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CDSCO import licence for medicines, devices and cosmetics
How to import drugs, medical devices or cosmetics into India: registration certificate, import licence forms, SUGAM portal, documents and the ₹1,000 fee CDSCO lists. Steps and official links.
Official sources checked: 2 Oct 2026
The short answer
How to import drugs, medical devices or cosmetics into India: registration certificate, import licence forms, SUGAM portal, documents and the ₹1,000 fee CDSCO lists. Steps and official links. Key facts: Issued by: Central Drugs Standard Control Organisation (CDSCO); Validity: As stated on the licence; Time: Online through the SUGAM portal.
Source: cdsco.gov.in. Not yet matched to an official page; confirm on the official portal before paying.
What it is
CDSCO controls the import of drugs, medical devices and cosmetics. For drugs, the overseas manufacturer's premises and products are first registered and a Registration Certificate is issued in Form 41. The Indian importer then applies for an import licence in Form 10.
Applications are made on CDSCO's online system SUGAM by the foreign manufacturer's local authorised agent, or by a foreign manufacturer that holds a wholesale licence in India. For medical devices the application is in Form MD-14 and the import licence is in Form MD-15.
Who needs it
Importers of drugs (bulk drugs and finished formulations), medical devices including in vitro diagnostics, and cosmetics. A retail drug licence for selling is a different state-level licence, covered on our drug licence page.
Official fees
| Fee | Official amount |
|---|---|
| Import licence in Form 10: one drug | ₹1,000Official document, older edition: not officially verified SourceFrom CDSCO's guidance document, which is undated. Confirm the current fee. |
| Import licence in Form 10: each additional drug | ₹100Official document, older edition: not officially verified SourceSame document. |
| Registration certificate for the foreign manufacturer (Form 41) | Charged in US dollarsNot officially verified SourceCDSCO charges the overseas manufacturer separately for the site and each drug. Check the current schedule on CDSCO. |
| Medical device import licence (MD-15) and cosmetics registration | See SUGAMNot officially verified SourceWe did not find a current official fee table. |
Fees and rules change and can differ between offices. Confirm the fee on the official portal before you pay. Amounts marked Not officially verified could not be checked on an official page.
Documents to keep ready
- Registration Certificate in Form 41 for the drug (issued to the manufacturer)
- Application for import licence in Form 8 and an undertaking in Form 9
- Power of attorney or authorisation for the Indian agent
- Challan or online payment receipt for the fee
- Wholesale licence of the Indian importer, where the Rules ask for it
- Notarised declarations and other papers listed in CDSCO's checklist
Steps to apply
- Check the import checklist for your product on the CDSCO site. CDSCO import checklist
- The overseas manufacturer applies for registration of its premises and drugs (Form 40) through its Indian agent. Fee: Check CDSCO
- When the Registration Certificate (Form 41) is issued, the importer applies for the import licence (Form 10) on SUGAM. CDSCO imports Fee: ₹1,000 + ₹100 each extra (dated)
- Keep the licence endorsed for each consignment as CDSCO requires.
Where to apply
- CDSCO imports and registration: Forms, checklists and SUGAM
- CDSCO guidance document: Registration and licence steps
Govt License is not a government website. We never take government fees or apply for you.
Medical devices and cosmetics
Medical devices (and in vitro diagnostic devices) are applied for on SUGAM in Form MD-14 and the import licence is Form MD-15. Cosmetics have their own registration under the Cosmetics Rules. The fee tables are on CDSCO's site; we do not copy an amount from them.
After you apply
What to do once the form is submitted: where to track it, how long it takes, why it gets rejected and what the law says if you do not have it.
Track your application
Typical time
For drugs, the Registration Certificate (Form 41) is issued within 9 months of a complete application, plus up to 3 more months in special cases. Apply online on the SUGAM portal
Checked on 5 Oct 2026 Source
If you operate without it
Importing drugs, cosmetics or medical devices without the needed registration and licence is an offence, and the goods can be seized. We could not read the Act text on an official page, so no amount is stated.
Law: Drugs and Cosmetics Act 1940 section 13; Customs Act 1962 section 111
Not officially verified
Common reasons for rejection and how to fix them
| Reason | How to fix it |
|---|---|
| Documents missing from the checklist | Upload every document in the CDSCO import checklist. |
| Manufacturer or product not registered | Get the registration certificate first, then apply for the import licence. |
| Wrong form or fee | Use the right form for your product and pay the fee on SUGAM. |
Not officially verified
Govt License is an independent guide. Fines and rules change, so confirm on the official portal. Items marked Not officially verified could not be checked on an official page.