JD({"d":"<div class='nfeed'><b id='dtspecial'>00:00<\/b> <font style='font-weight:bold'>COVID-19: Drugs control organisation issues guidelines for trial, marketing of vaccines<\/font><br>The Central Drugs Standard Control Organisation (CDSCO) said the requirements and guidelines to conduct clinical trial or grant of permission for the marketing of new drugs including vaccines are prescribed under New Drugs and Clinical Trials Rules, 2019.<br><br>According to an official release, the Indian Council of Medical Research (ICMR), has further informed that the stages of vaccine development include the following steps: Identification and development of an appropriate vaccine strain which may be safe and immunogenic. Full characterisation of the vaccine strain by in-vitro experiments; pre-clinical studies in small animals like rats, mice, rabbits, guinea pigs, hamsters etc. These are safety and dose determination studies.<br><br>Preclinical studies in large animals (depending upon feasibility and availability) to determine safety, protective efficacy and potential dose and formulation.<br><br>Phase I human clinical trials which establish the safety of the product. The numbers are usually less than 100.<\/div>","entype":"Text","h":"","img":"","imgalt":"","imgcaption":"","key":"False","link":"","s":35,"sub":"","t":"Sep 18, 2020-19:37:48","title":"The Central Drugs Standard Control Organisation (CDSCO) said the requirements and guidelines to conduct clinical trial or grant of permission for the marketing of new drugs including vaccines are prescribed under New Drugs and Clinical Trials Rules, 2019.<br><br>According to an official release, the Indian Council of Medical Research (ICMR), has further informed that the stages of vaccine development include the following steps: Identification and development of an appropriate vaccine strain which may be safe and immunogenic. Full characterisation of the vaccine strain by in-vitro experiments; pre-clinical studies in small animals like rats, mice, rabbits, guinea pigs, hamsters etc. These are safety and dose determination studies.<br><br>Preclinical studies in large animals (depending upon feasibility and availability) to determine safety, protective efficacy and potential dose and formulation.<br><br>Phase I human clinical trials which establish the safety of the product. The numbers are usually less than 100.","type":"nfeed"});