'Drug and Cosmetic Act 1940 (Part - 2)- Detailed info of Schedule- (M) - 04'

20:43 Jun 7, 2022 1 1

'T Y B. Pharmacy  Scope: This course is designed to impart basic knowledge on important legislations related to the profession of pharmacy in India. Objectives: Upon completion of the course, the student shall be able to understand: 1. The Pharmaceutical legislations and their implications in the development and marketing of pharmaceuticals. 2. Various Indian pharmaceutical Acts and Laws 3. The regulatory authorities and agencies governing the manufacture and sale of pharmaceuticals 4. The code of ethics during the pharmaceutical practice  Learning Objectives: On successful completion of the following theory topics, a learner should be able to Knowledge: To understand. Basic principles, purpose, and dimensions of the laws To understand the significance and relevance of Pharmaceutical laws in India Important rules and regulations and procedures made to execute the laws To discuss the purpose of the board To explain the definitions in the; To describe the qualifications for membership and the make-up of the Board To explain the rule-making authority of theBoard; To discuss the responsibilities of theBoard; To discuss inspections by the Board or its representative; To learn the various laws governing the manufacturing, sale, research & usage of drugs To understand the significance of Schedule M and Schedule Y related Manufacturing & clinical trials. Identify potential fraud and abuse legal issues of narcotic &psychotropic substance. To study the quality & prices of essential medicine. Learner knowledge about Patents, the procedure for a patent application, and IPR. To understand the regulatory system for the safety and effectiveness of medicine and quality of product' 

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