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Drug regulator says no need for bridging trials on foreign approved vaccines before India roll out

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: A+ 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”.

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Foreign Coronavirus Vaccines Like Pfizer, Moderna A Step Closer With Key India Waiver

In a big move to clear the way for foreign vaccines like Pfizer and Moderna, the drug regulator has done away with the requirement of India-specific trials.

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India's Drug Regulator DCGI Exempts Local Bridging Trials For Foreign Vaccines Approved By WHO And Select Overseas Regulators

India's Drug Regulator DCGI Exempts Local Bridging Trials For Foreign Vaccines Approved By WHO And Select Overseas Regulators
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India to stop carrying out trials of vaccines in a bid to speed up roll out

Just three per cent of Indians have been vaccinated and campaigns have stopped in many states due to shortages

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Moderna, Pfizer a step closer as India exempts foreign Covid 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).

United kingdomHimachal pradeshNational control laboratory of country originNational expert group on vaccine administrationCentral drugs laboratoryDrug controller generalUse listingNational expert groupVaccine administrationNational control laboratoryஒன்றுபட்டது கிஂக்டம்கச ul லிஇமாச்சல் பிரதேஷ்மைய மருந்துகள் ஆய்வகம்மருந்து கட்டுப்படுத்தி ஜநரல்பயன்பாடு பட்டியல்