How to Import Generic Medicines from India: A Buyer's Guide
Buyer's Guide · For importers, distributors & tender suppliers
India is the world's largest supplier of generic medicines, exporting affordable, quality-assured pharmaceuticals to over 200 countries. For importers, distributors, and tender suppliers, sourcing from India involves selecting a WHO-GMP certified manufacturer, obtaining registration dossiers for your national authority, and arranging the right documentation and supply terms. This guide walks through the process.
Step 1: Choose a WHO-GMP certified manufacturer
The most important first step is confirming the manufacturer holds WHO-GMP certification, indicating the facility meets World Health Organization good manufacturing practice standards. For products destined for donor-funded procurement, also check whether the specific product holds WHO Prequalification (WHO-PQ), a stricter standard often required for international tenders. Verify the manufacturer's certifications, product range, and export experience for your region.
Step 2: Confirm the products and formulations you need
Confirm the manufacturer produces the exact molecules, strengths, and dosage forms your market requires, including any paediatric or specialised formulations. A broad portfolio from a single manufacturer simplifies sourcing and consolidates your supply relationship.
Step 3: Obtain registration dossiers for your national authority
Most countries require imported pharmaceuticals to be registered with the national regulatory authority before they can be marketed, for example NAFDAC in Nigeria, the Pharmacy and Poisons Board in Kenya, or the FDA in Ghana. Registration requires a regulatory dossier in CTD (Common Technical Document) or ACTD (ASEAN Common Technical Document) format. A capable manufacturer provides these dossiers and supports the registration process.
Step 4: Agree commercial and supply terms
Establish minimum order quantities, pricing, packaging and labelling requirements, private-label options, and lead times. For ongoing supply, clarify the manufacturer's capacity and ability to maintain consistent quality across repeat orders.
Step 5: Arrange documentation and logistics
Pharmaceutical imports require specific documentation, which commonly includes a certificate of analysis, certificate of pharmaceutical product (CoPP), GMP certificate, invoice and packing list, and shipping documentation. Confirm the manufacturer's experience exporting to your country and their ability to provide the required documents.
Step 6: Understand registration timelines
Product registration with a national authority takes time and should be planned for in advance. Working with a manufacturer experienced in your market, with dossiers ready, helps avoid delays.
Sourcing from BioGalen
BioGalen Pharmaceuticals is a WHO-GMP certified manufacturer and exporter of generic medicines across 26 therapeutic categories, supplying importers, distributors, and tenders across Africa and beyond. We provide CTD and ACTD dossiers, regulatory support, flexible packaging, and private labelling. Explore our product catalogue, see our antimalarial range, or request a quote.
Frequently Asked Questions
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