REGULATORY INSTITUTIONS – Continued

2.CENTRAL DRUG STANDARD CONTROL ORGANISATION (CDSCO)

The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices,

It serves parallel function to the European Medical Agency of the European Union, the PDMA of Japan,the FDA of US and the MHRA of the UK…

Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices, under the gamut of Ministry of Health and Family Welfare.

The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC).

It is divided into zonal offices which do pre-licensing and post-licensing inspections, post-market surveillance, and recalls when needed

 

Leave a Reply

Your email address will not be published. Required fields are marked *