Mumbai Indian manufacturer of Russian-developed Sputnik V vaccine to focus on single-shot production sputnik light Because of the complex process involved in rolling out a two-dose COVID-19 vaccine.
Dr Reddy’s Lab, which tied up with the Russian Development Investment Fund (RDIF) last year to co-develop and market the vaccine in India, including technology transfer, is undergoing clinical trials. sputnik light in India.
Apart from Reddy’s, Gland Pharma, Panacea Biotech Ltd., Morepan Labs, Hetero Labs and Serum Institute of India have tied up with RDIF for manufacturing and selling Sputnik V for domestic market as well as for export. “Our focus is only on Sputnik Lite. We have finished the registration batch. We are waiting for Dr Reddy’s Lab to finish the clinical trials and get permission from the Drug Controller General of India,” said Chief of Panacea Biotech Executive Officer Rajesh Jain said in response to the queries. “We hope to get the DRL (Dr Reddy’s Lab) permission by December. If all goes well, we will start commercial production from January.”
Dr Reddy’s did not respond to questions from the story. However, during a recent investor call, the company said that the focus will be on Sputnik Lite.
Dr Reddy’s Chief Executive Erez Israeli said, “Specific for Sputnik, we are exploring several development opportunities, including Sputnik Light as a vaccine or as a booster dose, Sputnik Lite for adolescents and export opportunities.” Are included.”
When asked by an analyst whether the company could meet the target of manufacturing 125 million doses of Sputnik V, which was contracted by the RDIF, the Israeli stated that Sputnik Lite’s qualifications as a vaccine and booster are “in new status”. new opportunities”. For the company “in the medium term, it is mainly about boosters, which certainly depends on the protocol that a country adopts, especially a country from emerging markets, so it remains to be seen, But this is an opportunity.”
Sputnik V is a combination of two viral vector platforms Ad26 and Ad5.
According to experts, manufacturing two doses is similar to manufacturing two different vaccines, requiring two separate production lines. Mint Speak to
The logistics to store and transport the vaccine also require stringent cold chain facilities to maintain -19°C. In India, six months after the launch of Sputnik V, production delays, high price ( 1,200 for a single dose) and storage issues caused private hospitals to reduce demand. The RDIF, too, is positioning Sputnik Lite as the go-to vaccine after the sovereign fund realized difficulties in supplying components for the second dose.
According to Dr Reddy’s confession, the company missed out on the huge demand for a nationwide vaccination campaign between June and August as it was not able to supply the second dose of Sputnik V. Now, Indian drugmakers are betting on DGCI’s approval for Sputnik Lite. As a booster shot and for vaccination of children.
Gland Pharma, which has the contract to manufacture 250 million doses, said the focus would be on Sputnik Lite. “The idea is to focus on Sputnik Lite. That’s where the demand is coming in, especially outside India,” Gland Pharma chief executive officer Srinivas Sadu said in an analyst call in October. “In the first few months, we are trying to make Sputnik Lite and the post that will shift to Sputnik V, but there are two limitations, one is the existing export restriction. After we apply they are special permission for the no-objection certificate. One of the companies has received it. Two, there are challenges on the regulatory front too – Sputnik Lite is still not approved in India,” said Sadu.
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