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Export vaccines and blood products

Vaccines from Pune and Hyderabad supplied to UN agencies and health ministries; WHO prequalification is the key.

Free to exportHS 3002
HS code
3002
Vaccines for human and veterinary use, antisera, immunological products and blood fractions (3002).
Export policy
Free to export
Free to export under ITC(HS) Schedule 2 as checked in November 2026. Vaccines must come from a CDSCO-licensed maker. Vaccines themselves are generally outside SCOMET, but pathogens, toxins and some biological equipment are controlled under SCOMET Category 2. Confirm your exact 8-digit line on the DGFT ITC(HS) search before you ship.
Registrations
4
IEC, GST and those below
India’s exports, 2025-26
US$ 2.25 bn
to 186 countries

What is exported

India is one of the world's largest vaccine suppliers by volume, with major makers in Pune and Hyderabad (Genome Valley) supplying UNICEF, PAHO, GAVI-funded programmes and health ministries. In 2025-26 India exported about US$ 2.2 billion under HS 3002; Nigeria led, followed by the USA, Indonesia, DR Congo, Mexico and Bangladesh. This is a manufacturer-led trade with strict cold-chain and regulatory rules.

Varieties, grades and forms

  • Childhood vaccinesDPT, measles–rubella, BCG, polio, pentavalent and rotavirus vaccines for immunisation programmes.
  • Adult and travel vaccinesTyphoid, hepatitis, rabies and influenza vaccines.
  • Antisera and immunoglobulinsAnti-snake venom, anti-rabies and tetanus sera.
  • Veterinary vaccinesFoot-and-mouth, poultry and other livestock vaccines.

Where it is grown or made

  • MaharashtraPune
  • TelanganaHyderabad — Genome Valley
  • OtherTamil Nadu (Chennai, Coonoor), Gujarat (Ahmedabad), Himachal Pradesh (Kasauli)

Export packing

  • Vials or ampoules in cartons with vaccine vial monitors, packed in validated insulated shippers with ice packs or in reefer containers.
  • Temperature data loggers in every shipment; packing follows WHO guidelines for international shipment of vaccines.

Who buys abroad

  • UNICEF Supply Division and PAHO
  • Ministries of health (national immunisation programmes)
  • Licensed private importers and hospital chains
  • Veterinary departments and livestock companies

The quality buyers ask for

Potency and safety
Potency, sterility, endotoxin and identity tests per WHO recommendations and the pharmacopoeia
Presentation
Single- or multi-dose vials or prefilled syringes as the tender asks
Vaccine vial monitor
VVM type matched to the vaccine's heat stability (WHO PQS)
Cold chain
2–8 °C (or frozen) storage and transport; freeze-sensitive products must not freeze
Remaining shelf life
Minimum remaining shelf life on delivery as set in the contract

Certificates

  • CDSCO manufacturing licence and marketing authorisationRequiredRequired to make and export vaccines from India.
  • Lot release (Central Drugs Laboratory, Kasauli)RequiredNational control laboratory release of each lot.
  • WHO prequalificationOften askedRequired for UN procurement (UNICEF, PAHO).
  • Registration in the importing countryRequiredEach country's regulator must license the vaccine, though many rely on WHO prequalification.
  • COPPOften askedCertificate of Pharmaceutical Product issued through CDSCO for registration abroad.

Shipping, storage and shelf life

Container load

Insulated passive shippers on air pallets, or temperature-controlled (reefer) containers for large sea shipments.

How it travels

Mostly air freight with temperature-controlled handling at both airports.

Storage

2–8 °C cold rooms with continuous monitoring and backup power.

Shelf life

Set by the licence, commonly one to three years.

What goes on the pack and carton

  • Name, strength, dose, route, batch, expiry, storage conditions and maker, as approved in the registration.
  • Outer cartons: "Keep refrigerated 2–8 °C", "Do not freeze" and shipping indicators.
  • Language and format as the UN agency or importing regulator requires.
Where to get it tested

The Central Drugs Laboratory, Kasauli, is the national control laboratory for vaccines and sera. NABL-accredited biological labs support quality-control testing.

Benefits of exporting this product

Where to register

  • PharmexcilBiotech and biological products are listed under Pharmexcil in Appendix 2T.pharmexcil.com ↗
  • CDSCOManufacturing licence and marketing authorisation; lots are tested and released through the Central Drugs Laboratory, Kasauli; CDSCO issues the COPP that importing regulators ask for.cdsco.gov.in ↗

Quality and checks

  • WHO prequalification is required for supply to UNICEF and other UN procurement; regulated markets need their own licence (US FDA BLA, EU marketing authorisation).
  • Lot release certificate from the national control laboratory and the importing country's own lot release where required.
  • Cold chain of 2–8 °C (or frozen for some products) with vaccine vial monitors, data loggers and validated shippers.
How to start small

Vaccines are not a trader's first product. A newcomer can work with a licensed maker on veterinary vaccines or as an agent for government tenders in Africa and Asia, where the maker holds the registration and ships directly.

Where new exporters go wrong

  • Cold-chain breaks at airports; book temperature-controlled handling end to end.
  • Tendering without WHO prequalification where the buyer requires it.
  • Short remaining shelf life on arrival; most tenders demand a minimum shelf life.

Documents this product needs

Schemes that apply

Sources (7)
  1. Department of Commerce, Export Import Data Bank — India's exports of HS 3002 by country, 2025-26
  2. DGFT — Appendix 2T: Export Promotion Councils and the products under each
  3. DGFT — ITC(HS) export policy search (Schedule 2) and SCOMET list (Appendix 3)
  4. CDSCO — Central Drugs Standard Control Organisation
  5. Central Drugs Laboratory, Kasauli (vaccines and sera testing)
  6. WHO — Prequalification of medical products (vaccines, medicines, diagnostics)
  7. Pharmexcil — official site

Trade data

Indian vaccines and blood products exports in numbers

From the Department of Commerce’s TradeStat, country by country. US$, Indian financial years (April–March).

Exports in 2025-26
US$ 2.25 bn
+12.8% a year on average, 2020-21 to 2025-26
Change from 2024-25
↑ +26.4%
US$ 1.78 bn → US$ 2.25 bn
Buyer countries
186
Average export price
US$ 280.30
per kg · 8,015 tonnes shipped · US$ 257.50 the year before
Nigeria: US$ 172 mnUnited States of America: US$ 103 mnIndonesia: US$ 97.9 mnMexico: US$ 93.6 mnBangladesh: US$ 79.6 mnPhilippines: US$ 69.1 mnNetherlands: US$ 64.9 mnIran: US$ 56.4 mnBrazil: US$ 54.3 mnKenya: US$ 50.9 mnRussia: US$ 49.9 mnTürkiye: US$ 49.2 mnAlgeria: US$ 43.7 mnEthiopia: US$ 43.7 mnVietnam: US$ 41.6 mnSri Lanka: US$ 38.6 mnSudan: US$ 37.8 mnEgypt: US$ 33.3 mnUnited Arab Emirates: US$ 30.6 mnColombia: US$ 30.5 mnUnited Kingdom: US$ 27.3 mnNigeria: US$ 172 mnNigeriaUnited States of America: US$ 103 mnUnited States of AmericaIndonesia: US$ 97.9 mnIndonesiaMexico: US$ 93.6 mnMexicoBangladesh: US$ 79.6 mnBangladeshPhilippines: US$ 69.1 mnPhilippinesNetherlands: US$ 64.9 mnIran: US$ 56.4 mnBrazil: US$ 54.3 mnKenya: US$ 50.9 mnRussia: US$ 49.9 mnTürkiye: US$ 49.2 mnAlgeria: US$ 43.7 mnEthiopia: US$ 43.7 mnVietnam: US$ 41.6 mnSri Lanka: US$ 38.6 mnSudan: US$ 37.8 mnEgypt: US$ 33.3 mnUnited Arab Emirates: US$ 30.6 mnColombia: US$ 30.5 mnUnited Kingdom: US$ 27.3 mnIndia
Where Indian vaccines and blood products goes — among our 80 countries, 2025-26
2020-21: US$ 1.23 bn1.2k2020-212021-22: US$ 1.46 bn1.5k2021-222022-23: US$ 1.47 bn1.5k2022-232023-24: US$ 1.68 bn1.7k2023-242024-25: US$ 1.78 bn1.8k2024-252025-26: US$ 2.25 bn2.2k2025-26
India’s vaccines and blood products exports, year by year · US$ million

The price cycle

India’s average export price per kg each year (total value ÷ total quantity). Highest in 2020-21, lowest in 2021-22 — a 146% swing between them. Keep this swing in mind when you quote.

2020-21: US$ 418.97 per kg418.972021-22: US$ 170.42 per kg170.422022-23: US$ 252.96 per kg2024-25: US$ 257.50 per kg2025-26: US$ 280.30 per kg280.302020-212021-222022-232023-242024-252025-26
Average export price of Indian vaccines and blood products · US$ per kg · dotted = year in between not available

What next: a projection from the trend

The past trend carried forward — not a forecast by any authority. Sudden changes in policy, prices or demand are not in it.

2020-21: US$ 1.23 bn2020-212021-22: US$ 1.46 bn2021-222022-23: US$ 1.47 bn2022-232023-24: US$ 1.68 bn2023-242024-25: US$ 1.78 bn2024-252025-26: US$ 2.25 bn2025-262026-27: US$ 2.35 bn (US$ 2.17 bn – US$ 2.54 bn)2.3k2026-272027-28: US$ 2.61 bn (US$ 2.39 bn – US$ 2.86 bn)2.6k2027-28
India’s vaccines and blood products exports and projection · hollow bars = projection, line = likely range
By 2027-28: US$ 2.61 bn

Likely range US$ 2.39 bn to US$ 2.86 bn.

Trend
+11.3% a year
Fit (R²)
0.94
Based on
6 years of official figures

Method: a straight line through the logarithm of yearly exports (log-linear regression); range = ±1 standard error.

Biggest buyer countries

By value in 2025-26. Change is against 2024-25.

Name2025-26Change
1NigeriaUS$ 172 mn+157.4%
2United States of AmericaUS$ 103 mn+20.1%
3IndonesiaUS$ 97.9 mn+116.3%
4DR CongoUS$ 96.3 mn+94.4%
5MexicoUS$ 93.6 mn+1,533.3%
6Pakistan IrUS$ 92.7 mn+29.2%
7BangladeshUS$ 79.6 mn+33.1%
8PhilippinesUS$ 69.1 mn-5.6%
9NetherlandsUS$ 64.9 mn+65%
10IranUS$ 56.4 mn+148%
11NigerUS$ 55.5 mn+281.2%
12BrazilUS$ 54.3 mn-52.8%

Where demand is rising and falling

Only countries that buy at least US$ 1 million or 1% of India’s exports of this product. Change from 2024-25 to 2025-26.

High demand

  1. MexicoUS$ 5.7 mn → US$ 93.6 mn+1,533.3%
  2. NigerUS$ 14.6 mn → US$ 55.5 mn+281.2%
  3. NigeriaUS$ 66.7 mn → US$ 172 mn+157.4%
  4. IranUS$ 22.8 mn → US$ 56.4 mn+148%
  5. SudanUS$ 17.3 mn → US$ 37.8 mn+118.7%
  6. IndonesiaUS$ 45.3 mn → US$ 97.9 mn+116.3%
  7. RussiaUS$ 23.8 mn → US$ 49.9 mn+109.7%
  8. Sri LankaUS$ 19 mn → US$ 38.6 mn+102.7%

Low demand

  1. IraqUS$ 43.9 mn → US$ 20 mn-54.4%
  2. BrazilUS$ 115 mn → US$ 54.3 mn-52.8%
  3. CanadaUS$ 32.1 mn → US$ 17.7 mn-44.9%
  4. KenyaUS$ 72.6 mn → US$ 50.9 mn-30%
  5. PeruUS$ 23.9 mn → US$ 19.3 mn-19.3%
  6. UgandaUS$ 28.3 mn → US$ 23.7 mn-16.1%

New buyers: Countries that bought nothing from India in 2024-25 and did in 2025-26.

  • Malta · US$ 4.8 mn

Which forms sell, and at what price

India’s exports by 8-digit tariff line, 2025-26. Average price = total value ÷ total quantity (TradeStat): the average of every shipment on that line, not the price of any one deal.

Tariff lineValue 2025-26ChangeQuantityAverage price
Others-of-vaccines for human medicine3002 41 29 · Vaccines, toxins, cultures of micro-organisms and similar products, for human medicineUS$ 628 mn+61.7%1,836 tonnesUS$ 341.81 per kgwas US$ 279.76
Immunological products, put up in measured doses or in forms or packings for retail sale3002 15 00 · Blood, human or animal, antisera, other blood fractions and immunological products, immunological products…US$ 397 mn+30%521 tonnesUS$ 762.60 per kgwas US$ 714.74
Others-of-vaccines for human medicine3002 41 19 · Vaccines, toxins, cultures of micro-organisms and similar products, for human medicineUS$ 351 mn+4.2%1,352 tonnesUS$ 259.49 per kgwas US$ 207.76
Measles, mumps and rubella (mmr)3002 41 23 · Vaccines, toxins, cultures of micro-organisms and similar products, for human medicineUS$ 173 mn-5.3%488 tonnesUS$ 354.70 per kgwas US$ 421.08
Others-of-antisera and other blood fractions:3002 12 90 · Blood, human or animal, antisera, other blood fractions and immunological products, antisera and other…US$ 132 mn+20.7%591 tonnesUS$ 223.13 per kgwas US$ 354.11
Polio (single vaccines for)3002 41 14 · Vaccines, toxins, cultures of micro-organisms and similar products, for human medicineUS$ 125 mn+24.1%496 tonnesUS$ 252.53 per kgwas US$ 218.77
Rabies (single vaccines for)3002 41 16 · Vaccines, toxins, cultures of micro-organisms and similar products, for human medicineUS$ 79.4 mn+43.2%346 tonnesUS$ 229.22 per kgwas US$ 197.16
Cholera and typhoid (single vaccines for)3002 41 11 · Vaccines, toxins, cultures of micro-organisms and similar products, for human medicineUS$ 74.4 mn+10.2%117 tonnesUS$ 636.04 per kgwas US$ 567.81
Cultures of micro-organisms (excludinguding yeast)3002 49 10 · Toxins, cultures of micro-organisms and similar products in item 3002.3US$ 37.3 mn+3.8%432 tonnesUS$ 86.29 per kgwas US$ 82.59
Tuberculosis (single vaccines for)3002 41 15 · Vaccines, toxins, cultures of micro-organisms and similar products, for human medicineUS$ 37 mn+37.2%129 tonnesUS$ 286.30 per kgwas US$ 245.24
Immunological products, mixed, not put up in measured doses or in forms or packings for retail sale:3002 14 00 · Blood, human or animal, antisera, other blood fractions and immunological products, immunological products…US$ 36.9 mn+24.1%16 tonnesUS$ 2346.88 per kgwas US$ 34783.63
Others-of-others-of-humn,anml,bld for mdcnl use; mdfd imunlgcl prdt w/n_bitech prcs;vccns,txns,cltr_mcrgnsm,ether smlr p; cell3002 90 90 · Toxins, cultures of micro-organisms and similar productsUS$ 29 mn+23.6%545 tonnesUS$ 53.19 per kgwas US$ 83.13
Diphtheria and tetatus (dt)3002 41 22 · Vaccines, toxins, cultures of micro-organisms and similar products, for human medicineUS$ 25.6 mn+19.5%329 tonnesUS$ 77.94 per kgwas US$ 79.10
Immunological products, unmixed, not put up in measured doses or in forms or packings for retail sale3002 13 00 · Blood, human or animal, antisera, other blood fractions and immunological products, immunological products…US$ 24.5 mn+57.3%1.3 tonnesUS$ 19292.45 per kgwas US$ 8360.13

The world market

Each country’s own recorded exports and imports in UN Comtrade, 2023 (the latest year nearly every country has reported).

World imports
US$ 320.4 bn
2023
India among exporters
#19
of 140 countries
India’s share of world exports
0.5%
US$ 1.68 bn
Left for others to win
US$ 315 bn
exported by other countries

Top exporters — your competitors

  1. 1SwitzerlandUS$ 52.4 bn 16.6%
  2. 2USAUS$ 49.9 bn 15.8%
  3. 3GermanyUS$ 46.9 bn 14.8%
  4. 4IrelandUS$ 44.4 bn 14%
  5. 5BelgiumUS$ 31.2 bn 9.8%
  6. 6ItalyUS$ 11.8 bn 3.7%
  7. 7AustriaUS$ 10.2 bn 3.2%
  8. 8FranceUS$ 9.55 bn 3%
  9. 9NetherlandsUS$ 8.18 bn 2.6%
  10. 10SpainUS$ 7.39 bn 2.3%

Biggest buyers in the world

  1. 1USAUS$ 82 bn 25.6%
  2. 2GermanyUS$ 36.8 bn 11.5%
  3. 3BelgiumUS$ 22.4 bn 7%
  4. 4SwitzerlandUS$ 17.5 bn 5.5%
  5. 5ChinaUS$ 16.9 bn 5.3%
  6. 6FranceUS$ 15.9 bn 5%
  7. 7JapanUS$ 14.1 bn 4.4%
  8. 8ItalyUS$ 11.1 bn 3.5%
  9. 9United KingdomUS$ 9.28 bn 2.9%
  10. 10IrelandUS$ 7.26 bn 2.3%

Opportunity: what these countries buy from the world, and from India

Each country’s own recorded imports in UN Comtrade, latest year it has reported. The long light part of each bar is demand other countries are filling today.

United States of AmericaUS$ 109.2 bnIndia 0.2% · gap US$ 109 bn
GermanyUS$ 39.1 bnIndia 0.6% · gap US$ 38.8 bn
ChinaUS$ 17.7 bnIndia 0% · gap US$ 17.7 bn
JapanUS$ 13.7 bnIndia 0% · gap US$ 13.7 bn
FranceUS$ 13.1 bnIndia 0.3% · gap US$ 13.1 bn
ItalyUS$ 12.8 bnIndia 0% · gap US$ 12.8 bn
United KingdomUS$ 9.28 bnIndia 0.1% · gap US$ 9.27 bn
NetherlandsUS$ 7.83 bnIndia 0.5% · gap US$ 7.79 bn
CanadaUS$ 6.88 bnIndia 0.5% · gap US$ 6.85 bn
SpainUS$ 6.55 bnIndia 0% · gap US$ 6.55 bn

TradeStat’s 2023-24 quantities are double-counted, so that year is left out of the price. Sources: TradeStat — Export Import Data Bank, Department of Commerce · UN Comtrade database (United Nations Statistics Division) · Figures taken 29 October 2026.

Step by step

How to export vaccines and blood products

India is one of the largest vaccine producers in the world by doses and a major supplier to UNICEF and national immunisation programmes, especially for childhood vaccines. Competitors include large European and US vaccine companies at the high end and makers in China, Indonesia and Brazil in public-sector markets. Demand is driven by national immunisation programmes, donor funding through GAVI, and outbreak response. Openings are mainly for licensed makers with WHO prequalification; traders can work on veterinary vaccines and as agents in tenders.

  1. 01Licence and prequalify

    CDSCO licence; WHO prequalification for UN tenders.

  2. 02Register abroad

    File dossiers or use WHO collaborative registration where available.

  3. 03Bid or contract

    UN long-term agreements, ministry tenders or private importers.

  4. 04Release lots

    CDL Kasauli lot release and importing-country release.

  5. 05Plan the cold chain

    Validated shippers, data loggers and booked cold space at both ends.

  6. 06Ship and claim

    File the shipping bill; claim RoDTEP (no drawback AIR on 3002).

  7. 07Payment

    UN agencies pay on agreed terms after delivery; for private buyers use advance or LC.

Meet buyers

Trade fairs

Questions

Questions about exporting vaccines and blood products

Can a trader export vaccines?
Only in partnership with a licensed maker that holds the registrations; the cold chain and lot release stay the maker's responsibility.
What is WHO prequalification?
WHO's assessment of quality, safety and efficacy; UN agencies buy only prequalified vaccines.
Is there duty drawback on vaccines?
The All Industry Rate for heading 3002 is Nil; RoDTEP is 0.7% for most human vaccine lines.
Which council?
Pharmexcil (biotech and biological products).
Are vaccines SCOMET items?
Vaccines are generally outside SCOMET, but some pathogens, toxins and biological equipment are controlled; confirm on DGFT.
Sources (6)
  1. CDSCO — Central Drugs Standard Control Organisation
  2. Central Drugs Laboratory, Kasauli (vaccines and sera testing)
  3. WHO — Prequalification of medical products (vaccines, medicines, diagnostics)
  4. Pharmexcil — official site
  5. DGFT — Appendix 4R, RoDTEP schedule for DTA exports w.e.f. 10.10.2024 (Notification 32/2024-25); rates continued to 31.12.2026 by Notification 41/2026-27
  6. Gazette of India — Notification 77/2023-Customs (N.T.) dated 20.10.2023: All Industry Rates of duty drawback

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