India-based pharmaceutical company Dr. Reddy’s Laboratories has received the Drug Controller General of India (DCGI) authorisation for import and use of Russian Covid-19 vaccine Sputnik V in India.

The Indian regulator granted the authorisation for restricted use in emergency situations, based on provisions of the New Drug and Clinical Trials rules, 2019 under the Drugs and Cosmetics Act.

In September last year, the company has teamed up with the Russian Direct Investment Fund (RDIF) for conducting clinical trials and distribute the Sputnik V vaccine in India.

As part of the partnership, Dr. Reddy’s has conducted the Phase 2/3 clinical trials of the vaccine in India, in addition to the trials conducted by RDIF in Russia.

Dr. Reddy’s Laboratories co-chairman and managing director GV Prasad said: “We are very pleased to obtain the emergency use authorisation for Sputnik V in India.

“With the rising cases in India, vaccination is the most effective tool in our battle against Covid-19. This will enable us to contribute to our nation’s effort of vaccinating a significant proportion of our population.”

Sputnik V was developed by the Gamaleya Research Institute in Moscow, using a technology platform of human adenoviral vectors.

Sechenov University has evaluated the vaccine in early-stage clinical trials and was first granted regulatory approval in Russia, in August last year.

According to an article published in the peer-reviewed journal Lancet, Sputnik V has demonstrated a vaccine efficacy of 91.6% in preventing Covid-19.

Sputnik V is currently approved for use in 60 countries and ranks second among the world’s Covid-19 vaccines in terms of the number of approvals issued by government regulators.

Dr. Reddy’s is engaged in providing APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations in gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology therapeutic areas.

The company offers the products and services through its pharmaceutical services & active ingredients, global generics, and proprietary products business divisions.