Dr Reddy’s working on next step to roll out Sputnik V at 2 to 8 degrees Celsius

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While Dr Reddy’s Labs will start with importing Sputnik V in a frozen form from Russia it is also in the process of generating additional stability data for the vaccine to be stored in the 2 to 8 degrees Celsius range, Deepak Sapra, Dr Reddys Chief Executive Officer, API and Services has said.</p>
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This data will be available in a few months, after which we will make the necessary amendment request to the regulator and request for the storage condition to be modified to 2 to 8C," Sapra told reporters at a press conference on Wednesday in Hyderabad.</p>
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"In addition to the product which is at -18 degrees Celsius today, we are in the process of generating additional stability data on the 2 to 8 degrees Celsius temperature range. This data will be available in a few months, after which we will make the necessary amendment request to the regulator and request for the storage condition to be modified to 2 to 8C," Sapra told reporters.</p>
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The first stocks of the vaccine that arrive from Russia will have to be stored at -18 degrees Celsius for which Dr Reddy’s will use its own as well as the government’s deep freeze storage facilities, Sapra said. </p>
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He said the necessary cold storage infrastructure is in place to distribute Sputnik V vaccine in India, which will be available during the current quarter which ends in June.</p>
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However, according to experts since there are limited deep freeze facilities available in the country, the mass distribution will accelerate only when the vaccine switches to the powder form version which can be stored at normal refrigeration temperatures of 2 to 8 degrees Celsius.</p>
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Drug maker Dr Reddy's on Wednesday said it will be importing Sputnik V vaccine from Russia in this quarter, and supplies from Indian manufacturers will commence from next quarter.</p>
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Sapra said that the vaccine will be imported in a frozen condition from Russian Direct Investment Fund (RDIF) with which it has an agreement to distribute 125 million human doses ( 250 million vials) in India, maintaining -18 to -22.</p>
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The doses will be kept outside for 15-20 minutes before being administered to the people.</p>
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Dr Reddys Laboratories on Tuesday said it has received approval from Indian drug regulator for restricted emergency use of the Sputnik vaccine in the country.</p>
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Earlier the Russian sovereign fund RDIF said that more than 50 million doses of Sputnik V vaccine will be available every month in India from May.</p>
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Dr Reddy's as per its licensing agreement with RDIF can produce up to 250 million doses of the Sputnik V vaccine, the deal allows to expand the volumes by mutual consent.</p>
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The company also clarified that it isn't seeking any funding from the government to ramp up capacities.</p>
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Hyderabad-based Dr Reddy’s Laboratories (DRL), the Indian partner for Russia’s Sputnik V, will use the government’s vaccination cold chain infrastructure, along with its own cold chain capabilities, for last-mile distribution of the vaccine in India.</p>
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Further, 60-70 per cent of Sputnik V’s global production is set to take place in India which is a global vaccine manufacturing hub, said DRL.</p>