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How to Get a CDSCO License in India - BizAdvisors


How to Get a CDSCO License in India?

How to Get a CDSCO License in India

To assure the safety, effectiveness, and quality of the medical products produced, imported, and distributed in the nation, CDSCO is continually working to increase openness, accountability, and standardization in its services. It is essential to obtain CDSCO License in India. By the Drugs and Cosmetics Act, CDSCO is in charge of approving new drugs, conducting clinical trials, establishing drug standards, regulating the quality of imported drugs into the nation, and coordinating the efforts of State Drug Control Organizations by offering professional advice to ensure consistency in the application of the Drugs and Cosmetics Act. In this blog, you will get to learn about the procedure for obtaining a CDSCO License in India.

Assessing Authority for the CDSCO License in India

The National Regulatory Authority (NRA) of India is the Central Drugs Standard Control Organization (CDSCO) under the Directorate General of Health Services, Ministry of Health & Family Welfare, and Government of India.

For the regulation of medications and cosmetics, the Drugs and Cosmetics Act of 1940[1] and the rules of 1945 have given central and state regulators a variety of duties. It calls for the uniform application of the Act and its implementing rules to protect patients’ safety, rights, and well-being by policing the use of pharmaceuticals and cosmetics.

Need for CDSCO License in India

To guarantee the safety, effectiveness, and quality of the medical products produced, imported, and distributed in the nation, CDSCO is continually working to increase openness, accountability, and standardization in its services.

Who may obtain a CDSCO License in India?

The following can obtain a CDSCO License in India:-

  • Pharma Products
  • Cosmetics 
  • Medical equipment
  • Therapeutic Trials

Purposes for CDSCO Certification

The following can be considered as the main purposes for CDSCO Certification:-

The Central Drug Standard Control Organization’s main objective through it is to design CDSCO License in India guidelines to make sure that no heavy metals and other toxins are used in the production of cosmetic products.

  • Many of these substances are ineligible to be listed among the CDSCO-registered medications.
  • The product is made without using or testing any animals.
  • The general public can safely consume the product.

Make sure that only CDSCO-approved medications, medical equipment, and other products are permitted for import. Registrations such as the CDSCO registration for medical devices, the CDSO voluntary registration, the CDSCO test license, the CDSCO wholesale license, the CDSCO dual license, and others have been made necessary for that reason.

Simply stated, you must obtain CDSCO certification before crossing the border into India with cosmetics because, much as with medicines, cosmetics contain several hazardous substances. Therefore, CDSCO cosmetic import registration for cosmetics is necessary, just as it is for any import of a medication.

CDSCO License and Certification

Following is the required systemization in order to acquire CDSCO License and Certifications in India:-

  • CDSCO production authorization for a particular product
  • The nation of the product’s origin issues a CDSCO free sale certification (just the free sale certificate) to the maker.

License Charge

The processing charge for licenses for CDSCO registration

Testing Report Cosmetic Product Specifications

  • The testing procedure you used on your cosmetic item
  • Make sure you don’t forget to complete any of the CDSCO registration checklists mentioned above. It is the formula for a successful CDSCO registration.

The local authorized agent of the foreign manufacturer with either a manufacturing or sale license or by the foreign may submit an application for registration and import to the Licensing Authority under the Act, i.e., the Drugs Controller General (I) at CDSCO, FDA Bhawan, Kotla Road, Near BAL Bhawan, and New Delhi.

Required Documents for CDSCO License in India

The following are the documents that are required in order to obtain a CDSCO License in India:-

  • Name of the business, firm, or other organization importing or manufacturing the medical device, as well as its specifications and norms
  • Information on medical devices and IVDs
  • The National Accreditation Board for Certification has accredited a certificate of compliance with the ISO 13485 standard. Bodies, the International Accreditation Forum,

Or the International Accreditation Board for Certification Bodies about such medical devices

  • For imported medical devices, a Free Sale Certificate (FSC) from the country of origin is required
  • The declaration that the information provided by the applicant is accurate, and signed by the importer or manufacturer

Procedure for obtaining CDSCO Registration in India

The following steps are included in the CDSCO registration process for the import of cosmetics:-

  • Assemble the necessary paperwork.
  • By registering on the CDSCO SUGAM portal, you can submit and file a CDSCO online application.
  • Wait for the CDSCO to review and approve your application after you’ve completed the CDSCO application paperwork.
  • Obtaining the registration number required for cosmetics importation.
  • The CDSCO form comes in a variety of forms. Therefore, select the option outlined in the CDSCO product registration criteria.


At BizAdvisors.io, we view your demand for cosmetics import registration with a critical eye. BizAdvisors.io offers assistance with all aspects of CDSCO License in India Registration, from writing your cover letter to making sure you have the necessary papers on hand, from submitting your application to executing a careful follow-up to address any problems that may arise. We are the best option for the import license for cosmetics. The affordable professional CDSCO cosmetic registration fees are just another benefit of choosing us. Our CDSCO License Registration consultants charge a little fee but provide enormous value. Get in touch with our CDSCO License in India Registration consultants at BizAdvisors.io to begin obtaining cosmetic import licenses right away.

Read our article:All You Need to Know About CDSCO Wholesale

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