DCGI paves way for Sputnik V vaccine import: Dr. Reddy’s

The Emergency Use Authority from the Drugs Controller General of India (DCGI) for Sputnik V paves the way for the import and use of the Russian COVID-19 vaccine in the vaccination program in the country.

However, on the cards, the timing of the EUA matters in the context of reports that stocks of two approved vaccines are rapidly moving to multiple locations across India, among more people to qualify and to receive the jab Are interested in Several state governments have in recent times appealed to the Center to recoup vaccine supplies.

Sputnik V, developed by Russia’s Gamalaya National Research Institute of Epidemiology and Microbiology, will join Kovishield and the indigenous Kovaxin that was approved and used by India as arguably one of the largest vaccination programs globally in January. Is one. Just a few weeks after Sputnik V became the first COVID-19 vaccine to be registered globally, in August by Russia, the Russian Direct Investment Fund named Dr. Announced a partnership for clinical trials in Reddy’s laboratories as well as distributing the first 100 million in India. .

Announcing the receipt of the EUA, Drs. Reddy said on 13 April that development paves the way for vaccine imports.

“Dr. Reddy’s laboratories have obtained permission to import Sputnik from the Drugs Controller General of India. [V] A statement by a Hyderabad-based drugmaker states that vaccines in India for restricted use in emergency situations as per the provisions of the New Drug and Clinical Trial Rules, 2019 under the Drug and Cosmetics Act. A top-level executive of the pharma chief also confirmed, a few months ago, that the vaccine would initially be imported.

Co-Chairman and Managing Director GV Prasad said, “We are very pleased to receive the Emergency Use Authority for Sputnik V in India. With increasing cases in India, vaccination is the most effective tool in our fight against COVID-19. This will enable us to contribute to our nation’s effort to vaccinate a significant proportion of our population. “

In September, Dr. Since announcing its partnership with Reddy, Russia’s sovereign wealth fund has forged ahead with manufacturing agreements with five companies to produce an estimated 850 million doses based on the human adenoviral vector platform. While Hetero Biopharma, Gland Pharma, Stelis Biopharma, Virchow Biotech and Panacea Biotec are companies with which production partnerships have been announced, sources say there may be some more to add to the list in the coming days.

On the Sputnik V production process in the country, sources said the process involved transfer of technology, production of batches for approval and moving from a central laboratory that obtained manufacturing licenses from DCGI. Production of the first Sputnik V in India is likely to be available in June, which may take at least a few months.

The Russian vaccine, which has an efficacy of 91.6% according to a publication in The Lancet, is now approved for use in 60 countries. It uses two different vectors for two shots during vaccination. According to RDIF, Sputnik V costs less than $ 10 per shot “making it affordable worldwide.”