New Delhi: The Serum Institute of India (SII) is seeking regular marketing authorisation from the country's drug regulator for its Covid-19 vaccine Covishield, reported news agency PTI on Monday.
The application sent to the Drugs Controller General of India (DCGI) by Prakash Kumar Singh, Director, Government and Regulatory Affairs at Serum Institute of India (SII) comes just a couple of days after Prime Minister Narendra Modi held a meeting with domestic COVID-19 vaccine manufacturers.
The application 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.
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 the Covishield vaccine. In total, as many as eighteen countries of the European Union had approved the Covishield vaccine so far.