Panacea Biotec gets regulator’s nod to produce Sputnik V jabs
Sputnik V has been part of India’s covid vaccination drive since 14 May after receiving the emergency use authorization on 12 April
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Panacea Biotec has received a licence from the Drugs Controller General for manufacturing the Sputnik V vaccine in India, after the first batch of the covid-19 vaccine cleared all quality-control tests at the Gamaleya Center, Russia, the company said.
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Panacea tied up with Russian Direct Investment Fund (RDIF) to produce the vaccine developed by Gamaleya Research Institute of Epidemiology and Microbiology. Sputnik V has been part of India’s covid vaccination drive since 14 May after receiving the emergency use authorization on 12 April.
“Panacea Biotec is delighted to announce the obtaining of the manufacturing licence to produce Sputnik V vaccine in India. On this occasion, we thank the leadership of Prime Minister Narendra Modi and the government of India for timely hand-holding and expediting clearances to enable ‘Make in India’ vaccines," said Rajesh Jain, managing director, Panacea Biotec.
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The first batch of Sputnik V, manufactured at Panacea Biotec’s Baddi facility in Himachal Pradesh, passed quality control checks at the Gamaleya Center in Russia and the Central Drugs Laboratory, Kasauli. The vaccine has got regulatory clearances from 67 countries with a total population of over 3.5 billion people.
Sputnik V is based on a proven platform of human adenoviral vectors that cause common cold. The vaccine uses two different vectors for the two doses, which provides longer immunity compared to vaccines using the same delivery mechanism for both shots.
The safety, efficacy and lack of negative long-term effects of adenoviral vaccines have been proven by more than 250 clinical studies over two decades. There are no strong allergies caused by Sputnik V, the company said. The vaccine can be stored at +2+8 C in a refrigerator without any need to invest in additional cold chain infrastructure. The government has fixed the price of the vaccine at ₹1,145 per dose at paid vaccination centres.
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In May, Dr Reddy’s Laboratories launched the covid vaccine in the Indian market. The first dose was administered in Hyderabad as part of a limited pilot. The pharma firm partnered with RDIF to conduct clinical trials of Sputnik V and distribute the vaccine in India in September 2020.
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