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picture1_Academic Pdf 154096 | Bp 505t Pharmaceutical Jurisprudence


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File: Academic Pdf 154096 | Bp 505t Pharmaceutical Jurisprudence
teaching plan pharmaceutical jurisprudence school sop school of pharmacy academic session 2022 23 for students batch 2022 23 1 course no bp 505 t 2 course title pharmaceutical jurisprudence 3 ...

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                                       St.James College of Pharmaceutical Sciences  
                                                  St.James medical Academy 
                                                    River Bank, Chalakudy 
                 Programme:           B.Pharm                                   Sem.:     V 
                 Name of Course:  Pharmaceutical Jurisprudence                 Course     BP 505 T 
                 (Subject)                                                     Code: 
                 Teaching faculty  Aravind R 
                 of the course 
                                               Summary of the Lecture Plan 
                 Topic                                                Lectures                            Hours 
                                             Drug and Cosmetic act, 1940 and its rules 1945-                 1 
                           Unit I            Objective, definition, Legal definition of Schedules to 
                                             the Act and rule 
                                             Import of Drugs                                                 2 
                                             Manufacture of Drugs- Condition of grant of License             2 
                                             for manufacture for new drug 
                                             Condition of grant of License for manufacture of                4 
                                             drug for test, examination and analysis, loan licence 
                                             and repacking license. 
                                             Detailed study of Schedule G, H, M, N, P, T, U, V, X, Y,        4 
                                             B, F 
                                             Sale of Drugs- whole sale, Retail sale and Restricted           2 
                                             license 
                               
                           Unit II           General labelling requirements and specimen label               1 
                                             for drugs and cosmetics, list of permitted colours.  
                                             Offences and penalties covering under D & C Act,                1 
                                             1940. 
                                             Administration of the act and rules                             3 
                                             Pharmacy Act 1948-Objectives, Definition, PCI                   1 
                                             State and Joint state Pharmacy council                          1 
                               
                                             Registration of Pharmacist, Offences and penalties              1 
                                             Medicinal and Toilet Preparation Act-1955                       2 
                                             Objectives, Definition, licensing, Manufacture in 
                          Unit III           bond and outside bond. 
                                             Export of alcoholic Preparation                                 1 
                                             Manufacture of Ayurvedic, Homeopathic, Patent &                 1 
                                             Proprietary Preparation. Offences and Penalties 
                                             Narcotic Drugs and Psychotropic substances Act-                 1 
                                             1985 Objectives, Definition, Authorities, Officers and 
                                             committee. 
                                             Regulation of cultivation and production of opium               3 
                                             Manufacture, sale and Export of opium, Offences and 
                                             Penalties 
                                              
                                         Drugs and Magic remedies Act- Objectives,               2 
                                         Definition, Prohibition of certain advertisement, 
                        Unit IV          class of exempted advertisement, offences and 
                                         penalties 
                                         Prevention of Cruelty to animal act-1960 Objectives,    2 
                                         Definition, IAEC Regulations, Offences and Penalties 
                                         National Pharmaceutical Pricing Policy                  3 
                                         DPC) 2013 
                                         Pharmaceutical Legislations                             3 
                        Unit V           Code of Pharmaceutical Ethics                           1 
                                         Medical termination of Pregnancy Act-1971               1 
                                         Right to information act                                1 
                                         Introduction to intellectual Property Right (IPR).      1 
              Major issues or Core aspects addressed/ covered:                                        
                                                          
               Drug and cosmetic Act, 1940 and its rule 1945 
               Objective, definition, Legal definition of Schedules to the Act and rule 
               Classes of drugs and cosmetics prohibited from import including Misbranded, 
               adulterated and spurious drugs. 
               Procedure for import and export drug and cosmetics, Offences and penalties. 
               Prohibition of manufacture and sale of certain drugs. 
               Conditions for the grand of license for manufacture, Type of License. 
               Procedure to be followed in manufacturing of new drug, drug for test, examination and 
               analysis, loan license and repacking license. 
               Detailed study of Schedule G, H, M, N, P, T, U, V, X, Y, B, F 
               Application of license for Whole sale trade, Retailer trade, and restricted license 
               Procedure for the sale of drug in whole sale and motor vehicle. 
               Offence and Penalties during Sale of drugs. 
               Packing of drugs- General label Requirement and specimen label for drugs. 
               List of Permitted colours. 
               Constitution and functions of Drug Technical Advisory Board, Drug Consultative 
               Committee 
               Role of Licensing authorities 
               Qualification, Duties and Procedures for Government analyst, Controlling authorities 
               and drug inspectors. 
               Pharmacy act 1948 
               Objective of Pharmacy act. 
               Pharmacy council of India: its constitution and functions 
               Educational regulations 
       State and joint state Pharmacy council: its constitution and functions, Registration of 
       Pharmacist 
       Offences and Penalties in Pharmacy Act 
       Medicinal and toilet Preparation Act, 1955 
       Objectives of Act, Definition covering the act, 
       Construction, design and procedure for manufacturing of alcoholic preparation in bond 
       and outside bond. 
       Export of medicinal preparation containing alcohol 
       Procedure for manufacturing of Ayurvedic and homeopathic preparation containing 
       alcohol. 
       Offences and penalties in Medicinal and toilet Preparation Act 
       Narcotic drugs and Psychotropic substance Act,1985 
       Objectives, Definition, Cannabis, Opium 
       Authorities- Controlled operations by Central government and state government 
       Administrative Agencies, Constitution and functions of Narcotic commissioner, NDPS 
       consultative committee, Deaddiction center 
       Search, Seizures and arrest 
       Disposal and attachment of seized articles 
       Cultivation of poppy and Manufacture of opium, Sale and Export 
       Offences and Penalties of NDPS Act. 
       Study of Salient features of Drugs and Magic remedies Act and its rules 
        Definition and objectives of the act 
       Prohibited advertisements 
       Prohibition on Import and export of certain products. 
       Offences and Penalties 
       Prevention of Cruelty to animal act-1960 
       Objectives, definitions. 
       Institutional animal Ethical Committee 
       Breeding and stocking of animals 
       Transfer and acquisition of animals for experiment, Record maintenance 
       Offences and Penalties 
       National Pharmaceutical Pricing authorities 
       DPCO 2013 
       Sale Price of bulk drugs 
       Retail Price of formulation 
       Retail price and ceiling price of scheduled formulation 
         National List of Essential Medicine (NLEM) 
                          
               Pharmaceutical Legislations                
               Chopra Committee 
               Hathi Committee 
               Mudaliar Committee 
               Indian Pharmacopoeial committee 
               Code of Pharmaceutical Ethics 
               Pharmacist in relation to his job, trade and medical Profession 
               Medical termination of Pregnancy act,1971 
               Medical termination of Pregnancy act,1971 
               Offences and Penalties 
               Right to information and act 
               Right to information and act 
               Introduction to intellectual Property Rights (IPR) 
               Patents, Design, Trade mark and  Industrial Design 
               Indian Patent act 1970 
               Articles patentable and nonpatentable 
                Procedure for applying patent 
              Sample Question From the chapters 
               Drug and cosmetic Act, 1940 and its rule 1945 
               What are the objectives of D &C act? 
               Describe various Classes of drugs and cosmetics prohibited from import? 
               Explain the procedure for import and export drug and cosmetics? 
               Write notes on duties of custom collectors under the provision of D and C Act. 
               Explain various type of manufacturing License and procedure for obtaining the same. 
               Write notes on loan license and repacking license. 
               Detailed study of Schedule G, H, M, N, P, T, U, V, X, Y, B, F 
               Write note trade of Drugs and cosmetics. 
               Procedure for the sale of drug in whole sale and motor vehicle. 
               Give offence and Penalties during Sale of drugs. 
               Mention the general requirements of packing, and labelling of drug 
               Write notes on qualification, duties and procedures to be followed by drug inspectors? 
               Give the constitution and functions of Drug Technical Advisory Board. 
               Give the role of Licensing authorities and Government analyst 
               Explain the qualification, Duties and Procedures for Government analyst. 
               Pharmacy act 1948 
               Give the objective of Pharmacy act. 
               Write the constitution and functions of Pharmacy council of India. 
               Write the constitution and functions of State Pharmacy council 
               Give the offences and Penalties in Pharmacy Act 
               Write notes on registration of Pharmacist. 
               Medicinal and toilet Preparation Act, 1955 
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...Teaching plan pharmaceutical jurisprudence school sop of pharmacy academic session for students batch course no bp t title credits contact hours learning assessment guided study total this is designed to impart basic knowledge on important legislations related objective the profession in india upon completion student shall be able understand and their implications development marketing pharmaceuticals outcomes various indian acts laws regulatory authorities agencies governing manufacture sale...

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