'SUBSCRIBE TO THE CHANNEL FOR INSTANT UPDATES. Learning Objectives: On successful completion of following theory topics, a learner should be able to Knowledge: Important rules and regulations and procedures made to execute the laws To discuss the purpose of the board To explain the definitions in the act; 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 representatives; 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. final year... Definitions, Advisory bodies DTAB and DCC Composition and function. Drug Control Laboratories and Government Analysts, Drug inspectors, Licensing Authorities, Controlling Authorities and Customs Collectors. Provisions governing import, manufacture and sale of drugs.Labeling and packaging of drugs. Various offences and corresponding penalties. Provisions applicable to manufacture and sale of Ayurvedic drugs. Broad content of various schedules of the Drugs and Cosmetic Act andRules. T Y B. Pharm Detailed study of Schedule G, H, M, N, P,T,U, V, X, Y, Part XII B, Sch F & DMR (OA) Sale of Drugs – Wholesale, Retail sale and Restricted license. Offences and penalties Labeling & Packing of drugs- General labeling requirements and specimen labels for drugs and cosmetics, List of permitted colors. Offences and penalties. Administration of the Act and Rules – Drugs Technical Advisory Board, Central drugs Laboratory, Drugs Consultative Committee, Government drug analysts, Licensing authorities, controlling authorities, Drugs Inspectors'
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