Pfizer likely to get indemnity in India

The government is likely to indemnify Pfizer Inc against future liabilities arising from adverse after-effects of its Covid-19 jabs, paving the way for their launch in India.

“The discussions are ongoing with Pfizer and (we) are close to achieving a breakthrough. We are ready to support them in terms of indemnity with certain conditions, similar to what has been granted in other countries,” said a government official.

The same support will be granted to Moderna and other international vaccine makers if they apply for Emergency Use Authorisation, said the official.

Need for bridging trials waived

Moderna will be in a position to supply jabs only by the year-end or early next year.

A Pfizer spokesperson said the company remains engaged with the government towards making its Covid-19 vaccine available for use in India’s immunisation drive. “As these discussions are ongoing, we are unable to share any additional details at this time,” said the spokesperson.

Countries like the US and UK have granted vaccine makers immunity against being sued for adverse effects.

Pfizer is in discussions with the Indian government for supplying 50 million vaccine doses between July and October. The US company has made indemnity an important precondition for beginning supplies.

Government sources said discussions have speeded up after the recent visit of foreign minister S Jaishankar to the US. “The issue of vaccine procurement from US drug makers was the key item of the minister’s agenda,” said the official.

Once the government takes a decision on indemnity issue, foreign vaccine makers will just require a go-ahead from India’s drug regulator to import the vaccines to India. “This won’t even have to go to the Subject Expert Committee (SEC),” said the official.

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In another important development that could accelerate the entry of these jabs into the country, the Drug Controller General of India (DCGI) on Tuesday waived the requirement for conducting bridging clinical trials for well established vaccines and did away with the need for testing every batch of imported jabs.

As reported by ET, the vaccines that have been approved for restricted use by regulatory bodies in the US, EU, UK, Japan or by the WHO and which are well established will be exempted from the requirement of conducting post approval bridging trials as well as requirement of testing every batch of vaccines by the Central Drugs Laboratory (CDL), Kasauli.



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