Where India's pharma exports come from and which port or airport they leave through
India's pharmaceutical industry ranks third in the world by volume and eleventh by value, with more than 3,000 companies and 10,500 manufacturing units; exports were USD 30.5 billion in 2024-25, to 191 countries, half of them directed to highly regulated markets such as the United States and Europe, and India hosts the most USFDA-approved plants outside the United States.[8] The same government explainer names Maharashtra, Gujarat, Telangana, Karnataka and Andhra Pradesh as established manufacturing hubs.[8]
The pairing below is geography, not a rule: your forwarder books the port or airport that suits the US destination and the temperature class of the cargo.
- Hyderabad and Telangana: Chennai (INMAA), Krishnapatnam (INKRI) or Visakhapatnam (INVTZ) by road, or Nhava Sheva (INNSA) by rail from an inland container depot; cold-chain cargo flies from Hyderabad. Airlift's Hyderabad branch arranges the pickup and export clearance.
- Ahmedabad, Vadodara and the Gujarat belt: Mundra (INMUN), Hazira (INHZA), Pipavav (INPAV) and Nhava Sheva; Airlift's Ahmedabad and Gandhidham branches cover the factories and the Mundra end.
- Mumbai and Pune: Nhava Sheva by road, air from Mumbai; Airlift's Mumbai and Navi Mumbai branches handle both.
- Baddi and Himachal Pradesh: by road or rail through an inland container depot to Nhava Sheva or Mundra; Airlift's New Delhi branch coordinates the inland leg.
- Bengaluru: Chennai by road or through an inland container depot; Airlift's Bengaluru and Chennai branches cover the lane.
- Visakhapatnam: its own port, with Chennai and Krishnapatnam as alternatives.
Drug export procedure in India: the manufacturing license, the CDSCO export NOC and the port NOC
Drugs covered by the Drugs and Cosmetics Act, 1940 are regulated by the Drugs Controller General of India, and customs applies that regime at the Shipping Bill. Custom houses publish their own procedure; at Nhava Sheva it is Jawaharlal Nehru Custom House's Public Notice 88/2026 of July 20, 2026. When the manufacturer files the Shipping Bill for drugs other than unapproved, new or banned drugs, the documents prescribed by DGFT Public Notice 173 (RE-2008)/2004-2009 of April 13, 2009 are uploaded in e-Sanchit; when an exporter other than the manufacturer files it, the exporter or its customs broker produces the documents to the Assistant Drugs Controller (ADC), CDSCO, for an ADC NOC, and customs then ordinarily does not call for the same documents again.[2] For a merchant exporter that port NOC is the gate, so build the ADC's review into the cargo-ready date, and ask your CHA what the custom house at your port requires.
Unapproved, banned or new drugs made solely for export are a separate track. CDSCO's order of April 30, 2024 withdrew the powers delegated to State and UT Licensing Authorities from May 15, 2024: since then the manufacturer must obtain the NOC from the CDSCO zonal office online through the SUGAM portal before the State Licensing Authority issues the manufacturing license for those drugs.[3] JNCH's notice allowed export clearance on a post-facto CDSCO NOC only up to September 30, 2026, after which clearance is strictly subject to that order, and the particulars declared in the Shipping Bill (description, brand, grade, specification, unit quantity code, weight, country of origin) must correspond with the NOC.[2]
CDSCO's revised guidance of July 17, 2025 sets out the NOC. A manufacturer holding a license in Form 25, Form 28 or Form 28-D (or the matching loan license) registers once online with the zonal office (Step I), with legal undertakings in Annexure I (API maker) or Annexure II (formulation maker), the State manufacturing license, reconciliation data for earlier NOCs and the importing country's NRA approval, or, where that is not available, the documents the guidance lists instead, such as an unapproved API's pharmacopoeial status (IP, USP, BP, JP or EP) or a formulation's approval in a listed stringent regulatory authority country (the United States, EU member states, Canada, Japan, Australia or Switzerland). The NOC is valid for one year or until the sanctioned quantity is exhausted, whichever is earlier.[1] At release (Step II) the firm selects the NOC, fills the quantity reconciliation, uploads the Certificate of Analysis, enters the purchase order, export invoice and Shipping Bill details, and submits the original label and the SLA's export license copy; NDPS and banned drugs stay on quantity- and PO-specific NOCs, and the formulation maker undertakes that export-only stock carries the inscription "For export only - Not for domestic consumption".[1] The Shipping Bill and ICEGATE guide covers the filing itself.
WHO-GMP and COPP certificates, and the Pharmexcil or AYUSHEXCIL RCMC
Your US buyer's gate is FDA, not a WHO certificate, but buyers in other markets and tender boards ask for a WHO-GMP certificate and a Certificate of a Pharmaceutical Product (COPP). The certificate is the primary document of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, a voluntary international agreement, and national regulatory authorities issue it.[5] In India, CDSCO's circular of June 25, 2025 moved the grant of WHO-GMP COPP to the Online National Drugs Licensing System (ONDLS) portal, and its circular of September 26, 2025 covers COPP applications for products still under consideration for license approval.[4]
The RCMC is what the Foreign Trade Policy asks for when you apply for an authorization or any other benefit or concession under it, unless specifically exempted: paragraph 2.57 of FTP 2023 requires a Registration-cum-Membership Certificate from the competent authority, and paragraph 2.56 recognizes the Export Promotion Councils as registering authorities for the product groups in Appendix 2T.[6] For drugs the council is the Pharmaceuticals Export Promotion Council of India (Pharmexcil), entry 17 of Appendix 2T, in Hyderabad, covering bulk drugs and their intermediates, formulations, biotech and biological products, diagnostics, surgicals, nutraceuticals and pharma industry services, collaborative research, contract manufacturing, clinical trials and consultants, and pharma-related services.[7] DGFT Public Notice 23/2023 of July 31, 2023 added the AYUSH Export Promotion Council (AYUSHEXCIL) as entry 39 for medicaments of the Ayurvedic, Unani, Siddha, Homoeopathic and Biochemic systems and listed cosmetics such as face creams, hair oils, bath oil (thailam) and medicated toilet soaps; RCMCs already issued by Pharmexcil or Chemexcil for those items stay valid until expiry.[7] The IEC, AD code, LUT and RCMC guide walks through the registrations, and the RoDTEP, drawback and IGST refund guide covers the export incentives.
FDA establishment registration and drug listing for a foreign manufacturer (21 CFR Part 207)
Under 21 CFR 207.17, every foreign establishment that manufactures, repacks, relabels or salvages a drug that is imported or offered for import into the United States must register; a private label distributor that does none of those things does not, and where several sites are under common ownership the parent may register all of them.[9] FDA's import page adds that foreign establishments must register before offering a drug for import, renew annually, identify a US agent and include all known importers in the registration.[10]
Under 21 CFR 207.69 a foreign registrant must designate a single United States agent who resides or keeps a place of business in the United States and is not a mailbox or answering service; the agent handles FDA communications, including emergency ones, answers questions about the imported drugs and helps FDA schedule inspections, and what FDA gives the agent counts as given to you.[9] Registration is reviewed and updated every year between October 1 and December 31, and a change of establishment name or address, or of the official contact or US agent, is reported within 30 calendar days (21 CFR 207.29).[9]
Each registrant lists every drug it manufactures, repacks, relabels or salvages for commercial distribution, under an NDC with its own labeler code and, for private-label goods, also one with the distributor's labeler code (21 CFR 207.41); listings are reviewed and updated each June and December (21 CFR 207.57).[9] An active pharmaceutical ingredient is an unfinished drug under 21 CFR 207.1, so an API plant registers and lists too; at entry the DLS code carries the Drug Listing Number for a bulk API or the NDC for a finished drug.[9][11] Registration and listing are not approval.
The product must be covered: NDA, ANDA, BLA, OTC monograph, and why unapproved new drugs are refused
Section 505(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a)) forbids introducing a new drug into interstate commerce unless an approval of an application filed under subsection (b) (a new drug application) or subsection (j) (an abbreviated new drug application, the generic route) is effective for that drug.[14] FDA's import page states the consequence at the border: if the product requires an NDA, ANDA, BLA or IND and does not have one, it will be subject to refusal, and imported drugs are checked for registration, listing, drug application, labeling and drug cGMPs as applicable.[10] Import Alert 66-41 lets FDA detain unapproved new drugs without physical examination, charging that the article appears to be a new drug without an approved NDA and is subject to refusal under section 801(a)(3); a firm on its Red List must show that its shipment contains no unapproved new drug to get a release.[13]
The ANDA or NDA may be your buyer's, a US partner's or your own; its number goes on the entry as the DA code, with the manufacturing site's registration number (REG) and the listing number or NDC (DLS).[11] Nonprescription drugs can also be marketed without an approved application if they conform to an OTC monograph under section 505G of the FD&C Act (21 U.S.C. 355h), added by the CARES Act on March 27, 2020, under which FDA issues and amends monographs by administrative order.[15] Their labels follow the Drug Facts content and format of 21 CFR 201.66.[16] Whether a given product is covered is a question for your buyer's regulatory team or counsel; this guide does not answer it.
Two edge cases. FDA allows unapproved drugs in only for further processing or incorporation into another product that is then exported, on the conditions on its import-for-export page.[10] And controlled substances are outside this guide: under 21 CFR 1312.11 no one may import a Schedule I or II controlled substance, a narcotic in Schedules III to V, or certain designated non-narcotics without DEA registration and an import permit, applied for on DEA Form 357 (21 CFR 1312.12); other non-narcotics in Schedules III to V come in on an import declaration (21 CFR 1312.18).[21] On the Indian side, NDPS drugs stay on quantity- and PO-specific CDSCO NOCs.[1] If your product is in either category, start with your buyer's DEA-registered importer and your CHA, not with the freight booking.
What your buyer's broker files: the ACE entry, PREDICT, the product code and the Affirmation of Compliance codes
FDA entry reviewers compare the declared manufacturer, importer or consignee, product description, Affirmation of Compliance (A of C) codes and intended use code in the importer's entry transmission against FDA's own data; the PREDICT screening tool checks the declared information, and FDA may examine or sample the goods. FDA says correct and accurate entry data and A of C codes help expedite the review.[10] Airlift files the ISF as the NVOCC and arranges the US customs entry through licensed customs brokers; the data below has to come from you.
A of C codes are three-letter affirmations made on an FDA line, each with a qualifier. FDA's ACE list dated March 10, 2026 includes REG, the drug registration number of the firm manufacturing the product, a unique facility identifier that for CDER is currently preferably the DUNS number; DLS, the Drug Listing Number for a bulk API or the NDC for a finished drug; DA, the NDA, ANDA or therapeutic biologic application number (for example DA 123456 for CDER); and IND for investigational drugs. It warns that declaring a code not on the list results in an entry rejection.[11] A of C codes are mandatory only in some cases, set out in FDA's supplemental guide, so your buyer's broker decides what to transmit; your job is to put the right numbers on the invoice and packing list.[10]
Checklist for the shipping documents: the manufacturing site's drug registration number (DUNS), the NDC or listing number per line, the application number where one applies, lot numbers and expiry dates, the product description written the way the drug is listed, and the storage statement. Each FDA line also carries an FDA product code, five to seven characters that should match the actual product name or invoice description.[12] The US import rules for Indian exporters guide covers the importer security filing, entry and bond from the exporter's seat.
US labeling (21 CFR Part 201) and DSCSA serialization for prescription drugs
The label is printed in India, so US labeling rules land on your packaging line. Under 21 CFR 201.1 a drug in finished package form is misbranded if its label does not bear conspicuously the name and place of business of the manufacturer, packer or distributor; 21 CFR 201.15 covers the prominence of required statements; and 21 CFR 201.66 sets the content and format of OTC Drug Facts labeling, which is followed even where an applicable monograph conflicts, unless the monograph specifically provides otherwise.[16] For prescription drugs, settle with the application holder who approves the US artwork before it goes to print.
For prescription drugs the Drug Supply Chain Security Act adds serialization. Under 21 U.S.C. 360eee-1(b)(2), from not later than four years after November 27, 2013 a manufacturer must affix or imprint a product identifier on each package and homogeneous case of product introduced in a transaction into commerce, and under subsection (g)(1) interoperable, electronic tracing at the package level took effect ten years after that date.[17] As of October 15, 2026, FDA's exemptions page lists a general exemption only for small dispensers, until November 27, 2027; trading partners that do not qualify and cannot meet the enhanced requirements must request a waiver, exception or exemption.[18] Which party applies the identifier and how transaction data is exchanged are points to settle with your US buyer before artwork is locked.
Keep the India-side labeling consistent with it. CDSCO's export NOC undertakings require labels as per Rule 94 of the Drugs and Cosmetics Rules and, for export-only stock, the inscription "For export only - Not for domestic consumption", and the original label is submitted to the port office at release.[1] One artwork that satisfies both the US application and the Indian export label avoids a relabeling step in a US 3PL.
Nutraceuticals and Ayurvedic products: dietary supplements are food (DSHEA), with facility registration and prior notice
A product sold in the United States as a dietary supplement does not go through the drug gates above. FDA regulates dietary supplements under a different set of regulations from conventional foods and drugs; under the Dietary Supplement Health and Education Act of 1994, firms may not market adulterated or misbranded products and are responsible for evaluating safety and labeling before marketing.[19] For import the product is food: 21 CFR 1.227 lists dietary supplements and dietary ingredients among the examples of food.[20] The claims matter: Import Alert 66-41 also reaches products labeled as dietary supplements whose claims appear to make them unapproved new drugs.[13]
Two filings follow. The Indian facility must be registered with FDA as a food facility before it manufactures, processes, packs or holds food for consumption in the United States (21 CFR 1.225 and 1.230(a)), with a unique facility identifier recognized by FDA (21 CFR 1.232(a)(2)), and the registration is renewed every other year between October 1 and December 31 of each even-numbered year (21 CFR 1.230(b)), so a renewal window runs to December 31, 2026.[20] And every shipment needs a prior notice confirmed by FDA before arrival: no less than 8 hours before arrival by water, 4 hours by air or rail and 2 hours by road, submitted no more than 30 calendar days ahead through ABI/ACE/ITDS or 15 days ahead through FDA's Prior Notice System Interface (21 CFR 1.279).[20] The glossary explains FDA prior notice; your buyer's broker may file it with the entry, but the facility registration number is yours to supply.
On the Indian side the RCMC follows the product: nutraceuticals sit with Pharmexcil, while Ayurvedic, Unani, Siddha, Homoeopathic and Biochemic medicaments sit with AYUSHEXCIL.[7] A product licensed as a drug in India but sold as a supplement in the United States carries both sets of paperwork. How a product is classified in the United States is for your buyer's regulatory counsel, not this guide.
Temperature control: reefer containers, air freight for cold chain, data loggers
The label's storage statement decides the equipment, and your stability data sets the limits. For reference, the long-term stability conditions in ICH Q1A(R2), which FDA publishes as guidance, are 25 °C ± 2 °C/60% RH ± 5% RH (or 30 °C ± 2 °C/65% RH ± 5% RH) for the general case, 5 °C ± 3 °C for products intended for storage in a refrigerator and -20 °C ± 5 °C for products intended for a freezer.[22] A product labeled for refrigerated storage moves in a reefer container set to the label range, or by air in qualified passive or active packaging; ask your QA team which excursions the stability data allows before you choose between a dry and a reefer container for room-temperature product.
WHO's model guidance for time- and temperature-sensitive pharmaceutical products sets the habits buyers expect: label shipping containers with the temperature range for transport or storage; use freeze indicators, electronic loggers or other suitable indicators in passive and active shipping containers (for internal distribution, and preferably for external distribution) and document their status on arrival; set the recording frequency to the logger's storage capacity and the expected transport period; and for air freight apply the IATA time and temperature-sensitive label under Chapter 17 of the IATA Perishable Cargo Regulations to the outer packages, overpacks or bulk containers.[23] Give the logger download to your buyer with the COA.
The lane guide's air freight section explains how the India to USA air lane works, and the chargeable weight calculator shows how insulated packaging pushes the chargeable weight above the actual weight. Two practical limits: Airlift does not book dangerous goods by air, so if an air shipment is classed as dangerous goods (some APIs and solvents, or the refrigerant used), that is a service Airlift does not offer; and a reefer moving inland by road or rail from Hyderabad, Baddi or Ahmedabad needs power for that leg, which is booked with the container. FCL ocean freight and LCL consolidation both run from Airlift's Indian branches.
Pharma export documents, India to the USA: COA, batch records, invoice with NDC and ANDA numbers
The general document set is in the export documents checklist and the pillar guide, how to export from India to the USA. Pharma adds a regulatory layer at both ends. In India: the State manufacturing or export license, the CDSCO export NOC where the drug is unapproved, new or banned, the ADC port NOC where a merchant exporter files at Nhava Sheva, the Certificate of Analysis, the original label, and a Shipping Bill whose particulars match the NOC.[1][2] In the United States: the manufacturer's registration number, the NDC or listing number and the application number on the invoice so the broker can transmit REG, DLS and DA, the approved labeling, and the DSCSA product identifier on each package and case for prescription drugs.[11][17]
Batch records and stability data are not import documents, but your buyer's quality agreement may give it the right to request them. A certificate of origin is buyer- or bank-driven. The table summarizes the gates by product class.
| Product class | India license or body | US gate | Who files | Shipping mode |
|---|---|---|---|---|
| Finished prescription formulation approved in India | State manufacturing license; at Nhava Sheva, PN 173 documents in e-Sanchit, or an ADC NOC if a merchant exporter files[2]; Pharmexcil RCMC for FTP benefits[7] | Registered establishment and listed drug (21 CFR 207)[9]; approved NDA or ANDA[14]; Part 201 labeling and DSCSA identifier[16][17] | Manufacturer registers and lists; buyer's broker files the ACE entry with REG, DLS, DA[11] | Dry or reefer FCL per label; air for cold chain or urgency |
| Formulation unapproved or new in India, made solely for export | CDSCO zonal export NOC via SUGAM before the State license, since May 15, 2024[3]; Step II release at the port office[1] | Same as above; a US approval (often the buyer's ANDA) is what lets it be marketed there[10] | Manufacturer applies for the NOC; buyer's broker files the entry | As above; label "For export only"[1] |
| Active pharmaceutical ingredient (bulk drug) | State license (Form 25/28); CDSCO NOC if unapproved in India, with NRA approval or pharmacopoeial status[1] | Registered establishment and listing (the API is an unfinished drug under 21 CFR 207.1); DLS code with the Drug Listing Number[9][11] | Manufacturer registers and lists; buyer's broker files | Dry FCL or LCL; reefer if the label requires; Airlift does not book DG by air |
| OTC product under an FDA monograph | State license; PN 173 documents or ADC NOC at Nhava Sheva[2] | Registration and listing; monograph conditions under section 505G[15]; Drug Facts format (21 CFR 201.66)[16] | Manufacturer registers and lists; buyer's broker files | Dry FCL or LCL |
| Nutraceutical sold as a dietary supplement | Indian license as applicable (ask your CHA); Pharmexcil RCMC for nutraceuticals[7] | Food facility registration, renewed October 1 to December 31 of even years; prior notice before arrival (21 CFR 1.225, 1.230, 1.279)[20]; drug claims can trigger Import Alert 66-41[13] | Facility registers; buyer's broker files entry and prior notice | Dry FCL or LCL; reefer for probiotics or heat-sensitive items |
| Ayurvedic, Unani, Siddha, Homoeopathic medicaments sold in the US as supplements | Indian license as applicable (ask your CHA); AYUSHEXCIL RCMC[7] | Food facility registration and prior notice as above[20] | As above | Dry FCL or LCL |
| Controlled substances (NDPS in India; DEA schedules in the US) | Quantity- and PO-specific CDSCO NOC[1]; NDPS permits | DEA registration and import permit or declaration (21 CFR 1312.11, 1312.12, 1312.18)[21]; outside this guide | DEA-registered importer applies for the permit | Per the permit; ask before booking |