New Delhi [India], June 3 (ANI): India on Thursday said it remains engaged with US vaccine manufactures and also US administration for maintaining the supply chain of essential raw material needed by domestic manufacturers of coronavirus vaccine.
Drug regulator says no need for bridging trials on foreign approved vaccines before India roll out
DCGI modifies earlier order on emergency approval of well-established vaccines, waives several requirements, but retains assessment of first 100 beneficiaries before proper roll out.
Himani Chandna 2 June, 2021 10:32 am IST Text Size:
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New Delhi: The country’s apex drug regulator Tuesday announced it was waiving off the requirement of conducting post-approval bridging trials in India for well-established vaccines as well as testing each batch of vaccines at the Central Drugs Laboratory (CDL) in Kasauli.
The Drugs Controller General of India (DCGI)’s decision to make these exemptions for all “well established” vaccines was made from the standpoint “that millions of individuals have already been vaccinated”.
Like other nations, the Indian government is also expected to grant indemnity to foreign drugmakers like Pfizer and Moderna if they seek drug regulator's nod for the Emergency Use Authorisation (EUA)
Read more about DCGI waiver may bring foreign vaccines like Pfizer, Moderna a step closer on Business Standard. 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