Mandatory Excipients Disclosure on Drug Labels from March 2026: Health Ministry
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.
Rule 96 of the Drugs and Cosmetics Rules, 1945, governs the labelling requirements for all pharmaceutical products sold in India. It specifies the information that must appear on drug packaging, including the name and quantity of active ingredients, manufacturing and expiry dates, storage conditions, batch number, and directions for use. The recent amendment now mandates that the qualitative details of excipients—the inactive substances used in drug formulation—be printed on the label of the innermost container, ensuring greater transparency for healthcare professionals and patients.
The move follows recommendations of the Drugs Technical Advisory Board (DTAB), which had earlier emphasized the importance of including excipient details on labels to enhance patient safety and prescribing decisions.
The Health Ministry also noted that the changes were introduced after due consultation and are aimed at ensuring better compliance and safety standards for consumers as well as healthcare professionals.
