November 29, 2023

20226 PLT Pharmacy Law & Ethics D Pharm

Pharmacy Law & Ethics D Pharm


General Principles of Law, History and various Acts related to Drugs and Pharmacy profession

Pharmacy Act-1948 and Rules:
Objectives, Definitions,
Pharmacy Council of India; its constitution and functions,
Education Regulations,
State and Joint state pharmacy councils,
Registration of Pharmacists,
Offences, and Penalties.  

Pharmacy Practice Regulations 2015

Drugs and Cosmetics Act 1940 and Rules 1945 and New Amendments
Objectives, Definitions,
Legal definitions of schedules to the Act and Rules

Import of drugs: Classes of drugs and cosmetics prohibited from import, Import under license or permit.

Manufacture of drugs: Prohibition of manufacture and sale of certain drugs, Conditions for grant of license and conditions of license for manufacture of drugs,  Manufacture of drugs for the test, examination and analysis, manufacture of a new drug, loan license and repacking license.   Study of schedules C and C1, G, H, H1, K, P, M, N, and X.  

Sale of Drugs: Wholesale, Retail sale and Restricted license,
Records to be kept in a pharmacy,
Drugs Prohibited for manufacture and sale in India  
Administration of the Act and Rules
Drugs Technical Advisory Board, Central Drugs Laboratory, Drugs Consultative Committee, Government analysts, licensing authorities, controlling authorities, Drug Inspectors.

Narcotic Drugs and Psychotropic Substances Act 1985 and Rules
Objectives, Definitions
Authorities and Officers, Prohibition, Control and Regulation,
Offences and Penalties

Drugs and Magic Remedies (Objectionable Advertisements) Act 1954
Objectives, Definitions,      
Prohibition of certain advertisements,
Classes of Exempted advertisements,
Offences and Penalties.

Prevention of Cruelty to Animals Act-1960:
Objectives, Definitions,
CPCSEA – brief overview, Institutional Animal Ethics Committee, Breeding and Stocking of Animals, Performance of Experiments, Transfer and Acquisition of animals for an experiment, Records, Power to suspend or revoke the registration, Offences, and Penalties.

Poisons    Act-1919:   
Introduction,    objective,    definition, possession, possession for sales and sale of any poison, import of poisons

FSSAI (Food Safety and Standards Authority of India) Act and Rules:
brief overview and aspects related to manufacturing, storage, sale, and labelling of Food Supplements

National Pharmaceutical Pricing Authority:
Drugs Price Control Order (DPCO) – 2013.
Objectives, Definitions, Sale prices of bulk drugs, Retail price of formulations, Retail price and ceiling price of scheduled formulations,
Pharmaceutical Policy 2002,
National List of Essential Medicines (NLEM)

Code of Pharmaceutical Ethics:
Definition, ethical principles, ethical problem solving, registration, code of ethics for Pharmacist in relation to his job, trade, medical profession, and his profession,
Pharmacist’s oath.

Medical Termination of Pregnancy Act and Rules: basic understanding, salient features, and Amendments

Role of all the government pharma regulator bodies

Central Drugs Standards Control Organization (CDSCO), Indian Pharmacopoeia Commission (IPC)

Good Regulatory practices (documentation, licenses, renewals, e-governance) in Community Pharmacy, Hospital Pharmacy, Pharma Manufacturing, Wholesale business, inspections, import, export of drugs and medical devices

Introduction to BCS system of classification,
Basic concepts of Clinical Trials, ANDA, NDA, New Drug development, New Drugs, and Clinical Trials Rules, 2019. Brand v/s Generic, Trade name concept,
Introduction to Patent Law and Intellectual Property Rights, Emergency Use Authorization

Blood bank: basic requirements and functions

Clinical Establishment Act and Rules: Aspects related to Pharmacy

Biomedical Waste Management Rules 2016: Basic aspects, and aspects related to pharma manufacture to disposal of pharma / medical waste at homes, pharmacies, and hospitals

Bioethics: Basic concepts, history, and principles.
A brief overview of ICMR’s National Ethical Guidelines for Biomedical and Health Research involving human participants

Introduction to the Consumer Protection Act

Introduction to the Disaster Management Act

Medical Devices – Categorization, basic aspects related to manufacturing and sale

F Y D Pharm & S Y D Pharm Notes, Books, Syllabus, PDF, Videos

First Year D PharmSecond Year D Pharm
20111 PHT Pharmaceutics Theory20221 PGT Pharmacology Theory
20051 PHP Pharmaceutics Practical20056 PGP Pharmacology Practical
20112 PCT Pharmaceutical Chemistry Theory20222 CMT Community Pharmacy & Management Theory
20052 PCP Pharmaceutical Chemistry Practical20057 CMP Community Pharmacy & Management Practical
20113 PYT Pharmacognosy Theory20223 BCT Biochemistry & Clinical Pathology Theory
20053 PYP Pharmacognosy Practical20058 BCP Biochemistry & Clinical Pathology Practical
20114 HPT Human Anatomy Physiology Theory20224 PTT Pharmacotherapeutics Theory
20054 HPP Human Anatomy Physiology Practical20059 PTP Pharmacotherapeutics Practical
20115 SPT Social Pharmacy Theory20225 HCT Hospital & Clinical Pharmacy Theory
20055 SPP Social Pharmacy Practical20060 HCP Hospital & Clinical Pharmacy Practical
20226 PLT Pharmacy Law & Ethics

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