India is a global pharmaceutical leader, earning its reputation as the “Pharmacy of the World.” With a legacy of providing affordable, high-quality generic drugs and vaccines, India plays a pivotal role in global health, making essential medications accessible to millions.
Did you know, “India ranks third globally in terms of pharmaceutical production volume but is fourteenth in production value”?. This highlights the country’s immense manufacturing capacity but also underscores the need for value-driven innovation and higher-margin product development to enhance its global competitiveness.
The USA market offers immense opportunities for Indian pharmaceutical exporters, but navigating its complex regulatory landscape and competitive market can be challenging. Whether you’re scaling your business or entering this lucrative market for the first time, understanding the process to export pharmaceutical products from India is crucial.
Step-by-Step Guide to Export Pharmaceutical Products from India
Exporting pharmaceutical products involves several steps, including obtaining necessary licenses, understanding the market and target audience, and obtaining IEC, which is essential for any business engaging in international trade. Here’s a step-by-step process:
1. Research and Market Analysis
Before initiating the export process, pharmaceutical companies must:
- Identify target markets: Understand demand for specific pharmaceutical products in various regions.
- Research regulations: Study import and drug registration requirements for the destination country.
- Evaluate competition: Analyze pricing, competitors, and local market dynamics.
2. Obtain Importer Exporter Code (IEC)
An Importer Exporter Code (IEC) is a mandatory requirement for exporting pharmaceutical products from India. Here’s how to obtain it:
- Visit the DGFT Website: Access the Directorate General of Foreign Trade (DGFT) portal.
- Register on the Portal: Create a user profile and link it to your business’s PAN (Permanent Account Number).
- Submit Application:
- Fill out the IEC application form (ANF 2A).
- Upload required documents:
- PAN card of the business entity.
- Aadhaar card or Voter ID of the proprietor/partners/directors.
- Address proof of the business location.
- Bank certificate or a canceled cheque.
- WHO: GMP certification
- Pay Fees: Submit the applicable fees online.
- Verification and Issue: The IEC code is issued electronically upon verification, typically within 1-2 business days.
3. Registration and Compliance
Pharmaceutical exports are heavily regulated to ensure product safety and efficacy. Exporters need to:
- Register the product: Obtain necessary approvals from regulatory bodies in the importing country (e.g., FDA in the USA, EMA in Europe).
- Comply with local and international laws: Adhere to Good Manufacturing Practices (GMP) and international standards like ISO 13485. Ensure adherence to Good Manufacturing Practices (GMP) as per WHO guidelines and comply with internationally recognized standards like ISO 13485, which govern the quality management systems for medical devices and related products. Additionally, exporters must stay updated with the legal frameworks and import regulations of target countries, such as labeling requirements, drug stability data, and pharmacovigilance obligations.
- Acquire certifications: These may include Certificate of Pharmaceutical Product (CPP) and Good Distribution Practice (GDP) certificates.
4. Documentation
Accurate documentation is essential for smooth customs clearance. Along with licenses, proper permissions are also required. Essential documents include:
- Export license: Authorization for exporting pharmaceuticals.
- Permission from regulatory authorities: Specific permits for certain pharmaceutical products based on the importing country’s requirements.
- Certificate of Analysis (COA): Confirms the product’s quality and composition.
- Shipping bill: A document required for customs clearance.
- Packing list and invoice: Detailing product quantity, description, and pricing.
- Import permits: Issued by the importing country to authorize product entry.
5. Packaging and Labeling
Packaging must comply with international standards to maintain product integrity and safety. Requirements include:
- Tamper-evident packaging: Ensures the product remains unaltered during transit.
- Clear labeling: Includes product name, batch number, expiry date, and instructions in the local language if required.
Case Example: For temperature-sensitive drugs, companies use cold-chain packaging solutions.
6. Delivery and Order Fulfillment
Once the products are ready, ensure efficient delivery and order management:
- Choose a reliable logistics partner: Opt for carriers experienced in handling pharmaceutical products, especially those requiring temperature control.
- Customs clearance: Work with customs brokers to ensure timely clearance of shipments.
- Track and monitor: Use tracking tools to monitor the shipment in real-time and address potential delays.
- Final delivery: Coordinate with local distributors or retailers in the destination country to deliver the product to end-users.
Get in Touch with Reliable Shipping and Logistics
Efficient and reliable shipping is critical in the pharmaceutical export process due to the sensitive nature of the products. Pharmaceuticals often require strict temperature controls, real-time visibility, and compliance with international shipping standards to maintain product integrity and ensure timely delivery. Here’s how businesses can manage shipping and logistics effectively.
General Considerations for Pharmaceutical Shipping
- Partner with Experienced Providers:
- Collaborate with logistics partners experienced in pharmaceutical exports.
- Ensure they offer end-to-end services, including customs clearance and last-mile delivery.
- Leverage Advanced Technology:
- Use shipment tracking systems to monitor deliveries in real time.
- Opt for platforms that integrate documentation, compliance management, and shipment visibility.
- Plan for Customs and Regulations:
- Work with customs brokers to navigate complex import/export requirements.
- Ensure all shipping documents, such as Certificates of Analysis (COA) and product registrations, are in order.
Intoglo: A Trusted Door-to-Door Logistics Provider for India-to-USA Shipments
Intoglo specializes in providing seamless, door-to-door logistics solutions for businesses exporting goods, including pharmaceutical products, from India to the USA. By working directly with shipping lines, truckers, and customs brokers, Intoglo eliminates the delays and extra charges caused by intermediaries, ensuring reliable and cost-effective shipping.
Key Features and Services of Intoglo
- Direct Partnerships: Intoglo works directly with shipping lines, truckers, and customs brokers, avoiding agents to ensure faster and cost-effective cross-border shipments.
- End-to-End Logistics Support:
- Origin pickup and CFS (Container Freight Station) handling.
- Customs clearance at both origin and destination.
- Ocean freight services and last-mile delivery in the USA.
- AI-Based HTS Code Scanner:
- Exporters can use Intoglo’s AI-powered HTS (Harmonized Tariff System) Code Scanner to identify the correct HS Code for various pharmaceutical products.
- Simply take a photo of the item, and the system will provide the appropriate HS Code, ensuring faster customs clearance and compliance with international trade regulations.
- Global Team Support: Teams operate across Indian and US time zones to provide seamless support and address queries promptly.
- Instant Rates: Offers instant pricing for full container loads on the India-to-USA trade lane, simplifying cost planning for exporters.
- Extensive Warehouse Network: Access to over 50 warehouses in multiple US locations, providing storage flexibility and faster delivery options.
- Advanced Tracking with Glotrack:
- Real-time shipment visibility from pickup to delivery.
- Manage multiple shipments on a single platform.
- Receive timely updates via WhatsApp notifications.
- Diverse Client Base: Trusted by over 200 clients, including MSMEs, D2C brands, and large enterprises, catering to first-time and seasoned exporters alike.
Explore Intoglo’s comprehensive logistics templates designed to simplify your export journey! From commercial invoice to packing list, these ready-to-use resources ensure you stay organized and efficient at every step. Tailored for exporters, these templates save time, reduce errors, and streamline cross-border shipping processes.
Visit Intoglo Templates to access these powerful tools and elevate your logistics management today!
A Profitable Opportunity for Indian Pharmaceutical Exporters
Indian pharmaceutical exporters have a golden opportunity in the global market, particularly in the U.S., driven by the demand for high-quality medicines. India excels in exporting generic drugs, over-the-counter medicines, APIs (Active Pharmaceutical Ingredients), and vaccines. With low manufacturing costs, a skilled workforce, and strong compliance with international quality standards, the sector offers lucrative margins.
Let’s explore how cost advantages and export trends bolster this thriving sector:
Manufacturing Cost Advantages
India’s pharmaceutical industry stands out globally due to its significant manufacturing cost advantages. With a valuation of nearly $50 billion as of 2023, the industry is projected to reach $130 billion by 2030. This rapid expansion highlights India’s robust position in the global pharmaceutical market.Â
This competitive advantage is fueled by several key factors that position India as a global pharmaceutical hub, making it an ideal source of affordable and high-quality medicines:
- Lower Production Costs: Skilled labor, affordable raw materials, and strong infrastructure reduce production expenses by 30-40% compared to Western markets.
- Consistent Monthly Performance: On average, India exports $2–3 billion worth of pharmaceutical products each month, showcasing a steady performance and resilience in international trade.
- Global Generic Medicine Leader: India accounts for 20% of global pharmaceutical exports, establishing its dominance in affordable drug manufacturing.
- Vaccine Powerhouse: India supplies over 60% of the world’s vaccines and plays a pivotal role in international healthcare.
- Government Support: Incentives under the Production Linked Incentive (PLI) scheme promote production, R&D, and attract foreign investment.
- Stringent Quality Compliance: Adherence to global quality standards ensures reliability and trust in Indian pharmaceutical exports.
With these benefits, Indian pharmaceutical exporters are ideally placed to meet the increasing global demand, especially in regions seeking affordable yet high-quality medicines and vaccines.
Quality and Efficiency in Production
India’s pharmaceutical industry is renowned for its ability to combine quality and efficiency in production. Advanced manufacturing technologies, state-of-the-art facilities, and a skilled workforce ensure the production of pharmaceuticals that meet stringent international standards.
- Advanced Technology Integration: Modern production methods enhance precision, reduce waste, and streamline processes, leading to cost effectiveness and faster delivery timelines.
- Regulatory Compliance: Indian pharmaceutical plants are approved by major regulatory authorities such as the US FDA, WHO, and EU GMP, ensuring adherence to global safety and efficacy standards.
- Robust Supply Chain Management: Efficient logistics and supply chain frameworks support seamless production and export operations.
- Focus on Innovation: Investment in research and development drives continuous improvement, enabling exporters to stay competitive in evolving markets.
This focus on quality and efficiency not only enhances India’s reputation but also reinforces its ability to cater to the growing global demand for affordable and reliable pharmaceutical products.
Top 10 Destinations for Exporting Medicines from India
India’s pharmaceutical industry has established a strong global presence, exporting high-quality and affordable medicines to over 200 countries. Key markets like the United States, the UK, and Brazil dominate India’s pharmaceutical industry, while emerging destinations are opening new growth opportunities. Below are the top 10 destinations for Indian pharmaceutical exports:
- Middle East
- Asia
- CIS
- North America
- Africa
- European Union
- ASEAN
- Latin America
- Caribbean (LAC)
- Other parts of Europe
India pharmaceutical Export Trends
India’s pharmaceutical export industry continues to demonstrate robust growth, solidifying its position as a key player in the global pharmaceutical market. Despite challenges in the global trade landscape, the sector has maintained a strong upward trajectory, driven by quality manufacturing, competitive pricing, and expanding market reach.
Key Statistics and Insights
- Impressive Growth Amidst Challenges: In the fiscal year 2023-24, India’s pharmaceutical exports reached a record $27.9 billion, representing a 9.67% growth compared to the previous year. This achievement is particularly remarkable given the overall decline of 3% in India’s total exports during the same period.
- Dominance in Global Markets:
- The United States remains the largest importer of Indian pharmaceutical products, accounting for over 31% of total exports.
- Other major markets include the UK, Netherlands, South Africa, and Brazil, each contributing approximately 3% to the export tally.
- These markets underscore India’s strong foothold in both developed and emerging economies.
- Global Recognition and Reach
- With exports to nearly 200 countries, India has established itself as a reliable source of affordable, high-quality pharmaceutical products worldwide.
- Market Diversification and Expansion
In FY24, India expanded its export reach to new regions, including Montenegro, South Sudan, and Chad. This diversification not only reflects India’s growing global footprint but also highlights emerging opportunities in untapped markets.
Conclusion
Exporting pharmaceutical products from India offers immense opportunities, given the country’s position as a global leader in affordable, high-quality medicines. However, the process demands meticulous planning, compliance with international regulations, and efficient logistics.
As India continues to expand its global footprint, exporters must leverage advanced tools and trusted logistics solutions to stay competitive. A reliable partner like Intoglo can simplify your export journey with seamless door-to-door services, real-time tracking, and comprehensive support across the India-to-USA trade lane.
Take the next step in scaling your pharmaceutical export business. Explore Intoglo’s solutions today and experience hassle-free shipping. Visit Intoglo to learn more and streamline your logistics operations effortlessly!
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