background

Neutral Code for Pharmaceutical Drug Export Services in India


Page Image

Neutral Code for Pharmaceutical Drug Export Services in India – By Biomaxgen

At Biomaxgen, we offer comprehensive consultancy services for the pharmaceutical industry, tailored to meet the regulatory and documentation needs of manufacturers, exporters, and traders. One of our specialized services is assisting pharmaceutical exporters in obtaining a Neutral Code for Pharmaceutical Drug Export in India.

With increasing global demand for Indian pharmaceutical products, exporters face numerous compliance and documentation hurdles—especially when exporting products manufactured by third-party contract manufacturers. The Neutral Code system provides a reliable solution for this by allowing exporters to use their own name and details on export documents without revealing the manufacturer’s identity. At Biomaxgen, we help businesses understand, apply for, and maintain compliance with Neutral Code requirements, enabling seamless export operations across the globe.

What is a Neutral Code in Pharmaceutical Export?

A Neutral Code is an exporter-specific product code allotted by the Central Drugs Standard Control Organization (CDSCO) in India. It enables pharmaceutical exporters to export finished formulations or APIs using their own brand or trade name—even if the product is manufactured by a third-party contract manufacturer.

This unique code helps in maintaining confidentiality of the manufacturer’s details, which is a common business requirement in contract manufacturing or third-party pharma arrangements. By using a Neutral Code, an exporter becomes the brand owner in international markets, allowing them to control marketing, branding, and pricing strategies without exposing backend production sources.

Key Benefits of Neutral Code for Pharma Exporters

Getting a Neutral Code from CDSCO has many strategic advantages:

1. Brand Confidentiality

Exporters can maintain exclusive rights over their brand and product identity without revealing the manufacturer’s name on export-related documents like the Certificate of Pharmaceutical Product (COPP), FSC, COA, and commercial invoices.

2. Third-Party Manufacturing Enablement

Neutral Code is ideal for traders and exporters who don’t own manufacturing units but rely on contract manufacturers. It offers them full legal status for exporting goods.

3. Ease of International Registration

Most importing countries require registration documents showing a legitimate exporting entity. A Neutral Code ensures that the exporter’s name appears on key certificates and regulatory approvals.

4. Regulatory Acceptance

The CDSCO officially issues Neutral Codes after verifying the documents, ensuring full compliance and legal approval from the Indian drug regulatory authority.

5. Business Expansion

With a Neutral Code, exporters can launch multiple brands, register products in multiple countries, and work with several manufacturers while retaining a single identity for global trade.

Who Needs a Neutral Code?

You should apply for a Neutral Code if you are:

  • A pharmaceutical exporter without your own manufacturing license

  • A trader sourcing products from third-party manufacturers for global markets

  • A marketing authorization holder aiming to protect your product identity

  • An Indian pharma company seeking to expand to regulated or semi-regulated markets under your own name

  • An entrepreneur or startup entering the export business using contract manufacturing

Documents Required for Neutral Code Application

To obtain a Neutral Code from CDSCO, the following documents are generally required:

  1. Cover Letter stating purpose and product list

  2. Export Drug License from State Drug Authority

  3. Manufacturing Agreement with contract manufacturer

  4. Product Labels & Packaging Artwork (as per export requirement)

  5. Declaration of No Objection from the manufacturer

  6. Authorization Letter from the manufacturer to use their facility

  7. Form 10 (Application for Export NOC)

  8. Undertaking for Neutral Code usage

  9. Drug License copy of the manufacturer

  10. Exporter’s company profile, GST, and PAN details

Note: The exact list may vary based on state regulations or product category (Formulations, APIs, Injectables, etc.).

Biomaxgen’s Neutral Code Consultancy Services

At Biomaxgen, we simplify the complex process of obtaining a Neutral Code by offering end-to-end consultancy support, from documentation to coordination with CDSCO and State Drug Control Departments.

1. Initial Evaluation and Consultation

We assess your business model, current licenses, and product portfolio to determine eligibility and the best application strategy for Neutral Code certification.

2. Document Preparation

Our team drafts, verifies, and compiles all necessary documents including agreements, declarations, and forms. We also assist in preparing product packaging and labeling in compliance with CDSCO requirements.

3. Liaison with Drug Regulatory Authorities

We coordinate directly with the CDSCO and State Drug Control Offices on your behalf to ensure timely submission and error-free documentation.

4. Follow-Up and Clarification

In case of queries or objections from regulatory bodies, we help prepare appropriate clarifications or revised submissions to avoid unnecessary delays.

5. Post-Approval Compliance

Once the Neutral Code is granted, we continue supporting you with regulatory updates, renewal timelines, and assistance in related certifications like COPP, FSC, and WHO-GMP.

Why Choose Biomaxgen for Neutral Code Services?

With our in-depth knowledge of pharmaceutical regulations and licensing in India, Biomaxgen has successfully helped numerous pharma companies, exporters, and contract manufacturers establish their identity globally using Neutral Codes.

Here’s why businesses trust us:

  • ✅ Regulatory Expertise: Years of experience in CDSCO and international pharma documentation

  • ✅ Pan-India Network: Local presence across key pharma hubs like Gujarat, Maharashtra, Uttarakhand, Telangana, and Himachal Pradesh

  • ✅ Timely Processing: Efficient handling of documentation and regulatory coordination

  • ✅ Confidential Handling: Ensuring secure data management and business privacy

  • ✅ Affordable Solutions: Competitive pricing for startups, exporters, and medium-scale enterprises

  • ✅ Customized Approach: Each Neutral Code application is tailored to your specific product and target market

How the Neutral Code Process Works

Here is a simplified step-by-step flow of how we help you secure a Neutral Code:

  1. Client Consultation and Eligibility Review

  2. Document Drafting and Verification

  3. Manufacturer Coordination and Legal Agreements

  4. Filing of Application with CDSCO

  5. Regulatory Liaison and Updates

  6. Certificate Issuance with Neutral Code Number

  7. Support with Export Documentation (COPP, FSC, etc.)

FAQs – Neutral Code for Pharmaceutical Export

Q1: Is a Neutral Code the same as a Manufacturing License?
No, a Neutral Code is for exporters who don’t own a manufacturing facility. It allows them to export products manufactured by another party under their own trade name.

Q2: Can I apply for a Neutral Code for multiple products?
Yes, exporters can apply for a Neutral Code for multiple products, provided they have agreements in place with manufacturers for each product.

Q3: How long does it take to obtain a Neutral Code?
Typically, the approval process can take 2–4 weeks, depending on the documentation and responsiveness of regulatory authorities.

Q4: Do I need a new Neutral Code for each manufacturer?
Yes, each Neutral Code is linked to a specific exporter-manufacturer-product combination. If you work with multiple manufacturers, separate applications are required.