Documents Required to Export Medicines From India

India supplies medicines to almost every country in the world, but every export shipment depends on the right paperwork. Missing one document can hold a consignment at customs or delay product registration by months. Here is the checklist importers and exporters work through.

What licences does a pharma exporter need?

An Indian pharma exporter needs an Importer Exporter Code (IEC) from the Directorate General of Foreign Trade (DGFT), and a Registration-cum-Membership Certificate (RCMC) from Pharmexcil, the pharmaceutical export promotion council. The products must be made at a site with a valid drug manufacturing licence issued by the state drug authority.

Which product certificates do importing countries ask for?

Most regulators ask for a Certificate of Pharmaceutical Product (COPP) or a Free Sale Certificate, a GMP certificate for the manufacturing site, and a product registration dossier, often in the Common Technical Document (CTD) format. The dossier usually includes specifications, test methods, stability data and batch records supplied by the manufacturer.

Which documents travel with each shipment?

Every consignment needs a commercial invoice, packing list, certificate of origin, shipping bill, bill of lading or airway bill, and a Certificate of Analysis (CoA) for each batch. Some countries also require an import permit issued to the buyer before the goods leave India.

How SRL Life helps

SRL Life supplies a Certificate of Analysis with every batch, together with specifications, batch manufacturing records and stability data for registration, and adapts labels and packing to the importing country. Planning your first export order? Share your product list and target market with our team.