The Central Drugs Standard Control Organisation (CDSCO) has sent fresh instructions to state and union‑territory drug controllers to inspect every pharmaceutical factory by the end of 2025. The goal is to make sure all plants meet India’s updated good manufacturing practices, known as Schedule M, which were revised last year to meet WHO standards.
In a directive dated November 7, Drug Controller General of India Rajeev Raghuvanshi asked each state agency to submit a monthly inspection report. The reports should detail any problems found and the steps taken to fix them. If a factory fails to meet the revised Schedule M rules, the notice warns that “strict action” will follow.
Schedule M sets the benchmark for quality, safety and testing of medicines. Large pharma companies closed the compliance window in June 2024. Smaller manufacturers were given a longer grace period, ending in December 2025, after earlier extensions. Now the new mandate ends that one‑year leeway for micro, small and medium enterprises (those with revenues of up to ₹250 crore) and pushes them to meet the rules by January 1, 2026.
Industry groups had asked for more time, arguing that the costs of upgrading plants could threaten small businesses. The CDSCO rejected those pleas, citing recent safety concerns. A toxic cough syrup produced in a Chennai factory was linked to child deaths in Madhya Pradesh last September, prompting the regulator to tighten oversight.
The announcement also reminds drug makers that plants must upgrade to WHO‑recommended norms. These upgrades include measures to prevent cross‑contamination and enable routine batch testing during production.
By July, all state councils will report back to CDSCO on each inspection. The regulator stresses that the aim is cleaner, safer medicines for the country, and it will enforce penalties on any non‑compliant factories before the January 2026 deadline.
Source: ianslive
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