India mandates tighter drug quality norms, raising compliance pressure across pharma supply
Revised Schedule M quality norms are now mandatory, requiring non-compliant manufacturers to upgrade or exit. The policy push also spans domestic API production, biologics, Jan Aushadhi expansion, trade-margin controls and closer medical-device procurement scrutiny.
India is enforcing revised WHO-GMP quality norms, requiring non-compliant drugmakers to upgrade or close. The government is also weighing trade-margin controls, expanding Jan Aushadhi offerings, supporting domestic API production and prioritising biologics, quality surveillance and tighter medical-device procurement scrutiny.
Why this matters
The move follows a House panel's call for a permanent cap on anti-cancer drug trade margins, extending policy pressure from medicine pricing to manufacturing quality and procurement.
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