Quick Overview
India exported $ 30.5 billion in pharmaceutical products in FY 2025. The US alone accounts for 34% of all Indian pharma exports. But getting medicines from your factory in India to a warehouse in New Jersey involves distinct steps - from market research to last-mile delivery. Miss one, and your shipment stalls. This guide covers every step with the precision a serious exporter needs.
Exporting medicines to the USA is not like exporting regular goods. Every shipment must meet strict FDA compliance, product labelling rules, and batch-level quality documentation requirements. Even one missing certificate or incorrect declaration can trigger customs delays, inspection, or rejection at the US port.
Want to know why India dominates pharma exports, what products you can export, and how to get started? Read our detailed article on “Want to Export Pharmaceuticals from India? The Complete Guide.”
The 7-Step Process to Export Pharmaceutical Products
Step 1: Market Research and Opportunity Analysis
Pharma exports are market-specific. Product demand, pricing, and approvals vary by country, so validate the opportunity before investing in registrations.
- Identify target products: Are you exporting generics, APIs, OTC, or biologics? Each has a different regulatory path and margin profile.
- Check destination compliance: USA requires FDA registration/approval; EU requires EMA/EU-GMP; many other markets accept WHO-GMP.
- Analyse competition and pricing: Benchmark competitors and define your target price range.
- Evaluate demand: Use DGCI&S export data, Pharmexcil reports, and IMS Health insights.
Step 2: Obtain Your Importer Exporter Code (IEC)
IEC is mandatory to export from India and receive foreign payments.
1. Register on the DGFT portal (dgft.gov.in)
2. Link PAN to the account
3. Fill out Form ANF 2A - the IEC application form.
4. Upload PAN, ID proof, address proof, and bank details, and WHO-GMP certificate (required for pharma).
5. Pay the application fee.
6. IEC is issued online in 1–2 working days after verification.
Step 3: Regulatory Registration and Compliance
This step takes the longest, as approvals vary by market and may take months. Start early.
- CDSCO registration: Register facility/products with CDSCO and obtain Certificate of Pharmaceutical Product (CPP) for each product you plan to export.
- US FDA (USA exports): Facilities exporting to the US must be registered with the US FDA. Products must either be ANDA-approved (for generics) or hold full NDA approval.
- WHO-GMP certification: Required for most non-US, non-EU markets. Apply through your State Licensing Authority.
- Good Distribution Practice compliance: Needed for proper storage and transport validation
- ISO 13485: Required for medical device exports or combination products alongside pharmaceuticals.
- Pharmexcil membership: Not mandatory, but membership in the Pharmaceuticals Export Promotion Council of India is helpful for export support and market access.
Step 4: Prepare Your Export Documentation
Pharmaceutical exports require strict documentation. Even one missing certificate can lead to customs delays, FDA holds, or shipment rejection.
| Document | Purpose |
| Export Licence / NOC | CDSCO no-objection certificate authorising the export |
| Certificate of Pharmaceutical Product (CPP) | Confirms the product is manufactured and approved in India |
| Certificate of Analysis (COA) | Lab-verified quality and composition of the batch |
| Commercial Invoice | Declares price, quantity, and buyer/seller details |
| Packing List | Detailed breakdown of cartons, weights, and dimensions |
| Shipping Bill | Mandatory document filed with Indian customs for clearance |
| Bill of Lading / Airway Bill | Issued by the carrier, proof of shipment and title during transit |
| Import Permit (destination country) | Approval required by the importing country before entry |
| MSDS | Required for APIs and certain regulated/chemical substances |
Step 5: Packaging and Labelling Compliance
Pharma packaging is not just for protection; it must meet strict regulatory standards. Non-compliance can lead to shipment rejection.
- Tamper-evident packaging: Mandatory for most markets. Seals must be intact on delivery.
- Cold-chain packaging: Vaccines, biologics, and many injectables require validated cold-chain packaging. Use insulated shippers with phase change materials or dry ice for long-haul ocean shipments.
- Labelling in local language: Many countries (France, Brazil, Gulf states) require labels in the local language alongside English.
- Mandatory label content: Product name, generic name, batch number, manufacturing date, expiry date, storage conditions, manufacturer name and address, and regulatory approval numbers.
- US FDA labelling rules: For the US market, labels must comply with 21 CFR Part 201. This includes specific font sizes, content hierarchy, and NDC (National Drug Code) formatting.
Step 6: Book Freight and Clear Customs
This is where strong documentation prevents delays and extra costs.
- Choose your freight mode: Ocean (LCL/FCL) for bulk shipments; air for urgent or high-value pharma goods.
- Confirm the HS Code: Most pharma falls under HS Chapter 30. The correct 8-digit HS code is essential for duty and clearance.
- Indian customs (origin): Your CHA files the Shipping Bill on ICEGATE. Keep COA, CPP, NOC (if required), invoice, and packing list ready.
- US customs (destination): CBP clears the shipment with FDA oversight. Missing filings or compliance gaps can lead to holds and delays.
- FDA Prior Notice: For sea freight, the notice must be filed at least 8 hours before arrival in the USA.
Step 7: Last-Mile Delivery and Order Fulfilment
Customs clearance is not the final step. You must plan delivery from the US port or warehouse to the buyer.
- Use a US 3PL warehouse if storage or distribution is needed.
- Confirm delivery details with the buyer in advance
- Ensure real-time shipment tracking.
- Define your returns and rejection policy before shipment. Pharmaceutical rejections at the US border can be complex - you need a customs broker and potentially a destruction or re-export plan.
Once these seven steps are in place, the next priority is execution. Intoglo helps pharmaceutical exporters manage end-to-end India-USA logistics, including pickup, export customs clearance, ocean freight, US customs coordination, warehousing, and last-mile delivery- so shipments move without delays.
Get in touch with Intoglo for hassle-free India - US shipping.
📩 contact@intoglo.com | 📞 +91 84697 08714
Conclusion
Exporting pharmaceutical products from India is a seven-step process that rewards exporters who invest in preparation. Get your IEC, your regulatory certifications, and your documentation in order - then partner with a freight forwarder who understands the pharmaceutical supply chain.
FAQs
How long does it take to get all approvals and export pharmaceuticals from India for the first time?
Usually 6-18 months, depending on the destination market and product type. IEC takes 1-2 days, WHO-GMP may take 3–6 months, and US FDA compliance/inspection readiness may take 12+ months.
What is the correct HS Code for pharmaceutical products?
Most pharma products fall under HS Chapter 30. APIs may fall under 2941 / 2936 / 3003 / 3004, and vaccines under 3002. Always confirm the exact 8-digit HS Code before filing export documents.
Do I need to file an FDA Prior Notice for every pharmaceutical shipment to the USA?
Yes, FDA Prior Notice is mandatory for every shipment entering the USA. It must be filed electronically via FDA/CBP systems before arrival (timeline depends on mode of transport).
What happens if my pharmaceutical shipment is held at US Customs?
CBP or FDA may hold the shipment due to missing filings, labelling issues, or random inspection. You may need to submit documents quickly through your broker. If non-compliant, the shipment may be re-exported or destroyed.
Do I need a US importer or FDA agent to export pharmaceuticals to the USA?
Yes, to export to the USA, you typically need a US importer of record and a US FDA Agent (mandatory for foreign FDA-registered facilities). Without this, shipments can face FDA delays.
