What is the CDSCO Market Standing Certificate

In India, recognized medical devices are governed as drugs under the Drugs and Cosmetics Act of 1940 and its Rules from 1945. CDSCO accelerated the application process regarding the issue of market standing and non-conviction certificates for notified medical devices in India. This action is aimed at assisting Indian medical device importers or manufacturers in submitting applications for a Market Standing Certificate CDSCO of Notified Medical Devices. This would apply to the Indian importers and manufacturers of medical devices intending to obtain a Market Standing CDSCO Certificate of Notified Medical Devices and who have a current manufacturing or import license.

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The Market Standing Certificate from CDSCO is essential for demonstrating a pharmaceutical product's compliance with regulatory standards, ensuring quality assurance, facilitating international trade, and building market credibility. It is a key document in the pharmaceutical industry's regulatory and business processes.

The MSC is therefore very critical to be obtained by the pharmaceuticals more so by those eyeing export markets since it validates that the product is of good quality and it complies with the regulatory requirements increasing its credibility both in local and international markets.

Why is the Market Standing Certificate Required?

The Market Standing Certificate issued by CDSCO is an overall inevitable document for all the pharmaceutical companies within India. It has a few important purposes to serve, including the following:

Regulatory Compliance

The MSC is one of the requirements under the regulatory process when a manufacturer intends to export pharmaceutical products. It shall confirm and attest that the medicinal product has been sold in India for a certain number of years with no major regulatory or quality complaints. Hence, this certification ensures that the product meets the Indian regulatory authority's safety, efficacy, and quality standards, which is a fundamental requirement for compliance with domestic and international regulations.

Quality Assurance

The drug lag is represented by the MSC, which assures that the product has always been on the market and has, in fact, satisfied GMP and other essential regulatory standards. For a health professional or any consumer, such assurance is most vital, for it provides a signal of reliability and safety for pharmaceutical products.

Facilitation of International Trade

There are so many regulatory agencies worldwide that need evidence that a pharmaceutical product has been marketed successfully in its home country before it could be approved for sale in such a jurisdiction. The MSC could provide the required evidence to a foreign authority, thereby accelerating the approval processes in other countries. This would be in the interest of Indian pharmaceutical companies who would like to make a push into the international markets, as it proves acceptance of the product in the market and the observance of regulatory requirements.

Credibility and Building of Trust in the Market

The MSC aids the engendering of credibility and trust from the stakeholders in healthcare provision, patients, and regulatory authorities. It serves to assure the stakeholders that a product has been vetted and is of high quality. Such trust is integral to enlarging and retaining a substantial market presence at both the domestic and international levels.

Documentation for Legal and Business Transactions

Besides regulatory and quality assurance roles, the MSC may prove a useful document in legal and business transactions. This may be used to support cases in litigation or negotiation and as part of due diligence in pharmaceutical industry mergers and acquisitions.

Purpose and Importance of MSC

• Regulatory Compliance: The MSC, very often, is a requisite in the process of regulatory compliance for the export of pharmaceutical products. It essentially states that the drug has an established record of safety and efficacy in India.
• Quality Assurance: The CDSCO certificate assures that the product is manufactured following standards laid down by the CDSCO, which is the national regulatory authority for pharmaceuticals in India.
• International Trade: For Indian pharmaceutical companies looking to export their products, the MSC is a key document that helps in gaining approval from foreign regulatory agencies. It serves as proof of the product's market presence and compliance with local regulations

Procedure for Obtaining The Market-Standing Certificate CDSCO

The procedure for procuring the Market Standing Certificate from CDSCO, India, involves several steps that guarantee the product under consideration has a provable market existence and adherence to the regulatory standards. Here is the general procedure for obtaining the MSC:

Preparation and Documentation

Before applying for the MSC, ensure you have all documentation in order:

• Product approval documents: Documents confirming that the pharmaceutical product is approved by competent authorities in India. This normally includes the Drug Manufacturing Licence and Marketing Authorization.
• Sales Data: It refers to all details on the sale performance of a given product within a specific period, usually for several years. The data will help indicate the consistency of the product's existence and its acceptance in the market.
• Compliance Records: These are documents relating to the compliance of Good Manufacturing Practices and other associated regulations. This may contain inspection reports and quality control-related records.

Application Submission

The application for obtaining the MSC from CDSCO, whether at the central level or through the respective Zonal Office, whichever the regulatory provisions dictate, shall be accompanied by the following:

• A formal request for issuing the MSC.
• The prescribed documentation, including the approval and sales records of the product.
• A cover letter describing the request and enumerating the enclosed documents.

Review and Verification

The application and information furnished, on submission, shall be carefully reviewed and verified by the CDSCO. It may consist of:

• Document Verification: The authenticity of the documents submitted and whether they are complete.
• Inspection Reports: Depending on the requirement, the CDSCO may scrutinize inspection reports or even carry out further inspections to verify if standards given for that particular regulation are complied with.

Grant of CDSCO Certificate

Where the application and documentation are satisfactory, the Market Standing Certificate shall be issued by the CDSCO. This certificate confirms that the product has been marketed in India for a stipulated time without considerable regulatory and quality problems.

Renewal

The certificate of the MSC normally has a validity period. At the end of this period, companies can have their CDSCO certificates renewed by providing updated sales data and compliance records in return, to prove continuous market presence and adherence to regulations.

Documents Are Needed To Obtain the Market Standing Certificate CDSCO

• Covering Letter – The purpose of the application should be made very clear in the cover letter. Any other relevant or important information may be furnished in the covering letter like the list of documents being submitted indexed with page nos. The covering letter should be duly signed and stamped by the authorized signatory mentioning their name and title and name and address of the company.
• A Valid Copy of the central licensing Authority's license allowing manufacturing of the medical devices, for sale, distribution, or import, and the list of approved products therein.
• Bills of Entry and Import Information (in case of import) for the last three years of the products in question.
• The manufacturer or importer shall sign a legal declaration on a 100 Rupee registered, notarized stamp that states no legal action taken against them or that they have not been found guilty as a consequence of adverse events, market complaints, or NSQ reports of any products in India.
• Products requiring a Market Standing CDSCO Certificate list (in compact Disc also).

Validity and Renewal of CDSCO Market Standing Certificate

An MSC is normally subjected to a certain validity period, after which it may need to be renewed. The renewal will require fresh documentation to continue showing compliance and market presence.

Conclusion

The CDSCO Market Standing Certificate is the most important document required by any Pharmaceutical house in India with a vision to reach the international markets. It not only serves the purpose of complying with regulations but adds to the credibility and marketing of pharmaceutical products globally.