Schedule M and WHO-GMP mean more records, validated equipment, and stricter quality checks—it's a mountain of paperwork and investment, yaar. For my mid-sized unit, upgrading is a tightrope walk between bank loans and keeping the production line running. The obvious answer is that it ensures quality, but the real pinch is that it favours the big players who can afford it easily. I know this because my cousin's small API unit in Ahmedabad had to sell a plot just to fund the new air-handling units they demanded.
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