The government has faced mounting calls to approve more vaccines during the surge among the 1.3 billion population and a slower-than-expected mass inoculation drive.
Sputnik V is the third drug to be approved by India after Oxford-AstraZeneca’s Covishield and Covaxin, which was developed by Indian firm Bharat Biotech.
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The SEC expert panel said the Russian vaccine should be authorised “in emergency situations” and this has been accepted, the
G.V. Prasad, co-chair of pharmaceutical company Dr Reddy’s Laboratories, said his firm was “very pleased to obtain the emergency use authorisation”.
“With the rising cases in India, vaccination is the most effective tool in our battle against Covid-19,” he added.
The jabs will need to have been already been granted emergency-use authorisation by regulators, such as the US Food and Drug Administration, the European Medicine Agency and others in Britain and Japan or the
A requirement for pre-approval clinical trials would be replaced by post-authorisation trials.
“I think it’s significant… it’s basically one more step to opening vaccinations to the private sector, and it’s good, because the government sector alone will not be able to take care of the load,” virologist Shahid Jameel told AFP.
“So if Pfizer or Moderna wants to bring in their vaccines through a supplier, not a manufacturer, then it is now possible.”
India on Monday reported more than 161,000 new cases — the seventh consecutive day that more than 100,000 infections have been recorded. That took the country’s total to almost 13.7 million.
Local authorities have imposed night curfews and clamped down on movement and activities.
In India’s financial capital Mumbai, authorities have ordered the construction of three more 2,000-bed field hospitals in the next six weeks. The number of beds for Covid-19 patients has also been ramped up in New Delhi.
Sputnik V, backed by the Russian Direct Investment Fund (RDIF), already has production agreements in India to produce 852 million doses.