Conditional Market Authorization

  • IASbaba
  • January 28, 2022
  • 0
UPSC Articles
Print Friendly, PDF & Email

Conditional Market Authorization

Part of: Prelims and GS-II -Health

Context: The National Regulator, Drugs Controller General of India (DCGI), has given nod to market authorization of two COVID19 vaccines, Covaxin and Covishield for use in adults subject to certain conditions.

Key takeaways 

  • The market authorization of two COVID19 vaccines, Covaxin and Covishield, in the country by DCGI is subject to the following conditions:
    • Firm shall submit data of overseas ongoing clinical trials of the product with due analysis on six monthly basis or as and when available, whichever is earlier.
    • The vaccine shall be supplied for programmatic setting and all vaccinations done within the country to be recorded on CoWIN platform and Adverse Event Following Immunization [AEFI], Adverse Event of Special Interest [AESI] shall continue to be monitored.

What is Conditional Market Authorization?

  • Conditional Market Authorization” is a new category of market authorization that has emerged during the current global pandemic of COVID19.
  • The approval pathways through this route are fast-tracked with certain conditions to enhance the access to certain pharmaceuticals for meeting the emerging needs of drugs or vaccines.

News Source: TH

For a dedicated peer group, Motivation & Quick updates, Join our official telegram channel – https://t.me/IASbabaOfficialAccount

Subscribe to our YouTube Channel HERE to watch Explainer Videos, Strategy Sessions, Toppers Talks & many more…

Search now.....

Sign Up To Receive Regular Updates