Drug Import Licence (CDSCO Form 10 & Form 41)
Importing medicines or bulk drugs into India for sale takes two approvals from CDSCO: a Registration Certificate in Form 41 for the foreign manufacturer and its product, then an import licence in Form 10 for the Indian importer. You apply for both on the SUGAM portal. We prepare the dossier, file the forms and stay on the file until both are granted.
What it is
A drug import licence is CDSCO’s permission for an Indian business to bring a specific drug, made at a specific foreign site, into India. It covers finished formulations such as tablets and injections. It also covers bulk drugs (active pharmaceutical ingredients) that Indian manufacturers buy for production.
The law is the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945. First, the foreign manufacturer’s premises and each drug are registered: the application is in Form 40 under Rule 24A and the Registration Certificate is issued in Form 41 under Rule 27A. Then the Indian importer applies in Form 8 under Rule 24 and receives the import licence in Form 10 under Rule 23. Drugs listed in Schedule X use Form 8A and Form 10A instead. Applications are filed on CDSCO’s SUGAM portal (cdscoonline.gov.in).
Who it applies to
Importers of finished medicines
Pharma distributors and marketing companies that buy formulations from an overseas manufacturer and sell them in India under that manufacturer’s registration.
Manufacturers buying bulk drugs
Take a tablet unit in Faridabad that switches to an API from an overseas supplier. That API, and the plant it comes from, must be covered by a Registration Certificate and an import licence before the first lot ships.
Indian agents of foreign companies
The Indian authorised agent files Form 40 on behalf of the foreign manufacturer, backed by a power of attorney, and is answerable to CDSCO for the product.
Why it matters
No licence, no clearance
Drugs can only enter through the ports named in Rule 43, where CDSCO port offices check the Registration Certificate and import licence before customs clearance.
It ties quality to a named site
The Registration Certificate covers a named manufacturing site and named drugs, so anyone can trace where a batch was made.
Buyers ask for it
Distributors, hospitals and tender authorities ask for both certificates before they buy an imported drug.
Documents required
From the Indian importer
- Wholesale drug licence (Form 20B/21B) or a drug manufacturing licence
- Company or firm constitution documents
- Import Export Code and GST registration
- Covering letter and authorisation for the person signing
From the foreign manufacturer
- Power of attorney appointing the Indian agent, duly authenticated
- Manufacturing licence, GMP certificate, Free Sale Certificate and Certificate of Pharmaceutical Product (COPP)
- Plant Master File and Drug Master File
- Undertaking in Form 9 and the information in Schedule D(I) and D(II)
For the product
- Specimen labels meeting Rule 96
- Permission under the New Drugs and Clinical Trials Rules, 2019, if it is a new drug
- List of drugs with strengths and pack sizes
How it works
Check whether it is a new drug
This step decides the whole route. We confirm whether the drug is a “new drug” under the NDCT Rules, 2019. If it is, permission in Form CT-18 (application) leading to Form CT-19 or CT-20 is needed before the import route opens.
Get your State drug licence first
The importer needs a wholesale or manufacturing licence from the State Drugs Controller. For a Faridabad or Gurugram business that means the Haryana drugs control office. If you are starting fresh, we arrange your wholesale drug licence first.
File Form 40 for registration
We collect the manufacturer’s dossier and check each document against CDSCO’s checklist. Here is the catch: foreign documents often arrive unauthenticated or with a site address that differs from the GMP certificate. We fix those before we pay the fee and file Form 40 on SUGAM.
Reply to queries until Form 41 is issued
CDSCO examines the dossier and may raise queries. We draft replies with the manufacturer until the Registration Certificate is granted.
Apply in Form 8 for the import licence
With Form 41 in hand, we file Form 8 with Form 9 and get the import licence in Form 10. Your shipments can then clear at the notified port.
Registration Certificate vs import licence
| Registration Certificate | Import licence | |
|---|---|---|
| Covers | Foreign manufacturing site and each drug | The Indian importer’s right to import those drugs |
| Forms | Form 40 → Form 41 (Rules 24A, 27A) | Form 8 → Form 10 (Rules 23, 24); Form 8A → 10A for Schedule X |
| Government fee | USD 10,000 for the site and USD 5,000 per drug, as stated in CDSCO’s import FAQ | ₹10,000 for one drug and ₹1,000 for each additional drug (Rule 24) |
| Time limit | Nine months, extendable by three months (Rule 27A) | Granted after the Registration Certificate |
| Validity | Three years | Three years (Rule 28) |
Timelines
Registration within nine months
Rule 27A requires CDSCO to issue Form 41 within nine months of receiving a complete application. It may extend this by three months, with reasons recorded in writing.
Import licence lasts three years
Under Rule 28 the Form 10 licence is valid for three years from issue, unless suspended or cancelled earlier.
Renew before expiry
If you apply for renewal at least three months before expiry, the existing licence continues until CDSCO decides. In practice, we put re-registration of Form 41 on the same calendar, so the two never fall out of step.
What happens if you import without a licence
Your consignment waits at the port
The CDSCO port office will not clear it without a valid Form 41 and Form 10 for that drug and that site. Every day of waiting adds demurrage.
Seizure and prosecution
Importing a drug without a licence is an offence under the Drugs and Cosmetics Act, 1940, and the consignment can be seized.
Stock you cannot sell
Drugs that entered without a valid licence cannot lawfully be stocked or sold, so the money tied up in them is stuck.
Frequently asked questions
What is the difference between Form 41 and Form 10?
Form 41 registers the foreign manufacturer’s site and its drugs, while Form 10 licenses the Indian importer. You need both, in that order. The Registration Certificate is applied for in Form 40 under Rule 24A, and the import licence in Form 8 under Rule 24. CDSCO will not issue Form 10 for a drug that is not covered by a valid Form 41.
Who can apply for a drug import licence?
An Indian business holding a valid wholesale drug licence or a drug manufacturing licence can apply. It acts as the authorised agent of the foreign manufacturer, backed by an authenticated power of attorney. A private limited company, LLP, partnership or proprietorship can qualify, as long as the State licence is in place first.
How much is the government fee for Form 10?
Rule 24 sets the import licence fee at ₹10,000 for a single drug and ₹1,000 for each additional drug in the same application. The Registration Certificate in Form 41 carries a separate fee in US dollars, payable in the rupee equivalent. We list every fee in your quote so nothing comes as a surprise.
How long does the Registration Certificate take?
Rule 27A gives CDSCO nine months from receipt of a complete application to issue Form 41. In exceptional cases it may take three more months, with reasons recorded in writing. A complete dossier on day one keeps you well inside that window, because most of the waiting comes from back-and-forth on missing documents.
How long is the import licence valid?
A Form 10 import licence is valid for three years from the date of issue under Rule 28, unless it is suspended or cancelled sooner. If you apply for renewal at least three months before it expires, the old licence continues until CDSCO decides. We track both dates for you.
Do new drugs follow the same route?
Not at first. A new drug under the New Drugs and Clinical Trials Rules, 2019 needs import permission before the usual route applies: you apply in Form CT-18 and receive permission in Form CT-19 or CT-20. A drug generally stays a new drug for four years from its first approval, and some categories longer. We check the status before filing anything.
Can I import a small quantity for testing first?
Yes. Rule 33 of the Drugs Rules, 1945 allows small quantities to be imported for examination, test or analysis under a test licence in Form 11, applied for in Form 12. The drugs cannot be sold and records must be kept. New drugs for clinical trials use Form CT-16 and CT-17 instead.
Which ports can imported drugs come through?
Only the ports listed in Rule 43 of the Drugs Rules, 1945, where CDSCO has port offices to check licences. These include major sea ports such as Chennai, Kolkata and Mumbai and notified air cargo terminals. Tell your freight forwarder early so the shipment is routed to a notified port.
What it costs
Our fee plus the government fee that applies to your case, quoted before you commit. Tell us the situation and we will price it exactly.
Government fees: ₹10,000 for the first drug and ₹1,000 for each additional drug on the import licence (Rule 24), plus the Registration Certificate fee shown in the table above. CDSCO may also charge an inspection fee if it decides to inspect the overseas site.
Our role
We handle the regulatory side: the eligibility check, dossier review, SUGAM filing and fees, query replies, and later the renewals and change notifications. Technical documents such as the Drug Master File, stability data and GMP certificates come from the manufacturer, and any testing is done by approved laboratories. We do not run a lab or certify product quality ourselves.
Ready to begin?
Share the drug list and the manufacturer’s details, and we will map the Form 41 and Form 10 route, fees and documents for you.