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India’s pharmaceutical and clinical research sectors stand at a critical inflection point. As the world’s third-largest medicine producer by volume and an emerging hub for biologics, diagnostics and digital therapeutics, India requires a regulatory framework that is agile, transparent and grounded in scientific expertise. While recent steps by the Central Drugs Standard Control Organisation (CDSCO), including e-governance platforms and updated trial rules, are commendable, persistent challenges constrain its effectiveness.