CDSCO Sugam Portal Registration Process in 2025

CDSCO Sugam Portal Registration Process in 2025

Sugam Portal is a CDSCO registration that an individual intending to apply any kind of license, product approval, or license renewal will follow under the drug and medical regulation Indian system. It is an online site operated by the government, and any business dealing in pharmaceuticals, medical equipment, cosmetics or blood products should also register on the site prior to starting any regulatory proceedings.

In 2025, this portal continues to be the only authorized digital route to submit regulatory applications to the Central Drugs Standard Control Organization (CDSCO). The registration is mandatory and needs to be done by importers, manufacturers, testing labs, and marketers who want to get permission to sell or distribute health-related products in India.

The Role of CDSCO and the Sugam Portal

CDSCO is a wing of the ministry of health and family welfare of India. It guarantees that only effective and safe drug, cosmetic products, and device enter the Indian market. Its official portal to submit the application, upload documents, and keep a track on the approvals and communicate with the authority is the Sugam Portal.

The portal simplifies regulatory submissions and replaces older manual systems. Since its launch, thousands of pharma companies, hospitals, and startups have moved their compliance process onto Sugam to speed up approvals and avoid delays.

Who Needs to Register on the Sugam Portal?

Anyone who wants to submit an application to CDSCO must register on Sugam first. This includes:

• Indian manufacturers of drugs or cosmetics
• Importers of medical devices, drugs, or raw materials
• Wholesale distributors and agents
• Research organizations conducting clinical trials
• Authorized Indian agents of foreign manufacturers
• Testing laboratories and contract research firms

In short, if you need a license or approval from CDSCO, Sugam is where your journey begins.

Types of Applications Handled Through Sugam

The Sugam Portal accepts a wide range of applications, including:

Each category has a specific workflow and required forms. Your first step is creating a verified account on Sugam, and then you can apply under the relevant category.

Read More Medical Device Import License

Step-by-Step Registration Process on Sugam Portal (2025)

Let’s walk through each step in detail. The registration is free and completely online.

Step 1: Go to the Official Sugam Portal

Open https://cdsco.gov.in. Select the “Sugam Portal” link on the homepage. It will redirect you to the registration platform.

Step 2: Choose Your Registration Type

Under the “New Registration” tab, you will find multiple options such as:

• Indian Manufacturer
• Importer
• Cosmetic Manufacturer
• Foreign Manufacturer with Indian Agent
• Testing Laboratory

Select the one that matches your business activity. If you select the wrong category, your application might get rejected.

Step 3: Fill in Basic Details

After selecting your type, the system will ask you for:

• Organization name
• Type of firm (Proprietorship, Pvt Ltd, etc.)
• Address with PIN code
• Email and mobile number
• Contact person details

You must also mention the CIN number (Company Identification Number) if it is a registered company.

Step 4: Upload Required Documents

The following documents must be uploaded in clear scanned format:

• PAN Card of Organization
• Address Proof
• Authorization Letter
• Valid Email ID Proof
• Digital Signature Certificate

Step 5: Submit the Registration Form

Once you fill in all the details and upload all the documents, just “Submit”. You will get a confirmation email on your registered address.

The form then goes to the CDSCO zonal office for verification. If the details are correct, your user ID will be approved within 3–5 working days.

Step 6: Login and Access Dashboard

After receiving login credentials, go back to the Sugam portal and sign in using your ID and password. You can now:

• Submit new applications
• Track application status
• Download issued licenses
• Respond to CDSCO queries
• Modify registered information

The dashboard also keeps a history of every form you submit and its approval status.

Things to Keep in Mind During Registration

• Email ID and Mobile Number must belong to the company and should remain active. All future alerts will be sent to this number.
• Digital Signature Certificate (DSC) is required for several future submissions. Get one in advance.
• User Type Selection is critical—choose correctly to avoid future rejection.
• Timely Updates: If your address, contact person, or company name changes, you must update it on Sugam immediately.

Post-Registration Activities

Once registered, you can start applying for specific licenses. For example:

• Drug importers can apply for Form 10/41
• Device manufacturers can seek a manufacturing license
• Cosmetic importers can upload product dossiers
• CROs can submit clinical trial applications

Read More How to get CDSCO cosmetics registration?

Each license has a unique form and document checklist. Some require offline verification or site inspections. The portal will guide you step by step.

What to Do If Registration Is Rejected?

Sometimes, CDSCO may reject your registration due to:

• Incomplete or mismatched documents
• Incorrect user type
• Duplicate entries
• Invalid digital signature

You will receive a reason for rejection. After correcting the issue, you can reapply from the beginning. There is no penalty for resubmission, but it may delay your product launch.

Advantages of Using Sugam Portal in 2025

CDSCO’s Sugam Portal is now more advanced, secure, and faster than older systems. Here’s how it helps:

• One-stop platform for all regulatory needs
• Real-time tracking of applications
• Online communication with CDSCO officers
• Document repository for future use
• Faster approvals and fewer paperwork delays
• Ease of business for startups and foreign companies

For businesses in pharma, health tech, or biotech, Sugam is the only path to legal compliance and regulatory success in India.

Final Words

At Agile Regulatory, we help businesses like yours complete the CDSCO Sugam Portal registration quickly and without hassle. 

With deep domain knowledge and on-ground coordination, we make sure your registration is accepted on the first try. Whether you're applying for a drug import license or a new cosmetic registration, we’ll handle the process while you focus on growing your business.

Need help with CDSCO Sugam Portal registration? Connect with Agile Regulatory now—compliance made simple.