CDSCO Market Standing Certificate: Everything You Need to Know

Written by Sudhriti M

19 June 2024

Companies secure a market standing certificate to demonstrate the potential of their business. The CDSCO issues the market standing certificate for pharmaceutical and medical device companies. Read on to find out more about the CDSCO market standing certificate, its implications, and application process.

What is a market standing certificate?

Market standing certificate (MSC) is a document that demonstrates the certified company has a proven track record of business performance. It is issued by the government authority or other authorized bodies to certify the company has a good reputation. This document is usually required for acquiring bank loans and tenders or contracts. This document proves the creditworthiness of the company. The Central Drugs Standards Control Organization (CDSCO) is the apex regulatory body for drugs, medical devices, and cosmetics in India. CDSCO market standing certificate is issued to certify the good reputation of a pharmaceutical or medical device company.

The purpose of a CDSCO market standing certificate:

  • A CDSCO market standing certificate proves the company has a valid CDSCO manufacturing license. This also certifies the fact that the company has been actively manufacturing and selling products in the Indian market.
  • This certificate is usually required by foreign regulatory bodies for registering your product in foreign countries.

Market standing certificates types

Two types of market standing certificate are issued.

  1. Domestic market standing certificate: This certificate is issued to the companies that operate in India or within the jurisdiction of the region where the certificate is issued.
  2. International market standing certificate: This certificate is issued to those companies that operate in multiple countries or jurisdictions.

Benefits of CDSCO market standing certificate

A CDSCO market standing certificate has multiple benefits for business or companies.

  • Increased business opportunities: To participate in certain government and public sector tender and contract bids, an MSC is mandatorily required. An MSC makes it easier to secure loans from banks.
  • Competitive edge: An MSC certified company has a competitive edge over non-certified companies when acquiring business opportunities.
  • Improved company credibility and reputation: The market standing certificate demonstrates the company’s good business status and reputation in the industry. This certificate enhances the company’s credibility and reputation among suppliers, investors, and customers. It is a validation of the company’s financial stability and business performance.

Eligibility for obtaining the CDSCO market standing certificate:

  • A valid CDSCO manufacturing license issued by the Central Licensing Authority (CLA) or State Licensing Authority (SLA) is required.
  • The company must be actively manufacturing and selling the specific product in the Indian market for which it has applied for the MSC.

Validity of the MSC

The market standing certificate is valid for 1 year from the date of issuance or till the validity of the manufacturing license, whichever is earlier.

Issuing authority for the CDSCO market standing certificate

The authority (CLA or SLA) that had issued the CDSCO manufacturing license will issue the CDSCO MSC.

Supporting documents required for market standing certificate application

  • A cover letter clearly stating the reason for the market standing certificate application.  The list of documents submitted, which should be indexed with page numbers. Also, any other important and relevant information may be highlighted in the letter. The authorized signatory should duly sign and stamp the cover letter. Additionally, the name and designation of the authorized signatory and the name and address of the firm should be stated. The cover letter should clearly mention the intent of this application.
  • A valid copy of the CDSCO manufacturing license to manufacture or import license. Also, the approved product list issued by the CLA.
  • The company must sign a legal declaration on a 100 Rupee registered notarized stamp. The legal declaration should be stating that no legal action has been taken against the company. Also, it should state that the company has not been found guilty of market complaints, not of standard quality reports, and adverse events.
  • List of products for which the CDSCO market standing certificate is being applied.
  • Bills of entry and import information (if applicable) for the past three years for the products for which the MSC is being applied.

Some additional documents that maybe required are financial statements, business licenses, tax returns, and customer and supplier reference letters. Some other regulatory approval documents and other supporting documentation may be required.

All documents have to be complete and accurate and should be certified. The documents should be written in the official language of the issuing authority. The documents should be arranged in a logical order so that it is easy to refer to. For the complete list of documents and document preparation support, contact us.

How to obtain the CDSCO market standing certificate?

An application has to be made to the Central Licensing Authority by the company holding a valid license to manufacture the concerned product for sale or distribution.

  1. Fill up the relevant application form.
  2. Prepare and submit the necessary supporting documents. The required documents have been previously detailed.
  3. The required application fee has to be paid.
  4. The regulatory authority will review the application and verify the information provided in the supporting documents.
  5. Once the concerned authority is satisfied, the regulatory body will issue the CDSCO market standing certificate to the company.

We have provided an overview of the CDSCO market standing certificate application process steps.

Detailed checklist for pharma companies to secure a market standing certificate in India

We have curated this checklist for the market standing certificate application in India.

  • Covering letter indicating the purpose of market standing certificate application
  • List of products for which the CDSCO market standing certificate is being applied for
  • Copy of product approval for applied drugs
  • Copy of manufacturing licence in form 25 or 28, as applicable
  • Certificate issued by charted accountant certifying the production and sales activity for the stipulated period
  • Legal form
  • Invoices for the applicable products
  • Format of certificate in tender form
  • Government fee challan for the application

How can Pharmadocx Consultants help you secure the market standing certificate in India?

Armed with more than 27 years of experience and having served over 600 clients, we have in depth knowledge of the CDSCO regulatory requirements. We have helped set up more than 250 manufacturing facilities and plants. Our team of experts has helped with over 200 drug license application. We have simplified the CDSCO regulatory journey for all our clients. Our service ranges from licensing and certification to documentation and plant designing. We at Pharmadocx Consultants provide an all-encompassing service for CDSCO regulatory compliance in India.

To prove the good status and reputation of your company, you will need a market standing certificate. This certification demonstrates a proven a track record of business performance. However, the application process is not simple. Proper knowledge of the application process and correct preparation of supporting documents are required. Navigating through this process maybe difficult. However, you need not worry. CDSCO market standing certificate is one of our areas of expertise. Pharmadocx Consultants will be your trusted ally throughout the application process. We will simplify the application process by guiding and mentoring you. Our team of experts will prepare the documents so that the certificate application process will be seamless without any hiccups. Simply call/Whatsapp on 9996859227 or email at [email protected] and we will provide all the assistance you require.

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