Dr Reddy's Hopes To Submit Sputnik V Light Trial Data To Drug Regulator In November

Dr Reddy's Laboratories Ltd is expected to submit Phase 3 trials data of single-dose Russian COVID-19 vaccine Sputnik Light to the Indian drug regulator next month, even as the city-based firm is getting ready to conduct trials of the jab in 2 to 18 year old children in two cohorts.

Deepak Sapra CEO – API and Services Dr. Reddy's said the drug maker is in discussions with the Drug Controller General of India to conduct trials on introducing Sputnik V as booster dose.

He also said Dr Reddy's is trying to engage in discussions with the Centre for Sputnik V Government supplies even as the company sees “softness” in the off take of the vaccine in the private sector.

“As far as Sputnik Light is concerned we are in the midst of our clinical trials and we expect that we are able to update post our submission to the DCGI in the month of November."

"As far as Sputnik as a booster dose is concerned, we have finalised our protocol. We are in discussions with DCGI for initiating the trials for Sputnik booster dose,” Mr Sapra said in a virtual press conference.

Addition to the servicing the Indian requirements, Dr Reddy's is in discussions with its partners to take the jab to other countries notably in Asia-Pacific, Africa and Latin America, he further said.

“We are seeing softness in the off take of the vaccine in the private sector in India,” the official said.

According to the recommendations of the SEC meeting held in August last, Dr Reddy's, which has tied up with Russian Direct Investment Fund to market the jab in India, presented updated safety, immunogenicity and efficacy data of Phase III clinical trial of Sputnik Light vaccine conducted in Russia, along with the proposal to conduct the clinical trial in India.

The trials of Sputnik as booster dose and paediatric dose are being conducted by RDIF outside India, Mr Sapra explained adding that the trials in India may take off in November.