**Executive Summary**
This document is a response to questions regarding the National Policy for Rare Diseases (NPRD), specifically addressing patient registration, financial assistance, treatment status, and the establishment of a National Rare Diseases Fund. The response was provided by the Minister of State in the Ministry of Health and Family Welfare and references ongoing legal proceedings in the Supreme Court, which have stayed directions from the Delhi High Court. The response date is February 6th, 2026.
**Key Points / Main Content**
* **Policy Overview:**
* The Government framed the National Policy for Rare Diseases (NPRD), 2021, to address the challenges posed by rare diseases in India.
* The primary responsibility of healthcare services lies with State Governments, however the Union government has framed this policy to aid this group.
* **Financial Assistance:**
* Financial support up to Rs. 50 lakhs per patient is provided under NPRD, 2021, for treatment of Group 3 rare diseases.
* Advance funds are released to the Centres of Excellence (CoEs) as soon as a demand for money is raised, in accordance with extant General Financial Rules (GFR).
* **Patient Registration and Treatment:**
* Over 2800 Group 3 rare disease patients have been registered under the NPRD to date.
* Patients are treated through designated Centres of Excellence (CoEs) based on recommendations from Rare Disease Committees.
* **National Rare Diseases Fund and Litigation:**
* The Delhi High Court issued directions regarding the adequacy of the Rs. 50 lakhs cap and the National Rare Disease Fund via Order dated 04.10.2024.
* The Supreme Court has stayed the High Court's order via its Order dated 09.12.2024, making the matter sub judice.
**Impact Analysis**
**Patients with Rare Diseases**
* **Impact:**
* Patients with rare diseases may receive financial support of up to Rs. 50 lakhs for treatment under the National Policy for Rare Diseases (NPRD) based on its guidelines.
* The stay order by the Supreme Court may affect the implementation of the National Rare Diseases Fund and associated financial ceilings, leading to uncertainty regarding future support.
* **Action Required:**
* Patients should continue to register under the NPRD through designated Centres of Excellence (CoEs).
* Patients need to remain informed about the ongoing legal proceedings and potential changes to the financial assistance framework.
**State Governments**
* **Impact:**
* State Governments retain the primary responsibility for providing healthcare services, including those for rare diseases.
* The NPRD and its financial provisions provide a framework for supporting rare disease treatment, but States need to coordinate with CoEs.
* **Action Required:**
* State Governments should collaborate with designated Centres of Excellence (CoEs) to ensure proper implementation of the NPRD.
* States need to stay updated on the legal proceedings related to the National Rare Diseases Fund and its potential implications for healthcare funding.
**Centres of Excellence (CoEs)**
* **Impact:**
* CoEs serve as the primary treatment centers for patients with rare diseases, following guidelines from the Rare Disease Committee.
* CoEs receive advance funds based on demand, impacting their ability to provide timely treatment.
* **Action Required:**
* CoEs should continue to register patients under the NPRD and provide treatment based on existing guidelines.
* CoEs need to adhere to General Financial Rules (GFR) when requesting funds.
Key Entities Referenced
National Policy for Rare Diseases (NPRD), 2021: A policy framed to mitigate the challenges posed by rare diseases in India, providing financial support for treatment.
Centres of Excellence (CoEs): Designated centers for treating patients with rare diseases, based on recommendations of the Rare Disease Committee.
Delhi: Location of the High Court that issued directions regarding the adequacy of financial assistance and the creation of a National Rare Diseases Fund.
Ministry of Health and Family Welfare: The primary ministry responsible for the National Policy for Rare Diseases.
National Rare Diseases Fund: A proposed fund intended to provide financial assistance for rare disease treatment, subject to legal proceedings.
GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARRED QUESTION No. 1213
TO BE ANSWERED ON6thFEBRUARY2026
NATIONALPOLICYFOR RARE DISEASES
1213. DR. BYREDDY SHABARI:
Will the Minister of HEALTH ANDFAMILYWELFARE be pleased to state:
(a) the number of patients registered under Group 3(a) of the National Policy for Rare
Diseases, 2021, disease-wise and State/UT-wise;
(b) the number of such patients who have received financial assistance under the said
policy in the country along with the amount disbursed to each patient;
(c) the number of patients who have completed treatment, those who have exhausted the
50 lakh financial assistance cap and require continued or lifelong therapy and those who
have died during treatment or while awaiting financial support, under the said policy;
(d) whether the Government has reviewed the adequacy of the Rs. 50 lakh cap in light of
recent directions of the Hon’ble Delhi High Court regarding the creation of a National
Rare Diseases Fund with flexible financial ceilings and if so, the details thereof; and
(e) the current status and expected timelines for establishing and operationalising the
proposed National Rare Diseases Fund, along with the reasons for any delay, if any, in its
establishment and operationalisation?
ANSWER
THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY
WELFARE
(SHRIPRATAPRAO JADHAV)
(a) to (c) 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 inIndia,the Government hasframedthe National Policyfor Rare Diseases (NPRD),
2021. Under the policy, Financial support up to Rs. 50 lakhs per patient is provided under
NPRD, 2021 for treatment of patients suffering from rare diseases including Group 3
diseases indentified underNPRD. The number of Centre of Excellences underthe policy has
been increased from 8 to 15 since its inception. Till date, More than 2800 Group 3 rare
diseases patients have been registered under the NPRD. The patient of rare diseases are
treated through the designated Centres of Excellence (CoEs) based on the recommendations
of the dedicated Rare Disease Committee of the concerned Center of Excellence (CoE)
within the extantguidelines. Advance funds are released tothe CoEsassoon asa demandfor
moneyisraised by theminaccordancewith the extantGeneral FinancialRules(GFR).
(d) & (e) Vide Order dated 04.10.2024, the Hon’ble High Court of Delhi issued various
directions to the Government regarding adequacy of the Rs. 50 lakhs cap and National Rare
Disease Fund. However, the same has been stayed by the Hon’ble Supreme Court vide its
Order dated09.12.2024.Therefore,the matter issub judice inthe Apex Court.
******