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Despite intensive research, depression research scientists still do not know the cause or causes of depression. Some people are born with chemical imbalance that causes mental frustrations and often times leads to depression. Several of these studies conclude with positive findings, leaving ellipses of expectations. This dramatic statistic summarises the paradoxical state of Ayurvedic drugs in the medical world today. To understand the problem, it helps to first understand the scale of effort and investment necessary to develop a single new modern drug.
If some research findings are too disconnected and conflicting, other research is of poor quality. One set of scientists argues that a rabid nationalistic fervour for everything Indian has made Ayurvedic practitioners regard the classical texts as the last word, insisting that modern scientific endorsement is not important for them. Another set of scientists points the finger the other way, claiming it is Western science that is arrogant and has not tried hard enough to accommodate Ayurveda. One of the reasons why research into Ayurveda is so underdeveloped is that there has always been an alternative—the herbal route. The Drug Controller General of India (DCGI) allows firms to manufacture and sell Ayurvedic medicines as long as they are described in the ancient texts. Liv.52 today has a 47 per cent market share in liver drugs in India, garnering annual revenue of Rs 167 crore. Three of the gastroenterologists (who typically treat liver diseases) I spoke to for this story said they would never prescribe Liv.52, except as a placebo. No treatment is needed here, unless symptoms such as nausea or fever develop, in which case, the doctor prescribes drugs for these symptoms.
Ironically, The Himalaya Drug Company is known as one of the few Ayurvedic drug firms in India that undertakes clinical research. Despite the impeccable reputation of the journal it was published in, the study comes with a few caveats.
But is it even possible for Ayurveda-based drugs to meet the requirements of modern medicine? What this handful of examples proves is that ancient Ayurvedic doctors had put together a virtual treasure trove of medicines thousands of years ago without access to modern scientific methods. To understand the bias that scientists such as Vaidya talk about, the process of developing Ayurveda-based drugs needs some elucidation.
Till 2004, the US Food and Drug Administration (FDA) did not have guidelines for testing herbal extracts as drugs, making it impossible for herbals to meet the same stringent regulatory requirements that synthetic drugs needed to clear. Moreover, Ayurvedic drugs rely on the concept of synergy, which means single compounds may not work well enough alone. Such unorthodox mechanisms of action made Ayurvedic drugs opaque to modern medicine for a long time.
Comparing the drug with a placebo is important because many patients recover from illnesses without any treatment. The first hurdle is that any Ayurvedic herb comes in several varieties—some of high quality and some of little use.
Meanwhile, synthetic ways to make Artemisinin gave low yields, making them a poor alternative. Given the difficulties of developing Ayurvedic drugs, their best hope is the interest of large pharmaceutical firms with the competence and funds to develop them. While creating such complicated deterrents to drug research, India has not created any incentives.
In 2003, India did make an attempt in this direction with an ambitious programme to foster innovation. In sharp contrast, China has made major strides in promoting Traditional Chinese Medicine (TCM) research, despite being up against the same problems. According to Ikhlas Khan, who heads the Mississippi-based Centre for Research into Indian Systems of Medicine (CRISM) that collaborates with US regulatory bodies to promote scientific acceptance of Indian medicine, “Modernisation of TCM is a national priority in China and is backed by financial support from [their] Government. In March 2008, the US Pharmacopeial Convention, a non-profit American body that works with the government, entered an agreement with the Chinese Pharmacopoeia Commission to improve the quality of traditional Chinese medicine. In 2009, Chinese Universities developed a natural extract database in collaboration with Harvard University, which painstakingly adheres to high standards of quality for herbs, explicitly to resolve the problem of variability in herb samples for clinical trials.
A civic leadership incubator programme in Bangalore attempts to teach future political leaders skills of governance.
Modern diseases such as asthma, diabetes and Alzheimer’s are linked to changes in the hundred trillion odd microbes residing in our bodies.
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It affects the way you feel about things and situations, and you feel about yourself, the way you eat and sleep, the way your memory is working. It may be manifested in varying degrees; from feeling of slight sadness to utter misery and dejection. Method : Join the tips of the index finger and thumb and keep the other 3 fingers stretched and joined.
That is the number of research papers and studies on the herb Ashwagandha in the online database of medical literature known as Pubmed. The range of medical conditions for which Ashwagandha is being investigated today is dazzling—among them cancer, protection against chemotherapy, memory impairment, skin pigmentation, stress, sore throat, depression, tooth decay, tuberculosis and hormonal disorders. Reams upon reams of research exists, much of it dramatic and worded most optimistically, but they are not taken seriously by modern medicine. Firms that sell over-the-counter Ayurvedic drugs can buy positive research results for a price, says Sanyasi Kalidindi, the founder of US-based Ayurvedic drug research firm Natreon. Like the seven blind men and the elephant in the Indian parable, every scientist has a different perspective. Also, the jingoistic zeal has led to looser regulations for Ayurveda, which has seriously harmed the credibility of this ancient form of medicine. It is harder to develop a drug from Ayurveda than it is to build a synthetic molecule, because of the large number of compounds in each Ayurvedic herb. Unlike modern drugs, DCGI does not require Ayurvedic medicines to show clinical-trial data proving they are safe and effective. This liver tonic is a combination of six herbs and a bhasma, a preparation in which a metal (iron in this case) is treated according to a process defined in Ayurvedic texts.
Such a market share would not be attainable if consumers of modern medicine were not also taking Liv.52. This study found that the drug was able to clear the virus effectively in patients of chronic liver disease. The key question is: do these herbal drugs offer the same proof of efficacy that modern drugs do? Reserpine had harsh side effects and was eventually replaced by better blood-pressure drugs, but it is still in occasional use.
While these drugs were developed outside India, scientists from the Central Drug Research Institute, an Indian government organisation, developed cholesterol-lowering drug Guggulipid from the herb Guggul in 1986. Such medicines tend to go the dietary-supplement route, which means modern medicine practitioners cannot prescribe them.
The medicine itself, such as Chyawanprash, is a mixture of several herbs, increasing complexity by an order of magnitude. Today, though, the FDA does not require a single active ingredient to be isolated from a herb for it to become a drug.
Traditional Chinese Medicine preparations outnumber Indian preparations in the herbal drug applications with the FDA.
A drug developer must prove that it is the drug that caused the cure and not the body’s own recovery mechanism.
It turns out that even though modern science accepts such drugs, the challenges are no less formidable. Next, it must be standardised, which means ensuring the presence of the active compounds in it. For many such drugs, their makers have had to rely on the availability of the actual plant through agriculture. But according to Ram Vishwakarma, many steps taken by the Indian government have repelled such interest. This act restricts access to Indian plants for research and drug development, leaving pharmaceutical firms in India and abroad up in arms about it.
It was called the National Millennium Indian Technology Leadership Initiative, under which several grants were given to research organisations to develop herbal drugs. While this applies mostly to supplements, such attempts at standardising quality can only help TCM. Comparing China’s effort with programmes driven by the Indian government, Vishwakar- ma says our approach is simply not widespread enough. Depression is a very unpleasant malady and is far more difficult to cope with than a physical crisis, as well as the mental stress and strain of day-to-day life, usually leads to this disorder.
Herbal extracts of Ashwagandha proliferate in the market, but no self-respecting psychiatrist would prescribe any of them for anxiety, one of the claimed indications for Ashwagandha.
Unlike in the case of a synthetic drug developed by a pharmaceutical firm, where all clinical research protocol is adhered to strictly, chaos reigns in the Ayurvedic drug sector. The logic of this sanction is that centuries of use has already made the case for these medicines. Indeed, according to Pralhad Patki, Himalaya’s head of research, many allopathic doctors prescribe it. Except in chronic cases, the virus causing hepatitis is usually self-limiting, meaning the patient’s body fights it away and a spontaneous recovery occurs in a couple of months in 99 per cent of cases.


Quinine, the frontline treatment for malaria in the 1940s, was first isolated from the bark of the Cinchona tree in 1820 by two French researchers. Each time you synthesise a pure compound, you can be sure it is the same drug, with the same predictable effects. The best proven example of synergy is Trikatu—a mix of three peppers prescribed to improve digestion in Ayurveda. In 2010, Dansheng Dripping Pill, a traditional Chinese medicine, became the first herbal drug since Veregen to enter Phase 3 clinical trials.
Plus, the drug must show that it is at least as effective as the standard treatment already in use. Developing a single-compound drug from Ayurveda is a bit like finding a needle in a haystack.
Second, the herb that grows in summer is different from the one that grows in winter, which is different from the one that grows in monsoon. It is only when the right herbs have been found after crossing these many impediments that the drug developer begins to look for the needle—the compound in the herb that really works.
The price of the antimalarial Artemisinin, which is widely used to treat malaria in Sub-Saharan countries, fluctuated wildly in the 2000s due to short supply.
We are struggling to find out whether we are conforming with the law,” says Swati Piramal, the vice-chairperson of Piramal Enterprises, one of the few Indian firms researching traditional-medicine leads for new drugs. Thousands of other herbs and formulations are in similar stasis—they enjoy immense popularity and a Rs 8,000 crore market among Indians, but modern medicine rejects many of them.
If so, what is one to make of the thousands of ‘scientific’ studies arguing for Ayurvedic drugs?
After ten years of drug development, a drug may enter the late stage of testing, known as phase 3 trials, and fail to prove its efficacy.
The law has allowed a market for herbal medicines to flourish, promoting firms like The Himalaya Drug Company and Dabur.
To claim a cure for hepatitis, a modern drug would require more data than Himalaya currently provides for Liv.52 HB. This is what Ciba-Geigy scientists did when they isolated Reserpine from Charaka’s Sarpagandha. More accurately, it is like finding a needle in many haystacks, because a drug maker is trying to find this compound in a mixture of many herbs.
Third, it is possible that the herbs available millenniums ago, when the ancient Ayurvedic texts were written, do not even exist anymore or have mutated. To get to Guggulipid, CDRI scientists had to pare away several other compounds that were merely co-passengers on the bus. They have all hit roadblocks either during research or before being launched in the market.
We should be doing 500 trials at a time, not one or two,” he argues, reasoning that the failure rate is high for clinical trials. You need the help of specialists, and then you can start and have to start helping yourself. To put it another way, Ayurvedic medicines have barely got their foot in the door of mainstream modern medicine, and to many researchers in the field, this situation is a colossal disappointment. But on the downside, the thousands of formulations being sold in the market have never undergone modern scientific testing. A remarkable success story is that of the blood-pressure lowering drug Reserpine, which was isolated from Rauwolfia Serpentina or the Indian snakeroot by Ciba-Geigy scientists in the 1950s. It is also what scientists at the Central Drug Research Institute did when they isolated Guggulipid from the Guggul herb during Nityaanand’s tenure. The NBA can also impose and collect some kind of fee or tax for the use of the nation’s biological resources. A herbal psoriasis drug by Lupin was said to be in Phase 2B clinical trials in 2009, after which there has been no news of it. Whether these tests would validate the claims made by the ancient texts is anybody’s guess. Sage Charaka had documented the snakeroot or Sarpagandha in his very ancient text, Charaka Samhita.
At least four other drugs developed for conditions ranging from diabetes to arthritis by a network of Indian research organisations and hospitals reached late stage trials.
But negotiations between CSIR and drug developers to commercialise these drugs have made little leeway, says Bhushan Patwardhan, who steered several of the Millennium Initiative’s herbal drug-development programmes.



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