DRL may launch Sputnik V under EUA in March

Dr Reddy’s Laboratories (DRL) plans to apply for emergency use approval (EUA) for the Russian Sputnik V from the Indian drug regulator in March and launch the vaccine around the same time.

Meanwhile, DRL is in discussions with the Russian Direct Investment Fund (RDIF) to expand the scope of this partnership on Sputnik to other countries where Hyderabad-based pharma major has strong presence. DRL is partnering RDIF for conducting the clinical trials and would be marketing the

Sputnik V in India at present.

The bridge trials on 1,600 participants in India was ongoing. The phase 2 trials are completed and the phase 3 is on. These trials are to assess the immunogenicity and safety of the vaccine candidate on the Indian population.

Deepak Sapra, chief executive officer (API and pharma business) of DRL, said the company would submit the dossiers with data analysis from the trials before the regulator in March. Once the vaccine gets the drug regulator’s go-ahead, DRL expects to launch it in March itself.

On the pricing front, the firm said it was discussing the Indian situation with RDIF. In India, vaccine makers like Serum Institute of India have announced two separate pricings — one for the government and the other for the private market. Sapra said discussions on the India pricing were on.

He explained the company lined up supplies of 125 million patient doses (each patient needs two jabs) for Indians from its partners over the next 12 months.