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Pfizer, Moderna, Serum & the indemnity issue; what is it and what it means for India?

Foreign pharma majors, such as Pfizer and Moderna, have said that they will export their COVID-19 vaccines to India only if the deal is the Indian government and the company is guarded against legal cases for any severe side effects

The indemnity clause is currently a thorny issue between the Centre and the foreign pharma majors, such as Pfizer and Moderna The indemnity clause is currently a thorny issue between the Centre and the foreign pharma majors, such as Pfizer and Moderna

India is currently facing an acute shortage of COVID-19 vaccines with the Centre receiving brickbats for its vaccination policy, which fell short when the country was hit by a severe second wave of COVID-19 in March-April.

Although the government halted the exports of COVID-19 vaccine shots earlier given under its "Vaccine Maitri" programme and scrambled to procure more jabs to address the shortage, it is also likely to grant indemnity to Pfizer, Moderna, and now Serum Institute of India (SII) to expedite the vaccination process in the country.

Serum Institute became the latest pharma company to ask for indemnity from liability, stating that all vaccine manufacturers, whether Indian or foreign, should be protected against legal suits for any severe side effects. The Centre has thus far not provided indemnity to any COVID vaccine maker.

Also Read: Pfizer, Moderna COVID-19 vaccines likely in India soon; Centre may grant indemnity

But what is indemnity?

Indemnity means protection against a loss or any other financial stress. In the given context, indemnity is like granting a concessional request of legal defence from any claims associated with the use of companies' COVID-19 vaccines in India.

The Centre has thus far not provided indemnity to any COVID vaccine maker. The clause, commonly used in insurance contracts, means if the Centre grants an indemnity to a vaccine manufacturer to roll out its jabs in the country, the government, and not the company, would be liable to indemnify any citizen who alleges to have side effects after taking the dose.

Who has asked for indemnity?

The indemnity clause is currently a thorny issue between the Centre and the foreign pharma majors, such as Pfizer and Moderna, which have said that they will export their COVID-19 vaccines to India only if the company is guarded against legal cases.

The Serum Institute too became the latest pharma company to ask the Centre to ensure protection against liability. Pfizer and Moderna, which are among the best COVID-19 vaccine shots in the international market being over 90 per cent effective, have been approved by over 40 countries, comprising the UK and the US.

Also Read: COVID-19 vaccine: Serum Institute seeks indemnity against liabilities 

What's the Centre's stand on the indemnity clause?

The government is reportedly likely to grant indemnity to foreign drugmakers like Pfizer and Moderna to hasten approvals of the coronavirus vaccines in India. This is along the lines of the approach adopted by the US and other countries that have rolled out their COVID-19 vaccines.

Like other nations, the Indian government is also expected to grant indemnity to these companies if they seek drug regulator's nod for the Emergency Use Authorisation (EUA).

Meanwhile, in another development that would bolster the availability of vaccines, the Drug Controller General of India (DCGI) has waived the requirement of testing every batch of foreign-made COVID-19 vaccines by the Central Drugs Laboratory, Kasauli and post-launch bridging trials for such firms.

Also Read: India, Pfizer seek to resolve dispute over COVID-19 vaccine indemnity

When will Pfizer, Moderna COVID-19 vaccines be available in India?

Several sources in the government have indicated that Pfizer has already signalled that it would be able to export some vaccine doses to India by July 2021.

Regarding the indemnity clause, a government source in the know has stated the Centre would possibly look at rules and practices followed by other nations on granting indemnity coverage.

"Why would India want to stop the manufacturers? If indemnity is the only hurdle, it will be seen by the government on the basis of practices followed internationally," said the source.

In response to India Today's query on its ongoing discussions with the Centre, Pfizer said, "This is an ongoing discussion with the government, therefore we are unable to confirm more. As of May 3, we have shipped more than 430 million doses of the Pfizer-BioNTech COVID-19 vaccine worldwide and our shipment accuracy is 99.9. We continue to increase manufacturing capacity to exceed 2.5 billion vaccine doses in 2021."

"As we have maintained all along, during this pandemic phase, across the world Pfizer will supply the COVID-19 vaccine only to central governments and supranational organisations for deployment in national immunisation programs. The allocation of doses and implementation plan within a country is a decision for local governments based on relevant health authority guidance," the US-based pharma major added.