Regulatory ยท CDSCO Consultant
CDSCO Import License
Authorisation to import regulated drugs and health products into India.
What is CDSCO Import License?
A CDSCO Import Licence (Form MD-14/MD-15 for devices, or the applicable Import Licence for drugs) authorises a company to bring a regulated drug or medical device into India for sale or distribution, and is a prerequisite for customs clearance of such shipments.
The import licensing framework exists to ensure that any drug or device manufactured outside India meets the same safety and quality bar as domestically produced products before it reaches Indian patients and consumers, and to fix clear accountability with a named Indian entity for every regulated import.
An import licence is granted to the Indian importer, not the overseas factory directly โ the factory's manufacturing and quality credentials (GMP certification, Free Sale Certificate, and similar) are submitted in support of the importer's application, and the importer becomes the accountable party in India for that product's ongoing compliance, including recalls and adverse-event reporting where applicable.
Because the licence is built around a specific product-manufacturer-importer combination, a change on any side of that triangle โ a new manufacturing site, a different overseas plant for the same product, or a change of importing entity โ typically requires an amendment or fresh filing rather than being automatically covered under the existing licence.
Who Needs It
Key Benefits
Documents Required
- Free Sale Certificate from the country of origin
- Site Master File / GMP certificate of the overseas manufacturer
- Wholesale Licence of the importing entity
- Product technical/device master file and labelling
- Power of Attorney or authorisation from the overseas manufacturer to the Indian importer
Our Process
Free Sale Certificate Verification
We verify the overseas manufacturer's Free Sale Certificate and supporting quality documentation.
Importer Eligibility Check
We confirm the importing entity holds (or can obtain) the wholesale licence and infrastructure the import licence application requires.
Application Filing
The import licence application is filed on SUGAM with technical and quality files.
Query Resolution
We respond to any clarification requests from the reviewing authority on the manufacturer's or importer's documentation.
Grant & Renewal Tracking
Once granted, we track the licence's validity period for timely renewal.
Validity & Renewal
For medical devices, the MD-15 import licence is granted for 5 years from the date of issue and, in practice, continues on an ongoing basis thereafter as long as a licence retention fee is paid before each 5-year mark; for drugs, the import licence (Form 10/10A) is generally valid for 3 years from issue or until the underlying Registration Certificate (Form 41, also typically valid 3 years) expires, whichever comes first โ we track whichever renewal or retention-fee trigger applies to your product and file well ahead of the deadline to avoid a lapse.
Penalty for Non-Compliance
Importing a regulated drug or device without a valid import licence is an offence under the Drugs and Cosmetics Act, 1940 (Section 27(b), carrying imprisonment of not less than three years, extendable to five, and a fine of not less than โน1,00,000 or three times the value of the goods seized, whichever is more) and, for devices, under the equivalent Medical Device Rules provisions carrying a comparable imprisonment and fine exposure โ alongside shipment seizure at customs and, in serious cases, prosecution.
Frequently Asked Questions
How long is an import licence valid?
It depends on the product: a medical device import licence (MD-15) runs for 5 years and then continues indefinitely provided the retention fee is paid on time, while a drug import licence (Form 10/10A) is generally valid for 3 years or until the underlying Registration Certificate expires, whichever is earlier โ we track renewal triggers on your behalf either way.
Can multiple products be listed on one import licence?
Yes, related products from the same manufacturing site can often be listed together, though each product still needs to meet the applicable classification and documentation requirements, and each additional product typically adds its own per-product government fee.
Does the licence transfer if we change our overseas manufacturer?
No โ switching manufacturing sites for the same product typically requires an amendment or fresh site-specific filing, since the licence is tied to the specific manufacturer's quality credentials.
Who is responsible for adverse events after import?
The Indian importer named on the licence carries this accountability domestically, in coordination with the overseas manufacturer, so importers should have a reporting process in place before the product goes to market.
What happens if I miss the retention-fee or renewal deadline?
For device licences, missing the 5-year retention-fee window can result in the licence being treated as lapsed; for drug import licences, late renewal risks a gap in your legal authorisation to import โ we build in a buffer well before either deadline so filings aren't made at the last moment.
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