Indian companies roped in for the manufacture of Sputnik V

India is developing itself as a production hub for the Covid -19 vaccine of Russia, Sputnik V, as it moves forward in getting approval from the drug regulator of India.

An insider from the company stated, “Russians have swept up unused manufacturing capacity. Many companies will be using their unused biological capacity to manufacture Sputnik V”. The 100 million doses that can come from Dr Reddy’s can increase sharply as Sputnik has signed an agreement with companies that include Gland, Virchow, Strides, and Hetero, according to an insider. On Thursday, the subject expert committee under the drug regulator is expected to take up an application on Dr Reddy’s Laboratories for the marketing of Sputnik V.

According to a source, it points out to the fact that companies like Serum Institute of India (SII), Panacea Biotech, and Biocon might manufacture Sputnik in the near future. He further said, “These companies have expressed interest and are exploring the making of Russian vaccine in India”.

Virchow Biotech, Hyderabad, in the previous week was the fourth company to collaborate with Russia’s sovereign fund RDIF (Russian Direct Investment Fund). In the country, it shall manufacture almost 200 million doses of the vaccine every year. Before this, Hetero Group signed an agreement with RDIF to manufacture 100 million doses. The other two are with Gland Pharma and Stelis Biopharma, producing 252 million doses and 200 million doses respectively.

RDIF partnered with Dr Redddy’s Laboratories in September 2020 for the clinical trials and the distribution of vaccines in the country. Once it gets approved, Sputnik V is expected to be imported in the initial stage.

An insider from the company reported, “So many companies have tied up and hence the combined capacities will be much larger than anyone vaccine manufacturing company in India. More companies are tying up. It is essentially using the capacities which are available in India. The companies are incentivized to take it by the provision of technology transfer”.

RDIF’s easy tech transfer has played a vital role. A source exclaimed, “Their tech transfer is open source. They have not restricted anybody. They have given it without agreement”. Once Sputnik V gets approved by the drug regulator, these companies shall have to conduct a bridging trial.

The source concludes, “They may be asked to conduct a bridging study. They will need to test the Indian version of the vaccine. But that decision will be taken once it gets approval. To start with, Dr Reddy’s will import it. The companies are serious about introducing huge quantities in India”.