Pregabalin moved to Schedule H1; ₹1,800 cr segment faces tighter chemist compliance
Health Ministry has reclassified pregabalin under Schedule H1, mandating prescription-only sale, separate retailer registers and packaging warnings. Sun Pharma, Torrent, Intas and Micro Labs lead the ₹1,800 crore CNS segment now exposed to stricter chemist-counter controls and audit risk.
Health Ministry has moved pregabalin under Schedule H1, mandating prescription-only sale and separate retailer registers. The ₹1,800 crore segment, sold by Sun Pharma, Torrent, Intas and Micro Labs, faces tighter chemist compliance and packaging warning requirements.
Why this matters
The Schedule H1 reclassification adds pregabalin to a controlled list previously used for habit-forming drugs, raising compliance load on chemists and audit exposure for the four leading manufacturers in the CNS segment.
Retail-brand signals steady at 528 over the last 90 days.