Pfizer and New Delhi are unable to reconcile differences over a demand by the US pharmaceutical company for legal protection from any claims linked to the use of its COVID-19 vaccine, Reuters said citing two sources.
Thus far, India has not given any COVID-19 vaccine manufacturer 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 rolled out, including Britain and the United States.
"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 them (Pfizer). If somebody moves court, the central government will be responsible for everything, not the company," the source added.
Pfizer and the 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.
India, which is facing a shortage of shots as 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, which has a population of 1.35 billion. The second source said that the other issue being discussed was the government's insistence on a local trial for any vaccine approval.