New Delhi2 hours ago
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DGCI chief VG Somani said – This decision has been taken in view of the increase in Kovid cases in India and the need to increase the availability of vaccines.
The government has given relaxation in the rules for the vaccine of foreign companies in the country. The Drug Controller General of India (DCGI), India’s top drug regulator, has announced this. Now the vaccines of Karena made abroad will not have to undergo trials in the country, provided it has been approved for use in foreign countries and has received emergency use approval from the World Health Organization (WHO).
However, samples of every batch of vaccine being made in the country will continue to be tested in the lab as before. This decision of DCGI has cleared the way for the vaccines of American companies Pfizer and Moderna to come to the country. These two companies were demanding this for a long time.
According to DCGI, vaccines that have been approved by the Food and Drug Administration of the US, EMA, EK, MHRA of Britain and PMDA of Japan will no longer require trials or trials in the country. DGCI chief VG Somani has said that this decision has been taken in view of the increase in the number of Kovid cases in India and the need to increase the availability of vaccines.
This exemption is given – now there is no post-launch breeding trial of vaccines made abroad
The rule of testing every batch of a foreign vaccine has been exempted. That is, the post-launch brewing trial to be held in the Central Pharmaceutical Laboratory of Kasaili, Himachal Pradesh will not be done. Pfizer and Moderna had placed a condition for this. Now only the first 100 people who will be given the vaccine, the safety of the vaccine will be checked in those people.
Biggest question: If there is any loss, who will be responsible?
Abolishing the Breezing Trial is absolutely a wrong decision. Even if there is an emergency, the company should not be exempted from conducting trials during vaccination. Random testing of some samples is necessary, because the basic principle of medicine is that there should be no harm or benefit. If there is a loss after such exemption, then who will be responsible, this responsibility should be fixed.
Dr. Sanjay Roy, President, Indian Public Health Association (IPHA)