DGCI nod to Zydus Cadila for human clinical trials of Covid-19 vaccine
July 03, 2020
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, a top government official told news agency 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 & 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)
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