Country import guides
How a hospital, licensed importer or physician in each country can legally receive a medicine from India. The regulator, the route and who applies, the documents, typical approval times and shipping lanes.
Lanes from India
25- Africa8
- Middle East7
- Europe1
- Russia and Central Asia3
- Asia Pacific2
- Latin America4
- Country guides
- 25
- Regions covered
- 6
- Sources cited
- 231
- Destinations in the rules engine
- 250
Short answer
A medicine that is not registered in the destination country usually enters under a special-access, named-patient or import-permit route, requested by a licensed local party such as a hospital, an importer or the treating physician. Each guide sets out that country's regulator, routes, documents, typical timelines and shipping lanes from India, with its sources.
25 of 25 guides
Africa
8 guidesEgypt
Regulator: EDA
Main route
EDA import approval for a special request, product marketed in a reference country
Licensed Egyptian importing company or the requesting entity, for a hospital or other entity
Courier 3 to 6 daysAir cargo 5 to 10 daysPending confirmationEthiopia
Regulator: EFDA
Main route
EFDA special import authorisation for an unregistered medicine
EFDA-licensed importer, usually at the request of a hospital or the Ministry of Health
Courier 4 to 7 daysAir cargo 5 to 10 daysPending confirmationGhana
Regulator: FDA Ghana
Main route
FDA eMDA import permit for a registered product
Business licensed by FDA Ghana as an importer
Courier 4 to 7 daysAir cargo 6 to 12 daysPending confirmationKenya
Regulator: PPB
Main route
Prescription drug import permit (named patient)
Licensed wholesale dealer appointed by the patient, guardian, doctor or hospital
Courier 3 to 6 daysAir cargo 4 to 9 daysPending confirmationNigeria
Regulator: NAFDAC
Main route
NAFDAC import permit for a registered product
Nigerian importer that holds, or is authorised by the holder of, the NAFDAC registration
Courier 4 to 7 daysAir cargo 7 to 14 daysPending confirmationSouth Africa
Regulator: SAHPRA
Main route
Section 21 named patient application
The treating health care provider in South Africa, with a SAHPRA-licensed importer or wholesaler named on the application
Courier 3 to 6 daysAir cargo 5 to 10 daysPending confirmationTanzania
Regulator: TMDA
Main route
TMDA special permit for an unregistered product
Hospital, healthcare provider, government institution or TMDA-registered importing wholesaler
Courier 3 to 6 daysAir cargo 4 to 9 daysPending confirmationUganda
Regulator: NDA
Main route
NDA import licence and verification certificate
Importer licensed by the NDA
Courier 4 to 7 daysAir cargo 5 to 10 daysPending confirmation
Middle East
7 guidesIraq
Regulator: Ministry of Health
Main route
Ministry of Health import licence for a registered product
Iraqi scientific bureau acting for the registered foreign manufacturer
Courier 4 to 8 daysAir cargo 7 to 14 daysPending confirmationKuwait
Regulator: KDFC
Main route
Registration requested by Ministry authorities (Resolution 100 of 2023)
Ministry of Health authorities, with the licensed local agent for the product
Courier 2 to 5 daysAir cargo 3 to 8 daysPending confirmationOman
Regulator: DSC
Main route
Import of a non-registered drug through a licensed warehouse
Licensed pharmaceutical warehouse in Oman, acting for a public or private health institution
Courier 2 to 5 daysAir cargo 3 to 8 daysPending confirmationQatar
Regulator: MOPH
Main route
Import approval through the Pharmacy e-System
Licensed agent, registered importer, hospital or health centre with a Pharmacy e-System account
Courier 2 to 4 daysAir cargo 3 to 7 daysPending confirmationSaudi Arabia
Regulator: SFDA
Main route
SFDA approval to import an unregistered medicine for a named patient
Licensed Saudi hospital or health facility, together with its licensed importer
Courier 3 to 5 daysAir cargo 4 to 9 daysPending confirmationTürkiye
Regulator: TİTCK
Main route
Supply from abroad on prescription (yurt dışından ilaç temini)
The treating physician applies to TİTCK, and TEB or the SGK pharmaceutical warehouse imports
Courier 2 to 5 daysAir cargo 4 to 8 daysPending confirmationUnited Arab Emirates
Regulator: EDE
Main route
EDE import permit for a registered medicine
Licensed UAE medical warehouse acting as the local agent named in the marketing authorisation
Courier 2 to 4 daysAir cargo 3 to 7 daysPending confirmation
Europe
1 guidesRussia and Central Asia
3 guidesKazakhstan
Regulator: KMFK
Main route
Conclusion for an unregistered medicine for a specific patient or patients with rare diseases
Kazakh healthcare organisation or its importer, with a letter from the regional health authority
Courier 4 to 8 daysAir cargo 6 to 14 daysPending confirmationRussia
Regulator: Minzdrav
Main route
Ministry of Health conclusion for a specific patient's vital needs
Russian medical organisation or another eligible Russian legal entity, such as a wholesaler, through its Gosuslugi account
Courier 5 to 10 daysAir cargo 7 to 14 daysPending confirmationUzbekistan
Regulator: CPPS
Main route
Ministry of Health order for orphan medicines or dangerous infections
Ministry of Health, usually on a request from a hospital or licensed importer (confirm the filing route)
Courier 5 to 9 daysAir cargo 6 to 14 daysPending confirmation
Asia Pacific
2 guidesPhilippines
Regulator: FDA
Main route
Compassionate Special Permit for named patient use
Licensed physician for an identified patient, with an FDA-licensed importer supplying the product
Courier 4 to 7 daysAir cargo 4 to 10 daysPending confirmationVietnam
Regulator: DAV
Main route
Import licence for special treatment needs (Decree 163, Article 54)
Licensed Vietnamese drug importer, on the written request of the hospital or other medical facility
Courier 3 to 6 daysAir cargo 5 to 10 daysPending confirmation
Latin America
4 guidesBrazil
Regulator: ANVISA
Main route
Exceptional import by a health establishment for its own use (RDC 488/2021)
Brazilian public or private health establishment, including units linked to a health plan
Courier 5 to 9 daysAir cargo 8 to 16 daysPending confirmationColombia
Regulator: INVIMA
Main route
Vital medicine not available for a specific patient (Decree 481 of 2004, article 8)
The patient or a public or private person or entity, naming the authorised pharmaceutical establishment that will import
Courier 5 to 9 daysAir cargo 8 to 15 daysPending confirmationMexico
Regulator: COFEPRIS
Main route
Sanitary import permit for special treatments (COFEPRIS-01-010-C)
Mexican public or private institution holding a sanitary licence or operating notice
Courier 5 to 8 daysAir cargo 7 to 14 daysPending confirmationPeru
Regulator: DIGEMID
Main route
Exceptional authorisation for individual prevention and treatment (TUPA 118)
The patient, or a relative or other person holding a simple power of attorney from the patient
Courier 5 to 9 daysAir cargo 8 to 15 daysPending confirmation
How to use a country guide
Each guide follows the same order, so the facts that differ between countries are easy to compare.
- 1
Find the legal route
Check which route applies to the medicine and who files the application. It is almost always a local hospital, importer or the treating physician, never the exporter.
- 2
Collect the documents
Use the document checklist to gather the permit, prescription or licence evidence the regulator asks for, and the shipment documents the exporter provides.
Document checklist builder - 3
Plan the timeline
Add sourcing, Indian export checks, the destination permit and transit. The lead time estimator does the sum for any guide country.
Lead time estimator - 4
Send the request
Request a quote with the destination set. The reply lists availability, the route, the documents and a realistic lead time.
Request a quote
Your country is not listed yet?
Guides are published once a country's routes have been researched and sourced. Requests to other destinations are still reviewed case by case, and the route is confirmed before a quote is issued. Sanctioned destinations are not supplied.
Request a quote for another countryStart here
- Access routes
How named-patient supply works
Named-patient supply is a legal exception that lets a medicine without a local licence reach one identified patient. The treating physician documents the clinical need, a licensed hospital or importer obtains the regulator's approval or files a notification, and the supplier ships to that licensed consignee rather than to the patient's home.
7 min read - Access routes
Importing unlicensed medicines into the UK: MHRA notification and specials
An unlicensed medicine can be imported into the UK only by a WDA(H) or MSL holder that has notified the MHRA, to meet an individual patient's special clinical need under regulation 167. Imports from India normally run through an MSL holder. The goods go to the importer and then a pharmacy, not straight to the patient.
6 min read - Documents
Pharma export documents explained: CoA, COPP, GMP, proforma and packing list
A medicine export from India rests on three sets of papers. Commercial documents cover the proforma, commercial invoice, packing list and air waybill. Quality documents cover the batch certificate of analysis, COPP and GMP certificate. Regulatory documents cover the destination import permit and any Indian export NOC. Each must match the others exactly.
6 min read
Questions about import routes
Who applies for the import permit, the buyer or the exporter?
In almost every country the local party applies: the hospital, the licensed importer or the treating physician, depending on the route. The exporter supplies the documents the application needs, such as the certificate of analysis, the GMP certificate and the proforma invoice.
Can a medicine be shipped directly to a patient?
Generally no. Prescription medicines go to a licensed consignee such as a hospital pharmacy or importer, under the route the destination allows. Patients and families can start a request, and it is then routed through the treating physician.
How current are these guides?
Each guide shows when its content was updated and whether a regulatory specialist has confirmed it. Guides marked as a research summary are based on official and published sources but should be checked with the regulator or a local agent before goods ship.
Are controlled medicines covered?
Controlled narcotic and psychotropic medicines need an export authorisation in India for every consignment and an import certificate from the destination. They are not supplied through online requests.
Have a medicine in mind?
Send the medicine, quantity and destination. The reply covers availability, the route, the documents and the lead time.