On Tuesday, the Union Health Ministry of India announced that the drug regulator of the country has granted permission for restricted emergency use of the Russian COVID-19 vaccine Sputnik V under certain conditions. It also stated that Dr. Reddy’s Laboratories (DRL) will import and market the vaccine for use in India.
The Drugs Controller General of India’s (DCGI) approval paves the way for the availability of the third vaccine in India. On Monday, the Central Drugs Standard Control Organization’s (CDSCO) Subject Expert Committee (SEC) on COVID-19 recommended approving Sputnik V for restricted emergency uses under certain regulatory conditions and after that on Tuesday, the DCGI’s approval came forward.
In January, the DCGI gave the emergency use authorization for two COVID-19 vaccines, Bharat Biotech’s Covaxin and Serum Institute of India’s Covishield of Oxford-AstraZeneca.
In a statement, the ministry said that DRL had applied for the approval of importing and marketing Gam-COVID-Vac combined vector vaccine aka Sputnik-V. Russia’s M/s Gamaleya Institute developed the vaccine for Emergency Use Authorization.
Russia’s National Research Center for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation developed the Gam-COVID-Vac combined vector vaccine (Component I & Component II) is approved in 30 nations across the globe.
For getting the regulatory permission for importing and marketing the vaccine in India, DRL has collaborated with the National Research Center for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation. The efficacy and immunogenicity results from phase 3 clinical trials of Russia have been published in the Lancet journal.
The CDSCO is continuously assessing the data from the clinical trial in consultation with the Subject Expert Committee (SEC) as a rapid regulatory response. The SEC includes domain knowledge experts from the fields of immunology, pulmonology, microbiology, pediatrics, pharmacology, internal medicine, etc.
The Ministry said, “After detailed deliberation, the SEC recommended for grant of permission for restricted use in emergency situations subject to various regulatory provisions.” The vaccine, which has to be stored at -18°C, is for 18 years and above for active immunization to prevent the deadly COVID-19 disease. It should be given in two doses of 0.5 ml each with an interval of 21 days.
The ministry further added, “After careful consideration, the recommendations of the SEC have been accepted by the Drugs Control General (India). DRL will import the vaccine for use in the country.