Regulatory Milestone: The 2026 CDSCO Biologics Guidelines

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2026-01-20 10:27:32 -

In mid-2025, the CDSCO (Central Drugs Standard Control Organisation) released the "Revised Guidelines on Similar Biologics," which became the enforcement standard for 2026. These rules streamline the approval process by aligning Indian standards with the WHO and EMA (European Medicines Agency) frameworks. This regulatory harmony is a game-changer, as it allows data from Indian clinical trials...

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