In January 2016, India’s Central Drugs Standard Control Organisation (CDSCO) introduced SUGAM, an online portal, for filing applications of various services. The services offered by the SUGAM includes online submissions, review, and grant of NOC/permission.
SUGAM online licensing portal of CDSCO has been launched by the Ministry of Health and Family Welfare. SUGAM is e-Governance system to perform various functions administered by the CDSCO under the Drugs and Cosmetics Acts, 1940 which includes the approval of New Drugs, clinical trails, medial devices, ethics committee, vaccines and cosmetics. The SUGAM registration provides an opportunity for the user to apply for the licenses through the online licensing system.
Type of Licenses
- Certificate of Registration – Form 41 for Drugs
- Certificate of Registration – Form 41 for Medical Devices
- Certificate of Registration – Form 41 for Diagnostic Kit
- Certificate of Registration – Cosmetics
- License of Import – Form 10 for Drugs
- License of Import – Form 10 for Medical Devices
- License of Import – Form 10 for Diagnostic Kit
- Clinical Trial Test License
- BE NOC for Clinical Trial for importing/manufacturing a New Drug
- Permission to conduct GCT
Benefits of the SUGAM
- Applicants can directly apply for all import licenses to the CDSCO
- Easy tracking of status of submissions
- Easy query handling
- Applicants can directly upload documents related to activities of submission
Eligibility
- The importer (Application in Form 8)
- Indian Agent
- Corporate
- Foreign Enterprise holding Indian Subsidiary
- Manufacturing Unit
- All applicants those who wish to get their products (regulated by the CDSCO) registered or imported have to apply through this portal.
- All the applicants who have submitted their application forms to CDSCO via hard copies have been requested to apply or resubmit their documents through this online application portal to avail smoother and hassle-free services by the CDSCO
Documents
- Identity Proof: PAN Card, Aadhar, Driving License, Voter Identity Card, etc.
- Address Proof: Legal Passport, Aadhar, Copy of CIN, IEC, Utility bill, Property tax bill, etc.
- Undertaking in a given format.
- Any other documents (if applicable)
How to register?
Step 1: To register on SUGAM, log on “cdscoonline.gov.in” and click on “LOGIN/SIGN UP”.
- Applicants such as corporate, importers, Indian agents, subsidiaries can register themselves on the portal.
- Manufacturing units are not allowed to register on the portal directly.
- Manufacturing units can use the login created by the corporate for SUGAM on their behalf.
Step 2: After clicking on “LOGIN/SIGN UP”, a registration form will pop up that needs to be filled duly by an authorized/responsible person.
- The Unique corporate ID must be used as the username for the portal.
- Users are required to upload and submit the ID proof, undertaking and address proof on the portal along with the form.
- After submitting the application, a confirmation link is sent to the registered email ID.
- Once the user clicks on this confirmation link, the account gets activated and the application is sent to CDSCO for approval.
- If approved, an email will be sent to the user else, rejection mail will be sent.
Step 3: To login, users are required to enter the login details on the portal and login.
FAQs
What is SUGAM Drug License Registration?
SUGAM is an online portal developed by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare, India. It enables pharmaceutical companies, importers, and distributors to apply for and manage various drug licenses and approvals, including manufacturing, sales, import, and clinical trial permits.
Who needs a SUGAM Drug License?
- Manufacturers of pharmaceutical products like drugs, medical devices, and cosmetics.
- Importers of drugs or pharmaceuticals planning to distribute or sell in India.
- Distributors, stockists, and wholesalers in the pharmaceutical sector.
- Organizations conducting clinical trials for drugs and medical devices.