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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.

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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”.

Bridging trials are supplementary trials performed in a new region or country to get more clinical data on efficacy, safety and dose regimen.

Citing the “huge vaccination requirements” in India in the “wake of the recent surge of COVID-19 cases”, a notice issued by the Central Drugs Standards Control Organisation (CDSCO), the top drug regulatory agency, said that “for approval of COVID-19 Vaccines in India for restricted use in 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… the requirement of conducting post approval bridging clinical trials can be exempted.”

The notice, signed by DCGI V.G. Somani, also exempts the “requirement of testing of every batch of the vaccine by the Central Drugs Laboratory (CDL), Kasauli… if the vaccine batch/lot has been certified and released by National Control Laboratory of Country of Origin.”

It also cites India’s need for increased availability of imported vaccines to meet the national requirements while adding that “even though the domestic manufacturing of COVID-19 vaccines is getting augmented”.


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Modification of earlier order

This notice is a partial modification of an earlier notification, dated 15 April, which allowed urgent approval for all vaccines approved by top international regulators, including the US (FDA), Europe (EMA), UK (MHRA), Japan (PMDA) or which are listed in the World Health Organization’s Emergency Use Listing. However, there was a need to conduct bridging trials alongside post approval within 30 days of approval.

Now, such requirements have been waived off.

The CDL, though, will conduct a review process to check the documents and certifications of all such vaccines. Further, the regulator has retained the requirement of assessing the first 100 beneficiaries for seven days for safety outcomes before the vaccine is rolled out at large.

“Scrutiny and review of their summary lot protocol and certificate of analysis of batch/lot shall be undertaken by CDL Kasauli for batch release as per the standard procedures…,” the notice said.

“…the requirement of assessment on the first 100 beneficiaries for 7 days for safety outcomes before the vaccine is rolled out for further immunization programme, along with other procedures for filing of applications and timelines for processing of the applications, etc. as laid down in the notice dated 15.04.21 shall remain the same,” it said.

(Edited by Manasa Mohan)


Also read: India’s Covid vaccine policy is bound to promote inefficiency, inequality


 

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