The word SUGAM means “easy to approach” in Sanskrit. Just like how it means it was developed by CDSCO to streamline the regulatory process and also to promote digital India. SUGAM full form is System for Unmanned Gateways Approval of Manufacturers. The application process on SUGAM is online—you log in, select the right form, fill in the details, attach the documents, and then wait for CDSCO to review and respond.
Keep reading to know more about what it is, its benefits, registration process and more.
What Is CDSCO SUGAM Portal?
CDSCO SUGAM is an online portal developed by the Central Drugs Standard Control Organization (CDSCO) in India. CDSCO, the national regulatory body of India, under e governance has introduced online service for the filling of the application via “SUGAM” portal. The software system, SUGAM, is an online web portal. It was put in place in 2016 for import and registration and later on for Cosmetics, Good Clinical Trials (GCT), biologicals and other divisions. In this web portal applicants can apply for:
- NOCs
- Licenses
- Registration Certificates
- Permissions & Approvals
Benefits Of SUGAM For Regulatory Submissions
The benefits that SUGAM portal allows are as follows:
- Electronic submission: For the sake of ease of doing business and also keeping in mind the vision of the Indian Government to promote digital India, SUGAM portal allows the applicants to submit their applications online.
- Decrease the burden of paperwork: Since the submissions are made online, there is decreased need for paperwork and this streamlines and speeds up the regulatory submission and approval processes.
- Keeping track of the application status: The status of the applications submitted can be tracked from the applicant dashboard.
- Transparency: Since they can track the application status it provides with a high level of transparency.
- Direct interaction with the Regulators: This online web portal allows a direct connection with the regulatory authority which allows any query resolution to be trouble free and expedite the application processing.
- Direct access: Applicants can directly apply to the CDSCO for import licenses and can also upload any documents that are relating to the activities of submission.
- Role based access control and actions: By the execution of role-based access control and actions, SUGAM portal provides a single platform for all its stakeholders to access the service provided by the portal.
- Consolidation of drug regulatory framework: Entire regulatory framework of the drug has been consolidated and brought to the centre thereby serving as a centralized dashboard for the monitoring of various regulatory clearance all over India.
- Workflow: SUGAM provides an integrated workflow from the start, that is, from applying for the permission/license to the grant of permission/license.
Also Read: CDSCO Medical Device Approval Cost
How To Register On SUGAM Portal?
CDSCO SUGAM registration process is mainly about creating an account, uploading the right documents, and getting approval from CDSCO before you can submit any applications. For the user to apply to any form they must first need to register on the portal.
CDSCO SUGAM Required Documents
When you create an account on the CDSCO SUGAM portal, a few core documents are mandatory. These usually include:
- Proof of corporate address (such as a utility bill or company registration certificate)
- ID proof of the authorized person signing up
- Power of Attorney (where applicable)
- Manufacturing license or wholesale license (Form 20B/21B for pharma businesses)
- Any division-specific approvals if you are applying for medical devices, cosmetics, or trials
Keeping these ready in PDF format will save you delays during registration.
CDSCO SUGAM Portal Registration Step by Step
Below Step by step process of the SUGAM portal takes you through signup, verification, filling out the registration form, and final confirmation. Once approved, you can use the same login for future submissions.
Step 1: Log on to https://cdscoonline.gov.in/CDSCO/homepage, you can find login/signup on the top left corner.
Corporate, Indian Agent, Importer, Foreign Enterprise holding Indian Subsidiary, Cosmetics, Ethics Committee, Formulation R&D Organization, BA/BE Approved Sites, Sponsors (BA/BE & CT) are the applicants who can register via this portal is one thing to be noted. Other details to be noted are that the direct registration of manufacturing unit is not allowed on the portal. For login on the portal, the manufacturing unit uses the login credentials created for them by the corporate.
Step 2: After clicking on the login/signup you can find “sign up here”. By clicking on that a new window demanding the registration purpose opens up on the portal.
Step 3: “Select purpose of registration” can be seen. Click on that and a drop-down list shows up. You have to select the purpose from it and hit submit. You can also cancel the registration purpose by hitting the cancel button.
Step 4: After submitting the registration purpose, the applicant registration form is presented to you to fill out. User can now register by filling out the form.
Step 5: After the registration application has been successfully submitted, “Registration Completed Successfully” will appear on the screen.
This registration guide is meant to walk applicants through each stage clearly so there’s no confusion about what documents or details CDSCO expects.
Also Read: CDSCO Pharmaceutical Regulations in India
Guidelines For Sugam Registration
The corporate email id must be unique, and this is used as username in the registration form as well as for future communication. Password must contain 6 characters, and it has to be strong so it should include at least one from each of the following:
- One number
- One lowercase letter
- One uppercase letter
- A special character
Details of ID Proof, Power of Attorney, Proof of Corporate Address and Manufacturing License or Wholesale Licenses (Form 20B & Form 21B) must be provided and kept ready in the PDF format before signing up for the process. For filling the Formulation R&D Registration Form, DST Registration Number is compulsory. You can receive the registration and verification message on the registered mobile number if you have opted to receive SMS alerts. A confirmation link will be sent to the registered email ID after you have submitted the form to verify the registration.
The user can then verify the account by clicking on the link sent via registered mail ID. After clicking on the verification link, the user’s registration application will be sent out to the CDSCO officials for approval.
Different Divisions On Which Applications Allowed On The SUGAM Portal
SUGAM portal allows applications for the following divisions:
- Import and Registration
- Medical Devices and Diagnostics
- Cosmetics
- BA/BE (Bioavailability/ Bioequivalence)
- Good Clinical Trial (GCT)
- Ethics
- Test License
- Personal License
- Biologicals
- Export NOC Division
- New Drug
- Subsequent New Drug
- Fixed Dose Combination (FDC)
Since the regulatory requirements are ever-changing and also with an increase in the digitalization of the regulatory framework in India, it can be confusing and make it difficult to stay in compliance with these regulations. Artixio Consulting delivers broad support for Pharmaceuticals, Biologics, Medical Devices, Cosmetics and many more in India. Our consultants in India are highly skilled and experienced in product registration, licensing and other services as well. Reach out to us at info@artixio.com
Also Read: CDSCO Cosmetics Registration in India for Importation
FAQs
Q1: What is the full form of SUGAM portal?
A: System for Unmanned Gateways Approval of Manufacturers is the expansion of SUGAM. This is an online web portal put forward by the CDSCO, the National Regulatory Body in India.
Q2: Who can use the SUGAM portal for registration?
Corporate, Indian Agent, Importer, Foreign Enterprise holding Indian Subsidiary, Cosmetics, Ethics Committee, Formulation R&D Organization, BA/BE Approved Sites, Sponsors (BA/BE & CT) are the ones who can register through this portal.
Q3: How to Apply on CDSCO SUGAM Portal?
To apply on the SUGAM portal, you first need to complete the registration. After logging in, choose the right division, fill the form, upload the documents, and submit.
Q4: How does the SUGAM portal improve the registration process in India?
It simplifies the process of registration by serving as a single platform for its stakeholders to assess the services provided, compliance with the standards, can track the application status, high level transparency, decreases the need for paperwork and increases the ease of business. All these contribute to a faster approval process.
Q5: Can foreign companies register their products on SUGAM?
Foreign companies can register their products on SUGAM, but they need to appoint an authorized agent in India, meet all the necessary requirements meant for the documentation and quality and must also be in compliance with the regulatory guidelines or standards.
Q6: Is SUGAM only for drug registration?
SUGAM is not only for the drug registration but is also used for medical devices and diagnostics, cosmetics, biologicals and other divisions too. It is not for registration alone as well, it is used in gaining approvals and permissions, license, NOC’s.
