**Executive Summary**
This document addresses Starred Question No. 190 in Lok Sabha regarding the treatment of Sickle Cell Anemia, to be answered on December 12, 2025. It discusses the government's response to recent developments in gene therapy for SCD, including research from Yale University and the launch of an indigenous CRISPR-based gene therapy named BIRSA-101. The document also outlines the National Sickle Cell Anaemia Elimination Mission (NSCAEM) and available services for SCD patients, aiming for a "Sickle Cell-Free India by 2047."
**Key Points / Main Content**
* **Gene Therapy Developments:**
* Two gene therapies for Sickle Cell Disease (SCD) have been recently approved by the U.S. Food and Drug Administration (FDA), researched by doctors at Yale University.
* In November 2025, the Government of India launched BIRSA-101, an indigenously developed CRISPR-based gene therapy for SCD, through the Ministry of Science & Technology.
* A technology-transfer agreement has been signed with the Serum Institute of India (SII) for production and future scale-up.
* The initiative aims to provide an affordable, accessible treatment.
* **National Sickle Cell Anaemia Elimination Mission (NSCAEM):**
* Aims to provide affordable, accessible, and quality care to SCD patients.
* Screenings are conducted at all health facilities from District Hospitals upto Ayushman Arogya Mandir (AAM) level to identify patients and carriers.
* Hydroxyurea, a drug for managing SCD, is included in the National Health Mission (NHM) Essential Drugs List.
* **Services for SCD Patients:**
* Free Hydroxyurea drug.
* Regular follow-up of diseased individuals.
* Counseling on lifestyle management, pre-marriage, and pre-natal decisions.
* Nutritional support through folic acid tablets.
* Yoga and wellness sessions.
* Management of crisis symptoms and referral to higher facilities.
* **Support for States/UTs:**
* The Ministry provides technical and financial support for screenings and drug procurement for sickle cell anemia, based on proposals received as Programme Implementation Plans (PIPs) under NHM.
**Impact Analysis**
**Stakeholder: SCD Patients and Carriers**
* **Impact**: Access to affordable and accessible gene therapy (BIRSA-101) and improved quality of life through NSCAEM and associated services.
* **Action Required**: Participate in screenings at health facilities from District Hospitals upto Ayushman Arogya Mandir (AAM) level.
**Stakeholder: States/UTs**
* **Impact**: Opportunity to receive technical and financial support for SCD screening and drug procurement.
* **Action Required**: Submit Programme Implementation Plans (PIPs) to the Ministry under NHM.
**Stakeholder: Ministry of Health and Family Welfare**
* **Impact**: Responsible for overseeing the implementation of NSCAEM and providing support to States/UTs.
* **Action Required**: Provide technical and financial support to States/UTs based on approved PIPs.
**Stakeholder: CSIR-Institute of Genomics & Integrative Biology (CSIR-IGIB) and Serum Institute of India (SII)**
* **Impact**: Development and production of BIRSA-101 gene therapy.
* **Action Required**: Continue to collaborate and ensure the successful production and distribution of the therapy.
Key Entities Referenced
National Sickle Cell Anaemia Elimination Mission (NSCAEM): A mission that aims to provide affordable, accessible and quality care to Sickle Cell Disease (SCD) patients, including screenings at various health facilities.
BIRSA-101: An indigenously developed CRISPR-based gene therapy for Sickle Cell Disease (SCD).
Ministry of Health and Family Welfare: The Indian government ministry responsible for providing technical and financial support for Sickle Cell Disease (SCD) screenings and drug procurement.
National Health Mission (NHM): A national mission under which Hydroxyurea has been included in the Essential Drugs List for SCD treatment.
GOVERNMENT OFINDIA
MINISTRY OFHEALTH AND FAMILYWELFARE
DEPARTMENT OF HEALTH AND FAMILYWELFARE
LOK SABHA
STARRED QUESTION NO. 190
TO BE ANSWERED ON THE 12TH DECEMBER, 2025
TREATMENT OF SICKLE CELLANEMIA
†*190. SHRI GAJENDRASINGH PATEL:
Will the MINISTER OF HEALTH AND FAMILY WELFARE be pleased
to state:
(a) whether a successful treatment/therapy for Sickle Cell Anemia has reportedly
been discovered by the Yale University in the United States of America and if so,
the details thereof; and
(b) whether the Government proposes to provide treatment/therapy to patients of
Sickle Cell Anemia across the country in consultation with the said University and
if so, the details thereof?
ANSWER
THE MINISTER OFHEALTH AND FAMILYWELFARE
(SHRI JAGAT PRAKASH NADDA)
(a)& (b) AStatement is laid on the Table of the House.STATEMENT REFERRED TO IN REPLYTO LOK SABHA
STARRED QUESTION NO. 190 FOR 12TH DECEMBER, 2025
(a) & (b) As per news reports, two gene therapies for Sickle Cell Disease (SCD) have
recently been approved by the U.S. Food and Drug Administration (FDA). These
gene therapies have been researched by the doctors of the Yale University (United
States of America).
In November 2025, Government of India launched an indigenously developed
CRISPR-based gene therapy for Sickle Cell Disease (SCD), named BIRSA-101,
through the Ministry of Science & Technology. The therapy has been developed by
CSIR-Institute of Genomics & Integrative Biology (CSIR-IGIB), and a
technology-transfer agreement has been signed with the Serum Institute of India (SII)
for production and future scale-up. The initiative aims to provide an affordable,
accessible treatment for affected populations—particularly tribal and high-burden
regions—and aligns with the national vision of a “Sickle Cell-Free India by 2047. ”
Further, under the National Sickle Cell Anaemia Elimination Mission (NSCAEM),
which aims to provide affordable, accessible and quality care to SCD patients,
screenings are conducted at all health facilities from District Hospitals upto
Ayushman Arogya Mandir (AAM) level across the country to identify Sickle Cell
diseased patients and carriers. Hydroxyurea, a drug which is used for management of
Disease, has been included in National Health Mission (NHM) Essential Drugs List
at Sub-Health Centres, Primary Health Centres (PHC)/ Urban PHC, Community
Health Centres (CHC) and District Hospitals for SCD treatment. Patients living with
SCD are provided with the following services/ facilities for improving their quality of
life through AAMs:
Free of cost Hydroxyurea drug is provided.
Follow-up of diseased individuals at frequent intervals.
Counseling regarding lifestyle management, pre-marriage and pre-natal
decisions.
Nutritional supplementation support through distribution of folic acid tablets.
Conducting yoga and wellness sessions.
Management of crisis symptoms and referral to higher facilities.
This Ministry provides technical and financial support to the States/UTs for
conducting screenings and procurement of drugs for sickle cell anaemia, based on the
proposals received in the form of Programme Implementation Plans (PIPs) under
NHM.
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