India is one of the largest exporters of medicines in the world. Known as the “Pharmacy of the World,” India supplies affordable and quality medicines to more than 200 countries. The demand for Indian medicines, including generic drugs and over-the-counter products, continues to grow in Asia, Africa, Europe, and the United States.
For new exporters, understanding the regulations, documentation, and process is very important. Medicines are highly regulated products, so exporters must comply with strict government rules in both India and the importing country.
Government Authorities Involved
The export of medicines from India is supervised by multiple government bodies.
- DGFT (Directorate General of Foreign Trade): Grants the Importer Exporter Code (IEC), which is mandatory.
- CDSCO (Central Drugs Standard Control Organization): Approves drugs and issues export permissions.
- State Licensing Authority: Provides manufacturing and wholesale drug licenses.
- NPPA (National Pharmaceutical Pricing Authority): Regulates pricing of essential medicines.
- Pharmaceuticals Export Promotion Council of India (PHARMEXCIL): Supports exporters through schemes, buyer-seller meets, and trade promotion.
- Customs Department: Handles clearance and shipping of consignments.
Step-by-Step Export Process
1. Business and License Setup
The exporter must set up a registered company. A Drug Manufacturing License or Wholesale Drug License from the State Drug Control Authority is required.
2. Importer Exporter Code (IEC)
The IEC from DGFT is mandatory for all exporters. It can be applied for online.
3. CDSCO and State Approvals
The exporter must obtain product approvals and permissions from CDSCO and state drug authorities. Some medicines require a No Objection Certificate (NOC) from CDSCO before export.
4. PHARMEXCIL Registration
Register with Pharmaceuticals Export Promotion Council (PHARMEXCIL) to get RCMC (Registration-Cum-Membership Certificate). This provides access to trade fairs, market information, and government benefits.
5. Market Research
Study demand in importing countries. Each country has its own regulations for drugs. Some require product registration before import. Exporters must ensure compliance with those standards.
6. Buyer Agreement
Once a buyer is found, confirm product specifications, price, quantity, and shipping terms. Many buyers ask for WHO-GMP (Good Manufacturing Practice) certification.
7. Quality Standards and Certification
Medicines must comply with Indian Pharmacopoeia, USFDA, or EU standards depending on the destination. Quality testing from approved labs is necessary.
8. Packaging and Labeling
Export packaging must meet international norms. Labels should include product name, manufacturer, expiry date, batch number, and storage conditions. Tamper-proof and moisture-proof packaging is preferred.
9. Customs and Shipping
The exporter must file a shipping bill with Customs through the ICEGATE portal. After clearance, goods are shipped by air or sea. Medicines are mostly sent via air cargo due to urgency and shorter shelf life.
Key Documents Required For Exporting Medicines From India
- Importer Exporter Code (IEC) – from DGFT
- Manufacturing or Wholesale Drug License – from State Licensing Authority
- NOC (if required) – from CDSCO
- WHO-GMP or equivalent certification
- PHARMEXCIL RCMC Certificate
- Commercial Invoice
- Packing List
- Airway Bill / Bill of Lading
- Certificate of Analysis (COA)
- Certificate of Origin
- Free Sale Certificate (if required by importing country)
Government Support for Medicine Exporters
The Indian government provides several schemes and support mechanisms.
- PHARMEXCIL Support: Helps in export promotion, financial assistance for trade fairs, and buyer-seller meets.
- Duty Drawback Schemes: Refunds part of customs duties to exporters.
- GST Refunds: Exporters can claim refund of GST paid.
- Financial Assistance: Exporters can apply for subsidies for packaging and quality certifications.
- Ease of Doing Business: Online systems for IEC, CDSCO approvals, and Customs have simplified the process.
Benefits of Exporting Medicines from India
- High Global Demand: Indian medicines are trusted worldwide for quality and affordability.
- Large Manufacturing Base: India has strong pharma production capacity.
- Government Support: PHARMEXCIL, CDSCO, and DGFT provide active support to exporters.
- Reputation: Indian companies have approvals from WHO, USFDA, and EU.
- Profitability: Exports of generics, APIs (Active Pharmaceutical Ingredients), and formulations provide good margins.
Challenges in Medicine Export
Medicine exports are highly regulated. Exporters face strict challenges such as:
- Country-specific product registration requirements.
- Need for GMP certifications.
- Stringent quality testing.
- High compliance costs.
- Competition from China and other pharma-exporting countries.
These can be managed with proper planning, certifications, and partnerships with international buyers.
Conclusion
Exporting medicines from India is a rewarding business with global demand and strong government support. By following the right steps—such as getting IEC, drug licenses, CDSCO approvals, and PHARMEXCIL registration—exporters can enter international markets confidently.
Government bodies like DGFT, CDSCO, and PHARMEXCIL guide and support this process. Exporters must ensure strict quality, packaging, and compliance to succeed. With India’s strong pharma base and reputation, medicine exports will continue to grow, creating opportunities for both new and experienced businesses.