In a positive development, the first batch of Sputnik V COVID-19 vaccines manufactured by Hyderabad-based Hetero Biopharma has received clearance from Central Drugs Laboratory (CDL) which is based in Himachal's Kasauli, reports Economic Times.
With CDL’s approval for its batch of Sputnik V, Hetero Biopharma will now use it to begin the phase-3 clinical trials of the jab. The bridging trial will take about two months after which the company will be able to take up full-fledged production in India.
The norms mandate a phase-3 bridging clinical trial for all internationally-approved vaccines which are manufactured in India.
It should be noted that Hetero Biopharma has a partnership with the Russian Direct Investment Fund (RDIF) to produce over 100 million doses of Sputnik V in India.
Other than Hetero Biopharma, RDIF also has partnerships with several other Indian pharmaceutical players to manufacture the vaccine in India. These include partnerships with Virchow Biotech, Gland Pharma and Stelis Biopharma to produce up to 200 million, 252 million and 200 million doses per year, respectively.
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