Substance or rule
Heavy metals in ayurvedic medicines: the Indian labelling rule and foreign alerts
Last checked 10 October 2026
India's rule is a label: Rule 161 requires 'to be taken under medical supervision' on ASU medicines with Schedule E1 substances; the US FDA has listed named firms' products for lead or mercury since 1 Apr 2021, which is not a finding about ayurvedic medicines in general.
- Classification
- Restricted under the Drugs and Cosmetics Act, 1940 (ASU and homoeopathic provisions)
- Decided by
- Drugs and Cosmetics Rules 1945 (India); US Food and Drug Administration (foreign alerts)
- Reference
- Drugs and Cosmetics Rules 1945, Schedule E1 and Rule 161; US FDA Import Alert 99-42 (updated 22 Sep 2026); FDA warning of 2 Dec 2025
- Latest action
- 7 April 2026
- Last checked
- 10 October 2026
Photo: Ayurvedic herbs 02.jpg by Vis M (CC BY-SA 4.0). All photo credits.
US FDA Import Alert 99-42: foods and products with heavy metals
Scope. A record here does not by itself mean a product or company is unsafe or banned today. Regulatory actions can apply to one batch, one formulation, one period or one state. Always check the linked government document for the current position, and tell us if something is out of date. How we label records.
Below: Blacklisted's explanationWe organise and explain what the document says. The document above is the authority.
Key facts
- Indian rule
- Rule 161 and Schedule E1: the label 'to be taken under medical supervision'. It is a labelling rule, not a limit on any metal
- US FDA Import Alert 99-42
- Baidyanath bati products (lead and mercury, 1 Apr 2021); Falcon System (lead, 8 May 2025); Kerala Ayurveda Guluchyadi Kwath (lead, 7 Apr 2026)
- US FDA warning, 2 Dec 2025
- Rheumacare, sold via NavaFresh.com: lead, mercury, arsenic, strychnine, brucine; manufacturer not named
- Maharashtra FDA table
- An unlabelled 'Mulpeshi Vikas' found to contain mercury
The Indian rule we record is a labelling one. Under Rule 161 of the Drugs and Cosmetics Rules, ayurvedic, siddha and unani medicines containing substances listed in Schedule E1 must carry the label 'to be taken under medical supervision'. It is not a limit on any metal, and the sources we read do not say which products it covers.
Outside India, the US FDA has listed particular firms' products for lead or mercury. Its heavy-metals import alert 99-42 names Baidyanath bati products (1 Apr 2021), Falcon System of Ayurvedic Products (8 May 2025) and Kerala Ayurveda's Guluchyadi Kwath (7 Apr 2026). On 2 Dec 2025 it warned about an unapproved product, Rheumacare, reporting lead, mercury, arsenic, strychnine and brucine. These are US border measures, not Indian actions.
In India, Maharashtra FDA's failed-test table lists an unlabelled product, 'Mulpeshi Vikas', found to contain mercury. It cannot be attributed to any licensed company. None of these findings says that ayurvedic medicines generally contain heavy metals.
What this means for you
Named products, not a category
Every finding here is about a named firm or product. None is a finding about ayurvedic medicines in general.
A US alert is not an Indian action
Import alerts concern goods entering the United States. We found no Indian regulator action on the products they name.
This is a record of official orders, not medical advice. Do not stop a prescribed medicine without asking your doctor or pharmacist.
Common questions
Do ayurvedic medicines contain heavy metals?
This page makes no such claim. It records named products flagged by the US FDA and one unlabelled product in Maharashtra's table, and the Indian labelling rule for Schedule E1 substances.
Official sources and primary records
- US FDA Import Alert 99-42: foods and products with heavy metalsRegulatorUS Food and Drug Administration · 22 September 2026
- FDA warns about heavy metal poisoning associated with certain unapproved ayurvedic drug productsRegulatorUS Food and Drug Administration · 2 December 2025
- Maharashtra FDA: not of standard quality (NSQ) alerts tableRegulatorMaharashtra Food and Drug Administration · 9 October 2026
- Regulator