A day after India accorded emergency use authorisation to Sputnik V , marketing partner for the Russian COVID-19 vaccine Dr. Reddy’s Laboratories said the imported product will be available in the country by this quarter.
It will start this quarter, via the imported route and the availability will be ramped up next quarter once the Made in India Sputnik V comes on stream. Discussions with the government and other stakeholders on pricing are under way, the Hyderabad-based pharma major’s senior leadership said on Wednesday.
The contract with Russian Direct Investment Fund (RDIF), which has partnered Dr. Reddy’s for clinical trials and distribution, is 250 million vaccine units (125 million people doses). This number is extendable, CEO of API and Services business Deepak Sapra said.
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Separately, the RDIF has entered into production pacts with six vaccine makers in the country, he said. About 60-70% of the global volumes of Sputnik V will be made in India. Most of it will be used in the country, he said, adding Sputnik is being made in Russia and a few other countries.
In a presentation during the interaction, in which chairman Satish Reddy and co-chairman and managing director GV Prasad participated, Mr. Sapra said the vaccine has a storage condition of minus 18-22 degrees C and a shelf life of six months. Dr. Reddy’s has lined up the cold chain and made logistics arrangements to ensure delivery up to the last mile throughout the country. It will also be collaborating with the government and leverage some of the infrastructure of the immunisation programmes.
The vaccine will be imported in frozen form. Additional stability data is also being generated on the 2 to 8 degree C temperature range. This will be available in a few months, after which the necessary amendment request will be made to the regulator, he said.
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Based on the human adenovirus vector platform, Sputnik V is a two dose intra-muscular vaccine to be taken three weeks apart. Dr. Reddy’s, which undertook the clinical trials in the country, is also responsible for harmonisation of quality produced in India. It will provide stewardship to manufacturing sites where the production will commence soon. It will also be responsible for the regulatory, safety and pharmaco-vigilance aspects of the vaccine in India.