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Small Business Innovation Research Initiative (SBIRI) Phase II grant & soft loan up to ₹1 Crore+ for commercial scale-up & clinical validation
Commercial Biotech Scale-up
Grant + soft loan assistance
Scale-up & validation tenure
Pilot trials, field tests & certifications
Govt of India
The SBIRI Phase II Scheme is the advanced commercialization and scale-up funding component of the Small Business Innovation Research Initiative operated by BIRAC, Department of Biotechnology (DBT), Government of India.
Targeted at biotechnology startups and MSMEs that have successfully completed proof-of-concept validation (either through SBIRI Phase I or equivalent R&D programs), Phase II provides substantial funding of up to ₹1 Crore to ₹3 Crores (structured as a combination of grant-in-aid and low-interest soft loans) to drive full-scale commercialization.
The scheme covers pilot manufacturing batch production, multicentric clinical validation trials, stability testing, field trials in agriculture, national and international regulatory clearances (CDSCO, CE, FDA), and packaging design.
Phase II acts as the decisive capital bridge that transforms laboratory successes into marketable, revenue-generating commercial biotech products.
Capital infusion of up to ₹1-3 Crores distributed across rigorous clinical and commercialization milestones.
Substantial budget for multi-site human clinical trials, animal toxicology, and multi-location crop field tests.
Funds tooling, cGMP pilot production, quality control instrumentation, and batch validation.
Direct guidance on securing CDSCO manufacturing licenses, BIS standards, and ISO 13485 certifications.
Patient financial structure with founder-friendly low-interest terms and flexible repayment schedules.
Support for international PCT patent prosecution and global regulatory filings.
Indian registered biotech companies (Private Limited, Public Limited, or LLP) with DSIR-recognized R&D units.
At least 51% of equity shareholding must be owned by Indian resident citizens.
Must have successfully completed Proof-of-Concept validation (TRL 5+) with verifiable laboratory trial data.
The company must have fewer than 500 employees (Small & Medium Enterprise definition).
Must be willing to contribute the required matching promoter co-funding share.
Must have obtained all necessary preliminary regulatory ethics clearances (IBSC, IAEC, IEC).
Secures multi-crore capital to execute expensive clinical trials and pilot manufacturing without venture dilution.
Drastically accelerates time-to-market for medical devices, diagnostic kits, and biological formulations.
Preserves 100% equity ownership and corporate governance freedom for founding promoters.
Validation and certification from the Department of Biotechnology, unlocking institutional hospital procurement.
Direct credentialing for raising high-valuation Series A/B venture capital rounds.
Dedicated project oversight by senior pharmaceutical regulatory experts and principal investigators.
Certificate of Incorporation, MoA / AoA, and Indian Shareholding Certificate (CA Certified).
Proof of Successful Proof-of-Concept (SBIRI Phase I Completion Report or Comprehensive Lab Validation Data).
Detailed Phase II Scale-up Proposal (Clinical Protocol, Pilot Manufacturing Plan, Regulatory Strategy).
Itemized Budget Breakdown with matching promoter co-funding commitment.
Audited Financial Statements for the last 3 financial years.
Regulatory NOCs & Ethics Approvals (CDSCO CT NOC, IBSC, IEC).
Company Bank Account Details & Cancelled Cheque.
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Businesses granted a 3-year tax holiday
Funding
Guide 2025
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