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Gireesh Babu, New Delhi October 13 , 2026
The Union Ministry of Ayush has amended the Drugs Rules, 1945, revising the list of poisonous substances under Ayurveda, Siddha, Sowa-Rigpa, and Unani Systems of medicines under the Schedule E(I) of the Rules, expanding the list of substances to include mercury, copper, lead, tin and brass among other minerals and plant-based substances.

The amendment, issued after considering objections and suggestions received from the public on draft notification issued on January 28, 2025, has come into force from the date of its publication in the Official Gazette.

Under the revised Schedule, arsenic trioxide or pentaoxide or white arsenic, arsenic trisulphide, arsenic disulphide or realgar, mercury or hydrargyrum, copper sulphate (CuSO4), cinnabar or mercuric sulphide or hydrargyri bisulphuratum, copper, lead (plumbum), tin (stanum), brass, stibnite (black antimony), litharge or lead oxide or PbO, amalgam of mercury and sulphur or other metals or minerals, red sulphide of mercury, green vitriol, yellow oxide of mercury, galena or lead (II) sulphide, and copper acetate, among others as poisonous substance for the Ayurveda, Siddha, Sowa-Rigpa and Unani systems of medicines.

The revised Schedule lists 16 substances of plant origin in Ayurveda system instead of 13 earlier, 20 substances of plant origin in Siddha System as against 17 earlier, 13 substances of plant origin in Unani System in the place of eight in the previous list. Sowa Rigpa has been added to the list afresh with the amendment, with 13 substances of plant origin listed under the Schedule.

Drugs of plant origin listed in Schedule E (I) of the Drugs Rules, 1945 when used in the preparation of Bhasma or Parpam or Kushta or Thalsman and Sindhuram or Chendooram are exempted.

Two drugs of animal origin - snake poison and types of mylabris, a beetle - have been listed in the revised schedule, for the Ayurveda, Siddha and Unani systems, while snake poison has been listed as poisonous substance for Sowa Rigpa also.

The list of drugs of mineral origin has been revised, expanding the list for Ayurveda system to 20 from 7 in the previous list, and 17 for Unani system 17 from 10 in the previous list. 18 mineral-based drugs has been added to the list of Siddha system, and 9 has been added to the Sowa Rigpa system through the revised Schedule.

"Any other ingredients not specifically mentioned in the above list containing arsenic or mercury as a chemical constituent shall be considered to be Schedule E (1) drug," said the Ministry of Ayush.

In the previous Schedule E (I), the poisonous substances in the Ayurveda and Unani systems were categorised as drugs of vegetable origin, animal origin and mineral origin, along with list of poisonous substances in Siddha system of medicines.

According to the Rules, for issue of license with respect to patent or proprietary medicines containing any of the ingredients of Schedule E(I) safety study, and experience or evidence of effectiveness including published literature and proof of effectiveness are required. The same is applicable to issue of license for Balya and Poshak medicines, Saundarya Prasadak k (Husane afza/Azhagu Sodhan) products.

Under the labelling norms for ayurvedic, Siddha and Unani drugs in the Drugs Rules, the container of a medicine for internal use made up ready for the treatment of human ailments shall, if it is made up from a substance specified in Schedule E(l), be labelled conspicuously with the words 'Caution: to be taken under medical supervision' both English and Hindi languages.

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