More Indian cos could make Sputnik vaccine

India is poised to become a manufacturing hub for Russia’s Covid-19 vaccine, Sputnik V, as it inches towards getting an approval from India’s drug regulator.“Russians have swept up unused manufacturing capacity. Many companies will be using their unused biological capacity to manufacture Sputnik V,” said a company insider, on the condition of anonymity. While 100 million doses can come immediately from Dr Reddy’s, this can go up sharply as Sputnik has signed agreements with companies like Gland, Virchow, Strides and Hetero, insiders said. The subject expert committee under the drug regulator is likely to take up an application of Dr Reddy's Laboratories to market Sputnik V on Thursday.It is indicative that companies like Serum Institute of India (SII), Panacea Biotec and Biocon may also get into manufacturing Sputnik, not immediately but down the line, a source said. “These companies have expressed interest and are exploring the making of Russian vaccine in India,” he added.Last week, Virchow Biotech of Hyderabad became the fourth company to join hands with Russia’s sovereign fund RDIF (Russian Direct Investment Fund). Vichrow will produce up to 200 million doses per year of vaccine Sputnik V in the country. Prior to this, Hetero Group signed an agreement with RDIF to make 100 million doses. The other two are with Gland Pharma (252 million doses) and Stelis Biopharma (200 million doses).With Dr Reddy’s Laboratories, RDIF partnered in September 2020 for the clinical trials as well as distribution of the vaccines in the country. Once it gets an approval, Sputnik Vis likely to be imported initially.“So many companies have tied up and hence the combined capacities will be much larger than any one vaccine manufacturing company in India. More companies are tying up. It is essentially using the capacities which are available in India. The companies are incentivised to take it by provision of technology transfer,” the company insider added.The easy tech transfer by RDIF has played a crucial role. “Their tech transfer is open source. They have not restricted anybody. They have given it without agreement,” added a source. However, these companies will have to conduct a bridging trial once Sputnik V gets an approval from the drug regulator.“They may be asked to conduct a bridging study. They will need to test the Indian version of vaccine. But that decision will be taken once it gets an approval. To start with, Dr Reddy’s will import it. The companies are serious about introducing huge quantities in India,” said the source.

from Economic Times https://ift.tt/3ftDPk3