The nod came after the Hyderabad-based company submitted a reworked application to the Drugs Controller General of India (DCGI) on October 13 with more information on phase 2 and 3 trials.
"This will be a multi-centre and randomized controlled study, which will include safety and immunogenicity study", said a joint statement issued by Dr Reddy's and Russian Direct Investment Fund (RDIF).
On August 11, 2020, Sputnik V, developed by the Gamaleya National Center of Epidemiology and Microbiology, was registered by the Ministry of Health of Russian Federation and became the world's first registered vaccine against Covid-19 based on the human adenoviral vectors platform.
The same day, it was reported that Delhi-based Mankind Pharma had signed an agreement with the Russian Direct Investment Fund (RIDF) for the distribution and sale of Sputnik V in India.
According to Dr Jadhav, India will get 60-70 million dosages of vaccines by December 2020 but they will hit the market in 2021 after the clearance of licensing.
After a review meeting chaired by Prime Minister Narendra Modi on the COVID-19 pandemic situation, and vaccine delivery, distribution and administration preparedness, the Prime Minister's Office said in a statement that three vaccines are in advanced stages of development in India, out of which two are in Phase II and one is in Phase-III.
Meanwhile, the Ministry of Health has said that India has exponentially scaled up its testing capacity from one in January to more than 9.32 crore at present.
Sputnik V is now undergoing phase 3 clinical trial in Russian Federation and the proposed number of subjects is 40,000.
However, whether the shot can safely protect people from the disease will become clear only when final Phase 3 trials - which are ongoing outside China - are complete.
At present, SII is conducting phase 2 and 3 trials of the vaccine. While scientists had raised doubts about SputnIk V's safety and efficacy as Russian President Vladimir Putin announced its development to the world without its data being published and without large-scale trials being conducted, however, later medical journal Lancet had said that two trials of the vaccine in June and July involving 76 participants showed that all the participants developed antibodies to the novel coronavirus without any serious side-effects. RDIF, which is marketing the Sputnik V, will supply 100 million doses to Dr Reddy's.
China has already given hundreds of thousands of essential workers at ports, hospitals and other high-risk areas across the country an experimental vaccine, according to officials.