Serum Institute obtains DCGI nod to produce Sputnik V vaccine in India

The Drug Controller General of India (DCGI) has granted approval to the Serum Institute of India (SII) to produce Russia’s Covid-19 vaccine, Sputnik V, in the country.

Based on an adenovirus vector, the vaccine is given in two doses with a gap of 21 days.

SII is the sixth company in India to sign an agreement with the Russian Direct Investment Fund for the local manufacturing of the vaccine.

Earlier, Gland Pharma, Hetero Biopharma, Panacea Biotech, Stelis Biopharma and Virchow Biotech have entered deals to produce the vaccine.

The DCGI permitted SII to produce the vaccine in the country for examination, test and evaluation at the company’s licenced facility in Hadapsar city of India, with some conditions.

Central Drugs Standard Control Organisation (CDSCO) sources said that the SII has to submit copies of the agreement between the company and Sputnik V developer, Gamaleya Research Institute of Epidemiology and Microbiology, for transfer of cell bank, virus stock and technology.

Furthermore, SII was advised to submit evidence of the permissions granted by the Indian government’s Review Committee on Genetic Manipulation for cell bank and virus stock import and to start the vaccine’s research and development (R&D).

Currently, SII is manufacturing AstraZeneca-Oxford University’s Covid-19 vaccine in the country under the brand name Covishield and is working to produce US-based Novavax’s vaccine for the disease.

In April, the DCGI granted permission to Dr Reddy’s Laboratories to import Sputnik V into India for restricted use in emergency situations.

Separately, the Subject Expert Committee of CDSCO in India has authorised Zydus Cadila to conduct Phase I and II clinical trials of its neutralising monoclonal antibodies-based combination therapy, ZRC-3308, for mild covid-19 treatment.

In another development, the Reliance Foundation has sought the Indian Government’s permission to import two million doses of Johnson and Johnson’s (J&J) Covid-19 vaccines to inoculate its employees in the country, PTI reported.