Pfizer's insistence on indemnity against adverse effects delaying approval of its Covid-19 vaccine in India: Report 

Pfizer has been successful in signing a similar indemnity clause with many other countries that absolve the company from paying any legal cost in case of an adverse event. However, unlike those countries, India does not offer this indemnity clause to pharma companies.  

Pfizer is reportedly insisting on indemnity against lawsuits in India that may arise in case its Covid-19 vaccine leads to adverse effects such as serious illness or even death. The company's demand has become a major hurdle in the way of approval of its jab and Pfizer's discussions with the government authorities are essentially stalled on this issue, The Economic Times reported quoting people who are in the know of the developments.

Pfizer has been successful in signing a similar indemnity clause with many other countries that absolve the company from paying any legal cost in case of an adverse event. However, unlike those countries, India does not offer this indemnity clause to pharma companies.

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Both Serum Institute of India and Bharat Biotech had also demanded an indemnity clause but their requests were turned down by the Government of India.

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Pfizer CEO Albert Bourla recently said the company was in discussion with the Indian government seeking an “expedited approval pathway” for its COVID-19 vaccine while announcing the US drugmaker’s donation of medicines worth more than Rs517 crore to India.

However, the ET report quoted officials of the Indian government as saying that the demand for indemnity is the major roadblock for approval.

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“This cannot be given to one company. If it is given to Pfizer then the domestic companies will ask for the same too,” The Economic Times quoted an official as saying.

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Indemnity clauses are being included all over the globe by countries like the UK, the US, Canada, Singapore. Considering the extraordinary situation, these nations have shifted at least a part of potential liabilities to the government. The UK government granted Pfizer legal indemnity, protecting it from being sued in a case of health complication caused by its vaccine. The United Stated granted indemnity to both Moderna and Pfizer.

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