What is a Free Sale Certificate?
A Free Sale Certificate (FSC), also known as a Certificate of Free Sale, is an official document issued by the Central Drugs Standard Control Organization (CDSCO) or the respective State Drug Licensing Authority in India. It confirms that a particular pharmaceutical or medical product is freely sold or distributed in India, and is approved for domestic use as per Indian drug laws.
The FSC is a prerequisite for registering Indian-manufactured drugs, cosmetics, or medical devices in foreign countries. It assures foreign regulators that the product is of acceptable quality and safety standards and is legally sold in India without any restrictions.
Why is a Free Sale Certificate Important?
An FSC serves as a global passport for your pharmaceutical products. Many countries – especially in Africa, Latin America, Southeast Asia, the Middle East, and Eastern Europe – require an FSC during:
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Product registration or licensing
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Import clearance by local authorities
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Tender participation in government contracts
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Launching new products in global markets
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Renewal of marketing authorizations abroad
In simple terms, without an FSC, many countries will not even consider your pharmaceutical product for import or approval.
Types of Products Requiring FSC
Biomaxgen helps businesses obtain FSCs for the following product categories:
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Finished pharmaceutical formulations (oral, injectable, topical)
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Active Pharmaceutical Ingredients (APIs)
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Medical devices
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Cosmetics and personal care products
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Ayurvedic and herbal products (depending on local authority requirements)
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Veterinary medicines
Whether you are exporting tablets, syrups, injectables, APIs, or any other drug-related product, having a Free Sale Certificate is crucial for regulatory clearance.
Who Needs an FSC?
You should apply for a Free Sale Certificate if:
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You are a pharmaceutical manufacturer planning to export your products
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You are an exporter or marketing company using third-party manufacturing units
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You are a trader exporting medical devices or cosmetic products
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You are applying for product registration in another country
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You are participating in an international tender that demands proof of sale in India
Documents Required for Free Sale Certificate
To obtain an FSC from CDSCO or State FDA, the following documents are typically required:
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Application Letter from the company
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Copy of Valid Drug Manufacturing License (Form 25/28/29)
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Approved Product Permission with composition
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Certificate of Pharmaceutical Product (COPP) (if available)
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Batch Manufacturing Record (BMR) or product label/sample
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Undertaking by the manufacturer stating that the product is freely sold in India
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Marketing Authorization/Approval Letter
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Product labels and packaging artwork
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Company registration documents (PAN, GST, IEC if exporter)
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Authorization letter (if filed by an agent or consultant)
Please note that the list may vary depending on the state or product category.
Biomaxgen’s FSC Consultancy Services
At Biomaxgen, we offer end-to-end support for obtaining Free Sale Certificates from the appropriate regulatory bodies. We help both small and large-scale pharmaceutical companies through the complex regulatory process and ensure timely approvals.
1. Eligibility Assessment
We begin with a free consultation to determine your eligibility for FSC based on your product type, existing licenses, and target export countries.
2. Document Preparation
We assist in preparing and organizing all documents required for the FSC application, including drafting undertakings, formatting product labels, and compiling compliance evidence.
3. Coordination with CDSCO/State FDA
Our team submits your application to the correct authority and follows up regularly to ensure smooth and quick processing.
4. Query Resolution
In case of any objections, deficiencies, or queries raised by the authorities, we prepare the appropriate responses and clarifications.
5. Certificate Issuance
Once approved, the Free Sale Certificate is issued to the applicant. We help in securing both physical and digital formats as per the requirement of the importing country.
Why Choose Biomaxgen?
Choosing Biomaxgen means working with an experienced regulatory partner that ensures accuracy, compliance, and speed. Here’s why our clients trust us:
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✅ Specialized in pharma export documentation
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✅ 100% compliance with CDSCO guidelines
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✅ Support for multiple states and jurisdictions in India
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✅ Tailored solutions for manufacturers, exporters, and traders
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✅ Fast turnaround time
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✅ Affordable pricing for startups and growing businesses
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✅ Transparency and confidentiality assured
Whether you are exporting to Africa, ASEAN countries, Europe, or Latin America, we ensure your Free Sale Certificate meets all destination country requirements.
Free Sale Certificate Issuing Authorities
In India, the following agencies issue FSCs depending on the product type:
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CDSCO (Central Drugs Standard Control Organization) – For regulated drugs, vaccines, and certain APIs.
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State FDA (Food & Drug Administration) – For non-scheduled drugs, cosmetics, and formulations.
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Department of AYUSH – For ayurvedic and herbal products.
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Export Promotion Councils (in some cases) – For trade-specific FSCs or where required by importing authorities.
At Biomaxgen, we determine the correct authority based on your product classification and streamline the application process accordingly.