Sale, Stock & Distribution Licences
State-level licences for wholesale and retail sale, stocking, and distribution of medical devices across India. Granted by the State Drugs Controller of the state where the premises are located — a separate licence is required per state of operation. Mandatory before any commercial sale of imported or domestically-manufactured devices through your channel. Compliance hinges on qualified competent person credentials, premises layout, and complete distribution records.
2 CDSCO forms in this category
Application for Licence for Sale, Stock, Exhibit, or Offer for Sale or Distribution of Medical Devices
Application for a license to sell, stock, exhibit, or distribute medical devices.
Licence to Sell, Stock, Exhibit, or Offer for Sale or Distribution of Medical Devices
License granted for the sale, stock, exhibition, or distribution of medical devices.
When you need these licences
Use this list to confirm whether this category applies to your device, role, or use case.
Wholesalers and distributors
Entities distributing medical devices to retailers, hospitals, or institutions.
Retailers
Pharmacies and shops selling medical devices directly to end-users.
Adequate premises
Storage premises meeting condition-and-area requirements for the device category.
Documentation checklist
- Premises layout and ownership/lease documents
- Qualified person / pharmacist details
- Storage condition documentation
- List of devices proposed to be sold
- Sources of supply (manufacturer / importer)
- Application fee challan
Step by step
- 01
Premises preparation
Set up storage area meeting category-specific requirements.
- 02
Qualified person engagement
Pharmacist or qualified technical person for prescription devices.
- 03
MD-41 filing via SUGAM
State-level application with premises details and device list.
- 04
Premises inspection
State drug inspector verifies premises and records.
- 05
Licence issuance (MD-42)
Sale licence granted, typically valid in perpetuity with annual self-declarations.
- 06
Scope expansion
Additional devices can be added through endorsements.
Common questions
Each state requires its own licence. We manage multi-state portfolios as a single coordinated engagement.
Different fees and slightly different premises requirements. Wholesale focuses on B2B; retail allows direct sale to consumers.
For prescription-only devices, yes — a registered pharmacist or qualified technical person is required.
Typically 4–6 weeks per state with clean premises and documentation.
Need help with sale & distribution licensing?
We'll send a fixed-fee quote and indicative timeline within 48 hours.
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