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- Import License For CDSCO is mandatory for businesses importing drugs, cosmetics, or medical devices into India under the Drugs and Cosmetics Act, 1940
- Whether you need a Drug import license, Cosmetic import license, or Medical Devices Import License, understanding CDSCO’s documentation, registration timelines, and inspection protocols prevents costly shipment detentions at customs
- The application process involves Form 10A submission, site inspections, and compliance documentation with state drug authorities or CDSCO headquarters
- Processing timelines range from 45-90 days depending on product category, with license validity between 3-5 years requiring periodic renewals
Introduction
Importing health-related products into India is not as easy as clearing customs and delivering the goods. Every shipment of pharmaceuticals, medical devices, or health supplements that crosses the Indian border has passed through an important regulatory checkpoint – the Central Drugs Standard Control Organization (CDSCO). As the pharmaceutical regulatory body in India, CDSCO has the power to say what goods come into the healthcare supply chain in India.
Whether you are a multinational pharmaceutical company, medical device distributor or startup that is generating new health innovations in the Indian market, it is non-negotiable to engage with the regulatory framework that is CDSCO Certification. This organization has a defined mandate: to protect 1.4 billion people by ensuring that every health product imported in India is subject to review before its products are placed on pharmacy shelves, hospital wards or clinic cabinets.
But CDSCO is not simply a gatekeeper for accessing the healthcare market in India. CDSCO is the architect that builds the infrastructure for pharmaceuticals arriving in India, setting standards that are aligned with global best practices while responding to the needs of the Indian healthcare context. Life saving drugs for managing cancer, surgical devices, Ayurvedic herbal remedies, diagnostics are just a few samples of the products that are exposed to the oversight of the CDSCO framework.
Last month, a Mumbai-based distributor called our office in near-panic. His shipment of orthopedic surgical kits—worth ₹47 lakhs—was stuck at Nhava Sheva port for three weeks. Customs wouldn’t release it because he thought a general IEC code would suffice. He didn’t realize medical devices required a separate Import License For CDSCO before the consignment even left Germany.
Understanding CDSCO’s Role in Import Regulation
The CDSCO or Central Drugs Standard Control Organization is India’s primary health regulator for imported goods, and operates under the Ministry of Health and Family Welfare. The CDSCO has the responsibility of administering the Drugs and Cosmetics Act, 1940. The CDSCO ensures that any health product (which includes the broad categorization of all kinds of pharmaceutical products, medical devices, diagnostic kits, and health supplements) is proven to be safe and of quality before being consumed.
The CDSCO has developed a regulatory framework that is based on a risk-based system; for example high risk products like new drugs, biologics and implantable medical devices undergo substantial review and appraisal that includes clinical data review and inspection of the manufacturing facility. Lower risk products like common generics and Class A medical devices can have an accelerated path through to regulatory approval that shortens time to market approval while protecting the safety of consumers.
What is CDSCO?
The CDSCO, which stands for Central Drugs Standard Control Organization, is India’s main health authority for imported products, and is a part of the Ministry of Health and Family Welfare. The CDSCO is responsible for the administration of the Drugs and Cosmetics Act, 1940. The CDSCO makes sure that the health product (which includes the broad categorization of all kinds of pharmaceutical products, medical devices, diagnostic kits, and health supplements) is established to be safe and quality prior to being provided to consumers.
What is Import License For CDSCO?
A CDSCO import license is the official approval to import regulated health products into India. When you import medicines, cosmetics, or medical devices and accessories, your CDSCO import license indicates to the CDSCO that you have authorized regulated health products that will be safe for consumers.
The import licensing process exists for a very good reason – public health protection. To incentivize importers to adhere to a proper licensing process, the Cosmetic Drug Safety Control Organization has created a framework to ensure quality control and accountability in the supply chain along with transparency and traceability in the distribution system. The licensing process provides assurance that the products have not been illegally replicated, the labeling is appropriate, and the products meet quality standards, which are enforced in the import ecosystem.
Types Of CDSCO Import License
The Central Drugs Standard Control Organization (CDSCO) regulates imports of health and beauty products into India through specialized licenses. Here’s what you need to know:
Three Main License Types
Cosmetics License
- Covers: Skincare, makeup, hair care, fragrances, oral care
- Timeline: 4-8 weeks approval
- Validity: 3 years
Drug Import License
- Covers: Prescription meds, OTC drugs, vaccines, APIs, biologicals
- Forms: Form 10 (sale/distribution), Form 10A (testing), Test license (clinical trials)
- Timeline: 6-24 months depending on drug type
- Validity: 3 years
Medical Device License
- Covers: Diagnostic equipment, surgical tools, implants, IVD devices
- Risk classification: Class A (low) to Class D (high risk)
- Timeline: 4-6 months registration + 2-3 months license
- Validity: 5 years
1. Cosmetic Import License in India
Cosmetics and skincare products are becoming increasingly popular in India, and as such, many brands are likely to explore access to revenue opportunities in this burgeoning market. However before importation, sale or distribution of any cosmetic product in the territory of India, the law requires a Cosmetic Import License to be issued by the Central Drugs Standard Control Organization (hereafter the CDSCO), pursuant to the provisions in the Drugs and Cosmetics Act, 1940.
The cosmetic import license ensures safety, quality, and labeling standards for cosmetic products imported into India are maintained and verified by CDSCO. Obtaining a cosmetic import license is important for the protection of Indian consumers from toxic or harmful ingredients, and for certifying the compliance of its imported cosmetics to safety standards aligned to those of the exporting country in addition to complying with international best standards.
Who needs cosmetic import licensing?
Any Indian entity (importer, distributor, and/or authorized agent) who wishes to import finished cosmetic products into India must obtain a cosmetic import license. To apply for a cosmetic import license, the applicants must also have a valid wholesale/manufacturing license under Form 20C or 20D and have authorization from a foreign manufacturer.
Common Cosmetic Products Requiring CDSCO Import License
| Category | Examples of Products |
| Skin Care | Moisturizers, Sunscreens, Face Creams, Serums |
| Hair Care | Shampoos, Conditioners, Hair Oils, Hair Colorants |
| Makeup | Lipsticks, Foundations, Mascaras, Eyeliners |
| Fragrance & Deodorants | Perfumes, Body Sprays, Deodorants |
| Personal Care | Soaps, Shaving Creams, Lotions, Body Wash |
| Nail Products | Nail Polish, Nail Removers, Nail Serums |
| Baby Cosmetics | Baby Lotion, Baby Shampoo, Baby Oil |
2. Drug Import License
The Drug Import License is mandatory for importing any pharmaceutical product, whether finished formulations or bulk drug substances, into India. The CDSCO evaluates each drug’s safety, efficacy, and quality before approving it for import.
Who Needs It ?
- Indian agents of foreign manufacturers
- Indian pharmaceutical importers or distributors
- Contract manufacturers importing bulk APIs
Types of Licenses
| License Type | Purpose |
| Form 10 | Import of commercial drugs (other than Schedule X) |
| Form 10A | Import of drugs for testing and analysis |
| Form 11 | Import of drugs in small quantities for research or personal use |
Common Drug Categories Requiring CDSCO Import License
| Drug Type | Examples of Products |
| Antibiotics | Amoxicillin, Azithromycin, Ciprofloxacin |
| Painkillers & Anti-inflammatory | Ibuprofen, Paracetamol, Diclofenac |
| Cardiovascular Drugs | Atorvastatin, Amlodipine, Metoprolol |
| Anti-Diabetic Medicines | Metformin, Glimepiride, Insulin Injections |
| Vitamins & Nutraceuticals | Multivitamins, Vitamin D3, Omega-3 Capsules |
| Vaccines & Biologicals | Influenza Vaccine, Insulin, Monoclonal Antibodies |
| Oncology Drugs | Cisplatin, Paclitaxel, Imatinib |
3. Medical Devices Import License
The Medical Devices Import License is regulated under the Medical Device Rules, 2017, and it applies to all medical devices classified as Class A, B, C, and D, based on risk classification.
This license ensures that the imported devices conform to international safety, design, and performance standards prior to being sold in India.
Who Needs It
- Importers of diagnostic, surgical, or therapeutic devices
- Authorized Indian agents of foreign manufacturers
Common Medical Devices Requiring CDSCO Import License
| Device Category | Examples of Products |
| Diagnostic Equipment | X-ray Machines, CT Scanners, Ultrasound Systems |
| Surgical Instruments | Scalpels, Forceps, Scissors, Surgical Sutures |
| Implants & Prosthetics | Pacemakers, Stents, Hip Implants, Knee Implants |
| Monitoring Devices | Blood Pressure Monitors, Glucometers, ECG Machines |
| Therapeutic Devices | Nebulizers, Infusion Pumps, Dialysis Machines |
| Dental Devices | Dental Chairs, Orthodontic Brackets, Dental Drills |
| Ophthalmic Devices | Contact Lenses, Intraocular Lenses, Phaco Machines |
| Hospital Equipment | Ventilators, Defibrillators, Sterilizers |
Documents Required for All Import License Applications
Regardless of whether you are importing cosmetics, drugs or medical devices, there are several essential documents that are necessary for any CDSCO Import License application. This documentation consists of those that demonstrate the credibility of the importer, compliance with regulatory standards, and traceability of all imported products that are approved and permitted for importation into India.
Presented below is the complete listing of common documents needed for all CDSCO import license categories:
| Document Type | Description / Purpose |
| Importer’s PAN, GST, and CIN Certificate | Proof of the legal and financial identity of the importing company, ensuring business registration under Indian law. |
| Valid Import-Export Code (IEC) | Mandatory registration code issued by the Directorate General of Foreign Trade (DGFT) that authorizes import and export activities in India. |
| Product Details with Intended Use | A detailed description of the product, including category, specifications, and purpose of import (commercial sale, testing, or clinical use). |
| Authorization Letter / Power of Attorney | Legal authorization issued by the foreign manufacturer appointing the Indian applicant or importer as its authorized representative. |
| Authorized Signatory ID Proof | Copy of the PAN, Aadhaar, or passport of the authorized signatory submitting the CDSCO application. |
| Business Registration Certificate / Udyam Registration | Proof of business existence in India; applicable for proprietorships, partnerships, or companies. |
| Valid Wholesale or Manufacturing License (Form 20B/21B/20C/20D) | Demonstrates that the importer holds a valid license for storing, selling, or distributing regulated products in India. |
| Free Sale Certificate (FSC) from Country of Origin | Confirms that the product is freely sold and approved by the regulatory authority of the exporting country. |
| Undertaking for Compliance | A self-declaration ensuring adherence to all relevant CDSCO laws, labeling requirements, and post-import responsibilities. |
| Label and Packaging Details | Draft artwork and labeling details demonstrating compliance with CDSCO’s labeling norms and ingredient disclosure rules. |
| List of Products Applied for Import | Category-wise list of products with their trade name, dosage/form, and composition, for which the license is sought. |
| Quality Certificates (if applicable) | Certificates like ISO 9001, ISO 13485, or GMP that demonstrate adherence to recognized quality management systems. |
Process for CDSCO Import License
The Central Drugs Standard Control Organization (CDSCO) has a systematic and transparent process for drug, cosmetic, and medical device products. There are different application forms for each category, but the overall procedure is the same regardless of the product type.
Presented below is the common procedure for importers seeking CDSCO approval:
Step 1: Determine the Product Category
The applicant should first identify whether the product is a drug, cosmetic or medical device according to the CDSCO classification.
Step 2: Register on the CDSCO Portal
- All applications must be submitted through the Portal.
- To conduct import trade, Importers must set up an account via their company PAN, GST and IEC.
- Once their SYS account is approved, the user can use the import application form and upload documents electronically.
Step 3: Compile and Upload Required Documents
- Applicants must compile and upload all required documents including company details, product specifications, manufacturing licenses, test reports, and letters of authorization.
- It is required that all files are electronically signed using a valid Digital Signature Certificate (DSC).
Step 4: Complete and Submit the Relevant Application Form
A record of each type of product should be submitted using the relevant application form, as follows in the table below.
- Form 10 / 11 – Drug Import License
- Form 42 / 43 – Cosmetic Import License
- Form MD-14 / MD-15 – Medical Device Import License
- Each form requires accurate details of the manufacturer, product composition, and intended use.
Step 5: Application Review by CDSCO Officials
- The submitted application is reviewed by the CDSCO officer.
- If any clarification or document is missing, the officer raises a query through the portal.
- Applicants must respond promptly to avoid delays.
Step 6: Approval by Licensing Authority
- Once the review is complete, the application is forwarded to the Licensing Authority (CDSCO HQ or State Office) for final approval.
- After verification, the official Import License is granted.
Step 7: Receive Import License
The approved license is issued in digital form through the portal, allowing the importer to legally import and distribute the product in India.
CDSCO Import License: Fees, Timeline, Validity & Renewal
The Central Drugs Standard Control Organisation (CDSCO) administers the importation of cosmetics, drugs and medical devices for the protection of the health and safety of the public and in order to improve of the quality of the products – ensuring that safe, effective and high quality products are imported and made available in the Indian market.
Before importing products, every applicant should be aware of the fees, processing time, validity and renewal of all types of import licenses that are issued by CDSCO.
1. CDSCO Import License Fees
The import license fee depends on:
- The type of product (Drug, Cosmetic, or Medical Device)
- The number of variants or models
- The number of manufacturing sites included in the application
All payments are made digitally through the payment portal, linked with the CDSCO platform.
Applicants must upload the fee receipt along with other supporting documents during submission.
2. CDSCO Import License Timeline
The approval timeline for CDSCO import licenses varies depending on product classification, document completeness, and internal review.
On average, the approval process involves the following stages:
| Stage | Description | Estimated Duration |
| Application Review | Preliminary scrutiny of documents by CDSCO | Varies by product category |
| Query Resolution | Clarification or additional information requested | Depends on applicant response time |
| Technical Evaluation | Safety, labeling, and compliance review | Based on product complexity |
| Final Approval | Issuance of license after verification | Within standard regulatory timeframe |
3. Validity of CDSCO Import License
The validity of the import license differs depending on the category of product:
| License Type | Applicable Form | License Validity |
| Drug Import License | Form 10 / 11 | Valid for a fixed period as prescribed by CDSCO |
| Cosmetic Import License | Form 42 / 43 | Generally valid for a fixed tenure from the date of issue |
| Medical Device Import License | Form MD-14 / MD-15 | Valid for multiple years from issuance |
4. Renewal Process for CDSCO Import License
The renewal process is mandatory to continue importing after the expiry of the existing license.
Renewal can be completed online through the CDSCO Portal by following these steps:
Step-by-Step Renewal Process
- Login to the CDSCO Portal with your registered importer credentials.
- Select “Renewal” under the appropriate import license category.
- Upload updated documents, including:
- Existing license copy
- Renewal request letter
- Updated product list (if applicable)
- Latest fee payment receipt
- Submit the application online and monitor progress through the portal.
- Receive the renewed license in the same format upon approval.
5. Renewal Timeline and Compliance
To avoid any interruption in import activities, it’s recommended to apply for renewal well before the license expiry date.
| License Type | Renewal Application Period | Recommendation |
| Drug Import License | Before license expiry | Apply at least 1–2 months prior |
| Cosmetic Import License | Before license expiry | Apply 45 days in advance |
| Medical Device Import License | Before license expiry | Apply 2–3 months prior |
Why Choose Diligence Certifications for CDSCO Import License
Getting an import license from the CDSCO for drugs, cosmetics and medical devices can be quite difficult and lengthy. There are strict regulations, abundant documentation and even digitized submission of forms, and minor deficiencies, inaccuracies or mistakes in the forms can lead to delays or rejection. This is where Diligence Certifications can help – we are your trusted partner to help you have a painless, smooth and compliant process for your import license.
1. Expertise Across All Product Categories
We have extensive experience handling import licenses for drugs, cosmetics, and medical devices. Our experts help you:
- Correctly classify your product
- Identify the right CDSCO form and license type
- Prepare documents specific to your product category
2. Complete Documentation Support
Proper documentation is the backbone of a successful application. Our team assists in:
- Preparing product dossiers, master files, and compliance certificates
- Drafting Power of Attorney and authorization letters
- Ensuring all documents meet CDSCO’s digital submission standards
3. End-to-End Application Assistance
We handle the entire application process on your behalf:
- Accurate form filling
- Uploading digitally signed documents
- Payment verification and submission
- Tracking application status until license approval
4. Faster Approval & Risk Reduction
By working with us, you minimize common delays caused by:
- Missing or incomplete documents
- Misclassification of products
- Delayed responses to CDSCO queries
Our structured approach ensures faster approval and reduces the risk of rejection.
5. Post-License Compliance & Renewal Support
Our services don’t stop at license issuance. We provide ongoing support for:
- License renewal before expiry
- Updates on regulatory changes
- Record-keeping and compliance management
6. Trusted & Reliable Partner
With years of experience in regulatory approvals, Diligence Certifications is a trusted partner for importers in India and abroad.
- Transparent, client-focused approach
- Strong expertise in CDSCO regulations
- Commitment to accuracy, compliance, and efficiency
Conclusion
Obtaining an Import License for CDSCO is not a process of government bureaucracy or checking boxes, it is showing your product is in accordance to India’s public health standards. If you require a Drug import license for pharmaceuticals, a Cosmetic import license for beauty products, or a Medical Devices Import License for medical devices, the core components remain the same: completed documentation, manufacturer credentialing, and evidence of product safety.
The Mumbai distributor mentioned earlier? His story ended well. We helped secure an emergency import permission (a provisional mechanism CDSCO uses for critical devices), released his orthopedic kits under supervision, and processed his full license parallelly. He spent an extra ₹1.8 lakhs on demurrage and express consultancy fees—painful but manageable. The lessons stuck: he now starts license applications before placing purchase orders with European suppliers.
Your CDSCO Import License strategy should begin at the product sourcing stage, not at the shipping stage. Confirm manufacturer registrations, verify testing protocols, budget compliance costs, and establish timelines figuring a 90-120 days minimum. The importers that treat obtaining regulatory approval as the end step instead of the first step continue to spam memories of lost opportunity, credibility, and future sale.
If you plan to import therapeutic or cosmetic products to India, map your complete regulatory pathway before signing agreements with your supplier. The cost of getting it right the first time is always cheaper than correcting it once a crisis is already in place.
Frequently Asked Questions
What is a CDSCO Import License?
A CDSCO Import License is a legal document issued by the Central Drugs Standard Control Organization (CDSCO) that allows a company to import a drug, cosmetic or medical device into India. The CDSCO Import License would confirm the imported article complies with the relevant quality, safety and regulatory compliance.
Who would be required to have a CDSCO Import License?
Any Indian company wishing to import a drug, cosmetic or medical device would need to acquire a CDSCO Import License prior to importing the goods into India. This would include importers, distributors and Indian representatives of foreign manufacturers.
What types of CDSCO Import Licenses are there?
Import License for Drugs: Related to prescription medicine, OTC drugs, vaccines, and Active Pharmaceutical Ingredients ("APIs").
Import License for Cosmetics: Related to skincare, makeup, hair care products, fragrances, and personal care products.
Import License for Medical Devices: Related to diagnostic, therapeutic, surgical, and monitoring devices classified as Class A to Class D based on risk.
What documentation is required for a CDSCO Import License?
Generally, the following documentation would be required:
The importer must provide their PAN, GST and CIN.
Import-Export Code (IEC).
Details of the product and its intended use.
Letter of authorization from the manufacturer.
Digital Signature of authorized signatory.
Certificate of Free Sale (FSC) from the country of origin.
Label and packaging.
Quality certificates such as ISO or GMP, if applicable.
What is the process for obtaining a CDSCO Import License?
Determine the product category (drug, cosmetic, medical device)
Register on the CDSCO SUGAM portal
Compile and upload required documents
Submit the relevant form (Form 10/10A/11 for drugs, Form 42/43 for cosmetics, MD-14/15 for medical devices)
Respond to queries from CDSCO officials
Receive the approved digital license
How long does it take to get a CDSCO Import License?
Cosmetics: 4–8 weeks
Medical Devices: 4–6 months for registration + 2–3 months for license
Drugs: 6–24 months depending on type and complexity
What is the validity of a CDSCO Import License?
Cosmetics: Typically 3 years
Drugs: Typically 3 years
Medical Devices: Typically 5 years
Licenses must be renewed periodically before expiry to continue importing.
How can a CDSCO Import License be renewed?
Renewal is done online through the CDSCO portal by submitting:
Existing license cop
Renewal request letter
Updated product list, if applicable
Latest fee payment receipt
It is recommended to apply for renewal 1–3 months before expiry to avoid delays.
Can importing without a CDSCO license lead to penalties?
Yes. Importing regulated products without a valid CDSCO license can result in:
Seizure of goods at customs
Heavy fines or legal action
Suspension of future import applications
How can Diligence Certifications help with CDSCO Import License?
Diligence Certifications provides end-to-end support:
Expert guidance on product classification and license type
Complete documentation preparation and digital submission
Application tracking and query resolution
Renewal support and compliance management
