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MUMBAI : Indian manufacturers of the Russia-developed Sputnik V vaccine will shift focus on producing the single-shot Sputnik Light due to the complex process involved in rolling out the two-dose covid-19 vaccine.

Dr Reddy’s Lab, which tied up with the Russian Development Investment Fund (RDIF) last year to co-develop and market the vaccine in India, including technology transfer, is running clinical trials for Sputnik Light in India.

Besides Dr Reddy’s, Gland Pharma, Panacea Biotec Ltd, Morepan Labs, Hetero Labs, and Serum Institute of India have tied up with RDIF to manufacture and sell Sputnik V in the domestic market as well as for exports. “Our focus is only on Sputnik Light. We have finished registration batches. We are awaiting Dr Reddy’s Lab to finish the clinical trials and obtain permission from the Drugs Controller General of India," said Rajesh Jain, chief executive officer, Panacea Biotech, in response to queries. “We expect DRL (Dr Reddy’s Lab) to get the permission by December. If all goes well, we will start commercial production from January."

“Going forward, we believe Sputnik continues to be relevant and meaningful in the vaccination program. Our lifecycle management of Sputnik will see us take a multi-pronged approach with the single-dose Sputnik Light vaccine (first dose of the two-dose Sputnik V) as a standalone vaccine, as a booster dose, and Sputnik V for the paediatric population with relevant clinical trials," said Dr Reddy's spokesperson in an emailed response to Mint. The spokesperson added that the company is in the midst of clinical trials for Sputnik Light and expects to update on the status of the trial after its submission to the DCGI soon.

During a recent investor call the company had reiterated the focus would be on Sputnik Light.

“Specific to Sputnik, we are exploring several growth opportunities, which include Sputnik Light as a vaccine or as a booster dose, Sputnik Light for adolescents, and export opportunities," said Erez Israeli, chief executive, Dr Reddy’s.

To an analyst query on whether the company could meet the target of manufacturing 125 million doses of Sputnik V, which it was contracted to do by RDIF, Israeli said the qualification of Sputnik Light as a vaccine and booster offer “newer opportunities of newer positioning" for the company. “In the medium term, it is primarily about the booster, which of course depends on the protocol that a country adopts, especially a country from the emerging markets, so it is yet to be seen, but this is an opportunity."

Sputnik V is a combination of two viral vector platforms of Ad 26 and Ad 5.

The manufacturing of the two doses is as good as manufacturing two different vaccines that require two separate production lines, according to experts Mint spoke to.

The logistics to store and transport the vaccine also require stringent cold chain facilities, maintaining -19 degrees Celsius. In India, six months after Sputnik V was launched, production delays, high price ( 1,200 for one dose) and storage issues led to private hospitals scaling down demand. RDIF, too, is positioning Sputnik Light as the go-to vaccine after the sovereign fund realized the difficulty of supplying the components for the second dose.

According to Dr Reddy’s admission, the company missed the massive demand between June and August for the nationwide vaccination drive as it would not have been able to supply the second dose of Sputnik V. Now, Indian drug makers are betting on DGCI’s approval for Sputnik Light as a booster shot and for vaccinating children.

Gland Pharma, which is contracted to manufacture 250 million doses, said the focus would be on Sputnik Light. “The idea is to focus on Sputnik Light. That is where the demand is coming, especially outside India," said Srinivas Sadu, chief executive officer, Gland Pharma, in an analyst call in October. “In the first few months, we are trying to manufacture Sputnik Light and post that will shift to Sputnik V, but there are two limitations, one is the existing export embargo. They are giving special permission for no-objection certificates once we apply. One of the companies has received it. Two, there are also challenges on the regulatory front—Sputnik Light is still not approved in India," Sadu added.

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