Lok Sabha Question No. 4850 (UNSTARRED), answered on 2022-04-01
Subject: Stem Cell Research
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Sunil Dattatray Tatkare, Subhash Ramrao Bhamre, Anurag Sharma, Supriya Sadanand Sule, Amol Ramsing Kolhe, DNV Senthilkumar. S.

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

## LOK SABHA UNSTARRED QUESTION NO. 4850 TO BE ANSWERED ON 1 st  APRIL, 2022

## STEM CELL RESEARCH

## 4850    SHRI SUNIL DATTATRAYTATKARE:

DR. SUBHASH RAMRAO BHAMRE:

SHRI ANURAG SHARMA:

SHRIMATI SUPRIYA SULE:

DR. AMOL RAMSING KOLHE:

DR. DNV SENTHILKUMAR. S.:

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

- (a) the details of guidelines formulated by the Government to regulate stem cell research and therapy in the country;
- (b) whether the Government has put in place any mechanism to take care of the violations of the  aforesaid  guidelines  and  regulation  and  if  so,  the  details  thereof  and  if  not  the  reasons therefor;
- (c) the funds allocated and utilized for the purpose of Stem Cell Research and Therapy in the country during each of the last three years and the current  year, State/UT-wise along with the achievement made in the field;
- (d) whether  Stem  Cell  Research  Therapy  are  being  carried  out  in  Government  Medical Colleges and Hospitals in the country and if so, the details thereof and if not the reasons therefor; and
- (e) whether the facility of molecular diagnostic is available in the Government hospitals in the country and if so, the details of the hospitals where such facility is available?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (DR. BHARATI PRAVIN PAWAR)

- (a)  &  (b):  Ministry  of  Health  &  Family  Welfare  has  notified  New  Drugs  and  Clinical  Trials Rules,  2019  under  Drugs  and  Cosmetics  Act  1940.    'Cell  or  stem  cell  derived  product'  is covered under the definition of 'New Drugs' under the said rules.  As and when complaint is received with respect to violation of New Drugs and Clinical Trials Rules, 2019 the matter is taken up for appropriate action as per the rules.

Besides,  Indian  Council  of  Medical  Research  (ICMR),  an  Autonomous  Body  under Department  of  Health  Research  has  issued  National  Guidelines  for  Stem  Cell  Research (NGSCR-2017).They  provide  guidance  to  all  stakeholders  including  scientists,  clinicians  and industry and can be accessed online at:

https://main.icmr.nic.in/sites/default/files/guidelines/Guidelines\_for\_stem\_cell\_research\_2017.p df.

- (c)  Funds released during last three years (till date) under Stem Cell research may be seen at Annexure.

As informed by Department of Bio-Technology, support has been provided for projects  on  basic  biology  of  stem  cells,  early  and  late  translational  research,  developing  gene editing  technology  for  potential  therapeutic  applications  and  creation  of  animal  models  for various  human  diseases.    In  the  programme  on  accelerating  the  application  of  stem  cell technology in Human diseases, a novel hematopoietic stem cell based lentiviral vector mediated gene therapy product for possible treatment of Haemophilia A has been developed.

(d)   Stem Cell Research is carried out in some Government Medical Colleges and Hospitals in the country. Stem Cell Therapy is offered only in approved disease conditions i.e hematological cancers and disorders.  Therapeutic use of stem cells for other diseases is experimental and not standard of care, so same has to be done only under the purview of clinical trials to establish scientific evidences with its safety and efficacy.

(e) National Medical Commission in the Minimum Standards Requirements for Admissions Annually Regulations 1999 provide for setting up of a BSL-2 level, RTP-CR facility laboratories in the Deptt of Microbiology in all the Medical Colleges.  The molecular labs, testing for COVID -19, including those in Government Hospitals are listed in ICMR website at https://www.icmr.gov.in/pdf/covid/labs/COVID\_Testing\_Labs\_29032022.pdf

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## ICMR

| Year                      | Total funds released (in Rs)   |
|---------------------------|--------------------------------|
| 2019                      | 4,36,19,531/-                  |
| 2020                      | 68,82,564/-                    |
| 2021                      | 3,08,34,008/-                  |
| 2022 (As on 28 th March ) | 10,00,000/-                    |

## DBT

## Funds Released

(Rs in Lakhs)

| State/UT        | 2021-22   | 2020-21   | 2019-20   | 2018-19   |
|-----------------|-----------|-----------|-----------|-----------|
| Andhra Pradesh  | - -       |           | 14.49     |           |
| Assam -         |           | -         | -         | 6.36      |
| Chandigarh (UT) | -         | 4.99      | 5.85      | 7.16      |
| Delhi (UT)      | 141.80    | 30.59     | 103.71    | 84.35     |
| Gujarat -       |           | -         | 18.89     | -         |
| Haryana 13.30   |           | 38.52     | 16.32     | -         |
| Karnataka       | -         | 1566.89   | 2718.55   | 821.58    |
| Kerala          | 15.00     | 14.61     | 14.79     | 36.25     |
| Maharashtra     | 74.22     | 86.42     | 98.12     | 65.93     |
| Odisha -        |           | -         | 6.58      | 8.01      |
| Punjab          | 21.81     | -         | 15.95     | 7.82      |
| Tamilnadu       | 96.29     | 688.06    | 560.61    | 42.92     |
| Telangana       | 29.54     | 17.35     | 9.33      | 35.38     |
| Uttar Pradesh   | -         | 22.99     | 13.07     | 12.40     |
| West Bengal     | -         | -         | 16.85     | 37.85     |

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