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Get Online CDSCO Import License in Delhi, India

by anandkumar

The CDSCO (Central Drugs Standard Control Organization) under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India. Its headquarters is located at FDA Bhawan, Kotla Road, New Delhi 110002 and also has six zonal offices, four sub zonal offices, thirteen Port offices and seven laboratories spread across the country.

The central government have established 6 zonal offices of CDSCO (Central Drugs Standard Control Organization) at Mumbai, Kolkata, Chennai, and Ghaziabad, Hyderabad, Ahmedabad, 5 various Sub-Zonal offices and Port offices, which works in close collaboration with the state control administration and assist them in securing uniform enforcement of the Drug Act.[6]

The CDSCO is responsible for the approval and regulation of New Drugs and Clinical Trials in the Country, laying down the standards for Drugs, control over the quality of imported drugs, coordinating the activity of State Drug Control Organizations. Under the new dispensation, foreign manufacturers have to apply for a registration certificate for their manufacturing premises and the individual drugs to be imported and Ayurvedic registration, Glucometers, Homeopathic Medicine Licenses, Import license, Manufacturing licenses, and Testing laboratories by the designated licensing authority under Schedule M-II of Drugs and Cosmetics Rules.

If you are setting up a new medical device business, we can help bring your products to market in India. As an import consultant, we can help you get the CDSCO importer license and register your product to satisfy Indian regulatory requirements. We can help you with a complete process ranging from laisoning with the CDSCO (Central Drugs Standard Control Organization) and getting approvals for your product.

An importer must hold a valid (wholesale and manufacturing) CDSCO license issued under Central Drugs Standard Control Organization (CDSCO). It is mandatory to have this license for importing medical devices. All the foreign manufacturers exporting to India get their products registered, imported, and marketed in India through an importer from M/s. The CDSCO also provides a Certificate of import license for all Medical Device and therapeutic goods such as pharmaceuticals for human use, biological, blood, and blood components, diagnostic kits, etc. CDSCO module to register and license Manufacturers, Wholesalers, Testing Laboratories, and Other related applications like renewal, temporary permits, amendments, etc.

Process for CDSCO Import License:

To obtain CDSCO Registration, you need to follow the standard online procedure entailing the following points:

  • Go to the CDSCO official Portal.
  • Search for cosmetic import
  • Go through the guidelines thoroughly. If you can’t, consult with a CDSCO expert to do the same.
  • Fill the online application form for CDSCO approval.
  • Take the printout of the filled application form.
  • Attach the application form with the physical copies of the required documents and submit it to the regional CDSCO office.
  • The application and the documents will go through a thorough assessment. If everything is in order, you’ll obtain CDSCO registration.

The Documents required for CDSCO License.

The Documents you need to successfully obtain CDSCO license approval to import cosmetics are as follows:1

  • A cover letters.
  • A document containing all the information to be present on the cosmetic’s label.
  • Ingredient list of the product.
  • Manufacturing license of the product.
  • Free sale certificate for the product issued by the product’s country of origin.
  • Declaration that all toxic materials are within regulatory standards.
  • Declare that no animals were test during the product’s manufacturing process.
  • Declaration that the product is free from any prohibited materials.
  • Sample of the product.
  • Import Export Code.

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