Sputnik Light launch in India hits roadblock as DCGI denies permission for Phase 3 trials

Even as India is looking to boost its vaccination drive further, sources revealed that the Drugs Controller General of India rejected the application of Dr Reddy's to conduct phase 3 trials of Sputnik Light. Developed by the Gamaleya Research Institute of Epidemiology and Microbiology and financed by the Russian Direct Investment Fund, Sputnik Light has demonstrated the efficacy of 79.4% as compared to 91.4% for the two-shot Sputnik V. Reportedly, the DCGI took up the application for discussion on Wednesday and did not find any scientific rationale to conduct phase 3 trials of Russia's single-dose COVID-19 vaccine. 

This is likely to delay the launch of this vaccine in India. The global phase 3 clinical trial of Sputnik Light involving 7,000 Russians was conducted in multiple countries including Russia, the UAE and Ghana. In a statement issued after the approval of the vaccine in May, the Gamaleya Research Institute of Epidemiology and Microbiology stated that it had proven effective against all strains of COVID-19 and no serious adverse events were reported. It is pertinent to note that the domestic production of Sputnik V will begin in August with a target of manufacturing 850 million doses.

COVID-19 vaccination in India

Apart from COVISHIELD and COVAXIN, the DCGI accepted the recommendations of the Subject Expert Committee of the Central Drugs Standard Control Organisation, paving way for the approval of Sputnik V and Moderna on April 12 and June 29 respectively. Moreover, the Union government declared that those vaccines that have been granted emergency approval for restricted use by USFDA, EMA, UK MHRA, PMDA Japan, or which are listed in WHO (Emergency Use Listing) will be granted emergency use approval in India. In a huge announcement on April 19, the Centre allowed the vaccination of all adults from May 1 onwards.

But, the vaccination drive was adversely affected since May 1 owing to a shortage of doses and the decentralized vaccine procurement policy. Addressing the nation on June 7, PM Modi rolled back this policy and announced that the Centre will procure 75% of the vaccine stock and distribute it to the states for free from June 21. Most importantly, this stock can now be used for all adults and not just those aged above 45. A total of 27,24,98,853 persons have been inoculated whereas 5,80,69,297 of them have received the second dose of the vaccine too.