The approval process was fast-tracked following recommendation by the subject expert committee on COVID-19, considering the emergency and unmet medical need during the pandemic.
“DCGI Dr V G Somani has given approval for the phase I and II clinical trials (on humans) of the potential novel coronavirus vaccine developed by Zydus Cadila Healthcare Ltd on Thursday after its animal studies was found to be successful,” a official source in the know of the developments told PTI.
The assent for human trials was given after the company submitted data of clinical trial on animals to the DCGI, in which the vaccine candidate was found to be successful with respect to safety and immunogenicity, sources said.
The company is likely to start enrolment of subjects soon.
“The phase I and II trials will take around three months to be completed,” the source said.
A couple of days earlier, the country’s ‘first’ indigenous Covid-19 vaccine candidate Covaxin, developed by Hyderabad-based Bharat Biotech in collaboration with the Indican Council of Medical Research and National Institute of Virology (NIV), had got the nod for human clinical trials from the DCGI.
India’s Covid-19 tally rose to 6,04,641 on Thursday with a single-day increase of 19,148 cases, just five days after it crossed the five-lakh mark, while the death toll rose to 17,834 with 434 new fatalities, according to the Union Health Ministry.