DCGI approves Serum & Bharat Biotech COVID-19 vaccines

  • The Central Drugs Standard Control Organisation (CDSCO) has decided to accept the recommendations of its Subject Expert Committee (SEC), and approved the Covid-19 vaccines of both Serum Institute of India and Bharat Biotech for restricted use in the country.
  • Along with that, permission was granted to Cadila Healthcare for the conduct of Phase III clinical trial.

WHAT IS EMERGENCY USE AUTHORISATION?

  • For vaccines and medicines, approval is granted after an assessment of their safety and effectiveness, based on data from trials. 
  • The fastest approval for any vaccine until now — the mumps vaccine in the 1960s — took about four-and-a-half years after it was developed. 
  • In emergency situations, like the current one, regulatory authorities around the world have developed mechanisms to grant interim approvals if there is sufficient evidence.

WHICH ARE THE VACCINES?

  • One vaccine is Covishield, the Indian variant of the AZD1222 vaccine developed by Oxford University and AstraZeneca.
  • It was manufactured by the Serum Institute of India (SII).
  • The other vaccine that has got emergency use authorisation is Covaxin. 
  • It was manufactured by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

WHO WILL BE THE FIRST RECIPIENTS?

  • The first in line will be 30 million (3 crore) workers in the forefront of India’s battle against the novel coronavirus.
  • This will Include 1 crore healthcare workers and 2 crore frontline workers.
  • Also receiving the vaccine in the first phase will be a third priority group – consisting of some 27 crore persons above age 50, and persons below age 50, but with associated comorbidities.
  • The government aims to complete the first phase of vaccinations by August 2021.
CDSCO
  • The Central Drugs Standard Control Organisation (CDSCO) is the national regulatory body of India for pharmaceuticals and medical devices.
  • Headquarters: New Delhi, India.
  • Organisation executive: Dr. V. G. Somani, Drugs Controller General of India.
  • Minister responsible: Harsh Vardhan, Minister of Health and Family Welfare.

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