The pharmaceutical industry in India is one of the largest contributors to the global supply of medicines and pharmaceutical api (raw materials). India is known as the “pharmacy of the world,” supplying affordable and quality medicines across more than 200 countries. At the heart of this industry are pharmaceutical APIs (Active Pharmaceutical Ingredients), which form the foundation of any drug formulation.
For any pharmaceutical exporter from India, understanding the export process, the documents required, and compliance with both domestic and international regulations is crucial. In this article, we will take a detailed look at the pharmaceutical API export process and documents required, covering everything from business setup to logistics and customs clearance.
Business Registration and Licenses
The first step in becoming a pharmaceutical export company is ensuring that the business is legally registered and holds the necessary licenses.
Company Registration
The exporter must register under the Companies Act or as a partnership/LLP, depending on the business model.
Import Export Code (IEC)
Issued by the Directorate General of Foreign Trade (DGFT), the IEC is mandatory for all types of exports.
Drug License
For pharmaceutical APIs, a valid manufacturing or wholesale license is mandatory under the Drugs and Cosmetics Act.
GMP Certificate for Export
A Good Manufacturing Practices (GMP) certificate demonstrates compliance with quality standards and is often a prerequisite for entering regulated markets.
Having these licenses in place ensures the exporter is recognized as a compliant and trusted pharmaceutical supplier from India.
Product-Specific Compliance
Pharmaceutical APIs are subject to strict regulatory oversight worldwide. Before exporting, the exporter must ensure compliance with product-specific guidelines.
Drug Master File (DMF)
Many importing countries require a DMF submission to assess the safety and efficacy of an API.
Certificate of Analysis (CoA)
Every batch of API must be accompanied by a CoA to prove quality, potency, and purity.
Stability Data & Impurity Profile
For regulated markets, detailed stability studies and impurity profiles are necessary to demonstrate consistency.
Without these documents, it is difficult for a pharmaceutical API supplier to gain market acceptance.
Market Research and Partnerships
Understanding the target market is critical before initiating exports. This includes:
Identifying demand trends: Certain APIs are more in demand in specific countries depending on therapeutic needs.
Finding reliable partners: Collaborating with local distributors, medicine import export companies, or agents helps in smooth market entry.
Understanding local regulations: Each country has unique requirements. For example, Latin American countries may ask for product registration certificates, while European nations might need EU-GMP approval.
Exporters often rely on guidance from bodies like the Pharma Export Promotion Council of India (Pharmexcil), which provides valuable support in understanding regulatory frameworks and market opportunities.
Order Processing and Documentation
Once a buyer is identified and the purchase order is finalized, the export process begins. This stage involves:
- Confirmation of the purchase order with detailed product specifications.
- Preparation of pro forma invoice and commercial invoice.
- Ensuring the availability of all regulatory and product-specific documents.
- Quality check and batch release of the API.
Proper documentation at this stage avoids delays during shipment and customs clearance.
Documents Needed for Pharmaceutical Exports
Documentation is one of the most critical aspects of the pharmaceutical API export process. Missing paperwork can lead to shipment rejections, fines, or legal action. Let’s break down the categories:
1. Company and General Export Documents
- Import Export Code (IEC)
- Drug License
- Company Registration Certificate
- GST Registration Certificate
- GMP Certificate for Export
- Certificate of Pharmaceutical Product (COPP)
2. Product-Specific Documents
- Certificate of Analysis (CoA)
- Drug Master File (if required)
- Stability Studies
- Impurity Profile
- Manufacturing License copy
- Free Sale Certificate (for some markets)
3. Shipment Documents
- Commercial Invoice
- Packing List
- Bill of Lading / Airway Bill
- Insurance Certificate
- Certificate of Origin (issued by Chamber of Commerce)
4. Destination Country Requirements
- Country-specific registrations or approvals
- Local health authority clearance (e.g., FDA for USA, EMA for Europe)
5. NOC from Drug Controller
In India, an NOC (No Objection Certificate) from the Drug Controller is required for the export of certain restricted pharmaceutical APIs. This ensures that domestic demand is not compromised while fulfilling export obligations.
Maintaining a checklist of these documents required for pharma exports is essential for smooth operations.
Logistics and Customs Clearance
Pharmaceutical APIs are sensitive products that often require temperature-controlled logistics and specialized handling.
- Logistics Selection: Choose logistics providers experienced in handling pharmaceutical shipments. Cold-chain management is crucial for temperature-sensitive products.
- Customs Clearance: Accurate declaration of goods, HS codes, and proper documentation is vital. Customs authorities scrutinize pharma exports closely to prevent misuse.
- Insurance: Comprehensive insurance coverage ensures protection against loss or damage during transit.
This step is where coordination between the pharmaceutical export company, freight forwarder, and customs agents becomes most important.
Step-by-Step Guide to Export Pharmaceutical Products from India
Here’s a simplified step-by-step process for exporting APIs from India:
- Register business and obtain IEC & licenses.
- Identify target markets through research and Pharmexcil support.
- Ensure product-specific compliance (DMF, CoA, GMP certificate).
- Finalize buyers and sign agreements.
- Prepare pre-shipment documents such as invoices, CoA, and stability data.
- Apply for NOC from the Drug Controller, if applicable.
- Arrange logistics and insurance.
- File shipping bill with customs and complete clearance procedures.
- Dispatch shipment via sea or air.
- Post-shipment documentation (e.g., Bill of Lading) shared with the buyer for customs clearance at the destination.
Following this structured process minimizes risks and ensures compliance.
India Pharmaceutical Export Trends – Key Statistics and Insights
India plays a leading role in global pharma exports, particularly in the API segment. Some key insights:
- India ranks 3rd globally in terms of pharmaceutical production by volume.
- In FY 2024, Indian pharma exports crossed USD 27 billion, with APIs contributing a significant share.
- The USA, Europe, and Africa remain the top export destinations, while Latin America and Southeast Asia are emerging markets.
- Demand for APIs related to chronic diseases (like diabetes, cardiovascular, and CNS disorders) is rising globally.
Support from the Indian government, including the Production Linked Incentive (PLI) scheme and Pharmexcil, has strengthened India’s position as a pharmaceutical outsourcing company and a reliable pharmaceutical supplier from India.
Why Documentation and Compliance Matter
Pharmaceutical exports are highly regulated to ensure safety, quality, and ethical trade. Incorrect documentation or non-compliance not only causes shipment delays but can also damage credibility. For a pharmaceutical API supplier, strong documentation practices build trust and long-term partnerships.
The pharmaceutical API export process is complex but rewarding for companies that follow compliance, maintain quality standards, and build strong international partnerships. From business registration and licenses to logistics and customs clearance, every stage requires attention to detail. Ensuring that all documents required for pharma exports are in place helps avoid setbacks and builds a reputation for reliability.
India’s pharmaceutical industry continues to thrive, and with its strong regulatory framework, skilled workforce, and cost advantage, Indian exporters are well-positioned to dominate global markets. Whether you are a growing pharmaceutical export company or an established pharmaceutical outsourcing company, understanding the export process is key to expanding globally.
