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Why India needs to regulate Ayurveda to win the world market for natural remedies

If India can put in a proper regulatory system, it stands to gain enormously as a producer and exporter of traditional herbal medicines.

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The ‘Coronil’ controversy last month highlighted the problems with regulating Ayurveda in India. Patanjali claimed to have developed an Ayurvedic medicine that would protect people from Covid-19 and also cure the disease. Later revelations raised doubts about these claims and the process of testing these medicines.

The episode highlighted how modern thinking is creeping into alternative medicine. This is good, and India stands to gain enormously as a producer and exporter of traditional herbal medicines.

The world’s growing fascination with natural remedies, traditional and alternative medicines and herbs augurs well for India. These can provide a substantial source of income for farmers and companies across the country.

Traditional medicines have been used in India, even though there is little quality control or trials. A very small quantity of herbal medicines produced in India is exported, as they do not meet the regulatory standards required by importing countries. While they can be a great source of income and exports for India, we will need a modern regulatory system to succeed.

Even at its current levels, with little exports, estimates are that Ayurveda is a Rs 30,000 crore industry in India.


Also read: Ayurveda, FMCG, Covid, controversy — Baba Ramdev and the Patanjali school of marketing


Promoting alternative medicines

Successive governments have taken steps to promote alternative medicines. In 2003, the government published the first official list of Ayurvedic medicines, called a pharmacopoeia. The publication of a pharmacopoeia is the first step towards formalising any medical system.

In 2014, the Narendra Modi government merged the regulation of Ayurveda, Yoga, Unani, Siddha, and Homoeopathy (collectively called AYUSH) into a separate eponymous ministry.

Recently, the government decided to sell Ayurvedic medicines in Jan Aushadhi stores.

In 2017, the All India Ayurveda Institute was set up in Delhi, on the lines of the famous All India Institute of Medical Sciences. The government is encouraging farmers to grow Ayurvedic plants in various states to diversify agriculture and boost farm income. The budgetary allocation for alternative medicines has doubled since the present government has come to power.

Why Ayurveda needs regulation

The ‘Coronil’ controversy emphasises the role the government has to play beyond encouraging the use of Ayurveda. At the core of promoting alternative medicines are two government regulatory functions: One, ensuring safety, and two, checking the truth of claims about efficacy. In addition to all the other schemes, the government has to emphasise on these two functions.

Contrary to popular belief, Ayurvedic medicines can be dangerous to health. The dangers arise primarily for three reasons: (i) All plants are not safe for consumption, (ii) Use of ashes and non-plant materials, (iii) Illegal addition of allopathic medicines.

Ayurveda uses many plants which are toxic to humans, like datura and nux vomica, in large doses. It is essential that their dosage is limited or the plants are treated before they are included in the medicine.

Similarly, ashes may concentrate dangerous metals in the formulation. As recently as 2017, the Food and Drug Administration of the US warned against the use of certain Ayurvedic medicines. The FDA found the medication to contain dangerous levels of lead. This is not the first time this has happened.

Some unscrupulous medicine manufacturers go a step further. They mix allopathic medicines in Ayurvedic drugs, usually steroids. Some steroids (mostly corticosteroids) give a false sense of well-being by improving circulation and alertness. For the wrong ailments, like infections, they may accelerate the underlying disease, but since the patient gets a steroid highhe or she feels better and ascribes it to the medicine. A study by the King Edward Memorial Hospital in Mumbai found around 40% of Ayurvedic drugs tested contained steroids.

Uncontrolled use of poisonous plants, presence of heavy metals, and outright fraud (adding steroids) damages the reputation of Indian medicine. The unscrupulous and negligent manufacturers make profits by cheating, but harm the status of the entire industry.

The problem is worse in international markets. While we in India may be able to distinguish between established brands and suspicious ones, this is difficult sitting in the US. A patient with a negative experience will probably avoid all Ayurvedic medicines.


Also read: Unethical, unreasonable to ignore Ayurveda for Covid treatment & prevention, say researchers


Two necessary steps

The first step of regulation of medicines is to ensure safety. Irrespective of whether they have any therapeutic effect, an AYUSH medicine should not harm patients. While the government published guidelines for the development and manufacture of Ayurvedic drugs, the enforcement of these provisions is inadequate. Lax enforcement of detailed regulations undermines the efforts made to develop the rules in the first place and encourage a culture of ignoring the law. Even companies which start by complying with the legislation may slowly slip up if they observe systemic non-compliance.

The second step after enforcing safety provisions is checking therapeutic claims. Therapeutic claims are very difficult to establish in allopathic medicines. In alternate medicine, this may be even tougher. Unlike allopathic medicine, the active ingredient is usually not extracted in Ayurveda. This makes Ayurvedic medicines less potent and may take longer timelines to show effectiveness. However, Ayurvedic medicine manufacturers mustn’t make claims about curing conditions or diseases which are demonstrably false. Such false claims have a similar effect to dangerous medicines. Perceptions will develop that false claims dominate the whole field. Even where Ayurvedic medicines have positive outcomes, customers will be sceptical.

Regulation of any medical system has concentrated on safety and efficacy to protect patients. However, another role that governance plays is in developing trust in the system. When confidence in a system erodes, the effectiveness of subsidies, promotional campaigns and other schemes will be limited. Along with the promotion of AYUSH and farming of herbs, if we set up proper regulation of Ayurvedic medicines, we will not merely protect patients, but also promote Ayurveda as a safe and effective system of medicine, a system in which India can be a world leader.


Also read: Modi govt’s love for Ayurveda may be undermining ancient medicinal system


 

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16 COMMENTS

  1. I am a pharmacist, engaged in international business, exporting allopathic products for almost 2 decades ….

    I am quite conversant with the regulatory framework of pharma around the world …. And …. In many ways the framework itself is at odds with Ayurveda …. Let me explain how …. And this is the key to opening a mindset, not just for the world, but also for Indian government regulators who are struggling with this dilemma ….

    Allopathy is based on the platform of single ingredient / substance – action premises … quinine is a purified (extracted / isolated) form of cinchona bark, paracetamol – of Willow bark ….

    Steadily the purification and isolation mindset has progressed into almost madness …. Dextro / Levo purification (not elaborating this here) …. And such so called “progress” has been made … to an extent that now the rage is impurity profiling …. And “unknown-impurity” levels of more than a few minuscule percentages are not acceptable ….. total madness in my personal opinion and having more commercial implications rather than scientific or therapeutic and entry barrier strategies

    On the other hand co-prescription trend has been on the rise, this is a ray of light in the darkness of treating the human body as a mechanical appendage and a pot of known chemical mixture reacting predictably …..

    The insane rush to control side effects is now nearing a dead end …. Purity does not guarantee that , infact it accentuates it , and , the concoction that mixtures of Ayurveda are … tend to have a balance of ingredients that balance lifestyle and need for therapeutic intervention …..The willow and cinchona barks are admixtures of such proportions that has a balancing effect of potent therapeutic parts and seemingly inactive ingredients that tend to control the side effects, or the co-prescription effect that is the trend I was talking about …. Nature has it inbuilt into these potions …. In a manner of speaking

    Ayurveda has refined these remedies with experience, in terms of dilution, doses, shelf life and intervention symptoms

    Now the crux … such multi-ingredient concoctions cannot fit in the regulatory framework of single ingredient mindset that occidental allopathy has enforced …. Which cannot differentiate between heavy metal and chelated process ( bhasm ) and throws the baby out with the bath water ….

    The world beyond this is world of solutions, creative reconciliation and empathy …. The free lunch must end here ….

    • I very much doubt that you studied pharmacy.

      Where in Ayurveda are dilution, doses, shelf life specified?
      How do you know that it has been refined with experience? On what basis did you come to that conclusion?
      How do you know that willow and cinchona have balancing effects? On what basis do you say that these barks are better than the tablets? Where is your proof? Are the 2 barks even mentioned in Ayurveda for malaria? Where?
      In Ayurveda nothing is properly specified. That’s a problem.
      Ayurveda people don’t want regulation because they seem to want to mix steroids and paracetamol, sell for high prices and not get caught.

      Its Ayurveda that needs to fix its mindset, not the world. Otherwise, any one can sell anything as Ayurveda without standardizing. How can a doctor today prescribe anything if he cannot even be sure what it contains? Patient’s life is at stake.

  2. ayurveda and homeopathy withstood the uninformed and prejudiced criticisms of those whose only passport is their ignorance,disturbance in vayu pitta kapha depends on law of karma,these are words of dc das gupta in homeopathic herald 1940 june vol111 no 4under article oedema.homeopaths by look at your face can tell touble say puffiness below eyebrow at upper eyelid kidney some fault is there,you bite nails means under tension or some brain sclerosis,allopaths drain out all money of poor person in tests only nothing left for medicines.there are many vested interests and these holy sciences bearing brunt and tea time laughing stock of modern doctors who get their kins treated secretly from top grade homeopaths of ajit kulkarni lm khan like status..

    • Ayurveda and homeopathy have not withstood any educated criticism.
      That is why they are used only in India where people are ignorant like you.

      Only fools who don’t understand microbiology etc talk about “vayu pitta kapha” and “law of karma”.
      People like you are uneducatable. Only in India can someone this dumb retire as an engineer, nowhere else in the world.

  3. Posting again since I seem to have replied to a post by error.

    40% of Ayurvedic drugs tested contained steroids

    This is a mind-boggling statistic. It says many things.

    It says that Ayurvedic pharma does not believe in its own drugs, obviously!!! The believers are the fools, not the herbal pharma. They are solely in it for the money.

    It says that much of them are quite simply, frauds. To cover it up, they lecture about spirituality. And fools believe all that.

  4. Need major improvement in its scripting. Most of Illa’s videos are unnecessarily lengthy as information in them is repetitive. This could easily have been shorter and snappy video

  5. Have the fdi or usa have ever check how the bhasma(ashes) are prepared and how the toxic mineral and plant products are being purified , also their is prescribed dosage of the medicine.
    Since 10 cent ad the bhasma( ashes) are be purified and used as medicine to make compatibility to gi tract for absorption and non toxic side effects .
    Have any body gone through this ,if not then don’t copy the things what told by USA , when they will sell it we never rise over voice

  6. The entire science of the Western modern medicine is developed without knowing how a human mind and human body works.

    The Western modern medicine is developed for the prime purpose of harvesting huge profit.

    The present world order imposed on humanity by the colonial imperial capitalists is based on money and profit.

    The Western science is about physical things. The physical things are only a physical manifestation of subtle energy.

    The modern science is evidence based and had created a world order of regulations.

    Indian spiritual science is the knowledge of People who had realised God.

    Ayurveda is part of this spiritual science which cannot come under the regulations of the modern medicine.

    The govt of India being under the control of the Western political powers cannot declare Ayurveda as spiritual science.

    What a pity.

    • What nonsense!!!
      The entire science of medical science developed by knowing how human mind works, specifically how people get fooled into thinking that things that don’t work, actually work. That is why there are placebo trials.

      Medicine is very much physical and not spiritual. When quack medicine does not work, it resorts to all trash explanations like spiritual to escape regulation.

      There isn’t a word of truth in anything you wrote.

    • And modern medicine developed without knowing how human body works?
      Seriously man, did you even stop to think for 1 second before just typing?

      The whole of modern medicine is based on knowing how body works, how organs work, how tissues work, how cells work, what reactions happen inside cells and so on.
      It is Ayurveda that is completely ignorant of how body works and instead uses fictional theories that are obviously false.
      They teach modern science in even Ayurveda courses now. Nobody wastes time teaching Ayurveda fiction outside Ayurveda because that would be silly.

      Think before you type!!!!

      If Ayurveda is spiritual, go practice it in a temple and stop calling these quacks doctors and charging medical fee. Call them priests and not professionals. Work for donations, not fees. You can’t have it both ways.

  7. Heartening to know learned, esteemed economist is routing for Indian way. This is precisely lacked in a lot other who give great idea in western template. This have far reaching efforts on lively hoods of crores of farmers and customers alike.

    • 40% of Ayurvedic drugs tested contained steroids

      This is a mind-boggling statistic. It says many things.

      It says that Ayurvedic pharma does not believe in its own drugs, obviously!!! The believers are the fools, not the herbal pharma. They are solely in it for the money.

      It says that much of them are quite simply, frauds. To cover it up, they lecture about spirituality. And fools believe all that.

  8. Very good article. But India need to focus on rejuvenation of Western ghats in kerala, karnataka and maharashtra and Himalayas…because most of herbs grow naturally in these forests and efficacy of herbs are more when they are taken from forests…Ayurveda is a very big industry if modernized only to effect required.. Government’s focus is needed to revive the forests and organic agricultural practices also help in preventing diseases..

  9. Sensible article. If we subject traditional practices to the rigorous cycle of experiment-observation-inference – a lot of claims of efficacy fall by the wayside. There was very little understanding of germs causing diseases more than two centuries ago, so systems of medicines based on theories before that are unlikely to get it right.
    Ivesting in research on herbal, low cost and easily accessible remedies is the right thing to do. What is more important to do though is to first accept that we should be ready to reject any form of treatment that contradicts science based medicine. That does away with the distinction between “allopathic” and “alternative ” medicine.
    As the saying goes, “Keep an open mind, but not so open that the brain falls off “

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