PFIZER INDEMNITY CLAUSE LEADS TO INDIA DEADLOCK
Pfizer and the Indian government are at loggerheads over a demand by the US drugmaker for legal protection from any claims linked to the use of its Covid-19 vaccine in one of the world’s biggest markets, two people familiar with the matter said.
India has not given any manufacturer of a Covid-19 vaccine indemnity against the costs of compensation for side effects, which is a condition Pfizer has obtained in many countries, including Britain and the US.
“The whole problem with Pfizer is the indemnity bond. Why should we sign it?” a government official with direct knowledge of the matter told Reuters.
INDIA HAS NOT GIVEN ANY MANUFACTURER INDEMNITY AGAINST COSTS OF COMPENSATION FOR ANY SEVERE SIDE EFFECTS
NEW DELHI: The Centre and Pfizer are at loggerheads over a demand by the US drugmaker for legal protection from any claims linked to the use of its Covid-19 vaccine in one of the world’s biggest markets, two sources told Reuters.
India has not given any manufacturer of a Covid-19 vaccine indemnity against the costs of compensation for any severe side effects, which is a condition Pfizer has obtained in many countries where its shots have already been widely rolled out, including Britain and the US.
“The whole problem with Pfizer is the indemnity bond. Why should we sign it?” a government source with direct knowledge of the matter told Reuters.
“If something happens, a patient dies, we will not be able to question Pfizer. If somebody challenges in court , the central government will be responsible for everything, not the company,” the source added.
Pfizer and India’s health ministry did not reply to requests for comment on Friday.
The second source said Pfizer was not going to change its position on the indemnity issue.
Both sources declined to be named as they were not authorised to talk to the media.
India, which is facing a shortage of shots as coronavirus cases soar, pledged last month to fast-track approvals for overseas vaccine makers including Pfizer, Moderna and Johnson and Johnson.
However, none have since sought permission from India’s drug regulator to sell their vaccine in the country, which has a population of 1.35 billion.
The second source said that the other issue being discussed between Pfizer and New Delhi was the government’s insistence on a local trial for any vaccine approval. Pfizer withdrew its application for emergency use authorisation for the vaccine developed with Germany’s BioNTech in February after India insisted on such a trial.
But three other shots on sale in India, developed by AstraZeneca, Russia’s Sputnik V and Bharat Biotech in collaboration with state-run Indian Council of Medical Research, have completed the small-scale safety trials.
A third source said that India’s foreign minister would visit the United States this month or in early June to try and address Pfizer’s concerns and ease exports of vaccine raw materials to India.