How to Export Pharmaceuticals from India: Step-by-Step Guide for 2025
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- by MI September 17, 2025
India has emerged as one of the leading exporters of pharmaceutical products globally, supplying high-quality medicines, APIs, and formulations to over 200 countries. With the growing demand for affordable and effective medicines, exporting pharmaceuticals can be a profitable business opportunity. This guide will walk you through the step-by-step process of exporting pharmaceuticals from India while ensuring compliance with regulations and maximizing market reach.
Step 1: Understand Export Regulations for Pharmaceuticals
Before starting, it is crucial to understand the rules governing pharmaceutical exports:
- Licensing Authority: Pharmaceuticals exports are regulated by the Central Drugs Standard Control Organization (CDSCO) and Directorate General of Foreign Trade (DGFT).
- Export License: Obtain a Drug Export License (Form 10) from CDSCO. This is mandatory to export drugs and pharmaceutical products.
- Compliance Standards: Ensure compliance with WHO-GMP (Good Manufacturing Practices) standards and US FDA or EU regulations, depending on your target market.
Step 2: Register Your Business
Your pharmaceutical company must be legally recognized:
- Company Registration: Register your company under Private Limited, LLP, or Proprietorship as per Indian laws.
- GST Registration: Ensure your company has GST registration for tax compliance.
- IEC Code: Apply for an Import Export Code (IEC) from DGFT, which is mandatory for exporting any product from India.
Step 3: Product Compliance and Documentation
Exporting pharmaceuticals requires accurate documentation:
- Certificate of Pharmaceutical Product (CPP)
- Quality Test Reports from NABL-accredited labs
- Invoice and Packing List
- Bill of Lading / Airway Bill
- Certificate of Analysis (CoA)
Proper documentation ensures smooth customs clearance and builds trust with international buyers.
Step 4: Identify Target Markets
Research potential markets where Indian pharmaceuticals are in demand:
- USA, Europe, Canada: High standards, need FDA/EU approval
- Africa and Middle East: Growing demand for generic medicines
- Asia and South America: Emerging markets with cost-sensitive consumers
Consider factors like regulatory compliance, market demand, and competition while choosing the export destination.
Step 5: Partner with Buyers and Distributors
Finding reliable buyers is critical:
- Attend pharma trade fairs like CPhI Worldwide
- Use B2B platforms such as IndiaMART, TradeIndia, and Global Sources
- Collaborate with international distributors who understand local regulations
Ensure proper agreements and contracts to secure payments and maintain credibility.
Step 6: Packaging and Shipping
Pharmaceutical exports require specialized handling:
- Packaging: Must comply with WHO standards and include proper labeling
- Storage: Some products require temperature-controlled shipping
- Shipping: Choose a reliable logistics provider familiar with pharmaceutical exports
Step 7: Customs Clearance and Payment
Follow the proper customs and payment procedures:
- Customs Filing: Submit documents to Indian customs for clearance
- Payment Terms: Use Letter of Credit (LC), TT (Telegraphic Transfer), or Advance Payment for secure transactions
- Insurance: Always insure shipments to protect against damage or loss
Step 8: After-Sales Support
Maintaining long-term relationships is key for repeat orders:
- Provide technical support and guidance for your products
- Ensure compliance with the importing country’s post-market surveillance rules
- Gather feedback to improve product quality and delivery
Conclusion
Exporting pharmaceuticals from India is a profitable venture if you follow the regulatory guidelines, proper documentation, and market research. By understanding the export process and maintaining high-quality standards, Indian pharmaceutical companies can successfully reach global markets and expand their business internationally.
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