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India Exempts Foreign Covid Vaccines From Bridging Trials

India Exempts Foreign Covid Vaccines From Bridging Trials

In view of the threat of second wave of corona and increasing cases, the government is only emphasizing on increasing the speed of vaccination. Therefore, to increase the speed of vaccination, DCGI has taken a big decision.

Indian drug regulatory company DCGI has now removed the conditions for conducting separate trials of Pfizer and Moderna Company to bring them to India at the earliest. Vaccines that have received emergency use approval from the US FDA and the World Health Organization will not have to go through a separate trial process in India.

DCGI President VG Somani has given this information by issuing a notice. Let us tell you that Pfizer and Moderna are those foreign vaccine companies, who had demanded compensation from the government and exemption for separate trials in India. Although the Government of India has not given any decision on compensation, but has agreed not to conduct a separate trial.

DCGI said that vaccines that are approved by the US FDA, EMA, UK MHRA, PMDA Japan or listed on the WHO emergency use list and which have already been used on millions of people are approved. Vaccine testing and bridging trials may be exempted by CDL, Kasauli.

It has been said in the notice that the first 100 beneficiaries of these vaccines will have to be monitored for seven days in view of safety.

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