§1How big it is

§2Ways to get started

  • Biofertiliser / biopesticide unit
  • Contract research or testing lab
  • Diagnostic kit assembly (CDSCO licence)
  • Enzyme or probiotic blending
  • Bioinformatics / data services start-up via BIRAC BIG grant

See the Business Encyclopedia

§3Hubs and clusters

    §4Licences and registration

    1. CDSCO / state drug licence for biologics and diagnostics
    2. IBSC institutional biosafety committee and RCGM approval for GMO work
    3. Biofertiliser registration under FCO; biopesticide registration with CIB&RC
    4. DSIR recognition of in-house R&D (optional, for tax and grants)
    5. Udyam Registration (MSME) - free, online, PAN + Aadhaar based
    6. GST registration (mandatory above turnover threshold or for inter-state supply)
    7. Shops & Establishments registration or Factory Licence (Factories Act) depending on set-up
    8. State Pollution Control Board Consent to Establish / Operate per CPCB 2025 Red/Orange/Green/White/Blue category (White exempt)
    9. IEC - Importer Exporter Code from DGFT (only if importing or exporting)

    §5Regulators

    • Department of Biotechnology (DBT)
    • CDSCO (drugs, vaccines, diagnostics)
    • RCGM / GEAC (genetically modified organisms)
    • FSSAI (food enzymes, nutraceuticals)
    • Fertiliser Control Order (biofertilisers) / CIB&RC (biopesticides)

    §6Government help

    • BIRAC schemes - BIG (Biotechnology Ignition Grant), SBIRI, BIPP
    • BioE3 Policy and biomanufacturing hubs
    • PLI for pharmaceuticals / bulk drugs (where relevant)
    • Bio-incubators supported by BIRAC
    • Cross-sector schemes: Udyam-linked MSME benefits, PMEGP, CGTMSE credit guarantee, Stand-Up India, Startup India (DPIIT recognition), RoDTEP / duty drawback and Export Promotion Mission for exporters

    All schemes

    §7For exports

    • Pharmexcil (biopharma, vaccines)
    • DGFT

    §8Pros and cons

    Merits

    • Fast growth from USD 10 bn to USD 165.7 bn in a decade [PIB Bioeconomy 2025]
    • Grant funding for start-ups (BIRAC)
    • Policy push through BioE3

    Demerits

    • Long R&D and approval cycles
    • Specialised talent and lab capital needed
    • Multiple regulators depending on product
    • IP and biosafety compliance

    Sources

    1. PIB backgrounder (DBT): India - A Global Bioeconomy Powerhouse (5 Sep 2025)
    2. Department of Biotechnology
    3. BIRAC