CRO Reforms: Tilting Scale towards Accelerated Growth & Transparency

India's clinical research ecosystem is undergoing a major transformation, driven by a wave of regulatory reforms and rapid market expansion.

- Ayesha Siddiqui

Valued at $2.05 billion in 2024, the country's clinical trials market is projected to grow at a CAGR of 8.64 per cent through 2030. This momentum has made India the third-largest destination for clinical trials globally, with nearly 18,000 new studies registered in 2024, a 50 per cent increase over the year (Invest India).

To further enhance the sector, the Central Drugs Standard Control Organisation (CDSCO) has introduced the New Drugs and Clinical Trials (NDCT) (Amendment) Rules, 2024. The new framework includes the mandatory registration of contract research organisations and proposed amendments that simplify test licence and bioequivalence (BA/BE) study approvals. These measures aim to shorten drug development timelines and strengthen India's role in global clinical research. The launch of the SUGAM portal and the One Nation-One Drug Licensing System has replaced paper-based applications with online submissions, improving transparency, reducing delays, and standardising approvals across states.

As India implements the new rule, the country's clinical research landscape is entering a new phase. To understand how these changes are being viewed within the industry, BioSpectrum India gathered perspectives from organisations across the clinical research value chain. Their collective views reflect a cautiously optimistic sector that sees the reforms as both a compliance requirement and a growth opportunity. The 2024 New Drugs & Clinical Trials (Amendment) Rules have received strong support from India's clinical research community, which views them as a pivotal step toward global alignment, efficiency, and greater regulatory clarity.