Pharmaceutical Exports from India: A Complete Guide to Exporting Medicines Successfully

1. Obtain a valid manufacturing license (Form 10 & 11) for the products intended for export.
2. Acquire an Importer-Exporter Code (IEC) from the Directorate General of Foreign Trade (DGFT).
3. Ensure WHO-GMP or ISO certification to meet international quality standards.

1. Register products in countries where required, submitting complete dossiers and test reports.
2. Proper registration prevents shipment rejections and builds credibility with local authorities.

1. Verify labeling requirements, language mandates, and storage guidelines.
2. Ensure all product details, dosage instructions, and safety information are clearly indicated.

1. Identify high-demand products such as generic drugs, nutraceuticals, and specialty formulations.
2. Analyze pricing, competition, and distribution channels.
3. Evaluate import restrictions, taxes, and duties to assess profitability.

1. Reduces the risk of regulatory issues.
2. Helps tailor products to meet local preferences.
3. Provides realistic forecasting for shipment volumes.

1. Collaborate with reliable distributors or agents who understand the local market.
2. Clearly define territory, minimum order quantities, and delivery schedules in agreements.
3. Maintain transparent communication and timely support to strengthen trust.

1. Provide product training and marketing materials.
2. Share samples, brochures, and digital resources.
3. Offer online support tools to simplify ordering and communication.

1. Plan cold-chain logistics for temperature-sensitive products.
2. Use experienced freight forwarders for international shipments.
3. Maintain insurance coverage to prevent financial losses during transit.

Have Questions?

Reach Out to Us

1. Market Identification : Select countries with high demand and low competition. Trade data and export reports help in choosing profitable markets. Understanding local regulations ensures smoother market entry.
2. Licensing and Certification : Obtain necessary approvals including IEC registration, drug manufacturing licenses, and WHO-GMP certification. Certifications establish credibility and ensure compliance with international standards.
3. Product Registration and Approvals : Register products where required. Submit product dossiers, test reports, and GMP certificates. Proper registration prevents shipment rejection and ensures regulatory compliance.
4. Packaging and Labeling Compliance : Use tamper-proof, export-ready packaging. Include all required product details and translate labels if necessary. Correct labeling reduces delays at customs and increases market acceptance.
5. Quality Assurance : Conduct strict quality checks for each batch. Maintain batch-wise records and certificates. Ensuring high quality builds trust with distributors and regulators alike.
6. Logistics Management : Choose freight forwarders with pharmaceutical experience. Plan for temperature-controlled storage if needed. Efficient logistics preserve product integrity and ensure timely delivery.
7. Documentation for Customs Clearance : Prepare commercial invoices, packing lists, bills of lading, and certificates of origin. Proper documentation streamlines customs clearance and avoids shipment delays.
8. Financial and Contractual Management : Set pricing models such as FOB, CIF, or Ex-Works. Secure payments via Letters of Credit or advance payments. Well-defined contracts protect both exporter and importer.
9. Distributor and Partner Management : Select distributors with local market expertise. Provide training and marketing support. Strong relationships improve sales, brand presence, and credibility.
10. Compliance and Ethical Practices : Follow international drug promotion guidelines. Avoid counterfeit or substandard products. Ethical practices protect the brand and reduce legal risks.
11. Market Expansion Strategies : Start with one country and expand gradually. Introduce new product lines based on market demand. Planned expansion minimizes risk and maximizes growth.
12. Monitoring and Feedback : Track sales, distributor performance, and customer feedback. Maintain records for complaints or recalls. Monitoring ensures timely corrective actions and market reliability.
13. Risk Management : Ensure shipment insurance. Prepare contingency plans for regulatory changes or logistical delays. Backup suppliers and logistics options minimize disruption.
14. Technology and Automation : Implement ERP or CRM systems to track orders, inventory, and payments. Digitized documentation simplifies audits and compliance. Real-time monitoring enhances operational efficiency.
15. Continuous Learning : Stay updated on global pharmaceutical regulations. Attend expos and training programs. Educating staff and partners ensures adherence to best practices and sustained growth.