BHARAT BIOTECH VACCINE GAINS DCGI NOD

BHARAT BIOTECH VACCINE GAINS EDGE ON DCGI NOD

Bharat biotech gained an edge in the race among a few entities in the country and several more globally to ready a vaccine for COVID-19 

Drug controller general of India DCGI cleared its product for human clinical trials 

Indian council of medical research (ICMR), National Institute Of Virology (NIV) was instrumental in the development of the vaccine

Trials of Covaxin, the vaccines, will begin next month

Drugs Controller General of India (DCGI) is a department of the Central Drugs Standard Control Organization of the Government of India

 

Responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera in India

DCGI lays down the standard and quality of manufacturing, selling, import and distribution of drugs in India

Drug Controller General of India, comes under the Ministry of Health & Family Welfare

 

Medical Device Rules 2017 by the Government of India, DCGI will also act as Central Licensing Authority (CLA) for the medical devices which fall under the purview of these rules

DCGI will be the direct licensing authority for Class C and Class D devices, whereas it will coordinate licensing for Class A and B devices through State drug controllers

DCGI heads the Indian drug regulatory body the Central Drugs Standard Control Organisation (CDSCO), whose functions include ensuring the quality of drugs and cosmetics sold in the country, approval of new drugs and regulating clinical trials 

4 zonal offices of CDSCO at Mumbai, Kolkata, Chennai, and Ghaziabad, various Sub-Zonal offices and Port offices, which works in close collaboration with the state control administration and assist them in securing uniform enforcement of the Drug Act.