Parliament Question: Financial Assistance under National Policy for Rare Diseases, 2021

GOVERNMENTOFINDIA MINISTRYOFHEALTH AND FAMILYWELFARE DEPARTMENTOFHEALTH AND FAMILYWELFARE LOK SABHA UNSTARREDQUESTION NO. 4623 TO BE ANSWERED ON20THMARCH 2026 FINANCIALASSISTANCEUNDERNATIONALPOLICYFORRAREDISEASES, 2021 4623.SHRIGLAKSHMINARAYANA: Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate: (a) the total number of patients sanctioned one-time financial assistance of up to Rs. 50 lakh under the National Policy for Rare Diseases, 2021 since its inception, year-wise and State- wise; (b) the number of beneficiaries who have exhausted the sanctioned assistance, year-wise along with the number of beneficiaries currently continuing treatment and those who have discontinued treatment due tolackof funds; (c) the total funds allocated, released and utilised under the said policy during the last five years, year-wisealong with the amountremainingunutilised; (d) whether the Government maintains data on patients who are presently without treatment after exhausting the financial assistance and if so, the details thereof including age-wise and disease-wise; (e) whether representations have been received from patients seeking continuation of financialsupport for chronic and ultra-rare disease patientsrequiringlifelongtherapy; and (f) the steps taken or proposed to be taken by the Government to ensure continuity of treatment for patients who have exhausted the one-time assistance limit under the National Policyfor Rare Diseases, 2021? ANSWER THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY WELFARE (SHRIPRATAPRAO JADHAV) (a) Ministry of Health andFamily Welfare hasframed National Policy for Rare Diseases (NPRD), 2021. Health being a State subject, the primary responsibility of providing healthcare services is that of the State Governments. However, to mitigate the challenges posed by Rare Diseases in India, the policy provides financial and medical assistance for treatment of Rare Diseases in the designated Centers of Excellence (CoEs). Rare Disease patients can get treatment in any of the 15 CoEs irrespective of States. The lists of total number of patients sanctioned financial assistance of up to Rs. 50 lakhs based on the recommendation of the dedicated Rare Disease Committees of the CoEs under NPRD, year wise andCoE wise isannexed.(b) Around 1545 beneficiaries are currently continuing treatment under NPRD. The following table shows the number of patients whose treatment has been discontinued after exhaustion of the financial assistance providedtothem underNPRD: S.No. Year No. of patients 1. 2023 37 2. 2024 42 3. 2025 63 4. 2026 22 (c) The funds released to the CoEs under the policy for treatment of rare diseases, year- wise, are asfollows: (In Crores INR) S.No. Financial Year Fundsreleased 1. 2021-22 3.15 2. 2022-23 35.00 3. 2023-24 109.00 4. 2024-25 116.00 Unutilized funds with the CoEs are carried over to next year for utilization. As on date, Rs. 83.14cr.iscurrentlyavailable with the CoEsfor utilization. (d) There are around 164 patients who have exhausted their financial assistance under NPRD. Most of these patients are suffering from Group III rare diseases, where the cost of treatmentexceeds the financialassistance providedunderNPRD. (e)and(f) Representations have been received from patients seeking continuation of financial support for treatment of some rare diseases. In regard to ensuring continuity of treatment and increasing the one-time assistance limit under the policy, the matter is sub judice before Hon’ble SupremeCourt of India inPetition for SpecialLeavetoAppeal (C) No. 28777/2024, wherein Hon’ble Court has directed the Union of India tocomply with the terms and conditions of the extant guidelines of the policy. Further, following measures have been takentoensure the welfare of rare disease patients:  Some Made-in-India drugs have become available at 1/10th of the price of the imported Reference Listed Drug (RLD) as NITI Aayog constituted a Committee for ‘Drugs and Dosage Formsfor Rare Diseases: Engagementwith Manufacturers’ tofast track indigenous development and marketing of identified orphan drugs by engaging with domestic manufacturers.  The Ministry of Finance provides exemption from Basic Customs Duty (BCD) and Integrated Goods and Services Tax (IGST) on most of the drugs, medicines and Food for SpecialMedical Purposes(FSMP),subject toextantrules.  The Department of Pharmaceuticals has initiated implementation of ‘Production Linked Incentive’ scheme for pharmaceuticals which provides financial incentives to the manufacturers selected for domestic manufacturing of various product categories, includingrare disease medicines.Annexure Total no.ofpatientssanctioned onetime financialassistance of uptoRs.50 Lakh Centersof Excellence(CoEs) underNPRD 2021 2022 2023 2024 2025 2026 All India Institute of Medical 19 37 176 107 28 Sciences, NewDelhi Maulana Azad Medical College, 0 4 6 16 0 Delhi Sanjay Gandhi Post Graduate Institute of Medical Sciences, 0 16 25 32 26 Lucknow Post Graduate Institute of Medical 42 180 320 300 57 Educationand Research, Chandigarh Centre for DNA Fingerprinting & Diagnostics with Nizam’s Institute of 19 45 100 138 26 Medical Sciences, Hyderabad King Edward Medical Hospital, 0 10 23 35 4 Mumbai Institute of Post-Graduate Medical 4 13 20 80 16 Educationand Research, Kolkata Center for Human Genetics (CHG) with Indira Gandhi Hospital, 44 118 157 170 173 Bengaluru Institute of Child Health and Hospital 0 12 17 9 0 for Children(ICH & CH), Chennai All India Institute of Medical 0 0 6 43 18 Sciences (AIIMS), Jodhpur Sree Avittam Thirunal Hospital (SAT), Government Medical College, 0 13 28 43 0 Thiruvananthapuram All India Institute of Medical 0 0 0 1 0 Sciences, Bhopal Regional Institute of Medical 0 0 0 0 0 Sciences, Imphal (New CoE) Assam Medical College andHospital, 0 0 0 0 0 Dibrugarh (New CoE) All India Institute of Medical 0 0 0 0 0 Sciences, Patna(New CoE)