At Biomaxgen, we specialize in providing regulatory and compliance consultancy services to the pharmaceutical industry in India. Among our core offerings is our expert assistance in obtaining the CDSCO Performance Certificate for Drugs, a critical document required by Indian pharmaceutical exporters when registering their products in foreign markets. With our deep understanding of Indian drug regulations and export documentation, we ensure a seamless and timely experience for companies looking to expand globally.
What is a CDSCO Performance Certificate?
A CDSCO Performance Certificate is an official document issued by the Central Drugs Standard Control Organization (CDSCO) under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. This certificate affirms that a pharmaceutical product is being manufactured and sold in India in compliance with the Drugs and Cosmetics Act and Rules, and that the applicant company has a consistent and approved track record of performance in the production and supply of quality drugs.
It is often demanded by foreign drug regulatory authorities or tendering agencies to evaluate the credibility, compliance, and operational capacity of the exporting company.
Purpose of the CDSCO Performance Certificate
The primary objective of the CDSCO Performance Certificate is to provide evidence to foreign governments, public procurement agencies, or health ministries that the exporter or manufacturer:
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Has been manufacturing the product(s) under valid licenses
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Has a history of satisfactory performance and no violations
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Is compliant with Indian regulatory norms
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Has successfully supplied pharmaceutical products either in the domestic or international market
This certificate may also be referred to as a Performance Statement, Supplier Performance Certificate, or Capacity Certificate depending on the importing country’s terminology.
Who Needs the Performance Certificate?
The CDSCO Performance Certificate is typically required by:
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Pharmaceutical manufacturers exporting products to regulated or semi-regulated markets
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Third-party exporters applying for tenders or product registrations abroad
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Marketing authorization holders dealing in generic formulations or APIs
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Companies participating in WHO tenders, government procurement contracts, or UN/NGO supply chains
It is particularly crucial when:
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Registering a product in countries like Tanzania, Kenya, Uganda, Zambia, Nigeria, Ethiopia, and several Latin American and CIS countries
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Participating in international bids or tenders
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Applying for a Certificate of Pharmaceutical Product (CoPP)
Common Uses of CDSCO Performance Certificates
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Drug registration in foreign countries
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Tender submission to Ministries of Health or government procurement agencies
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Prequalification dossiers for organizations like WHO, UNICEF, MSF, or UNDP
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As part of the Regulatory Dossier during product evaluation
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Validation of past performance for large-scale supply contracts
Documents Required to Apply for a CDSCO Performance Certificate
At Biomaxgen, we guide you through the correct and complete document checklist. Typically, the following documents are required:
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Application Letter on the company’s letterhead
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Copy of valid Drug Manufacturing License (Form 25, 28, etc.)
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Approved Product Permission with composition
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Purchase Orders or Invoices showing past sales (preferably international)
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Batch Release Certificates or QA reports (if applicable)
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Details of regulatory approvals from other countries (if available)
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Undertaking by the manufacturer regarding product compliance
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Product packaging/label samples
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PAN, GST, IEC certificate of the company
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Authorization Letter (if submitted by an agent or consultant)
Note: The final list may vary based on the specific CDSCO zonal office handling your application.
Our CDSCO Performance Certificate Services at Biomaxgen
We provide end-to-end assistance in obtaining the CDSCO Performance Certificate, whether you are a manufacturer or an exporter. Our process includes the following key stages:
1. Eligibility Review
We assess whether your business and product qualify for the CDSCO Performance Certificate. This includes evaluating your manufacturing licenses, product approvals, and sales history.
2. Document Compilation
We help you gather and prepare the required documents in the appropriate format, including drafting the application letter, undertaking, and necessary compliance statements.
3. Application Submission
Biomaxgen submits your application to the appropriate CDSCO Zonal Office (North, South, East, or West) and ensures all information is accurate and complete.
4. Liaising with CDSCO Officials
We handle all communications, respond to queries, and follow up with CDSCO officers on your behalf to avoid delays or rejections.
5. Certificate Issuance
Once approved, we help you obtain a digitally signed or physically stamped certificate, ready to be submitted to foreign authorities.
Why Choose Biomaxgen?
At Biomaxgen, we are committed to regulatory excellence and customer success. Here’s why top pharmaceutical companies and exporters choose us:
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✅ Decades of cumulative pharma regulatory expertise
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✅ Experienced in CDSCO and international export documentation
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✅ Fast, efficient, and transparent service
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✅ Coverage across all Indian CDSCO zonal offices
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✅ Support for third-party manufacturers and exporters
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✅ Affordable consultancy packages for startups and MSMEs
Our team ensures compliance with all relevant norms and accelerates your time to global market entry.
Timelines and Validity
Processing Time:
The average processing time for the CDSCO Performance Certificate is 15–30 working days, depending on your zone and the completeness of your documents.
Validity:
Typically, the certificate is valid for one year, but may vary depending on the importing country’s requirements.