Biomaxgen is a leading pharmaceutical consultancy firm offering specialized services to pharmaceutical companies across India. One of our core services is assisting clients in obtaining the CDSCO Market Standing Certificate, a critical document required for regulatory submissions, product registrations, and international expansion. With our in-depth knowledge of CDSCO processes and a strong understanding of industry regulations, we help our clients simplify and accelerate their compliance journey.
What is a CDSCO Market Standing Certificate?
The Market Standing Certificate (MSC) is an official document issued by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare, Government of India. This certificate confirms that a pharmaceutical company or manufacturer has a credible and consistent presence in the Indian market for a specific period, generally more than three years.
It is often required by:
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Foreign regulatory agencies for product registration
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Import/export licensing authorities
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Government tenders and contracts
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WHO GMP, EU GMP, or other regulatory submissions
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Drug master file (DMF) submissions
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International business development and alliances
Essentially, the Market Standing Certificate acts as proof of a company’s reliability, experience, and commitment to quality pharmaceutical production in India.
Why is the Market Standing Certificate Important?
For Indian pharmaceutical manufacturers and exporters, a Market Standing Certificate offers several strategic and operational benefits:
1. International Recognition
It provides a strong endorsement of the company’s market presence and product reliability to overseas regulatory authorities. This can significantly ease the process of international product registrations, import permissions, and global marketing authorizations.
2. Evidence of Experience
The MSC serves as proof that a company has successfully manufactured and marketed a particular drug for a sustained period, usually 3 years or more. This is a standard requirement by regulatory bodies in many countries.
3. Competitive Edge in Tenders
Many government and institutional buyers—both in India and abroad—require proof of consistent product availability in the market. MSC strengthens your eligibility and credibility in such procurements.
4. Regulatory and Legal Compliance
In regulatory processes, MSC is often part of a broader dossier submission, especially for products involving export, new registrations, or renewal of existing licenses. Non-compliance or lack of this document can delay the entire process.
5. Business Expansion
Pharma companies aiming to enter new markets or introduce new products often need the Market Standing Certificate as part of their application package. It supports business growth and regulatory smoothness.
Biomaxgen’s CDSCO Market Standing Certificate Consultancy Services
At Biomaxgen, we understand how crucial this certification is for your business growth and regulatory operations. Our consultancy services are designed to provide end-to-end support for obtaining your CDSCO Market Standing Certificate quickly, accurately, and efficiently.
1. Eligibility Assessment
We start by assessing your company’s eligibility for obtaining the Market Standing Certificate. Our team evaluates the number of years your product has been in the market, sales data, drug license copies, and manufacturing records. If any gaps are found, we help in addressing them proactively.
2. Documentation Support
CDSCO requires a precise set of documents to issue the certificate. Our expert team assists in compiling, preparing, and formatting all necessary documents, including:
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Drug License Copy
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Product Permissions
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Manufacturing Site Details
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Product Sales Data
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Marketing Authorizations
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Affidavits and Declarations
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Company Profile
We ensure that your documentation is error-free, complete, and formatted in accordance with CDSCO’s submission guidelines.
3. Application Filing with CDSCO
Once all documents are in place, we handle the application filing process with CDSCO or the State Licensing Authority (SLA), depending on the jurisdiction. We maintain a direct liaison with relevant officials to ensure timely processing and quick turnaround.
4. Follow-up and Liaison
We take complete responsibility for follow-ups with CDSCO, clarifying queries, and resubmitting documents (if needed). Our strong working relationships with regulatory officers help us navigate bureaucratic procedures efficiently.
5. Final Certificate Delivery
Once approved, we deliver the original Market Standing Certificate to the client along with digital copies. We also provide additional support for attestation, notarization, or apostille if needed for foreign regulatory use.
6. Renewal and Maintenance
If your MSC is nearing expiration or you need additional certificates for new products, we offer renewal services and help maintain compliance in the long term.
Who Needs a Market Standing Certificate?
Biomaxgen’s MSC services are ideal for:
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Pharmaceutical Manufacturers: Formulation and API producers who need regulatory documents for exports.
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Exporters and Traders: Companies dealing in global pharmaceutical trade who require certification for customs or foreign buyers.
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New Product Developers: Innovators and startups planning to register drugs internationally.
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Contract Manufacturers (CMOs): Facilities that need MSCs to meet partner or principal requirements.
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Marketing Authorization Holders (MAHs): For supporting regulatory filings in various countries.
Why Choose Biomaxgen?
When it comes to regulatory services, accuracy, speed, and reliability are crucial. Biomaxgen is a trusted name in pharmaceutical consultancy for a reason.
✅ Regulatory Expertise
Our team consists of experienced regulatory consultants who have successfully handled hundreds of CDSCO submissions, including Market Standing Certificates.
✅ End-to-End Services
We don’t just offer advice—we walk with you from start to finish. From eligibility check to final certificate delivery, we manage the entire process.
✅ Time-Efficient Processes
Thanks to our deep understanding of CDSCO workflows and personal liaison with authorities, we significantly reduce application processing time.
✅ Transparent Pricing
We offer cost-effective and transparent service packages with no hidden fees. Whether you are a startup or an established company, we have a plan that suits your budget.
✅ Personalized Guidance
Every client has unique needs. We provide tailored solutions to help you meet specific regulatory goals and timelines.
The Biomaxgen Process: Simple and Streamlined
Here’s how we help you obtain your CDSCO Market Standing Certificate in five easy steps:
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Initial Consultation and Eligibility Check
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Document Collection and Preparation
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Application Filing with CDSCO or State Authority
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Regulatory Liaison and Response Handling
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Certificate Issuance and Delivery
Conclusion: Take the Right Regulatory Step with Biomaxgen
A CDSCO Market Standing Certificate is more than just a document—it is a powerful tool that validates your company's experience, enhances your credibility, and facilitates entry into regulated markets. Whether you’re looking to export, participate in government tenders, or file product registrations abroad, this certificate is essential.