CDSCO Registration and Licences for Drugs, Devices and Cosmetics
CDSCO registration is the approval you need from the Central Drugs Standard Control Organisation before you import drugs, cosmetics or medical devices into India, or make Class C and Class D medical devices here. We work out which licence fits your product, prepare the file, and apply on the SUGAM or Medical Devices Online portal.
What it is
CDSCO is India’s national regulator for drugs, medical devices and cosmetics. Its head, the Drugs Controller General (India), is the Central Licensing Authority. “CDSCO registration” is a loose term. In practice it means one of several approvals, and which one depends on what you sell and whether you make it here or bring it in.
The parent law is the Drugs and Cosmetics Act, 1940. Three sets of rules under it matter for business: the Drugs Rules, 1945 for imported drugs, the Medical Devices Rules, 2017 for every medical device, and the Cosmetics Rules, 2020 for imported cosmetics. Drug and cosmetic applications go on the SUGAM portal (cdscoonline.gov.in). Device applications go on the Medical Devices Online portal (cdscomdonline.gov.in).
Who it applies to
You import drugs
An Indian importer needs a registration certificate for the overseas manufacturer and its products, and then an import licence. The foreign company usually appoints an Indian agent to hold these.
You import or make medical devices
Every importer of a medical device needs an import licence from CDSCO. The one exception is Class A devices that are non-sterile and non-measuring, which are registered on the portal instead. Makers of Class C and Class D devices get their manufacturing licence from CDSCO too; Class A and B makers go to the State Licensing Authority.
You import cosmetics
Creams, shampoos, make-up and other cosmetics made abroad need an import registration certificate in Form COS-2 before they ship.
Why it matters
Sell without legal risk
Without the right CDSCO approval you cannot lawfully import or sell the product. Hospitals and distributors ask for the licence copy before they buy.
Know who answers to the regulator
The Indian licence holder answers to the regulator for quality complaints, recalls and labelling.
Pay once every five years
Device licences and cosmetic import certificates no longer expire. They stay valid in perpetuity as long as the retention fee is paid every five years.
Which CDSCO approval do you need?
Find your product and your role. The table gives the form you apply in and the certificate you receive.
| Your situation | Apply in | You receive | Granted by |
|---|---|---|---|
| Importing a drug (overseas site and products) | Form 40 | Registration certificate, Form 41 | CDSCO |
| Importing a registered drug | Form 8 | Import licence, Form 10 | CDSCO |
| Importing a medical device (Class A sterile or measuring, B, C or D) | Form MD-14 | Import licence, Form MD-15 | CDSCO |
| Making a Class C or D medical device | Form MD-7 | Manufacturing licence, Form MD-9 | CDSCO |
| Making a Class A or B medical device | Form MD-3 | Manufacturing licence, Form MD-5 | State Licensing Authority |
| Importing cosmetics | Form COS-1 | Registration certificate, Form COS-2 | CDSCO |
Selling drugs from a shop or warehouse is a separate matter. That needs a state drug licence for wholesale or retail sale from your state drugs controller, not CDSCO.
Here is how it plays out. Say a Faridabad trading company is appointed Indian agent by an overseas maker of diagnostic kits. It first needs a wholesale licence. Then it files Form MD-14 covering the overseas site and each kit, and the in vitro diagnostic fee rows apply.
Documents required
From the Indian applicant
- Certificate of incorporation or firm registration, PAN and GST
- Importer Exporter Code (IEC) for imports
- Wholesale or manufacturing licence, where the rules require one (device import licences do)
From the overseas manufacturer
- Power of attorney appointing the Indian agent, authenticated by a First Class Magistrate in India, the Indian Embassy or by apostille
- Free sale certificate from the country of origin
- Manufacturing licence and quality certificates such as ISO 13485 for devices
About the product
- Product list with composition or specifications, and Indian labels
- For devices: Device Master File and Plant Master File
- Test reports from the manufacturer or an accredited lab
How it works
Pin down the approval you need
Drug, cosmetic or device? Which risk class? Import or manufacture? The answers decide the form and the authority.
Set up the Indian entity and portal login
You need an Indian entity, an IEC and, for device imports, a wholesale or manufacturing licence. We then register you on the right portal.
Build the dossier with the manufacturer
In practice, the technical files come from the manufacturer or its consultant. We list the gaps, check everything against the schedule and assemble the upload. Here is the catch: the power of attorney must be authenticated by a First Class Magistrate, the Indian Embassy or by apostille, so we check that before anything else.
File, pay and answer queries
We submit the form, pay the government fee through Bharatkosh and track the application. When CDSCO raises a query, we draft the reply with you and refile.
Keep the licence in force
After grant we diarise retention fees, post-approval changes and new products to be added.
Timelines
Medical device import licence
Rule 36 gives CDSCO nine months from the date of application to grant Form MD-15, if the documents are in order.
Class C and D manufacturing
The site is inspected within 60 days of the application; the licence follows within 45 days of the inspection report (Rules 23 and 25).
Cosmetic import registration
CDSCO can take up to six months to decide a COS-1 application under the Cosmetics Rules, 2020.
What happens if you skip it
Goods held back
Importing in breach of Chapter III of the Act is an offence under Section 13, and the consignment waits while you apply.
Prosecution for unlicensed manufacture or sale
Under Section 27(b), manufacturing or selling a drug without a valid licence carries three to five years in prison and a fine of at least ₹1 lakh or three times the value of goods seized. Medical devices are drugs under the Act.
Buyers walk away
Hospitals, pharmacies and distributors ask for licence numbers before they buy. Without one, the sale stalls.
Frequently asked questions
What is CDSCO registration?
It is the everyday name for approvals the Central Drugs Standard Control Organisation grants under the Drugs and Cosmetics Act, 1940. The main ones are the drug registration certificate (Form 41), drug import licence (Form 10), device import licence (Form MD-15), Class C and D manufacturing licence (Form MD-9) and cosmetic import registration (Form COS-2). We confirm which one applies to your product before anything is filed.
Do I need CDSCO approval to sell medicines from my shop?
No, a retail or wholesale chemist shop is licensed by your state drugs controller, not CDSCO. CDSCO comes in when you import drugs, cosmetics or medical devices, or manufacture Class C or D devices. If you trade in medical devices only, the State Licensing Authority grants a registration certificate in Form MD-42 instead. We can handle the state application alongside any CDSCO work.
Can a foreign company apply to CDSCO directly?
Usually not. The Medical Devices Rules, 2017 let only an authorised agent in India, holding a manufacturing or wholesale licence, apply for a device import licence. Drug registration works the same way through an Indian agent. The foreign manufacturer appoints that agent by a power of attorney authenticated by a First Class Magistrate in India, the Indian Embassy or by apostille.
Which portal is used for CDSCO applications?
Drugs and cosmetics are filed on the SUGAM portal at cdscoonline.gov.in. Medical devices are filed on the Medical Devices Online portal at cdscomdonline.gov.in, which is also linked from the National Single Window System. Government fees are paid online through Bharatkosh. We create the login and track every query from that one account.
How long is a medical device import licence valid?
It stays valid in perpetuity unless it is suspended or cancelled. The condition is that the licence holder pays a retention fee every five years from the date of issue, under Rule 37 of the Medical Devices Rules, 2017. We keep the five-year date in our compliance calendar and remind you well before it falls due.
What are the government fees for a device import licence?
They are set in US dollars by the Second Schedule. For Class C or D devices (non-IVD) the fee is $3,000 per overseas site and $1,500 per distinct device. Class B is $2,000 per site and $1,000 per device; Class A is $1,000 per site and $50 per device. We total it from your product list before filing.
Does Taxhint do product testing or audits?
No. Testing is done by accredited laboratories, audits of Class A and B sites by notified bodies registered with CDSCO, and inspections by CDSCO officers. Our job is the regulatory side: choosing the route, preparing and checking documents, filing on the portal, replying to queries and keeping the licence in good standing. We coordinate with your lab and consultant.
Do I need a company to get a CDSCO licence?
You need an Indian legal entity with a fixed address, PAN, GST and an IEC for imports. A proprietorship or partnership can apply, but a foreign principal often finds a private limited company easier to contract with and audit. We can set up the entity and the licences together in one plan.
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.
For medical device import licences, the Second Schedule of the Medical Devices Rules, 2017 sets these fees:
| Device class | Per overseas site | Per distinct device |
|---|---|---|
| Class A (non-IVD) | $1,000 | $50 |
| Class B (non-IVD) | $2,000 | $1,000 |
| Class C or D (non-IVD) | $3,000 | $1,500 |
| Class A or B IVD | $1,000 | $10 |
| Class C or D IVD | $3,000 | $500 |
If CDSCO decides to inspect the overseas site, a further $6,000 is payable. Class C and D manufacturing licences cost ₹50,000 per site and ₹1,000 per device.
Ready to begin?
Tell us the product and where it is made. We will tell you the exact CDSCO approval, the fee and the documents, before you spend a rupee.