To speed up approvals for Pfizer and Moderna in India, the government may grant a major concession requested by them – indemnity from liability.
Health Ministry sources have said other countries have done it and “there is no problem” in granting indemnity or legal protection from any claims linked to the use of a company’s COVID-19 vaccine.
“If these companies have applied for Emergency Use Authorisation in India, then we are ready to give them indemnity,” the sources said.
In another key waiver, the drug regulator has done away with the requirement of India-specific trials for foreign vaccines approved by specific countries and WHO for emergency use.
The Drug Controller General of India (DCGI) has waived the requirement for foreign companies to carry out “post-launch bridging trials” and to test the quality and stability of their vaccines in India if they have approvals from specific countries or health bodies.
But even with these concessions, it will take some time for Pfizer and Moderna to join India’s vaccine programme because of the huge worldwide demand for Covid shots.
Pfizer, which is ready to offer 5 crore doses to India between July and October, had in talks with the government stressed on indemnity, sharing efficacy trials and approvals for its vaccine in various countries and by WHO.
Pfizer has immunity in countries like the US where it cannot be sued for any adverse effects. India has so far not given any manufacturer indemnity against the costs of compensation for any severe side effects.
“We are engaged with Pfizer and they have indicated the availability of a certain amount of vaccine in the coming months, possibly starting in July and we are looking at what their expectations from the government are and they are looking at what our expectations from them are,” VK Paul, the head of the National Expert Group on Vaccine Administration, had said last month.
“They have requested indemnity to all the nations including the country of origin. We are examining this request and will take a decision in the larger interest of people and on merits. This is under discussion and there is no decision as of now,” Dr Paul, a NITI Aayog member, had said.