DBT backs 3D tissue models to replace animal testing amid evolving regulatory framework

New Delhi: The Department of Biotechnology (DBT), under the Ministry of Science & Technology, has launched initiatives to develop advanced 3D tissue models, including organoids, in-vitro systems, and 3D-printed platforms. These models hold promise for applications in cell therapy, drug discovery, and disease pathophysiology studies, aiming to reduce reliance on animal testing.

In a written reply in the Lok Sabha on July 30, 2025, Dr. Jitendra Singh, Union Minister of State (Independent Charge) for Science & Technology, shared that BRIC-inStem, an autonomous DBT institute, is working on 3D tissue and organoid models to assess developmental toxicology of new chemical entities. These efforts could eventually replace animal models in pre-clinical toxicology research. However, the DBT has not yet established validation protocols for such non-animal alternatives.

Preliminary consultations have been initiated by BIRAC to address regulatory challenges, but formal engagement with regulatory bodies is still pending. Additionally, India currently lacks a national repository or publicly accessible database of validated non-animal testing methods.

While DBT continues to support research and innovation in non-animal methodologies—particularly in areas such as cell therapy, pre-clinical screening, and disease biology—there are no mandates or incentives within its funding guidelines to prioritize these approaches, even where scientifically viable.

BIRAC has extended support to organizations such as Pandorum Technologies, Reagene Biosciences, ISMO Bio-Photonics, Strand Life Sciences, and Sri Ramachandra Institute for Higher Education and Research for developing 3D tissue models, organ-on-chip platforms, and in-vitro systems. Additionally, BRIC-inStem has spun off a company focused on producing affordable lab reagents and toxicology models for academic and industrial use in India.

As of now, the Department has not pursued any international collaborations in this field.

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