In July 2021, six patients walked into Mumbai hospitals jaundiced, exhausted, and with liver enzymes ten to twenty times the upper limit of normal. None had viral hepatitis. None drank heavily. None were on hepatotoxic prescription drugs. They had one thing in common — they had each been drinking Giloy (Tinospora cordifolia) daily for several weeks as part of COVID-era “immunity boosting” protocols.
The case series was published in the Journal of Clinical and Experimental Hepatology by a team led by Dr. Aabha Nagral at Jaslok Hospital. Within weeks, the Ministry of AYUSH publicly disputed the findings. The hepatologists responded with DNA barcoding evidence confirming the samples were genuine Giloy. The Indian National Association for the Study of the Liver published a supporting letter. The dispute went mostly unreported in mainstream Indian media, mostly unindexed by Indian health blogs, and mostly skipped by the e-commerce platforms still selling Giloy juice with “natural, safe for everyone” labels.
This is the full investigation into what actually happened — the patient timeline, the lab findings, the histological evidence, the regulatory dispute, and what it means for the ₹6,000+ crore Indian herbal supplement market.
What Exactly Happened to the Mumbai Patients?
Between September 2020 and December 2021, hepatologists across Mumbai began noting an unusual pattern. Patients presenting with severe liver injury did not fit the standard etiologies — no recent viral exposures, no acetaminophen overdose, no alcohol abuse, no Ayurvedic preparation containing arsenic, lead, or mercury (a common cause of Indian herbal DILI). What linked them was Giloy.
The Patient Profile
The published series included six patients, expanded in subsequent INASL communications to a broader Indian cohort. The demographic pattern across the published cases looked like this:
- Median age: late 40s to early 50s
- Mixed gender, with a slight skew toward women
- Most patients had been taking Giloy for 3–8 weeks continuously
- Forms consumed varied — fresh juice, bottled Giloy juice, Ghan Vati tablets, Giloy churna mixed in water
- Several patients were taking multiple Ayurvedic preparations concurrently (Giloy + Tulsi + Ashwagandha was a common stack during the COVID wave)
- Most had no prior liver disease and normal baseline liver enzymes
The Presenting Symptoms
The clinical presentation followed a recognisable pattern of drug-induced liver injury:
- Jaundice — yellowing of skin and eyes, present in over 80% of the published cases
- Dark, tea-coloured urine
- Pale or clay-coloured stools (cholestatic pattern in some patients)
- Persistent nausea and reduced appetite
- Pruritus (itching without rash) — present in around 60% of patients
- Fatigue out of proportion to other symptoms
- Right upper quadrant abdominal discomfort
Symptoms typically appeared gradually, with patients dismissing early jaundice as “weakness from COVID” before presenting at 1–3 weeks of symptom progression.
The Lab Findings
Lab values at presentation were severe:
| Parameter | Typical Range at Presentation | Normal Range |
|---|---|---|
| Total bilirubin | 8–15 mg/dL | <1.2 mg/dL |
| ALT (SGPT) | 500–1,500 U/L | <40 U/L |
| AST (SGOT) | 400–1,200 U/L | <40 U/L |
| Alkaline phosphatase | Mildly to moderately elevated | <120 U/L |
| INR | 1.4–2.5 | <1.1 |
| Antinuclear antibody (ANA) | Positive in most | Negative |
| Anti-smooth muscle antibody (ASMA) | Positive in several | Negative |
| IgG | Markedly elevated | Normal |
The autoantibody profile (ANA, ASMA positivity, elevated IgG) is the same biochemical signature seen in autoimmune hepatitis — but in patients who had never previously had autoimmune disease and were not on drugs typically associated with classical AIH triggers.
The Biopsy Evidence
Liver biopsies were the deciding diagnostic step. They showed:
- Interface hepatitis — inflammation at the boundary between hepatic lobules and portal tracts
- Dense plasma cell infiltration — the cellular hallmark of autoimmune hepatitis
- Mild to moderate fibrosis in some patients
- No evidence of viral inclusions, granulomas, or steatohepatitis
- No bile duct destruction (ruling out primary biliary cholangitis)
This histology is identical to what hepatologists see in classical drug-induced autoimmune hepatitis caused by nitrofurantoin (an antibiotic), minocycline (an antibiotic), methyldopa (an antihypertensive), and a small list of other agents now well-known to trigger this exact pattern.
The biopsy findings ruled out the AYUSH Ministry’s initial counter-hypothesis that patients had viral hepatitis or alcohol-related liver injury misattributed to Giloy.
The AYUSH Ministry’s Response
Within weeks of the case series publication, the Ministry of AYUSH issued a public statement disputing the findings. The key arguments were:
- Species misidentification — patients had likely consumed Tinospora crispa, not Tinospora cordifolia, and crispa is a known hepatotoxin sold in Thai markets
- Insufficient causality assessment — the case series did not perform a formal RUCAM (Roussel Uclaf Causality Assessment Method) score to establish drug-injury causality
- Confounding by concurrent drug use — several patients had taken multiple herbs and possibly allopathic drugs simultaneously
- Population context — millions of Indians have safely consumed Giloy for thousands of years; six unverified cases cannot overturn that experience
The ministry described the Nagral et al. paper as “misleading” and called for it to be retracted or revised.
The political subtext was significant. The 2021 statement landed in the middle of an ongoing public-relations push by AYUSH-aligned organisations promoting Giloy, Tulsi, and Ashwagandha as COVID-era immunity boosters. A peer-reviewed case series questioning Giloy’s safety in this specific use case threatened both the immunity-booster narrative and the broader push for Ayurvedic integration into mainstream Indian healthcare.
The Hepatologist Rebuttal — DNA Barcoding
The Mumbai team — and an extended group of Indian hepatologists under the INASL banner — responded with three lines of evidence.
1. DNA Barcoding of Patient Samples
Where retained Giloy samples were available, the team performed DNA barcoding using the rbcL and matK plastid gene markers — the same molecular method used globally for species identification in herbal pharmacognosy. Samples were sequenced and compared against the NCBI GenBank database for Tinospora species.
The result: the samples were genuine Tinospora cordifolia. The AYUSH species-misidentification hypothesis did not survive molecular verification.
This finding was significant because routine market sampling in India does find adulteration — a 2022 study in the Journal of Ayurveda and Integrative Medicine documented around 28% of commercial Giloy samples being the wrong species. But in this specific cohort, where samples could be tested, the consumed product was not crispa or any other lookalike.
2. RUCAM Causality Assessment
The team subsequently performed formal RUCAM scoring on the published cases. RUCAM assigns points based on:
- Time to onset of symptoms after starting the herb
- Course of liver enzymes after stopping the herb (de-challenge)
- Risk factors (age, alcohol, pregnancy)
- Concurrent drug use
- Exclusion of competing causes
- Previous information on the herb’s hepatotoxicity
- Response to re-challenge (when accidentally reintroduced)
Most cases scored in the “probable” or “highly probable” causality range — the standard threshold for accepting drug-induced liver injury attribution in the international DILI literature.
3. INASL Position Statement
The Indian National Association for the Study of the Liver — the apex Indian hepatology body — published a position statement in Hepatology Communications and other journals supporting the hepatotoxicity signal. The statement noted:
- Multiple Indian centres independently reporting similar cases
- Biopsy patterns consistent across cases (interface hepatitis with plasma cell infiltrate)
- Successful de-challenge in most patients (liver enzymes normalised after stopping Giloy)
- No alternative cause identified despite extensive workup
INASL recommended that Giloy and related Tinospora-containing products carry a hepatotoxicity warning, that patients with pre-existing liver disease avoid the herb, and that any course longer than 4 weeks be monitored with liver function tests.
The AYUSH Ministry has not formally accepted INASL’s recommendations as of 2026.
What Has Happened Since 2021
In the years following the original case series, additional Indian hepatology centres have reported cases that fit the same pattern.
Continued Case Reporting
PGIMER Chandigarh, AIIMS Delhi, Sir Gangaram Hospital New Delhi, and other tertiary hepatology centres have published or presented at national hepatology conferences further cases attributable to Tinospora cordifolia. The cumulative Indian case count is now substantially higher than the original six.
The clinical pattern across these subsequent reports remains consistent — chronic daily Giloy users developing autoimmune-like hepatitis 3–8 weeks after starting the herb, with autoantibody positivity and interface hepatitis on biopsy.
The Ashwagandha Parallel
The Giloy hepatitis story has not stayed isolated. Since 2017, more than 35 global case reports of Ashwagandha-associated liver injury have been published, including an Indian case series of 8 patients with 37.5% mortality concentrated in those with pre-existing chronic liver disease. For the detailed parallel, see our Ashwagandha medicine deep dive, which covers the FSSAI 2026 leaf ban and the 35-case-report literature.
The two stories share an uncomfortable pattern. Both herbs are widely marketed in India as “safe, natural” supplements. Both have documented case series in peer-reviewed Indian and international journals. Both share a 3–8 week latency window for hepatic presentation. Both are sold without hepatotoxicity warnings on packaging. And both are routinely stacked together in COVID-era and ongoing “immunity kit” formulations.
What Regulatory Action Has Followed
The FSSAI prohibited Ashwagandha leaves in food and nutraceutical products in April 2026, citing safety concerns including liver toxicity data. No equivalent regulatory action has been taken for Giloy. The species-adulteration problem with Tinospora has not been addressed through mandatory DNA-barcoded species certification. The AYUSH Ministry’s premarket approval pathway does not require DILI safety surveillance for traditional Ayurvedic medicines.
This gap is not unique to India. Globally, the regulation of herbal supplements remains far weaker than for pharmaceutical drugs — but India, as the world’s largest producer of Ayurvedic herbs, carries an outsized responsibility for product-level safety surveillance.
Why Does Giloy Cause Liver Damage in Some People?
The pharmacological mechanism is still being elucidated. Three working hypotheses dominate the current Indian hepatology literature.
Hypothesis 1: Idiosyncratic Immune Response
Giloy contains potent immunomodulatory alkaloids — tinosporin, berberine, cordifolioside A, and others. In a small subset of users with predisposing immune genetics (particular HLA haplotypes), these compounds may trigger an autoimmune response targeting hepatocytes. This is the same general mechanism behind nitrofurantoin-induced autoimmune hepatitis and minocycline-induced AIH.
This hypothesis is consistent with the biopsy findings (interface hepatitis with plasma cell infiltrate) and the autoantibody positivity. It also explains why most users tolerate Giloy without incident — only those with a specific immunogenetic susceptibility react.
Hypothesis 2: Quassinoid Toxicity
Giloy contains bitter quassinoid compounds — a class of molecules with documented hepatic effects at high concentrations. Concentrated forms of Giloy (Ghan Vati tablets at higher doses, satva, prolonged daily juice intake) may deliver enough quassinoid exposure to cause direct hepatocellular stress in susceptible individuals.
This hypothesis is consistent with the 3–8 week onset window, the dose dependence observed in case reports, and the resolution after stopping the herb.
Hypothesis 3: Adulterated Product (the AYUSH position)
The AYUSH Ministry’s original hypothesis — that affected patients had consumed Tinospora crispa rather than Tinospora cordifolia — could not be sustained after DNA barcoding ruled out species misidentification in tested samples. However, a related concern remains valid: market Giloy in India does have adulteration problems, including occasional admixture with crispa, sinensis, and Cocculus hirsutus. For the broader adulteration picture, our companion guide on spotting fake Giloy in Indian markets covers visual ID and lookalike species in detail.
The reality is likely a combination of all three. Most Indians who develop Giloy hepatitis are probably consuming genuine cordifolia, but with an immunogenetic predisposition that turns Giloy’s immunomodulatory effect into a self-directed autoimmune attack on the liver.
What This Means for Indian Users
If you are currently taking Giloy or considering it, here is the practical takeaway from the Mumbai cases and follow-up literature.
Who Should Avoid Giloy Entirely
- People with any pre-existing liver disease — fatty liver (any grade), hepatitis B or C, alcoholic liver disease, cirrhosis, autoimmune liver disease, primary biliary cholangitis
- People with active autoimmune disease anywhere in the body — lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, Hashimoto’s thyroiditis with active flares
- People taking other hepatotoxic drugs daily — anti-tubercular medications, methotrexate, valproic acid, isoniazid
- Pregnant or breastfeeding women
- Solid organ transplant recipients
- Children under 12 (no safety data)
Who Can Use Giloy with Reasonable Safety
Healthy adults using Giloy short-course (under 4 weeks) for specific indications — acute viral fever support, dengue adjunct therapy under medical supervision, or as a 6-week diabetic adjunct with home glucose monitoring.
For dosing, sourcing, and the full picture of safe vs unsafe Giloy use, see our Giloy medicine deep dive.
What to Monitor
For any course of Giloy longer than 4 weeks:
- Baseline liver function test (LFT) before starting — ALT, AST, ALP, total bilirubin, GGT
- Repeat LFT at 4 weeks of continuous use
- Stop immediately at any sign of yellowing of skin or eyes, dark urine, persistent nausea, fatigue out of proportion to activity, or right-upper-abdominal discomfort
- Get a repeat LFT within 48 hours of stopping if any symptoms appear
For context on what your routine bloodwork actually means, see our CBC test guide for India, which explains the panels that often get drawn alongside LFTs.
What to Tell Your Doctor
If you visit a hepatologist or any treating physician for a non-liver-related issue, mention any Giloy use within the past 6 months. Drug-induced liver injury is frequently missed because patients do not consider herbal supplements as “drugs” worth mentioning, and physicians do not always ask. The Indian DILI registry data suggests that herb-induced liver injury is significantly under-reported because of this communication gap.
Why the AYUSH Ministry’s Dispute Matters
The 2021 dispute between Indian hepatologists and the Ministry of AYUSH was not just a technical disagreement about one case series. It exposed a broader regulatory tension.
The Core Conflict
On one side, conventional Indian hepatologists — trained in modern evidence-based medicine, using internationally recognised causality assessment tools (RUCAM), publishing in peer-reviewed journals, and supported by molecular biology (DNA barcoding) — documented a clinically significant safety signal.
On the other side, the Ministry of AYUSH — tasked with promoting and integrating traditional Indian medical systems — responded by disputing the methodology rather than accepting the safety data. The political and economic context made an honest engagement with the findings difficult: any acknowledgement of Giloy hepatotoxicity would undermine years of immunity-booster marketing and the broader AYUSH integration agenda.
What an Evidence-First Response Would Look Like
A scientifically rigorous regulatory response to the Nagral et al. paper would have included:
- Independent reproduction of DNA barcoding on additional patient samples
- A formal AYUSH-led DILI surveillance programme for Ayurvedic herbs with documented case reports
- Mandatory hepatotoxicity warnings on Giloy product labels
- Updated AYUSH guidance limiting continuous use to 4–6 weeks
- A patient-facing public communication acknowledging the safety signal while contextualising the risk magnitude
None of these has happened as of 2026. The regulatory gap remains.
What Patients Can Do in the Meantime
In the absence of regulatory action, patient awareness is the primary safety mechanism. This is true for many Indian Ayurvedic and traditional preparations — see our companion piece on Giloy drug interactions that Indian doctors do not mention for the wider safety picture.
For the broader context on autoimmune diseases that Giloy can flare, including the connection to thyroid problems in India — particularly Hashimoto’s thyroiditis, the most common autoimmune disease in Indian adults — read the full thyroid pillar guide.
What the 2021 Mumbai Cases Tell Us About Indian Herbal Safety
The narrow lesson: Giloy can cause severe autoimmune-like hepatitis in a small minority of users, particularly with chronic daily use, and the standard “natural and safe” marketing is not supported by evidence.
The broader lesson: Indian herbal supplement regulation has not caught up with the scientific literature on these herbs. The Ayurvedic safety database that does exist — case reports in PubMed, INASL position statements, FSSAI advisories — is fragmented, inconsistently followed, and not surfaced on product packaging.
This makes individual patient awareness the most important safety mechanism. If you are using Giloy, Ashwagandha, Tulsi, or any Indian herbal preparation regularly, treat it as a pharmacologically active drug — get baseline bloodwork, monitor for adverse symptoms, limit continuous use, and tell every treating physician you see.
Three concrete behaviours protect most users:
- Cycle, do not chronically dose. No published safety data exists for daily Giloy use beyond 12 weeks. Cycle 4–6 weeks on, 2 weeks off.
- Get a baseline and follow-up LFT. Before any course longer than 4 weeks, baseline LFT. Repeat at 4 weeks.
- Stack with caution. Combining Giloy with Ashwagandha, Tulsi, or other immunomodulators amplifies the autoimmune flare risk. Do not stack without medical supervision.
For ongoing context on the broader Indian herbal landscape — including how brand quality varies and why one in five tested Giloy samples is the wrong species — see our companion deep dives on Giloy brand purity and adulteration and the Giloy medicine pillar guide.
Frequently Asked Questions
Has anyone died from Giloy-induced hepatitis in India?
The original 2021 Mumbai case series did not report deaths directly attributed to Giloy hepatitis, but subsequent Indian DILI reporting has included at least one progression to acute liver failure requiring transplant evaluation. The contrast with the Ashwagandha Indian case series — 8 patients, 3 deaths, all in patients with pre-existing chronic liver disease — is instructive. Severity of Giloy hepatitis depends primarily on pre-existing liver health, time to recognition and discontinuation, and access to specialist care.
Can the liver fully recover after Giloy hepatitis?
In most cases, yes. Most patients in the Mumbai series recovered completely after discontinuation and corticosteroid therapy, with liver enzymes returning to normal over 1–4 months. A minority developed persistent autoimmune hepatitis requiring long-term immunosuppression. The factors that predict full recovery are early recognition, prompt cessation of the herb, absence of pre-existing chronic liver disease, and appropriate corticosteroid management.
How can a doctor diagnose Giloy hepatitis specifically?
There is no specific blood test for Giloy-induced liver injury. Diagnosis is based on a combination of clinical history (recent Giloy use), exclusion of viral hepatitis and other causes, autoantibody pattern (ANA, ASMA positivity), elevated IgG, and liver biopsy showing interface hepatitis with plasma cell infiltrate. RUCAM scoring formalises the causality assessment. The pattern is indistinguishable from classical autoimmune hepatitis on biopsy alone — the temporal link to Giloy intake is what makes the diagnosis.
Are bottled Giloy juices safer than fresh juice or tablets?
Not necessarily. The Mumbai cases included patients on fresh juice, bottled juice, and tablet forms. Bottled juice has lower bitter principle content than fresh extraction (40–60% loss with pasteurisation and storage), but the immunomodulatory compounds responsible for the hepatic immune response are not exclusively the bitter alkaloids. Pasteurised juice can still trigger an autoimmune-like reaction in susceptible individuals.
Does adding Tulsi or Ashwagandha to Giloy make liver injury more likely?
Plausibly yes, though no large dataset has tested this directly. Both Tulsi and Ashwagandha share an immunomodulatory mechanism with Giloy. Combining them increases the cumulative immune-stimulatory load, which may increase the likelihood of triggering an autoimmune-pattern hepatic response in genetically susceptible individuals. Ashwagandha specifically has 35+ documented liver injury cases globally. The combined “immunity kit” approach popular during COVID likely amplified both risks simultaneously.
What is the safest dose of Giloy if I want to use it occasionally?
For acute viral fever support: 20–30 ml of fresh juice once or twice daily for 5–7 days only, then stop. For diabetic adjunct use: 250–500 mg Ghan Vati tablet once daily for 4–6 weeks, with home glucose monitoring and a baseline LFT. Avoid open-ended daily use. Avoid stacking with other Ayurvedic immunomodulators. Avoid the herb entirely if you have any liver disease, autoimmune condition, transplant history, or are pregnant.
Are there any other Indian herbs with similar liver injury risk?
Yes. Beyond Giloy and Ashwagandha, Indian DILI registry data has documented liver injury cases with kava, kratom, green tea extract (when consumed in concentrated supplement form), garcinia cambogia, and several traditional Ayurvedic preparations containing heavy metals (Bhasmas). The “herbal = safe” assumption breaks down repeatedly in the published Indian hepatology literature. Any concentrated herbal preparation used daily for weeks deserves the same scrutiny as a prescription drug.
Is there a public Indian database of herb-induced liver injury cases?
Not a fully public one. INASL maintains a working group on herb-induced liver injury, and Indian DILI cases are reported into international DILI registries (LiverTox, the US-led NIH database). A patient-facing Indian registry where consumers can report adverse events is one of the gaps INASL has called out. Until such a registry exists, published case series and peer-reviewed reports are the primary safety signal — and most are not surfaced on product labels.
What should I do if I have already been taking Giloy daily for several weeks?
If you have been taking Giloy daily for more than 4 weeks: (1) stop the herb today; (2) book a liver function test in the next 1–2 weeks; (3) watch for jaundice, dark urine, fatigue, nausea, or right-upper-abdominal pain over the next 4 weeks; (4) inform any treating physician — particularly if you are on other prescription drugs — about your recent Giloy intake. If your LFT is normal and you have no symptoms after 4 weeks of stopping, the risk window has passed.
Where can I read the original Mumbai case series paper?
The original paper by Nagral et al. is published in the Journal of Clinical and Experimental Hepatology (2021). Subsequent INASL position letters are available in Hepatology Communications. Both are accessible through PubMed and standard medical journal databases. We have linked the journal references in the sources section of our Giloy medicine deep dive.
This article is for informational purposes only and does not constitute medical advice. The 2021 Mumbai Giloy hepatitis case series, the AYUSH Ministry response, the DNA barcoding rebuttal, and the INASL follow-up letters are publicly available in the cited peer-reviewed Indian and international hepatology journals. If you are currently taking Giloy and experiencing any symptoms consistent with liver injury — yellowing of skin or eyes, dark urine, persistent nausea, unusual fatigue, or upper-right abdominal pain — stop the herb immediately and consult a qualified hepatologist or gastroenterologist for evaluation. For severe acute liver failure cases, liver transplant evaluation may become necessary. The information presented here is sourced from the cited case series and is current as of May 2026.