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CDSCO Import License

A CDSCO Import License is the central approval you need to legally import drugs, cosmetics, medical devices or in-vitro diagnostics...

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Key takeaways

A CDSCO Import License authorises the import of drugs, cosmetics, medical devices and in-vitro diagnostics into India.
It is granted by the Central Drugs Standard Control Organisation (CDSCO) under the Drugs and Cosmetics Act, 1940.
Applications are filed online through the CDSCO SUGAM portal.
A foreign manufacturer must appoint an Indian Authorised Agent who holds a valid wholesale or manufacturing licence.
The product category decides the form: Form 41 (registration), Form 10 (drug import) or the Medical Devices Rules forms for devices and IVDs.
Importers must hold a Free Sale Certificate and quality documentation from the country of origin.
Licences are typically perpetual subject to retention fees, with registrations renewed in line with the applicable rules.

Overview

What is a CDSCO Import License?

A CDSCO Import License is the central government approval that allows a business to bring regulated health and personal-care products into India. It is issued by the Central Drugs Standard Control Organisation (CDSCO), the national regulatory authority that works under the Directorate General of Health Services, Ministry of Health and Family Welfare.

The licence confirms that imported products meet Indian safety, efficacy and quality standards before they reach the market. Whether you import finished medicines, bulk drugs, cosmetics, surgical instruments or diagnostic kits, you cannot lawfully clear them through customs and distribute them without the appropriate CDSCO registration and import licence.

Products that need a CDSCO import licence

Finished formulations and bulk drugs (APIs)
Medical devices and surgical instruments
In-vitro diagnostic (IVD) kits and reagents
Cosmetics manufactured outside India
Vaccines, sera and biological products
Disinfectants and notified health products

Types of CDSCO import licence

The exact licence and application form depend on the product category. Each is governed by the Drugs and Cosmetics Act, 1940 and the specific rules made under it, such as the Medical Devices Rules, 2017 and the Cosmetics Rules, 2020.

Product	Approval required
Drugs (finished & bulk)	Registration Certificate in Form 41, followed by an import licence in Form 10.
Cosmetics	Import Registration Certificate in Form COS-2 under the Cosmetics Rules, 2020.
Medical devices	Import Licence in Form MD-15 under the Medical Devices Rules, 2017.
In-vitro diagnostics	Import Licence in Form MD-15, with the device classified by risk (A to D).

Key role	Responsibility
Foreign manufacturer	Holds the product, site and quality documentation submitted to CDSCO.
Authorised Agent	India-based licence holder who files and holds the import approval.
Importer / Indenting Agent	Clears, stores and distributes the goods after approval.
CDSCO	Reviews the dossier, queries gaps and grants the licence.

Applicability

Who needs this licence?

Any business that imports regulated drugs, cosmetics, medical devices or diagnostics into India for sale, distribution or use must hold the relevant CDSCO approval. A foreign manufacturer cannot apply directly; it must work through an Indian Authorised Agent who holds a valid wholesale or manufacturing licence.

Importers and trading houses bringing in finished medicines
Distributors of imported medical devices and surgical equipment
Diagnostic laboratories importing IVD kits and reagents
Brands importing finished cosmetics into India
Pharmaceutical companies sourcing bulk drugs and APIs
Indian subsidiaries acting as agents for overseas manufacturers

How it works

The application process, step by step

The process is fully online through the CDSCO SUGAM portal. The path differs slightly between drugs, cosmetics and medical devices, but the broad stages are consistent.

Drugs (Form 41 & 10)

Appoint an agent
The foreign manufacturer authorises an Indian agent holding a valid wholesale or manufacturing licence.
Registration
File Form 40 on SUGAM to obtain the Registration Certificate (Form 41) for the manufacturing site and products.
Import licence
Apply in Form 8 / 9 for the import licence in Form 10 against the registered products.
Grant
CDSCO reviews the dossier, raises queries if any, and issues the licence for legal import.

Devices & cosmetics

Classify
Determine the device risk class (A to D) or confirm the cosmetic category before filing.
Compile the dossier
Assemble the Free Sale Certificate, ISO/quality certificates and the device master or product file.
Submit
File Form MD-14 for devices or Form COS-1 for cosmetics on the SUGAM portal.
Grant
CDSCO assesses safety and quality and issues Form MD-15 or Form COS-2.

Paperwork

Documents required

Covering letter and the prescribed application form (Form 40, MD-14 or COS-1)
Power of Attorney appointing the Indian Authorised Agent
Wholesale or manufacturing licence of the importer or agent
Free Sale Certificate from the country of origin
Manufacturing licence and site / GMP certificate of the foreign unit
ISO 13485 or equivalent quality certificate (for devices)
Product details, specifications and labels / artwork
Schedule D(I) and D(II) information, where applicable

Lifecycle

Validity & renewal

The drug import licence in Form 10 remains valid subject to payment of the prescribed retention fee.
A Registration Certificate (Form 41) is generally valid for 3 years unless suspended or cancelled.
Medical device and cosmetic import registrations are perpetual, subject to retention fees and continued compliance.
Approvals can be suspended or cancelled by CDSCO for non-compliance or safety concerns.

Need related approvals? See our Cosmetic License and BIS Certification services.

Budgeting

Fees, timeline & cost factors

Government fees are charged per site and per product in US dollars or rupees, depending on the category, and they vary with the number of products and the device risk class. The typical components are:

Cost factor	Details
Registration / site fee	Payable per manufacturing site covered in the dossier.
Per-product fee	Charged for each distinct product or device endorsed on the licence.
Retention fee	Periodic fee to keep a perpetual licence in force.
Documentation & filing	Dossier preparation, agent appointment and SUGAM submission.
Timeline	Typically 3 to 9 months, depending on category, completeness and CDSCO queries.

Not sure which form you need?

Tell us what you import and where it is made, and we will map the exact licence, forms, documents and timeline for your products.

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Why it matters

Benefits of a CDSCO import licence

Legal import

Clear customs and distribute regulated products without the risk of seizure, penalties or detention.

Smooth clearance

A valid registration and licence streamline port clearance and supply continuity.

Market credibility

Hospitals, pharmacies and distributors prefer importers with CDSCO approvals in place.

Patient safety

Approved products meet Indian safety, efficacy and quality standards.

Partner confidence

Overseas manufacturers trust agents who maintain valid Indian approvals.

Scalable portfolio

Add new products and sites to your approvals as your import business grows.

Why Diligence Certifications

Your import-licensing partner

CDSCO import approvals turn on a precise dossier, the right form for the product, and clear handling of every query the authority raises. Our regulatory team manages the full lifecycle so your goods reach the market without avoidable delay.

Correct classification of drugs, devices, IVDs and cosmetics
Authorised Agent appointment and Power of Attorney drafting
Complete dossier assembly and SUGAM filing on your behalf
Proactive responses to CDSCO queries and deficiency letters
Retention-fee tracking and renewal reminders
End-to-end support from registration to import licence

FAQ

Frequently asked questions

What is a CDSCO Import License?

It is the central approval issued by the Central Drugs Standard Control Organisation that allows a business to legally import drugs, cosmetics, medical devices or in-vitro diagnostics into India under the Drugs and Cosmetics Act, 1940.

Can a foreign manufacturer apply directly?

No. A foreign manufacturer must appoint an Indian Authorised Agent who holds a valid wholesale or manufacturing licence, and the agent files and holds the import approval on the manufacturer’s behalf.

Which form applies to my product?

Drugs require a Registration Certificate in Form 41 and an import licence in Form 10; medical devices and IVDs use Form MD-15; and cosmetics use the import registration Form COS-2 under the Cosmetics Rules, 2020.

How are applications submitted?

All applications are filed online through the CDSCO SUGAM portal, where you upload the dossier, pay the fees and track the status of your application.

How long does approval take?

It usually takes 3 to 9 months, depending on the product category, the completeness of the dossier and how quickly CDSCO queries are resolved.

How long is the licence valid?

Drug and device import licences are generally perpetual subject to retention fees, while a drug Registration Certificate is typically valid for three years. All approvals depend on continued compliance and can be suspended or cancelled by CDSCO.

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