How to get a CDSCO Market Standing Certificate

Introduction

The Central Drugs Standard Control Organisation (CDSCO) serves as India’s apex regulatory authority for pharmaceuticals, medical devices, cosmetics, and clinical trials. Operating within this highly regulated sector requires companies to consistently demonstrate reliability, compliance, and long-term business stability in order to build trust with regulators, partners, and stakeholders.

• One of the key documents that reflects these attributes is the Market Standing Certificate (MSC). Issued through the regulatory framework, the MSC acts as an official confirmation of a company’s operational track record, market presence, and adherence to statutory obligations under the Drugs & Cosmetics Act and Rules.
• For organizations seeking to expand their presence—whether by participating in government tenders, applying for product registrations, or pursuing international regulatory approvals—the MSC is often a mandatory prerequisite. It serves not only as proof of compliance but also as a mark of trustworthiness in a competitive market.
• As a consulting partner, we assist businesses in navigating the complexities of the MSC application process, ensuring that all documentation, regulatory interactions, and procedural requirements are handled with efficiency, authenticity, and professionalism. By leveraging our expertise, companies can secure the MSC seamlessly and strengthen their reputation in both domestic and international markets.

What is a Market Standing Certificate?

A Market Standing Certificate (MSC), issued under the authority of the Central Drugs Standard Control Organisation (CDSCO) in coordination with the respective State Licensing Authority (SLA), is an official regulatory document that validates a company’s established presence and reliability in the Indian pharmaceutical or medical device market.
This certificate goes beyond being a mere formality—it serves as documented evidence of a company’s operational history, regulatory compliance, and business stability. By obtaining an MSC, an organization demonstrates that:

• It is a licensed and recognized manufacturer or marketer, duly approved by the CDSCO and/or the State Licensing Authority.
• It has been actively engaged in the pharmaceutical or medical device sector for a specified and verifiable duration.
• It has consistently adhered to the provisions of the Drugs & Cosmetics Act, 1940, and the Rules, 1945, thereby maintaining regulatory compliance.
• It enjoys a trustworthy and reliable standing in the Indian market, making it eligible for participation in tenders, product registrations, and international collaborations.

When is a Market Standing Certificate Required?

A Market Standing Certificate (MSC) is not merely a regulatory formality—it becomes a critical requirement in several business and compliance scenarios within the pharmaceutical and medical device industry. Key instances where companies are expected to furnish an MSC include:

• Drug or Medical Device Registration – During applications for new product approvals or import registrations, regulatory authorities generally required in request an MSC to confirm that the applicant has an established operational history and regulatory compliance.
• Tender Participation – Government departments, procurement agencies, and private institutions often mandate an MSC to ensure that only companies with proven reliability and a sustained market presence are eligible to bid.
• International Approvals and Export Licensing – Global regulatory agencies and trade partners may require an MSC when assessing Indian exporters, as it serves as proof of consistent compliance with CDSCO norms and credibility in the domestic market.
• Business Expansion and Strategic Alliances – In cases of mergers, acquisitions, technical collaborations, or joint ventures, the MSC provides assurance of a company’s market reliability, making it an important document for building trust with prospective partners and investors.

Who Issues the Certificate?

The Market Standing Certificate is issued by the State Licensing Authority (SLA), which works in coordination with CDSCO. Applicants need to approach the relevant SLA office where the company holds its drug manufacturing or wholesale license.

Documents Required for Market Standing Certificate

While requirements vary by state, the general set of documents includes:
1.    Application Form (in prescribed format).
2.    Copy of valid Drug Manufacturing License / Wholesale License.
3.    List of approved products being manufactured/marketed.
4.    Details of company establishment and operations (years in business).
5.    Undertaking of compliance with Drugs & Cosmetics Act, 1940 and Rules, 1945.
6.    Fee receipt (if applicable).

Step-by-Step Process for Obtaining a Market Standing Certificate

1.    Document Compilation – Gather all required documents, such as valid manufacturing/wholesale licenses, approved product lists, and compliance records under the Drugs & Cosmetics Act and Rules.
2.    Application Filing – Submit the completed application, along with supporting documents and applicable fees, to the respective State Licensing Authority (SLA).
3.    Regulatory Review & Verification – The SLA carefully examines the application to confirm market presence, validate product approvals, and ensure regulatory compliance.
4.    Certificate Issuance – Once verification is complete, the SLA issues the Market Standing Certificate, officially recognizing the company’s operational standing and reliability in the industry.

Validity of the Certificate

The validity of an MSC is generally 1–2 years, depending on state regulations. Companies should ensure timely renewal to avoid rejection in tenders, product registrations, or other regulatory processes.

Importance of CDSCO Market Standing Certificate

A Market Standing Certificate (MSC) is a vital document for companies in the pharmaceutical and medical device sector, as it strengthens their position in both domestic and global markets. Its importance can be understood through the following aspects:

• Trust and Reliability – Serves as official recognition of the company’s established presence and trustworthy reputation in the industry.
• Regulatory Compliance – Acts as documented proof that the company consistently adheres to the standards and requirements laid down by CDSCO and the State Licensing Authorities.
• Enhanced Market Access – Essential for product registrations, tender submissions, and export approvals, enabling companies to enter new markets with confidence.
• Strategic Business Expansion – Strengthens credibility during mergers, acquisitions, collaborations, and technical tie-ups, thereby supporting sustainable growth and long-term partnerships.

Conclusion

• Securing a CDSCO Market Standing Certificate (MSC) is a strategic milestone for any company operating in India’s pharmaceutical or medical device landscape. This certificate goes beyond compliance—it validates a company’s operational history, sustained presence, and adherence to regulatory frameworks, providing tangible proof of its ability to operate responsibly and effectively in a competitive environment.
• An MSC unlocks opportunities for participating in government tenders, obtaining product registrations, and exploring international markets. It also serves as a credible reference for potential collaborators, investors, or partners assessing a company’s operational integrity and market experience.
• By partnering with experts who understand the regulatory nuances and documentation requirements, businesses can navigate the MSC application process efficiently, avoid procedural pitfalls, and secure approval without unnecessary delays.
• In a rapidly evolving industry, the Market Standing Certificate is not just a regulatory requirement—it is a strategic credential that signals operational maturity, market legitimacy, and readiness for sustainable growth.
   

For more details, please visit Metacorp