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Even as the Department of Biotechnology (DBT) has been taking initiatives to develop 3D tissue models that can eliminate the use of animal models for studying developmental toxicity, there are more steps required including development of protocols and mandates on funding projects for better adoption of alternatives to animal testing.
The DBT 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, said Dr Jitendra Singh, Minister of State (Independent Charge) for the Ministry for Science and Technology & Earth Sciences in the Lok Sabha.
Responding to a question on whether the DBT has engaged with regulatory authorities like Central Drugs Standard Control Organisation (CDSCO) or Committee for Control and Supervision of Experiments on Animals (CCSEA) to facilitate the recognition and adoption of these alternatives, the Minister said, that the Department has not yet started the process.
"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," said the Minister.
There is no national repository or any public accessible database of validated non-animal testing methods yet been established, he added.
On a question 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, the Minister said that the Department is fostering and catering support to research and 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," he added.
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. However, DBT has not undertaken any international collaboration in finding alternatives to animal testing, he added.
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