Serum Institute seeks DCGI regular marketing authorization for Covishield
New Delhi: Serum Institute of India (SII) on Monday sought regular marketing authorisation for Covid vaccine, Covishield from Drugs Controller General of India (DCGI).
The application sent to the DCGI said that SII has already submitted phase-3 clinical study results of 24,244 subjects from the UK, Brazil and South Africa to the Central Drugs Standard Control Organisation (CDSCO) in June. Apart from that the phase 3 clinical study results of 32,379 subjects from the US, Chile and Peru were submitted on July 9.
The source said that the company has already administered over 100 crores doses till now under India's mass vaccination program which itself is a testimony to the success and efficacy of the Covishield vaccine.
Read also: Serum Institute sees 'large' Covid-19 vaccine exports as output nearly quadruples
If Covishield gets the approval for regular market authorization from DCGI, it will be the second vaccine in the world to receive such authorisation.
In another development, European nation Poland has also recognized Covishield as a vaccine equivalent to those recognized by the European Union. The approval will exempt quarantine for those coming to Poland after getting Covishield vaccine. In total, as many as eighteen countries of European Union had approved the Covishield vaccine so far.
Read also: CDSCO allows Serum Institute to enrol 7-11 year-olds in COVID vaccine trial
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