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Health ministry unlikely to extend Schedule M GMP deadline for MSME pharma

Business Standard · business-standard.com Free Intermediate India

December 2025 report that the revised Schedule M good manufacturing practice deadline for MSME drug makers (turnover of Rs 250 crore or less) stayed at 31 December 2025, with risk-based inspections from January 2026, when only about 26% of an estimated 6,500 MSME manufacturers had filed upgrade plans.

  • A new plant must meet revised Schedule M from day one.
  • Expect risk-based inspections; budget for GMP upgrades, not just the building.
  • Third-party (loan licence) manufacturing depends on the maker's Schedule M compliance.
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  4. The January 2025 report of the one-year extension for drug makers under Rs 250 crore turnover, and the conditions attached: a... medicaldialogues.in Article · News Health Ministry grants additional one year relief to MSME pharma companies to upgrade facilities under Schedule M Medical Dialogues
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