Drug Regulatory Affairs Detailed Syllabus for B.Tech third year first sem is covered here. This gives the details about credits, number of hours and other details along with reference books for the course.<\/p>\n
The detailed syllabus for Drug Regulatory Affairs B.Tech 2016-2017 (R16) \u00a0third year first sem is as follows.<\/p>\n
B.Tech. III Year I Sem. \u00a0 \u00a0L\/T\/P\/C
\nCourse Code:PS505 \u00a0 \u00a0 \u00a0 3\/1\/0\/3<\/p>\n
Course Objectives<\/strong> – Various procedures for approval of API and formulations for manufacture, sale,\u00a0export and import of drugs.<\/p>\n Course Outcome<\/strong>: The clear information about the regulations in India and abroad is gained by the\u00a0students.<\/p>\n UNIT I\u00a0<\/strong>Introduction to Drug regulatory affairs, organisation structure of India, in central and state Division of\u00a0drug controller of India and their function<\/p>\n UNIT II<\/strong>\u00a0Procedure for obtaining manufacturing for basic drug and formulation, sale of drugs, import & export of\u00a0drugs and their permission procedures.<\/p>\n UNIT III<\/strong>\u00a0Application for procedures for approval for formulations and Active Pharmaceutical Ingredient.<\/p>\n