How to Export Pharmaceuticals from India — Complete Compliance Guide
Everything you need to know about exporting pharmaceutical products from India — mandatory licences, WHO-GMP, CDSCO NOC, market-specific requirements, temperature-controlled logistics, and documentation.
India is the world's pharmacy — the largest supplier of generic medicines globally, exporting to over 200 countries. But pharmaceutical exports are among the most regulated export categories in India. The right licences, the correct documentation for each market, and a freight partner with temperature-control capability are all mandatory, not optional. This guide covers everything.
Mandatory licences and certifications for pharma export
Manufacturing Licence (Form 25 / 25A)
State Drugs ControllerRequired for any manufacturer of drugs or pharmaceutical formulations. Without this, no CDSCO NOC can be issued.
CDSCO No Objection Certificate (NOC)
Central Drugs Standard Control OrganisationExport NOC from CDSCO is required for exporting drugs. Apply at cdscoonline.gov.in. Required per product or product group for many markets.
WHO-GMP Certificate
State Drugs Licensing AuthorityMandatory for exporting to Africa, Middle East, Southeast Asia, and many regulated markets. Proves your facility meets WHO Good Manufacturing Practice standards.
IEC Code
DGFTMandatory for all commercial exports from India.
GST Registration + LUT
GST NetworkFor zero-rated export without IGST payment.
Certificate of Pharmaceutical Product (CoPP)
CDSCORequired by many countries as proof that the product is licensed for sale in India. Some markets require this in addition to WHO-GMP.
Market-specific requirements
Each destination market has its own import requirements. These are the most common markets for Indian pharma exports.
| Market | Key Requirements | Notes |
|---|---|---|
| USA | FDA facility registration, Prior Notice, DUNS number | Strictest regulated market. Full FDA inspection may be required. |
| EU / UK | EU GMP certification, Marketing Authorisation in destination country | EMA standards. EU GMP is separate from WHO-GMP. |
| Africa (most countries) | WHO-GMP certificate, CoPP, country-specific registration | NAFDAC (Nigeria), KEBS (Kenya), SAHPRA (South Africa) each have own requirements. |
| UAE / Gulf | WHO-GMP, MOH product registration in destination country | Gulf markets have strong demand for Indian generics. |
| Southeast Asia | WHO-GMP, ASEAN harmonised dossier in some markets | Philippines, Indonesia, Vietnam are major markets. |
| Russia / CIS | GMP inspection by Russian authorities, product registration | Russian GMP is separate from WHO-GMP. Long registration timelines. |
Temperature-controlled logistics for pharma
Cold Chain
Vaccines, biologics, insulin, some APIs
Cool boxes with dry ice or gel packs. GDP-compliant air cargo terminals at BOM, DEL, HYD, BLR.
Controlled Room Temperature
Most tablets, capsules, oral liquids
Insulated packaging for air transit. Sea freight with reefer containers for long routes.
Frozen
Some biologics, diagnostic reagents, plasma
Dry ice with defined CO2 replacement schedule. Charter or dedicated freighter for large volumes.
Pharma export document checklist
Frequently asked questions
Q: What licences are required to export pharmaceuticals from India?
Minimum: Manufacturing Licence, CDSCO Export NOC, WHO-GMP Certificate (for most markets), and IEC code. For the USA, add FDA facility registration.
Q: Can a pharma trading company (not manufacturer) export medicines from India?
Yes. Traders can export pharma with a valid Drug Distribution Licence and by sourcing from WHO-GMP-certified manufacturers. The CoPP and WHO-GMP certificate would be from the manufacturer.
Q: How long does CDSCO NOC take?
Typically 2–4 weeks. Apply online at cdscoonline.gov.in. Ensure your manufacturing licence and GMP certifications are current before applying.
Q: Is air freight always required for pharma exports from India?
No — most solid dosage forms (tablets, capsules) travel safely by ocean freight in temperature-controlled (reefer) containers. Air freight is mandatory for cold chain (2–8°C) products and urgent shipments.
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