Dr Reddy's Laboratories will begin supplying Sputnik V coronavirus vaccines, imported from Russia, in May. The drug major is also going to tap domestically sourced jabs as their production speeds up in India.
However, the vaccine's pricing, along with how many doses will be supplied at the outset, has not been determined yet.
Meanwhile, talks between the Centre and the Hyderabad-based drug major are on. Dr Reddy's is the sole licensing partner for Sputnik V in India.
Dr Reddy's Laboratories on Tuesday said it has received approval from the Indian drug regulator for restricted emergency use of COVID-19 vaccine Sputnik in the country. The company has received permission from the Drug Controller General of India (DCGI) to import the Sputnik vaccine into India for restricted use in emergency situations as per the provisions of the New Drug and Clinical Trials Rules, 2019, under the Drugs and Cosmetics Act, Dr Reddy's said in a regulatory filing.
Following the DCGI's approval of the emergency use authorisation of Sputnik V, RDIF CEO Kirill Dmitriev said that the coronavirus vaccine's roll out in small quantities will likely begin as early as May 2021. Dmitriev added that production on a larger scale will start by July 2021 with plans to produce 500 million doses.
He stated that Sputnik V is safer than Moderna and Pfizer's COVID-19 vaccines, adding that Mexican data has also shown "very less serious adverse events" for Russia's jab.
Regarding the pricing of Sputnik V, Dmitriev said, "We are in talks with the Indian government on the pricing of the vaccine for private and govt rollout - it will be more affordable than the existing vaccines of the world."
Meanwhile, the RDIF has said that India has become the 60th country to approve the use of Sputnik V against coronavirus and more than 850 million doses of the vaccine are going to be produced in the country annually.
The vaccine's approval by DCGI was based on results of clinical trials in Russia as well as positive data of additional Phase III local clinical trials in India conducted in partnership with Dr Reddy's Laboratories.
Sputnik V has been approved for use in countries with a total population of 3 billion people, or about 40 per cent of the global population, and India has become the 60th country to approve Sputnik V, RDIF, Russia's sovereign wealth fund, said in a statement.
India is the most populated country to register the vaccine and is also the leading production hub for Sputnik V, it added.
In September 2020, Dr Reddy's had partnered with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V and distribute the vaccine in India.
In addition to the trials conducted in Russia by RDIF, phase II/III clinical trials of the vaccine were carried out by Dr Reddy's in India.