The Union Ministry of Ayush amended the Drugs Rules, 1945, to revise Schedule E(I), which lists poisonous substances used in medicines prepared under the Ayurveda, Siddha, Sowa-Rigpa and Unani systems. The revised schedule expands the list of mineral-based substances and updates the classification of plant- and animal-derived ingredients used in traditional medicines. The amendment follows the Ministry’s consideration of objections and suggestions received from the public on a draft notification issued on January 28, 2025. It came into force on the date of its publication in the Official Gazette.
Revised Schedule E(I) Adds More Mineral-Based Substances
The amendment significantly expands the list of mineral-origin substances classified as poisonous under Schedule E(I). These include mercury, copper, lead, tin and brass, along with several chemical compounds and mineral preparations. The revised schedule identifies substances such as arsenic trioxide and arsenic pentoxide, arsenic trisulphide, realgar, mercury, copper sulphate, cinnabar (mercuric sulphide), lead oxide (litharge), stibnite, galena, copper acetate, green vitriol and yellow oxide of mercury.
It also includes amalgams of mercury with sulphur, metals or other minerals, as well as red sulphide of mercury and other specified substances. The Ministry has further clarified that any ingredient not explicitly listed but containing arsenic or mercury as a chemical constituent will also be treated as a Schedule E(I) drug.
Schedule Updates Plant-Origin Substances Across Four Systems
The revised schedule increases the number of plant-origin substances listed under three traditional medicine systems and introduces a separate listing for Sowa-Rigpa.
The updated numbers are as follows:
Ayurveda: 16 plant-origin substances, up from 13.
Siddha: 20 plant-origin substances, up from 17.
Unani: 13 plant-origin substances, up from eight.
Sowa-Rigpa: 13 plant-origin substances listed under the revised schedule.
These changes expand the scope of Schedule E(I) across the four systems of traditional medicine.
Animal-Origin Substances Also Included
The revised schedule identifies two substances of animal origin: snake poison and specified types of Mylabris, a genus of blister beetles. Snake poison is listed for Ayurveda, Siddha, Unani and Sowa-Rigpa, while the two animal-origin substances are included for the Ayurveda, Siddha and Unani systems as specified in the schedule.
Mineral-Origin Listings Expanded Across Traditional Medicine Systems
The amendment also substantially revises the number of mineral-origin substances covered under Schedule E(I).
According to the revised schedule:
Ayurveda: 20 mineral-origin substances, compared with seven previously.
Unani: 17 mineral-origin substances, compared with 10 previously.
Siddha: 18 mineral-origin substances are included in the revised list.
Sowa-Rigpa: Nine mineral-origin substances have been added under the revised schedule.
These changes broaden the regulatory classification of mineral-based ingredients used in traditional medicines.
Exemptions for Certain Traditional Preparations
The revised provisions exempt plant-origin drugs listed under Schedule E(I) when used in preparing specified traditional formulations, including Bhasma, Parpam, Kushta, Thalsman, Sindhuram and Chendooram. The exemption applies to the specified preparations under the applicable provisions of the Drugs Rules, 1945.
Licensing Requirements for Medicines Containing Schedule E(I) Ingredients
Under the Drugs Rules, 1945, manufacturers seeking licences for patent or proprietary medicines containing Schedule E(I) ingredients must meet specified safety and efficacy requirements. These include safety studies and evidence of effectiveness, supported by relevant published literature and other acceptable proof. Similar requirements apply to licensing Balya and Poshak medicines and specified beauty-related preparations, including Saundarya Prasadak products and their corresponding Unani and Siddha categories.
Mandatory Medical-Supervision Warning on Labels
The amendment also highlights the importance of appropriate labelling for traditional medicines containing Schedule E(I) substances.
Under the applicable labelling requirements, containers of medicines intended for internal use and containing substances listed in Schedule E(I) must prominently display the warning:
“Caution: To be taken under medical supervision.”
The warning must appear in both English and Hindi.
As reported by pharmabiz.com, by expanding Schedule E(I) and updating the classification of potentially poisonous ingredients, the Ministry of Ayush aims to strengthen the regulatory framework governing traditional medicines. Manufacturers and other stakeholders should review the revised schedule and applicable licensing and labelling requirements to ensure compliance.