India Makes Disclosure of Excipients on Drug Labels Mandatory

Government of India has published the Gazette notification to make disclosure of Qualitative details of Excipients mandatory on the drug label. As per the Gazette notification issued on 18th August, 2025 the modified Rule 96 making disclosure of excipient details on the drug label will be effective from 1 March 2026. The revised Rule 96, clause ix of the Drugs & Cosmetics Act & Rule, (Part IX, Labelling and Packing of Drugs other than Homoeopathic Medicines) will read as:

(Rule) 96. Manner of Labelling.—(1) Subject to the other provisions of these rules, the following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any drug and on every other covering in which the container is packed, namely:—

“(ix) qualitative details of excipients.”

Government of India had proposed amendments to drug labelling norms, including disclosure of excipients on the drug label in July 2024 (G.S.R. 391 (E).

Reference:

Gazette Notification: 2025.08.18_G.S.R. 554(E) – (Inclusion of details of excipient on every strip of medicines under Rule 96, in sub-rule (7) of Drugs Rules, 1945)