Context
In the Budget 2025–26, the government introduced BioPharma SHAKTI Mission to boost domestic production of biologics and biosimilars and promote human-based (non-animal) testing methods, as animal models often fail to predict human response.
Key understanding
- Why shift from animal testing?
• Animal models often give wrong or incomplete results for humans.
• Leads to drug failures in clinical trials and safety risks. - What are biologics?
• Drugs made from living cells (complex, advanced medicines).
• Used in cancer, diabetes, autoimmune diseases.
• Examples: monoclonal antibodies, insulin, vaccines. - What are biosimilars?
• Cheaper versions of biologics after patent expiry.
• Not exact copies but highly similar in effect.
• Help in reducing treatment cost. - What is the solution?
• Shift to human-relevant models:
• Organoids (mini organs)
• Organ-on-chip
• 3D bioprinting
• These better mimic human biology → more reliable results. - BioPharma SHAKTI Mission (Budget focus)
• Boost domestic manufacturing of biologics and biosimilars
• Promote non-animal testing methods
• Support research, startups, and infrastructure
• Aim: Make India a global hub for affordable biologics
Challenges
• High cost and infrastructure needs
• Regulatory clarity still evolving
• Patent delays affect biosimilar entry
