Moderna, Pfizer one step closer as Drug Controller exempts foreign Covid-19 vaccines from bridging trials

The decision to waive trials will only apply to the vaccines which have been approved for restricted use by US FDA and other countries or which are listed in WHO Emergency Use Listing (EUL). 

The Drug Controller General of India (DCGI) on Wednesday gave the nod to the foreign Covid-19 vaccines for restricted use in emergency situations without bridging trials to test the quality of the doses. DCGI Chief, V G Somani, in a letter, stated that the decision to waive trials will only apply to the vaccines which have been approved for restricted use by the US FDA and other countries or which are listed in the WHO Emergency Use Listing (EUL). The landmark decision is likely to clear the way for vaccines like Moderna and Pfizer, who had already placed request with the Indian government to allow them to import the jabs without indemnity and post-approval local trials.