India's Health Ministry has expanded Schedule H2 QR code requirements from a curated list to entire therapeutic classes, shifting from revenue-based to risk-based regulation. This aims to track defective batches, combat counterfeit drugs, and address concerns of foreign regulators. The move, along with the Jan Vishwas Act 2026, redefines enforcement priorities, but implementation hinges on real-time database access, pharmacist vigilance, and MSME support.
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- ›Schedule H2 introduced: 2022-23
- ›New coverage: Entire therapeutic classes
- ›Target this Data: Schedule H2 introduced in 2022-23; expansion to entire therapeutic classes in 2026.
- ›Target this Nodal Body: Health Ministry (Ministry of Health and Family Welfare).
- ›Target this Legal Point: Jan Vishwas Act 2026 — distinguishes procedural vs substantial non-compliance.
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