Lok Sabha Question No. 304 (UNSTARRED), answered on 2023-07-21
Subject: Tackling Sickle Cell Anemia using CRISPR CAS-9 Therapy
Ministry: HEALTH AND FAMILY WELFARE
Asked by: T.N. Prathapan, Shashi Tharoor

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA UNSTARRED QUESTION NO. 304 TO BE ANSWERED ON 21 ST  JULY, 2023

## TACKLING SICKLE CELL ANEMIA USING CRISP CAS-9 THERAPY

## 304. SHRI T.N. PRATHAPAN: DR. SHASHI THAROOR:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

- (a) whether  any  progress  has  been  made  by  the  Council  of  Scientific  and  Industrial Research  (CSIR) in  its  efforts  to  combat  Sickle  Cell  Anemia  using  CRISPR  CAS-9 therapy and if so, the details thereof;
- (b) whether  the  Government  has  allocated  any  Budget  and  expenditure  for  research  on Sickle Cell Anemia and if so, the details thereof, year-wise, since 2020;
- (c) the  details  of  the  work  accomplished  so  far  on  Sickle  Cell  Anemia  by  the  Gene Therapy  Advisory  and  Evaluation  Committee  (GTAEC)  of  the  Department  of Biotechnology (DBT) and the National Apex Committee for Stem Cell Research and Therapy (NAC-SRT); and
- (d) the  steps  taken/proposed  to  be  taken  by  the  Government  to  achieve  the  target  of eradicating  Sickle  Cell  Anemia  from  India  by  2047,  considering  the  high  cost  and early stage of development of the cure involving gene therapy and stem implants?

## ANSWER

## THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE

## ( PROF. S.P. SINGH BAGHEL )

(a)  Council of Scientific & Industrial Research (CSIR), through its constituent laboratories namely, CSIR-Institute of Genomics and Integrative Biology (CSIR-IGIB), Delhi and CSIRIndian Institute of Chemical Technology (CSIR-IICT), Kolkata has engaged in Research & Development for gene editing approaches for sickle cell anemia therapy under CSIR Sickle Cell Anemia Mission. Under this Mission, CSIR-IGIB along with CSIR-IICB has provided proof-of-concept correction of sickle cell anaemia mutation in patient-derived cells and the increase  in  Fetal  hemoglobin  (HbF)  production  through  Hereditary  Persistence  of  Fetal Hemoglobin  (HPFH)  editing  [publication  in  Proceedings  of  the  National  Academy  of

Sciences, 2019]. CSIR leads are now taken forward towards a dedicated Phase-I clinical trial with funding from Department of Science and Technology and the Ministry of Tribal Affairs.

(b)  T he  details  of  funds  allocated  and  expenditure  for  research  on  Sickle  Cell  Anemia Mission as per Council of Scientific & Industrial Research (CSIR) are as under;

Rs. in lakh

|               | FY 2020-21   | FY 2020-21   | FY 2021-22   | FY 2021-22   | FY 2022-23   | FY 2022-23   |
|---------------|--------------|--------------|--------------|--------------|--------------|--------------|
| Budget        | Released     | Expenditure  | Released     | Expenditure  | Released     | Expenditure  |
| Non Recurring | 577.00       | 577.00       | 190.50       | 52.20        | 50.50        | 50.49        |
| Recurring     | 681.01       | 619.51       | 920.40       | 668.14       | 920.39       | 837.12       |
| Total         | 1258.01      | 1196.51      | 1110.90      | 720.35       | 970.89       | 887.61       |

[Beside above, Rs. 4317.6 lakh has been budget and spent by ICMR on Research Projects for Sickle Cell Anemia since 2020]

(c ) NAC-SCRT National  Apex  Committee  for  Stem  Cell  Research  (NAC-SCRT)  and Gene  Therapy  Advisory  and  Evaluation  Committee  (GTAEC)  was  constituted  as  an independent body of experts and stakeholders and same were notified by the Department of Health Research, Ministry of Health and Family Welfare, Govt. of India in 2009 and 2017 respectively  to  oversee  the  activities  in  the  field  of  stem  cell  research  and  gene  therapy research in India to provide a hand holding for the investigators/ industry and also give preInvestigational New Drug (IND) consultations. However, no specific research work/guidelines  related  to  sickle  cell  anemia  was  allocated/conducted  by NACSCRT  and GTAEC till March 2023.

(d) Sickle cell disease is a genetic blood disease which affects the whole life of patient. It is  more common in the tribal population of India, but occurs in non tribals too. It not only causes anemia but also pain crisis, reduced growth, and affects many organs like lungs, heart, kidney, eyes, bones and the brain.

To eliminate sickle cell disease, Sickle Cell Anaemia Elimination Mission has been launched by Hon'ble Prime Minister from Madhya Pradesh on 1st July, 2023. The Objectives of the Mission is provision of affordable and accessible care to all Sickle Cell Diseased patients, quality  of  care  for  SCD  patients  and  reduction  in  the  prevalence  of  Sickle  Cell  Disease through awareness creation, universal screening of 7 crore people in the age group of 0-40 years in affected 278 districts of tribal areas, and counselling through collaborative efforts of central ministries and state government.

Through ministry  of  tribal  affairs,  awareness  and  counseling  material  has  been  developed. IEC and media activities are adopted for propagation of disease, screening and management. State  Govt.  has  to  play  an  important  role  in  implementation  of  mission  activities.  State Government is doing screening by scheduling outreach campaign in villages and schools/hostels. The preventive measurement and management of disease is also an important component of mission.

Under the National Sickle Cell Anaemia Elimination Mission, patients living with Sickle Cell disease are provided with the following services/ facilities for improving their quality of life through Ayushman Bharat-Health and Wellness Centres (AB-HWC);

- Regular follow-up of diseased individuals at frequent intervals.
- Counseling regarding lifestyle management.
- Nutritional supplementation support through distribution of folic acid tablets.
- Conducting yoga and wellness sessions.
- Management of crisis symptoms and referral to higher facilities.

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