How BioPharma SHAKTI can transform biologics with non-animal models
Biologics, a growing class of complex drugs, are increasingly used for chronic diseases, but animal models often fail to reliably predict their safety and efficacy in humans. This has prompted a shift towards human-relevant non-animal methodologies (NAMs) like organoids and 3D bioprinting. The 2026 Union Budget's Biopharma SHAKTI strategy aims to boost domestic production of biologics and biosimilars. NAMs can reduce development costs and timelines, but their adoption in India is slow due to challenges in translating innovation to industry, lack of sustained funding, and regulatory hurdles like patent evergreening and slow approval processes. Aligning with industry realities and ensuring regulatory clarity is crucial for India to realize the vision of Biopharma SHAKTI.
Key Points
- Animal models are often unreliable in predicting the safety and efficacy of biologics in humans, necessitating a shift to non-animal methodologies (NAMs).
- NAMs, such as organoids and 3D bioprinting, are derived from human cells and more accurately replicate human biology.
- The Biopharma SHAKTI strategy, announced in the 2026 Union Budget, aims to boost domestic production of biologics and biosimilars.
- Challenges to NAM adoption in India include difficulties in translating lab innovations to industry, insufficient funding, and regulatory hurdles like patent evergreening and slow approval processes.
- Regulatory clarity, sustained funding, and industry alignment are crucial for the successful implementation of the Biopharma SHAKTI vision and widespread NAM adoption.
Exam Facts
- The 2026 Union Budget announced the Biopharma SHAKTI strategy.
- The strategy has an allocation of ₹10,000 crore over five years.
- The New Drugs and Clinical Trials (Amendment) Rules 2023 promote the use of non-animal methodologies.
- NAMs can reduce drug development costs by 10-26% and lead optimization time by 19%.
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