Hetero gets drug panel's nod to make Sputnik V vaccine
The Hindu
: A subject expert committee that advises India’s drug regulator has recommended Hetero Biopharma's proposal to manufacture Sputnik V, the Russian COVID-19 vaccine.The panel's decision, which
: A subject expert committee that advises India’s drug regulator has recommended Hetero Biopharma's proposal to manufacture Sputnik V, the Russian COVID-19 vaccine.
The panel's decision, which will help enhance availability of the vaccine, followed a proposal from the Hetero group firm that included interim safety and immunogenicity results from the Phase III clinical trial it had conducted.
The committee, which examines COVID-19 related proposals under an accelerated approval process, at its meeting on September 16 recommended to the Central Drugs Standard Control Organization (CDSCO) that Hetero Biopharma be allowed to manufacture the vaccine. “After detailed deliberation, the committee recommended for grant of permission to manufacture Sputnik V vaccine for restricted use in emergency situations subject to various regulatory provisions," the panel said as per the minutes of the meeting.
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