Sugam Drug License Registration

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. Let us look in detail about the registration procedure of SUGAM Drug License in this article.

Services Provided at SUGAM

The SUGAM portal that allows the applicants to avail the below-listed services:

Online Submission of the applications in various departments of the CDSCO portal.
The applicant can apply for the license under the Import and registration division to CDSCO. And can also review and track the status of the applied applications.
Grant of No Objection Certificate (NOC)
The applicants can also answer back to the queries that are raised.

Type of Licenses

The below following are the application forms that can be filed online through SUGAM portal:

Form 10 for Drug
Form 10 for Diagnostic Kit
Form 41 for Diagnostic Kit
Form 41 for Drug
Form 41 for Medical Device
Form 10 for Medical Device
BE NOC for Clinical Trial
Post Approval Change for the Drug, Medical Device and Diagnostic Kit
Test License for the Clinical Trial

Eligibility Criteria

The following is the eligibility criteria to obtain licenses under the SUGAM portal is mentioned below:

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

Note: As per the Health Ministry, the applicants who have already registered on the portal can submit the hard copies of the applications. The registered applicants have to submit their application through this application system online along with a hard copy for the license registration.

Documents Required

The documents required for the SUGAM Drug License are provided below:

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)

Online SUGAM Registration Procedure

Access the Portal Step 1: The SUGAM portal can be accessed by all the stakeholder by using the official website. Registration Process Step 2: Applicants can click on the “Sign up here" to register on the portal. Step 3: Now, the applicant has to fill the form and click on the “Submit” button after accepting the terms and conditions to complete the sign-up process. An SMS will be sent to the registered number confirming the successful sign-up. Step 4: If the applicant has an account already, they can log in using the Id and Password. Import License/ Registration Certificate Step 5: To apply for the Import License/Registration Certificate click on the Form Submission on the menu bar. Step 6: Select Department as “ Import and Registration” and Select Form as either “Form 40” or “Form 8”. Step 7: Enter the Correct information as same will be printed on the License Issued by the Authority. Step 8: After that, it will be redirected to the Applicant and Manufacturer Detail where the applicant has to fill the form details and click on “Save and Continue” button to proceed further. Step 9: It will be re-directed to the “Drug Details” page where the applicant needs to fill the form details and click on the “Next” button to proceed further. It will be re-directed to the “Manufacturing Unit Details”. Note: Application can be applied both for “Bulk Drug” and “Finished Formulation. If the user changes the option Application applied for in Drug Details part then all drugs of Bulk Drug or Finished Formulation will be deleted. Step 10: Select the application type as ‘Endorsement’, furnish all the details, enter the registration number and click on ‘Continue’. Step 11: After selecting department as “Import and Registration” and selecting form as “Form 40”, it will be redirected to “Applicant and Manufacturer Detail” page Step 12: Enter valid Registration Certificate Number (RC). In the case of Endorsement, new drugs can be added, but the premises cannot be added and it will remain the same. Upload Documents Step 13: Click on the “Save and Continue” button to continue further. It will be redirected to the new “Checklist” page. Step 14: Click on each point to upload the document electronically. Upload all the requested documents and click on the “Submit” button on the checklist page to proceed further. Payment Process Step 15: It will be re-directed to the “Payment” page where the applicant has to select the Mode of payment that can be “ Online” or through “Challan”. Step 16: After making the payment, the RC Application form will be submitted successfully and application form will be forwarded to the respective Designated Officer. Kindly note down the Reference Number generated for future reference.

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Frequently Asked Questions

Common questions about SUGAM Drug License Registration: Online CDSCO Licensing System.

SUGAM is an e-Governance system launched by the Ministry of Health and Family Welfare to streamline various functions administered by the Central Drugs Standard Control Organization (CDSCO) under the Drugs and Cosmetics Acts, 1940. It offers an online licensing portal for approvals related to new drugs, clinical trials, medical devices, ethics committees, vaccines, and cosmetics.

The SUGAM portal allows applicants to submit applications online for various departments of the CDSCO, apply for licenses under the Import and Registration division, track the status of their applications, and respond to queries raised by the regulatory authorities. It also facilitates the grant of No Objection Certificates (NOCs) through the online system.

Applicants can file various application forms online through the SUGAM portal, including Form 10 and Form 41 for drugs, diagnostic kits, and medical devices, BE NOC for clinical trials, post-approval changes for regulated products, and test licenses for clinical trials.

The SUGAM portal is open to importers (applying in Form 8), Indian agents, corporate foreign enterprises with Indian subsidiaries, manufacturing units, and all applicants who wish to get their products regulated by the CDSCO registered or imported into India.

The required documents for SUGAM Drug License registration include identity proof (PAN card, Aadhaar, driving license, voter ID, etc.), address proof (legal passport, Aadhaar, copy of CIN, IEC, utility bill, property tax bill, etc.), an undertaking in a given format, and any other applicable documents.

Applicants can access the SUGAM portal's official website and click on the "Sign up here" option to register. They need to fill out the registration form, accept the terms and conditions, and submit the form. An SMS will be sent to the registered number confirming successful sign-up.

To apply for an Import License or Registration Certificate, applicants need to select the "Import and Registration" department and the appropriate form (Form 40 or Form 8) on the SUGAM portal. They then need to fill in the required details, upload the necessary documents, and complete the payment process online or through a challan.

Applicants can log in to their SUGAM account and review the status of their submitted applications under the "Import and Registration" division. They can also respond to any queries raised by the authorities through the online system.

As per the Health Ministry's guidelines, all applicants who wish to get their products regulated by the CDSCO registered or imported into India are encouraged to apply through the SUGAM online application portal to avail smoother and hassle-free services.

Yes, registered applicants on the SUGAM portal can submit hard copies of their applications along with the online submission for license registration, as per the Health Ministry's instructions.