Working on stability data on 2 to 8 C, temp range for Sputnik V vaccine: Dr Reddy’s

Dr Reddy’s Laboratories is in the process of generating additional stability data for Russia’s COVID-19 vaccine Sputnik V, which has a storage condition of -18 C, on 2 to 8 C, a senior official of the drug-maker said.

Deepak Sapra, Dr Reddy’s CEO, API and Services, told that the vaccine would be imported in a frozen condition from the 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 would 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 8 C temperature range. This data would 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 the Sputnik V vaccine in India, which would be available during this quarter. Dr Reddy’s Laboratories has received approval from the Indian drug regulator for restricted emergency use of COVID-19 vaccine Sputnik in the country.

The company has received 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 said in a regulatory filing.

In September 2020, Dr Reddy’s and RDIF entered into a partnership to conduct clinical trials of the Sputnik V developed by the Gamaleya National Research Institute of Epidemiology and Microbiology and the rights for distribution of the first 100 million doses in India. Later it was enhanced to 125 million. Sapra further said the quantity can be further enhanced with mutual agreement.

Meanwhile, Dr Reddy’s, in a statement, said it is ramping up the production of Remdesivir which is used in treating COVID-19 patients and bringing to market a liquid product that is faster to make and supply.

It said, “We have also reduced our MRP by 50 per cent so that price is not a barrier to access, and a much larger number of patients can access it.”