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COVID-19: DGCI accords conditional market approval for Covaxin, Covishield

India’s drug regulator granted conditional regular market approval for COVID-19 vaccines Covishield and Covaxin for the restricted utilization in adult population.

COVID-19: DGCI accords conditional market approval for Covaxin, Covishield
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On Thursday, January 27, the Drugs Controller General of India (DCGI), India’s drug regulator granted conditional regular market approval for COVID-19 vaccines Covishield and Covaxin for the restricted utilization in the adult population, reported the news agency ANI.

According to the report, the Union Health Ministry elaborated on how the vaccines will not be made available in medical stores, but hospitals and clinics will be able to purchase them. Apart from this, vaccination data will have to be submitted to the DCGI every six months, in addition to it being uploaded on the CoWin portal.

Based on the account, the Central Drugs Standard Control Organization (CDSCO) elucidated on how the proposal for regular market approval were reviewed by it in consultation with the Subject Expert Committee on coronavirus.

After deliberation, the status of the vaccines was updated from restricted use in an emergency situation to the new drug permission in accordance with the rules in the adult population with conditions.

While the Covishield vaccine is manufactured by the Serum Institute of India based in Pune, Covaxin is manufactured by Bharat Biotech based in Hyderabad.

Dr Mansukh Mandaviya, Union Health Minister, took to Twitter saying, "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."

Also Read: Omicron Scare: Senior Citizens Account For 84% Of Mumbai's COVID-19 Fatalities In January

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