How to Export Generic Medicines from India: Licences, Registration and Buyers
India supplies a large share of the world's generic medicines and is often called the pharmacy of the world. Buyers range from distributors and hospital tenders in Africa, Asia and Latin America to wholesalers in regulated markets. Unlike most products, medicines cannot be sold abroad until they are registered in the buyer's country, so the export plan starts with regulation, not price.
To export generic medicines from India, the manufacturer needs a drug manufacturing licence and usually WHO-GMP certification, and the exporter needs an IEC, GST registration with an LUT and an RCMC from Pharmexcil. Each product must be registered with the regulator in the importing country, which needs a dossier, a Certificate of Pharmaceutical Product (COPP) and often a site inspection. Follow DGFT's barcoding rules for export packs and keep the cold chain for products that need it.
Licences and registrations in India
- Drug manufacturing licence: issued by the State Licensing Authority under the Drugs and Cosmetics Act. Merchant exporters work with licensed manufacturers, often under a loan licence or contract manufacturing arrangement.
- GMP: plants must follow the revised Schedule M. Most importing countries expect WHO-GMP certification, and regulated markets inspect plants themselves.
- IEC, GST and LUT: see the IEC guide and the LUT guide.
- Pharmexcil RCMC: the Pharmaceuticals Export Promotion Council registers pharma exporters. See the RCMC guide.
- CDSCO permissions: some exports, such as products not approved for sale in India, need an export NOC from CDSCO.
Product registration in the buyer's country
This is the longest step. The importer or your local agent files a registration dossier, often in the Common Technical Document (CTD) format, with stability data, bioequivalence studies for some products, and a COPP issued by the Indian regulator. Timelines range from a few months in some markets to several years in regulated markets.
- Regulated markets: the USA (ANDA approval from the FDA), the EU and the UK need full dossiers and plant inspections.
- Semi-regulated markets: many countries in Africa, Asia, the CIS and Latin America register products through their national regulators, sometimes relying on WHO prequalification or other approvals.
HS codes, barcoding and labelling
Finished medicines in measured doses fall under HS heading 3004, and active ingredients (APIs) mostly under chapters 29 and 30. DGFT requires track and trace barcoding on export packs of drugs at the levels it specifies, so check the current notification. Labels must follow the registered artwork for each country, including language, batch, expiry and storage conditions.
Shipping and cold chain
Most tablets and capsules ship as general cargo with temperature monitoring. Vaccines, insulin, biologics and many injectables need a 2 to 8 degree cold chain with validated packaging and data loggers, usually by air. Use a forwarder experienced in pharma, and keep the GDP (good distribution practice) records the buyer asks for. See the air vs sea freight guide.
Pricing, tenders and payment
Many buyers are government tenders and NGOs that buy on price, registration status and delivery record. Private distributors want exclusivity and marketing support. Quote per pack or per thousand units, FOB or CIF, with shelf life at dispatch stated. Use a letter of credit or advance with new buyers, and consider ECGC cover for regular accounts. See the ECGC guide.
Where to find medicine buyers
The USA, the UK, South Africa, Nigeria, Kenya, Russia, Brazil, the Philippines and many other markets buy Indian generics. On BuyGenix you can see live generic medicine requirements, OTC medicine buyers and the full pharma and healthcare category. Always confirm that the buyer holds an import licence in their country.
Frequently asked questions
Can a merchant exporter export medicines from India?
Yes. Merchant exporters buy from licensed manufacturers, often under contract or loan licence arrangements, but the product must still be registered in the importing country.
What is a COPP?
A Certificate of Pharmaceutical Product is issued by the exporting country's regulator in the WHO format. Importing regulators use it to register a medicine.
Is Pharmexcil registration mandatory?
Pharma exporters register with Pharmexcil for the RCMC, which is needed for export benefits and is commonly expected for drug exports.
How long does product registration abroad take?
It varies from a few months in some markets to several years in regulated markets such as the USA and the EU.
Starting pharma exports?
We handle IEC, GST, LUT and RCMC registration so you can focus on licences and product registration.
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