**Summary:**
The Department of Biotechnology (DBT), under the Ministry of Science and Technology, is actively supporting the development of non-animal testing alternatives, including 3D tissue models, organoid models, and in-vitro systems. These initiatives aim to reduce and eventually eliminate animal models in areas such as cell therapy, preclinical drug discovery, and disease pathophysiology research. BRICinStem, a DBT autonomous institute, is specifically working on 3D models to assess the developmental toxicology of new chemical entities.
While DBT is fostering research and innovation in this area and BIRAC has supported multiple projects, the department has not yet developed validation protocols for these non-animal alternatives, nor has it engaged with regulatory authorities to facilitate their recognition and adoption. A national repository or publicly accessible database of validated non-animal testing methods is also currently lacking.
DBT's funding guidelines for research projects and biotech startups do not yet mandate or incentivize the use of non-animal methods where scientifically feasible. BIRAC has provided support to entities like Pandorum Technologies, Reagene Biosciences, ISMO BioPhotonics Pvt. Ltd., Strand Life Sciences and Sri Ramachandra Institute for Higher Education and Research for developing relevant models and platforms. BRICinStem has a spinoff company focused on producing affordable lab reagents and toxicology models. The DBT has not yet engaged in any international collaborations in this particular area.
This information was provided by Dr. Jitendra Singh, Union Minister of State (Independent Charge) for Science & Technology.
Key Entities Referenced
Department of Biotechnology: An Indian government department under the Ministry of Science and Technology, responsible for initiatives in biotechnology.
BRICinStem: An autonomous institute of the Department of Biotechnology involved in developing 3D tissue and organoid models.
BIRAC: Biotechnology Industry Research Assistance Council, supports projects related to non-animal testing methods.
Pandorum Technologies: A company supported by BIRAC for developing 3D tissue models.
Reagene Biosciences: A company supported by BIRAC for developing 3D tissue models.
Strand Life Sciences: A company supported by BIRAC for developing 3D tissue models.
Sri Ramachandra Institute for Higher Education and Research: An institute supported by BIRAC for developing 3D tissue models and platforms for nonanimal methods.
Dr. Jitendra Singh: Union Minister of State Independent Charge for Science Technology, Minister of State Independent Charge for Earth Sciences.
Ministry of Science & Technology
PARLIAMENT QUESTION: Status of Adoption of
Alternatives to Animal Testing
Posted On: 30 JUL 2025 4:51PM by PIB Delhi
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 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.
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. No such national repository or any public accessible database
of validated non-animal testing methods has yet been established.
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.
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. Department of
Biotechnology has not undertaken any international collaboration in this area.
This information was given by Dr. Jitendra Singh, Union Minister of State (Independent Charge) for Science
& Technology, Minister of State (Independent Charge) for Earth Sciences, MoS PMO, Department of Atomic
Energy and Department of Space, MoS Personnel, Public Grievances and Pensions, in a written reply in the
Lok Sabha today.
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NKR/PSM/AV
(Release ID: 2150220)