The Drug Controller of India had approved the Russian-made Sputnik V COVID19 vaccine for emergency use on April 12. However, almost three months later, the vaccine’s commercial launch is yet to happen.

Hyderabad-based pharmaceutical company Dr. Reddy’s Laboratories is in agreement with the Russian Direct Investment Fund (RDIF) to supply and manufacture the Sputnik V vaccine in India. 

The company has informed the press that due to the requirement of quality tests of every batch of the vaccine and dependence on imports from Russia, delay in its commercial launch is being reported. The full scale commercial launch will be delayed by a ‘few more weeks’, it has said.

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Why does Sputnik V require every batch of its consignment to be tested?

On June 2, the Kasauli-based Central Drugs Laboratory had announced that it is relaxing the norms of testing every batch of the foreign-made COVID19 vaccine in order to ensure quicker delivery of the vaccines in the wake of vaccine shortages across the country.

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But the relaxation of norms was announced for COVID19 vaccines that have been approved by the World Health Organization (WHO), US Food and Drug Administration, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, UK, Pharmaceuticals and Medical Devices Agency, Japan.

However, WHO and the western countries haven’t yet fully approved the Sputnik V vaccine and India is at present testing every batch of the imported vaccine from Russia.

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What is the present status of the commercial launch of Sputnik V in India?

Russia had sent the first consignment of Sputnik V to India on May 1 and the vaccine was initially launched as a ‘limited pilot soft launch’ on May 14. So far, almost 75,000 people in India have been inoculated with the Russian vaccine.

The efficacy rate of Sputnik V has been reported to be 91.6 per cent as compared to Covishield’s 70 per cent and Covaxin’s 78 per cent.

The vaccine is presently available in 22 cities including Hyderabad, Visakhapatnam, Bengaluru, Mumbai, Kolkata, Delhi, Chennai, Miryalaguda, Vijayawada, Baddi, Kolhapur, Kochi, Raipur, Chandigarh, Pune, Nagpur, Nashik, Coimbatore, Ranchi, Jaipur, Lucknow and Patna.

However, the availability of Sputnik V is scarce as compared to Covishield and Covaxin.

Second dose of Sputnik V

Meanwhile, Dr. Reddy’s Laboratory has stated on July 12 that the full-scale roll out of the Sputnik V is being delayed because the supply of the second dose of the vaccine is still awaited.

“As a matter of responsibility, we would not like to announce a full-fledged commercial launch until we have an equivalent quantity (of the second dose),” Dr. Reddy’s was quoted as saying by Reuters.

“It is our commitment to ensure supply of component 2 in equal quantity and on time to all partner hospitals to whom we have supplied dose 1,” the company added.

Preparedness for Sputnik V commercial rollout

The pilot soft launch of the vaccine has been reported to have prepared the pharmaceutical company for its larger commercial rollout. 

“Our cold storage and other logistical arrangements are being executed in line with our commercialisation plan and are on track with no issues,” Dr Reddy’s was quoted as saying.

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“This pilot phase has allowed us to test our cold storage arrangements of -18 degree C temperature in these cities, CoWIN integration, track-and-trace and other logistical arrangements ahead of our commercial launch,” it added.

The company has received around 300,000 vials of the Sputnik V vials from Russia so far. It was expecting a consignment of the vaccines to arrive from Russia by June which has not arrived yet.

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Dr Reddy’s is in charge of distributing 250 million doses of Sputnik V in India and the first 50 millions will be directly imported from Russia. The remaining 200 million will be manufactured in India itself.