Consulting Services for CDSCO Registration
Expert Support for Fast and Hassle-Free CDSCO Approvals.
Overview of Central Drugs Standard Control Organisation (CDSCO)
The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory authority responsible for ensuring the safety, quality, and effectiveness of drugs, medical devices, and cosmetics. Operating under the Ministry of Health & Family Welfare, CDSCO oversees product approvals, licensing, clinical trials, and compliance with national standards. It works alongside state drug authorities to regulate the import, manufacture, distribution, and sale of medical products across India. Through stringent evaluation and monitoring, CDSCO plays a crucial role in safeguarding public health and maintaining regulatory standards in the pharmaceutical and medical device sectors.
Key Features & Benefits
-
Medical Device Import : The Medical Device Import Certificate authorizes a company to legally import medical devices in compliance with regulatory standards.
-
Pharmaceuticals Import : The Pharmaceuticals Import Certificate allows a company to legally import pharmaceutical products while complying with regulatory standards.
-
Medical Device Manufacturing : The Medical Device Manufacturing Certificate authorizes a company to produce medical devices in compliance with regulatory standards.
-
Pharmaceuticals Export : The Pharmaceuticals Export Certificate permits a company to export pharmaceutical products in compliance with regulatory standards.
-
Clinical Trials : The Clinical Trials Certificate authorizes a company to conduct clinical research in compliance with regulatory and ethical standards.
-
New Drugs Development : The New Drugs Development Certificate authorizes a company to research and develop new pharmaceutical products in compliance with regulatory standards.
Quick Enquiry
🔒 100% Confidential • No Spam
Registration Process
How to Register online on SUGAM Portal
Visit CDSCO Portal
Access the SUGAM portal and start your online registration process.
Apply for Registration
Fill in the registration purpose and submit the application form online.
Fill Vital Details
Provide all required information, including the Registered Indian Address details.
Email Verification
Click the confirmation link sent to your registered email to activate your CDSCO account.
Submission to Authority
The activated application is sent to the concerned authority for approval.
Authority Review
The authority reviews the application and processes the registration with the applicable fee.
Approval Notification
Receive an approval email or rejection email on your registered email ID.
Registration Complete
Once approved, your CDSCO Registration is completed and ready for use.
Only Scanned Copies are Required
Mandatory Documents for CDSCO Registration
GST Certificate
Copy of the company's GST registration certificate.
Aadhaar & PAN
Aadhaar and PAN card of the authorized person.
IEC Certificate
Import Export Code of the company.
Power of Attorney
Power of Attorney along with undertaking from the authorized agent.
Wholesale / Manufacturing License
Valid license for wholesale or manufacturing of products.
Free Sale Certificate
Notarized certificate proving free sale of the product abroad.
Business & Manufacturing License
Business registration certificate and Manufacturing License (notarized).
Inspection Report
Any inspection report of the last 3 years, if available.
Quality Certifications
Any quality assurance certificate or CE certificate (notarized).
Plant & Device Master Files
Plant Master File and Device Master File details.
Product & Device Info
Descriptive information of the device, product specifications, variants, and accessories.
Labelling Info
Labelling information including labels, instructions for use, etc.
Regulatory Forms
Important Forms for Medical Devices & Cosmetics
MD-9
• For Medical Device Manufacturing
MD-14
• For Import of Medical Devices
MD-12
• For Test License of Medical Devices
MD-22
• For Clinical Trials of Medical Devices
COS-12
• For Manufacturing of Cosmetics
Form – 19
• For Import of API for Sale in India
Form – 45
• For Import of Bulk Drugs & APIs in India
Form CT – 27
• For Unapproved Drugs Manufacturing for Clinical Trials
Common Questions
CDSCO Registration FAQs
What is the Central Drugs Standard Control Organization (CDSCO)?
CDSCO, under the Directorate General of Health Services, Ministry of Health & Family Welfare, ensures the safety, efficacy, and quality of medical products manufactured, imported, and distributed in India. It has 8 divisions:
1. Bioavailability/Bioequivalence (BA/BE) studies
2. New Drugs Development and permissions
3. Import & Registration of Drugs and Cosmetics
4. Biological studies
5. Cosmetics regulation
6. Medical Device & Diagnostics permissions
7. The Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committee (DCC)
8. Clinical Trials
CDSCO permission to import new drug or investigational new drug
Any individual, institute, or business entity planning to import new drugs, formulations, or conduct clinical trials/BA/BE studies in India must obtain prior CDSCO permission before actual import.
CDSCO Registration to Import Drugs (Excluding Schedule X)
To import drugs not included in Schedule X, the entity must possess a drugs manufacturing or wholesale registration. Documents required:
1. Drugs wholesale/manufacturing business registration
2. Valid RC attested by the Indian agent/manufacturer
3. Permission from CDSCO under rule 122A for new drugs
4. Original labels/specimen labels for bulk drugs/finished formulation
CDSCO permission for manufacturing of medical devices
Documents required:
1. Undertaking detailing required facilities (equipment, instruments, personnel)
2. List of equipment and instruments
3. List of qualified personnel
4. Justification of quantity to be manufactured
5. Test protocols for finished devices
6. Quality management certificates from suppliers
7. Manufacturing license by State Pollution Control Board
8. Site layout / site plan
9. Certification of site with raw component details
10. DPR / Process Flow Chart
CDSCO permission for Import of Cosmetics
Documents required:
1. Covering letter mentioning purpose of application
2. Authorization from manufacturer (authenticated)
3. Filled Part-I of Second Schedule D
4. List of ingredients with percentage
5. Product labels
6. Specifications & testing methods
7. Pack insert
8. Manufacturing licenses / undertaking for no provision
9. Free Sale Certificate (authenticated)
10. Non-Animal Testing Declaration
11. Declaration for Heavy Metal and Hexachlorophene content
Procedure for online application to CDSCO
Visit the SUGAM portal of CDSCO → select type of certification → upload required documents → enter company details → pay registration fees → application is forwarded to concerned CDSCO officer → site inspection conducted → queries resolved → CDSCO certificate issued → permission granted.
Ready to Get Your CDSCO Registration?
Our experts will guide you through the entire CDSCO registration process quickly and efficiently, ensuring compliance with all regulations.
Talk to an Advisor Today