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DCGI permits human clinical trials for COVID-19 vaccine of Zydus Cadila

Pharma giant Zydus Cadila has become the second candidate in India to receive the Drug Controller General of India’s approval to enter human trials for COVID-19 vaccine. According to a senior government official, the pharma giant has submitted data to DCGI based on animal trial, which was found satisfactory.

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Published : Jul 3, 2020, 2:01 AM IST

New Delhi: The Drug Controller General of India (DCGI) on Thursday granted permission to pharma giant Zydus Cadila to conduct phase I and phase II human clinical trials for COVID -19 vaccine.

The move comes as a rapid response after recommendation by the subject expert committee as approved by DCGI, an official told to a news agency.

"The company has submitted data to DCGI based on animal trial, they conducted. Animals like- mice, rabbits, guinea pigs, rats were used and these animals developed antibodies against the virus," a senior government official told a news agency.

Read: Bharat Biotech’s COVID-19 vaccine first in India to receive nod for human trials

"Their animal trial data was inspected thoroughly and was found satisfactory. And now, DCGI has granted permission to Zydus Cadila to conduct Phase I & II clinical trial for COVID -19 vaccine on humans after successful animal trial," said the official. So far, India has two indigenous manufacturers for the potential COVID-19 vaccine.

In the recent past, DCGI has given permission to Bharat Biotech International Limited (BBIL), who has partnered with the Indian Council of Medical Research (ICMR) to conduct Phase I & II human clinical trials to develop an indigenous vaccine for COVID-19--in the name COVAXIN.

The Bharat Biotech using the virus strain isolated at ICMR's National Institute of Virology (NIV), Pune to develop the vaccine.

(ANI)

Also Read: Bharat Biotech aims to produce world's cheapest COVID-19 vaccine

New Delhi: The Drug Controller General of India (DCGI) on Thursday granted permission to pharma giant Zydus Cadila to conduct phase I and phase II human clinical trials for COVID -19 vaccine.

The move comes as a rapid response after recommendation by the subject expert committee as approved by DCGI, an official told to a news agency.

"The company has submitted data to DCGI based on animal trial, they conducted. Animals like- mice, rabbits, guinea pigs, rats were used and these animals developed antibodies against the virus," a senior government official told a news agency.

Read: Bharat Biotech’s COVID-19 vaccine first in India to receive nod for human trials

"Their animal trial data was inspected thoroughly and was found satisfactory. And now, DCGI has granted permission to Zydus Cadila to conduct Phase I & II clinical trial for COVID -19 vaccine on humans after successful animal trial," said the official. So far, India has two indigenous manufacturers for the potential COVID-19 vaccine.

In the recent past, DCGI has given permission to Bharat Biotech International Limited (BBIL), who has partnered with the Indian Council of Medical Research (ICMR) to conduct Phase I & II human clinical trials to develop an indigenous vaccine for COVID-19--in the name COVAXIN.

The Bharat Biotech using the virus strain isolated at ICMR's National Institute of Virology (NIV), Pune to develop the vaccine.

(ANI)

Also Read: Bharat Biotech aims to produce world's cheapest COVID-19 vaccine

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