Dr. Reddys denied permission to conduct phase-3 trials for Sputnik Light COVID-19 vaccine

New Delhi, July 01: Dr. Reddy's Laboratories has been denied permission to conduct the phase 3 trials for the Sputnik Light COVID-19 vaccine by India's top regulatory body.

An ANI report said that the Central Drugs Standard Control Organisation (CDSCO) refused to allow the Hyderabad based pharmaceutical company to conduct phase 3 trials of Sputnik Light which is a one shot vaccine. The reason being cited is that it did not find the scientific rationale behind the same.

On Wednesday, the subject expert committee set up by the government discussed the application seeking permission to carry out trials in India. Dr. Reddys wanted to test the immunogenicity of the vaccine. Based on the results of the earlier trials of Sputnik V, the immunogenicity data of both the components was noted. The immunogenicity data with a single dose was not very good and hence the Subject Expert Committee did not find the rationale to conduct the trial again.

If Sputnik Light is approved in India, then it is likely to be priced at around Rs 730. Sputnik V had received the nod for emergency use in India in April. The Sputnik V, which is a two dose vaccine is being manufactured by Dr. Reddy's Laboratory.