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

ANI | 1 month ago

By Priyanka Sharmam, New Delhi, July 3: 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, a top government official told ANI.

The move comes as a rapid response after recommendation by the subject expert committee as approved by DCGI.

"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 ANI.

"Their animal trial data was inspected thoroughly and was found satisfactory. And now, DCGI has granted permission to Zydus Cadila to conduct Phase I and 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 and 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.

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

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