HYDERABAD: Russian Covid-19 vaccine, Sputnik V, which received emergency use authorisation (EUA) earlier this week, will be available for use in India in April-June quarter with imports coming from Russia. Local manufacturing will kick in from July-September quarter, top officials of Dr Reddy’s Laboratories said on Wednesday.
“The first batches are going to be produced by RDIF (Russian Direct Investment Fund) and will be imported to India by us,” Dr Reddy’s Laboratories co-chairman and managing director GV Prasad said. Sources added that RDIF could begin shipping the doses from Russia as early as mid-May once the vaccine batches are tested and approved by Indian regulators.
Dr Reddy’s has a contract with RDIF for distributing 125 million people equivalent doses (250m units comprising 125m doses each of vectors Ad26 and Ad5 to be injected 21 days apart). This would be a combination of imports and locally manufactured doses and can be increased subject to mutual discussions, Deepak Sapra, CEO APIs & pharmaceutical services, Dr Reddy’s Labs said.
Most vaccine doses made in India will be used in India till vaccine availability eases. Only after that will Sputnik V exports start from India, Sapra said. Sapra also indicated that about 60-70% of the global production of Sputnik V will come out of India, where six manufacturers have been tied up. Dr Reddy’s Labs has entered into a contract manufacturing tie-up with Bengaluru-based Shilpa Medicare for manufacturing an undisclosed quantum of doses.
Sapra said the vaccine has a shelf life of six months and while ideal storage temperature is -18 to -22 degrees C, the firm is in the process of generating additional stability data on +2 to +8 degrees C range. “This data will be available in a few months after which we will make the necessary amendment request to the regulator for storage condition to be modified to 2-8 degree C, which will make the process of storage and transportation easier,” Sapra said.
The firm has been testing cold chain through simulation scenarios from Hyderabad as far as Manipur in North East, Ladakh in north and Tamil Nadu in the south. It has lined up cold chain infrastructure to ensure temperature of -18 to -22 degree C is maintained from factory to the transportation from Russia to India and from global distribution centre in Hyderabad to various parts of country through air and road.
