India permits use of Sputnik-V vax in emergency situations

The Drugs Controller General India (DCGI) gave its nod for the emergency use of the vaccine based on recommendations of the the Subject Expert Committee (SEC) and careful consideration, Ministry of Health and Family Welfare (MoHF) said on Tuesday.

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

The vaccine is indicated for active immunisation to prevent Covid-19 disease in individuals of 18 years and above, said the Ministry, adding "the vaccine should be administered intramuscularly in two doses of 0.5 ml each with interval of 21 days. 

"The vaccine has to be stored at -18 degrees Celsius. The vaccine comprises of two components I & II, which are not interchangeable."

The Ministry said that the recommendations of the SEC have been accepted by the Drugs Controller General (India) after careful consideration, and that "Dr. Reddy's Laboratories Ltd. (DRL) will import the vaccine for use in the country".

The countrywide vaccination drive started from January 16. Two vaccines have been approved for Emergency Use Authorisation (EUA) by the National Regulator-- Drugs Controller General of India (DCGI). These are "Covishield" manufactured by Serum Institute  of India (SII) and "Covaxin" manufactured by Bharat Biotech International Limited (BBIL).

DRL had applied for the grant of permission to import and market Gam-COVID-Vac, developed by Gamaleya Institute, Russia for Emergency Use Authorisation. The Gam-COVID-Vac combined vector vaccine (Component I and Component II) has been developed by National  Research Centre for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation, Moscow, Russia and is approved in 30 countries across the world.

DRL has collaborated with National Research Centre for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation 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 the journal Lancet.

"DRL was permitted to conduct a Phase-II and III clinical trial in the country. The firm has submitted interim data from the ongoing Phase-II and III clinical trial in the country.

"The data from the clinical trial is being continuously assessed by the 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," the Ministry said.

"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, SmPC etc," it said.

The approval of the vaccine in Russia along with its conditions and restrictions was also reviewed by the SEC, said the Ministry, adding the SEC noted that the safety and immunogenicity data presented by the firm from the Indian study is comparable with  that of the Phase III clinical trial interim data from Russia.

Further, the Ministry noted that the Central government has been leading the fight against Covid-19 with a proactive and "whole of government" approach, with focus on containment, surveillance, testing, Covid appropriate behaviour and vaccination.

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