DCGI Cuts Drug Approval Timelines Below 150 Days

India's Drug Controller General of India (DCGI) has cut drug approval timelines by more than 50%, with clinical trial approvals now processed in 120, 135 days and marketing authorizations granted in under 150 days, according to Economic Times data for calendar year 2025. DCGI Rajeev Singh Raghuvanshi confirmed that no application exceeded the 150-day mark during the period, a marked departure from prior norms that made India a slower regulatory destination relative to peers. The regulator has also eliminated the requirement for prior approval at the pre-clinical stage, reducing friction at the earliest phase of drug development where speed materially affects R&D investment decisions. For pharmaceutical companies operating in or entering India, the compressed timeline directly improves capital efficiency on pipeline assets and reduces the regulatory risk premium that has historically made India less attractive for early-stage clinical work. Watch whether faster approvals translate into measurable increases in clinical trial filings and foreign sponsor participation over the next two to four quarters.