📚 Pharmacy Law and Ethics Notes PDF Download | DPharm

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Chapter 1: General Principles of Law and Pharmaceutical Legislation

Syllabus Topics to Learn

General principles of law; history and development of pharmaceutical legislation; introduction to various Acts related to drugs and pharmacy profession in India.

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Chapter 2: Pharmacy Act 1948 and Pharmacy Practice Regulations

Syllabus Topics to Learn

Objectives and definitions of the Pharmacy Act 1948; constitution and functions of the Pharmacy Council of India; Education Regulations; State and Joint State Pharmacy Councils; registration of pharmacists; offences and penalties; and Pharmacy Practice Regulations 2015.

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Chapter 3: Drugs and Cosmetics Act 1940 and Rules 1945

Syllabus Topics to Learn

Objectives

Definitions

And important schedules under the Drugs and Cosmetics Act and Rules; import

Manufacture

And sale of drugs; conditions for licenses; manufacture of drugs for examination and analysis; loan and repacking licenses; study of Schedules C

And X; prohibited drugs; administration of the Act; and functions of DTAB

CDL

DCC

Drug Inspectors

And licensing authorities.

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Chapter 4: Narcotic Drugs and Psychotropic Substances Act 1985

Syllabus Topics to Learn

Objectives

Definitions

Authorities

Prohibition

Control

Regulation

Offences

And penalties under the Narcotic Drugs and Psychotropic Substances Act and Rules.

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Chapter 5: Drugs and Magic Remedies Act 1954

Syllabus Topics to Learn

Objectives

Definitions

Prohibition of objectionable advertisements

Exempted advertisements

Offences

And penalties under the Drugs and Magic Remedies (Objectionable Advertisements) Act.

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Chapter 6: Prevention of Cruelty to Animals Act 1960

Syllabus Topics to Learn

Objectives and definitions of the Prevention of Cruelty to Animals Act; overview of CPCSEA; Institutional Animal Ethics Committee; breeding

Stocking

Transfer

Acquisition

And experimentation on animals; records

Suspension of registration

Offences

And penalties.

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Chapter 7: Poisons Act 1919

Syllabus Topics to Learn

Introduction

Objectives

Definitions

Possession

Sale

And import of poisons under the Poisons Act 1919.

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Chapter 8: FSSAI Act and Rules

Syllabus Topics to Learn

Overview of Food Safety and Standards Authority of India (FSSAI) Act and Rules; regulations related to manufacture

Storage

Sale

And labelling of food supplements.

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Chapter 9: National Pharmaceutical Pricing Authority and DPCO

Syllabus Topics to Learn

Objectives and provisions of National Pharmaceutical Pricing Authority (NPPA); Drugs Price Control Order (DPCO) 2013; pricing of bulk drugs and formulations; ceiling prices; Pharmaceutical Policy 2002; and National List of Essential Medicines (NLEM).

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Chapter 10: Code of Pharmaceutical Ethics

Syllabus Topics to Learn

Definition and principles of pharmaceutical ethics; ethical problem solving; registration; code of ethics for pharmacists in relation to profession

Trade

And medical profession; and pharmacist’s oath.

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Chapter 11: Medical Termination of Pregnancy Act

Syllabus Topics to Learn

Basic understanding

Important provisions

Salient features

And amendments of the Medical Termination of Pregnancy Act and Rules.

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Chapter 12: Government Pharmaceutical Regulatory Bodies

Syllabus Topics to Learn

Role and functions of government pharmaceutical regulatory bodies including Central Drugs Standard Control Organization (CDSCO) and Indian Pharmacopoeia Commission (IPC).

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Chapter 13: Good Regulatory Practices

Syllabus Topics to Learn

Good regulatory practices including documentation

Licensing

Renewals

E-governance

Inspections

Import and export of drugs and medical devices in community pharmacy

Hospital pharmacy

Pharmaceutical manufacturing

And wholesale business.

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Chapter 13: Drug Development and Intellectual Property Rights

Syllabus Topics to Learn

Introduction to BCS classification system; basic concepts of clinical trials

ANDA

NDA

And new drug development; New Drugs and Clinical Trials Rules 2019; brand and generic medicines; trade names; introduction to patent law and intellectual property rights; and Emergency Use Authorization.

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Chapter 15: Blood Bank

Syllabus Topics to Learn

Basic requirements

Functions

Storage

Handling

And services provided by blood banks in healthcare systems.

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Chapter 17: Clinical Establishment Act and Rules

Syllabus Topics to Learn

Introduction and important provisions of Clinical Establishment Act and Rules related to pharmacy services and healthcare establishments.

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Chapter 17: Biomedical Waste Management Rules 2016

Syllabus Topics to Learn

Biomedical waste management rules and regulations; handling

Segregation

Storage

Transport

And disposal of pharmaceutical and medical waste in homes

Pharmacies

Hospitals

And pharmaceutical industries.

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Chapter 18: Bioethics

Syllabus Topics to Learn

Basic concepts

History

And principles of bioethics; overview of ICMR National Ethical Guidelines for Biomedical and Health Research involving human participants.

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Chapter 19: Consumer Protection Act

Syllabus Topics to Learn

Introduction to the Consumer Protection Act and its relevance in pharmacy practice and healthcare services.

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Chapter 21: Disaster Management Act

Syllabus Topics to Learn

Introduction

Objectives

And importance of the Disaster Management Act in healthcare and pharmaceutical services.

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Chapter 21: Medical Devices

Syllabus Topics to Learn

Categorization of medical devices; basic concepts related to manufacture

Regulation

Storage

And sale of medical devices.

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Subject Overview

Course Code ER20-26T

Syllabus Status 100% PCI Aligned

Total Units 21 Units

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