Serum Institute seeks regulatory nod to make Sputnik V
Serum has been in talks with RDIF for a few months now to put in place a manufacturing agreement for the vaccine
Serum Institute of India has sought approval of the Drugs Controller General of India (DCGI) for test production of Sputnik V while it holds talks with the vaccine developer’s global commercializing partner, Russian Direct Investment Fund, for a production pact.
“It is a preliminary licence for test manufacturing. Serum Institute has been in talks with RDIF for a few months now to put in place a manufacturing agreement for the vaccine. Those talks are still underway,” said a person with knowledge of the matter, requesting anonymity.
A deal with RDIF will make it the third contract manufacturing agreement for covid-19 vaccines for Serum Institute. The Pune-based company currently has such agreements for the Covishield and Covovax vaccines.
Serum Institute currently has authorization for Covishield, a version of the vaccine co-developed by Oxford University and AstraZeneca plc. It is also doing a bridging study in India for Covovax, a vaccine developed by US-based Novavax.
The world’s largest vaccine maker has committed almost all its capacity into making covid vaccines so far, planning to produce 100 million Covishield doses starting July, as well as an undisclosed number of doses of Covovax. It has signed contracts with AstraZeneca and Novavax to make one billion doses each of Covishield and Covovax, respectively.
Serum Institute has already started manufacturing Covovax, although the vaccine is yet to secure authorization anywhere in the world.
Meanwhile, the Indian distributor for Sputnik V, Dr Reddy’s Laboratories, is working on expanding the supply of the Russian vaccine since its launch on 14 May. The company on Thursday partnered with Snowman Logistics for temperature-controlled end-to-end logistics solutions to transport the two-dose vaccine across India.
Snowman will handle delivery via its temperature-controlled warehouses in Mumbai, Delhi-National Capital Region, Kolkata, Chennai, and Bengaluru. The company will offer storage, order processing, shipper packing and secondary transportation from these locations.
Cold storage is crucial for Sputnik V as it requires a storage temperature of -18 degree Celsius.
Dr Reddy’s is in a pact with RDIF to distribute 250 million doses of the covid-19 vaccine across India. The Hyderabad-based drugmaker has priced the vaccine at ₹995 per dose, including taxes, and currently supplies it in limited quantities through imports from Russia.
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First Published:3 Jun 2021, 11:51 PM IST
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