CDSCO Registration vs State FDA Approval: The Complete Guide

The Two Regulatory Authorities Explained

India’s pharma and medical device regulatory landscape involves two distinct levels of authority:

• CDSCO (Central): Handles new drugs, Class C/D medical devices, IVDs, and imported cosmetics at the national level.
• State Licensing Authorities (State FDA): Handle drug manufacturing licenses, retail/wholesale drug licenses, Class A/B medical device licenses, and cosmetic manufacturing licenses at the state level.

CDSCO Registration — What Requires Central Approval

• Class C and Class D medical devices (both domestic manufacturing and imports)
• New drug approvals and fixed-dose combinations (FDCs)
• In-vitro diagnostic (IVD) devices
• Cosmetics imported from outside India
• Online pharmaceutical platforms (certain categories)

State FDA Approval — What Goes to State Licensing Authority

• Retail and wholesale drug licenses
• Drug manufacturing licenses (for existing formulations)
• Cosmetic manufacturing licenses
• Class A and Class B medical device licenses
• Loan licenses (contract manufacturing)

Can One Business Need Both CDSCO and State FDA?

Yes — and this is very common. A pharmaceutical manufacturer may need a State FDA manufacturing license AND CDSCO approval if they want to manufacture and sell a new drug (new molecule). A medical device importer needs an MD-15 import license from CDSCO, but if they also want to manufacture in India, they’ll need a State FDA manufacturing license for Class A/B devices.