Lok Sabha Question No. 1705 (UNSTARRED), answered on 2025-07-30
Subject: Status of Adoption of Alternatives to Animal Testing
Ministry: SCIENCE AND TECHNOLOGY
Asked by: Shri Tangella Uday Srinivas

## GOVERNMENT OF INDIA MINISTRY OF SCIENCE AND TECHNOLOGY DEPARTMENT OF BIOTECHNOLOGY

## LOK SABHA

## ADMITTED UNSTARRED QUESTION NO.  1705 TO BE ANSWERED ON 30.07.2025

## Status of Adoption of Alternatives to Animal Testing

1705. Shri Tangella Uday Srinivas:

## Will the Minister of SCIENCE AND TECHNOLOGY

be pleased to state:

(a)  whether  the  Department  of  Biotechnology  (DBT)  has  developed  or  funded  protocols  for validation  of  non-animal  alternatives  such  as  organ-on-chip,  3D  tissue  models,  or  in  vitro systems for use in regulatory or toxicological testing, if so, the details thereof;

(b) whether DBT has engaged with regulatory authorities like CDSCO or CPCSEA to facilitate the recognition and adoption of these alternatives; if so, the details thereof;

- (c) whether the Government has created or is planning to create a national repository or publicly accessible database of validated non-animal testing methods, if so, the details thereof;

(d)  whether  DBT's  funding  guidelines  for  research  projects  and  biotech  startups  include provisions  that  mandate  or  incentivise  the  use  of  non-animal  methods  wherever  scientifically feasible, if so, the details thereof;

(e)    the  details  of  the  number  of  startups  or private  research  institutions supported  by  DBT  or BIRAC  during  the  last  five  years  for  developing  or  commercialising  cruelty-free  testing technologies, and

(f) whether any international collaborations exist in this area, if so, the details thereof?

## ANSWER

## MINISTER OF STATE (INDEPENDENT CHARGE) FOR THE MINISTRY OF SCIENCE AND TECHNOLOGY & EARTH SCIENCES

## (Dr. Jitendra singh)

- (a) Department of Biotechnology has undertaken initiatives to nurture and develop 3D tissue models  like  organoid  models  or  in-vitro  systems  -  3D  printed  models  for  potential applications  in  cell  therapy,  pre-clinical  models  for  drug  discovery, in-vitro cell  based

models for understanding disease pathophysiology. One of DBT autonomous institutesBRIC-inStem  is  developing  3D  tissue  and  organoid  models  to  test  and  quantify  the developmental  toxicology  of  new  chemical  entities  that  could  enable  drug  discovery programs  by  eliminating  the  use  of  animal  models  for  studying  the  developmental toxicity. However, the Department has not yet developed protocols for validation of nonanimal alternatives.

- (b) Preliminary  consultative  discussion  have  been  initiated  by  BIRAC  to  discuss  the regulatory challenges in this regard, however the Department has not yet engaged with the regulatory authorities to facilitate the recognition and adoption of these alternatives.
- (c) Sir, no such national repository or any public accessible database of validated non-animal testing methods has yet been established.
- (d) Department  is  fostering  and  catering  support  to  research  &  innovation  for  developing processes or technologies for application of non-animal methods in areas of cell therapy, pre-clinical models for drug discovery for screening drugs/lead molecules/ new chemical entities/ vaccines etc, and in-vitro based models for disease biology. However, as of now DBT's funding guidelines for research projects and biotech start-ups has not mandated or incentivized the use of non-animal methods wherever scientifically feasible.
- (e) BIRAC has supported projects to Pandorum Technologies, Reagene Biosciences, ISMO Bio-Photonics Pvt. Ltd., Strand Life Sciences and Sri Ramachandra Institute for Higher Education and Research for developing 3D tissue models, organ-on-chip, in-vitro model systems  and  platforms  for  non-animal  methods.  One  of  DBT's  autonomous  instituteBRIC-inStem has a spin-off company dedicated to developing alternate and affordable lab reagents and toxicology models for Indian academia and industry.
- (f) Department of Biotechnology has not undertaken any international collaboration in this area.

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