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Ministry of Ayush revises list of poisonous substances under Drugs Rules, 1945
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Gireesh Babu, New Delhi
February 11 , 2025
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The Ministry of Ayush has issued a draft amendment to the Drugs Rules, 1945, to restructure and update the list of poisonous substances under Ayurveda, Siddha, Sowa-Rigpa, and Unani Systems of medicines under the Schedule E(I) of the Rules.
The proposed amendment to the Schedule E(I) of the Drugs Rules, has been published in the Official Gazette for information of all persons likely to be affected by it, and the Ministry also issued notice to all concerned persons that the draft amendment shall be taken into consideration on or after a period of 30 days from the date of publication.
Any objections and suggestions which may be received from any person in respect of the draft amendment before the expiry of thirty days shall be considered by the Central government, said the notification.
The amendment enlists the poisonous substances on the basis of botanical name and picking up the drugs in the respective systems of medicines prepared using the particular substance.
The draft proposes a list of 24 drugs of plant origin, instead of 13 'drugs of vegetables' listed for the ayurvedic system, 17 for Siddha and eight for Unani system of medicine in the existing Drugs Rules. The draft also mentions that 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.
Two drugs of animal origin - snake poison and types of mylabris, a beetle - have been listed especially for the Siddha and Unani systems, as against snake poison for ayurvedic system and snake poison and beetle poison for Unani systems of medicines in the Rules till now.
The draft amendment also lists 20 drugs of mineral origin, listing the name of these drugs present in each of the four systems of medicines. This is compared to the seven drugs of mineral origin listed under the ayurvedic system, and nine under the Unani system of medicine. The updated list include drugs containing arsenic, copper sulphate, copper, lead, tin, brass, stibnite, litharge, lead oxide and an amalgam of mercury and sulfur or other metals and minerals, green vitriol, yellow oxide of mercury, among others.
Any other ingredients not specifically mentioned in the list containing arsenic or mercury as a chemical constituent shall be considered to be Schedule E (I) drug, adds the draft amendment dated January 28, 2025.
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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