The revised Schedule M and WHO-GMP require a serious investment in quality systems—data integrity, upgraded facilities, and robust documentation. For a mid-sized unit, upgrading means massive capital expenditure and operational disruption, often a fight for survival. I see this from my metro desk, but my old family home in Himachal has that same leaky roof; everyone knows what needs fixing, but finding the lakhs before the rain comes is the real battle, yaar.
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