Executive Summary:
The Department of Biotechnology (DBT) addresses questions regarding the adoption of alternatives to animal testing. While the DBT has supported the development of 3D tissue models and in vitro systems, it has not yet developed validation protocols for non-animal alternatives or engaged with regulatory authorities for their recognition. There are no current plans for a national repository of validated non-animal testing methods, nor are there mandated incentives for using such methods in DBT's funding guidelines.
Key Points / Main Content:
Development and Validation:
* DBT has supported the development of 3D tissue models (organoid and 3D printed), and in vitro systems for applications in cell therapy, preclinical drug discovery, and disease pathophysiology understanding.
* BRICinStem (DBT autonomous institute) is developing 3D tissue and organoid models to test the developmental toxicology of new chemical entities to enable drug discovery programs by eliminating the use of animal models for studying the developmental toxicity.
* The Department has not yet developed protocols for validation of non-animal alternatives.
Regulatory Engagement:
* BIRAC has initiated preliminary consultative discussions regarding regulatory challenges.
* The Department has not yet engaged with regulatory authorities to facilitate the recognition and adoption of these alternatives.
National Repository:
* No national repository or publicly accessible database of validated non-animal testing methods has been established.
Funding Guidelines:
* DBT fosters and supports research innovation for developing processes or technologies for non-animal methods in cell therapy, preclinical drug discovery (screening drugs/lead molecules/new chemical entities/vaccines), and in vitro-based models for disease biology.
* DBT's funding guidelines do not mandate or incentivize the use of non-animal methods.
Supported Projects:
* BIRAC has supported projects at Pandorum Technologies, Reagene Biosciences, ISMO BioPhotonics 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.
* BRICinStem has a spinoff company dedicated to developing alternate and affordable lab reagents and toxicology models for Indian academia and industry.
International Collaboration:
* The Department of Biotechnology has not undertaken any international collaboration in this area.
Impact Analysis:
Research Institutions/Startups:
Impact: May receive funding for developing non-animal testing methods and technologies.
Action Required: Consider applying for DBT/BIRAC funding for relevant projects, focusing on cell therapy, drug discovery, and disease biology using non-animal methods.
Regulatory Authorities (CDSCO, CPCSEA):
Impact: May be involved in future discussions regarding the recognition and adoption of non-animal testing alternatives.
Action Required: Await engagement from DBT/BIRAC to participate in discussions and provide input on regulatory challenges.
Indian Academia and Industry:
Impact: May benefit from the development of alternate and affordable lab reagents and toxicology models.
Action Required: Explore opportunities to collaborate with BRICinStem's spinoff company for accessing new reagents and models.
Key Entities Referenced
Department of Biotechnology (DBT): A department under the Ministry of Science and Technology, Government of India, responsible for promoting and developing biotechnology in India.
Shri Tangella Uday Srinivas: Member of Lok Sabha who asked the unstarred question No. 1705 regarding the status of adoption of alternatives to animal testing.
Central Drugs Standard Control Organisation (CDSCO): A regulatory authority in India responsible for drug regulation.
Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA): A regulatory body in India that oversees and regulates animal experimentation.
Biotechnology Industry Research Assistance Council (BIRAC): An industry-academia interface that empowers emerging biotech companies to undertake strategic research and development activities.
Dr. Jitendra Singh: Minister of State (Independent Charge) for the Ministry of Science and Technology and Earth Sciences.
BRICinStem: An autonomous institute of DBT that is developing 3D tissue and organoid models to test and quantify the developmental toxicology of new chemical entities.
Pandorum Technologies: A startup supported by BIRAC for developing 3D tissue models, organ-on-chip, and in-vitro model systems.
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 basedmodels for understanding disease pathophysiology. One of DBT autonomous institutes-
BRIC-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 non-
animal 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 institute-
BRIC-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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