The Serum Institute of India on Wednesday sought permission from the Drug Controller General of India to manufacture Russian Covid vaccine Sputnik v locally. The institute has submitted an application for test analysis and examination. Once these permissions are received, an emergency use authorisation (EUA) would be required.

Russia’s Sputnik V vaccine is currently being manufactured by Dr Reddy’s Laboratories.

Russia’s Covid-19 vaccine Sputnik V is first foreign vaccine to be approved in India after the approval of SII’s Covishield and Bharat Biotech’s Covaxin. With this, the SII will manufacture 2 of 3 Covid vaccines approved by India.

Recently, India received its latest consignment of nearly 3 million doses of the Sputnik V from Russia, making it the third and largest delivery of the imported Covid-19 vaccines. The doses arrived on specially-chartered freighter at Hyderabad Airport in Telangana.

Earlier government sources had said that six lakh imported double-dose of Sputnik-V will be available in May 2021, one crore imported doses in June 2021 and 2.8 crore doses (2.4 Crore imported and 40 Lakh manufactured in India) in July 2021. August 2021 onwards, locally manufactured Sputnik V vaccine will be available in the domestic market and technology-transfer arrangement for manufacturing of Sputnik-V vaccine has been firmed up with six Indian manufacturers, sources added.

Currently, Dr Reddy’s Laboratories has a tie-up with the Russian Direct Investment Fund (RDIF) to make the Sputnik V Covid vaccine in India. Dr Reddy’s received the EUA for Sputnik V in India on April 13 and also permission from DCGI to import the Russian vaccine. The first lot of the vaccines has been imported with three million units arriving in the country on Tuesday.

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SII has committed to make 100 million Covishield vaccines a month from June. It has started manufacturing the Novavax vaccine, in small batches, at its Pune plant, even as it awaits regulatory clearance in the US and subsequently in India.

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Mumbai has received three bids for the supply of Russia’s Sputnik V Covid vaccine, the government sources informed on Monday. The Brihanmumbai Municipal Corporation had placed the tenders for one crore doses on May 11. These were issued under India’s latest nationwide Covid-19 inoculation policy, allowing state governments to procure Covid vaccine doses directly from producers.

Sources told that the deadline for submission of bids ends tomorrow. Of the three received till now, one was made directly by the Russian Direct Investment Fund (RDIF) and the other two by its independent representatives. Sources also told that the legal, technical and financial aspects of the bids will be decided in two weeks, in consultation with the Maharashtra government after the bids close tomorrow.

As per the reports, the RDIF are willing to transfer one crore Covid vaccine doses in 60 days to BMC. The proposed import of Sputnik V, if it happens, will be independent of the manufacture of the vaccine which is being handled in India by Hyderabad-based Dr Reddy’s.

Sputnik V was developed by the Moscow-based Gamaleya Research Institute of Epidemiology and Microbiology and was registered on August 11, 2020, by the Russian Ministry of Health. It is cleared for use in India but it yet to get clearance from the World Health Organization.

Mumbai’s success in receiving bids for Covid vaccine supply comes amid instances where Punjab and Delhi have revealed that the private manufacturers they approached had refused them, opting to deal only with the Central government.

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In a joint statement on Monday, the Russian Direct Investment Fund and the pharmaceutical firm Panacea Biotec said that the full scale production of Sputnik V has been launched in India this summer

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As several states reported vaccine shortage across the country, Indian envoy to Russia, Bala Venkatesh Varma announced on Saturday that India will start the production of Russian Covid vaccine Sputnik in August. He said Russia has supplied over 2 lakh doses of the vaccine to India.

Varma also assured that three million Sputnik V doses will be supplied in bulk by May-end and the number is expected to increase to 5 million by June. As per the present plan, more than 850 million doses of the Sputnik V will be produced in India.

The Indian Envoy also informed that Sputnik will be produced in India in three phases- first, supply from Russia – fully made – which has already started, Second, RDIF will send to India in bulk which will be ready for use but it will have to be filled in various bottles in India. Third, the Russian side will transfer the technology to Indian company and the Indian company will produce it fully in India. All these 3 put together will be about 850 million doses.

The Russian vaccine manufacturers have collaborated with Dr Reddy’s in India and has already supplied over two lakh doses to India. He said Sputnik V has already supplied 150,000 doses and then 60,000 doses to India.

Sputnik V has been approved to be imported from Russia, but is yet to be widely available in the country. The company had said the imported doses of the vaccine are presently priced at a maximum retail price of Rs 948, with 5% GST per dose, amounting to Rs 995.4 per dose.

Only three vaccines have been approved to be sold in India — Covaxin, Coveshield and Sputnik V.

The first consignment of imported doses of the vaccine from Russian Direct Investment Fund (RDIF) landed in India on May 1 and received regulatory clearance from the Central Drugs Laboratory.

Reddy’s Laboratories had earlier in the month soft-launched imported Covid-19 vaccine, with Deepak Sapra, a senior executive of the drug-maker, taking the first shot.

Taking about the Sputnik Light vaccine, the Ambassador also said that New Delhi hopes that the Russian Sputnik Light vaccine will be approved for use in India.

Sputnik Light is the first component (recombinant human adenovirus serotype number 26 (rAd26)) of the Sputnik V coronavirus vaccine, according to the Russian Direct Investment Fund (RDIF), the sovereign wealth fund marketing the vaccine abroad.

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In a statement the RDIF said that the single-dose Sputnik Light vaccine demonstrated 79.4% efficacy as per the data taken from 28 days after the injection was administered. An efficacy level of near 80% is higher than that of many two-dose vaccines. The Sputnik V vaccine was registered in India in April.  

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Russian Covid vaccine Sputnik V, the first vaccine against Covid-19 in the world has reached India and will be available in the market from next week onwards, NITI Aayog member VK Paul said on Thursday. The first batch of the vaccine from Russia has arrived and more batches will be arriving soon.

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Production of Sputnik V will commence in India from July onwards. India is looking to produce 15.6 crore doses of the Russian Covid vaccine. Dr Reddy’s Laboratories is the Indian partner of the Russian vaccine. India will have 2 billion doses of Sputnik V in the next five months – made by India and used by India, Dr VK Paul said.

Indian regulators had granted regulatory approval or restricted use authorisation to Sputnik V on April 12. Sputnik V has an efficacy rate of 91.6 per cent. Clinical trial data published in The Lancet indicated that the vaccine appears safe and effective.

Meanwhile, the total number of people vaccinated in India so far is 17,72,14,256.

The nationwide Covid-19 vaccination in India began on January 16 with healthcare workers, sanitation workers, defence forces, police and other paramilitary forces getting to be the first to get the jab. The second phase of Covid-19 inoculation drive commenced on March 1 for those above 60 years of age and for people aged 45 and above with co-morbidities. The central government had decided to start the Covid-19 vaccination for all adults from May 1.

However, Covishield and Covaxin, made by Bharat Biotech of Hyderabad, are the two vaccines being used in India.

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The first consignment of 1,50,000 doses of Russian Covid-19 vaccine Sputnik V will be landed India on Saturday while another three million doses are scheduled to arrive this month.

According to diplomats based in Moscow and New Delhi, the flight carrying 150,000 doses of the preventive vaccine left Russian shores this morning and will be handed over to Dr Reddy’s Laboratories. The vaccines will be delivered to Dr Reddy’s Laboratories, which has joined hands with Russian Direct Investment Fund (RDIF) to produce Sputnik V in India.

Before the doses are handed over for vaccination, the Indian partner of the Russian vaccine will seek mandatory approval from the Central Drugs Laboratory, Kasauli.

Sputnik V is one of three vaccines other than Pfizer and Moderna that have an efficacy of over 90% against the coronavirus disease. It was given regulatory approval or restricted use authorisation in India on April 12.

On April 13, the Drug Controller General of India approved the use of Sputnik V vaccine against coronavirus in the country. India became the 60th country to approve Sputnik V. In September 2020, Dr Reddy’s and RDIF entered into a partnership to conduct clinical trials of SputnikV, developed by the Gamaleya National Research Institute of Epidemiology and Microbiology and is supported by the Russian sovereign wealth fund, Russian Direct Investment Fund or RDIF.

Initially, India had received the rights for the distribution of the first 100 million doses in India but later, it was enhanced to 125 million.

According to officials, some five million “filled and finished” bottles of Sputnik V will arrive in a container from Russia in June and some 10 million-plus vaccines in July. The Sputnik V vaccine delivery started after Prime Minister Narendra Modi had a long conversation with Russian President Vladimir Putin on April 28.

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The vaccine has been registered in India under the emergency use authorization procedure 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.

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Russian Covid vaccine Sputnik V manufacturer in India Dr Reddy’s Laboratories on Thursday clarified that the discussions on its pricing are still pending and there is no final decision yet. This development comes a day after announcing that Russia’s Sputnik V vaccine could be sold at $10 (around Rs 750) a dose in India.  

Dr Reddy’s said in a statement that the lab will share an update once there are further developments in this regard. The decision on the pricing of the imported doses of Sputnik V in India are still on the table.

GV Prasad, the Managing Director of Dr Reddy’s Labs on Wednesday said that the imported product would only be for the private market, it is allowed for the private market completely. 

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He said that the pricing model will have to figure out in the next few days and also confirmed that the cost of Sputnik V would be lower when its production started in India. That product will be available both for the public and private market.

Talking on on the third vaccine to be cleared for emergency use in India against the world’s worst Covid surge, Prasad said said that the import of Sputnik V will start in May. Asking about the number of doses would available by May-June, he said that it is still being negotiated.

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The Serum Institute of India has said its vaccine Covishield, developed by Oxford-Astrazeneca, will be sold at Rs 400 a shot to state governments and Rs 600 to private hospitals. The Centre will continue to receive Covishield doses at Rs 150 each.

Sputnik V is the only Covid vaccine other than those of Pfizer and Moderna to show an effectiveness of over 91% against Covid-19 when taken in two doses, 21 days apart. The first lot of Sputnik vaccines will be fully developed and ready to administer from Russia.

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Indian Ambassador to Russia, Bala Venkatesh Varma has confirmed that the first batch of Russia’s Covid-19 vaccine Sputnik V will be delivered to India within the upcoming next 10 days. He said the production of the vaccine will start in India in May and it is likely to go upto 50 million doses a month. Sputnik V will be the third vaccine to be used in India against Covid-19.

In January, India’s drug regulator Drug Controller General of India had approved the emergency use of two Covid-19 vaccines Covaxin of Bharat Biotech and Covishield of Oxford-AstraZeneca manufactured by Serum Institute of India in Pune. 

Bala Venkatest told reporters that the first shipment of Sputnik V will take place by the end of this month and the production will be launched in May and it will slowly increase. 

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With this, India has become the 60th country to authorise the use of the Russian Sputnik V vaccine against coronavirus. Last week, the DCGI had registered the vaccine under the emergency use authorization procedure, 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. 

While Addressing a virtual press conference last week, Russian Direct Investment Fund CEO Kirill Dmitriev had said besides five drug companies that the Russian firm had ties ups with, they are looking at a couple of more firms for the possible production pacts. Dmitriev had said Sputnik V is an Indian-Russian vaccine because lots of production of sputnik V will be done in India. 

According to an earlier release, RDIF has agreements with India’s Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma and Virchow Biotech aimed at production of more than 850 million doses per year. 

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Earlier this week, the government had decided to fast-track emergency approvals for all coronavirus vaccines that have been given a similar nod by the World Health Organization or regulators in the United States, Europe, Britain or Japan.

The move may make several vaccines available to India, including those made by Pfizer, Moderna and Johnson & Johnson.

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