CDSCO: central drugs standard control organization || Trek Pharma

 

CDSCO: CENTRAL DRUGS STANDARD CONTROL ORGANIZATION

The Central Drugs Standard Control Organization (CDSCO) is the regulatory body for pharmaceuticals and medical devices in India.

Here are the general guidelines for product registration with the CDSCO:

Application Submission:

The application for product registration must be submitted in the prescribed format along with the necessary documents and fees.

Review of Application:

The CDSCO will review the application and conduct a technical evaluation of the product to determine its safety, efficacy, and quality. If the application is found to be incomplete or insufficient, it will be returned to the applicant for further information.

Site Inspection:

The CDSCO may conduct a site inspection of the manufacturing facility and other relevant sites to ensure compliance with Good Manufacturing Practices (GMP) and other regulations.

Import and Export Licenses:

If the product is being imported or exported, the applicant must obtain an import or export license from the CDSCO.

Approval:

If the product is found to be safe, effective, and of good quality, the CDSCO will grant approval for marketing and sale in India.

Post-Marketing Surveillance:

The CDSCO may conduct post-marketing surveillance to ensure ongoing compliance with regulations and to monitor any adverse events associated with the product.

 

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