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Export Pharmaceuticals to USA from India

Pharmaceutical exporters take their RCMC from the Pharmaceuticals Export Promotion Council (Pharmexcil), which DGFT assigns bulk drugs, formulations, herbal and homeopathic medicines, diagnostics and related services. Medicaments are HS heading 3004. Among the 12 countries on this site, the United States is the largest buyer of Indian pharmaceutical products in the data below.

Official sources checked: 2 Oct 2026

Pharmaceutical exporters take their RCMC from the Pharmaceuticals Export Promotion Council (Pharmexcil), which DGFT assigns bulk drugs, formulations, herbal and homeopathic medicines, diagnostics and related services. Medicaments are HS heading 3004. Among the 12 countries on this site, the United States is the largest buyer of Indian pharmaceutical products in the data below.

In FY 2025-26, India's exports to USA of medicaments (HS 3004) were US$ 8,198.5 million, which is 37.5% of India's total exports of the same products (US$ 21,866.0 million), according to TradeStat.

How much does India export? FY 2025-26

Product2024-25 (US$ million)2025-26 (US$ million)ChangeAll countries, 2025-26 (US$ million)Share to USA
HS 30049,491.98,198.5-13.6%21,866.037.5%

Trade values are in US$ million for the financial year 2025-26 (April 2025 to March 2026), as published by TradeStat, Department of Commerce (data from DGCI&S) and fetched on 2026-10-02. They can be revised later. Shares and changes are calculated from those figures. Year-on-year change compares 2025-26 with 2024-25.

India-side licences and registrations for pharmaceuticals

LicenceIssued byMain official fee
IEC code (Importer Exporter Code)DGFT, Ministry of Commerce₹500Checked on official page Source
Pharmexcil RCMCPharmaceuticals Export Promotion CouncilSet by the CouncilTo confirm Source
AD code (Authorised Dealer code)Your bank gives the code; Customs registers it on ICEGATENo amount shownTo confirm Source
GST LUT (Form GST RFD-11)GST Department (filed on the GST portal)No amount shownTo confirm Source
Certificate of origin (e-CoO)Agencies authorised by DGFT (chambers, EPCs and others)₹200Checked on official page Source

Fees and rules change and can differ between offices. Confirm the fee on the official portal before you pay. Amounts marked To confirm could not be checked on an official page.

Policy check

DGFT's export schedule (2021 edition) requires a health certificate issued jointly by CAPEXIL and the Regional Animal Quarantine Officer for heparin and its salts. Other medicaments are not restricted in the lines we read. Restricted lines in chapter 29 cover ozone-depleting chemicals.

DGFT's lists we read: restricted imports (2019), prohibited imports (2019), export schedule (2021). Current policy: DGFT policy search. HS chapter details: Chapter 30: Pharmaceutical products.

Trade agreement and certificate of origin

India-US interim trade framework (no FTA in force). A framework for an interim agreement was announced in February 2026. Talks on a bilateral trade agreement continued in April 2026.

India has no preferential agreement in force with the USA that is listed in DGFT's Appendix 2A, so shipments to the USA use the non-preferential certificate of origin (₹200) when the buyer asks for one.

Department of Commerce: United States-India Joint Statement (7 Feb 2026)

Steps for this route

  1. Get your IEC from DGFT (IEC guide). Fee ₹500.
  2. Register your bank's AD code on ICEGATE (AD code guide).
  3. Check manufacturing and quality licences your state drug authority issued for your plant.
  4. Ask your US buyer which regulatory registrations they need on the US side. We do not cover US rules.
  5. Keep batch records and test reports with the export papers.
  6. File the shipping bill on ICEGATE and keep the e-BRC after you are paid (export guide).

Common questions

Which council covers pharmaceuticals?
Pharmexcil. DGFT's Appendix 2T lists bulk drugs, formulations, herbal, ayurvedic, unani and homeopathic medicines, biotech products, diagnostics and more.
What is the Pharmexcil fee?
We did not find it on an official page, so it is shown as To confirm.
Is there a trade agreement with the USA?
No agreement is in force. A framework for an interim agreement was announced in February 2026.
Does heparin need special papers?
Yes. DGFT's schedule asks for a health certificate issued jointly by CAPEXIL and the Regional Animal Quarantine Officer.
Is Govt License a government website?
No. Govt License is an independent guide. We link to the official government portals where you apply and pay. Always confirm the fee on the portal before paying.