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India Exempts Foreign Covid Vaccines From Bridging Trials

The Drug Controller General of India (DCGI) in an order issued on Tuesday said bridging trial is not needed for foreign vaccine if it is certified and released by National Control Laboratory of country of origin.

India Exempts Foreign Covid Vaccines From Bridging Trials
The new relaxation will pave way for Pfizer, Moderna and other companies developing vaccines to sell their vaccines in India almost the same time as they launch it in the country of origin. | Representational Image
India Exempts Foreign Covid Vaccines From Bridging Trials
outlookindia.com
2021-06-02T09:55:52+05:30

India has exempted foreign Covid vaccines approved by specific nations or health bodies from bridging trials in the country.

The Drug Controller General of India (DCGI) has relaxed rules for importing COVID-19 vaccines doing away rules that mandate bridging clinical trials and testing of each batch of imported vaccines in the country.

This will pave way for Pfizer, Moderna and other companies developing vaccines to sell their vaccines in India almost the same time as they launch it in the country of origin.

Earlier, any imported vaccine had to go through bridging clinical trials at India's Central Drug Laboratory (CDL) at Kasauli in Himachal Pradesh. However, in an order issued on Tuesday, the DCGI said the it is not needed if the vaccine is certified and released by National Control Laboratory of country of origin.

Meanwhile, the cumulative number of COVID-19 vaccine doses administered in the country has crossed 21.83 crore, the Union health ministry said on Tuesday.

It said 9,50,401 people in the age group of 18-44 years received their first dose and 15,467 their second dose of COVID-19 vaccine on Tuesday. 

Cumulatively, 2,13,01,448 people across the country have received their first dose and 39,282 their second dose since the start of phase three of the vaccination drive, the ministry said. 

Noting that Covid-19 vaccination drive is ramping up, Indian Council of Medical Research (ICMR) Director General Balram Bhargava on Tuesday said they hope to vaccinate the "whole country" by end of this year.

Addressing a press conference here, Bhargava also announced that enough doses to vaccinate 1 crore people per day will be possible by mid-July or August this year.

The ICMR Director General also appealed people to have patience, saying "we are equal to the US in terms of vaccinating people. However, our population is almost four times of the US, we should have patience".

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