How to Export Medicine from India in 2025 with Pharmexcil Registration

To export medicine from India in 2025 every pharmaceutical exporter must first register with Pharmexcil the official body that supports India’s pharmaceutical export sector. But Pharmexcil registration is just one step. You also need the right documents, licenses, and export code to send drugs or medical products to international markets.

This blog simplifies the full process—from getting Pharmexcil registration to understanding the export rules, document checklist, and fees. If you're planning to grow your business beyond India, this guide will show you the complete roadmap.

Why Indian Medicines Are in High Demand

India is known as the “Pharmacy of the World”. Because it supplies affordable high-quality medicines across 200+ countries. Indian drug exporters serve bulk buyers, hospitals and government healthcare projects globally

In 2025 demand for Indian medicines is expected to rise due to:

• Expanding healthcare systems in Africa and Asia
• Europe and North America’s aging population
• Global trust in India’s low-cost, WHO-GMP-compliant medicines
• Consistent supply of generics and vaccines

To enter this global market exporters need legal clearance through Pharmexcil and CDSCO

What Is Pharmexcil and Why Is It Mandatory?

Pharmexcil was set up to:

• Promote Indian pharma exporters globally
• Assist members with policy guidance
• Issue essential RCMC (Registration-Cum-Membership Certificate)
• Coordinate with Indian embassies and buyers abroad

As per government rules no pharmaceutical exporter can begin shipping without getting an RCMC from Pharmexcil

Read More Importance of CDSCO Online Registration for Pharmaceutical Companies

Step-by-Step Process to Export Medicines from India

Register Your Business with DGFT and Get IEC 

Before Pharmexcil registration you need to apply for an Import Export Code (IEC) through the DGFT (Directorate General of Foreign Trade)

You will need:

• PAN card of your company
• Business registration certificate
• Address proof
• Current account in a bank
• Digital signature certificate (DSC)

This IEC acts as your identity for all international trade transactions.

Apply for Pharmexcil RCMC

Once you get your IEC, you can apply for the RCMC on Pharmexcil’s portal. Documents required:

• IEC certificate
• Company PAN and GST
• Board resolution (for private limited firms)
• Proof of nature of business (Manufacturer / Merchant Exporter)
• Signature of authorized personnel
• Membership fee (varies with turnover)

The certificate remains valid for 5 years.

Get Drug License from CDSCO or State FDA

Depending on your product type you must get a manufacturing or wholesale drug license. You can apply either:

• Online through CDSCO SUGAM portal, or
• At your State Drug Licensing Authority

Without this license you cannot legally deal in any pharmaceutical product for export

Product Registration in Importing Country (If Required)

Some countries require product registration or market authorization before the drugs can be exported. This may involve:

• Submitting drug samples
• Product dossiers
• Clinical trial data
• Certificate of Pharmaceutical Product (CoPP)

You may need to work with agents or local drug regulators in the target country.

Comply with Packaging and Labeling Rules

India’s exporters must follow both Indian and importing country guidelines for packaging, which includes:

• Generic and brand name
• Dosage and batch number
• Manufacturing and expiry date
• Storage instructions
• Manufacturer and exporter details
• Barcode (if required)

Appoint a Freight Forwarder and Clear Customs

Once packaging is done, hire a licensed freight forwarder or CHA (Customs House Agent). The consignment for export must pass customs at the port of departure. Submit the following documents:

• Commercial invoice
• Packing list
• Shipping bill
• CoPP and test report (if needed)
• Bill of lading or airway bill

Claim Export Incentives (Optional)

Pharmaceutical exporters in India can also claim government incentives such as:

• Duty Drawback Scheme
• Remission of Duties and Taxes on Export Products
• GST refunds on zero-rated supplies

Pharmexcil also supports participation in international trade fairs, buyer-seller meets and market intelligence reports

Documents Required for Exporting Medicines from India

Below is a list of key documents:

Document	Purpose
Import Export Code (IEC)	Mandatory trade license
Pharmexcil RCMC	Industry body registration
CDSCO/State Drug License	Legal authority to deal in medicines
Commercial Invoice	Buyer-seller contract proof
Certificate of Analysis (CoA)	Product quality confirmation
Certificate of Origin (CoO)	Required for trade agreements
Packing List	Product and quantity breakdown
Shipping Bill	Export declaration
Bill of Lading / Airway Bill	Proof of shipment
CoPP or Product Dossier	Country-specific product clearance

Read More Homeopathy Registration: Retail and Wholesale Pharmacy

Estimated Costs Involved in Exporting Medicines

The cost of starting a pharma export business depends on scale, but initial fees include:

Cost Head	Estimated Range (INR)
IEC registration	₹500
Pharmexcil RCMC	₹5,000 to ₹10,000 (5 years)
CDSCO drug license	₹5,000 to ₹50,000 (varies by product)
Product dossier (per country)	₹15,000 to ₹1,00,000
Freight and logistics	₹10,000 to ₹50,000 per consignment

Agile Regulatory Helps You Export Medicines the Right Way

The pharma export process is full of approvals, paperwork, and updates. One missed step can delay your shipments or cancel your license. That’s why Agile Regulatory helps exporters like you get:

• Quick Pharmexcil RCMC
• CDSCO approvals
• Drug licensing and CoPP
• Documentation support
• End-to-end export setup

We reduce your paperwork burden and speed up your compliance. Whether you're a new exporter or a seasoned manufacturer Agile Regulatory is your trusted regulatory partner