India is no longer content with being known only as the “pharmacy of the world” for generics. The national ambition has shifted decisively toward innovation-led biopharma R&D, advanced biomanufacturing, and globally competitive healthcare technologies. At the centre of this transformation stands the Biotechnology Industry Research Assistance Council (BIRAC) — an institution that has evolved from a grant-making facilitator into a full-spectrum innovation architect.

This is not incremental growth. It is structural repositioning.

From Capacity Building to Global Ambition: The Evolution of BIRAC

Established in 2012 under the Department of Biotechnology (DBT), BIRAC was created to bridge academia and industry, de-risk early innovation, and catalyse biotech entrepreneurship. In its early years (2012–2017), India’s bioeconomy was valued at roughly $10 billion, and the country had only around 50 biotech startups. BIRAC’s role during this period was foundational:

• Seed funding for proof-of-concept projects
• Early translational grants through SBIRI (Small Business Innovation Research Initiative) and BIPP (Biotechnology Industrial Partnership Programme)
• Initial bio-incubation centres
• Basic IP and regulatory support

Private investment was limited. Regulatory pathways were complex. Innovation was largely incremental and domestically focused.

Fast forward to 2024–2026.

India’s bioeconomy has surged to approximately $151 billion, growing at sustained double-digit rates. The number of biotech startups has expanded dramatically — from 5,300 in 2022 to more than 11,000 by 2026, with 1,390 new incorporations in 2022 alone. Biopharma now represents the largest share of the bioeconomy at 35.65% (~$53.8 billion).

This transformation mirrors BIRAC’s own evolution.

BIRAC Today: A Full-Stack Innovation Ecosystem Enabler

BIRAC has transitioned from a grant administrator to an ecosystem architect. Its expanded toolkit now includes:

1. Scaled Funding Mechanisms

• BIG (Biotechnology Ignition Grant): ₹50 lakh grants supporting 6,700+ entrepreneurs for proof-of-concept.
• BIPP: Cost-sharing support for advanced R&D, focusing on Technology Readiness Level (TRL) 7+ technologies.
• SEED Fund: Equity investments up to ₹30 lakh; ₹30 crore invested across 112 ventures.
• Accelerating Enterpreneurs Fund (AcE Fund) (Fund-of-Funds): ₹174.5 crore base; ₹349 crore committed to 102 startups; leveraged ₹1,560 crore follow-on private capital.
• Support to over 3,500 startups and 2,165 projects since inception.

BIRAC funding increasingly catalyses private capital — a key marker of ecosystem maturity.

2. Infrastructure at National Scale

• 95+ (Bioincubators Nurturing Entrepreneurship for Scaling Technologies) BioNEST incubation centres
• ~10 lakh sq ft of incubation space
• 75+ incubators supporting 1,800+ incubatees
• E-YUVA pre-incubation centres nurturing student innovators

This network reduces infrastructure barriers and democratises access to advanced facilities, including shared labs, pilot-scale manufacturing, and regulatory advisory support.

3. Regulatory and Policy Integration

BIRAC’s Regulatory Affairs and Policy Advocacy (RAPA) division helps startups navigate Central Drugs Standard Control Organisation (CDSCO) approvals and compliance frameworks. Programs such as Promoting Academic Research Conversion to Enterprise (PACE) and Biotechnology Ignition Grant Scheme (BIG) address translational bottlenecks, ensuring innovations are regulatory-ready and globally competitive.

This regulatory scaffolding is crucial as India moves into complex biologics, cell therapies, precision medicine, and advanced diagnostics.

Mission-Driven Alignment: ANRF and the RDI Fund

India’s Anusandhan National Research Foundation (ANRF), established in 2023–24, aims to promote interdisciplinary research with strong private sector participation. BIRAC’s role has now expanded into that mission architecture.

BIRAC–RDI Fund (2025)

Under the broader Research, Development and Innovation (RDI) Scheme — a ₹1 lakh crore national innovation framework — BIRAC anchors a ₹2,000 crore biotech-focused RDI Fund over five years.

Unlike traditional grants, the RDI Fund deploys:

• Equity
• Convertible debt
• Long-term innovation loans

It focuses on scaling technologies from TRL 4 to TRL 9, precisely the “valley of death” where most biotech innovations globally stall.

This positions BIRAC as a structured capital bridge between laboratory innovation and industrial-scale commercialisation.

Biopharma SHAKTI and the Clinical Trial Expansion: A Structural Breakthrough

Under Union Budget 2026–27, the Government of India announced Biopharma SHAKTI (Strategy for Healthcare Advancement through Knowledge, Technology and Innovation) with an allocation of ₹10,000 crore over five years. The initiative aims to strengthen India’s biologics, biosimilars, and medical device ecosystem while accelerating innovation-led manufacturing.

A particularly transformative component aligned with this national thrust is the plan to establish and accredit 1,000+ clinical trial sites across India.

This expansion is a structural game-changer for several reasons:

1. Enabling Innovation, Not Just Manufacturing

India already has strong manufacturing capabilities, including 665 US FDA-approved plants — the highest outside the United States. However, innovative biologics and precision therapeutics require large, well-distributed, high-quality clinical trial networks. Expanding to 1,000 accredited sites strengthens India’s ability to conduct Phase I–III trials at scale.

2. Faster Recruitment and Diverse Populations

India’s demographic diversity becomes a scientific advantage. A broad, accredited clinical network improves recruitment speed, data quality, and statistical robustness — making India more attractive for global clinical programs.

3. Integrating with BIRAC’s Innovation Pipeline

BIRAC funds early and mid-stage innovation. The RDI Fund supports TRL 4–9 scale-up. The 1,000-site network enables late-stage validation and commercialisation. This creates a complete domestic innovation runway — from idea to global regulatory submission.

4. Global Confidence and Regulatory Credibility

Structured, GCP-compliant clinical infrastructure strengthens India’s reputation as a trusted R&D partner. This is essential for attracting global biologics programs and positioning India beyond generics into high-value innovation.

Together, SHAKTI funding and clinical expansion shift India’s role from cost-efficient producer to integrated innovation ecosystem.

National Biopharma Mission (i3): Building the Translational Backbone

Launched in 2017 with ₹1,500 crore (50% World Bank co-funded), the National Biopharma Mission accelerated vaccines, biologics, and device development, supporting 100+ startups and establishing shared facilities.

India’s COVID-19 response — including indigenous vaccine development — demonstrated how BIRAC-enabled infrastructure can respond rapidly at national scale.

BioE3 and Advanced Biomanufacturing

The 2024 BioE3 Policy promotes:

• Bio-based chemicals
• Carbon capture technologies
• Advanced industrial biotechnology
• High-performance biomanufacturing

This extends India’s biotech ambition beyond health into sustainable industrial transformation.

Global Positioning: From Generics to Innovation

India:

• Holds ~3% of the global biotech market
• Has 665 FDA-approved manufacturing plants
• Exports pharmaceuticals to 150+ countries

But the strategic pivot is toward innovative therapeutics, biosimilars, medical devices, and precision medicine.

India targets $150 billion biopharma turnover by 2025, with ambitions to rank among the top five global biomanufacturing hubs.

BIRAC’s IP management, translational funding, equity instruments, and global collaborations strengthen India’s ability to compete not only on cost — but on innovation.

Vision 2030: A $300 Billion Bioeconomy

BIRAC’s long-term vision aligns with India’s aspiration to build a $300 billion bioeconomy by 2030.

The shift is clear:

• Startups: 50 → 11,000+
• Bioeconomy: $10B → $151B
• Funding: Grants → Blended finance + equity + fund-of-funds
• Clinical Capacity: Fragmented → 1,000+ accredited sites
• Focus: Incremental innovation → IP-driven global R&D

India’s ambition to become a global biopharma R&D and manufacturing hub rests on:

1. Strategic policy vision (ANRF, RDI, SHAKTI, BioE3)
2. Scaled financial instruments
3. Expanded clinical trial infrastructure
4. Institutional enablers like BIRAC

Biopharma SHAKTI provides manufacturing thrust.
The 1,000 clinical trial expansion builds development muscle.
The RDI Fund supplies innovation capital.
BIRAC integrates all these layers into a coherent national pipeline.

If execution matches ambition, India’s next chapter will not merely be about supplying medicines to the world — but about discovering, developing, and delivering them from within.