Dr. Reddy's Laboratories, the only company licensed to sell the vaccine in India to come up with Sputnik V

Sputnik the vaccine gets emergency approval


India on Monday approved the urgent use of the Russian vaccine Sputnik V, adding a third shotgun to its military package amid a severe shortage of vaccines in other parts of the country and a record increase in covid cases. The progression of the academic committee (SEC) on Sputnik's shot will follow from Drugs Controller General of India (DCGI) V.G. Somani - comes at a critical time and gives the authorities more bullets to stop the second wave of the disease, the violence of which has shocked experts.

"The SEC commended the EUA (emergency use authorization) for Sputnik V. Now DCGI will consider Dr. Reddy's application, and once it has submitted to the EUA, it will be the last," said a development expert, requesting anonymity.

The Russian Investment Fund (RDIF), its global trade partner for the vaccine, confirmed in a statement that it was awaiting official communication on the proposal. The SEC’s recommendation for the Sputnik vaccine is based on sections 2 and 3 of the 1,600 participants ’study bridges by Dr. Reddy’s Laboratories in India. The study was aimed at determining the safety of the vaccine in the Indian population, as was the case in a Russian study. While Somani's approval will mean that India will soon get its third covid-19 vaccine, the supply is likely to be tight in the short term as Dr Reddy's Laboratories, the only company licensed to sell the vaccine in India, may begin importing it from Russia despite producing communications. and five Indian contractors.

While five vaccine manufacturers who signed the pacts with RDIF — Hetero Biopharma, Gland Pharma, Virchow Biotech, Stelis Biopharma, and Panacea Biotec — plan to produce around 850 million volumes a year, production is unlikely to start anytime soon. Hetero Biopharma, who signed a production agreement with RDIF in November, is late, said a second person, adding that the company had never started production. In November, when a $ 100 million production agreement was announced, both parties said they planned to start the production of Sputnik V in early 2021. Email inquiries sent to Heth and RDIF spokespersons on the production program were not answered at the time of publication. Gland Pharma, Virchow  Biotech, and Stelis Biopharma, who signed the bills last month, all gave a timeline between April and September to start production of the two-drug vaccine.

 
 

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