Serum Institute seeks DCGI nod to produce Sputnik V COVID-19 vaccine in India: Sources

In a significant move, Indian vaccine giant Serum Institute of India (SII) has test license from Drug Controller General of India (DCGI) to produce the Russian-based Sputnik V COVID-19 vaccine, report sources on Thursday. Currently, the  Russian Direct Investment Fund (RDIF) has tied up with Hyderabad-based Dr. Reddy's Labs to manufacture the vaccine in India. SII is currently involved in the production of Astrazenaca's COVISHIELD and Novovax.

SII seeks to manufacture Sputnik V

Sputnik V Light in India

As per ANI sources, Dr Reddy's is in talks with the Centre to bring Sputnik Light to the country and an application seeking regulatory approval is likely to be filed soon. Developed by the Gamaleya Research Institute of Epidemiology and Microbiology and financed by the Russian Direct Investment Fund, Sputnik Light has demonstrated the efficacy of 79.4% as compared to 91.4% for the two-shot Sputnik V. As of date, over 30 lakh Sputnik V doses have arrived in India but are yet to clear govt test approvals.

Meanwhile, SII has informed the government that it will be able to manufacture and supply 9-10 crore doses of Covishield in June. In a letter to Union Home Minister Amit Shah, the SII said its employees have been working round the clock despite the various challenges posed by the COVID-19 crisis. Of the 21,73,76,768 vaccine doses administered in India till date, SII-produced Covishield comprises of 19,28,67,370 doses.

 Amid multiple states reporting a shortage of COVID-19 vaccines, SII on May 12 had submitted its production plan to the Centre, informing it will ramp up the production of Covishield to 6.5 crore doses in June, seven crores in July and 10 crore each in August and September. Moreover, with rising domestic demand, SII's supply to COVAX has severely been hit during the second quarter of this year to the extent that there will exist a shortfall of 190 million doses by the end of June, a joint statement by the WHO, UNICEF, GAVI, and CEPI said. WHO chief Tedros Adhanom Ghebreyesus had reminded SII saying it needs to get back on track and catch up on its delivery commitments to COVAX after the devastating outbreak in India recedes.