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 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
United States.
"The whole problem with Pfizer is the indemnity bond. Why should we
sign it?" an Indian government source with direct knowledge of the
matter told Reuters.
"If something happens, a patient dies, we will not be able to
question them (Pfizer). If somebody challenges in a court of law,
the central government will be responsible for everything, not the
company," the source added.
Pfizer and India's health ministry did not reply to Reuters 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.
LOCAL TRIAL
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.
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 The second source said that the
other issue being discussed between Pfizer and
New Delhi was the Indian 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.
Albert Bourla, Pfizer's chief executive said on May 4 that he was
hopeful that the government would change its policy of local trials
and that a path to delivering the drugmaker's shots in India could
be found.
A third source told Reuters 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.
The Indian foreign ministry did not immediately respond to a request
for comment.
(Reporting by Neha Arora and Carl O'Donnell; Additional reporting by
Rupam Jain; Editing by Krishna N. Das and Alexander Smith)
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