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Friday
June 2021
10:51 PM IST
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Multan knocks Quetta out of PSL with 110-run win        WTC Final: Kohli eyes legacy, Williamson prize for consistency in battle of equals        India extends USD 100 million Line of Credit to Sri Lanka for solar energy projects        China successfully launches first crew to new space station        Biden, Putin discuss ambassadors, nuclear weapons and more        Pre-monsoon showers in national capital        Sonia taken Covid jabs, govt should inoculate all instead of creating non-issues: Cong        PM should acknowledge his mistakes, seek expert help to rebuild India: Rahul        PM invites world to invest in India        Yuvraj Singh becomes face of PUMA Motorsport in India        Dutee expects Olympics spot on basis of world rankings if not through qualification timing        India's fuel demand rebounds in June        Power consumption grows 9.3 pc in first half of June        UK expands COVID-19 vaccination drive to cover all over-21s        China says nuclear fuel rods damaged, no radiation leak        Tourists delighted after Taj Mahal reopens after two months        Odisha extends partial lockdown till July 1, opens borders with Chhattisgarh, Jharkhand        PM to launch customised crash course for Covid frontline workers        Unseeded Krejcikova wins maiden Grand Slam title in Paris        Diesel at Rs 100 mark in Rajasthan; Karnataka sees Rs 100/ltr petrol        
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National News
DCGI allows Serum Institute to manufacture Sputnik V Covid-19 vaccine in India
 
New Delhi: The Drug Controller General of India (DCGI), Dr VG Somani, on Friday granted the Serum Institute of India (SII) to manufacture the Russian-made Sputnik V vaccine against the coronavirus disease (Covid-19), days after the Pune-based vaccine manufacturer had applied for the same. "The DCGI has granted permission to the Serum Institute to manufacture the Sputnik Covid-19 vaccine in India for examination, test, and analysis at its licensed Hadapsar facility with certain conditions," news agency PTI reported, citing official sources.

India granted emergency use authorisation to Sputnik V on April 13. A test license, according to the Central Drugs Standards Control Organisation (CDSCO) website, is granted for the import of small quantities of drugs for purposes of examination, testing, or analysis. This license, unless suspended or revoked, will be enforced for a period of three years from the date of its issuance on June 4.

The Pune-based SII has collaborated with Gamaleya Research Institute of Epidemiology and Microbiology, Moscow, in Russia for developing Sputnik V at its licensed Hadapsar facility. The SII has already told the government that it will be able to manufacture and supply 10 crore Covishield doses in June, while it is also manufacturing the Novavax vaccine, the regulatory clearance for which is awaited from the United States.

Earlier on Thursday, the Serum Institute of India had sought out the much-coveted DCGI nod to manufacture the Russian vaccine. According to the four conditions set by the drug regulator, the Serum Institute was asked to submit a copy of the agreement between it and the Gamaleya Research Institute of Epidemiology and Microbiology for transfer of cell bank and virus stock and a copy of the agreement for technology transfer with Gamaleya.

The Pune-based SII was also asked to submit a copy of the RCGM permission to import cell bank and virus stock and a copy of the RCGM permission to initiate research and development of viral vector vaccine Sputnik V, an official source told PTI.

Sputnik V is currently being distributed in India by Dr Reddy’s Laboratories, which signed a pact with the Russian Direct Investment Fund (RDIF) that globally markets the Covid-19 vaccine developed by Russia’s Gamaleya Institute. As part of the deal, Dr Reddy’s will distribute the first 250 million doses of Sputnik V.


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