India classifies pregabalin as Schedule H1, requiring RMP prescriptions and tighter sales records

Penal action will follow for violations and non-compliance as India tightens controls on the sale of pregabalin, a move framed as a response to misuse and abuse, particularly among youth, The Hindu reported. ^[1]

The Union Health Ministry has now brought pregabalin under Schedule H1 of the Drugs Rules, 1945, through a gazette notification dated May 20, 2026. ^[1] Under the revised classification, the drug can be sold only against a valid prescription issued by a Registered Medical Practitioner (RMP). ^[1]

For retailers, the change comes with fresh record-keeping requirements: shops must maintain a separate register recording details of prescriptions and sales of pregabalin. ^[1] Manufacturers, meanwhile, must prominently display the prescribed “Schedule H1 Drug Warning” label on product packaging. ^[1]

The Ministry said the decision was taken “in view of reports received from certain States regarding the misuse and abuse of Pregabalin, particularly among youth.” ^[1] It also warned that violations and non-compliance would attract penal action under the Drugs and Cosmetics Act, 1940, and related rules. ^[1]