Sputnik in India.

Sputnik in India.

DCGI accords Reddy’s permission to import Sputnik V; India’s third vaccine

All you need to know about the Sputnik V; RDIF sets target of 50m doses a month

Agency Report | Hyderabad | 13 April, 2021 | 11:20 PM

Dr Reddy's Laboratories (DRL), the city-based pharmaceutical major has received permission from the Drugs Controller General of India (DCGI) to import the Sputnik V vaccine into India for restricted use in emergency situations.

“We are very pleased to obtain the emergency use authorization for Sputnik V in India. With the rising cases in India, vaccination is the most effective tool in our battle against Covid,” said DRL’s co – chairman and managing director G.V. Prasad.

According to the Hyderabad-based company, emergency use will be as per the provisions of the new drug and clinical trials rules, 2019 under the Drugs and Cosmetics Act.

The pharmaceutical major partnered with Russian Direct Investment Fund (RDIF) in September 2020 to conduct clinical trials of Sputnik V and distribute the vaccine in India.

“In addition to the trials conducted in Russia by RDIF. Phase II/III clinical trials of the vaccine were carried out by Dr. Reddy’s in India,” said a company official.

As per DRL’s statement, Sputnik V is approved to tackle coronavirus in 60 countries across the world, including ranking second among coronavirus vaccines globally in terms of the number of approvals issued by the government regulators.

“Sputnik V uses two different vectors for the two shots in a course of vaccination. The efficacy of Sputnik V was determined to be 91.6 per cent as per a published article in the Lancet, one of the world’s oldest and most respected medical journals,” said the official.

Considering the shortage of vaccines being experienced by many Indian states, DRL received DCGI’s permission within a day’s time after the subject expert committee (SEC) approved its application for the Russian vaccine candidate Sputnik V.

As Hyderabad-based pharmaceutical major Dr. Reddy’s Laboratories (DRL) announces it has received permission from the Drugs Controller General of India (DCGI) to import Sputnik V vaccine in India for restricted use in emergencies, here are a few things that you need to know about the Covid-19 jab.

After Covishield and Covaxin, Sputnik V, developed by Gamaleya National Research Institute of Epidemiology and Microbiology in Moscow, is now the third Covid-19 vaccine to get emergency use approval in India.

According to the guidelines, the vaccine is indicated for active immunisation to prevent Covid-19 in individuals more than 18 years old and it needs to be stored at minus 18-degree Celsius in its liquid form.

However, it can be stored at 2-8 degree C in its freeze-dried form in a conventional refrigerator, making it easier to transport and store.

In a recent study, published in the journal The Lancet, the efficacy of Sputnik V was determined to be 91.6 per cent.

“There is a need to generate evidence about its efficacy in the Indian population. Sputnik V will provide one more option to the country to boost its vaccination drive,” Harshal R Salve, Associate Professor at Centre for Community Medicine, All India Institute Of Medical Sciences (AIIMS), New Delhi, said.

According to Neha Gupta, Infectious Diseases Specialist at Medanta – The Medicity, Gurgaon, Sputnik V is a viral vectored vaccine and is likely to perform similar to Covishield.

The vaccine should be administered in two doses of 0.5 ml each with an interval of 21 days.

Indian Council of Medical Research’s N.K. Arora said that the composition of the first dose will be different from the second dose and there should be at least a three to four weeks gap between the first dose and the second.

Sputnik V is approved to tackle Covid-19 in 60 countries across the world, including ranking second among Covid-19 vaccines globally in terms of the number of approvals issued by the government regulators.

The emergency approval for Sputnik V comes amid reports of vaccine shortage in some states even as cases have increased dramatically over the past few days.

On Monday, the Union Health Ministry said that nearly 30 lakh doses of Covid-19 vaccine were given on Day 1 of the “Tika Utsav” which has pushed the cumulative coverage to 10.45 crore, as India’s average doses per day crossed the 40 lakh mark, continuing to be the highest globally.

In terms of number of cases, data from Johns Hopkins University (JHU) showed that India has overtaken Brazil, which is now at the third spot in the Covid-19 tally with over 1,34,82,023 cases.

More than 50 million doses of Sputnik V vaccine will be produced in India in a month over the summer in partnership with five Indian companies, Kirill Dmitriev, the CEO of Russian Direct Investment Fund (RDIF), said on Tuesday.

Over 850 million doses of Sputnik V are going to be produced in India annually, which will be sufficient to vaccinate more than 425 million people around the world.

India is the leading production hub for Sputnik V. RDIF has reached agreements with the leading pharmaceutical companies in the country, including Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma and Virchow Biotech, aimed at producing more than 850 million doses per year.

Dmitriev said in a media briefing that a big milestone has been reached with India giving approval for the Sputnik V vaccine on April 12. India is the most populated country to register the Russian vaccine. Total population of 60 countries where Sputnik V is approved for use is three billion people or about 40 per cent of the global population.

The vaccine has been registered in India under the emergency use authorisation procedure based on the results of clinical trials in Russia as well as positive data of additional Phase III local clinical trials in India conducted in partnership with Dr. Reddy’s Laboratories.

Dmitriev said the approval of the vaccine is a major milestone as Russia and India have been developing extensive cooperation on clinical trials of Sputnik V in India and its local production.

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 The Lancet, one of the leading medical journals.

Dmitriev said India is a vaccine-manufacturing hub and Russia’s strategic partner for production of Sputnik V. RDIF has created partnerships with a number of India’s leading pharmaceutical companies for the production of Sputnik V, which will provide for both vaccination of the population in India and global distribution of the Russian vaccine.

He added that the clinical trials showed very high immune response in India and confirmed the very high efficacy of Sputnik V.

Dmitriev said that five producers have been announced in India and a couple more will be announced in the next two weeks, including for fill and finish capability.

RDIF is not buying an equity stake in these companies but will provide working capital so that they can ramp up quickly.

He said some companies are already producing Sputnik V, but the real ramp-up of production will take two to three months over the summer. (IANS)