NEW DELHI: To fast track approvals for Pfizer and Moderna, the Union government may grant them legal protection (indemnity) from any claims linked to their use. This will be on the lines of indemnity granted in other countries. However, for that to happen they need to be cleared by the drug controller for limited emergency use.
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 costs of compensation for any severe side effects.
In another exemption, 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. Both Pfizer and Moderna fall in this category. Earlier, vaccines that had completed clinical tests outside the country were required by manufacturers to carry out bridging trials on the Indian population.
But even with these concessions, it will take some time for Pfizer and Moderna to join India's vaccine bandwagon because of the huge worldwide demand for Covid shots. Pfizer has offered 5 crore doses to India between July and October.
