Ayush Ministry Expands List Of Poisonous Substances In Traditional Medicines

The Union Ministry of Ayush has expanded the list of poisonous substances covered under the Drugs Rules, 1945, adding more mineral-based ingredients, including mercury, copper, lead, tin and brass, used in traditional systems of medicine.

The amendment brings additional substances under regulatory oversight and reinforces labelling and safety requirements for medicines containing these ingredients, said an official from the Ministry.

The revised Schedule E(I) covers medicines under the Ayurveda, Siddha, Sowa-Rigpa and Unani systems. The amendment, notified after considering public objections and suggestions on a draft issued on January 28, 2025, has come into force from the date of its publication in the Official Gazette.

The expanded list includes several substances containing potentially toxic elements, such as arsenic compounds, mercury and its compounds, copper sulphate, lead oxide, galena, copper acetate and stibnite, also known as black antimony. Other entries include cinnabar, litharge, red sulphide of mercury and amalgams of mercury with sulphur or other metals and minerals, said the official.

The Ministry has also clarified that any ingredient not specifically named in the list but containing arsenic or mercury as a chemical constituent will be treated as a Schedule E(I) drug. The revision expands the coverage of substances of plant and mineral origin across the four traditional systems of medicine, while bringing Sowa-Rigpa into the schedule as a separate category, he said.

Under the revised list, substances of plant origin have increased from 13 to 16 in Ayurveda, from 17 to 20 in Siddha and from eight to 13 in Unani. Sowa-Rigpa has been added with 13 plant-origin substances.

The mineral-origin category has also undergone substantial changes. The list for Ayurveda has expanded from seven substances to 20, while that for Unani has increased from 10 to 17. The revised schedule also includes 18 mineral-based substances for Siddha and nine for Sowa-Rigpa.

Two substances of animal origin — snake poison and types of Mylabris, a beetle — have been included for Ayurveda, Siddha and Unani. Snake poison is also listed for Sowa-Rigpa, said the official.

The changes are significant because the classification of these ingredients under Schedule E(I) carries specific requirements for licensing and labelling. Under the Drugs Rules, applications for licences for patent or proprietary medicines containing Schedule E(I) ingredients must be supported by safety studies and evidence of effectiveness, including relevant published literature and proof of efficacy.

Similar requirements apply to licences for Balya and Poshak medicines, as well as Saundarya Prasadak products, including Husane Afza and Azhagu Sodhan preparations.

The rules also prescribe a specific warning for medicines intended for internal use that contain substances listed in Schedule E(I), as per the official.

Their containers must prominently display the words "Caution: to be taken under medical supervision" in both English and Hindi.

The requirement is intended to ensure that consumers are clearly informed about the need for medical supervision when taking medicines containing these ingredients.

In the earlier Schedule E(I), poisonous substances in Ayurveda and Unani were categorised according to their vegetable, animal and mineral origins, alongside a separate list for Siddha medicines. The revised schedule updates these categories and extends the coverage to Sowa-Rigpa.

The inclusion of additional mineral-based substances is particularly relevant because traditional formulations may use metals and minerals as ingredients. Some preparations undergo specialised processing before use, but the presence of such ingredients makes adherence to prescribed manufacturing, safety and labelling requirements important.

The amendment follows the Ministry's consultation process on the draft notification issued in January 2025. With the revised provisions now in force, manufacturers and applicants seeking licences for medicines containing Schedule E(I) substances will need to comply with the applicable safety, efficacy and labelling requirements, the official added.