Dr Reddy’s Laboratories has sought permission from the Drugs Controller General of India’s (DGCI) to conduct the phase 3 human clinical trials of Sputnik V, the Russian vaccine to treat the coronavirus disease (Covid-19), according to news agency PTI.
Russia’s sovereign wealth fund has reached an agreement with the Hyderabad-based pharmaceutical firm for clinical trials and distribution of its experimental vaccine, which was approved by the Russian government in August.
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“The Dr Reddy’s Laboratories has applied to the DCGI seeking permission to conduct phase-3 human clinical trials of the Sputnik V vaccine against Covid-19 developed by Russia. The DCGI will carry out a technical evaluation of the application before giving its approval,” PTI quoted a source as saying.
The phase 3 trial of Sputnik V, developed by Gamaleya National Research Centre of Epidemiology and Microbiology and the Russian Direct Investment Fund (RDIF), is underway in Russia since September 1 on around 40,000 subjects, they added.
According to sources cited by the agency, it would be multi-centre, observer-blind, randomised controlled study. The RDIF had earlier said that upon regulatory approval in India, it shall supply 100 million doses of the vaccine to the Indian pharma company.
{{/usCountry}}According to sources cited by the agency, it would be multi-centre, observer-blind, randomised controlled study. The RDIF had earlier said that upon regulatory approval in India, it shall supply 100 million doses of the vaccine to the Indian pharma company.
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“Russia has a good history as far as manufacturing vaccines is concerned; they make good vaccines so we presume this vaccine is good. They have published the first study of 76 patients in the medical journal The Lancet which is showing good effectiveness and good antibody immunity generation,” Dr Balram Bhargava, director general of the Indian Council of Medical Research (ICMR), had said when RDIF and Dr Reddy’s had agreed to collaborate.
(With PTI inputs)