DCGI has taken a big decision to overcome the shortage of vaccine in the country. Foreign vaccines that have received emergency use approval from the World Health Organization and the US FDA will not have to be tested separately in India.
The government is emphasizing on increasing the pace of vaccination.
In view of the threat of second wave of corona and increasing cases. The government is only emphasizing on increasing the speed of vaccination. In such a situation, it is necessary to have more and more vaccine companies in India. Therefore, to increase the speed of vaccination, DCGI has taken a big decision.
There will be no separate local trial
The Indian Drug Regulatory Company i.e. DCGI has now removed the conditions of conducting separate trials for Pfizer and Moderna Company to bring them to India as soon as possible. To understand in simple language, the vaccines that have received emergency use approval from the US FDA and the World Health Organization will have to go through a separate trial process in India.
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Let us tell you that till now any foreign company had to conduct bridging trials before launching the anti-coronavirus vaccine in India. It tests the efficacy and safety of the vaccine on a limited number of local volunteers. Which is now exempt for companies.
drug regulatory company issued notice
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.
Vaccine used on millions of people will get exemption
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.
One crore people will get the vaccine every day by July-August.
However, 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. Let us inform that the government has claimed that it will vaccinate one crore people every day from July-August and by December 2021. The vaccination of the adult population of the country will be complete. However, the biggest obstacle in meeting this goal is the lack of a vaccine. In such a situation, the vaccine shortage can met by importing foreign vaccines.
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