Dr Reddy s working on stability data on 2 to 8 C temp range for Sputnik V vaccine

(Eds: Updating with company's statement on Remdesivir
production)
Hyderabad, Apr 14 (PTI): 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 on Wednesday.
Deepak Sapra, Dr Reddys Chief Executive Officer, API and
Services, told a press conference 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 Sputnik V vaccine in India, which would
be available during this quarter.
Dr Reddys Laboratories had, 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 Reddys had
said in a regulatory filing.
In September 2020, Dr. Reddys 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 Reddys, 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.
We have also reduced our MRP by50 per cent so that price
is not a barrier to access, and a much larger number of
patients can access it, the drug-maker said.
To ensure that patients and healthcare professionals have
full visibility on the availability of the drug in their
city, the company has built a dedicated website, updated in
real-time with city-wise availability of the product at
stockists and hospitals, it said adding that a dedicated
patient helpline for inquiries regarding Redyx (Remdesivir)
stock has been set up. PTI GDK APR
NVG NVG

(This story has not been edited by THE WEEK and is auto-generated from PTI)