CDSCO Approvals

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Required Documents

The following documents have to be submitted along with the CDSCO registration application:

  1. Document Identity for CDSCO Application
  2. CDSCO proof of residence of the applicant
  3. A copy of Site Registration issued by CDSCO for BE or BA.
  4. Work done by the concerned authority
  5. Undertakings allotted by the appropriate Authority
  6. produced or imported within the country

Other Services


CDSCO stands for the Central Drugs Standard Control Organization. It is the regulatory body for pharmaceuticals and medical devices in India. CDSCO is responsible for approving, regulating, and controlling drugs and ensuring their safety, efficacy, and quality.

CDSCO approval is essential for pharmaceutical companies to market and sell their drugs in India legally. It signifies that the drug has undergone rigorous testing and meets the required quality, safety, and efficacy standards set by CDSCO.

You can verify the CDSCO approval status of a drug by checking its product packaging or label for the CDSCO license number. You can also search the CDSCO website or use their online portals to access the approved drug list or inquire about specific approvals.

CDSCO grants various types of approvals for drugs, including new drug approvals, clinical trial permissions, import licenses, manufacturing licenses, and marketing authorizations. The specific approval type depends on the drug development stage and the intended purpose.

Obtaining CDSCO approval involves submitting a comprehensive application with detailed information about the drug, its formulation, manufacturing process, clinical trial data (if applicable), and supporting documentation. CDSCO experts review the application, and if it meets the requirements, approval is granted.

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