New Delhi: As India battles the Corona vaccine shortage, this comes as a breather. International drug makers like Pfizer and Moderna are likely to send their consignments soon, as India is likely to extend indemnity.
Many other nations have already granted indemnity to these companies.
The approval will be in line with the approach taken by US and other countries administering both vaccines, said a top govt official.
“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.
DCGI waiver paves the way for vaccine import
In another development, the Drug Controller General of India (DCGI) has waived the requirement of testing every batch of foreign-made COVID-19 vaccines. This would bolster the availability of vaccines.
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-19 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.
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.
