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Pharma & chemicals

Export generic medicines (formulations)

Tablets, capsules and injectables; every market needs product registration. The USA buys the most.

Free to exportHS 3004
HS code
3004
Medicaments in measured doses or packed for retail sale — tablets, capsules, syrups, injections. Bulk drugs (APIs) are in Chapter 29.
Export policy
Free to export
Free to export, but only from a licensed manufacturer under the Drugs and Cosmetics Act. Drugs not approved in India need a CDSCO export NOC, and narcotic or psychotropic drugs need separate authorisation.
Registrations
4
IEC, GST and those below
India’s exports, 2025-26
US$ 21.9 bn
to 202 countries

What is exported

India is a major supplier of generic medicines to regulated markets (USA, UK, EU) and to Africa, Latin America and CIS countries. In 2025-26 India exported about US$ 21.9 billion under HS 3004; the USA took the largest share, followed by the UK, South Africa, France, Brazil, Canada and Nigeria. Every importing country requires the product and often the factory to be registered with its drug regulator before sale.

Varieties, grades and forms

  • Tablets and capsules (oral solids)The largest share: antibiotics, diabetes, heart and pain medicines.
  • Injectables and sterile productsVials, ampoules and infusions; need sterile-plant approvals.
  • Oral liquids and syrupsEach batch must be tested for diethylene glycol and ethylene glycol before export.
  • Creams, ointments and topicalsDermatology products, mostly to emerging markets.
  • Veterinary formulationsMedicines for livestock and pets.

Where it is grown or made

  • GujaratAhmedabad, Vadodara and Ankleshwar
  • Telangana and Andhra PradeshHyderabad and Visakhapatnam
  • Himachal PradeshBaddi–Barotiwala–Nalagarh belt
  • MaharashtraMumbai–Thane, Aurangabad and Pune
  • Goa and SikkimFormulation plants of large companies

Export packing

  • Medicines are packed in blister or strip packs and printed cartons with the leaflet, then in shipper cartons; labels must match the registration in the buyer country.
  • Barcoding on primary, secondary and tertiary packs follows DGFT/CDSCO track-and-trace rules.
  • Temperature-sensitive products ship with data loggers in insulated or reefer containers; pallets must be ISPM-15 or plastic.

Who buys abroad

  • Licensed importers and distributors registered with the buyer country's regulator
  • Government health-ministry and hospital tenders
  • International procurement agencies (UN agencies, Global Fund)
  • Generic companies buying contract manufacturing

The quality buyers ask for

Pharmacopoeia
Product meets the monograph the importing country recognises: IP, BP, USP or Ph. Eur.
Assay and impurities
Content of active ingredient within limits; related substances and residual solvents within pharmacopoeial or ICH limits
Dissolution and bioequivalence
Dissolution profile matching the reference product; bioequivalence study where the regulator requires it
Stability
Stability data under ICH conditions for the climatic zone of the market (Zone IVb for hot, humid countries)
Dossier format
Registration dossier in CTD or eCTD format, as the importing regulator asks
GMP
Manufacture under the revised Schedule M (Good Manufacturing Practices) of the Drugs Rules and WHO-GMP; PIC/S, EU-GMP or US FDA cGMP for regulated markets

Certificates

  • Drug manufacturing licence (State Licensing Authority)RequiredYou cannot make medicines without it; the licence lists each product.
  • WHO-GMP certificate and COPPRequiredCertificate of Pharmaceutical Product in the WHO format, issued through CDSCO and the state authority; most non-regulated markets ask for it to register a product.
  • Product registration in the importing countryRequiredEach medicine must be registered with the importing country's regulator before it can be sold there.
  • CDSCO export NOCOften askedNeeded only in specific cases, for example exporting a drug not approved for sale in India or unapproved new drugs; check the CDSCO export guidance.
  • US FDA / EU-GMP / PIC/S inspectionOften askedNeeded to supply the USA, EU and other regulated markets.
  • WHO prequalificationOften askedNeeded to supply UN and donor-funded tenders for products such as HIV, TB and malaria medicines.

Shipping, storage and shelf life

Container load

Shipper cartons on pallets with data loggers; reefer containers (often set at 15–25 °C) for long sea voyages through hot regions. A 20-ft reefer holds about 10 standard pallets.

How it travels

Sea for regular supply; air for urgent, cold-chain or high-value products. Use GDP-compliant forwarders.

Storage

Store at the labelled condition (for example below 30 °C, protected from light and moisture); record temperatures.

Shelf life

As proven by stability data — commonly 24 to 36 months; importers often require a minimum remaining shelf life at arrival.

What goes on the pack and carton

  • Label as registered in the importing country: name, strength, batch, manufacturing and expiry dates, storage, manufacturer and importer details, in the required language.
  • India export track-and-trace: barcodes on secondary and tertiary packs as required by DGFT; check the current DGFT public notice for primary-level rules.
  • EU: unique identifier (2D data matrix) and anti-tampering device on prescription medicines under the Falsified Medicines Directive.
  • USA: product identifier with serialisation under the Drug Supply Chain Security Act.
Where to get it tested

Your own QC lab must test every batch. For outside testing, use NABL-accredited pharmaceutical labs (search 'pharmaceutical' in the NABL directory) or labs approved under the Drugs Rules by the state licensing authority. The Central Drugs Laboratory and regional drug testing labs work for regulators, not exporters. Pharmexcil can guide members on registration and testing.

Benefits of exporting this product

Where to register

  • CDSCO and State Drug Licensing AuthorityManufacturing licence for each product; WHO-GMP certificate and Certificate of Pharmaceutical Product (COPP), which most importing countries ask for; export NOC for drugs not approved in India.cdsco.gov.in ↗
  • Pharmexcil (Pharmaceuticals Export Promotion Council)RCMC for formulations and bulk drugs. Pharmexcil also circulates DGFT rules on export packaging and traceability — confirm the current position with them.pharmexcil.com ↗

Quality and checks

  • Product registration (dossier, usually in CTD format) with the drug regulator of each importing country — this can take a year or more.
  • Regulated markets inspect the factory: US FDA (ANDA and facility registration), UK MHRA, EU authorities; many African and Asian buyers accept WHO-GMP.
  • Batch certificate of analysis, stability data and labelling in the destination language.
How to start small

A trader can start as a merchant exporter with a WHO-GMP certified manufacturer that will share its COPP and dossiers. Choose a few common molecules, pick one or two markets with simpler registration (often in Africa or Asia), appoint a local importer who holds the registration, and plan for the registration time before the first order.

Where new exporters go wrong

  • Expecting quick orders — without product registration in the destination, the goods cannot be sold.
  • Shipping a drug that is not approved in India without the CDSCO export NOC.
  • Cold-chain breaks for temperature-sensitive products; use validated packaging and data loggers.

Documents this product needs

Schemes that apply

Sources (6)
  1. Department of Commerce, Export Import Data Bank — India's exports of HS 3004 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)
  4. CDSCO — Central Drugs Standard Control Organisation
  5. Pharmexcil — official site
  6. US Food and Drug Administration — Drugs

Trade data

Indian generic medicines (formulations) exports in numbers

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

Exports in 2025-26
US$ 21.9 bn
+4.7% a year on average, 2020-21 to 2025-26
Change from 2024-25
↓ -0.7%
US$ 22 bn → US$ 21.9 bn
Buyer countries
202
Average export price
US$ 26.76
per kg · 8,16,993 tonnes shipped · US$ 28.36 the year before
United States of America: US$ 8.2 bnUnited Kingdom: US$ 755 mnSouth Africa: US$ 678 mnFrance: US$ 617 mnCanada: US$ 517 mnAustralia: US$ 464 mnNetherlands: US$ 434 mnRussia: US$ 398 mnGermany: US$ 383 mnKenya: US$ 304 mnSri Lanka: US$ 235 mnNepal: US$ 217 mnUnited Arab Emirates: US$ 191 mnUnited States of America: US$ 8.2 bnUnited States of AmericaUnited Kingdom: US$ 755 mnUnited KingdomSouth Africa: US$ 678 mnSouth AfricaFrance: US$ 617 mnCanada: US$ 517 mnAustralia: US$ 464 mnAustraliaNetherlands: US$ 434 mnRussia: US$ 398 mnRussiaGermany: US$ 383 mnKenya: US$ 304 mnKenyaSri Lanka: US$ 235 mnNepal: US$ 217 mnUnited Arab Emirates: US$ 191 mnIndia
Where Indian generic medicines (formulations) goes — among our 30 countries, 2025-26
2020-21: US$ 17.4 bn17k2020-212021-22: US$ 17.1 bn17k2021-222022-23: US$ 17.6 bn18k2022-232023-24: US$ 19.6 bn20k2023-242024-25: US$ 22 bn22k2024-252025-26: US$ 21.9 bn22k2025-26
India’s generic medicines (formulations) 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 2025-26 — a 113% swing between them. Keep this swing in mind when you quote.

2020-21: US$ 56.98 per kg56.982021-22: US$ 28.06 per kg2022-23: US$ 28.63 per kg2024-25: US$ 28.36 per kg2025-26: US$ 26.76 per kg26.762020-212021-222022-232023-242024-252025-26
Average export price of Indian generic medicines (formulations) · 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$ 17.4 bn2020-212021-22: US$ 17.1 bn2021-222022-23: US$ 17.6 bn2022-232023-24: US$ 19.6 bn2023-242024-25: US$ 22 bn2024-252025-26: US$ 21.9 bn2025-262026-27: US$ 23.4 bn (US$ 21.9 bn – US$ 25 bn)23k2026-272027-28: US$ 24.8 bn (US$ 23 bn – US$ 26.7 bn)25k2027-28
India’s generic medicines (formulations) exports and projection · hollow bars = projection, line = likely range
By 2027-28: US$ 24.8 bn

Likely range US$ 23 bn to US$ 26.7 bn.

Trend
+5.9% a year
Fit (R²)
0.86
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
1United States of AmericaUS$ 8.2 bn-13.6%
2United KingdomUS$ 755 mn+1.3%
3South AfricaUS$ 678 mn+10.9%
4FranceUS$ 617 mn+7.8%
5BrazilUS$ 530 mn+37.2%
6CanadaUS$ 517 mn+4.8%
7NigeriaUS$ 480 mn+21.3%
8AustraliaUS$ 464 mn+10.6%
9NetherlandsUS$ 434 mn+17.3%
10RussiaUS$ 398 mn+4.8%
11GermanyUS$ 383 mn+8.9%
12PhilippinesUS$ 346 mn+1.7%

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. TanzaniaUS$ 182 mn → US$ 261 mn+43.5%
  2. MaltaUS$ 221 mn → US$ 305 mn+38%
  3. BrazilUS$ 386 mn → US$ 530 mn+37.2%
  4. NigeriaUS$ 395 mn → US$ 480 mn+21.3%
  5. MexicoUS$ 181 mn → US$ 219 mn+21.1%
  6. Sri LankaUS$ 199 mn → US$ 235 mn+18.1%
  7. NetherlandsUS$ 370 mn → US$ 434 mn+17.3%
  8. South AfricaUS$ 611 mn → US$ 678 mn+10.9%

Low demand

  1. United States of AmericaUS$ 9.49 bn → US$ 8.2 bn-13.6%

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
Other medcne put up for retail sale n.e.s3004 90 99 · Medicaments, consisting of mixed or unmixed products in heading no. 3004, for therapeutic or prophylactic…US$ 11 bn+12.3%3,49,470 tonnesUS$ 31.43 per kgwas US$ 29.63
Medicaments, consisting of mixed or unmixed products in heading no. 3004, for therapeutic or prophylactic… — other anticancer drugs3004 90 49US$ 992 mn-57.5%2,657 tonnesUS$ 373.44 per kgwas US$ 819.13
Other antihypertensive drugs3004 90 79 · Medicaments, consisting of mixed or unmixed products in heading no. 3004, for therapeutic or prophylactic…US$ 947 mn-12%14,732 tonnesUS$ 64.30 per kgwas US$ 68.76
Other nonsteroidal antiinflamatory, analgestics and antipyratic drugs3004 90 69 · Medicaments, consisting of mixed or unmixed products in heading no. 3004, for therapeutic or prophylactic…US$ 907 mn+1.2%56,553 tonnesUS$ 16.03 per kgwas US$ 17.03
Other antinistaninics ,antacids,antiulcer,antiemitics and other gastointestinal drugs3004 90 39 · Medicaments, consisting of mixed or unmixed products in heading no. 3004, for therapeutic or prophylactic…US$ 659 mn+2.1%17,658 tonnesUS$ 37.33 per kgwas US$ 35.44
Other mdcmnts containing pencllns/drvtvs throf with a pencllnc acid strctr/strptmycns or their dervativs put up for retale sa3004 10 90 · Medicaments, containing penicillins, streptomycins or their derivatives, for therapeutic or prophylactic…US$ 427 mn-1.9%12,269 tonnesUS$ 34.82 per kgwas US$ 38.41
Other cephalosporins and their derivatives3004 20 19 · Medicaments, containing antibiotics, for therapeutic or prophylactic uses, packaged for retail saleUS$ 350 mn-2.5%22,286 tonnesUS$ 15.70 per kgwas US$ 17.26
Phenobarbitone,mephobarbitone,primidone, phenytoin,carbamazpin,ethosucimid, valporicacid ,diazepa,lamotrigin,gab3004 90 81 · Medicaments, consisting of mixed or unmixed products in heading no. 3004, for therapeutic or prophylactic…US$ 318 mn-6.4%7,487 tonnesUS$ 42.43 per kgwas US$ 40.07
Medicaments, consisting of mixed or unmixed products in heading no. 3004, for therapeutic or prophylactic… — other antiepileptic drugs3004 90 82US$ 312 mn-7.9%6,311 tonnesUS$ 49.36 per kgwas US$ 45.79
Other anthelmintics drugs;antiamoebic and other antiprotozoal/antifungal drugs3004 90 29 · Medicaments, consisting of mixed or unmixed products in heading no. 3004, for therapeutic or prophylactic…US$ 304 mn-4.6%15,339 tonnesUS$ 19.82 per kgwas US$ 19.86
Ibuprofen with or without paracetamol or other compounds3004 90 63 · Medicaments, consisting of mixed or unmixed products in heading no. 3004, for therapeutic or prophylactic…US$ 289 mn-0.1%22,144 tonnesUS$ 13.04 per kgwas US$ 14.47
Other medicament containing other antibioticand put up for retail sale3004 20 99 · Medicaments, containing antibiotics, for therapeutic or prophylactic uses, packaged for retail saleUS$ 277 mn+19.3%5,237 tonnesUS$ 52.91 per kgwas US$ 49.41
Amoxycyllin in capsules, injections etc..3004 10 30 · Medicaments, containing penicillins, streptomycins or their derivatives, for therapeutic or prophylactic…US$ 275 mn+4.6%13,725 tonnesUS$ 20.05 per kgwas US$ 20.82
Other antitubercular drugs3004 90 57 · Medicaments, consisting of mixed or unmixed products in heading no. 3004, for therapeutic or prophylactic…US$ 259 mn+38.1%2,718 tonnesUS$ 95.28 per kgwas US$ 102.82

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$ 467.6 bn
2023
India among exporters
#9
of 160 countries
India’s share of world exports
4.3%
US$ 18.8 bn
Left for others to win
US$ 422.5 bn
exported by other countries

Top exporters — your competitors

  1. 1GermanyUS$ 67.7 bn 15.3%
  2. 2SwitzerlandUS$ 45.3 bn 10.3%
  3. 3ItalyUS$ 37.1 bn 8.4%
  4. 4USAUS$ 34.5 bn 7.8%
  5. 5BelgiumUS$ 27.8 bn 6.3%
  6. 6FranceUS$ 27.1 bn 6.1%
  7. 7IrelandUS$ 22.8 bn 5.2%
  8. 8United KingdomUS$ 19.2 bn 4.4%
  9. 9IndiaUS$ 18.8 bn 4.3%
  10. 10SloveniaUS$ 18.6 bn 4.2%

Biggest buyers in the world

  1. 1USAUS$ 87.4 bn 18.7%
  2. 2SwitzerlandUS$ 40.1 bn 8.6%
  3. 3GermanyUS$ 31.6 bn 6.8%
  4. 4ChinaUS$ 24.1 bn 5.1%
  5. 5BelgiumUS$ 21.8 bn 4.7%
  6. 6ItalyUS$ 20 bn 4.3%
  7. 7FranceUS$ 18.4 bn 3.9%
  8. 8United KingdomUS$ 16.5 bn 3.5%
  9. 9JapanUS$ 15.9 bn 3.4%
  10. 10SpainUS$ 14.3 bn 3.1%

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$ 94.7 bnIndia 12.9% · gap US$ 82.4 bn
GermanyUS$ 33.8 bnIndia 1.7% · gap US$ 33.3 bn
ChinaUS$ 22.5 bnIndia 0.6% · gap US$ 22.4 bn
ItalyUS$ 18.8 bnIndia 0.5% · gap US$ 18.7 bn
FranceUS$ 18 bnIndia 2.3% · gap US$ 17.6 bn
United KingdomUS$ 16.5 bnIndia 5.5% · gap US$ 15.6 bn
JapanUS$ 15.2 bnIndia 0.7% · gap US$ 15.1 bn
SpainUS$ 14.5 bnIndia 1.1% · gap US$ 14.3 bn
NetherlandsUS$ 10.2 bnIndia 3.2% · gap US$ 9.84 bn
CanadaUS$ 10.4 bnIndia 5.5% · gap US$ 9.82 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 generic medicines (formulations)

India is one of the world's largest suppliers of generic medicines by volume and is often called the pharmacy of the developing world; it is also a major supplier of generics to the USA. Competitors include China (strong in active ingredients), the EU's own generic makers, Israel, and growing producers in Bangladesh and Jordan. Demand comes from health systems that need low-cost medicines, patent expiries in rich markets, and donor-funded programmes that buy WHO-prequalified products. Openings for a smaller exporter are in registered products for Africa, Latin America, CIS and South-East Asia, and in contract manufacturing for companies that hold registrations.

  1. 01Pick products and markets

    Choose molecules you can make under GMP and markets where registration time and cost are manageable.

  2. 02Prepare the dossier

    Compile CTD dossiers with stability, validation and, where needed, bioequivalence data.

  3. 03Get WHO-GMP and COPP

    Apply through the state authority and CDSCO for WHO-GMP and a COPP per product.

  4. 04Register through a local partner

    Most countries need a local importer or marketing-authorisation holder to file and hold the registration.

  5. 05Produce, test and release

    Make batches under GMP, test in QC, and release with a certificate of analysis.

  6. 06Pack, serialise and ship

    Apply market-specific labels and barcodes, ship under controlled conditions, file the shipping bill and claim RoDTEP where allowed.

  7. 07Payment and pharmacovigilance

    Collect against LC or documents; keep complaint and adverse-event reporting systems running.

Meet buyers

Trade fairs

Questions

Questions about exporting generic medicines (formulations)

Can a trader export medicines without a factory?
Yes, as a merchant exporter with a wholesale drug licence, buying from licensed WHO-GMP manufacturers. The product must still be registered in the importing country.
How long does product registration take abroad?
It varies widely by country, from months to a few years. Ask the regulator or your local partner, and budget for fees and samples.
What is a COPP?
A Certificate of Pharmaceutical Product in the WHO format, confirming the product's licensing status and that the factory follows GMP.
Do I need to follow the revised Schedule M?
Yes. Revised Schedule M applies to all drug manufacturers in India, with timelines that differed for large and small firms. Confirm your current deadline and status on CDSCO.
Which council supports pharma exporters?
Pharmexcil (Pharmaceuticals Export Promotion Council) issues the RCMC and runs buyer-seller meets such as iPHEX.
Sources (6)
  1. CDSCO — Central Drugs Standard Control Organisation
  2. Pharmexcil — official site
  3. WHO — Good manufacturing practices (norms and standards)
  4. European Commission — Falsified medicines (safety features on medicine packs)
  5. NABL — search for accredited testing laboratories
  6. US FDA — Drugs

Who buys Indian generic medicines (formulations)

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