CDSCO / Zonal CDSCO Registration and Approval

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CDSCO / Zonal CDSCO Registration and Approval

CDSCO is the India’s Drug Regulatory Authority responsible for the pan-India enforcement of the Drugs and Cosmetics Act. Operating under the Ministry of Health & Family Welfare, the agency exercises regulatory control over the quality of drugs, cosmetics and notified medical devices and IVD before and after they are in the market.

Central CDSCO

Registration of firm at SUGAM

BABE Center Approval

BENOC & TL Application

CT Application

New Drug Application

Subsequent New Drug Application

Ethics Committee Registration

Post Approvals (Amendment and Notification)

Import License for MD & IVD

Manufacturing License for Class C & D MD & IVD

Import License for Cosmetics

Preparation of SMF/PMF & DMF

Zonal CDSCO

Registration of firm at NSWS

TL Application for Old Drug

Dual Use NOC Application

Export NOC Application

Post Approvals (Amendment and Notification)

Manufacturing License for Class C & D MD & IVD