About
Swarna Bhasma is a traditional Indian Ayurvedic preparation consisting of incinerated gold particles (gold ash), produced through the multi-step processes of shodhana (purification), dravana, and marana (incineration with herbal juices), yielding gold nanoparticles of approximately 28–57 nm. It has been used for centuries in Ayurvedic medicine as a rasayana (rejuvenator) and is traditionally indicated for conditions such as bronchial asthma, rheumatoid arthritis, diabetes mellitus, and nervous system disorders.
Safety summary
In vitro studies report that properly prepared Swarna Bhasma is non-cytotoxic, does not induce blood cell aggregation, and shows negligible complement or platelet activation; chronic administration in animal studies showed no hepatotoxicity on liver function tests. However, analytical studies have detected elevated levels of arsenic, antimony, and silver in commercial samples, and at least one case of severe drug-induced liver injury requiring liver transplant listing has been attributed to Ayurvedic bhasma use. No formal ADI has been established by any major regulatory authority; bioavailability in humans is confirmed but poorly characterized, and no universal manufacturing quality standards exist.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| EFSA (European Food Safety Authority) (European Union) | Restricted | Swarna Bhasma is not authorized as a food additive or novel food ingredient in the EU. Metal-based Ayurvedic preparations are not listed in the EU novel food catalogue and would require pre-market authorization. No EFSA opinion on Swarna Bhasma as a food ingredient has been issued.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Restricted | FSSAI Ayurveda Aahara Regulations (2022) explicitly exclude metal-based Ayurvedic drugs, bhasma, and pishti from the food/food ingredient category. Swarna Bhasma is regulated as an Ayurvedic medicine under the Drugs and Cosmetics Act, 1940 and Rules, 1945, not as a food ingredient. Its manufacture and sale require licensing under Ministry of AYUSH.source |
| FDA (Food and Drug Administration) (United States) | Restricted | FDA does not recognize Swarna Bhasma as a food ingredient or GRAS substance. Ayurvedic preparations containing metals are not approved as drugs or dietary supplements in the US; FDA has issued multiple import alerts on Ayurvedic products with elevated heavy metals.source |
Who should approach with care
Research citations
- 1FSSAI. Food Safety and Standards (Ayurveda Aahara) Regulations, 2022 – Gazette Notification, 2022. fssai.gov.in
- 2PubMed. Assessment of bioavailability of gold bhasma in human participants – A pilot study, 2018. ncbi.nlm.nih.gov
- 3PubMed. Enhanced Internalization of Indian Ayurvedic Swarna Bhasma (Gold Nanopowder) for Effective Interaction with Human Cells, 2018. pubmed.ncbi.nlm.nih.gov
- 4PubMed. Ayurveda metallic-mineral 'Bhasma'-associated severe liver injury, 2018. pmc.ncbi.nlm.nih.gov
- 5PubMed. Toxic metals in ayurvedic preparations from a public health lead poisoning cluster investigation, 2018. pmc.ncbi.nlm.nih.gov
- 6PubMed. Bhasma: The ancient Indian nanomedicine, 2014. pmc.ncbi.nlm.nih.gov
