vaidya Sala. Even assuming a wide range of medical formulations, a physician would not need more than 25-30 formulations, says Dr. Murali, who is also former GAMC superintendent Tripunithura.
Dr. Remya Krishnan, Associate Professor, Ayurvedic Clinical Pharmacology, Rajiv Gandhi Medical College of Ayurveda, Mahe, agrees. He admits it may sound incredible, but he says that all the diseases in the world could be treated with about 15 classic formulas.
The Sarangdhara Samhita, known as the pharmaceutical treatise describing 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, in addition to the Brihatrayee (The Greater Trio) —Charaka Samhita, Sushruta Samhita, and Ashtanga Hridaya / Sangraha de Vagbhatacharya — which provide the basis for the Ayurveda system.
In addition to these texts, there are also quite a few regional texts that provide formulas for classical drug compositions. Sahasrayogam is an important compendium of over a thousand medicines from the Kerala tradition, popular throughout South India. The formulations have also been picked up by many doctors and pharmacologists in the North.
The modern dilemma, in the first place, is related to this. With thousands of Ayurvedic formulations mentioned in these various texts, there are quite a few practitioners wondering if there is a need for new medications from where anyone can buy ayurvedic products online. The debate in the community is whether such innovation is the way forward for Ayurveda in its encounter with modernity. However, Ayurvedic pharmaceutical companies have introduced more than 500 to 600 new drugs. How do you fit them into the canon, if at all?
Proprietary Medicines
Now, any modification of the classic medication is considered a proprietary drug. Dr Sarala Karalam, Pharmaceutical Industrial Researcher at Vaidyaratnam Oushadhasala, Ollur, Kerala, says that even classical medicines that have been changed only in dose / form are called proprietary.
One of the main problems that people have faced in the modern era while taking Ayurvedic treatment is consuming classical medicines in the prescribed form / dosage as mentioned in the text. This is where proprietary drugs have won out, says Dr. P. Rammanohar, Research Director at the Amrita Advanced Center for Ayurveda Research. So the kashayams / kwath / kaada have been made into tablets, the lehyams have been made into granules, and the thailams (oils) have been made into capsules. Compared to their previous forms, these sparked a revolution that helped Ayurveda return to the field of public health, says Dr. Rammanohar.
Illustrating how a classic medicine could be converted to a proprietary dose, Dr. Karalam says that Nagaradilepa choornam, a classic medicine, if made in the form of a hydrogel, would constitute a new dose, allowing it to become a proprietary medicine. If the classic Amritothari kashayam, used to control fever, is modified into a suppository, it is a new drug delivery system. So again, owner. Only the change in presentation of a classic drug formulation, in an easy-to-use dosage form, makes it a new entity, owned by a pharmaceutical company.
Drugs that remain within the limits of their classical origin have also become patented drugs of the generic category, which have been standardized over the years. These are manufactured by most of the pharmaceutical companies as their mainstay. There are about 55 books that list the classical drugs of Ayurveda under the Drug and Cosmetics Act of 1940, Schedule 1, according to the Ayurvedic Pharmacopoeia of India. Different pharmaceutical companies that manufacture any drug on the list in their own drug delivery form could be considered property of the generic category including buy ayurvedic hair oil. Like paracetamol itself, it can be marketed through countless brand names.
For all that, Ayurveda is not a fixed canon. It allows the formulation of new drugs. New drugs had also evolved before and become popular locally, but their number was very small. However, it is the consumer-friendly approach to dose management that has brought a host of new drugs.
There is an interesting aspect to Ayurveda's inner capacity for innovation. Some medications that have emerged through the clinical experience of physicians have shown good results, says Dr. Rammanohar. That's because, as Dr. Karalam points out, the wisdom of experience is very important in Ayurvedic drug development. Instead of the drugs going from the lab to the clinic, it's the other way around. The rationale for new drug development here comes from clinical experience and is then tested in the lab for results.
Neo-Ayurveda?
The design of new drug delivery systems may have generated a revolution in the market, but it also brought a new paradigm to Ayurveda itself. New drugs had emerged that have no reference in classical texts. Many Ayurvedic doctors have a hard time deciding whether these new drugs, classified as proprietary and patented (P&P) drugs, are reliable enough to include in their prescriptions. Because, new innovations in medicines must at least be in sync with the basic Ayurvedic foundation. They? That partly explains why these drugs are still given only a supporting role, if any. The main line of treatment is provided by classic drugs, says Dr. Rammanohar.
Dr. Pavana J., a specialist at the District Ayurveda Hospital, Kollam, and a great devotee of classical drugs, agrees. She says that she prescribes P&P medications, but only for support in certain limited cases. She also cautions that patients should not buy them without a prescription, as many of these contain traditional pharmacological elements that come with restrictions and should not be taken beyond a stipulated period.
Harilal Madhavan, a faculty member of the Indian Institute of Education and Scientific Research, Thiruvananthapuram, describes this new mutation in Ayurveda as a "reformulative" regimen. Dr. Madhavan, a development economist who specializes in indigenous Asian medicine, health and pharmaceutical policy, says that "reformulating" simply means turning the classic formulation around. It could mean removing one ingredient or replacing one ingredient, adding another, or increasing or decreasing the amount of either, thus producing a “new” formula over which the company can have a proprietary right.
Although these formulations for ayurvedic handwash are classified as proprietary and proprietary drugs, they are not actually proprietary per se, says Dr. Madhavan. These drugs only require marketing authenticity and that requires a license from the Drug Enforcement authorities. Therefore, they are marketed under the label "Ayurvedic Proprietary Medicine".
Compared to obtaining a real patent, with the three necessary phases of clinical trials, it is much easier to get a license for these drugs, he says. Instead of rigorous scientific data to support a patent, companies must establish just one justification for the combination and follow certain procedures, adds Dr. Madhavan. But it generates a kind of public credulity. Ayurvedic drug manufacturers, especially those with large-scale production, sourcing new products on store shelves is itself seen as an indicator of their growth towards modernity, with proper research techniques. Even most Kerala companies are happy with this "reformulating" regime, which can create a brand without having to search for actual patents, says Dr. Madhavan.
Of the 700 units in Kerala, there are only 19 companies that are engaged in large-scale production, most of the others belong to the small-scale sector. According to the rules, all companies must follow good manufacturing practices (GMP). Although complying with GMP is not really a guarantee of quality in all respects, perhaps it could contribute to some minimal qualities of the process.
Atomistic science
A new trend in Ayurvedic medicine manufacturing is to isolate different active alkaloids from a plant and classify them under the Ayurveda label. Dr. Karalam, who spent 20 years at Oushadhi, Kerala Ltd Pharmaceutical (Indian Medicine) Corporation, and had been part of the development and modification of 28 medicines, says that Ayurveda methodology is fundamentally different from that. Take a plant or part of a plant as a whole, not just 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 to make kashayams according to ancient principles to create water-soluble drugs. What is the state of curcumin? Is it soluble in water? "She asks. Also, the way a plant's active ingredient in a polyherbal preparation works could be different from how it might behave when isolated, she adds.
Outside of Kerala, various companies are involved in the manufacture of Ayurvedic medicines like ayurvedic mosquito coils that appear to be based on biomolecules, in the Western way, and backed by various research articles, says Dr. Madhavan. These companies make medicines with the Ayurvedic proprietary drug label in the same way that modern medicine is made, and they cater to a section of consumers looking for 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 Professor Madhulika Bannerjee of the University of Delhi, who has written extensively on Ayurveda, Dr. Madhavan says, "Modernization of Ayurveda should not be confused with modernization of its products."
Kerala remains an outlier. “Despite this growth parameter, Kerala has a different image compared to the rest of the country. look at this website Here most of the companies still produce more generic drugs and there hasn't been much innovation by making new drugs, apart from the reformulative approach, "he says. This is probably why Kerala continues to claim some authenticity in the Ayurveda system, he adds, "for being a service-oriented market and not just a product market."
(The writer is a Kochi-based freelance journalist and has covered The Hindu's health for 20 years. This report was funded by a grant from the Thakur Family Foundation. The foundation did not exercise any editorial control over the content of this report. This report is the first in a series of four articles that will cover various aspects of Ayurveda).