Indian government, Pfizer deadlock over legal protection issue
US drug major Pfizer's coronavirus vaccine is facing hurdles in entering the Indian market over demand for legal protection from any adverse effects that may follow after the use of its jabs, Indian media reports said
US drug major Pfizer's coronavirus vaccine is facing hurdles in entering the Indian market over demand for legal protection from any adverse effects that may follow after the use of its jabs, Indian media reports said.
Till now, India has not given any Covid-19 vaccine maker protection against legal liability in the form of compensation for any severe side effects, which Pfizer has obtained in many countries where its vaccine, developed with Germany's BioNTech, is being widely administered, including Britain and the United States.
"The whole problem with Pfizer is the indemnity bond. Why should we sign it?" a government source was quoted as saying by 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.
Though the Indian government wants to fast track approvals for overseas vaccine makers, including Pfizer, Moderna and Johnson and Johnson, but none has sought approval from Drugs Controller General of India to sell their vaccines in world's largest market.
Another issue that is preventing Pfizer from accessing the Indian market is the Indian government's insistence on local trials before introducing the vaccine to the general population.
In February, Pfizer decided against selling its vaccine in India, withdrawing its application for emergency use authorisation after India said such a trial would be necessary.
However, three vaccines rolled out in India, developed by AstraZeneca, Russia's Sputnik V and Bharat Biotech's Covaxin, have completed safety trials.
On May 4, Albert Bourla, Pfizer's chief executive said he was hopeful that the Indian government would change its policy of local trials and a solution could be found to sell the vaccine in the Indian market, said the report.
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