Pregabalin will face tighter dispensing and monitoring requirements across India from November 12, 2026, following its inclusion in Schedule H1 of the Drugs Rules, 1945. The regulatory change prohibits over-the-counter (OTC) sales and requires chemists to dispense the medication only against a valid prescription issued by a registered medical practitioner. The Union Ministry of Health and Family Welfare notified the revised classification through notification G.S.R. 377(E), dated May 13, 2026.

The move upgrades pregabalin from Schedule H to Schedule H1, introducing stricter documentation and monitoring requirements for its sale and distribution. Under Schedule H1, pharmacies must maintain a separate register documenting the prescribing practitioner's details, patient information, and medicine supplied. These records must be preserved for the prescribed period, enabling regulatory…