Mumbai: The Drugs Controller General of India (DCGI) has exempted well-established COVID-19 vaccines from clinical trials and testing after approval of each batch at the Central Drugs Laboratory (CDL) in Kasauli, Himachal Pradesh. The norms are relaxed when certified by the national control laboratory of the country of origin.
DCGI chief VG Somani’s letter said this would apply to vaccines that have already been approved for emergency use by the US FDA, EMA, UK MHRA, PMDA Japan or the World Health Organization for restricted use.
“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 an 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.
“However, scrutiny and review of the summary lot protocol and certificate of analysis of batches of these vaccines will still be undertaken by CDL to release them for use in the country. Other procedures for the filing of applications and timelines for processing them will still have to be followed”, the letter added.
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.