DCGI grants regular market approval for Covishield, Covaxin with conditions

The Drugs Controller General of India (DCGI) on Thursday granted regular market approval for Covid vaccines – Covishield and Covaxin – for use in adult population with certain conditions.

Bharat Biotech’s Covaxin and Serum Institute of India’s Covishield have been given regular market approval with certain conditions of registration on the CoWin platform and the submission of safety data on a six-monthly basis.

“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”, said Union Health Minister Mansukh Mandaviya in a tweet.

In a subsequent tweet, the health minister said, “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”.

However, Covishield and Covaxin will not be available in shops soon. People will be able to buy them from hospitals and clinics only. Vaccination data has to be submitted to the DCGI every six months and updated on the CoWIN app.

The DCGI approval has come after the Subject Expert Committee of the Central Drugs Standard Control Organization recommended granting regular market approval to Covishield and Covaxin, subject to certain conditions.

Indian vaccines manufacturer Serum Institute of India (SII) and Bharat Biotech had submitted applications to the DCGI seeking regular market authorisation for their respective COVID-19 vaccines.




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