Zydus Healthcare’s COVID-19 vaccine gets DCGI approval for Human Clinical Trials
On 2nd July 2020, the Drug Controller General of India (DCGI) has given approval for human clinical trials to Ahmedabad based Cadila Healthcare Limited (Zydus Healthcare). The permission is for the Phase-I and Phase-II clinical trials of the vaccine.
Zydus Healthcare’s COVID-19 vaccine become the 2nd Indigenously developed vaccine to get the permission of the DCGI for human clinical trials after Bharat Biotech’s COVAXIN. The human clinical trials for the vaccine are expected to be completed in three months as per media reports.
Success during Clinical Trials on Animals
The approval for the human clinical trials was given by the DCGI based on the recommendation made by the COVID-19 Subject Expert Committee. The Subject Expert Committee recommendation was on the basis of the data provided to the DCGI by Zydus Healthcare on the success of their COVID-19 vaccine during clinical trials on the animals.
With respect to safety and immunogenicity, the potential novel coronavirus vaccine developed by the Zydus Healthcare was found to be successful during animal studies, this was informed by the Drug Controller General of India Dr. V.G. Somani.
Headquartered in Gujarat’s Ahmedabad, Zydus Healthcare is one of the leading manufacturers of generic drugs in India. It was founded in the year 1952 by Ramanbhai Patel. The company is also known as Cadila Healthcare Limited or Zydus Cadila Healthcare Limited.