CDSCO import licence for drugs, cosmetics and medical devices
CDSCO must approve every drug, cosmetic and medical device before you bring it into India. That covers APIs for your own plant too. We prepare and file your application with you. Then our customs team clears the goods at the port.
It depends on what you import. Pick the case closest to yours.
What do you want to import?
You need a registration and an import licence
CDSCO first registers the foreign plant and each drug. Then it licenses your firm to import them. Your firm must hold a wholesale or manufacturing drug licence in India. It must also be the manufacturer's agent, named in its power of attorney. A new drug also needs CDSCO's new drug permission first.
You need an import registration
CDSCO registers each product with its category, foreign site, variants and pack sizes. The manufacturer, its Indian agent or subsidiary or an importer can apply. You need no drug licence. A cosmetic you import in bulk to fill in India also needs the filler's cosmetic manufacturing licence. A cosmetic with a new ingredient needs CDSCO's permission first.
You need an import licence
The manufacturer's authorised agent in India applies. It must hold a wholesale or manufacturing licence or a registration to sell devices. The licence names each device and each foreign site. A new device with nothing like it approved, or a new IVD, needs CDSCO's permission first.
Register it online
Class A is the lowest risk class. A Class A device that is neither sterile nor measuring needs no import licence. You register it on CDSCO's online system and get a registration number. A sterile or measuring Class A device needs the full licence.
You need a test licence
Drugs you import only for tests or analysis need a test licence from CDSCO. So do devices for tests, trials, demonstration or training. Cosmetics for research such as shelf life trials need no registration. But you ask CDSCO's port office for its go-ahead first.
You need no import licence
The import approval belongs to the importer you buy from. To stock and sell drugs you need a drug sale licence, wholesale or retail. To sell only devices you register with your state drugs controller.
Every CDSCO import approval starts with these. For drugs and most devices the manufacturer also names an agent in India. It is often the manufacturer's importer or its Indian subsidiary. We never act as that agent.
Your product classifiedClass
Papers from abroadOrigin papers
Your login on CDSCO's portalPortal
CDSCO approvalApproval
The papers CDSCO asks for
Forms and undertakings
The form for your route signed by your signatory. The manufacturer adds its undertakings. For cosmetics it promises no testing on animals.
The manufacturer's authorisation
It names the applicant in India. The manufacturer has it authenticated at a magistrate or an Indian embassy, or by apostille. Class A devices registered online need none.
Your licence in India
For drugs a wholesale or manufacturing drug licence. For licensed devices one of those or a registration to sell devices. Cosmetics need none, unless they come in bulk to fill here. Then the filler's cosmetic manufacturing licence goes in the file.
Papers from abroad
A free sale certificate, which shows the product is sold freely at home. For a device it can come from the USA, the UK, the EU, Canada, Japan or Australia instead. The plant's licence there. Drugs add GMP and product certificates. Devices add a quality system certificate.
Technical files
For drugs the plant file and each drug's data. For devices the plant and device master files. For cosmetics the full formula with percentages.
Tests
Drug samples from recent batches go to a government lab. Stability data goes with them. Devices need batch test reports. Cosmetics need specifications and test methods.
Labels
Label artwork that meets Indian rules. API labels carry a QR code.
Fee receipt
The government fee paid online. We work out the amount for your products and sites.
How we get your CDSCO import approval
We prepare the file and work through CDSCO's portal with you. You sign where the law asks you to.
We work out whether your product is a drug, a cosmetic or a device. Then we find its class and the approval it needs.
Your manufacturer sends its papers. We check that every name and address matches. Then we build the file in the order CDSCO asks for.
Your signatory signs the form and the undertakings. The manufacturer signs its own part.
We file it with you from your login on CDSCO's portal. CDSCO may ask questions or test samples. It may also inspect the plant abroad. We answer each query with you.
CDSCO issues the approval. For drugs the registration comes first. Then we file for the import licence.
Our customs team files your bill of entry with the approval. CDSCO's port officer checks the goods. Then we bring your medicines to our licensed site, or the goods to your warehouse.
How we keep your CDSCO approvals live
Each approval has its own dates and duties. We track them for you.
Drug registration and licence
Before it runs out
A drug registration runs for a set term. Your import licence ends with it. We apply for both early so they stay in force while CDSCO decides.
Retention fees
Before each due date
A cosmetic registration certificate and a device import licence have no end date. A retention fee keeps each one alive. We remind you before it falls due. Miss the grace period and it counts as cancelled. An import registration number runs for a set term. We renew it in time.
Changes reported
When something changes
A new pack size, label, site or address needs CDSCO's approval or a notice. For drugs a move to a new address needs a fresh registration. We file it within the time the rules allow.
Fresh registration
When ownership changes
A change in who owns your firm or the manufacturer, or in its legal form, needs a fresh registration. A merger counts. We file at once.
Checks before it ships
Before each shipment
We check that the approval covers the product, the site and the pack size. We check the labels and the shelf life left.
Recalls and alerts
When a regulator acts
If a regulator anywhere stops, restricts or fails your product, you stop sending it out here. CDSCO must hear at once. We help you report it. If we hold the stock we set that batch aside.
Import and sale records
All the time
You keep a record of each batch you import and who bought it. We keep the records for the stock we hold.
Your licence in India
All the time
Your drug approvals and device licences rest on your licence in India. We remind you before its retention fee falls due.
Where CDSCO imports go wrong
Most trouble starts with papers that disagree or dates nobody tracked.
What goes wrongWhat we do
What goes wrong: The authorisation names a product or an address the form does not. CDSCO comes back with a query.
What we do: We match every name, address and product across the form, the authorisation and the certificates.
What goes wrong: A free sale certificate leaves out one shade or variant.
What we do: We check each variant against the certificate before we file.
What goes wrong: Drugs, cosmetics or devices land at a port that is not on CDSCO's list. They cannot clear there.
What we do: We route them only through the listed ports and airports.
What goes wrong: A drug arrives with too little shelf life left. Or a cosmetic's use-before date is too close.
What we do: We check the dates on your supplier's papers before it ships.
What goes wrong: The drug registration runs out while the goods are at sea.
What we do: We track every date and apply early. The old registration then stays in force.
What goes wrong: The label leaves out the importer's name or the approval number.
What we do: We check the label artwork against the rules before it goes to print.
From the port to our licensed warehouse
Your CDSCO approval lets the goods in. We clear them at the port and store your medicines at a licensed site.
Cleared by our own team
Our customs team files your bill of entry with your CDSCO approval. We stay with CDSCO's port officer for the check and any samples.
A licensed site for medicines
Our sites hold a wholesale drug licence with a qualified person named on it. Your medicines come in from the port and wait at room temperature. We run no cold rooms.
One team from file to port
The team that files with CDSCO also clears your goods. So your approval, your labels and your bill of entry agree.
CDSCO is India's central drug regulator. It must approve every drug, cosmetic and medical device before it comes into India. That covers goods for your own use, such as APIs for your plant. Personal use and a few other cases are left out. Drugs need a registration of the foreign plant and each drug, then an import licence. Cosmetics need an import registration. Devices need an import licence. Importers register some low-risk Class A devices online instead.
Who can apply for a CDSCO import licence?
For drugs the manufacturer's agent in India applies. It must hold a wholesale or manufacturing drug licence. A manufacturer with its own wholesale licence in India can apply itself. For cosmetics the manufacturer, its Indian agent, its Indian subsidiary or an importer can apply. For most devices the manufacturer's authorised agent applies. Any importer can register a Class A device that is neither sterile nor measuring. We never act as a manufacturer's Indian agent. The manufacturer appoints its own, often its Indian importer or subsidiary. We prepare and file the papers for that agent.
Can a trader import drugs without a drug licence?
No. Only a firm with a wholesale or manufacturing drug licence in India can apply to import drugs. It must also be the manufacturer's agent. A trader without one cannot import drugs. It can buy from an Indian importer. But it still needs a drug sale licence to stock and sell them.
What is the difference between a registration certificate and an import licence?
For drugs the registration certificate covers the foreign plant and each drug it sends to India. The import licence then lets your firm bring those drugs in. The registration comes first. A manufacturer with plants in different places needs a registration and an import licence for each plant.
Do I need a licence to import cosmetics into India?
Yes. Each cosmetic needs an import registration from CDSCO before it lands. It covers the category, the foreign site, each variant and each pack size. Your firm needs no drug licence. Small samples for research and a few other cases need no registration.
Can I import a cosmetic someone else has registered?
Yes. You apply for an import registration number with an undertaking. It runs for a set term. The product must already hold an import registration under the current Cosmetics Rules.
Is a licence needed to import medical devices?
Yes for most devices. The manufacturer's authorised agent applies for an import licence that names each device and each foreign site. The agent must hold a wholesale or manufacturing licence or a registration to sell devices. Class A devices that are neither sterile nor measuring follow a simpler route.
Is Class A medical device registration mandatory?
Yes. A Class A device that is neither sterile nor measuring needs no import licence. But the importer registers it on CDSCO's online system first. You upload the device details with the foreign site's registration or a free sale certificate. You declare that it meets the standards and quality system the rules set. A sterile or measuring Class A device needs the full licence.
Do I need a licence to sell imported medical devices?
Yes. Anyone who stocks or sells devices needs a drug sale licence or a registration to sell devices. A firm with a drug sale licence is already covered. A firm that sells only devices registers with its state drugs controller.
How long is a CDSCO registration valid?
It depends on the product. A drug registration runs for a set term and the import licence ends with it. Apply early and both stay in force while CDSCO decides. A cosmetic registration certificate and a device import licence have no end date. Each needs a retention fee on time or it counts as cancelled. An import registration number runs for a set term.
Which ports can drugs be imported through?
Only the ports, airports, inland container depots and land crossings the Drugs Rules list. Cosmetics use the same list. CDSCO has asked customs to clear medical devices only there too. New ports join it from time to time. We check your port is on it before your supplier books the freight.
Can imported medicine labels be stickered in India?
Only with CDSCO's permission. The work must happen at a site with a drug manufacturing licence. A wholesale licence is not enough, so we do not sticker or relabel drugs. Get the label right before the goods ship.
