Compliance
Compliance You Can Trust
We operate as a merchant exporter — sourcing from WHO-GMP certified Indian manufacturing partners — within the regulatory framework below. Requirements vary by product, destination and export status; this page explains the framework, not a guarantee of outcome for any specific shipment.
Direct-to-consumer prescription medicine export is illegal into almost every market. This platform operates strictly B2B — selling to licensed importers, wholesalers, hospital groups and government buyers who hold the import authorisation in their own country. We do not process consumer orders or ship prescription medicines to individuals. Read more in our guide onwhy this is a B2B platform.
The Licence Stack, in Order
These steps are sequential — several later steps require an earlier certificate as an input. Not every step applies identically to every product; a standard freely-exportable formulation, for example, does not require an Export NOC.
Company, PAN & Current Account
A private limited company or LLP, PAN and current account — foreign buyers and banks treat a private limited structure as materially more credible.
MCA / Bank
Importer-Exporter Code (IEC)
The ten-digit code without which no consignment can leave India, linked to PAN.
DGFT
Wholesale Drug Licence — Form 20B & 21B
Form 20B covers general medicines; 21B covers Schedule C and C(1) — biologicals, injectables and vaccines. Both are required to access the full catalogue.
State FDA
RCMC from Pharmexcil
Registration-cum-Membership Certificate, mandatory for all pharmaceutical exporters and the gateway to export incentives and market intelligence.
Pharmexcil
AD Code Registration + ICEGATE
The exporter's bank-issued Authorised Dealer code, registered at each port, without which customs cannot generate a shipping bill.
Bank / Customs
COPP / WHO-GMP Certificate
The Certificate of Pharmaceutical Product, in WHO format — for a merchant exporter, obtained through the manufacturing partner and issued against their plant.
State FDA / CDSCO
Export NOC from CDSCO
Required for new drugs, drugs unapproved in India but legal at the destination, banned drugs and NDPS substances — filed via the SUGAM portal. Not required for most standard, approved formulations.
CDSCO Zonal Office
Destination-Country Registration
Each destination country registers each product separately. This is usually the longest step — foreign regulators, not Indian ones, set the real timeline.
Foreign Regulator
Export Status Classification
Free
Freely exportable under a wholesale licence and RCMC. No CDSCO Export NOC needed for standard approved formulations.
NOC / Conditional
Needs a CDSCO Export NOC, a sector permission, or is subject to periodic DGFT quantity restrictions.
Controlled
NDPS or psychotropic. Narcotics Commissioner authorisation, PO-specific quantity NOC, and destination bans may apply.
Prohibited
Cannot be exported, or only under exceptional case-by-case central government permission.
Prescription status (whether a molecule can be sold without a prescription) is a separate question from export status. A molecule can be prescription-only in India but freely exportable — most of our catalogue — because the buyer's own pharmacy holds the prescription obligation, not us. See our Schedule H glossary entry for more.
Documents That Travel With Every Consignment
Special-Handling Categories
NDPS-Controlled Molecules
Narcotics, psychotropics and a defined Schedule X list require Narcotics Commissioner authorisation under NDPS Rules 55 & 58, decided within 21 working days, plus a purchase-order-specific CDSCO NOC. These are not part of our standard quotable catalogue.
Vaccines & Biologicals
Requires Form 21B, a validated cold chain, and — for UN procurement — WHO Prequalification. Quoted only against verified institutional or programme buyers.
Nutraceuticals & AYUSH
Regulated as food supplements in most markets — an FSSAI licence, not a drug licence, governs manufacture and export. Structure-function claims only; no disease-treatment claims.
Tier 1 Markets (US, EU, UK, Japan)
Finished-formulation supply requires an ANDA/EU-GMP-inspected manufacturing partner. We do not claim capability we do not hold — see our United States and Europe & UK market pages.
Important Disclaimer
Product availability, export eligibility, prescription classification, registration requirements, licensing requirements and destination-country rules may vary by product, formulation, strength, manufacturer and destination, and can change without notice — DGFT can move any formulation from "Free" to "Restricted" overnight. Content on this website is provided for sourcing and informational purposes and does not constitute legal, regulatory or medical advice. Verify current requirements with the relevant Indian and destination-country authorities before shipment, and engage a qualified regulatory consultant and customs broker before your first consignment. See our full Disclaimer.