NEW DELHI: Dr Reddy's Laboratories said on Tuesday it has received permission from the Drug Controller General of India (DCGI) to import Sputnik vaccine into India for restricted use in emergency situations.
The permission is subject to provisions of New Drug and Clinical Trials Rules 2019 under the Drugs and Cosmetics Act.
In September last year, Dr Reddy's had partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of
and distribute the vaccine in India.
In addition to trials conducted in Russia by RDIF. Phase two and three clinical trials of the vaccine were carried out by Dr Reddy's in India.
Here are five things you need to know about Sputnik V:
1 India is 60th country to approve Sputnik V
India is the 60th country to approve the use of Sputnik V against coronavirus, as per the Russian Direct Investment Fund (RDIF).
The vaccine has been approved for use in countries with a total population of 3 billion people or about 40 per cent of the global population. India is also the most populated country to register the vaccine.
Other countries that have approved the use of Sputnik V include Argentina, Bolivia, Hungary, UAE, Iran, Mexico, Pakistan, Bahrain and Sri Lanka.
2 Sputnik V has 91.6% efficacy rate
The Russian vaccine has an efficacy of 91.6 per cent and provides full protection against severe cases of Covid-19 as demonstrated by the data published in one of the leading medical journals, The Lancet.
3 What are the advantages of Sputnik V
As per the Russian Direct Investment Fund (RDIF), Sputnik V has a number of key advantages, including that there are no strong allergies caused by Sputnik V.
The price of the vaccine is less than USD 10 per shot.
It uses two different vectors for the two shots in a course of vaccination, providing immunity with a longer duration than vaccines using the same delivery mechanism for both shots.
4 India to produce 850 million doses of Sputnik V
More than 850 million doses of Sputnik V are going to be produced annually in India.
RDIF has agreements with India's Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma and Virchow Biotech. India will be the leading production hub for Sputnik V.
Hyderabad-based Dr Reddy's Labs will initially import the vaccine in small amounts to supply to the government.
The stocks are likely to increase with local supplies that are expected by June-July.
5 Sputnik V: India's third vaccine against Covid-19
Sputnik V will be the third vaccine to be used in India against coronavirus.
In January, DCGI had given the emergency use authorisation for two Covid-19 vaccines -- Covaxin of Bharat Biotech and Covishield of Oxford-AstraZeneca manufactured by Serum Institute of India in Pune.