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.
- 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