Dr Reddy's Laboratories Likely To 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.

Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.

We, however, have a request.

As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.

Support quality journalism and subscribe to Business Standard.

Digital Editor