Pregabalin Added to Schedule H1 Under Drugs (Second Amendment) Rules, 2026

The Government of India has notified that Pregabalin has been included in Schedule H1 (Serial No. 51) under the Drugs (Second Amendment) Rules, 2026. The move introduces stricter controls on the sale and dispensing of the medicine to address concerns regarding misuse and dependence.

Key Details:

• Pregabalin has been added to Schedule H1 as Serial No. 51.

• The medicine will now be available only against a valid prescription.

• Over-the-counter (OTC) sale of Pregabalin will no longer be permitted.

• Retail pharmacies and chemists will be required to maintain detailed sale records.

• Prescriptions and related records must be preserved for three years.

• The new provisions will come into force 180 days after notification.

• The measure aims to curb misuse and dependency while ensuring access for patients requiring treatment.