Indian producers to seek regulatory nod for Sputnik V vaccine soon

So far, Dr Reddy’s has received the first consignment of 1.5 lakh doses on May 1 with imported supplies of the first dose.

Hyderabad: Local manufacturers of Sputnik V vaccine are likely to approach the Indian regulator in the next 1-2 months for approvals. The companies are expected to absorb the technology of Russian Direct Investment Fund (RDIF), make the equivalent products and approach the regulator with relevant data.

Indian manufacturers of Sputnik V vaccine will soon submit for regulatory permissions for local manufacturing and the production is expected to begin from late June or early July.

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Till the time the local production begins, about 36 million doses of imported vaccine will be administered in India, meeting the vaccination needs of about 18 million people (two doses per person).

“The local manufacturers who have license from RDIF will send samples from initial batches for regulatory clearance to see that there is quality compliance and uniformity as per the expectations of the technology transfer,” said Dr Sauri Gudlavalleti, head, Integrated Product Development Organization (IPDO) and Research & Development, Dr Reddy’s Laboratories.

So far, Dr Reddy’s has received the first consignment of 1.5 lakh doses on May 1 with imported supplies of the first dose, while the company received on May 16, the second consignment with 60,000 doses of the second dose (vector).

The third consignment with 90,000 doses of the second dose component (to complete the two-dose administration for all 1.5 lakh people receiving the vaccination) is awaited and expected shortly, he added.

While the imported vaccine is priced high at present, local production is likely to reduce the price of the Sputnik V vaccine. Initially, Dr Reddy’s will be administering the vaccine (from 1.5 lakh dose consignment) through institutions and hospitals, and gradually make necessary arrangements with the governments to make vaccines available in government hospitals and centres.

The company is also in the process of integrating Sputnik V vaccine with the CoWin platform for people to register through it.

Meanwhile, Dr Reddy’s is expected to approach the Indian regulator to seek clearances for Sputnik Light (single dose vaccine) in the next few weeks, Gudlavalleti informed.

Also read:

Dr Reddy’s administers first dose of Sputnik V vaccine in Hyderabad

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