Reference
Pharmaceutical Export Glossary
Plain-language definitions for the licences, schedules and trade terms referenced throughout this site.
AD Code (Authorised Dealer Code)
A bank-issued code registered with customs at each port of shipment, required before a shipping bill can be generated.
ANDA (Abbreviated New Drug Application)
The US FDA application pathway for approving a generic drug, requiring bioequivalence data and a USFDA-inspected manufacturing facility.
API (Active Pharmaceutical Ingredient)
The biologically active component of a medicine, before it is formulated into a tablet, capsule or injection.
B2B (Business-to-Business)
Trade between businesses — here, an Indian exporter and a foreign importer, wholesaler or institutional buyer holding their own import licence.
CDSCO (Central Drugs Standard Control Organisation)
India's central drug regulatory authority, responsible for Export NOCs and new-drug approvals.
CEP (Certificate of Suitability)
An EDQM-issued certificate confirming an API meets European Pharmacopoeia quality standards.
CIF (Cost, Insurance and Freight)
An Incoterm under which the seller's quoted price includes shipping and insurance to the destination port.
COPP (Certificate of Pharmaceutical Product)
A WHO-format certificate confirming a product is manufactured and approved for sale in India, used by destination-country regulators to assess an import application.
CTD (Common Technical Document)
The internationally standardised dossier format used to register a pharmaceutical product with a regulator.
DGFT (Directorate General of Foreign Trade)
The Indian government body that regulates foreign trade policy, issues IEC codes, and can restrict export of specific goods.
DMF (Drug Master File)
A confidential technical file on an API's manufacturing process, filed with a regulator such as the US FDA.
Dossier
The complete technical and regulatory file submitted to register a product with a destination-country regulator.
e-BRC (Electronic Bank Realisation Certificate)
An electronic certificate confirming an exporter has received payment for a shipment, generated after funds are realised.
Export NOC (No Objection Certificate)
A CDSCO clearance required for new, unapproved, banned or NDPS-scheduled drugs before they can be exported.
FOB (Free on Board)
An Incoterm meaning the seller's responsibility ends once goods are loaded onto the shipping vessel.
FSSAI (Food Safety and Standards Authority of India)
The regulator governing food-category products, including nutraceuticals and most AYUSH supplements, rather than a drug licence.
HS Code (Harmonized System Code)
The internationally standardised customs classification code that determines duty, incentives and export-restriction status.
ICEGATE
India Customs' electronic gateway for filing shipping bills and other export/import documentation.
IEC (Importer-Exporter Code)
The ten-digit code, issued by DGFT, without which no consignment can legally leave India.
Merchant Exporter
An exporter who trades and ships pharmaceutical products sourced from manufacturing partners, rather than manufacturing in-house.
MOQ (Minimum Order Quantity)
The smallest quantity of a product a supplier is willing to fulfil in a single order.
NDPS (Narcotic Drugs and Psychotropic Substances Act)
The Indian law governing narcotics and psychotropic substances, under which certain medicines require special export authorisation.
Pharmexcil
The Pharmaceuticals Export Promotion Council of India, which issues RCMC and supports market intelligence and buyer-seller meets.
RCMC (Registration-cum-Membership Certificate)
A mandatory export-council registration for pharmaceutical exporters, issued by Pharmexcil.
Schedule H
The Indian drug schedule covering prescription-only medicines, dispensed against a registered practitioner's prescription.
Schedule H1
A higher-control subset of prescription-only drugs — including certain antibiotics and anti-TB drugs — requiring a separate pharmacy register.
Schedule X
The Indian drug schedule covering narcotics and a defined list of high-control substances, requiring a special licence.
WHO PQ (WHO Prequalification)
A World Health Organization quality assessment that unlocks procurement by UN agencies and major donor-funded health programmes.
WHO-GMP (WHO Good Manufacturing Practice)
A manufacturing-quality certification aligned to World Health Organization standards, widely accepted across Tier 2 and Tier 3 export markets.