DCGI permits restricted use in emergency situations of Sputnik-V anti-COVID-19 vaccine

New Delhi, April 13, 2021

The Drugs Controller General of India (DCGI) has granted permission for the restricted use in emergency situations of the Russia-made Sputnik-V anti-COVID-19 vaccine in India.

This follows the recommendation made to this effect by the Subject Experts Committee of the DCGI, subject to various regulatory provisions, after detailed deliberations.

Two vaccines have already been approved for Emergency Use Authorisation (EUA) by the national regulator -- Covishield, the Oxford-AstraZeneca vaccine manufactured by Serum Institute of India (SII) in Pune, and the indigenous Covaxin manufactured by Bharat Biotech International Limited (BBIL), Hyderabad.

Several other vaccines are at various stages of clinical development within the country.

According to a press release from the Ministry of Health & Family Welfare (MoHFW) today, Dr. Reddy’s Laboratories Ltd. (DRL) had applied for the grant of permission to import and market Gam-COVID-Vac combined vector vaccine, popularly called Sputnik-V, developed by Gamaleya Institute, Russia for Emergency Use Authorization.

The Gam-COVID-Vac combined vector vaccine (Component I & Component II) has been developed by the National Research Center for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation and is approved in 30 countries across the world.

DRL has collaborated with National Research Center for Epidemiology and Microbiology for obtaining regulatory approval for import for marketing in India. The interim results of Safety immunogenicity and efficacy from Russian Phase III clinical trial have been published in Lancet journal.

DRL was permitted to conduct a Phase-II/III clinical trial in the country. The firm has submitted interim data from the ongoing trial and the data is being continuously assessed by the Central Drugs Standard Control Organisation (CDSCO) in consultation with the Subject Expert Committee (SEC) as a rapid regulatory response.

The SEC consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine, and so on.

"The SEC deliberated on various critical areas for consideration including safety, immunogenicity, efficacy data from overseas clinical studies, indication, age group, dosing schedule, precautions, storage, warnings, adverse effects of special interest, risk benefit evaluation, proposed factsheet, PI, SmPCetc. The approval of the vaccine in Russia along with its conditions/restrictions was also reviewed by the SEC. The SEC noted that the safety & immunogenicity data presented by the firm from the Indian study is comparable with that of the Phase III clinical trial interim data from Russia," the release said.

"After detailed deliberation, the SEC recommended for grant of permission for restricted use in emergency situations subject to various regulatory provisions.

The vaccine is indicated for active immunization to prevent COVID-19 disease in individuals who are 18 years and above of age.

"The vaccine should be administered intramuscularly in two doses of 0.5 ml each with interval of 21 days. (Day 0: Component I & Day 21: Component II). The vaccine has to be stored at -18°C. The vaccine comprises two components I & II, which are not interchangeable.

"After careful consideration, the recommendations of the SEC have been accepted by the Drugs Control General (India). M/s DRL will import the vaccine for use in the country," the release added.

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