Ayurveda: Regulation of this alternate system of medicine is urgently needed on many fronts; here is why

Ayurveda’s popularity has arisen since the pandemic; but many still equate ‘natural’ and ‘traditional’ with ‘safe’ and ‘effective’

Sushmita (name changed) has been living with Type 2 diabetes mellitus for the past decade and hyperthyroidism for the past eight years now. To lead a normal life, she consumes Galvus, Gluconorm and Thyroxine for these ailments on a daily basis as prescribed by her physician. She follows a strict diet of only homemade food and barely eats outside. At 55 years of age, she is compelled to follow a watchful, healthy lifestyle.

General word-of-mouth introduced her to jamun seed powder, an Ayurvedic treatment which claims to keep blood sugar levels under control. So, she went to a nearby pharmacy in Kolkata, where she lives. But the Ayurvedic practitioner there suggested an even better option — Ayusulin, a ‘herbal’ treatment also meant to control diabetes.

She consumed Ayusulin twice a day, morning and evening, for two months alongside her prescribed medication until she began presenting symptoms of jaundice. Her eyes were becoming yellow, she was blacking out in the morning, feeling extreme weakness, dizziness, and losing her appetite.

“By the time it was three months since she had been taking Ayuslin, she was completely senseless,” her daughter (who wishes to remain anonymous) told Down To Earth (DTE). Sushmita was taken to AMRI Hospital in Kolkata where the doctor declared her chances of survival are dangerously low.

Due to concerns about the quality of treatment, Sushmita was shifted to Apollo Hospital, Chennai. Extensive tests were conducted, the results of which prompted the doctor to ask her daughter whether Sushmita is a drug addict.

Bilirubin is a yellowish pigment substance in the bile — a fluid produced by the liver — which forms after red blood cells break down. It is used as an indicator for jaundice.

Typically, an adult has a total serum bilirubin level of approximately 1.2 milligrams per decilitre (mg/dL) in the blood. Significant or clinical jaundice is when levels go above 3 mg/dL in the blood. Sushmita’s was hovering around 24-26 mg/dL.

“She was eventually diagnosed with acute-on-chronic liver failure. The doctors were adamant she needs a transplant,” her daughter said. She was put under a plasma exchange treatment, costing almost Rs 1.5 lakh per day. Sushmita’s ordeal lasted a total of three months where she was in and out of hospitals, racking up a bill of almost Rs 40 lakh.

Using the diagnosis of exclusion and results of their own tests, Sushmita’s doctors argued Ayusulin was killing the liver. But that isn’t exactly news.

Among Ayusulin’s many ingredients is a herb called gymnema sylvestre found in central and southern India, tropical Africa and tropical Australia. A December 2010 paper published in The American Journal of the Medical Sciences illustrated a case study where consumption of gymnema sylvestre led to drug-induced liver injury.

In conclusion, the paper notes: “This case highlights a major problem related to CAM (complementary and alternative medicine), which is considered by most patients to be safer than conventional drugs because it is based on ‘natural substances,’ resulting in low disclosure among the patients and requires the providers to ask specifically for herbs to be able to recognise potential adverse effects. Furthermore, these products often contain multiple active ingredients in unknown amounts; hence, their labelling and safety are often lacking, and their chemical composition is only partially known.”

The assumption that Ayurvedic drugs are safer than modern medicine because they are natural is among its many misconceptions. For the longest time, Sushmita was of the same opinion. Her daughter said people who are not doctors obviously think Ayurveda is natural. They believe the research is honest and that steroids play no role here.

Dr Saptarshi Bishnu, a Chennai-based hepatologist (liver expert) and Sushmita’s treating physician, has heard this reasoning from many of his patients.

“They often equate natural with non-toxic or non-lethal. They believe if it isn’t effective, at least it won’t cause any harm,” he told DTE. Clearly, that isn’t true.

Dr Bishnu treats at least one-two new patients — who have consumed Ayurvedic medicines — of liver injury every week. This trend has only increased since the COVID-19 pandemic which triggered unprecedented interest in ‘immunity boosters’ as a protective measure.

‘Ayurvedic drugs well documented causes for severe liver, kidney injury’

Ayurvedic herbals and supplements are well documented causes for severe liver and kidney injury, sometimes leading to death or organ transplantation.

“These are avoidable health burdens because the use of Ayurveda as healthcare is not mainstream and has no validated benefits and not endorsed by any medical clinical societies worldwide,” Dr Abby Philips, a senior consultant at the liver institute in Kerala, told DTE.

As per anecdotal evidence, the common diseases that patients look to initiate Ayurveda include prevention and treatment of seasonal viral infections, diabetes, gastrointestinal disorders such as irritable bowel syndrome, thyroid diseases, high blood pressure and management of high cholesterol and as add-on cancer therapies.

“Ayurvedic herbals are now the second most common cause for acute liver injury in India and herbal drugs/supplements are the commonest cause of worsening of chronic liver disease in the Asia-Pacific region,” Dr Philips said.

Hepatologists across the country encounter cases like Sushmita’s on a regular basis. Dr Chetan Kalal, a Mumbai-based liver specialist, illustrates another incident where a young male in his early twenties turned to Ayurvedic supplements to expedite his weight loss process.

After consuming these supplements daily for almost six months, he was diagnosed with intrahepatic cholestasis, a type of jaundice.

“Because of the Ayurvedic medicine, his bile duct was clinically narrowed. It took almost three months for him to recover. He was on the brink of needing a liver transplant,” Dr Kalal told DTE.

He believes people don’t consider Ayurveda as a threat and are very reluctant to accept facts. “Medicine should be evidence-based, not word-of-mouth,” he added.

With the rise of Ayurveda since the pandemic and its public perception of equating ‘natural’ and ‘traditional’ with ‘safe’ and ‘effective’, many like Dr Kalal have made a list of traditional treatments and supplements they run by their patients to ensure these are not the cause of disease.

“It’s a difficult time for us as doctors to not do this. I have a proper counselling note for my patients about the impacts of Ayurveda,” Dr Arun Valsan, a Kochi-based hepatologist, told DTE.

Drug regulation

Modern medicines also have side effects, for which safeguards are in place. Many argue that Ayurveda treatments need a similar regulatory framework, not just on paper but also in effect. But the state of drug regulation for Ayurveda and other alternative forms of medicine, is marred by loopholes galore.

In 1930, Ayurvedic medicines were examined by the Drugs Inquiry Committee which found practitioners were resistant to regulations on “sentimental grounds, stating that there is something higher and more vital in their system which is inscrutable and impenetrable by modern science.”

This was only the first hurdle. The second, more worrying one, was the absence of a standard composition of Ayurvedic medicines. In a sobering conclusion, the committee had argued: “Unless and until these drugs are investigated on scientific lines, control is not feasible.”

In 1964, the wheels on Ayurvedic drug regulation began moving when a new chapter was added to the Drugs & Cosmetics Act 1940 (D&C Act) for regulating the licensing, manufacture and quality control of Ayurveda, Unani and Siddha drugs.

The new chapter permitted the use of patent and proprietary Ayurvedic medicines where the manufacturing companies decide the formula, dosage and form of medicine based on the classical Ayurvedic texts.

“It made Ayurvedic medicine accessible over-the-counter in a more palatable medium but it was not without consequences,” Shailaja Chandra — former secretary of AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy) in the Government of India — told DTE.

Traditional medical systems are different because they address the specific constitution of each patient, not just the symptoms of a disease. Ayurveda lays down several lifestyle changes which got sidelined with the emphasis on manufactured drugs, Chandra explained.

While the new chapter was a welcome move, Dinesh S Thakur and Prashant Reddy T — public health activist and lawyer respectively — argue it was “merely an illusion of regulation” in their 2022 book, The Truth Pill, on the myth of drug regulation in India.

The amendments proposed every facet of the regulatory framework for modern medicine be replicated for traditional medicine except a pharmacopoeia.

A pharmacopoeia essentially standardises production of any drug such that its contents are identical, irrespective of manufacturer. These standards ensure a commitment to quality.

“Without standardisation of these traditional ‘cures’, there could be no uniformity or consistency in the market and hence no way to test these traditional ‘cures’ for their quality,” Thakur and Reddy write.

In such a scenario, regulation is impossible, as had already been cited three decades prior to the amendments by the Drugs Inquiry Committee in 1930. It wasn’t until 1986 that the Indian government began publishing the Ayurvedic pharmacopoeia and by 1995 it was made legally binding for the Ayurvedic industry.

So far, quality standards for around 670 raw medicinal plants and 150-160 classical Ayurvedic formulations are listed in the Ayurvedic pharmacopoeia,  a drug regulatory expert with decades of experience in the industry explained to DTE on the condition of anonymity.

However, this document differs in comparison to the pharmacopoeia for modern medicine, Thakur and Reddy note.

“A modern pharmacopoeia prescribes a range of tests that help determine the quality of a drug. These tests include the identity tests, the assay test to determine the content of active ingredient and dissolution test which measures the rate at which the drug dissolves in a solvent,” Thakur and Reddy write.

The dissolution test is critical because if the active ingredients in the drug don’t dissolve once consumed, it will not have the desired impact. This is where the Ayurvedic pharmacopoeia lapses.

A dissolution test is only applicable to solid dosage forms like tablets and capsules and classic Ayurvedic formulations don’t come in this configuration.

What we saw in the case of Sushmita, and many others like her, was the consumption of proprietary Ayurvedic medicines.

As per the drug regulations for Ayurvedic products, the ingredients of a proprietary medicine must be as per the Ayurvedic texts and the indication of its use must be based on “textual rationale”, the drug regulator cited earlier explained. To gauge evidence of effectiveness of ingredients, “published literature” is required, and for proof of effectiveness of the medicine, a “pilot study as per relevant protocol for Ayurveda and Siddha and Unani drugs” is needed.

“The drug regulations, recognising documented long history of use, do not mandate safety study for licensing of proprietary medicines, as long as each ingredient and the indications are as per authoritative texts,” the domain expert cited earlier said.

In case of new indications or differences with textual recipes, safety and effectiveness testing is required, he added

A similar argument was made in Parliament by Dr DS Raju, deputy minister of health, in 1981 where he said: “There is no doubt about their (Ayurveda and Unani) scientific aspect. They have stood the test of time. It does not require any proof as to their efficacy.”

In March 2013, the AYUSH Department came out with guidelines for Good Clinical Practices for Ayurveda, Siddha and Unani (ASU) medicines.

It noted in its preface: “Although the ASU systems are known for their long history of safe and effective use, yet validation of safety and efficacy using scientific and evidence-based methodologies is needed for the purpose of universal acceptability, gaining confidence of practitioners and satisfaction of end users in the products.”

Thakur and Reddy lauded this move as a “step in the right direction”, but the foreword washes its hands off responsibility noting these guidelines “are meant for voluntary use, not linked with any provisions of Drugs & Cosmetics Act, 1940, and the rules thereunder.”

Chandra believes the requirements of Chapter IV A of the D&C Act are not implementable because the state licensing authorities lack uniformity in the way they check for the quality of essential ingredients, adherence to pharmacopeial standards and the processes to be followed for Ayurvedic drugs.

The pharmaceutical approach of extracting an alkaloid or the active ingredient from a drug cannot be applied to traditional medicine which has scores of plant based ingredients in every formulation.

“Unless the ingredients are tested to check the purity of what goes into the formulation, using scientific identification and measurement methods (which are available) the claims of efficacy and safety cannot be pre-supposed, simply because the plants are ‘natural’ and by implication safe,” she argued.

Typically, the Ayurveda industry records an annual growth of 10-20 per cent, but the traditional form of medicine’s economy grew by up to 90 per cent since the pandemic, the former health minister had noted in February 2021.

Generations of Indians have reposed faith in the traditional systems of medicine and that faith is being revived through active promotion of AYUSH initiative, Chandra said.

With such a rise in its popularity, there is an urgent need to regulate the Ayurvedic system on many fronts. Here, Dr Philips lists a few: replacing testimonials and long history of safe use with evidence, performing rigorous trials which are strong in methodology, replicated and validated by multiple groups and ensuring a robust pharmacovigilance system on the ground.

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