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Core Purpose

Proposes amendment to Schedule E (I) of Drugs Rules, 1945, revising list of poisonous substances in Ayurveda, Siddha, Sowa-Rigpa, and Unani medicine.

Detailed Summary

The Ministry of AYUSH issued a notification proposing a draft amendment to Schedule E (I) of the Drugs Rules, 1945, concerning the list of poisonous substances in Ayurveda, Siddha, Sowa-Rigpa, and Unani systems of medicine. Published under section 33N of the Drugs and Cosmetics Act, 1940, the amendment aims to revise the list of toxic substances, categorizing them by plant, animal, and mineral origin and providing nomenclature across different traditional medicine systems. The notification invites objections and suggestions on this draft from affected parties, to be submitted within thirty days of the Gazette publication, for consideration by the Central Government.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-07022025-260797 EXTRAORDINARY PART II-Section 3-Sub-section (i) PUBLISHED BY AUTHORITY No. 82] NEW DELHI, TUESDAY, FEBRUARY 4, 2025/MAGHA 15, 1946 902 GI/2025 MINISTRY OF AYUSH NOTIFICATION New Delhi, the 28th January, 2025 G.S.R. 115(E). -The following draft amendment further to amend the Drugs Rules, 1945, the Central Government after consultation with the Ayurveda, Siddha, Unani Drugs Technical Advisory Board, proposes to make amendment in the Schedule E (I) of the Drugs Rules, 1945, in exercise of the powers conferred by section 33N of the Drugs and Cosmetics Act, 1940 (23 of 1940), is hereby published for information of all persons likely to be affected thereby and notice is hereby given that said draft amendment shall be taken into consideration on or after the expiry of a period of thirty days from the date on which the copies of this notification, as published in the official Gazette, are made available to the public; Any objections and suggestions which may be received from any person in respect of draft amendment before the expiry of the aforesaid period above shall be considered by the Central Government. Objections and suggestions to this draft amendment, if any, may be addressed to the Secretary, Ministry of Ayush, AYUSH Bhawan, 'B' Block, GPO Complex, INA, New Delhi – 110023 or emailed at dcc-ayush@nic.in. DRAFT RULES 1. Short title, and commencement: - (1) These rules may be called the Drugs (-- Amendment) Rules, 2025. (2) They shall come into force on the date of their publication in the Official Gazette. 2. In the Drug Rules, SCHEDULE E (I) shall be substituted namely- "LIST OF POISONOUS SUBSTANCES UNDER AYURVEDA, SIDDHA, SOWA-RIGPA, UNANI SYSTEM OF MEDICINE I. Drugs of Plant Origin - +-----+-------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ |S.No.| Botanical Name | Part Used | Name of the Drug in Ayurveda system| Name of the Drug in Siddha system | Name of the Drug in Sowa-Rigpa system| Name of the Drug in Unani system | +=====+=====================================+====================================+====================================+=====================================+================================----+================================----+ | 1. | Papaver somniferum L. | Except seeds | Ahipena | Abini | rGya-men | Afiyun | +-----+-------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 2. | Calotropis procera (Aiton) Dryand. /| Latex, Leaf, Root bark | Arka/ Alarka | Vellerukku/ Erukku | - | Madar | | | Calotropis gigantic (L.) Dryand. | | | | | | +-----+-------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 3. | Semecarpus anacardium L. f. | Fruit, Endosperm | Bhallataka | Cheramkottai | Go-Byi | Baladur | +-----+-------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 4. | Cannabis sativa L. | Except seeds | Vijaya/ Bhanga | KorakkarMuli | So-Ma-Nag-Po | Qinnab/ Bhang | +-----+-------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 5. | Baliospermum solanifoli um (Burm.) | Seeds, Root | Danti | Kattamanakku | - | - | | | Suresh Syn. Baliospermum montanum | | | | | | | | (Willd.) Mull. Arg. | | | | | | +-----+-------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 6. | Datura metal L. / Datura stramonium | Leaf, Root, Seeds, Whole Plant, | Dhattura | Vellaiummathai Seemaiummathai | Dha-Du-Ra | Dhatura | | | L. | flower | | | | | +-----+-------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 7. | Abrus precatorius L. | Seeds | Gunja | Kunri | - | Ratti | +-----+-------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 8. | Croton tiglium L. | Seeds | Jaipala | Nervalam | Dan-Rog | Habb-us-salateen | +-----+-------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 9. | Nerium oleander L. Syn. Nerium | Root, Leaf, Latex | Karaveera | Alari | - | Kaner | | | indicum Mill. | | | | | | +-----+-------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 10. | Gloriosa superba L. | Root | Langali | KalappakiKizahangu | - | - | +-----+-------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 11. | Hyoscyamus niger L. | Seeds | Parasika Yavani | Kurosaniomam | Thang-Phrom-Lang-Thang-rTse | Bazr-ul-banj | +-----+-------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 12. | Aconitum ferox Wallex. Ser. | Root | Vatsanabha / Shringivisha | Nabi / karunabi | Bong-Nga-Nag-Po | Bish | | | Aconitum chasmanthum Stapf ex. Holm.| | | | | | +-----+-------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 13. | Strychnos nuxvomica L. | Seeds | Vishamushti | Etti | Ko- Byi-La | Kuchla | +-----+-------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 14. | Euphorbia neriifolia L. | Latex, leaf, Root | Snuhi | ilaikkalli | - | - | +-----+-------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | | Euphorbia stracheyi Boiss | Root | - | - | Khron-Bu | - | +-----+-------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | | Euphorbia fischeriana Steud | Root | - | - | Dur-Byid | - | +-----+-------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | | Euphorbia wallichii Hookf. | Whole plant | - | - | Thar-nu | - | +-----+-------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | | Euphorbia tirucalli L. (exempted for| Latex | - | Kodaikkalli | - | - | | | external use) | | | | | | +-----+-------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 15. | Nicotiana tabacum L. | Leaf | Dhoomrapatri/ Tamrakoot/ Tamakhu | Pugaielai | - | - | +-----+-------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 16. | Hydnocarpus pentandrus(Buch.-Ham.) | Seeds | Tuvaraka | Neeradimuthu | - | - | | | Oken Syn. Hydnocarpus laurifolia | | | | | | | | (Dennst.) Sleummer, Hydnocarpus | | | | | | | | wightianaBlume | | | | | | +-----+-------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 17. | Argemone Mexicana L. | Latex | Svarnakshiri | Pirammathandu | - | Satyanasi | +-----+-------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 18. | Conium maculatum L. | Latex | - | Koniyam | - | Shokaran | +-----+-------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 19. | Xanthium strumarium L. | Leaf | - | Maruloomatthai | - | - | +-----+-------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 20. | Oxythropis microphylla (Pall.) DC. | Whole plant | - | - | sTag-Sha-Nag-Po | - | +-----+-------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 21. | Anisodus tanguticus (Maxim.) Pascher| Seeds | - | - | Thang-Phrom-Nag-po | - | +-----+-------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 22. | Citrullus colocynthis (L.) Schrad. | Root | - | Atthruthummatti | - | - | +-----+-------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 23. | Cucumis melo L. Syn. Cucumi | Fruit | - | Kattuthumatti | - | - | | | strigonus Roxb. | | | | | | +-----+-------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 24. | Excoecaria agallocha L. | Latex | - | Thillai | - | - | +-----+-------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ Note: Drugs of plant origin listed in Schedule E (I) of the Drugs Rules, 1945 when used in the preparation of Bhasma/ Parpam/Kushta/ Thalsman and Sindhuram/ Chendooram are exempted. II. Drugs of Animal Origin - +-----+-------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ |S.no.| Name of the Drug | Name of the Drug in Ayurveda system| Name of the Drug in Siddha system | Name of the Drug in Sowa & Rigpa | Name of the Drug in Unani | +=====+===============================+====================================+====================================+================================-----+================================----+================================----+ | 1. | Snake poison | Sarpavisha | Paambukkadinanju | sBrul | Sanp | +-----+-------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 2. | Mylabris cichorii L./ Mylabaris| - | Erivandu | - | Telni Makkhi | | | pustulataThumb./ Mylabari | | | | | | | smacilenta/ Lytta vesicorata L.| | | | | +-----+-------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ III. Drugs of Mineral Origin - +-----+---------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ |S.no.| Name of the Drug | Name of the Drug in Ayurveda system| Name of the Drug in Siddha system | Name of the Drug in Sowa & Rigpa | Name of the Drug in Unani | +=====+=======================================+====================================+====================================+================================-----+================================----+================================----+ | 1. | Arsenic trioxide / pentaoxide/ White | Gauripashana | Gowri Padanam / Vellai Padanam | - | Sammul Far | | | Arsenic | | | | | +-----+---------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 2. | Arsenic trisulfide | Haratala | Manosilai | Ba-La | Hartal | +-----+---------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 3. | Arsenic disulphide/ Realgar | Manahashila | Thalagam (aritharam) | Ldon - Ros | - | +-----+---------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 4. | Mercury/ Hydrargyrum | Parada | Rasam | dNyul-Chhu | Para | +-----+---------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 5. | Hydrargyri perchloride/ Corrosive | Savverapashan/ Darachikna* | Veeram* | - | Darachikna* | | | sublimate of Mercuric Chloride(HgCl2) | | | | | +-----+---------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 6. | Hydrargyrisubchloridum/ Mercuric | Rasa Karpura | Rasakarpooram | - | Ras Kappor | | | Subchloride/Per Chloride of Mercury | | | | | | | (Hg2Cl2) | | | | | +-----+---------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 7. | Copper sulphate (CuSo4) | Tuttha | Thurusu | Big-Pan | Tootiya/ Nila Thotha | +-----+---------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 8. | Cinnabar/ Mercuric Sulphide/ | Hingula | Lingam | mTshal | Shingruf | | | Hydrargyribisulphuratum | | | | | +-----+---------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 9. | Copper | Tamra | Sembu | Zangs | Tamba | +-----+---------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 10. | Lead (Plumbum) | Naga | Karuvangam | Zha-Nye | Sisa | +-----+---------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 11. | Tin (Stanus) | Vanga | Velvangam | Gshah-dKar | Qalai | +-----+---------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 12. | Brass | Aara (Pittal) Pinga (Rajareeti) | Pithalai | Ra-Gan | Peetal | +-----+---------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 13. | Stibnite (black antimony) | Anjana(Neelanjana ) | Anjanakal | - | Hajarul Kohl | +-----+---------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 14. | Litharge/ Lead oxide / PbO | Mriddarshringa | Mirutharsingi | - | Murdarsang | +-----+---------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 15. | An amalgam of mercury and sulfur or | Kajjali | Gajjali | - | Kajjali | | | other metals/minerals | | | | | +-----+---------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 16. | Red sulfide of Mercury | Rasasindoor | Rasa chenduram | - | - | +-----+---------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 17. | Green vitriol | Kasisa | Annabedhi | - | Hira Kasees | +-----+---------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 18. | Yellow oxide of mercury | Rasanjana (Tarakshanjana) | Manjalrasanjanam | - | - | +-----+---------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 19. | Galena / Lead (II) Sulfide | Sauviranjana | Saviranjanam | - | Sange Surma | +-----+---------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ | 20. | Copper acetate (Cu(CH3COO)2) / Cupri | Zangar | Zangar | - | Zangar | | | subacetas | | | | | +-----+---------------------------------------+------------------------------------+------------------------------------+-------------------------------------+------------------------------------+------------------------------------+ *Prepared with various process as mentioned in authoritative books prescribed under first Schedule of Drugs and Cosmetics Act, 1940. Note: 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 (I) drug.". [F. No. T-11011/4/2024-DCC (AYUSH)] Dr. KOUSTHUBHA UPADHYAYA, Adviser (Ayurveda) Note: The principal rules were published in the Gazette of India, vide, Notification No. F. 28-10/45-H(1), dated the 21st December, 1945 and last amended, vide, notification number G.S.R. -- - dated the --.

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