Lok Sabha Question No. 3215 (UNSTARRED), answered on 2026-03-11
Subject: BioE3 Policy
Ministry: SCIENCE AND TECHNOLOGY
Asked by: Shri Vishaldada Prakashbapu Patil

## GOVERNMENT OF INDIA MINISTRY OF SCIENCE & TECHNOLOGY DEPARTMENT OF BIOTECHNOLOGY

## LOK SABHA

## UNSTARRED QUESTION NO.  3215 ANSWERED ON 11.03.2026

## BioE3 Policy

## 3215.   Shri Vishaldada Prakashbapu Patil:

Will the Minister of SCIENCE AND TECHNOLOGY

be pleased to state:

(a) the details of the overall value and impact of Government-backed initiatives such as the BioE3 policy and BIRAC on the growth and global competitiveness of lndia's biotech sector, especially in the context of R&D, local manufacturing, startup creation and scale-up to international standards,

(b) the details of the mechanisms for ensuring equitable access to public R&D funds including transparency in selection and monitoring of grants FDI recipients and the status of any public disclosure requirements and independent audit of these funds;

(c) the details of the strategies put in place to address major challenges for biotech startups such as access to late-stage capital regulatory approval delays and the geographic diversity of clinical trials; and

(d)  whether  the  Government  is  tracking  and  publishing  longitudinal  data  on  job creation and startup survival rates in this sector and if so, the details thereof?

## ANSWER

## MINISTER OF STATE (INDEPENDENT CHARGE) OF THE MINISTRY OF SCIENCE AND TECHNOLOGY & EARTH SCIENCES (DR. JITENDRA SINGH)

(a) The  BioE3  Policy  (Biotechnology  for  Environment,  Economy  &  Employment), approved by the Cabinet, is being implemented jointly by the Department of Biotechnology (DBT)  and  its  Public  Sector  Enterprise,  the  Biotechnology  Industry  Research  Assistance Council (BIRAC) for fostering high-performance Biomanufacturing and enabling start-ups, SMEs, industries and academia with access to shared infrastructure/facilities and resources for pilot  &  pre-commercial  scale  biomanufacturing  of  viable  commercial bio-based products.

Bio-enablers (Biofoundries & Biomanufacturing Hubs and Bio-AI Hubs) augment discovery and translational research across the sectorial verticals:

- i. Bio-based  chemicals,  Bioplastics,  Active  Pharmaceutical  Ingredients  (APIs),  and Enzymes
- ii. Functional Foods and Smart Proteins
- iii. Precision Biotherapeutics (monoclonal antibodies, mRNA therapeutics, cell & gene therapy)
- iv. Climate resilient agriculture (agribiologicals)
- v. Biofuels and Carbon capture
- vi. Futuristic marine and space research

DBT-BIRAC  has  launched  India's  first  Biofoundry  Network  at  8  academic  institutions, marking a landmark initiative aimed at transforming the country's biotechnology landscape and  achieving  a  $300  billion  bioeconomy  by  2030.  The  network  serves  as  a  national platform to support bioproduction scale-up at academia.

Further,  11  cutting-edge  Biomanufacturing  Platforms  have  been  set  up  at  industry  across India, offering shared infrastructure to start-ups, SMEs, industries, and academic institutions. These centers are supporting pilot and pre-commercial scale up of technologies across diverse sectors, including microbial biomanufacturing, sustainable agriculture, smart proteins, functional foods, precision biotherapeutics, marine biotechnology, carbon capture, and next-generation cell and gene therapies.

The  Biofoundry Network  and  Biomanufacturing  platforms  are  expected  to  play  a  pivotal role  in  India's  transition  to  clean  and  green  technologies,  reduce  import  dependence,  and establish the country  as a  frontrunner  in  the  global  Bioeconomy  impacting  health, agriculture, food, energy, and environment.

## The details of the projects are at Annexure I.

The BIRAC was set up by the DBT in 2012 and is playing a key role in strengthening R&D, startup creation, indigenous manufacturing, and providing global competitiveness to India's biotechnology  sector.  BIRAC  provides  a  structured  continuum  of  support  from  idea  to commercialization. Details of various programs of BIRAC and their impact are as follows:

- i. Biotechnology Ignition Grant (BIG): The Biotechnology Ignition Grant (BIG) is BIRAC's  flagship  early-stage  funding  programme  which  provides  grant-in-aid support of up to ₹50 lakh for a period of 18 months to startups and innovators for establishing  proof-of-concept  of  innovative  ideas.  The  scheme  is  implemented through  8  partner  incubators  that  provide  end-to-end  support  including  technical mentoring, IP facilitation, regulatory support, and market linkages, enabling translation of innovative ideas into scalable technologies.
2.  Over  the  past  13  years,  the  BIG  scheme  has  grown  into  one  of  India's  most credible  early-stage  biotech  funding  mechanisms,  providing  not  only  financial support  but  also  critical  ecosystem  access  for  innovators.  Since  inception,  the programme has supported more than 1,000 high-potential projects, facilitated the development  of  200+  products,  enabled  800+  intellectual  property  assets,  and supported startups in attracting over ₹3,500 crore in follow-on funding. Through these  interventions,  BIG  has  played  a  catalytic  role  in  seeding  science-led entrepreneurship and strengthening the early-stage biotech innovation ecosystem in the country.
- ii. Sustainable Entrepreneurship and Enterprise Development (SEED) Fund: The SEED  Fund  provides  first-equity-based  financial  support  of  up  to  ₹30  lakh  per startup to facilitate transition from proof-of-concept to early-stage commercialization.  This  support  enables  startups  to  reach  a  stage  where  they  can attract investments from angel investors or venture capitalists or access institutional financing.
4.  The  programme  is  implemented  through  16  BioNEST  incubators  acting  as SEED Fund partners, which identify and invest in promising startups through a structured selection process. To date, 153 biotech startups have been supported under  the  scheme,  strengthening  product  validation,  early  market  access,  and domestic manufacturing capabilities. The portfolio has generated 300+ intellectual property assets, and 105 supported startups have collectively raised over  ₹1,162  crore  in  follow-on  funding,  reflecting  strong  investor  confidence and commercialization potential.
- iii. Launching  Entrepreneurial  Driven  Affordable  Products  (LEAP)  Fund: The LEAP Fund is an equity-based programme aimed at accelerating commercialization and market entry of startups with validated technologies (above TRL-5). The scheme provides equity support of up to ₹100 lakh per startup to enable scale-up, regulatory advancement, manufacturing readiness, and product deployment.
6.  The  programme  is  implemented  through  6  designated  BioNEST  incubators serving as LEAP Fund partners, which invest in eligible startups through equity or equity-linked instruments. So far, 62 startups have been supported under this programme. These startups have generated 150+ intellectual property assets and collectively raised over ₹893 crore in follow-on funding, demonstrating successful scale-up and growing market traction.

Collectively, these initiatives strengthen India's biotechnology innovation ecosystem by promoting indigenous  R&D, facilitating technology translation, enabling manufacturing scale-up to international standards, attracting private investment, and supporting the growth of globally competitive biotech startups.

- iv. Pre-incubation  and  Incubation  Schemes: BIRAC  supports  innovation,  research translation, and startup creation through a network of incubation and pre-incubation programmes.

A total of 94 biotechnology incubation and pre-incubation centres have been set up by BIRAC across 25 states & UTs of the country under the following 2 schemes:

- I. BioNEST  (Bioincubators  Nurturing  Entrepreneurship  for  Scaling Technologies): The scheme supports the establishment of bio-incubators across India to promote innovation and entrepreneurship in biotechnology.
- II. E-YUVA (Empowering Youth for Undertaking Value Added Innovative Translational Research): This initiative fosters a culture of applied  research  and  innovation  among  students  and  young  researchers by providing pre-incubation support.

These Bioincubators are located within Universities, Research Institutes, Research Hospitals, or as stand-alone centres and provide comprehensive support to  entrepreneurs  and  startups  across  various  life  sciences  domains,  including healthcare, agriculture, and environmental solutions.

Through  the  BioNEST  and  E-YUVA  schemes,  BIRAC  has  supported  around 3000 + startups, entrepreneurs and students.

- v. Public-private  partnership  (PPP)  schemes :  BIRAC  through  its  PPP  schemes promote  development  of  biotechnological  interventions  across  the  country  by providing  financial  support  for  R&D,  infrastructure  and  output  of  academic  and institutional laboratories. The Schemes are as below:
- i. Early Stage Validation funding scheme: The Small Business Innovation Research Initiative (SBIRI) scheme provides financial support to Startups, LLPs  and  companies  for  advancing  their  established  proof  of  concept

(PoCs) towards early-stage validation, thereby addressing a critical gap in the product development cycle. Since the inception of the scheme, a total of  350+  projects  have  been  supported  benefiting  450+  beneficiaries. Overall, 316.75 Cr has been committed to drive innovation and development efforts. The supported projects have generated 800+ employment opportunities, demonstrating a strong impact on job creation. In  addition,  the  support  has  enabled  the  filing  of  53  patents  and  the development  or  commercialization of 90 products and  technologies, highlighting significant progress in research, innovation, and market-ready solutions.

- ii. Late  Stage  Validation  and  Pre-commercialization  funding  scheme: The  Biotechnology  Industry  Partnership  Program (BIPP) is  BIRAC's Flagship Scheme that provides financial support for scaling and commercializing  high  risk  innovations  through  cost  sharing  between BIRAC  and  the  industry.  BIPP  scheme  has  played  a  significant  role  in shaping  the  current  landscape  of  Indian  Biotech  industry.    To  its  credit, BIPP  scheme  has  provided  support  to  300+  beneficiaries,  employing 2000+ skilled force resulting in filing of 40+ IPs and development/commercialization of 100+ products.
- iii. Academia-Industry Research promoting funding scheme: Promoting Academic Research Conversion to Enterprise (PACE) scheme, through  its  two  components-Academia  Innovation  Research  (AIR)  and Contract  Research  Scheme  (CRS),  supports  academic  institutions  in translating  innovative  biotechnological  ideas  into  validated  proof-ofconcept  (PoC)  and  beyond,  eventually  enabling  industry-led  validation and commercialization. Since inception, 191 projects have been supported under the scheme involving 313 beneficiaries including 76 companies and 237  academic  organizations.  The  support  has  resulted  in  filing  of  26 patents and 10 products/technologies reaching TRL7-9.
- vi. Biotechnology Innovation Fund - AcE (Accelerating Entrepreneurs) is a Fund of funds  being  promoted  by  DBT  under  the  aegis  of  Make  in  India  initiative, implemented  by  BIRAC.  It  aims  to  foster  R&D  and  innovation  in  Biotechnology domains by plugging the gap of the 'Valley of Death' .  The fund was launched in the FY 2017-18 with a total corpus of INR 150 Cr. BIRAC implements this fund through investment and partnership with SEBI-registered AIFs (i.e. Venture Funds and  Angel  Funds  called  daughter  funds),  that  are  professionally  managed  and

## (b)

-  Grant applications in DBT and BIRAC are invited through detailed Calls advertised widely and are submitted through online portal.
-  All applications are reviewed  through  transparent, multi-tier grant evaluation mechanisms approved by the Department.
-  Grant Review Committees comprise majorly external members and subject experts.
-  The review committee also monitors the progress, if the project is sanctioned.
-  The technically selected applications are submitted to Internal Financial Scrutiny in DBT  and  BIRAC.  Additionally,  BIRAC  also  conducts  on-site  visits  for  major industry programs for a thorough assessment of the industry's infrastructure.
-  Following these processes, the grants are sanctioned through execution of MOU/GLA.
-  All grantees are open to audit at institutional level and CAG Audits.

(c) To address funding gaps and commercialization challenges:

-  Biotechnology Ignition Grant (BIG) de-risks early-stage innovation.
-  Sustainable  Entrepreneurship  and  Enterprise  Development  (SEED)  FUND provides early equity support for validation and commercialization.
-  Launching Entrepreneurial Driven Affordable Products (LEAP)  FUND supports  scale-up,  regulatory  preparedness,  manufacturing  readiness,  and  market deployment.

In  addition,  BIRAC  facilitates  investor  connect  platforms,  industry  linkages,  regulatory guidance  support,  and  incubation  through  BioNEST  centres  to  improve  access  to  capital, streamline regulatory pathways, and enhance market readiness.

desirous of investing in Biotech start-ups & SMEs. From the respective total fund corpus, each daughter fund commits to invest 2x of BIRAC's committed investment in the Biotech start-ups & SMEs.

-  After ploughing back INR 25 Cr returns from AcE fund, BIRAC has so far made  investment  commitment  of  INR  174.50  Cr  in  16  Daughter  Funds. Through  these  16  Daughter  funds,  106  biotech  startups/SMEs  have  been supported so far with a combined investment of more than INR 1500 Cr and follow on investment raised by the startups/SMEs are more than INR 6000 Cr.
-  Product  Commercialization  Program  Fund  (PCP  Fund)  is  to  accelerate  market launch, pilot-market validation, and largescale commercialization of biotechnology products/technologies developed by Indian startups.
-  Regulatory  Affairs  &  Policy  Advocacy  Division  of  BIRAC  intends  to  drive innovation through navigation of regulatory complexities, harmonization of regulations & policies at both national and global levels, and fervently advocate for policies  that  catalyse  the  growth  of  start-ups,  SMEs,  and  entrepreneurs  in  the dynamic landscape of regulatory and policy affairs.
-  Clinical trial networks established through  National Biopharma Mission (NBM), a PMU under BIRAC which accelerates Discovery Research to Early Development for Biopharmaceuticals address geographic diversity of clinical trials across the country

To  strengthen  India's  regulatory  and  policy  milieu,  BIRAC  has  created  a  dedicated Regulatory  Affairs  &  Policy  Advocacy  (RAPA) unit  which  drives  innovation  through navigation of regulatory complexities, harmonisation  of global regulations, and advocates for policies that catalyse the growth of start-ups, SMEs, and entrepreneurs. Key initiatives undertaken by RAPA to address major challenges faced by biotech startups are as follows:

-  The First Hub is  a  single  window facilitation  unit of  BIRAC designed to address the regulatory queries of innovators. Representatives from  key  organisations, including  CDSCO,  ICMR,  FSSAI,  NIB,  BIS,  GeM,  DBT,  and  BIRAC,  assist innovators  on  the  first  Friday  of  every  month.  To  date,  1000+  queries  have  been addressed through the FIRST Hub portal.
-  Regulatory Facilitation  for  Innovators  and  Entrepreneurs  (REFINE) program was launched on 22 November 2024 for advanced regulatory facilitation by productor technology-specific mentoring on regulatory documentation, application support, risk assessment, success metricsand licensing requirements.
-  Global  Regulatory  Knowledge  Exchange  Forum  for  Emerging  Technologies was  conceptualised  on  12  September  2024  for  fostering  policy  dialogue  and developing key strategies in the biomanufacturing sector. As part of this initiative, stakeholders' consultation meetings have been organised in emerging fields such as smart protein, cell & gene therapy products, Biosimilars , Quantum Computing , Complex in-vitro models, etc .
-  A strategic  consultation titled 'Strengthening India's Clinical Trial Regulation: Lessons  from  Other  Countries' was  convened  on  strengthening  India's  clinical trial regulatory ecosystem. Which brought together global regulatory leaders, subject
- experts,  clinicians,  CROs,  CDMOs,  industry  representatives,  and  policymakers  to exchange best  practices on  the governance  of  clinical  trials,  including  early-phase and  first-in-human  studies,  as  well  as  regulatory  sandboxes  for  innovative  and emerging  therapies.  The  white  paper  was  developed  to  capture  the  necessary regulatory reforms.
-  Capacity  building: Regulatory  workshops  and  webinars  were  organised  with  IIT Delhi,  RCB,  USP  to  enhance  innovators'  understanding  of  approval  pathways, clinical  trial  requirements,  documentation  standards,  and  international  regulatory expectations,  thereby  improving  compliance  readiness  and  reducing  avoidable delays. In addition, the National Regulatory Professionals Development program is being organised  to  build  the  capacity  of  regulatory  mentors  in  the  biopharma  and medical devices sectors.

(d) The Biotechnology Industry Research Assistance Council (BIRAC) tracks programme-level outcomes to assess longitudinal impact, including employment generation, follow-on funding mobilization, intellectual property creation, valuation growth, and startup progression across funding stages.

- I. The Biotechnology Ignition Grant (BIG) scheme provides grant-in-aid support of up to ₹50 lakh for 18 months to early-stage innovators to establish proof-of-concept and  develop  prototypes.  This  funding  enables  startups  to  hire  scientific,  and technical personnel during the formative phase, build core R&D teams, and de-risk technology  development.  As  a  result,  over  1000  BIG-supported  startups  have generated  approximately  3,000  jobs  while  strengthening  their  survival  prospects through structured milestone-based monitoring and incubation support.
- II. The Sustainable Entrepreneurship and Enterprise Development (SEED) Fund provides first-equity support of up to ₹30 lakh to post-proof-of-concept startups to facilitate  product  refinement, validation, and early commercialization. By enabling pilot  deployment, regulatory preparedness, and market entry, the scheme improves revenue potential and  investor confidence. The  153  supported  startups have collectively attracted over ₹1,162 crore in follow-on funding and generated around 3,000 employment opportunities, reflecting sustained growth and improved business viability.
- III. Similarly, the Launching Entrepreneurial Driven Affordable Products ( LEAP) Fund extends  equity  support  of  up  to  ₹100  lakh  to  startups  with  validated technologies  for  scale-up,  regulatory  advancement,  manufacturing  readiness,  and commercialization.  This  late-stage  support  helps  enterprises  expand  production

capacity,  enter  new  markets,  and attract  private capital.  The  62  supported  startups have  raised  over  ₹893  crore  in  follow-on  funding  and  generated  nearly  1,300 employment  opportunities,  demonstrating  strengthened  market  traction  and  longterm sustainability.

- IV. The Make in India (MII) Programme Management Unit (PMU) at Biotechnology Industry Research Assistance Council (BIRAC) publishes a comprehensive landscaping  report  of  India's  biotechnology  sector  titled  the India  BioEconomy Report (IBER).

As per the India BioEconomy Report 2025 (IBER 2025), the biotechnology sector in India has generated approximately 3.5 million jobs and has over 10,000 cumulative biotechnology startups in the country. The report also tracks the growth trajectory of the sector  over  time, thereby  providing  longitudinal  insights  into  the expansion of the biotech startup ecosystem.

## DBT-BIRAC Biofoundries Programs

1. Microbial Biofoundry for yeast and bacterial engineering at International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi.
2. Precision Biotherapeutics  for  scale  up  of  Monoclonal  Antibodies  (mAb)  and  Live Biotherapeutics at Translational Health Science and Technology Institute (THSTI), Faridabad
3. Agri-food  product  at  BRIC-  National  Agri-Food  and  Biomanufacturing  Institute, Mohali
4. Pilot Scale  Production of Biopesticides at Institute of Pesticide  Formulation Technology (IPFT), Gurgaon
5. Bioengineering  Research  Center  for  development  of  Indigenous  microbial  chassis for Bioproduction at BRIC- NCCS, Pune
6. Cancer  Cell  Therapy  Biomanufacturing  Hub  at  ACTREC,  Tata  Memorial  Center, Mumbai.
7. National Institute of Animal Biotechnology (NIAB) with HiMedia Laboratories Pvt. Ltd, Hyderabad-Nation's First Animal Stem cell repository
8. IIT-Madras  with  TICEL  Bio  Park  Ltd,  Chennai-Development  and  scale-up  of products used in cosmetics, food, pharma and Bioplastic Industry.

## DBT-BIRAC Biomanufacturing Platforms

1. Foundation for Science Innovation and Development (FSID), Bangalore with Tata Chemicals Limited- Pilot Scale Facility (100 L) to Scale up Specialty Chemicals and Enzymes.
2. Immunoadoptive  Cell  Therapy  Private  Limited,  Mumbai-GMP  grade  facility  for Gene Delivery vector.
3. Hi Tech Biosciences India Ltd, Pune- Fermentation facility (at a scale of 10 KL) to Produce drug Intermediates and Bio-energy Starter Cultures at Commercial Scale.
4. Embio  Ltd,  Mumbai-  Pilot  scale  and  large  scale  fermenters  for  Pre-commercial production of APIs.
5. Laurus  Bio,  Visakhapatnam-  Fermentation  Facility  for  Functional  Foods,  Smart Proteins, Bio-based Chemicals, Enzymes and Precision Biotherapeutics.
6. Virchow Biotech Private Limited, HyderabadCommercial Production of Monoclonal Antibodies and Biosimilars.
7. Agilent Bioplus LLP- scale up the production of gluconates.
8. Revelations  Biotech  Pvt.  Ltd-  commercial  production  of  Fructo-oligo  saccharides (FOS).
9. HiMedia Laboratories, Mumbai-1 KL scale for food based products, food additives, probiotics and cell growth stimulators.
10. Sundyota Numandis Probioceuticals Private Limited, Ahmedabad- QMS compliant facility for commercial production of probiotics and smart proteins.
11. Jindal Steel, Angul- Facility for sequestration of CO2 and its utilization for growing engineered microalgal strains.

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