Covaxin, Covishield get full market authorisation

The vaccines have been upgraded to the category of new drugs as opposed to the status of drugs for restricted use in emergency situation

NEW DELHI: The Drugs Controller General of India (DCGI) has granted full market authorisation to Covaxin and Covishield, the vaccines against Covid-19, under certain conditions, Union health minister Mansukh Mandaviya said on Thursday.

Full market authorisation is granted when there is enough data to demonstrate that a vaccine is safe and effective for most. (HT PHOTO/ Representative image)

“The @CDSCO_INDIA_INF has now upgraded the permission for COVAXIN and Covishield from restricted use in emergency situations to normal new drug permission in the adult population with certain conditions,” he tweeted.

The approval has been granted under the New Drugs and Clinical Trials Rules, 2019. The vaccines have been upgraded to the category of new drugs from drugs for restricted use in an emergency situation.

The manufacturers of the vaccines will have to keep documenting data from the real-world usage and clinical trials that are underway and submit it regularly to the regulator.

“The conditions include supply for programmatic settings including registration on the CoWin platform and to continue to submit safety data on a six-monthly basis,” said Mandaviya in another tweet.

The subject expert panel of the regulator on January 19 recommended full market authorisation for Covaxin and Covishield under certain conditions.

“SEC of CDSCO [Central Drug Standard Control Organisation] has recommended for upgrade of covishield and covaxin status from restricted use in emergency situations to grant of new drug permission with conditions In adult population, DCGI will evaluate the recommendations and give its decision,” CDSCO tweeted the day the recommendation was made.

Currently, both vaccines are being administered under the national Covid immunisation programme under emergency use authorisation.

Serum Institute of India (SII) and Bharat Biotech International Ltd, the manufacturers of Covishield and Covaxin, separately applied for full market authorisation, saying over a billion vaccine doses have been administered to beneficiaries under the immunisation programme.

The full market authorisation is granted when there is enough data to demonstrate that a vaccine is safe and effective for most people who receive it.

SII locally manufactures the Oxford-AstraZeneca Covid-19 vaccine under the brand name Covishield. Bharat Biotech has developed and manufactured Covaxin in collaboration with the Indian Institute of Medical Research.