DCGI approves Sputnik vaccine, deals signed for 850 million doses
The drugs controller general of India (DCGI), Dr VG Somani, on Tuesday approved Russian Covid-19 vaccine, Sputnik V, for emergency use in India, a day after regulator’s subject expert committee recommended that there was enough data to support that the vaccine was fit to be used.
Dr Reddy’s labs, which is conducting clinical trials in India on behalf of the makers of Sputnik V, said in a statement on Tuesday that they had received the national regulator’s emergency use approval. The company will import the vaccine for use in India.
“We are very pleased to obtain the emergency use authorisation for Sputnik V in India. With the rising cases in India, vaccination is the most effective tool in our battle against Covid-19. This will enable us to contribute to our nation’s effort of vaccinating a significant proportion of our population,” said GV Prasad, managing director, and co-chairman, Dr Reddy’s Labs.
The Russian developers of the Sputnik V Covid-19 vaccine have tied up with several Indian pharmaceutical firms to manufacture more than 850 million doses a year.
The developers – Gamaleya National Research Center for Epidemiology and Microbiology named and Russian Direct Investment Fund (RDIF) – initially tied up with Dr Reddy’s Laboratories for trials, regulatory approvals and distribution of the vaccine.
Since March, the developers have stitched up more agreements with Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma and Virchow Biotech.
India’s drug regulator has granted permission for restricted emergency use of the Russian Covid-19 vaccine Sputnik V with certain conditions, the Union Health Ministry announced on Tuesday, while stating that Dr Reddy’s Laboratories will import the vaccine for use in the country.
The approval by the Drugs Controller General of India (DCGI) paves the way for a third vaccine to be available in the country. The approval came after the Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organization (CDSCO) on Monday recommended granting approval to Sputnik V for restricted emergency use subject to certain regulatory conditions.
The DCGI in January had already given the emergency use authorisation for two Covid-19 vaccines — Covaxin and Covishield.
Dr Reddy’s Laboratories Ltd had applied for the grant of permission to import and market Gam-Covid-Vac combined vector vaccine, popularly called Sputnik-V, developed by M/s Gamaleya Institute, Russia for Emergency Use Authorization, the ministry said in a statement. 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, Moscow, Russia and is approved in 30 countries across the world.
DRL has collaborated with the National Research Center 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 3 clinical trial have been published in the Lancet journal. The firm was permitted to conduct a phase-2/3 clinical trial in the country and it has submitted interim data from the ongoing phase 2/3-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 as a rapid regulatory response. “After detailed deliberation the SEC recommended for grant of permission for restricted use in emergency situations subject to various regulatory provisions,” the ministry said. The vaccine is indicated for active immunization to prevent Covid-19 disease in individuals of aged 18 years and above and should be administered intramuscularly in two doses of 0.5 ml each with interval of 21 days.