By: Rahul Koul
Last updated : April 14, 2026 11:38 am
Outlines 1,500-member internal cadre, digital regulatory system, and faster SEC-led reviews
Dr Rajeev Raghuvanshi, Drug Controller General of India (DCGI) has detailed the structural changes underway at the Central Drugs Standard Control Organization (CDSCO) to strengthen long-term internal capacity and improve approval efficiency at the India Pharma 2026 event held by Department of Pharmaceuticals, FICCI and IPA in New Delhi.
"A major reform includes the sanctioning of 1,500 positions to build an internal regulatory cadre within CDSCO, a move designed to address longstanding manpower gaps and reduce dependence on external review resources," said Dr Raghuvanshi who also highlighted efforts to rationalise the regulatory burden by removing certain categories of drugs from direct CDSCO purview, alongside proposed changes based on stakeholder feedback that are expected to further shorten clinical trial review timelines.
Speaking at a high-level session on regulatory transformation, DCGI said that the reforms are already translating into measurable outcomes.
DCGI said that in the last one year, clinical trial approvals have consistently been completed within 150 days, representing more than a 50% reduction in timelines, while also improving both the quality and volume of approvals. "The faster review cycle was seen by participants as a major step toward improving predictability in India’s regulatory environment, an increasingly important factor for innovation-led pharma and biotech investments."
Looking ahead, Raghuvanshi said CDSCO is working on a digital regulatory system currently on the anvil, which is expected to bring researchers and innovators into regulatory conversations much earlier—from Phase 1 and potentially even discovery-stage discussions. "The move could significantly improve regulatory preparedness for novel therapies, biologics, and early-stage translational research, while reducing avoidable delays later in development."
The CDSCO is establishing a Digital Drugs Regulatory System (DDRS) as a unified, single-window portal to streamline pharma regulations, replacing the older SUGAM portal with an open-architecture platform. This system streamlines approvals, Clinical Trial applications, and online manufacturing/sale licenses, significantly reducing approval timelines for faster, more transparent compliance.
Dr Raghuvanshi acknowledged, however, that despite the progress made, the Subject Expert Committee (SEC) remains the biggest pain point, with structural limitations in external resource availability continuing to affect review speed.
The proposed internal cadre expansion, he said, is expected to gradually address these bottlenecks by building stronger in-house scientific and regulatory review capabilities.