Study on Accelerated Drug Approval Pathways in India for Life-Threatening Conditions: A Regulatory Perspective

Abstract

: Accelerated drug approval pathways in India have gained prominence to ensure timely access to therapies for life-threatening and rare diseases. The New Drugs and Clinical Trials Rules (NDCTR), 2019, introduced provisions for expedited and conditional approvals, allowing waiver of local trials under specific circumstances. This study examines India’s regulatory mechanisms, comparing them with global accelerated approval models to assess their effectiveness and limitations. Findings reveal improved timelines and structured procedures but highlight gaps in post-marketing surveillance, transparency, and consistency in applying waivers. Strengthening evidentiary standards, stakeholder communication, and regulatory guidance is essential to balance rapid access with patient safety and efficacy assurance.