Overview
- The Union Health Ministry published a Gazette notification on May 20 that moves pregabalin from Schedule H to Schedule H1 and gives a 180-day window for nationwide implementation.
- Under the new rules pregabalin will be sold only on a valid prescription from a registered medical practitioner and manufacturers must display a Schedule H1 warning on packaging.
- Retailers must keep a separate register logging patient and prescriber details and quantities dispensed with records retained for inspection, and violations can attract penalties under the Drugs and Cosmetics Act, 1940.
- The reclassification follows a 2024 DCGI sub‑committee review and a DTAB recommendation after state reports of youth misuse, seizures and illegal sales in places including Punjab, Haryana and Delhi.
- Major generic makers and distributors such as Pfizer, Sun Pharma, Torrent, Intas and Micro Labs will need to alter packaging and supply‑chain practices, and pharmacists should expect surprise inspections and tighter prescription checks that may change patient access and pharmacy operations.