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Dr Reddy’s Lab to approach regulator for Sputnik Light as booster dose

The Drugs Controller General of India (DCGI) in February granted approval to the single-shot Sputnik Light vaccine for restricted use in emergency situation in India

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Dr Reddy’s Laboratories is hoping to go to a regulator for its single-dose Sputnik Light jab as booster dose for approvals by June-end or early July, a senior official of the city-based drug-maker said last week.

Deepak Sapra, CEO, Active Pharmaceutical Ingredients and Services, Dr Reddy’s, told reporters that the company has currently put its Sputnik M, a COVID-19 vaccine for children (12-17 years of age) on the backburner, and prioritising Sputnik Light, the price of which is being re-worked.

We are currently in the midst of clinical trials for Sputnik Light as a universal booster which means that anybody has taken any vaccine – be it Covishield or Covaxin – can take Sputnik Light as a universal booster if we get a favourable result in our clinical trials. For this, we expect to go to the regulator towards the end of June or early July, Sapra said.

The Drugs Controller General of India (DCGI) in February granted approval to the single-shot Sputnik Light vaccine for restricted use in emergency situation in India.

In September 2020, Dr Reddy’s partnered with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V and distribute the vaccine in India. In April 2021, the DCGI granted approval to the two-dose Sputnik V vaccine for restricted use in emergency situation in India.

He said the drug major has sold 1.2 million doses of Sputnik V Vaccine in India so far.

Replying to query on the pricing of Sputnik vaccines, he said they were working on it and it would be in line with the competition.

The idea is to make it competitive or market-driven otherwise. The other thing is when we launched Sputnik earlier, it was getting imported from Russia. The product that is now available for booster is made in India. Pricing will be competitive in line with the market conditions,” he said.

The current pricing of Sputnik V is Rs 995 plus taxes per dose.

The official further said the company is filing for regulatory approvals for its COVID-19 portfolio of medicines in several countries where there is a surge.

Edits by EP News Bureau

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