The Drugs Controller General of India (DCGI) on Thursday refused to grant emergency-use authorisation to a single-dose Sputnik-Light COVID-19 vaccine. India’s drug regulator also ruled out the need for the conduct of the phase-3 trial of the Russian vaccine.

According to the Subject Expert Committee’s (SEC) recommendations on Central Drugs Standard Control Organisation (CDSCO) website, Dr Reddy’s Laboratories had submitted a proposal to the DCGI seeking market authorisation of Sputnik-Light, along with the interim safety and efficacy data generated from the phase 1/2 clinical trials in Russia, and presented the protocol for conducting the phase-3 clinical trial of the vaccine in India before the committee.

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The SEC meeting held on July 30 concluded that Sputnik-Light is the same as the component-1 of Sputnik V and as its safety and immunogenicity data in the Indian population has already been generated in a trial here, there seems to be inadequate data and justification for conducting a separate, similar trial. These recommendations were approved by DCGI. 

Sputnik Light demonstrated an efficacy of 79.4%, according to Dr Reddy’s Laboratories. The coronavirus vaccine is likely to be priced around Rs 730, Reuters reported. 

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The SEC of the CDSCO, which deliberated on the application, noted that Sputnik-Light is the same as the component-1 of Sputnik V.

Furthermore, the firm has already generated the safety and immunogenicity data of component-1 in the country.

The committee also noted that the phase-3 efficacy trial is ongoing in Russia and the efficacy data is yet to be generated, read the recommendations of the SEC.

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“After detailed deliberation, the committee recommended that the firm should present the safety, immunogenicity and efficacy data of the phase-3 clinical trial of Sputnik-Light that is being carried out in Russia for considering the proposal for the grant of MA (market authorisation) in the country.

“Further, as the safety and immunogenicity data of the component-1 in Indian population has already been generated in the country in another trial, there seems to be inadequate data and justification in conducting a separate, similar trial,” the recommendations read.