After the DCGI approval, Sputnik V will become the third vaccine to be used in India.
APRIL 13, 2021: The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) announced early on Tuesday that the Drug Controller General of India (DCGI) has approved the use of the Russian Sputnik V vaccine against coronavirus in the country. India has become the 60th country to approve Sputnik V.
The official Twitter handle of Sputnik V announced, “India, the world’s 2nd most populous nation, became the 60th country to register #SputnikV after positive results of local Phase 3 clinical study. Sputnik V is now authorized in 60 countries with population of over 3 bln people.”
The vaccine has been registered in India under the emergency use authorization procedure based on results of clinical trials in Russia as well as positive data of additional Phase III local clinical trials in India conducted in partnership with Dr Reddy’s Laboratories.
“We are very pleased to obtain the emergency use authorisation for Sputnik V in India. With the rising cases in India, vaccination is the most effective tool in our battle against COVID-19. This will enable us to contribute to our nation’s effort of vaccinating a significant proportion of our population,” Dr Reddy’s managing director GV Prasad said in a statement to CNN-News18.
India is the leading production hub for Sputnik V. RDIF has reached agreements with the leading pharmaceutical companies in the country (Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech) aimed at the production of more than 850 million doses per year.
The vaccine had on Monday received approval from India for its emergency use with certain conditions. The decision was taken by the Subject Expert Committee of the Central Drugs Standard Control Organization at a time when the country is witnessing a record surge of infection cases. India currently manufactures two vaccines – Pune-based Serum Institute of India’s Covishield developed by Oxford-AstraZeneca and Hyderabad-based Bharat Biotech’s Covaxin.
Sputnik V will become the third vaccine to be used in the country. (News 18)