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Indian Government Likely to Indemnify Pfizer and Moderna

Indemnity for Pfizer and Moderna…learn more…

Thursday, 3rd June 2021


Indian Government is likely to grant indemnity from liability to vaccine makers Pfizer and Moderna to hasten approvals.

This grant is tantamount to a concessional request of legal protection from any liabilities in connection with the use of the coronavirus vaccine in India.

High level government authorities have said, “there is no problem” in conceding such an indemnity from any claims linked to the use of a company's COVID-19 vaccine.

The Health Minister stated, “If these companies have applied for Emergency Use Authorisation in India, then we are ready to give them indemnity,” and added, “It is expected that they will be granted indemnity against legal proceedings along the lines of what has been allowed in other countries for Pfizer and Moderna.”

Yet another development that will help these approvals pick up speed, is the waiver accorded by the Drug Controller General of India (DCGI) on the mandate that every batch of foreign-made Covid-19 vaccines entering the country are to be tested by the Central Drugs Laboratory, Kasauli and a post-launch bridging trials for such firms.

The decision came after Pfizer and Cipla started making demands on similar lines during negotiations to supply imported vaccines to India.

The highest drug controlling body in the country has announced that the vaccines that are already approved by US FDA, EMA, UK MHRA, PMDA Japan or listed in WHO Emergency Use Listing will not need to undergo a post-approval bridging clinical trial.

Also Read : Centre Signs Agreement to Receive Second Indian Made Vaccine, Reserved Doses of 30M.

Indian Government is likely to grant indemnity from liability to vaccine makers Pfizer and Moderna to hasten approvals.

This grant is tantamount to a concessional request of legal protection from any liabilities in connection with the use of the coronavirus vaccine in India.

High level government authorities have said, “there is no problem” in conceding such an indemnity from any claims linked to the use of a company's COVID-19 vaccine.

The Health Minister stated, “If these companies have applied for Emergency Use Authorisation in India, then we are ready to give them indemnity,” and added, “It is expected that they will be granted indemnity against legal proceedings along the lines of what has been allowed in other countries for Pfizer and Moderna.”

Yet another development that will help these approvals pick up speed, is the waiver accorded by the Drug Controller General of India (DCGI) on the mandate that every batch of foreign-made Covid-19 vaccines entering the country are to be tested by the Central Drugs Laboratory, Kasauli and a post-launch bridging trials for such firms.

The decision came after Pfizer and Cipla started making demands on similar lines during negotiations to supply imported vaccines to India.

The highest drug controlling body in the country has announced that the vaccines that are already approved by US FDA, EMA, UK MHRA, PMDA Japan or listed in WHO Emergency Use Listing will not need to undergo a post-approval bridging clinical trial.

It said, “Testing every batch of vaccine by CDL, Kasauli can be exempted, if the vaccine batch/lot has been certified and released by National Control Laboratory of the country of origin.”

It was hitherto imperative for vaccines that had done their clinical studies in foreign lands, to carry out “bridging trials” or limited clinical trials on the Indian population that would give a perspective on how the drug works on people of Indian origin.

Pfizer had earlier sought a fast-track approval from the Centre and said their shots have shown “high effectiveness” against the virus strain that is prevalent in India now and on the people of Indian origin/ethnicity.

They also said, the Pfizer jab is suited to all above the age of 12 years and can be stored for a month at 2-8 degrees.

The News Talkie Bureau

Source:

NDTV

 


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