Drugs Thirteenth Amendment Rules revises the list of poisonous substances under ASU medicines

The Ministry of AYUSH has notified the Drugs (Thirteenth Amendment) Rules, 2026 (“Amendment”), which amend the Drugs Rules, 1945 (“Rules”). The Amendment substitutes the existing Schedule E(1), which specifies poisonous substances used under the Ayurveda, Siddha, Sowa-Rigpa and Unani systems of medicine. Under the Principal Rules, poisonous substances were listed separately for the Ayurvedic, Siddha and Unani (“ASU”) systems of medicine. The Amendment substitutes the existing list with a revised schedule that identifies substances by their botanical or chemical names, parts used and corresponding names across the four systems of medicine. The Amendment came into force on the date of its publication in the Official Gazette, i.e., 6^th October 2026.

Key Highlights:

1. The earlier lists for the Ayurvedic, Siddha and Unani systems have been replaced with a consolidated list covering Ayurveda, Siddha, Sowa-Rigpa and Unani systems of medicine.

2. The revised list identifies botanical names, parts used and corresponding names across the relevant systems of medicine. It includes entries for substances such as Euphorbia species, Nicotiana tabacum, Conium maculatum, Xanthium strumarium and Excoecaria agallocha.

3. The revised list includes substances such as snake poison and Mylabris species, with their corresponding names under the relevant systems of medicine.

4. The revised list specifies substances such as arsenic compounds, mercury and its compounds, copper sulphate, cinnabar, copper, lead, tin, brass, stibnite, litharge, green vitriol, yellow oxide of mercury, galena and copper acetate, along with their corresponding traditional names.

5. The revised format specifies corresponding names of listed substances under Sowa-Rigpa, alongside Ayurveda, Siddha and Unani.

6. The schedule retains an exemption for listed drugs of plant origin when used in preparing Bhasma, Parpam, Kushta, Thalsman, Sindhuram or Chendooram.

7. The revised schedule clarifies that any ingredient not specifically listed but containing arsenic or mercury as a chemical constituent shall be considered a poisonous substance under the schedule.

Source: E Gazette