Experienced team

Extensive experience adds excellence and integrity to decode the trajectory of Indian regulatory services

100% confidentiality

Medical Devices, In- Vitro Diagnostics, Cosmetics, New drugs, Veterinary or Biologicals, the confidentiality of data is always maintained.

Regulatory intelligence

With profound knowledge of the regulatory framework, we easily navigate with CDSCO licensing to propel success.

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Expanding With Every CDSCO Registration

We Know What We Are Offering To Our Client

We are a trusted regulatory solutions provider, offering unparalleled support to our clients to make their CDSCO License journey hassle-free in different industry verticals. Our seasoned regulatory professionals offer end-to-end assistance in the registration process for Drugs, Medical devices, Biologicals, Diagnostic kits, Veterinary, and Cosmetics.

While converting every application to regulatory approval, we get wonderful opportunities to learn the depth of prevailing regulations and compliances. Our meticulous attention to detail and regulatory standards help us to mitigate the risks of Non- Compliance and provide the best result to our clients.

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Vital Aspects of CDSCO License

Know how to process A New Drug Application in Indian Market

Before diving into the landscape of CDSCO licensing and regulatory compliance, you must understand the regulatory framework. Meeting the regulatory requirements is a time-consuming task and prone to errors if you fail to handle them with utmost care. From initial assessment and documentation to submission and follow-ups, a streamlined process must be taken care of. As registered and trusted CDSCO registration consultants, we offer 360 degrees assistance to our clients and let them drive their business forward. Therefore, we let you understand the primary aspects of the CDSCO License.

The Drugs and Cosmetics Act, 1940

Under this act, the Indian government regulates the manufacturing, import, distribution, and sales of Drugs, Cosmetics, Medical Devices, and In- Vitro Diagnostics to ensure their safety and effectiveness.

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Drugs Controller General of India (DCGI)

As a head of CDSCO, DCGI control over the import of drugs, approval of new drugs and clinical trials, meetings of the Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), approval of certain licenses as Central License Approving Authority.

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SUGAM Online Licensing

SUGAM is an e-Governance system, specially designed to administer various functions that include approval of New Drugs, Clinical trials, Medical devices, IVD, Vaccines, and Cosmetics. It is controlled by CDSCO.

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CDSCO Manufacturing License

Whether you seek a medical device or drug manufacturing license, you must understand the intricacies of the complete process and approach CDSCO and State Licensing Authorities for approval.

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(NSWS) The National Single Window System

National Single Window System is an online tool to help you find and apply for approvals based on your business needs. The KYA module provides information for 32 central departments and 32 states.

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Frequently Asked Questions (FAQ)

As National Regulatory Authority for Indian Pharmaceuticals and medical devices, CDSCO is responsible for New Drugs, Clinical trials, Medical devices, IVD, Vaccines, and Cosmetics under the Drugs and Cosmetics Act, 1940, and Drugs and Cosmetics Rules, 1945. There are certain steps you should follow to apply for a CDSCO certificate online:

  • Visit the CDSCO registration portal and click on the Login/Sign up bar (at the left corner)
  • If you don’t have an account, click to “Sign Up Here” and select the purpose of Registration purpose.
  • Click on to drop-down, select the option that defines your purpose of registration, and click on the “Submit” button.
  • A registration form will open. Once you fill out the form completely, click the “submit” button. A confirmation mail will be sent to your registered email id for verification.

Yes, one needs to submit a certificate of compliance with ISO-13485 (Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes) while registering for a newly notified medical device.

Under CDSCO, the Drugs Controller General of India (DCGI) plays a vital role in the approval of the Import of all Devices and manufacturing of certain medical devices. The manufacturing, sale, import, and distribution of medical devices in India are controlled under the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945, and New Medical Devices Rules 2017.

There are various types of drug licenses issued by the Central Drugs Standard Control Organization and State Directorate of Drugs Control: Retail, Wholesale, Manufacturing, and Import License.

  • Retail Drug License: Required to Sell Drugs on a Retail basis
  • Wholesale Drug License: Required to sell drugs on a wholesale basis.
  • Drug Manufacturing License: Issued to manufacture drugs under the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945.
  • Import License: Require to import Medical Devices, IVD, Drugs, Cosmetics, Biological, and Veterinary under the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945.

Under the Cosmetics Rules 2020, the following license is required to import cosmetics in India:

  • Application in Form COS-01: Required for a registration certificate for import of cosmetics into India.
  • Application in Form COS-04: Required for Import Registration Number for Import of already registered cosmetics.