STOCK MARKET BSE NSE

Serum Institute gets DCGI's nod to manufacture Covid jab Sputnik V in India

The Pune-based firm has collaborated with Gamaleya Research Institute of Epidemiology and Microbiology, Moscow in Russia for developing Sputnik V at its licensed Hadapsar facility.

Published: 04th June 2021 09:24 PM  |   Last Updated: 04th June 2021 10:59 PM   |  A+A-

A health worker shows a vial of Sputnik V COVID-19 vaccine during its administration to the employees of Dr. Reddys Laboratories as a pilot drive, in Hyderabad. (Photo | Special Arrangement)

A health worker shows a vial of Sputnik V COVID-19 vaccine during its administration to the employees of Dr. Reddys Laboratories as a pilot drive, in Hyderabad. (Photo | Special Arrangement)

By Express News Service

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.

ALSO WATCH | Is highly infectious B.1.617 variant spreading at a frightening speed?​



Comments

Disclaimer : We respect your thoughts and views! But we need to be judicious while moderating your comments. All the comments will be moderated by the newindianexpress.com editorial. Abstain from posting comments that are obscene, defamatory or inflammatory, and do not indulge in personal attacks. Try to avoid outside hyperlinks inside the comment. Help us delete comments that do not follow these guidelines.

The views expressed in comments published on newindianexpress.com are those of the comment writers alone. They do not represent the views or opinions of newindianexpress.com or its staff, nor do they represent the views or opinions of The New Indian Express Group, or any entity of, or affiliated with, The New Indian Express Group. newindianexpress.com reserves the right to take any or all comments down at any time.

flipboard facebook twitter whatsapp