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Africa and Latin America are among the fastest growing destinations for Indian generic medicines. Each country has its own regulator, registration process and import rules, so preparation is the difference between a smooth launch and a stalled shipment.
Market Selection
- Assess disease burden and demand for your therapeutic segments.
- Review the regulatory pathway and typical registration timelines.
- Identify reliable local distributors or licence holders.
Registration Essentials
- CTD or country specific dossier
- Stability data for the relevant climatic zone
- Bioequivalence data where required
- Samples, reference standards and registration fees
Export Documentation
Most shipments require a certificate of pharmaceutical product, GMP certificate, certificate of analysis, commercial invoice, packing list and certificate of origin. Some countries also require pre shipment inspection or legalisation.
Logistics and Payment
Choose incoterms carefully, confirm temperature requirements and agree on secure payment terms such as letters of credit for new partners.
Key takeaway
Registration is the longest step. Start dossier work early and build relationships with experienced local partners.
