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Kerala Kaumudi Online
Friday, 24 September 2021 3.04 AM IST

Moderna, Pfizer a step closer as India exempts foreign Covid vaccines from bridging trials

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​​​​​NEW DELHI: In a move to pave the way for the availability of vaccines like Pfizer and Moderna in India, the Drugs Controller General of India (DCGI) has exempted foreign Covid-19 vaccines approved by specific nations or health bodies from post-approval bridging trials in the country.


DCGI chief VG Somani said the decision to waive trials will only apply to the vaccines that have been approved for restricted use by the US FDA and other countries or which are listed on the WHO Emergency Use Listing (EUL).


The landmark decision is likely to clear the way for vaccines like Moderna and Pfizer, which had already requested the government to allow them to import the jabs without indemnity and post-approval local trials.

The decision was taken on the recommendation of the National Expert Group on Vaccine Administration for COVID-19 or NEGVAC.

"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 (EUL) and which are well-established vaccines from the standpoint that millions of individuals have already been vaccinated with the said vaccines, the requirement of conducting post-approval bridging clinical trials and the requirement of testing of every batch of the vaccine by the Central Drugs Laboratory (CDL), Kasauli can be exempted, if the vaccine batch/lot has been certified and released by National Control Laboratory of Country of Origin," DCGI chief, VG Somani said in the letter.


"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 tests outside the country were required by manufacturers to carry out bridging trials on the Indian population.

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TAGS: VACCINES, MODERNA, PFIZER, INDIA, TRIALS, WHO, EMERGENCY USE LISTING, KERALA, CENTRAL DRUGS LABORATARY
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