The Pharmaceutical Export Licence Stack: IEC to Destination Registration

The licences behind a legitimate pharmaceutical export business are sequential — several later steps require an earlier certificate number as an input. Understanding this stack helps buyers evaluate whether a supplier is operating on a genuine compliance foundation.

The sequence

• Company incorporation, PAN and current account — a private limited company is materially more credible to foreign buyers and banks than a proprietorship
• Importer-Exporter Code (IEC) from DGFT — the ten-digit code without which no consignment can leave India
• Wholesale drug licence, Form 20B and 21B, from the State Drug Licensing Authority — 20B covers general medicines, 21B covers Schedule C/C(1) biologicals and injectables
• RCMC from Pharmexcil — mandatory for all pharmaceutical exporters, and the gateway to export incentives and market intelligence
• AD Code registration with the exporter's bank, plus ICEGATE customs filing access
• COPP and WHO-GMP certification — held by the manufacturing partner for a merchant exporter, issued against their plant
• Export NOC from CDSCO — required only for new, unapproved, banned or NDPS-scheduled drugs, filed through the SUGAM portal
• Narcotics export authorisation — only relevant for NDPS-controlled molecules, which fall outside our standard catalogue
• Destination-country product registration — the step foreign regulators, not Indian ones, control, and the one that most determines actual timeline to first shipment

What travels with every consignment

• Commercial invoice with HS code, Incoterm and country of origin
• Batch-wise packing list
• Shipping bill generated on ICEGATE
• Bill of lading or airway bill
• Certificate of Origin
• Certificate of Analysis, batch-specific
• Certificate of Pharmaceutical Product (COPP), WHO format
• Free Sale Certificate
• GMP certificate of the manufacturing plant
• Manufacturing and wholesale licence copies
• Import permit or licence of the buyer, kept on file