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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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