<span style="color: #222222;">Central Drugs Standard Control Organisation, CDSCO has informed that requirements and guidelines to conduct clinical trial or grant of permission for marketing of new drugs including vaccines are prescribed under New Drugs and Clinical Trials Rules, 2019. Minister of State for Health Ashwini Kumar Choubey stated in a written reply in the Lok Sabha that CDSCO has granted test license permission for manufacture of COVID-19 Vaccine for preclinical test, examination and analysis to seven manufacturers in India.</span><br />'' <br />'' <span style="color: #222222;">An inactivated whole virion candidate vaccine for SARS-CoV-2 has been developed by Bharat Biotech International Ltd using the virus isolate provided by ICMR-National Institute of Virology, Pune. Characterization of the vaccine candidate has been undertaken at ICMR-NIV followed by safety and tolerability studies in small animals like rats, mice and rabbits. Phase II clinical trials are ongoing.</span><br />'' <span style="color: #222222;">&nbsp;</span><br />'' <span style="color: #222222;">A DNA vaccine has been developed by Cadila Healthcare Ltd. Pre- clincial toxicity studies were conducted in small animals and the vaccine has been found to be safe and immunogenic. Phase II clinical trials are ongoing.</span><br />'' <span style="color: #222222;">&nbsp;</span><br />'' <span style="color: #222222;">Serum Institute of India and ICMR have partnered for clinical development of two global vaccine candidates.&nbsp;More than 30 vaccine candidates have been supported which are in different stages of development.</span><br />
News On AIR | September 18, 2020 7:39 PM
CDSCO has granted test license permission for manufacture of COVID-19 vaccine: Govt