CDSCO Registration
Comprehensive CDSCO Registration Services in India
Tax Pal Solutions offers expert-led CDSCO registration for medical devices, drugs, cosmetics, and related products. Our team ensures regulatory compliance, smooth approvals, and proper documentation management to help your products enter the Indian market efficiently.
What is CDSCO?
The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory authority for pharmaceuticals, medical devices, and cosmetics. It oversees the manufacture, import, sale, and distribution of these products, ensuring safety, efficacy, and quality for public health.
Why CDSCO Registration Matters:
- Ensures product safety and efficacy
- Grants legal market access
- Approves new drugs and devices
- Standardizes nationwide regulatory practices
- Increases consumer trust and transparency
Types of CDSCO Registration
| Registration Type | Applicability | Outcome |
|---|---|---|
| Drug Manufacturing License | Indian manufacturers of drugs | Legal permission to produce medicines |
| Import License | Companies importing drugs, devices, cosmetics | Compliance with Indian quality standards |
| Registration Certificate for Drugs | Approved drugs | Legal distribution in India |
| Medical Device Registration | All medical devices sold in India | Safety verification and sale authorization |
| Clinical Trial Approval | Companies conducting trials | Ethical and regulatory clearance |
| GMP Certification | Manufacturing facilities | Quality assurance compliance |
| Certificate of Pharmaceutical Product (COPP) | Export of drugs | Proof of product approval in India |
Who Can Apply
- Importers: Entities importing drugs or medical devices
- Indian Agents: Representatives for foreign manufacturers
- Foreign Enterprises with Indian Subsidiaries: Apply through their subsidiary
- Domestic & Foreign Manufacturers: Medical devices, IVDs, and pharmaceuticals
- Research & Development Entities: For testing or clinical trials
Benefits of CDSCO Registration
- Legal Compliance – Meets Drugs & Cosmetics Act requirements
- Market Access – Sell in India, participate in tenders
- Enhanced Credibility – Trusted by consumers and healthcare professionals
- Quality Assurance – Verified safety and performance standards
- Competitive Advantage – Essential for government/private procurement
- Operational Efficiency – Avoid regulatory penalties
- International Recognition – Sometimes accepted globally
Product Categories Requiring CDSCO Registration
| Category | Examples |
|---|---|
| Pharmaceuticals | Vaccines, blood products, IV fluids, medicines |
| Medical Devices | Thermometers, BP monitors, diagnostic devices |
| Cosmetics | Skincare, haircare, personal care products |
| APIs (Active Pharmaceutical Ingredients) | Raw materials for drug formulations |
| Clinical Research Organizations | CROs conducting BA/BE studies and trials |
CDSCO Registration Process
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Access Portal – Login or sign up at CDSCO ePortal
-
Select Registration Purpose – Choose import, manufacture, clinical trial, or device registration
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Applicant Details – Provide type, organization info, and upload ID/address proofs
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Email Verification – Confirm account via the verification link
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Application Submission & Approval – CDSCO reviews application; approval completes registration
Key Documents Required
| Document | Purpose |
|---|---|
| Identity Proof | Verify applicant’s identity |
| Address Proof | Establish permanent address |
| Undertaking | Government attested compliance declaration |
| BA/BE Site Registration | For pharmaceutical testing sites |
| Manufacturing/Wholesale License | Legal authorization for production/distribution |
| Technical Product Details | Composition, specifications, intended use |
| Manufacturing Site Info | Process, raw materials, quality checks |
| QMS Certifications | ISO 13485 or equivalent for quality management |
| Clinical Data | Phase I-III trials for new products |
| Evidence of Conformity | Test and compliance reports |
| Labelling Details | Product name, batch, expiry, instructions |
| Ethics Committee Approval | Required for human clinical trials |
CDSCO Registration Fees
| Product Type | License/Registration | Fee Range |
|---|---|---|
| Medical Devices | Class A & B | License: ₹5,000; Device: ₹500 each |
| Medical Devices | Class C & D | License: ₹50,000; Device: ₹1,000 each |
| Import License (Devices) | Class A | ₹83,300/site; ₹4,165/product |
| Drugs | Biological Import | First: ₹10,000; Additional: ₹1,000 |
| Drugs | Registration Certificate | Premises: ₹8,33,000; Single drug: ₹4,16,500 |
| Cosmetics | Manufacturing | Up to 10 items/category: ₹10,000; Additional: ₹500/item |
| Cosmetics | Import | First category: ₹83,300; Variant: ₹4,165 |
Timeline for CDSCO Registration
| Product Type | Expected Duration |
|---|---|
| Class A Medical Devices | 1–3 months |
| Class B, C, D Devices | 6–9 months |
| New/Complex Products | 9–12+ months |
Challenges & Solutions
- Regulation Complexity – Seek expert guidance for compliance
- Extensive Documentation – Use detailed checklists for submission
- Indian Agent Requirement – Partner with a trusted local agent
- Delays & Queries – Submit complete applications; maintain communication
- Compliance with Device Rules – Follow Indian Medical Device Rules, ISO standards
- Labeling Errors – Ensure all mandatory info is included
- Ongoing Compliance – Regular audits and monitoring to maintain licenses
Certification
