blog

How To Export Pharmaceutical Products From India? 2024 Guide

June 8, 2024

Exporting pharmaceutical products from India to the international market, especially to the USA, involves navigating a complex web of regulatory requirements and ensuring stringent quality standards. As a leading exporter, India has established itself as a global pharmaceutical hub, supplying medicines to regions including North America, Europe, Africa, and beyond.

However, entering markets like the USA requires adherence to specific compliance measures such as the Importer Security Filing (ISF) and the Automated Manifest System (AMS).

To streamline this intricate process, Artemus offers specialized ISF and AMS software support, ensuring your pharmaceutical exports meet all USA compliance requirements seamlessly.

Table Of Contents

1 How To Export Pharmaceutical Products From India? The Process
2 Why India’s Role Is Important In The Global Pharmaceutical Industry
3 Understanding The Regulatory Environment
4 Documents Required For Export Of Medicines From India To Abroad
5 How Much Does It Cost To Export Medicines From India To USA
6 5 Most Exported Medicines From India
7 Artemus: Customs Compliance Support With ISF & AMS Software
8 FAQs
9 Conclusion

How To Export Pharmaceutical Products From India? The Process

Exporting pharmaceutical products from India involves navigating a series of regulatory, logistical, and compliance steps. Here is an in-depth guide on the process:

Step 1: Understand Regulatory Requirements

1.1. Drug Regulatory Authority

The Central Drugs Standard Control Organization (CDSCO) is the primary regulatory authority in India for pharmaceuticals. Exporters must ensure compliance with CDSCO guidelines.

1.2. Export Licensing

Pharmaceutical exporters need to obtain the following licenses and registrations:

Import-Export Code (IEC): Issued by the Directorate General of Foreign Trade (DGFT), this is mandatory for all exports.
Pharmaceutical License: Issued by the State Drug Control Organization, this ensures that the manufacturing facility complies with Good Manufacturing Practices (GMP).
Product Registration: In some cases, the product must be registered with the importing country’s regulatory authority.

Step 2: Market Research & Identifying Export Markets

2.1. Market Analysis

Conduct thorough market research to identify demand, regulatory environment, competition, and potential buyers in target markets.

2.2. Trade Agreements

Consider bilateral trade agreements and regional trade agreements which might simplify export processes and reduce tariffs.

Step 3: Documentation

3.1. Mandatory Documents

Proforma Invoice: Issued by the exporter to the importer.
Commercial Invoice: Final invoice detailing the products, quantities, and agreed prices.
Packing List: Details the contents, packaging, and specifics of each shipment.
Certificate of Analysis (CoA): Certifies the quality and purity of pharmaceutical products.
Bill of Lading/Airway Bill: Shipping document provided by the carrier.
Certificate of Origin: Issued by an authorized body, it certifies that the goods are of Indian origin.
Export License: Specific to controlled substances, if applicable.
GMP Certificate: Verifies adherence to Good Manufacturing Practices.
Health Certificate: Required by certain countries to verify that products are safe for human use.

Step 4: Manufacturing & Quality Control

4.1. Good Manufacturing Practices (GMP)

Ensure the manufacturing facility complies with GMP standards. Regular inspections and audits by regulatory bodies are crucial.

4.2. Quality Assurance

Implement stringent quality control measures. Each batch should be tested, and a Certificate of Analysis (CoA) should be issued.

Step 5: Packaging & Labeling

5.1. Compliance With Importing Country’s Regulations

Packaging and labeling must comply with the importing country’s regulations, including language requirements, expiration dates, and storage instructions.

5.2. Secure Packaging

Pharmaceutical products must be securely packaged to prevent contamination, damage, and tampering.

Step 6: Logistics & Shipping

6.1. Choosing The Mode Of Transport

Depending on the destination and urgency, choose between air freight and sea freight. Air freight is quicker, although it comes with higher costs.

6.2. Cold Chain Logistics

For temperature-sensitive products, ensure a cold chain logistics system is in place.

6.3. Freight Forwarder

Engage a reliable freight forwarder experienced in handling pharmaceutical products.

Step 7: Customs Clearance

7.1. Export Documentation

Ensure all export documents are complete and accurate to avoid delays at customs.

7.2. Customs Broker

Hiring a customs broker can facilitate smooth clearance through customs.

Step 8: Regulatory Compliance & Renewal

8.1. Regulatory Updates

Stay updated with regulatory changes in the importing countries and ensure ongoing compliance.

8.2. License Renewal

Renewing essential licenses and registrations promptly is vital to prevent any interruptions.

Why India’s Role Is Important In The Global Pharmaceutical Industry

India plays a crucial role in the global pharmaceutical industry, significantly impacting medicine availability worldwide. India exports pharmaceuticals to diverse regions, including the Middle East, Asia, Latin America, North America, Africa, and Europe. Notably, Africa, Europe, and North America receive nearly two-thirds of India’s pharmaceutical exports.

In 2021–22, major export destinations included the USA, the UK, South Africa, Russia, and Nigeria, with the USA leading with imports worth over $7 billion.

India’s pharmaceutical exports have shown consistent growth, especially to the USA, UK, and Russia, with compound annual growth rates (CAGR) of 6.9%, 3.8%, and 7.2%, respectively, over the past three years.

These figures highlight India’s pivotal role in ensuring global medicine supply, making it an indispensable player in the worldwide pharmaceutical landscape.

Understanding The Regulatory Environment

Understanding the regulatory environment for exporting pharmaceutical products from India is crucial for ensuring compliance and successful market entry. The Central Drugs Standard Control Organization (CDSCO) serves as the main regulatory body responsible for supervising the production, distribution, and export of pharmaceuticals in India.

Exporters must adhere to stringent guidelines set by the CDSCO, including obtaining necessary licenses such as the Import-Export Code (IEC) from the Directorate General of Foreign Trade (DGFT) and ensuring the manufacturing facility complies with Good Manufacturing Practices (GMP).

Additionally, the products must be registered with regulatory authorities in the importing countries, such as the US Food and Drug Administration (FDA) for the American market, which requires adherence to their specific standards and approval processes like the Drug Master File (DMF) and Abbreviated New Drug Application (ANDA).

Navigating this regulatory landscape involves meticulous documentation, rigorous quality control, and adherence to both Indian and international standards. Exporters need to stay informed about regulatory updates and maintain continuous compliance to avoid disruptions.

Documents Required For Export Of Medicines From India To Abroad

Exporting pharmaceuticals from India necessitates a comprehensive set of documents to ensure compliance with both Indian and international regulations. These documents verify the legitimacy of the exporter, the quality and safety of the pharmaceutical products, and adherence to regulatory requirements in the importing country.

Here is a detailed list of the necessary documents:

1. Company Documents

Company PAN Number: The Permanent Account Number (PAN) issued by the Income Tax Department of India is required to identify the exporting entity.
Incorporation Certificate: Issued by the Registrar of Companies, this certificate verifies the legal existence of the exporting company.
Bank Account Statements and Other Financial Documents: These documents establish the financial credibility and operational history of the company.

2. Regulatory & Compliance Documents

Import-Export Code (IEC) Number: This unique code, issued by the Directorate General of Foreign Trade (DGFT), is mandatory for any export activity.
Indian Trade Classification (HS) of the Product: The Harmonized System (HS) code for the specific pharmaceutical product being exported.
Bankers Certificate and Other Customs Documents: Certificates issued by the bank verifying the financial standing of the exporter, along with other necessary customs documentation.
Canceled Cheque: A canceled cheque from the company’s bank account is often required to verify bank details.
Proof of Ownership of Business Premises or Rental Agreement: Documents proving ownership or rental agreements for the premises where the business operates.

3. Quality & Safety Compliance

WHO: GMP Certification: Good Manufacturing Practice (GMP) certification issued by the World Health Organization (WHO) or equivalent authorities confirms that the products are manufactured under appropriate quality standards.

4. Product-Specific Information

Product Details: Comprehensive information about the pharmaceutical product, including its uses and benefits.
Approved Generic Names: The generic names of the active pharmaceutical ingredients (APIs) in the product.
Strength Per Dosage: The concentration of the active ingredients in each dosage.
Dosage Form: The form in which the drug is administered (e.g., tablet, capsule, injection).
Details Regarding Packaging: Information about the packaging materials and methods used to ensure product safety and integrity during transit.
List Of All Active Pharmaceutical Ingredients with Their Properties: Detailed chemical and pharmacological properties of each API.
Visual Description: A description of the physical appearance of the product, including color, shape, and markings.
List Of Countries Where The Product Has Been Approved, Rejected, and Withdrawn: A record of the product’s regulatory status in different countries, providing insights into its international acceptance and regulatory history.
Sites of Manufacture and Method of Synthesis: Information about the manufacturing sites and the synthesis methods used in the production of the pharmaceutical product.
Stability Testing: Data from stability tests demonstrating the product’s shelf life and conditions under which it remains stable.
Efficacy and Safety: Clinical trial results and other evidence supporting the product’s efficacy and safety.

How Much Does It Cost To Export Medicines From India To USA

Exporting medicines from India to the USA involves various costs that can vary widely based on factors such as the type of pharmaceutical product, volume of shipment, regulatory compliance, logistics, and market entry strategies. Here are the main cost components with approximate figures in US dollars:

1. Regulatory & Compliance Costs

Import-Export Code (IEC): The cost to obtain an IEC from the Directorate General of Foreign Trade (DGFT) is around $30-$50.
FDA Registration and Listing Fees: Registering an establishment with the US FDA and listing products can cost between $5,000 and $10,000 annually.
Drug Master File (DMF) and Abbreviated New Drug Application (ANDA) Fees: Submitting a DMF and obtaining an ANDA approval can cost anywhere from $150,000 to $300,000, depending on the complexity of the drug.
Good Manufacturing Practice (GMP) Compliance: Ensuring GMP compliance might involve costs ranging from $20,000 to $100,000 for facility upgrades, audits, and certifications.

2. Documentation & Legal Costs

Legal and Consultancy Fees: Hiring consultants and legal advisors to navigate the regulatory environment can cost between $10,000 and $50,000.
Documentation and Translation Costs: Preparing and translating necessary documents can cost around $1,000 to $5,000.

3. Manufacturing & Quality Control Costs

Batch Testing and Quality Assurance: Costs for testing each batch of pharmaceuticals and maintaining quality assurance standards can range from $5,000 to $20,000 per batch.
Stability Testing: Conducting stability tests can cost between $10,000 and $50,000, depending on the duration and complexity.

4. Packaging & Labeling Costs

Packaging Materials: High-quality packaging materials for pharmaceuticals can cost between $0.50 and $2.00 per unit, depending on the type of packaging.
Labeling Compliance: Ensuring labeling meets FDA requirements might cost around $2,000 to $10,000.

5. Logistics & Shipping Costs

Freight Costs: Air freight costs approximately $3 to $6 per kilogram, while sea freight is cheaper but slower, costing around $1,500 to $5,000 per container.
Cold Chain Logistics: For temperature-sensitive products, cold chain logistics can add $1,000 to $5,000 per shipment.
Insurance: Cargo insurance typically costs 0.5% to 1% of the shipment value.

6. Customs & Import Duties

US Customs Duties and Taxes: These can vary but generally range from 0% to 6.5% of the product value, depending on the classification of the pharmaceutical products.

7. Marketing & Distribution Costs

Market Entry and Promotion: Initial market entry and promotional activities in the USA can cost between $50,000 and $200,000.
Distribution Network Setup: Establishing a distribution network, including partnerships with local distributors, can cost $100,000 to $500,000.

Total Estimated Costs

Summing up these various components, the total cost to export medicines from India to the USA can range widely based on the specific circumstances and scale of the operation:

Small-Scale Exporter: Approximately $200,000 to $500,000
Medium-Scale Exporter: Approximately $500,000 to $1,000,000
Large-Scale Exporter: Over $1,000,000

These figures provide a rough estimate and can vary significantly depending on the type of pharmaceutical product, the volume of exports, and specific business strategies.

5 Most Exported Medicines From India

India ranks among the largest producers and exporters of pharmaceuticals globally. The country’s pharmaceutical industry has been growing rapidly over the years, driven by the increasing demand for medicines globally. Here are the 5 most exported medicines from India:

1. Anti-Infectives

Anti-infectives are the most exported medicines from India, accounting for a significant share of the country’s pharmaceutical exports. These medicines are used to treat various infections such as bacterial, viral, and fungal infections. India’s anti-infective exports include antibiotics, antiviral drugs, and antifungal medications.

2. Cardiovascular Medicines

Cardiovascular medicines are another significant export from India. These medicines are used to treat various heart-related conditions such as high blood pressure, high cholesterol, and heart failure. India’s cardiovascular medicine exports include beta-blockers, calcium channel blockers, and statins.

3. Gastrointestinal Medicines

Gastrointestinal medicines are used to treat various stomach-related conditions such as indigestion, constipation, and diarrhea. India’s gastrointestinal medicine exports include antacids, anti-diarrheal drugs, and laxatives.

4. Central Nervous System Medicines

Central nervous system medicines are used to treat various conditions such as depression, anxiety, and insomnia. India’s central nervous system medicine exports include antidepressants, anxiolytics, and sedatives.

5. Anti-Cancer Medicines

Anti-cancer medicines are used to treat various types of cancer. India’s anti-cancer medicine exports include chemotherapy drugs, targeted therapy drugs, and immunotherapy drugs.

Artemus: Customs Compliance Support With ISF & AMS Software

how to export pharmaceutical products from india

Artemus Transportation Solutions provides comprehensive customs compliance support through its software solutions, addressing the requirements of the Importer Security File (ISF) and Automated Manifest System (AMS).

With extensive experience in customs compliance and logistics, Artemus helps clients navigate the complex landscape of international shipping, ensuring seamless compliance with U.S. customs regulations.

FAQs

1. How Can I Start Exporting From India?

To start exporting from India, obtain an Importer Exporter Code (IEC) from the Directorate General of Foreign Trade (DGFT), identify your target markets, comply with export regulations, and establish a logistics and payment process.

2. How To Get A Drug License For Export?

To get a drug license for export in India, apply to the Central Drugs Standard Control Organization (CDSCO) with the required documentation, including manufacturing licenses, product details, and compliance certificates.

3. How To Find Buyers For Export?

To find buyers for export, utilize online B2B marketplaces, trade fairs, export promotion councils, and international trade directories.

Conclusion

Exporting pharmaceutical products from India is vital for both the economy and global healthcare. As a major supplier of affordable generic drugs, India ensures access to essential medications worldwide, particularly in developing countries.

This process, involving regulatory compliance and quality assurance, not only boosts India’s economic growth but also improves global health outcomes.