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DGCI Grants Conditional Market Approval for Covaxin & Covishield

While these vaccines will not be available in medical stores, hospitals and clinics can purchase them.

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India
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The Drugs Controller General of India (DCGI) granted conditional market approval for Covishield and Covaxin on Thursday, 27 January, news agency ANI reported.

While the vaccines will not be available in medical stores, hospitals and clinics can purchase them. Further, the vaccination data will have to be submitted to the DCGI every six months and be updated on the CoWIN app as well.

The development comes a week after a government subject expert committee (SEC), on 19 January, recommended the granting of regular market approval for Covishield and Covaxin.

Meanwhile, India reported 2,86,384 new COVID-19 cases and 573 deaths on Thursday.

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After the approval, Union Health Minister Dr Mansukh Mandaviya said in a tweet, "The Central Drugs Standard Control Organisation (CDSCO) 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 added, "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."

The government drive for free vaccination will continue, Mandaviya added.

So far, the first dose vaccination coverage in India is at 95 percent, while the second dose coverage is at 74 percent, the Ministry of Health said on Thursday. As many as 97.03 lakh eligible people have received the 'precaution dose'.

(With inputs from ANI.)

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Topics:  covaxin   COVISHIELD   DGCI 

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