Lok Sabha Question No. 1830 (UNSTARRED), answered on 2022-02-11
Subject: Research in Regenerative Medicine
Ministry: HEALTH AND FAMILY WELFARE
Asked by: C.N. Annadurai, Anurag Sharma, Gajanan Chandrakant Kirtikar, Dhanush M Kumar, Ganesan Selvam, Gautham Sigamani Pon, Manjulata Mandal

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

## LOK SABHA UNSTARRED QUESTION NO. 1830 TO BE ANSWERED ON 11 TH  FEBRUARY, 2022

## RESEARCH IN REGENERATIVE MEDICINE

## 1830.  SHRI C.N. ANNADURAI:

SHRI ANURAG SHARMA:

SHRI SELVAM G:

SHRI GAJANAN KIRTIKAR:

SHRI GAUTHAM SIGAMANI PON:

SHRIMATI MANJULATA MANDAL:

SHRI DHANUSH M. KUMAR:

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

- (a) whether the country is lagging in research and development of medicine and if so, the details thereof and the reaction of the Government thereto;
- (b) whether  the  Government  needs  to  increase  the  pace  of  research  in  regenerative medicine to come up to the global level, especially in the area of clinical trials and regulatory requirement and if so, the details thereof;
- (c) whether  the  Government  has  prepared  any  plan  of  action  in  this  regard  with  fixed targets and if so, the details thereof;
- (d) the funds allocated for the purpose during the last three years and the current year;
- (e) the  extent  to  which  the  Government has achieved the target and goals so far in this regard; and
- (f) whether  the  Government  has  entered  into  any  agreement  with  other  countries  for research and development of medicines and if so, the details thereof?

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

(a)  to  (f)  The  Government  of  India  has  conducted  stem  cell  research  through  various Departments/  Institutions  by  supporting  basic  as  well  as  clinical  research  through  national funding  agencies  like  the  Indian  Council  of  Medical  Research  (ICMR),  Department  of Biotechnology (DBT) and Department of Science and Technology (DST). The work done in this  field  has  resulted  in  the  establishment  of  state-of-art  infrastructure  at  over  40  premier health research and educational institutes in addition to supporting industry initiatives in India.

ICMR  has  released  the  National  Guidelines  for  Stem  Cell  Research  (NGSCR)  2017  which were  framed  in  harmonization  of  international  guidelines.  Government  has  supported  the ethical and scientific conduct of stem cell research through guidelines for stem cell research. Government  supports  using  hematopoietic  cell  transplantation  (HCT)  for  hematological disorders, as standard of care, as per NGSCR-2017.

ICMR has also released Evidence Based Status of Stem Cell Therapy for Human Diseases for creating  awareness  and  understanding  regarding  experimental  use  of  stem  cells  under  the purview of clinical trial and the document is available at the following link:

https://main.icmr.nic.in/sites/default/files/upload\_documents/Evidence\_Based\_Status\_of\_Stem \_Cell\_Therapy\_for\_Human\_Diseases\_v1.pdf.

The Government has notified the New Drugs and Clinical Trial Rules, 2019 for regulation of clinical  trials  and  New  Drugs  including  cell  &  stem  cell  derived  product,  gene  therapeutics product  and  xenografts  for  human  use,  which  contains  various  provisions  for  improving transparency  and  accountability  for  the  approval  process  and  to  promote  research  and development of the new drugs.

The total funds released by Indian Council of Medical Research (ICMR) during last three years under Stem cell research in fellowships and Ad-hoc project, are as below:

|   Year | Total funds released (In Rs.)   |
|--------|---------------------------------|
|   2019 | 4,36,19,531/-                   |
|   2020 | 68,82,564/-                     |
|   2021 | 3,08,34,008/-                   |

The Department of Biotechnology (DBT) has supported projects for 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. The funds released  by  the  DBT  during  the  last  three  years  and  the  current  year  in  this  area  is  Rs. 7345.58 Lakh.

*****