How it works ?
Complete this purchase process our executive wil contact you with all details i.e documents required, time line , price etc
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CDSCO Registration
CDSCO (Central Drugs Standard Control Organization) Registration is a mandatory process for manufacturers, importers, and marketers of drugs, medical devices, and cosmetics in India. The CDSCO, under the Ministry of Health and Family Welfare, ensures the quality, safety, and efficacy of drugs and medical devices in the country.Here’s a step-by-step overview of the CDSCO Registration Process:
Determine Eligibility:
Before applying for CDSCO registration, ensure that your product meets the requirements of the Drugs and Cosmetics Act, 1940, and related rules. The registration applies to pharmaceuticals, medical devices, diagnostics, and cosmetics.Prepare Required Documents:
Depending on the type of product, you will need specific documents, including:- Product details and specifications
- Manufacturing license or certificate of good manufacturing practices (GMP)
- Test reports or clinical data (if applicable)
- Certificate of Free Sale (if importing)
- Labeling and packaging details
Apply for Registration:
Submit the application online through the CDSCO portal or in person to the CDSCO office. Include all required documents, product details, and an application fee.Product Testing:
The CDSCO may ask for product samples for testing to verify their safety, quality, and compliance with regulatory standards.Review and Inspection:
The authorities will review the documents and conduct an inspection of the manufacturing facility (if applicable) to ensure compliance with standards.Grant of Registration:
Upon successful verification, CDSCO will grant the registration for your product. This registration allows you to market or import your drug, medical device, or cosmetic in India.Renewal:
CDSCO registration is valid for a specific period (typically 5 years) and must be renewed upon expiration.
This registration is crucial for ensuring product quality, gaining consumer trust, and accessing the Indian market legally.