Context: The drug regulator DCGI (Drugs Controller General of India) has granted emergency use authorisation (EUA) to Single-dose Sputnik Light COVID-19 vaccine in India.
About the vaccine
Sputnik Light is based on recombinant human adenovirus serotype number 26 (the first component of Sputnik V).
It is the world’s first registered combination vector vaccine for the prevention of COVID-19
As per the vaccine developer Russian Direct Investment Fund (RDIF), a one-shot vaccination regimen of Sputnik Light provides for ease of administration and helps to increase the efficacy and duration of other vaccines when used as a booster shot.
Emergency Use Authorization (EUA)
It is a regulatory mechanism to allow the use of vaccines and medicines to prevent and/or reduce the impact of life- threatening diseases or conditions as caused by COVID-19.
About Drugs Controller General of India
S/he is the head of department of the Central Drugs Standard Control Organization (CDSO) of the Government of India.
Central Drugs Standard Control Organisation works in close collaboration with the state control administration and assist them in securing uniform enforcement of the Drug Act.
Responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera in India.
DCGI also sets standards for manufacturing, sales, import, and distribution of drugs in India.
Comes under the Ministry of Health & Family Welfare.
