India brings Pregabalin under Schedule H1 controls
Pregabalin supply-chain operators must apply Schedule H1 prescription, register and labelling controls
PIB
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Change
India’s Health Ministry moved Pregabalin from Schedule H to Schedule H1 under the Drugs Rules, 1945, imposing stricter prescription, sale-record and labelling controls.
Why it matters
The notification changes Pregabalin from a standard prescription drug into a Schedule H1-controlled medicine. Retail sale now requires a valid Registered Medical Practitioner prescription, separate prescription-sale register entries, Schedule H1 warning labels on packaging, and compliance exposure under the Drugs and Cosmetics Act for violations.
Implications
- — Retail pharmacies must sell Pregabalin only against a valid Registered Medical Practitioner prescription and maintain a separate Schedule H1 register recording prescription and sale details.
- — Drug manufacturers must update Pregabalin packaging to display the prescribed Schedule H1 Drug Warning label.
- — Distributors, wholesalers, retailers and pharmacists handling Pregabalin must align stock movement and sale controls with Schedule H1 requirements or face penal action under the Drugs and Cosmetics Act and Rules.
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