Leveraging India’s Patent Regime for Affordable Orphan Drug Development: A Pathway for Not-for-Profit Innovation

India's distinctive patent law environment presents unique opportunities for notfor-profit organizations aiming to develop orphan drugs for rare diseases.Section 3(d) of the Indian Patent Act, which restricts the patentability of new forms of known substances lacking enhanced therapeutic efficacy, reduces intellectual property barriers that typically hinder drug repurposing efforts in other jurisdictions.The legal framework explored in this paper combined with India's compulsory licensing regime, offers a strategic advantage for mission-driven entitles seeking to advance treatments for underserved patient populations.This paper explores how notfor-profit organizations can leverage these legal provisions within the broader regulatory ecosystem, encompassing 'National Policy for Rare Diseases of 2021', 'Drugs and Cosmetics Act' and patent protection strategies.Through critical analysis of these legal and institutional frameworks, this paper finally proposes actionable strategies for strengthening orphan drug development by not-for-profit entities in India, ultimately aiming to deliver accessible and affordable treatments to individuals affected by rare diseases.