Drugs Amendment Rules 2025 notified through G.S.R. 127(E) on 12 February 2025, extending the revised Schedule M compliance deadline for MSME pharmaceutical manufacturers (annual turnover of Rs.250 crore or less) to 31 December 2025 through a conditional application architecture under Form A to the Central Licence Approving Authority.
Prevented simultaneous manufacturing-licence exposure for an estimated 8,500 MSME pharma units across India while preserving the WHO-GMP convergence intent of the December 2023 revision. Established a conditional-extension template for subsequent compliance-timeline recalibrations where regulatory convergence encounters MSME transition capacity.