Clinical Research

What is CDSCO?

Every nation under its Ministry of Health will have dedicated a dedicated governing body to look after every aspect of pharmaceutics and medical devices. India is a vast expanse of varied cultures and diversified population. To know how the regulations in India are presently placed, one should know about CDSCO. What is CDSCO?

The Central Drugs Standard Control Organization is the state regulatory body for Indian medical devices and pharmaceuticals, and serves analogous role to the Food and Drug Administration of the United States the PMDA of Japan, European Medicines Agency of the European Union etc.

Central Drugs Standard Control Organization Head quarter is positioned in New Delhi, the capital city of India and works under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India.

 Within the CDSCO, the Drug Controller General of India (DCGI) controls medical devices and pharmaceutical. Drug Controller General of India is in charge for endorsement of licenses of particular categories of Drugs such as I. V. Fluids, blood and blood products, Sera and Vaccines.

The DCGI in-turn is directed by the Drug Consultative Committee (DCC) and the Drug Technical Advisory Board (DTAB).  It is further divided into zonal offices which handles pre-licensing and post-licensing inspections, pharmacovigilance/post-market surveillance, and recalls when required.

Keeping in view what is CDSCO as governing body can do in handling this vast country. The Central Government of India has established four zonal offices of the CDSCO at Chennai, Mumbai, Ghaziabad and Kolkata. The Zonal Offices work in close association with the State Drug Control Administration and aid them in guaranteeing unvarying enforcement of the Drug Act and other related legislations throughout in Indian Sub-continent.

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