Published in Frontiers in Gastroenterology—an open-access research in digestive health, liver disease, infections, cancer and gastrointestinal care—the study found that about 40 percent of the patients developed acute-on-chronic liver failure (ACLF)—a condition where a patient with underlying chronic liver disease suddenly develops severe liver failure.
According to the study, among those who developed ACLF, around 39 percent died. Overall mortality among all patients studied was about 22 percent.
“We have published the largest analytical study of Ayurveda, Homeopathy, Siddha, Unani and Folk-Traditional Medicinal products that have harmed patients, presenting with liver damage, to our department,” wrote lead author Dr Cyriac Abby Philips, a Kerala-based specialist in Hepatology and Liver Transplant Medicine, who is popular on social media with the name ‘LiverDoc’.
Researchers say this is the most exhaustive analytical study that correlated clinical outcomes in such patients. “Our study’s data collection ended in 2023, but we continue to see patients coming in with liver damage linked to alternative medicine use,” Arif Hussain, Kerala-based clinical research associate and the study’s lead researcher who works with Dr Philips, told ThePrint.
How researchers found Ayush link
Explaining how the study concluded that liver damage was linked to Ayush medicines, Hussain explained that the study relied on diagnosis of exclusion and temporal association, meaning the liver injury was directly linked to the initiation and subsequent period of consumption of alternative medicines.
Researchers mandatorily ruled out other common causes of liver damage, such as viral hepatitis, alcohol use or other prescription drugs. After this, expert adjudication of the cases was undertaken to decide whether the alternative medicines were likely involved.
Hussain said the researchers did not use the now obsolete formal scoring system called RUCAM (Roussel Uclaf Causality Assessment Method), a standardised clinical scoring system used to determine the likelihood that a specific drug caused liver injury.
This is because, he said, RUCAM works best when a patient has taken only one medicine. In this study, many patients concurrently used several alternative medicine products at the same time, which makes such scoring tools unreliable. “The study’s primary focus was on analysing what was inside the products that potentially harmed the patients,” he said.
“We focused on what was inside the 386 alternative medicine products—heavy metals, hidden drugs, other undisclosed content—and then linked those findings to patient outcomes,” he explained. Hussain said this approach is similar to the practical method used by major international research groups that study drug-induced liver injury (DILI).
One such group is the Drug-Induced Liver Injury Network (DILIN) in the United States. Another is the Latin American Drug-Induced Liver Injury Network (LATINDILI), which studies liver injury cases across countries in Latin America. These networks investigate cases where medicines, supplements, or herbal products may have harmed the liver.
What Ayurveda experts say
Ayurveda experts ThePrint spoke to said the study’s conclusions should be interpreted cautiously. “The adverse outcomes reported are more plausibly attributable to adulterated, spurious, or misbranded products, which can occur across any healthcare system when manufacturing standards and regulatory oversight are inadequate,” said Professor Anupam Shrivastava, Head, Department of Rasa Shastra & Bhaishajya Kalpana and former medical superintendent, National Institute of Ayurveda (NIA), Jaipur.
“Such issues primarily reflect deficiencies in quality control and product authentication, rather than inherent toxicity of well-formulated medicines,” Shrivastava, who is also the chairman of IPR (Intellectual Property Rights) Cell, added.
In an elaborate written response to ThePrint, Shrivastava said, “The study does not specify dosage forms such as tablets, churna, vati, or arishta and their quantity. Instead, it uses broad categories, like herbal products, traditional medicines, complementary and alternative medicine (CAM) products, and unlabelled preparations. Because the specific product identities are not revealed, the findings cannot be independently addressed, verified or reproduced.”
Unlabelled products, heavy metals & hidden drugs
One of the most striking findings of the study, according to the researchers associated with the study, is unlabelled medicines—products sold without ingredient lists, batch numbers or manufacturer details.
Patients who died had consumed almost twice as many unlabelled products as those who survived. Mortality rose from about 14 percent among patients who took none of these products, to roughly 43 percent among those who consumed three or more.
According to Hussain, the results highlight the importance of traceability. “No medicines should be sold without labels or mislabelling today. But when it comes to alternative medicines, it is still happening,” said Hussain who is also a former homoeopathy practitioner.
“This is not limited to one system—it happens with Ayurveda, Homoeopathy, Siddha, Unani and others. We found that patients who consumed unlabelled products had higher mortality,” he added.
Laboratory testing revealed that many products contained toxic heavy metals above international safety limits. Mercury levels exceeded World Health Organisation limits in 34 percent of products, cadmium in 25 percent, arsenic in 21 percent, and lead in 14 percent. Siddha products demonstrated the highest prevalence of lead (56.2 percent) and arsenic (62.5 percent) exceedances compared to Ayurveda.
Cadmium exposure showed the strongest association with severe outcomes. Cadmium is a chemical that exerts toxic effects on the kidneys as well as the skeletal and respiratory systems, and is classified as a human carcinogen. About 76 percent of patients exposed to cadmium above safety limits developed ACLF, compared with around 23 percent among those not exposed, the study found.
“Usually we focus on arsenic, lead or mercury, but cadmium was an unexpected finding,” Hussain said. Researchers also detected hidden pharmaceutical drugs in about 27.7 percent of the products. These included corticosteroids, antibiotics, sedatives and painkillers such as nimesulide, a drug restricted in several countries due to liver safety concerns.
In December 2025, the central government banned nimesulide formulations above 100 mg, citing potential health risks.
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Liver toxic plants in many formulations
Beyond contamination and adulteration, the study also identified plant ingredients known to affect the liver in more than 40 percent of the products. These included Tinospora cordifolia (Giloy), Plumbago zeylanica (Chitrak) and Withania somnifera (Ashwagandha).
According to Hussain, some plant compounds themselves may have hepatotoxic effects. “Natural does not automatically mean harmless,” Hussain said. “If something has a biologically active compound that can harm the liver, it can cause injury regardless of whether it is natural or synthetic.”
The study also detected animal-derived compounds in around 31 per cent of products, often without disclosure on labels.
What govt says
On its part, the government has said it has strengthened monitoring of adverse reactions linked to Ayush medicines through a national pharmacovigilance system.
In a recent interview with ThePrint, Ministry of Ayush Secretary Vaidya Rajesh Kotecha said that the ministry operates a three-tier pharmacovigilance network with a National Pharmacovigilance Coordination Centre at the All India Institute of Ayurveda, five intermediary centres and 97 peripheral centres across the country.
Kotecha said the system was further reinforced with the Ayush Suraksha Portal, launched on 30 May, 2025. “This is an IT-enabled, centrally monitored platform for real-time tracking of Adverse Drug Reactions (ADRs) and misleading advertisements,” he said.
However, Hussain said that when patients develop complications, they rarely go back to the Ayush practitioner to report them. “It is very difficult for them to identify that the symptoms could be linked to the medicine they took. Instead, they usually get admitted to a hospital,” he said.
Regulatory gaps and lack of testing
The findings raise broader concerns about regulatory oversight of traditional and herbal medicines. Paradoxically, classical regulated Ayurveda formulations demonstrated the highest contamination rate (34.1 percent) compared to unlabelled products (23.1 percent), suggesting that regulatory classification did not ensure pharmaceutical purity.
In India, Ayush drugs are regulated under the provisions of the Drugs & Cosmetics Act, 1940 and the Rules framed thereunder. In the case of Ayurveda, Siddha, and Unani (ASU) drugs, there are two broad categories: classical formulations and patent or proprietary medicines. The requirements for grant of a manufacturing licence for ASU drugs are prescribed under Rule 158B of the Drugs Rules, 1945.
These include compliance with prescribed standards relating to safety, quality, proof of efficacy where applicable, and authentic classical or literary references.
For homoeopathic medicines, the regulatory framework for grant of manufacturing licences is laid down under Rules 85A to 85I of the Drugs Rules, 1945.
Manufacturing licences for Ayush drugs are granted by the state licensing authorities appointed by the respective state/UT governments. The Union Budget 2026–27 had announced upgrading Ayush pharmacies and Drug Testing Laboratories.
Kotecha had told ThePrint that a dedicated Ayush vertical has been established within the Central Drugs Standard Control Organisation—India’s apex drug regulator—with Ayush Drug Inspectors, which specifically oversees regulatory and enforcement matters related to Ayush drugs. “At the policy level, the ministry is working towards strengthening a regulatory framework that ensures quality, safety and clinical validation of Ayush drugs,” he said.
However, Hussain said that unlike modern pharmaceutical drugs, which must undergo extensive pre-clinical testing, clinical trials and post-market surveillance, many alternative medicines are entering the market with far fewer requirements. This regulatory gap, he said, allows issues such as contamination, adulteration and undisclosed ingredients to go undetected. “Stronger regulation, batch-level testing and proper labelling are essential.”
Debate over safety
The findings come amid ongoing debate about the safety and regulation of traditional medicines in India. A major limitation of the study, Dr Srivastava said, is that the exact medicines consumed by patients are not disclosed.
“Although the authors report analysing 386 medicinal products, they do not provide the names of the formulations, brands, or manufacturers. The study also does not specify dosage forms such as tablets, churna, vati, or arishta and their quantity. Instead, it uses broad categories like herbal products, traditional medicines, complementary and alternative medicine products, and unlabeled preparations. Because the specific product identities are not revealed, the findings cannot be independently addressed ,verified or reproduce,” he added.
This study identifies real problems in the supply chain and regulatory implementation, and those problems deserve serious attention,” said Dr Hemant Bhargav, associate professor at the Department of Integrative Medicine at National Institute of Mental Health and Neuro Sciences (NIMHANS), Bengaluru.
“What it does not do is indict classical Ayurveda as a system. It indicts an unregulated market and poor manufacturing practices, problems that principled Ayurveda practitioners have themselves been raising for years.”
He said that the answer is stronger quality standards and mandatory traceability, not abandoning traditional medicine. “This study actually makes the case for better regulation,” Dr Bhargav said.
(Edited by Nardeep Singh Dahiya)
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