Centre is expected to grant legal protection from liability to Pfizer and Moderna in order to expedite the approval process for anti-covid vaccines in India, news agency ANI reported.
“It is expected to grant indemnity against legal proceedings along the lines of what has been granted in other countries for Pfizer and Moderna vaccine companies,” ANI quoted government sources as saying.
The decision came in backdrop of pharma giants seeking government indemnity from costs relating to severe vaccine side-effects. The move will clear way for foreign vaccines like Pfizer and Moderna for the country’s urgent requirement.
Pfizer, which is ready to offer 5 crore doses to India between July and October, had stressed on indemnity, sharing efficacy trials and approvals for its vaccine in various countries and by WHO. Although Pfizer has obtained legal protection in several countries, including Britain and the United States, India has not given any manufacturer of a Covid-19 vaccine indemnity against the costs of compensation for any severe side effects.
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.
In a letter, DCGI Chief VG Somani letter said that this will be applicable for vaccines that have already been approved for restricted use by the US FDA, EMA, UK MHRA, PMDA Japan or listed for Emergency Use by the World Health Organisation.
“In light of the huge vaccination requirements and the need for increased availability of imported vaccines,… it has been decided that for approval of Covid Vaccines in India for restricted use in emergency situation which are already approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use listing,” he said.
“Testing every batch of vaccine by CDL, Kasauli can be exempted, if the vaccine batch/lot has been certified and released by National Control Laboratory of the country of origin,” it said.
Earlier, vaccines that had completed clinical studies outside the country were required to carry out “bridging trials” or limited clinical trials on the Indian population to know how the drug works on people of Indian origin.