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Exporting pharmaceuticals (HS 3004) — registration, GMP and the CPC

Last reviewed 2026-10 · 4 sections

Pharmaceuticals are the most regulated category India exports. Nothing about market entry is decided at the border: it is decided years earlier, in product registration and facility approval in the destination country.

Classification: bulk versus retail-ready

  • 3003 covers medicaments that are not put up in measured doses or retail packings — bulk or intermediate material.
  • 3004 covers medicaments put up in measured doses or for retail sale. The same active ingredient can fall in either line depending on presentation, which matters for duty and sometimes for regulatory treatment.
  • Vaccines, blood products, and goods with hormonal or antibiotic content have their own lines, and prepared products are distinguished from the bulk substances of chapter 29.

The gate is registration, not clearance

A product cannot simply be shipped to a regulated market and offered for sale. The product must be registered or authorised in the destination, and the facility that makes it must be approved and subject to inspection.

  • United States — applications for approval to market, facility registration and listing, and periodic cGMP inspection of the plant. The plant inspection is often the binding constraint, not the dossier.
  • European Union — marketing authorisation through the national or centralised route, with GMP compliance of the manufacturing site.
  • Most other markets — require a certificate of a pharmaceutical product issued by the Indian regulator in a standardised format, which the destination authority relies on when it has not inspected the site itself.

Where the evidence is produced

  • WHO-style good manufacturing practice certification of the facility, issued by the national regulator.
  • Certificate of Pharmaceutical Product — the standardised certificate that travelling regulators rely on.
  • Dossiers — the product file, including stability, method validation and pharmacopoeial standards, and the pharmacopoeia the product is tested to.
  • Cold chain — for biologics and temperature-sensitive products, validated shipping with a recorded temperature history is part of the release, not logistics.

Documents and market reading

  • Commercial invoice, packing list, transport document, certificate of origin; product registration evidence, GMP certificate, batch records and certificates of analysis.
  • Trade statistics for pharmaceutical products are dominated by large-volume, low-margin bulk shipments. Unit value comparisons across 3003 and 3004 — or across formulations — are meaningless without matching the product.

Use the tools

Sources & further reading

CDSCO — Central Drugs Standard Control Organisation U.S. FDA — drugs WHO — medicines & GMP

These guides summarise public material from the bodies named above. They are general information, not advice on a specific shipment, and they are not a substitute for a ruling from your customs authority or a qualified customs broker / consultant.

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