What changed
Mercury tightened from 2.0 to 1.0 ppm. Arsenic from 3.0 to 2.0 ppm. Lead unchanged at 10 ppm.
Scope covers both classical (Sharangadhara, Ayurveda Sara Sangraha references) and patent formulations. Bhasma-based formulations face the most material impact.
What classical-formulation brands must do
Re-test every classical SKU against the new ceiling. Bhasma-based formulations are most at risk — expect to lose 8 – 12% of SKUs across the industry to the new threshold.
Tighten raw-herb sourcing. Heavy-metal contamination is often soil-driven — re-qualify suppliers from low-industrial regions.
Bhasma reformulation
Mercury-containing bhasmas (Rasa Sindoora, Makaradhwaja) most affected. Some classical references inherently exceed the new Hg limit and may need to be sunset entirely.
Alternative formulations exist for most therapeutic targets — work with a registered Vaidya to find Hg-free equivalents.
Sunset planning
Sunset non-compliant SKUs before July to avoid licence-risk exposure. Brands that try to sell-through grey inventory post-July face inspection risk.
Communicate proactively with customers if a popular SKU is being sunset — brand-trust impact is the bigger risk than the SKU revenue.
- ›May 2026: Complete re-testing of all classical SKUs
- ›Jun 2026: Sunset non-compliant SKUs, clear inventory
- ›Jul 2026: New limits effective
- ›Q3 2026: Re-qualify raw-herb suppliers from low-industrial regions
- ›Q4 2026: Launch reformulated alternatives where possible
§ KEY TAKEAWAYS
- 01Re-test bhasma-based SKUs immediately
- 02Sunset non-compliant SKUs before July
- 03Tighten raw-herb sourcing — test at intake, not finished
- 04Work with registered Vaidya on Hg-free reformulations
- 05Communicate proactively if popular SKU is being sunset
- 068 – 12% SKU loss expected industry-wide
§ GLOSSARY
Technical jargon, acronyms and scientific terms used in this file — decoded.
- ASU & H drugs
- Ayurvedic, Siddha, Unani and Homoeopathy drugs — regulated under Drugs & Cosmetics Act Chapter IVA.
- ICP-MS
- Inductively Coupled Plasma Mass Spectrometry — the reference lab method for detecting heavy metals at ppm or ppb levels.
- ppm
- Parts per million — concentration unit; AYUSH heavy-metal limits are typically expressed in ppm.
- Rasa shastra
- Branch of Ayurveda using purified metals and minerals; subject to stricter heavy-metal scrutiny.


