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Serum Institute of India seeks DCGI’s permission to manufacture Sputnik V

Pharmaceutical companies are expressing their interest to manufacture covid vaccines to accelerate its production to be available for all. Joining the list is Serum Institute of India, which has filed an application with the Drug Controller General of India (DCGI) to get approval for manufacturing Sputnik V in India, according to sources.  

The drugmaker has also asked to permit it for test analysis and examination.  

This will be the third vaccine being manufactured by the Pune-based firm after Covishield and Covovax. The former produced jointly with Oxford University and latter with biotechnology company Novavax. 

Currently, Dr Reddy’s Laboratories is manufacturing Sputnik V of Russia in India. 30 lakh doses of the vaccine were flown down to Hyderabad on Tuesday in a consignment. 

Throwing light on the development, PTI quoted a source saying, “The Serum Institute of India (SII) put up an application to the Drugs Controller General of India (DCGI) on Wednesday seeking permission to manufacture the COVID-19 vaccine, Sputnik V, in India.” 

As for Covishield that remains in shortage in many parts of India, SII told the Centre that it will be able to manufacture and supply 10 crore doses of the vaccine in June. This will witness the simultaneous manufacture of Covovax vaccine, which awaits regulatory clearance from the United States.  

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The Drug Controller General of India had approved it for emergency use (EUA) in April.  

Meanwhile, arrangements with Biological-E have been finalized by the Union Health Ministry. It has book 30 crore covid vaccine doses, which will be manufactured and stored from August till December 2021, as per reports. The ministry released a statement on Thursday wherein it said an advance payment of ₹1,500 crore will be made to the company by the Centre.  

This will be the second made-in-India vaccine after Hyderabad-based Bharat Biotech. Interestingly, Biological E is also based in Hyderabad. The vaccine, which is currently in phase-3 of clinical trials, is an RBD protein sub-unit. 

SII’s application comes following the Centre’s recent announcement where it stressed the acceleration of vaccine development and manufacturing across the country to help everyone get the jab. Head of the Indian Council of Medical Research (ICMR) Dr Balram Bhargava said on Tuesday that by mid-July to early August, the nation will have sufficient vaccines to administer to 1 crore citizens each day. He added that everyone in India will be vaccinated by the end of 2021.  

Till now, 22,10,43,693 doses of covid-19 have been given to people, according to the union health ministry.