By Mitul Agarwal, B.Pharm, MBA. Published October 2026.
Starting a pharmaceutical import business means putting four things in place before the first shipment arrives. You need a registered company holding the right drug licences, which usually means a wholesale or import licence and a qualified pharmacist or other responsible person. You need storage and distribution that meet Good Distribution Practice. You need products that are registered in your country, or legally importable under an exemption. And you need GMP-certified suppliers who can provide the documents your regulator will ask for. Registration is almost always the slowest of the four, so choose your products and suppliers early.
It is a rewarding business, and an important one: in many countries, importers are the reason patients can get medicines at all. But it is also a regulated one, and the people who do well in it are usually those who respect the paperwork from the start. Here is how the journey normally runs.
1. Decide what kind of importer you want to be
Everything that follows, from the licences you need to the money you tie up and the time before your first sale, depends on how you plan to sell.
Most new businesses start as an importer and distributor of registered brands, representing a manufacturer whose products are registered, or will be, in their country. Others choose to become the marketing authorisation holder (MAH) and hold registrations in their own name, often for products made for them under contract or white label. That carries more regulatory responsibility, but you own the market access; our white-label manufacturing service is built around this model.
Some importers focus on government and hospital tenders, where product registration and supplier documents decide whether a bid is even considered; see our tender supply service. Others specialise in named-patient or special imports, bringing in medicines that are not registered locally for specific patients or hospitals under the country's exemption rules. Volumes are small and every order is documented; our global guide to named-patient import programmes explains how these work country by country.
2. Set up the company and get licensed
The details differ from country to country, but most regulators expect the same building blocks. You will need a registered company with drug trading or import among its stated activities, plus whatever general import registration your customs authority requires. You will need a drug wholesale or import licence from the national medicines regulator. And you will need approved premises: a warehouse inspected against Good Distribution Practice, with temperature mapping and monitoring, and cold storage if you plan to handle vaccines, insulin or biologics.
Regulators also want a named person to be accountable. Usually this is a registered pharmacist responsible for storage, distribution and recalls. In the EU and UK, a wholesaler names a Responsible Person, and importing from outside the EEA or UK also needs an import authorisation and a Qualified Person who certifies each batch. Controlled substances need separate licences again, and are outside the scope of this guide.
India as an example. An importer needs a wholesale drug licence from the state authority, an Importer Exporter Code (IEC) from DGFT and an import licence in Form 10 from CDSCO. Before that licence can be issued, the overseas manufacturer and each product must hold a registration certificate in Form 41. A new drug also needs CDSCO approval under the New Drugs and Clinical Trials Rules, 2019, before it can be imported for sale.
Our directory of drug regulators links to the licensing pages of each national authority.
3. Get the products registered
In almost every country, a medicine needs a marketing authorisation before it can be sold, and this is where most of the time goes. The application may be filed by the manufacturer through a local agent, or by you as the local MAH. It is built around a dossier, usually in CTD or ACTD format, containing the drug substance and drug product data, bioequivalence data for most oral generics, labels in the local language, and certificates such as the CoPP (Certificate of a Pharmaceutical Product) and the GMP certificate. Our guide to CTD and ACTD explains the formats.
Timelines range from a few months under reliance or fast-track routes to several years for a full review. Many countries now fast-track products already approved by a stringent regulator or prequalified by WHO, which can make supplier choice a strategic decision as much as a commercial one. Our import guides hub compares registration routes, tender systems and special-import rules across 45 countries.
4. Choose suppliers carefully, then verify them
Start with documents rather than prices. Ask for the GMP certificate, a CoPP for your destination, a sample CoA and the dossier format the supplier can provide, and confirm the GMP certificate with the authority that issued it. Make sure the approvals match your market: a WHO-GMP site suits many emerging markets, but some regulators and tenders require EU-GMP, US FDA or PIC/S approval. If you are in a hot, humid country (ICH climatic zone IVb), check that the product has stability data at 30°C and 75% relative humidity.
Then put the relationship in writing. A distribution or supply agreement should cover territory, exclusivity, minimum volumes and who pays for registration. A quality agreement should cover complaints, recalls and how changes will be notified. Our guides to verifying a pharmaceutical supplier and writing an RFQ that gets quoted go into this step in detail. If you are new to the terms suppliers use, our explainers on APIs and CROs, CDMOs and CMOs are a good primer.
5. Plan logistics, customs and payment
Agree Incoterms that suit the way the goods will travel: FCA, CIP or DAP are common for air freight, and FOB or CIF for sea freight. Finished medicines mostly fall under HS chapter 30, so check the duty, VAT and any pre-shipment inspection or import permit that applies to each consignment. Cold-chain products need validated packaging and data loggers from the factory to your warehouse; our cold-chain logistics service can help.
On payment, letters of credit are common for first orders, with advance payment or open account following as trust builds. Agree the minimum remaining shelf life on arrival as well. Tenders often set a minimum, so check it before you order.
6. Run the business compliantly
Once the goods are flowing, the work becomes steady discipline. Keep batch records so you know which batch went to which customer and can recall quickly if you have to. Report adverse events as your licence and the MAH's obligations require. Check price rules before you quote, because many countries control medicine prices or margins. And keep a calendar of renewals, since licences, registrations and GMP certificates all expire.
Mistakes worth avoiding
New importers tend to run into the same few problems: paying a supplier before checking its GMP certificate with the issuing authority; importing before a product is registered, or under the wrong exemption; choosing a supplier whose approvals do not match the regulator's or the tender's rules; skipping the quality agreement and discovering during a recall that nobody is responsible; and underestimating the time and cost of registration, then running short of cash before the first sale. None of them is hard to avoid if you know to look for it.
How PharmaTradz can help
PharmaTradz connects importers with GMP-certified manufacturers, mainly in India, and helps with the documents that registration and tenders depend on: CoPPs, GMP certificates, CoAs and dossiers, through our dossier licensing and registration service. Tell us your country, your products and the business model you have in mind, and send us an RFQ. Our buyer's checklist from inquiry to import walks through the whole process end to end.
Frequently Asked Questions(FAQs)
What licences do I need to import medicines?
Usually a company registration and customs import code, a drug wholesale or import licence from the medicines regulator, approved storage premises and a qualified pharmacist or responsible person. The products themselves must also be registered, or covered by an exemption.
Can I import medicines that are not registered in my country?
Only under a legal exemption, such as a named-patient, compassionate-use or special-import programme, and usually only against a prescription or a hospital request. Regular commercial sale needs registration.
How long does it take to start a pharma import business?
Setting up the company and getting licensed often takes a few months. Product registration takes longer: anywhere from a few months under fast-track or reliance routes to several years for a full review, depending on the country.
What licences does a pharma importer need in India?
A wholesale drug licence, an Importer Exporter Code and a CDSCO import licence in Form 10. Before that, the overseas manufacturer and its products need a registration certificate in Form 41.
Do I need to be a pharmacist to start a pharma import business?
Not always as the owner, but most countries require the business to employ a qualified pharmacist or responsible person who is accountable for storage, distribution and recalls.
