National Policy on Rare Diseases 2026: Strengthening Indigenous Manufacturing and Health Equity

The Ministry of Health and Family Welfare (MoHFW) has unveiled the National Policy on Rare Diseases (NPRD) 2026, marking a significant shift toward self-reliance in the treatment of rare genetic disorders. Rare diseases, often referred to as 'orphan diseases' because they affect a small percentage of the population, have historically been neglected by the pharmaceutical industry due to the high cost of research and limited market size. The 2026 policy addresses this by offering robust financial incentives to domestic pharmaceutical companies for the indigenous development and manufacturing of 'orphan drugs'. Key highlights of the policy include the creation of a dedicated fund for R&D, streamlined regulatory pathways for clinical trials of rare disease treatments, and a Production Linked Incentive (PLI) style framework for local manufacturers. By fostering a domestic ecosystem, the government aims to drastically reduce the cost of treatment, which currently runs into lakhs or even crores of rupees per patient annually, often making it inaccessible to the common citizen. Furthermore, the policy seeks to decrease India’s import dependency, as nearly 80-90% of drugs for rare diseases are currently sourced from international markets.