Home / Industries / CDSCO Compliance

CDSCO Import Compliance

Form COS-1, Form 10, MDR 2017 — CDSCO licences filed, queried and granted, with AIR mandates for foreign brands.

Get a Free Quote WhatsApp Us

CDSCO — India's Gateway for Cosmetics, Drugs & Devices

The Central Drugs Standard Control Organisation regulates the import of cosmetics, pharmaceuticals, biologicals and medical devices. No regulated product enters India commercially without its licence — and every application flows through the SUGAM online portal.

What CDSCO Regulates

CategoryInstrumentValidity
CosmeticsImport Licence — Form COS-13 years
Drugs / formulationsForm 10 / 10AAs specified
Medical devicesMDR 2017 RegistrationRisk-class based
IVDsMDR 2017 — IVD pathwayRisk-class based
Clinical trial materialRule 30A permissionPer study

The Application Journey

  • 1. Pre-assessment — correct category, form and document list confirmed
  • 2. Dossier build — FSC/CoPP, GMP certificate, formulations, labels, AIR authorisation
  • 3. SUGAM filing — electronic submission with fees
  • 4. Query rounds — technical clarifications drafted and filed by us
  • 5. Grant — licence issued; compliance calendar begins
  • 6. Lifecycle — renewals, amendments, additional products

The AIR Mandate — For Foreign Brands

Foreign manufacturers must appoint an Authorised Indian Representative who holds the licence and carries regulatory responsibility in India. Bruce Logistics serves as AIR for multiple international brands — one mandate can cover multiple products from the same manufacturer, formalised through a power of attorney and notified to CDSCO.

Common Questions

Frequently Asked Questions

What is the SUGAM portal?
CDSCO’s online licensing system through which all import licence applications are filed and tracked. We manage SUGAM filings end to end for our compliance clients.
Can one licence cover multiple product variants?
For cosmetics, shades and variants of an identical formulation can often sit on one licence; different formulations need separate licences. Drugs are licensed per formulation and strength. We structure the grouping to minimise cost.
How do we track regulatory changes after licensing?
Our compliance retainer includes monitoring of CDSCO circulars and rule amendments, with alerts and action plans whenever a change touches your products.

Ready to Simplify Your Imports?

Tell us what you're importing — we'll respond within 24 hours with a clear assessment and a transparent quote.

Get a Free Quote Chat on WhatsApp