NEW DELHI: India’s apex drug regulator on Friday granted permission to the Pune based Serum Institute of India (SSI) to manufacture the Russian Covid-19 vaccine Sputnik V in the country.
It is the sixth firm in India, after Gland Pharma, Hetero Biopharma, Panacea Biotech, Stelis Biopharma, Virchow Biotech to enter into an agreement for the Russian Direct Investment Fund, the sponsor of Sputnik V, for the vaccine’s local production.
Sources said that the Drug Controller General of India has granted approval SII to manufacture the vaccine in India for examination, test and analysis, apart from its manufacturing, at its licensed Hadapsar facility near Pune with certain conditions.
SII is already producing AstraZeneca-Oxford University’s Covid-19 vaccine in India under the brand name of Covishield and is also in the process of manufacturing coronavirus vaccine by the US-based Novavax.
Sources in the Central Drugs Standard Control Organisation meanwhile said that as per the conditions specified, the SII has been asked to submit copies of the agreement between it and the Gamaleya Research Institute of Epidemiology and Microbiology, the developer of the vaccine, for transfer of cell bank and virus stock and technology transfer.
The firm has also been asked to submit proof of the permissions by the government's Review Committee on Genetic Manipulation to import cell bank and virus stock and to initiate research and development of viral vector vaccine.
SII, had last month, applied to the RCGM under the department of biotechnology seeking clearance for import of strains and seed lots and cell banks, and for carrying out research and development.
Sputnik V was soft-launched in the country last month after nearly 2 lakh doses were imported by Hyderabad based Dr Reddy’s Lab from Russia but is expected to be available in significant quantities only after local production starts. Dr Reddy’s has said that it has the sole distribution rights of the first 250 million dose in India.
This vaccine, based on an adenovirus vector, like Covishield, has a reported efficacy of over 90 % against preventing Covid-19 vaccine and is administered in two doses at a gap of 21 days.
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