- Five pharma firms will manufacture Sputnik V vaccine in India
- Many parts in India are fighting a fresh wave of Covid
- The DCGI approval comes as several states flagged vaccine shortage
Russian-made Covid vaccine Sputnik V, the third vaccine to be approved by India, will be manufactured by five pharma firms in the country and 850 million doses are going to be produced annually. However, limited doses are going to be available by the end of April.
India's drug regulator, the Drugs Controller General of India or DCGI, approved the Russian vaccine after it got a green signal by a special committee - the Subject Expert Committee of the Central Drugs Standard Control Organization - on Monday as a lethal second wave sweeps the country. The approval comes as several states flagged a shortage in vaccine.
Manufactured in India by Dr Reddy's, Sputnik V has the highest effectiveness - 91.6 per cent -- after the Moderna and Pfizer shots. The vaccine is already in Phase 3 of clinical trials in India and Dr Reddy's had applied for emergency use approval of the vaccine in February.
In a statement, the Russia's sovereign wealth fund - the RDIF (Russian Direct Investment Fund) - said India is the most populated country where the Russian vaccine has got approval. Total population of 60 countries where Sputnik V is approved for use is 3 billion people or about 40 per cent of the global population.
The RDIF has reached agreements with five pharmaceutical firms in the country - Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech - aimed at production of more than 850 million doses per year.
"We believe that first doses will be delivered by the end of April or may be more realistically early May, but definitely in May India will be receiving the doses. And as you know, we have five great manufacturers in India that will be producing doses as well. But it will take couple of months to really ramp up production capacities. So, we believe by June, we will really be at good production capacity in India and will become a very meaningful player in vaccination programme in India. But before that we will be supplying doses, and will have a much smaller market share," Kirill Dmitriev, CEO of the Russian Direct Investment Fund, told NDTV.
In January, India had cleared two vaccines for emergency use - the Serum Institute of India's Covishield and Bharat Biotech's Covaxin.
The Serum Institute of India, the world's largest manufacturer of vaccines, is looking to tie up with the RDIF for the manufacture of the Sputnik V vaccine at their facilities in Pune.
The Russian vaccine -- along with Pfizer and AstraZeneca -- are the top three most preferred vaccines in the country, where 9 out of 10 respondents said they were ready to postpone their vaccination and wait for a vaccine with a higher efficacy, found an YouGov global survey, according to Kirill Dmitriev.
"India is a vaccine-manufacturing hub and our strategic partner for production of Sputnik V. The RDIF has created partnerships with a number of India's leading pharmaceutical companies for production of Sputnik V which will provide for both vaccination of the population in India and global distribution of the Russian vaccine. Over 850 million doses of Sputnik V are going to be produced in India annually sufficient to vaccinate more than 425 million people around the world," Mr Dmitriev said.
Kirill Dmitriev also claimed that the global poll about vaccine preference revealed that in India, Sputnik is the most recognizable vaccine. While 57 per cent people heard of the Russian vaccine, 55 per cent heard of Pfizer and 44 per cent of AstraZeneca.
"One in three respondents (36 per cent) among those who have made their choice, trusts Russia as a leading vaccine manufacturing country," Mr Dmitriev claimed.
As the production capacity is ramped up "India will be producing 10s and millions of doses every month," he said.
"So we expect the monthly production volumes in India to actually exceed 50 million doses a month in summer. Now to get there we are working on amounts that we will decide only after the final approval comes, because we need to priortise the countries which gave us approvals already. So right now, we will definitely have some doses ready for India market in May but this will not be a huge number, this will be something to get us started but eventually we will go to 50+ million doses a month in India of Sputnik V vaccine," he added.
India has been waiting for new vaccines as 16 of its states record a huge spike in infection. On Monday, the country logged 1,68,912 new Covid cases -- the sixth record rise in seven days. This morning, the country's tally was pushed to 1.36 crore cases with 1.61 lakh fresh infections.
"We are very pleased to obtain the emergency use authorisation for Sputnik V in India," Dr Reddy's Laboratories co-chairman and managing director G.V. Prasad said in a statement.