announced in Union Budget 2026-27
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high value future facing segment
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SHAKTI == Strategy for Healthcare Advancement through Knowledge Technology & Innovation
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objective: india into manu hub for biologics & biosimilars
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Rs.10,000Cr over 5 years funding
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Strategy:
- 3 new National institute of Pharmaceutical Education & Research (NIPER) & upgrade existing 7
- Create network of 1000+ accredited india clinical trial sites
- strengthen CDSCO to meet global standards
- create dedicated scientific review cadre & specialists
Challenges to biopharma industry in india
- regulatory hurdle
- multiple agencies (CDSCO, state dreg control authority)
- slow approval process
- high R&D cost + Govt DPCO reduce profits
- supply chain vulnerability: API from China
- Conflict w/ MNC pharma over patents, evergreening
Initiatives to boost biopharma
- National Biopharma Mission
- PLI for pharma (active pharma ingredient, medical devices)
- bulk drug parks in Gujarat, Andhra, Himachal
- Promotion of Research & Innovation in Pharma-MedTech
- BioE3
- Regulatory reforms to attract capital, technology, 100% FDI thru automatic route for greenfield pharma
- 74% for brownfield
- Biotechnology Ignition Grant
- Seed fund / Leap Fund
- Upgrading MSME facility to WHO Good Manufacturing Standards
- Bio RIDE Scheme
Way forward:
- target niche therapies to pivot to high value markets
- R&D initiatives similar to brazil, chile
- pvt sector participation through ANRF
- fast track licensing
- eg. Vietnam’s “Decree 19”
- shared infra for lower initial capital costs