It’s a government framework that supports orphan drug development through streamlined approvals, financial incentives, faster & priority reviews, patient assistance programs, and dedicated regulatory paths.
GNH India helps manufacturers and patients by facilitating supply under these policies—through Named Patient, Managed Access, Global Access programs, warehousing, and import licensing.
The policy defines and categorizes 63 rare diseases into three groups and offers financial aid up to ₹50 lakh per patient via Rashtriya Arogya Nidhi. It also designates 12 Centres of Excellence.
A Central Technical Committee periodically reassesses disease inclusion, with an aim to support diagnosis, treatment, research, awareness, and registry creation.
Despite the NPRD’s promise, more than 300 rare-disease patients in India—primarily children with Lysosomal Storage Disorders—remain treatment-deprived. Nearly 50 have died since 2022 due to exhaustion of the ₹50 lakh cap.
The Delhi High Court (Oct 2024) ordered creation of a ₹974 crore national fund and financing beyond the cap, but final execution is pending at the Supreme Court.
For patients with life-threatening rare conditions, a few months' delay can mean the difference between recovery and tragedy. GNH India's policy-driven support bridges vital gaps—ensuring critical medicines reach those who need them most.