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Tuesday, January 25, 2022

Indian Drugs Regulatory green signal to Sputnik V

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India’s drug regulator: Indian Drugs Controller General of India (DCGI) has approved Russia’s COVID-19 vaccine Sputnik-V for limited use in emergencies after being cleared by an expert panel. About 92 percent of the effective COVID-19 vaccine Sputnik-V may be available in India from the first fortnight of May. Speaking to reporters, Russian Direct Investment Fund (RDIF) CEO Kirill Dimitriv said, “By the end of April or the first week of May, some quantity of Sputnik V will be available in India.” He said that the top capacity of vaccines in India will be seen by July. He said that they are working closely with Indian companies and it is expected that more than 50 crore doses of Sputnik V will be prepared annually. Dimitriva said, “We have partnered with five companies and we are ready to partner with more companies.”

Hyderabad-based company Dr. Reddy’s Laboratories (DRL) has tied up with Russia’s Ministry of Health to obtain regulatory approval for the import of vaccines into India. This was approved by the Subject Expert Committee (SEC) on Monday. In an official statement, the Health Ministry said that after extensive deliberations, the SEC has recommended allowing limited use of this vaccine in emergencies subject to various regulatory provisions. According to a statement from the Ministry of Health of India, DRLA is collaborating with the National Research Center for Epidemiology and Microbiology of the Ministry of Health of Russia to get regulatory approval to import for marketing in India.

Russia vaccines have indicated active immunity to prevent COVID-19 disease in people over 18 years of age. Two doses of 0.5 ml of this vaccine should be given in the muscle at an interval of 21 days. This vaccine has to be stored at (-) 18 ° C. The vaccine has two components that cannot be replaced by each other. The Health Ministry said, ‘After careful consideration, the recommendations of the SEC have been accepted by the Controller General of Pharmaceuticals (India). DRL will import vaccines for use in the country. The National Regulatory Controller of India (DCGI) has so far approved two vaccines for emergency use (EUA). These include Kovishield prepared by Serum Institute of India (SII) and ‘Kovaxine’ vaccine prepared by Bharat Biotech International Limited (BBL). The Ministry of Health stated that several other vaccines are in various stages of clinical trials in the country.

“Dr. Reddy’s Laboratories Ltd. (DRL) had applied for permission to import and market Sputnik-V which has been produced by Russia’s Gamalaya Institute for limited use,” it said in a statement.

The gam-covid-vac vector vaccine (Component 1 and Component 2), popularly known as Sputnik-V, has been prepared by the National Research Center for Epidemiology and Microbiology of the Ministry of Health of Russia, and is developed in 30 countries around the world. Has been approved in. ‘ Interim results of the safety and efficacy of the safety and efficacy associated with Russia’s Phase III clinical trial have been published in the Lancet Journal. DRL was allowed to conduct Phase II and Phase III clinical trials in the country. The company has submitted interim data related to the ongoing second and third phase clinical trials in the country. The government said, “Clinical trial data is being continuously evaluated by CDSCO on the suggestion of the Subject Expert Committee (SEC) as a regulatory response.” The SEC consists of specialists with specialized knowledge in the fields of Pulmonology, Immunology, Microbiology, Pharmacology, Pediatrics, Internal Medicine etc. SEC important data including safety, immunity, data related to the impact of clinical trials abroad, age group, dosing time, caution, storage, warnings, adverse effects of special interest, risk benefit assessment, proposed factsheet, PI, SMPCETC Areas to be considered.

The SEC has also reviewed the approval given to the vaccine for its conditions / restrictions in Russia. The SEC said that the security and immunity offered by the companies in the Indian study could be compared with the interim data from Russia’s Phase III clinical trial. The SEC has, after extensive deliberations, recommended allowing limited use in emergencies subject to various regulatory provisions.

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Mirza Shehnaz
Shehnaz Ali Siddiqui is a Corporate Communications Expert by profession and writer by Passion. She has experience of many years in the same. Her educational background in Mass communication has given her a broad base from which to approach many topics. She enjoys writing around Public relations, Corporate communications, travel, entrepreneurship, insurance, and finance among others.
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