Proposal For Sputnik Light As Covid Booster Submitted To Drug Regulator

Drug major Dr Reddy’s Laboratories has submitted a proposal to the Drugs Controller General of India (DCGI) to register Sputnik Light vaccine as a booster dose against COVID-19, a top company official has said.

The Hyderabad-based drug major had partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of Sputnik V and distribute the vaccine in India in September 2020.

Last year, the company received permission from the DCGI to import the Sputnik vaccine into India for restricted use in emergency situations in April.

“As regards to Sputnik, we are now ready with capacities in India. We are working actively with the Government of India for registering Sputnik Light as a vaccine and as a booster dose of Sputnik V,” Dr Reddy’s Laboratories CEO Erez Israeli said in an analyst call.

The drug maker has also submitted a proposal to DCGI to conduct a trial to test Sputnik Light as a booster to other vaccines, he added.

“Sputnik continues to be a viable option for Dr Reddy’s for India and other countries,” Israeli stated.

He noted that the company will have to get approval from the authorities in India for the protocol of the trial.

“And pending that approval of that protocol, we will have a trial with other vaccines so it will serve as another option both private as well as the government for the booster in the future. We believe that the boosters will be part of our life and we’ll have to take it once or twice a year now,” Israeli said.

On exports, he noted that there were no restrictions on the overseas shipment of the vaccine.

“We can export the products, both the vaccine as well as the other products,” Israeli stated.

Dr Reddy’s has already launched molnupiravir in the country, expanding its portfolio to fight against the on-going COVID pandemic, Israeli noted.

“We are also working on certain export opportunities in line with the licensing rights obtained from Merck,” he added.