Home / News / India /  Sputnik Light in India: Dr Reddy's denied approval to conduct phase 3 trials

India's drug controller has denied permission to Dr Reddy's to conduct phase-3 trials of Russian-made single-dose Sputnik Light Covid-19 vaccine in India, reported news agency ANI.

The application is said to have been taken up for discussion on Wednesday.

Sputnik Light is the first component (recombinant human adenovirus serotype number 26 (rAd26)) of the Sputnik V coronavirus vaccine.

Earlier, reports in June had said that Dr Reddy's in talks with the central government for a speedy launch of the Sputnik Light vaccine in India.

There were also claims that all stakeholders, including the Russian manufacturer and its Indian partners, being directed to fast-track the application and regulatory approval procedures for the jab.

Russian Direct Investment Fund (RDIF) CEO Kirill Dmitriev had said in May that Russia expects to introduce Sputnik Light in India soon.

The vaccine has shown 79.4% efficacy against the coronavirus twenty-eight days after administration. Its phase-3 trials have so far been conducted in Russia, the UAE and Ghana.

Sputnik V in India

The two-dose Sputnik V had received the Drug Controller General of India's permission for restricted emergency use in April. Dr Reddy's Laboratories is importing the vaccine for use in India.

The Gam-Covid-Vac combined vector vaccine, popularly known as Sputnik V, is the third vaccine to get approval from Indian drug regulator for emergency use and is being used in a few private hospitals.

The vaccine has been developed by the National Research Center for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation and is approved in 30 countries across the world.

India plans to start local production of Sputnik V by August, said Indian envoy to Russia Bala Venkatesh Varma had said in May.

He said that over 850 million doses will eventually be produced in the country.

"The present plan is that over 850 million doses of the Sputnik vaccine will finally be produced in India. Almost 65-70% of Sputnik produced anywhere in the world will be from India, finally," said the envoy.

This will be achieved through production and transport in a phased manner.

Sputnik V is being transported to India in three phases -- direct exports, fill and finish mode and transfer of technology to Indian companies for full production.

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