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DCGI approves “Conditional Market Authorisation” of Covaxin and Covishield

Conditional Market Authorization" is a new category of market authorization that has emerged during the current global pandemic of C-19.

The Health Master

January 28, 2022

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DCGI CDSCO Regulator Drugs Controller General India — DCGI

Last Updated on December 31, 2023 by The Health Master

The Drugs Controller General of India (DCGI) has given the nod to the market authorization of two C-19 vaccines, Covaxin and Covishield, subject to certain conditions, today.

The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) had recommended the upgradation of status for the vaccines from restricted use in emergency situations to a grant of new drug permission with conditions for the adult population on January 19, 2022.

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The market authorization of two C-19 vaccines, Covaxin and Covishield, in the country by DCGI is subject to the following conditions:

The firm shall submit data from overseas ongoing clinical trials of the product with due analysis on a 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 the CoWIN platform. Adverse Events Following Immunization [AEFI], Adverse Events of Special Interest [AESI] shall continue to be monitored.
The firm shall submit the safety data, including AEFI and AESI, with due analysis on a six-monthly basis, or as and when available, whichever is earlier, as per the NDCT Rules, 2019.

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Of the global stringent regulatory authorities, only the United States Food and Drug Administration (USFDA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) of the UK have granted “Conditional Market Authorization” to Pfizer and AstraZeneca, respectively, for their C-19 vaccines.

“Conditional Market Authorization” is a new category of market authorization that has emerged during the current global pandemic of C-19.

The approval pathways thru this route are fast-tracked with certain conditions to enhance access to certain pharmaceuticals to meet the emerging needs of drugs or vaccines.

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