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Sat, Oct 11 2025
Raju Karn
The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory authority for pharmaceuticals, medical devices, and clinical trials. Acting under the Ministry of Health and Family Welfare, CDSCO ensures that drugs and medical devices available in India are safe, effective, and of high quality. Whether you are a pharmaceutical manufacturer, medical device importer, or healthcare entrepreneur, understanding CDSCO online services and regulations is crucial for legal compliance and smooth operations.
This blog will guide you through the full form of CDSCO, online registration, CDSCO Sugam, approved drugs, banned drugs, and other essential services. We’ll also explain how businesses can navigate the CDSCO MD online portal efficiently.
CDSCO stands for the Central Drugs Standard Control Organization. It is responsible for:
✔️ Approving new drugs and clinical trials
✔️ Regulating the manufacture, sale, and distribution of pharmaceuticals and medical devices
✔️ Ensuring quality standards are maintained across the healthcare sector
CDSCO plays a critical role in protecting public health and ensuring that drugs meet stringent safety and efficacy standards.
With digitization, CDSCO provides multiple online services to simplify compliance for businesses:
→ CDSCO Sugam: A portal to manage applications for licenses, approvals, and registrations. It allows applicants to submit forms and track approvals efficiently.
→ CDSCO Login: Registered users can log in to access their applications, submit documents, and receive updates on approvals.
→ CDSCO Online (Ondls CDSCO): This includes services such as import/export of drugs, registration of medical devices, and online approvals for clinical trials.
These online services reduce paperwork and make the compliance process more transparent.
Businesses looking to operate legally in India’s pharmaceutical or medical device industry must follow the CDSCO registration process:
• Ensure your organization complies with Indian manufacturing and import regulations.
• Confirm that your drug or medical device is not restricted or banned in India.
• Company incorporation certificate
• Manufacturing license or import license
• Product details and testing reports
• Use CDSCO Sugam or the CDSCO MD online portal.
• Upload all required documents.
• Fees vary depending on the type of product and approval required.
• CDSCO may conduct site inspections for manufacturers.
• The review ensures compliance with Good Manufacturing Practices (GMP).
• Upon successful review, the CDSCO issues approval for drugs or medical devices.
CDSCO approved drug list ensures that only safe and effective drugs are available in the market.
→ These drugs have undergone clinical trials and regulatory scrutiny.
→ Manufacturers must apply through the CDSCO online portal for approval.
→ Approved drugs are listed publicly and can be checked for verification.
✅ Benefits of Using Approved Drugs:
▪ Assures patient safety
▪ Enhances business credibility
▪ Avoids legal penalties
CDSCO regularly updates the CDSCO banned drugs list to remove unsafe or unapproved medications.
⛔ The banned list is crucial for pharmaceutical companies, importers, and distributors.
⛔ Companies must check the latest CDSCO banned drugs 2024 list before sourcing or manufacturing.
⛔ Violating this list can lead to severe legal actions and product recalls.
The CDSCO MD online platform focuses on the registration and compliance of medical devices.
✓ Manufacturers, importers, and distributors can apply for approvals digitally.
✓ Devices are classified based on risk, and approvals are granted accordingly.
✓ This portal ensures faster processing and better tracking for businesses.
Points to Remember:
📌 Class A & B devices have simplified registration procedures
📌 Class C & D devices require clinical evaluation
📌 Post-market surveillance is mandatory
Depending on whether you are registering a drug or medical device, the documents may vary slightly. Commonly required documents include:
◆ Application form through CDSCO Sugam
◆ Manufacturing or import license
◆ Product specifications and testing reports
◆ GMP compliance certificate
◆ Fee receipt of registration
Navigating CDSCO regulations can be complicated for startups and SMEs. PSR Compliance provides expert guidance for:
✅ Online CDSCO registration and login
✅ Preparing and verifying documents for submission
✅ Tracking CDSCO approved drug applications
✅ Staying updated with the CDSCO banned drugs 2024 list
✅ Assistance with CDSCO MD online medical device approvals
By partnering with PSR Compliance, businesses can focus on growth while ensuring full regulatory compliance.
A: CDSCO stands for Central Drugs Standard Control Organization.
A: CDSCO Sugam is the online portal for managing applications, submissions, and tracking of approvals for drugs and medical devices.
A: Approved drugs can be verified through the official CDSCO portal under the approved drug list section.
A: CDSCO MD online is the platform for medical device registration, classification, and post-market compliance.
A: The list is available on the official CDSCO website and should be checked before any manufacturing, import, or distribution.
A: Key documents include application form, manufacturing/import license, product specifications, GMP compliance certificate, and fee receipts
CDSCO is the backbone of drug and medical device regulation in India. Staying compliant ensures business credibility, patient safety, and avoids legal penalties. With digital services like CDSCO Sugam and CDSCO MD online, businesses can manage registrations efficiently.
For startups, SMEs, and healthcare entrepreneurs, partnering with PSR Compliance ensures a smooth CDSCO registration process, proper documentation, and timely approvals, helping you focus on business growth while staying fully compliant.