The National Policy for Rare Diseases (NPRD), 2021, is a government framework formulated by the Ministry of Health and Family Welfare to address the challenges of rare diseases in India. The policy was officially approved by the Union Cabinet and notified on March 30, 2021, following a directive from the Delhi High Court. It replaced the first National Policy for Treatment of Rare Diseases (NPTRD), which was formulated in July 2017 but faced implementation challenges, including lack of clarity on tertiary care support and bringing states on board.
The NPRD, 2021, aims to reduce the incidence and prevalence of rare diseases through a comprehensive preventive strategy, including awareness generation and screening programs. It categorizes rare diseases into three groups: Group 1 for disorders amenable to one-time curative treatment, Group 2 for diseases requiring long-term or lifelong treatment with relatively lower cost, and Group 3 for diseases with available but very high-cost and lifelong therapy.
A key mechanism is the provision of financial support of up to ₹50 lakh per patient for treatment at notified Centres of Excellence (CoEs). This financial assistance is provided for patients suffering from any category of rare disease and is now outside the Umbrella Scheme of Rashtriya Arogya Nidhi. Initially, the financial support was set at ₹20 lakh for Group 1 diseases under the Rashtriya Arogya Nidhi, but this was later expanded to ₹50 lakh for all categories. The policy also connects to the Pradhan Mantri Jan Arogya Yojana norms, as beneficiaries for the financial assistance are extended to about 40% of the population eligible under its criteria. Other provisions include designating 12 CoEs for diagnosis and treatment, establishing a National Consortium for Research and Development on Therapeutics for Rare Diseases (NCRDTRD), and creating a digital platform for voluntary crowdfunding. The policy also provides for exemption from Goods & Services Tax (GST) and Basic Customs Duty on imported drugs for rare diseases.