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CDSCO License Registration —
Drug & Medical Device License
Drug License · Medical Device Registration · Import License · Clinical Trial
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Everything Included in Your CDSCO License Service
From regulatory strategy to CDSCO approval — our RA experts handle every
step of your drug or medical device registration.
Regulatory Assessment
Dossier Preparation
SUGAM Portal Filing
Query Response Management
Inspection Coordination
Post-License Compliance
CDSCO License Types We Handle
We cover all CDSCO licenses and registrations under the Drugs & Cosmetics
Act and Medical Devices Rules, 2017.
Drug Manufacturing License
Pharmaceutical Manufacturing (Form 25/28)
DSCO approval for pharmaceutical drug manufacturing including allopathic, Ayurvedic, homeopathic, and biological drugs. Includes GMP compliance and site inspection coordination.
Drug Import License
Form 10 / Schedule D Import Authorization
CDSCO import license for bringing pharmaceutical drugs, raw materials, and Active Pharmaceutical Ingredients (APIs) into India. Required for customs clearance and market authorization.
Medical Device Registration
MDR 2017 — Class A, B, C, D Devices)
Registration of medical devices under Medical Devices Rules 2017. Class A/B devices on SUGAM portal, Class C/D require clinical evaluation. Covers diagnostics, implants, equipment.
Clinical Trial Authorization
CTA — New Drug Approvals (NDA))
CDSCO approval to conduct clinical trials for new drugs, biologicals, and medical devices in India. Includes Ethics Committee approval, CTRI registration, and CDSCO CTA application.
Cosmetics License
Cosmetic Import & Manufacturing)
CDSCO license for manufacturing or importing cosmetics in India under Schedule S of the D&C Act. Required for all cosmetic products including skin care, hair care, and color cosmetics.
In-Vitro Diagnostic (IVD) Kit
Diagnostic Reagents & Test Kits
CDSCO registration for diagnostic kits, reagents, test strips, and laboratory equipment used in clinical diagnosis. Includes COVID test kits, blood glucose meters, pregnancy tests.
Consequences of Non-Compliance with CDSCO
CDSCO and State Drug Controllers enforce strict action against unlicensed
pharmaceutical and medical device operations.
CDSCO Enforcement 2024: CDSCO conducted 500+ inspections and issued 200+ show cause notices to pharma and device companies for regulatory violations this year.
₹10 Lakh
10 Years Jail
Product Recall
License Cancelled
Import Seizure
Export Block
Why Get CDSCO License from Corpbiz
india's leading regulatory affairs consultancy for pharma and medical
devices with 3,000+ licenses and expert RA team.
3,000+
Licenses Issued
Expert
100%
Compliance
Pan India
Coverage
Market Authorization
Expert RA Team
Export Eligibility
Tender & Govt. Supply
Patient & Consumer Trust
Fast-Track Dossier Support
CDSCO License Process — 6 Key Steps
Our regulatory affairs team manages the complete CDSCO application from
regulatory strategy to license issuance.
STEP 1
Regulatory Strategy
Identify product classification, applicable regulations, license type, required data, and regulatory pathway for fastest approval.
STEP 2
Dossier Compilation
Prepare complete regulatory dossier including administrative, technical, quality, safety, and efficacy data in CDSCO-required format.
STEP 3
SUGAM Portal Filing
Submit application on SUGAM CDSCO portal with complete dossier and government fee. Receive application tracking number.
STEP 4
Query Response
CDSCO officer reviews application. We prepare and submit timely responses to technical queries and additional data requests.
STEP 5
Site Inspection
For manufacturing licenses, CDSCO/State Drug Inspector conducts GMP inspection. We prepare your facility and documentation.
STEP 6
License Issued
Receive CDSCO license certificate / registration number. Begin manufacturing, import, or sale with full regulatory authorization.
Documents Required for CDSCO License
Our RA team compiles and reviews all documents for a complete, query-free CDSCO application.
Company Registration
Certificate of Incorporation, MOA & AOA
Product Details
Complete product dossier with composition, specifications
Test Reports
Analytical test reports from accredited laboratory
GMP Certificate
WHO-GMP or Schedule M compliance certificate (for manufacturing)
Technical Staff
Qualifications of Competent Technical Staff (CTS) / Regulatory Officer
Manufacturing Premises
Site master file, layout, equipment list (for manufacturers)
Safety & Efficacy Data
Pre-clinical / clinical trial data as applicable for new drugs
Foreign Approval
Country of origin approval letter (for imported drugs/devices)
Labeling & Packaging
Proposed label, insert, and outer carton in CDSCO format
Who Needs CDSCO License
Any business manufacturing, importing, or selling drugs, medical devices, or cosmetics in India requires CDSCO approval.
Pharmaceutical manufacturers
Medical device companies
Pharma & device importers
Diagnostic kit manufacturers
Cosmetic importers & manufacturers
Clinical trial sponsors and trusted
Biotech & biologics companies
Hospital equipment suppliers
Frequently Asked Questions — CDSCO License
Get answers to CDSCO regulatory questions from our expert pharmaceutical
regulatory affairs team.
What is CDSCO and what does it regulate?
CDSCO (Central Drugs Standard Control Organisation) is India’s national regulatory authority under the Directorate General of Health Services, Ministry of Health. It regulates: drugs and pharmaceuticals (approval, manufacturing, import), medical devices (registration and quality standards), clinical trials and new drug approvals, cosmetics imports, and biological products. It operates under the Drugs & Cosmetics Act, 1940 and Medical Devices Rules, 2017.
What is the difference between CDSCO and State Drug Control?
CDSCO is the Central authority handling new drug approvals, import licenses, clinical trials, and medical device registrations. State Drug Controllers (Licensing Authorities) handle state-level manufacturing licenses, wholesale/retail drug licenses, and regulatory enforcement. For most pharmaceutical manufacturers, both CDSCO approval (Central) and State Drug Manufacturing License are required. Corpbiz coordinates with both Central and State authorities.
How are medical devices classified under MDR 2017?
Under Medical Devices Rules 2017, devices are classified into: Class A (Low Risk — stethoscopes, bandages, glasses), Class B (Low-Moderate Risk — MRI machines, ultrasound, hearing aids), Class C (Moderate-High Risk — CT scanners, implantable devices, dialysis machines), Class D (High Risk — pacemakers, active implantable devices, HIV test kits). Class A/B registration is done on SUGAM portal with self-declaration. Class C/D require clinical evaluation and CDSCO review.
What is the SUGAM portal?
SUGAM is CDSCO’s online regulatory submission portal (sugamhpb.gov.in) for filing pharmaceutical and medical device applications. All CDSCO applications including drug import licenses, new drug approvals, and medical device registrations are now filed online through SUGAM. Corpbiz has extensive experience navigating the SUGAM portal for all types of applications.
What is Schedule M and why is GMP compliance important?
Schedule M of the D&C Act lays down GMP (Good Manufacturing Practice) requirements for pharmaceutical manufacturing in India. The revised Schedule M (2023) aligns Indian GMP with WHO and international standards. CDSCO mandates Schedule M compliance for manufacturing licenses and inspects facilities against these standards. Corpbiz helps pharmaceutical manufacturers achieve Schedule M compliance and prepares them for CDSCO GMP inspections.
What is a Clinical Trial Authorization (CTA)?
CTA is CDSCO’s approval to conduct clinical trials for new drugs, biologicals, fixed-dose combinations, or new indications in India. The process includes: registered Ethics Committee approval, CTRI (Clinical Trials Registry India) registration, CDSCO CTA application with pre-clinical data. Phase I-IV trials all require CTA. Bioequivalence studies and BA/BE studies also require CDSCO approval. Corpbiz supports clinical trial sponsors through the complete CTA process.
What cosmetics require CDSCO import license?
All cosmetics imported into India require an import license from CDSCO under Schedule S of the D&C Act. This includes: skincare (creams, serums, sunscreen), haircare (shampoo, conditioner, hair dye), color cosmetics (lipstick, foundation, mascara), fragrances, and personal care products. The importer must register with CDSCO and obtain an import NOC per product. Corpbiz handles cosmetic import license applications for brands, distributors, and e-commerce importers.
How long does CDSCO license approval take?
CDSCO approval timelines vary by product type: Medical Device Class A/B: 30-90 days. Class C/D: 3-9 months. Drug Import License: 3-6 months. New Drug Approval: 12-24 months. Clinical Trial Authorization: 6-12 months. Cosmetic Import: 2-4 months. Corpbiz’s expert dossier preparation minimizes queries and delays to achieve fastest possible approvals.
What is required for medical device import from China or USA?
For importing medical devices, you need: CDSCO import license for each device, registration certificate on SUGAM portal, Indian Authorized Agent (IAA) appointment, device classification confirmation, country of origin approval certificate, test reports, and manufacturer’s authorization letter. Class C/D devices also require clinical evaluation data. Corpbiz has extensive experience with medical device import registrations from China, USA, Germany, Japan, and other manufacturing countries.
What is a CoPP (Certificate of Pharmaceutical Products)?
CoPP (Certificate of Pharmaceutical Products) is issued by CDSCO to Indian pharmaceutical manufacturers for drug exports. It certifies that the drug is manufactured in compliance with Indian GMP standards and is licensed for sale in India. Most importing countries require a CoPP from CDSCO before granting market authorization for Indian pharma exports. Corpbiz assists pharma manufacturers in obtaining CoPP for key export markets including Africa, ASEAN, and GCC countries.
Why choose Corpbiz for CDSCO license?
Corpbiz has processed 3,000+ CDSCO licenses with a dedicated regulatory affairs team including ex-pharmaceutical industry professionals and former CDSCO consultants. We handle the complete regulatory strategy, dossier preparation, SUGAM filing, query responses, and GMP inspection preparation. Our deep expertise spans drugs, medical devices, cosmetics, clinical trials, and CoPP applications — making us India’s most trusted CDSCO license consultancy.
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