Serum seeks permission to make Sputnik V, protection against liabilities

The Serum Institute of India (SII) has shown its willingness to manufacture Russia-made COVID vaccine, Sputnik V.

The Pune-based company, which is supposedly world’s largest vaccine manufacturer, has sought the permission of the Drug Controller General of India (DCGI) for the same, said reports.

If the DCGI okays company CEO Adar Poonawala’s request for clinical trials and production of Sputnik V, the Serum Institute of India will become the seventh company to manufacture the Russian jab.

Also read: 70% of Russian Sputnik V vaccines will be made in India

In addition to manufacturing Sputnik V, Poonawala is believed to have sought indemnity protection against liabilities, which means a vaccine-maker can’t be dragged to court in India. It may be noted that Serum (makers of Covishield) and Bharat Biotech (Covaxin) had sought indemnity protection last year as well, but they were denied the benefit by the Government of India. However, when news trickled in of foreign vaccine manufacturers Pfizer and Moderna getting indemnity protection in India, Poonawala too sought protection against liabilities.

Later, Poonawala spoke for indemnity for all vaccine makers. “We need to have the government indemnify manufacturers, especially vaccine manufacturers, against all lawsuits… Frivolous claims come up and you see in the media something being blown out of proportion. The government needs to step in with the right messaging,” he had said.

NITI Aayog member (Health) Dr VK Paul recently said that Pfizer’s application for indemnity is still under review.

Serum recently promised the Union government that it would manufacture 10 crore Covishield vaccines in June. The company is also ready to make Novavax vaccine, for which it has sought regulatory clearance for the US.

Also read: Centre in talks; Pzifer vaccine likely to reach India next month

Dr Reddy’s Laboratories, Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma and Virchow Biotech are the six manufacturers of Sputnik V, which is being promoted by Russia’s RDIF sovereign wealth fund.

DCGI gave emergency use authorisation to Sputnik V in April. The vaccine is currently being manufactured in India by Dr Reddy’s Laboratories.