Manas Dasgupta
NEW DELHI, May 22: Despite the centre’s “blue print” of vaccinating all adult population in the country by the end of December with a “flood of foreign-made vaccines” coming to India, none of the foreign vaccine manufacturers, with the exception of Russia’s Sputnik V, have so far have even applied for permission to sell their vaccines in India.
The government currently is holding talks with the US drug maker Pfizer for importing its vaccines to India but had so far not been able to resolve the issue, though still not reached an “impasse,” but the indemnity against compensation and compulsory local trial before approval was believed to be holding up a solution.
India pledged last month to fast-track approvals for overseas vaccine makers including Pfizer, Moderna and Johnson and Johnson. But none have since even sought permission from India’s drug regulator to sell their vaccines in India, possibly because of the shortage in their respective countries of production itself.
Pfizer and the Indian government are seeking to resolve tensions over a demand by the US drug maker for legal protection from any claims linked to the use of its Covid-19 vaccine.
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 used, including Britain and the United States.
But some form of legal protection is still on the table as India and Pfizer work to reach a vaccine deal, company sources said.
Reaching an agreement with Pfizer is critical for India to secure needed Covid-19 vaccine doses as local production capacity would not be able to meet the entire demand within the next seven months as has been targeted. Official sources have admitted this week that 98% of the country’s population remains susceptible to infection.
The external affairs minister S Jaishankar is scheduled to visit the United States next week when he was likely to take up with Pfizer the issue of its vaccine supply to ease its concerns. He could offer Pfizer some form of protection from lawsuits in exchange for the company providing additional assistance with distributing its shots in India but a total indemnity, as was being demanded by the company, might not be forthcoming, the sources said.
A Pfizer spokeswoman said the company is still in talks with India on a deal and they have not reached an impasse, adding that Pfizer remained hopeful about reaching an agreement.
Pfizer has been consistent in its position on indemnity and is not planning to change its approach for a deal with India, the sources said.
Another issue being discussed between Pfizer and New Delhi was the Indian government’s insistence on a local trial for any vaccine approval. The source added that Pfizer cannot finalize terms of a supply agreement, including indemnity, if the vaccine is not first authorized for use in India.
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.
Pfizer’s chief executive Albert Bourla 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 Pfizer’s vaccine in India could be found.