What is a CDSCO Market Standing Certificate (MSC)?

A Market Standing Certificate (MSC)

Issued by the Central Drugs Standard Control Organization (CDSCO) is an authorized document that verifies the following:

• The manufacturing facility possesses a current and valid drug/manufacturing license within India
• The listed product(s) have received approval and authorization for manufacture and sale
• The product is actively available in the Indian market
• No negative regulatory actions (such as suspension or cancellation) have been recorded against the product or company (based on available records)

It is frequently required for:

• Registration of pharmaceutical products for export
• Authorization for marketing in international markets
• Product licensing in foreign regulatory jurisdictions
• International government procurement and tenders

This certificate is distinct from:

• Free Sale Certificate (FSC) – validates that a product is freely available for commercial sale
• Non-Conviction Certificate (NCC) – confirms the absence of any conviction under the Drugs & Cosmetics Act

The MSC specifically addresses the regulatory standing and market presence of the product or company.

Who Can Apply?

• Licensed drug manufacturers
• Holders of loan licenses
• Manufacturers of medical devices
• Exporters authorized by the original manufacturer

Procedure to Obtain a CDSCO Market Standing Certificate

While the process may differ slightly across zonal offices, the general steps are as follows:

Step 1: Confirm Eligibility

The applicant must have:

• A current and valid Manufacturing License
• An active product approval on record
• No existing suspension or cancellation orders
• Proof that the product is actively sold within India

Step 2: Gather Required Documents

Standard documentation typically includes:

1. A formal application letter directed to the relevant CDSCO Zonal Office
2. A copy of the valid manufacturing license
3. Documentation confirming product permission
4. A comprehensive list of products for which the MSC is being requested
5. A signed declaration confirming that the products are currently marketed in India
6. A non-conviction declaration
7. A copy of the export order (where applicable)
8. Evidence of fee payment (if required)

Additional documents that may be requested:

• Recent sales invoices reflecting domestic transactions
• A copy of the GMP certificate

Step 3: Submit the Application

Applications should be submitted to:

• The relevant CDSCO Zonal Office with jurisdiction over the manufacturing location. OR
• Via the CDSCO SUGAM online portal (where applicable)
  

Step 4: Regulatory Review

During this stage, CDSCO may:

• Confirm the validity of the manufacturing license
• Assess the applicant’s regulatory compliance history
• Request an evaluation report from the State Drug Control Authority

Step 5: Issuance of the MSC

Upon successful verification:

• The MSC is issued on official CDSCO letterhead
• It includes the product name(s), license number, and manufacturing site details
• It may be addressed to a particular foreign regulatory body upon request

Processing Time: Generally ranges from 10 to 30 working days, subject to the respective zonal office.

Key Considerations

• Certain importing countries may require country-specific language or wording in the certificate.
• Apostille or embassy attestation may be necessary depending on the destination country.
• An MSC is generally valid for one year from the date of issuance, or until the expiry of the manufacturing/import license — whichever comes first. It serves as confirmation that a manufacturer maintains a compliant and established operational track record, and is commonly required for tenders, export processes, or regulatory filings.
• Fees and document requirements may vary across different CDSCO zonal offices.