Chemicals & Pharmaceuticals Export Guide

Industry Overview

India is the world's third-largest chemical producer by volume and the largest provider of generic medicines globally, supplying approximately 20% of the world's generic drug demand. Combined chemical and pharmaceutical exports crossed $41.5 billion in FY 2025-26, making this sector India's second-largest export category after engineering goods.

The sector encompasses several distinct subsectors, each with its own regulatory regime:

Major Manufacturing Hubs

India's chemical and pharma manufacturing is concentrated in a few key clusters, each with its own strengths:

• · Gujarat (Vadodara, Vapi, Ankleshwar GIDC). India's largest chemical cluster. Produces over 40% of the country's chemical output. Home to major dye, agrochemical, and specialty chemical units. Proximity to Mundra and Hazira ports gives logistics advantages.
• · Hyderabad (Genome Valley, Jeedimetla). India's bulk drug capital. Major API and intermediate production hub. Multiple FDA-inspected and WHO GMP-certified facilities.
• · Mumbai-Thane-Raigad. Headquarters of major pharma MNCs and Indian companies. Formulation and R&D hub with strong logistics connectivity via JNPT.
• · Visakhapatnam (Vizag). Bulk drug park under the PLI scheme. Growing API cluster with dedicated SEZ for pharma. Port access for bulk chemical exports.
• · Baddi-Nalagarh (Himachal Pradesh). Major formulation manufacturing hub. Tax incentive-driven cluster with over 500 pharma units.

HS Code Coverage

Chemical and pharmaceutical exports primarily fall under HS Chapters 28 through 38. Getting the HS code right is critical. It determines the duty rate, REACH obligations, regulatory requirements, and eligibility for Advance Authorisation and other export incentives.

Key Destination Markets & Duty Rates

Indian chemical and pharmaceutical exports reach over 200 countries. Market access requirements vary dramatically between regulated, semi-regulated, and unregulated markets.

Regulated Markets

Semi-Regulated & Emerging Markets

REACH Compliance for EU Exports

REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is the EU's chemical safety regulation and the single biggest compliance barrier for Indian chemical exporters targeting Europe. For a detailed breakdown, see our EU REACH Compliance Guide for Indian Exporters.

Registration Requirements by Tonnage Band

Only Representative (OR) Requirement

Indian manufacturers cannot register directly under REACH. You must appoint an Only Representative (OR) established in the EU/EEA who acts as your legal representative for REACH compliance. The OR takes on the obligations of a registrant, including maintaining the registration dossier, handling ECHA queries, and managing SIEF (Substance Information Exchange Forum) participation.

SVHC List & Authorisation

The Candidate List of Substances of Very High Concern (SVHC) currently contains over 240 substances. If your chemical is on this list, you must notify ECHA if it's present above 0.1% w/w in articles, and communicate safety information down the supply chain. Annex XIV substances require specific Authorisation to continue placing them on the EU market.

GHS Classification & Safety Data Sheets

The Globally Harmonized System of Classification and Labelling of Chemicals (GHS) provides a standardized approach to chemical hazard communication. However, different markets implement GHS with variations that exporters must navigate.

Key GHS Implementations by Market

• · EU. CLP Regulation (EC 1272/2008): Full GHS implementation with EU-specific classifications. Annex VI contains harmonised classifications for over 4,000 substances.
• · USA. OSHA HCS (29 CFR 1910.1200): GHS-aligned Hazard Communication Standard. Requires 16-section SDS and GHS-compliant labelling for workplace chemicals.
• · India. BIS IS 16218 : Indian GHS standard. Not yet fully mandatory for domestic use, but all exports must comply with the destination country's GHS implementation.

Safety Data Sheet (SDS) Requirements

Every chemical shipment must be accompanied by a 16-section Safety Data Sheet in the language of the destination country. The SDS must include:

1. Identification
2. Hazard identification
3. Composition/ingredients
4. First-aid measures
5. Fire-fighting measures
6. Accidental release measures
7. Handling and storage
8. Exposure controls/PPE
9. Physical/chemical properties
10. Stability and reactivity
11. Toxicological information
12. Ecological information
13. Disposal considerations
14. Transport information
15. Regulatory information
16. Other information

Pharmaceutical Certifications & Market Access

Pharmaceutical exports are among the most heavily regulated product categories. Each destination market has its own approval pathway, and Indian pharma companies typically maintain multiple certifications simultaneously.

WHO GMP. The Baseline

WHO Good Manufacturing Practice certification is the entry ticket for most global markets. In India, WHO GMP is certified by the Central Drugs Standard Control Organisation (CDSCO) through state drug controllers. A WHO GMP certificate is sufficient for exports to most African, Southeast Asian, Latin American, and Middle Eastern countries.

US FDA cGMP

For the US market (the world's largest pharma market by value) Indian manufacturers need FDA current Good Manufacturing Practice (cGMP) compliance under 21 CFR Parts 210/211 (finished dosage forms) or Part 211 (APIs under ICH Q7 guidance). Key elements:

• · Drug Master File (DMF): Filed with the FDA for APIs. Contains complete manufacturing, processing, and quality information. Referenced by the buyer's ANDA submission.
• · ANDA (Abbreviated New Drug Application): Required for generic finished dosage forms. Demonstrates bioequivalence to the reference listed drug (RLD) and pharmaceutical equivalence.
• · FDA Inspections: Pre-approval inspections (PAI) before ANDA approval and periodic surveillance inspections. Any Form 483 observations must be addressed within 15 business days. Warning Letters or Import Alerts can halt all exports from a facility.

EU GMP & EDQM

The EU requires compliance with EudraLex Volume 4 (EU GMP guidelines). For APIs, the European Directorate for the Quality of Medicines (EDQM) issues a Certificate of Suitability (CEP/CoS) that confirms the API monograph in the European Pharmacopoeia is adequate to control the quality of the substance. Alternatively, API manufacturers can support an EU Marketing Authorisation Holder's ASMF (Active Substance Master File, equivalent to a DMF).

Certificate of Pharmaceutical Product (COPP)

The COPP, issued by CDSCO under the WHO Certification Scheme, certifies that a pharmaceutical product is authorised for sale in India and that the manufacturing facility complies with GMP. Many importing countries (especially in Africa and the Middle East) require a COPP as part of their drug registration process. See our Export Documentation Guide for details on obtaining one.

Hazardous Materials Shipping

A large portion of chemical exports are classified as dangerous goods (DG) under international transport regulations. Incorrect DG documentation is one of the most common reasons for shipment detention at Indian ports.

IMDG Code (Sea Transport)

The International Maritime Dangerous Goods (IMDG) Code governs the transport of dangerous goods by sea. Indian exporters must:

• · Classify goods by UN number and assign the correct hazard class (1-9) and subsidiary risks
• · Use UN-approved packaging tested and marked per the applicable Packing Group (PG I = great danger, PG II = medium, PG III = minor)
• · Prepare a Dangerous Goods Declaration (DGD) per IMO format
• · Apply correct hazard labels, marks, and placards on packages and containers
• · Pack containers per the CTU (Cargo Transport Unit) Code with proper segregation from incompatible goods
• · Provide an emergency response procedure (EmS) code on shipping documents

IATA DGR (Air Transport)

Air freight of dangerous goods follows the IATA Dangerous Goods Regulations (DGR), which are more restrictive than IMDG. Many chemicals that can be shipped by sea are forbidden on aircraft. Key points:

• · The shipper must hold a DG air shipper certification (training valid for 24 months)
• · Quantity limits per package are significantly lower than for sea freight
• · Some substances are "Cargo Aircraft Only" (CAO) and cannot go on passenger flights
• · Pharmaceutical samples may qualify for limited quantity or excepted quantity provisions

Common Hazard Classes for Indian Chemical Exports

Controlled Substances & Dual-Use Chemicals

Certain chemicals face export controls beyond standard trade compliance. Violations can lead to criminal prosecution, not just administrative penalties.

NDPS Act & Precursor Chemicals

The Narcotic Drugs and Psychotropic Substances Act, 1985 controls the export of narcotic drugs, psychotropic substances, and precursor chemicals. Indian exporters of precursor chemicals (such as ephedrine, pseudoephedrine, acetic anhydride, and certain solvents) must obtain a No Objection Certificate (NOC) from the Narcotics Control Bureau (NCB) before export. The International Narcotics Control Board (INCB) Pre-Export Notification (PEN) system may also apply for shipments to certain countries.

Chemical Weapons Convention (CWC) Schedules

India is a signatory to the CWC, and the Chemical Weapons Convention Act, 2000 controls export of scheduled chemicals:

• · Schedule 1: Chemicals with very limited or no use outside chemical weapons (e.g., mustard gas, nerve agents). Export essentially prohibited except for very limited research purposes.
• · Schedule 2: Chemicals with limited commercial use (e.g., thiodiglycol, certain phosphorus compounds). Export requires an End-User Certificate and government approval. Cannot be exported to non-CWC states.
• · Schedule 3: Chemicals with significant commercial use (e.g., phosgene, triethanolamine, hydrogen cyanide). Export to non-CWC states requires End-User Certificate. Declarations to the National Authority (Cabinet Secretariat) are mandatory above threshold quantities.

Wassenaar Arrangement & Dual-Use Chemicals

India participates in the Wassenaar Arrangement, which controls the export of dual-use goods and technologies. Certain chemicals, biological agents, and production equipment fall under SCOMET (Special Chemicals, Organisms, Materials, Equipment and Technologies) list maintained by DGFT. Exporters of SCOMET items need a licence from DGFT's SCOMET division, and end-use monitoring may be required.

Export Incentives & Schemes

Indian chemical and pharmaceutical exporters can access several government schemes that significantly improve competitiveness.

RoDTEP (Remission of Duties and Taxes)

RoDTEP reimburses embedded central, state, and local taxes that are not refunded through other mechanisms. Rates for chemicals typically range from 0.5% to 2.5% of FOB value:

• · Organic chemicals (Ch. 29): 0.5. 1.5%
• · Dyes and pigments (Ch. 32): 1.0. 2.0%
• · Agrochemicals (Ch. 38): up to 2.5%
• · Pharmaceutical formulations (Ch. 30): 0.5. 1.5%

Advance Authorisation

One of the most valuable schemes for this sector. Advance Authorisation allows duty-free import of inputs (raw materials, intermediates, catalysts, packing materials) used in export production. For chemical and pharma manufacturers who import Key Starting Materials (KSMs) and intermediates, this can save 7. 15% on input costs depending on the applicable BCD.

The scheme works on Standard Input-Output Norms (SIONs) or ad-hoc norms. The export obligation must be fulfilled within 18 months (extendable to 36 months with endorsement), and minimum value addition must be 15%.

EPCG Scheme

The Export Promotion Capital Goods (EPCG) scheme allows import of capital goods at zero duty against an export obligation of 6x the duty saved, to be fulfilled over 6 years. For pharma companies setting up FDA/WHO-GMP compliant facilities or chemical manufacturers investing in specialty reactors and distillation columns, this substantially reduces CapEx.

Pharma PLI Scheme

The Production-Linked Incentive (PLI) scheme for pharmaceuticals has two components:

• · PLI for Key Starting Materials / Drug Intermediates & APIs: Covers 41 products where India has import dependence (mostly from China). Incentive of 5. 20% of incremental sales for 6 years.
• · PLI for Pharmaceutical Goods (Complex Products): Targets complex generics, biosimilars, cell-based therapies, gene therapies, and orphan drugs. Incentive of 3. 10% of incremental sales.

Bulk Drug Parks

The government has sanctioned three bulk drug parks (in Himachal Pradesh, Andhra Pradesh, and Gujarat) with common infrastructure funded up to Rs 1,000 crore each. Manufacturers in these parks benefit from shared effluent treatment, solvent recovery plants, testing laboratories, and logistics infrastructure, reducing per-unit production costs by an estimated 15. 25%.

Interest Subvention

The Interest Equalisation Scheme provides a 3% interest subvention on pre-shipment and post-shipment rupee export credit to MSME exporters and 2% for manufacturer exporters for specified products, including many chemical and pharma items. This is applied directly by the lending bank against the exporter's packing credit or post-shipment credit facility.

Export Promotion Councils

Registration with the relevant Export Promotion Council (EPC) and obtaining a Registration Cum Membership Certificate (RCMC) is mandatory for availing export incentives. The RCMC is valid for 5 years.

Environmental Compliance

Chemical and pharmaceutical manufacturing is one of the most environmentally scrutinised sectors in India. Non-compliance can result in plant closure orders from the National Green Tribunal (NGT) or state pollution control boards, directly affecting your ability to fulfil export orders.

Pollution Control Board (PCB) Requirements

• · Consent to Establish (CTE) and Consent to Operate (CTO) from the State Pollution Control Board under the Water Act and Air Act
• · Hazardous Waste Authorisation under the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016
• · Environmental Clearance (EC) for new projects or expansions under EIA Notification, 2006
• · Hazardous Waste Manifest for every consignment of hazardous waste generated, using Form 10 under HW Rules

Effluent & Emission Standards

Chemical units must comply with industry-specific effluent discharge standards notified under the Environment Protection Act. Zero Liquid Discharge (ZLD) is mandatory in certain clusters (e.g., parts of Gujarat GIDC). CEMS (Continuous Emission Monitoring Systems) are required for units falling under the 17 highly polluting categories identified by CPCB.

Export Compliance Checklist

Use this checklist before shipping any chemical or pharmaceutical export consignment. Missing even one item can result in shipment detention, rejection at the destination port, or loss of export incentives.

Pre-Export Checklist

• IEC (Importer Exporter Code) is valid and active on DGFT portal
• RCMC from CHEMEXCIL / Pharmexcil / CAPEXIL is current (valid for 5 years)
• HS code verified at 8-digit level for the correct duty rate and scheme eligibility
• Product not on SCOMET list, or SCOMET licence obtained from DGFT
• NCB NOC obtained for precursor/controlled chemicals (if applicable)
• REACH registration confirmed via Only Representative for EU exports
• Safety Data Sheet (SDS) prepared in destination country language, compliant with local GHS implementation
• GHS-compliant labels with pictograms, signal words, and hazard statements affixed
• WHO GMP / FDA cGMP / EU GMP certificate current for pharma exports
• COPP (Certificate of Pharmaceutical Product) obtained from CDSCO where required
• Drug licence and manufacturing licence valid for the exported product
• DG Declaration prepared per IMDG/IATA if product is hazardous. UN number, packing group, EmS codes confirmed
• UN-approved packaging used and marked with correct UN specification
• Advance Authorisation licence debited (if importing inputs duty-free)
• RoDTEP claim registered on ICEGATE with correct shipping bill details
• Certificate of Origin obtained for FTA preferential duty. see CoO guide
• Certificate of Analysis (CoA) for each batch with pharmacopeial specifications
• Pollution Control Board Consent to Operate (CTO) is valid and not expired
• Export documentation set complete: commercial invoice, packing list, shipping bill, bill of lading, insurance certificate

Frequently Asked Questions

What certifications do Indian pharma exporters need for the US market?

Indian pharmaceutical exporters targeting the US need FDA cGMP compliance (21 CFR Parts 210/211), a Drug Master File (DMF) for APIs, and an ANDA for finished dosage forms demonstrating bioequivalence. The FDA conducts periodic inspections of Indian facilities, and any Form 483 observations or Warning Letters can halt exports. Budget 2. 3 years from initial FDA facility inspection to first commercial shipment.

Is REACH registration mandatory for exporting chemicals to the EU?

Yes, for substances exported in quantities of 1 tonne or more per year per manufacturer. Indian companies must appoint an Only Representative (OR) in the EU to register on their behalf. Costs range from €10,000 for low-volume registrations to over €500,000 for high-tonnage substances requiring extensive testing data. Without registration, EU customs will block your shipment at the border.

What HS codes cover Indian chemical and pharmaceutical exports?

Chemical and pharma exports fall under HS Chapters 28. 38. The most important are Chapter 29 (organic chemicals, including APIs and intermediates), Chapter 30 (pharmaceutical preparations), Chapter 32 (dyes and pigments), and Chapter 38 (agrochemicals and specialty chemicals). Correct classification at the 8-digit level is critical as it determines duty rates, REACH obligations, and export incentive eligibility.

How do I ship hazardous chemicals by sea from India?

You must classify goods by UN number and hazard class per the IMDG Code, use UN-certified packaging appropriate to the Packing Group, prepare a Dangerous Goods Declaration (IMO format), apply correct hazard labels and placards, and provide EmS (Emergency Schedule) codes. The shipping line must accept the DG booking, and port authorities (e.g., at JNPT or Mundra) may inspect the container before loading.

What are the RoDTEP rates for chemical exports?

RoDTEP rates for chemicals typically range from 0.5% to 2.5% of FOB value. Organic chemicals (Chapter 29) attract 0.5. 1.5%, dyes (Chapter 32) get 1.0. 2.0%, and agrochemicals (Chapter 38) can go up to 2.5%. Rates are product-specific at the 8-digit HS level and are notified by DGFT. Claims are processed through duty credit scrips on ICEGATE.

What is the difference between WHO GMP and EU GMP?

WHO GMP is the baseline standard sufficient for most semi-regulated markets (Africa, Middle East, Southeast Asia). EU GMP (EudraLex Volume 4) is stricter, with more rigorous requirements for validation, environment monitoring, and documentation. EU GMP requires inspection by an EU member state authority, while WHO GMP is certified by India's CDSCO. For APIs going to the EU, an EDQM Certificate of Suitability (CEP) is the gold standard.

Can I use Advance Authorisation for duty-free imports of API raw materials?

Yes, Advance Authorisation is one of the most valuable schemes for pharma and chemical exporters. It allows duty-free import of Key Starting Materials, intermediates, catalysts, and packing materials used in export production. You need a Standard Input-Output Norm (SION) or an ad-hoc norm from the Norms Committee. The export obligation must be fulfilled within 18 months, and minimum value addition is 15%. This can save 7. 15% on input costs.

Which Export Promotion Council should I register with?

Register with CHEMEXCIL for basic chemicals, dyes, and cosmetics; Pharmexcil for APIs, formulations, and biotech products; or CAPEXIL for castor oil, shellac, and certain specialty chemicals. You need the RCMC from your relevant council to avail RoDTEP, Advance Authorisation, and EPCG benefits. If your product range spans multiple councils, register with each one.

Update history

• 2026-08-12 First published.