Dr Reddy's Laboratories testing stability of Sputnik V vax at 2 to 8 C temp range

Hyderabad: Dr Reddy's Laboratories (DRL) is in the process of generating additional stability data for Russia's Covid-19 vaccine Sputnik V, which has a storage condition of -18C, on 2 to 8 C, a senior official of the drug maker said on Wednesday.

Deepak Sapra, Dr Reddy's Chief Executive Officer, API and Services said at a media briefing that the vaccine will be imported in a frozen condition from Russian Direct Investment Fund (RDIF) with which it has an agreement to distribute 125 million human doses ( 250 million vials) in India, maintaining -18 to -22. The doses will be kept outside for 15-20 minutes before being administered to the people.

"In addition to the product which is at -18C, today we are in the process of generating additional stability data on the 2 to 8C temperature range. This data will be available in a few months, after which we will make the necessary amendment request to the regulator and request for the storage condition to be modified to 2 to 8C," Sapra told reporters. He said necessary cold storage infrastructure is in place to distribute Sputnik V vaccine in India, which will be available during the current quarter.

Dr Reddy's Laboratories on Tuesday said it has received approval from Indian drug regulator for restricted emergency use of Covid-19 vaccine Sputnik in the country.

The company has received the permission from the Drug Controller General of India (DCGI) to import the Sputnik vaccine into India for restricted use in emergency situations as per the provisions of the New Drug and Clinical Trials rules, 2019 under the Drugs and Cosmetics Act, Dr Reddy's had said in a regulatory filing.