Pune-based Serum Institute of India will produce the Russia-developed-vaccine Sputnik V from September. The Russian Direct Investment Fund (RDIF) said they have planned to produce over 300 million doses of vaccine in India per year.

The Technology transfer has already begun with SII receiving cell and vector samples from the Gamaleya Center. The Drug Controller General of India has approved the import and cultivation process has begun, said the RDIF.

Delighted to partner with the RDIF, Serum Institute chief Adar Poonawalla said he hopes to make a million doses of Sputnik V vaccine in the coming months with trial batches starting in the month of September. He said the vaccine would be accessible in full measure with high efficacy and a good safety profile across India and the world.

Given the uncertainty of the virus, Poonawalla added that it is important for international institutes and governments to collaborate and further bolster up the fight against the pandemic.

On the other hand, RDIF CEO Kirill Dmitriev said the strategic partnership is a major step to substantially increase our production capabilities demonstrating a perfect example of joining forces and expertise to save lives both in India and around the world.

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The development came when India is trying to ramp up its vaccination efforts to inoculate all the adult population by December. The country is currently struggling to fulfill the requirements of vaccines in various states. Delhi, meanwhile, has shut down several of its vaccine centres as the supply of Covishield is running out, Deputy Chief Minister Manish Sisodia has said.

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Adar Poonawalla’s Serum Institute of India has been granted permission by the Drug Controller General of India to manufacture the Russian Covid vaccine Sputnik V.

An official source told the media that the DCGI has granted permission to the Serum Institute to manufacture the Sputnik Covid-19 vaccine in India for examination, test and analysis at its licensed Hadapsar facility with certain conditions.

The test licence granted to the Serum Institute means it can develop and manufacture the product for testing, but not sell it.

The Pune-based institute has collaborated with Gamaleya Research Institute of Epidemiology and Microbiology, Moscow in Russia for developing Sputnik V at its licensed Hadapsar facility. The company had submitted an application to the DCGI in this regard on Thursday.

” The Serum Institute’s spokesperson told NDTV that the institute have got preliminary approval for Sputnik V but actual manufacturing will take several months. In the meantime, the firm’s focus remains Covishield and Covovax.  

The first dose of Sputnik V was administered in Hyderabad on May 14 as part of a soft launch by Dr Reddy’s Laboratories.

According to the four conditions set by the DCGI, the SII will have to submit a copy of the agreement between it and the Gamaleya Research Institute of Epidemiology and Microbiology for transfer of cell bank and virus stock and submit the copy of agreement for technology transfer with Gamaleya.

The Russian jab has now been registered for use in more than 65 countries but has yet to be approved by the EU or US health authorities.

At 91.6%, Sputnik V has a higher efficacy compared to the two vaccines that are currently being administered in India – Oxford-AstraZeneca’s Covishield, manufactured by the SII and Bharat Biotech’s Covaxin.

Another Russian vaccine, Sputnik Light, could be the first single-dose vaccine to be used in India and Dr Reddy’s will have discussions with the government and the regulator this month for an immediate launch, the company told NDTV on May 14.

The Russian vaccine is to be administered in two dosages at a gap of 21 days according to initial reports. Gamaleya had announced that the two doses of Sputnik V have an efficacy rate of 91%, while the single dose has 79.4% efficacy.

Sputnik V, which was launched in May by DRL is at the time the second most expensive vaccine at Rs 948 per dose that goes up to Rs 995.40 per dose after adding the 5% GST slab.

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The Serum Institute plans to seek restricted emergency use permission of the vaccine in India. An imported dose of Sputnik V costs Rs 995.40 in India. Russia’s Sputnik V vaccine is currently being manufactured by Dr Reddy’s Laboratories in India.

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Third stage trials of the Russian Sputnik V vaccine for coronavirus can begin in India within the next few weeks once the regulatory clearances are in, said an official of the private company that has tied up with the Russian state firm that developed the vaccine.

The Russian Direct Investment Fund (RDIF) and Dr Reddy’s Laboratories have gotten into a pact whereby the Indian firm will conduct Phase 3 studies in India, get local regulatory approvals and distribute the finished vaccine in India post the all-clear. Some 1,000 to 2,000 people will be enrolled in the Phase 3 trials at hospitals, both government and private.

Deepak Sapra, CEO for API and Pharmaceutical Services at Dr Reddy’s, told reporters he wanted to clear the first step by getting approvals from Indian regulators soon. Once approved, the Russian company is expected to supply 100 million doses of the coronavirus vaccine to India. Deliveries could potentially begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India.

Sputnik-V doses supplied in India will likely be a combination of Indian- and Russian-made doses, Sapra said, adding that RDIF and Dr Reddy’s would soon identify potential manufacturers in India. The RDIF has said vaccine deliveries to India could begin in late 2020, but Sapra suggested it could take longer.

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Russia was the first country to officially register a coronavirus vaccine in August. The vaccine has been named Sputnik V. It was developed by Russia’s Gamaleya Research Institute.

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