Mandatory Excipients Disclosure on Drug Labels from March 2026: Health Ministry
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New Delhi: All drug labels will now be required to clearly disclose the qualitative details of excipients along with the date of expiry, as the Union Health Ministry has notified the Drugs (Second Amendment) Rules, 2025 through a Gazette notification. The amended rules will come into force from March 1, 2026.
According to the Gazette notification, Rule 96 of the Drugs and Cosmetics Rules, 1945, has been revised to strengthen transparency in drug labelling. “The qualitative details of the excipients used in the drug along with the date of expiry of potency, wherever applicable, shall be printed on the label of the innermost container of the drug,” the amendment states.
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