| LESSON PLAN | ||
| Name of Faculty: | ||
| Discipline: | DIPLOMA IN PHARMACY | |
| Semester/Year: | Second year | |
| Subject/Code: | PHARMACY LAW AND ETHICS (ER20-26T) | |
| Lesson Plan Duration: | 45 Weeks (04 AUGUST 2025 to 30 JUNE-2025 Tentative) | |
| Work Load (Lecture) per week (in Hours): | ||
| WEEK | THEORY | |
| Lecture Day | Topic (Including assignment /Test) | |
| 1st | 1st | General Principles of Law, History and various Acts related to Drugs and Pharmacy profession |
| 2nd | Revision | |
| 3rd | Drugs and Cosmetics Act 1940 and Rules 1945 and New Amendments | |
| 2nd | 1st | Objectives, Definitions, Legal definitions of schedules to the Act and Rules |
| 2nd | Import of drugs – Classes of drugs and cosmetics prohibited from import | |
| 3rd | Import under license or permit | |
| 3rd | 1st | Study of schedule C and C1, G, H, H1, K, P, M, N, and X. |
| 2nd | Manufacture of drugs – Prohibition of manufacture and sale of certain drugs | |
| 3rd | Conditions for grant of license and conditions of license for manufacture of drugs | |
| 4th | 1st | Manufacture of drugs for test, examination and analysis |
| 2nd | Manufacture of new drug, loan license and repacking license. | |
| 3rd | Sale of Drugs – Wholesale, Retail sale and Restricted license | |
| 5th | 1st | Records to be kept in a pharmacy |
| 2nd | Drugs Prohibited for manufacture and sale in India | |
| 3rd | Administration of the Act and Rules – Drugs Technical Advisory Board | |
| 6th | 1st | Central Drugs Laboratory |
| 2nd | Drugs Consultative Committee | |
| 3rd | Government analysts | |
| 7th | 1st | Licensing authorities |
| 2nd | Controlling authorities | |
| 3rd | Drug Inspectors | |
| 8th | 1st | Revision |
| 2nd | Revision | |
| 3rd | Revision | |
| 9th | 1st | Revision |
| 2nd | Revision | |
| 3rd | Revision | |
| 10th | 1st | Revision |
| 2nd | Revision | |
| 3rd | Revision | |
| 11th | 1st | Revision |
| 2nd | Revision | |
| 3rd | Revision | |
| 12th | 1st | Revision |
| 2nd | Revision | |
| 3rd | Revision | |
| 13th | 1st Sessional Exam |
|
| 14th | 1st | Pharmacy Act-1948 and Rules: Objectives, Definitions |
| 2nd | Pharmacy Council of India; its constitution and functions | |
| 3rd | Education Regulations | |
| 15th | 1st | State and Joint state pharmacy councils |
| 2nd | Registration of Pharmacists, Offences and Penalties. | |
| 3rd | Pharmacy Practice Regulations 2015 | |
| 16th | 1st | The Medicinal and Toilet Preparations (Excise Duties) Act, 1955 |
| 2nd | Objectives, Definitions, Licensing , Offenses and Penalities | |
| 3rd | Narcotic Drugs and Psychotropic Substances Act 1985 and Rules | |
| 17th | 1st | Objectives, Definitions, Authorities and Officers, Prohibition, Control and Regulation, Offences and Penalties. |
| 2nd | Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 | |
| 3rd | Objectives,Definitions,Prohibition of certain advertisements,Classes of Exempted advertisements,Offences and Penalties | |
| 18th | 1st | Prevention of Cruelty to Animals Act-1960: Objectives, Definitions, CPCSEA - brief overview, Institutional Animal Ethics Committee, |
| 2nd | Breeding and Stocking of Animals, Performance of Experiments, Transfer and Acquisition of animals for experiment, Records, Power to suspend or revoke registration, Offences and Penalties. | |
| 3rd | Poisons Act-1919: Introduction,objective, possession | |
| 19th | 1st | Possession for sales and sale of any poison, import of poisons |
| 2nd | FSSAI (Food Safety and Standards Authority of India) Act and Rules: | |
| 3rd | Brief overview and aspects related to manufacture, storage, sale, and labelling of Food Supplements | |
| 20th | 1st | National Pharmaceutical Pricing Authority: Drugs Price Control Order (DPCO) - 2013. |
| 2nd | Objectives, Definitions, Sale prices of bulk drugs | |
| 3rd | Retail price of formulations | |
| 21th | 1st | Retail price and ceiling price of scheduled formulations |
| 2nd | Pharmaceutical Policy 2002 | |
| 3rd | National List of Essential Medicines (NLEM) | |
| 22th | 1st | Good Regulatory practices (documentation, licenses, renewals, e-governance) in Community Pharmacy |
| 2nd | Hospital pharmacy, Pharma Manufacturing, Wholesale business | |
| 3rd | Inspections, import, export of drugs and medical devices | |
| 23th | 1st | Revision |
| 2nd | Revision | |
| 3rd | Revision | |
| 24th | 1st | Revision |
| 2nd | Revision | |
| 3rd | Revision | |
| 25th | 1st | Revision |
| 2nd | Revision | |
| 3rd | Revision | |
| 26th | 2nd Sessional Exam |
|
| 27th | 1st | Code of Pharmaceutical Ethics: Definition, ethical principles, ethical problem solving, registration |
| 2nd | Code of ethics for Pharmacist in relation to his job, trade, medical profession and his profession, Pharmacist’s oath | |
| 3rd | Medical Termination of Pregnancy Act and Rules – basic understanding, salient features, and Amendments | |
| 28th | 1st | Role of all the government pharma regulator bodies – Central Drugs Standards Control Organization (CDSCO) |
| 2nd | Indian Pharmacopoeia Commission (IPC) | |
| 3rd | Introduction to BCS system of classification, Basic concepts of Clinical Trials, ANDA, NDA, New Drug development | |
| 29th | 1st | New Drugs and Clinical Trials Rules, 2019 |
| 2nd | Brand v/s Generic, Trade name concept | |
| 3rd | Introduction to Patent Law and Intellectual Property Rights | |
| 30th | 1st | Emergency Use Authorization |
| 2nd | Blood bank | |
| 3rd | Basic requirements and functions | |
| 31st | 1st | Clinical Establishment Act and Rules |
| 2nd | Aspects related to Pharmacy | |
| 3rd | Biomedical Waste Management Rules 2016 | |
| 32rd | 1st | Basic aspects, and aspects related to pharma manufacture to disposal of pharma / medical waste at homes, pharmacies,and hospitals |
| 2nd | Bioethics - Basic concepts, history and principles. | |
| 3rd | Brief overview of ICMR’s National Ethical Guidelines for Biomedical and Health Research involving human participants | |
| 33th | 1st | Introduction to the Consumer Protection Act |
| 2nd | Introduction to the Disaster Management Act | |
| 3rd | Medical Devices | |
| 34th | 1st | Categorization, basic aspects related to manufacture and sale |
| 2nd | Revision | |
| 3rd | Revision | |
| 35th | 1st | Revision |
| 2nd | Revision | |
| 3rd | Revision | |
| 36th | 3rd Sessional Exam |
|
| 37th | 1st | Revision |
| 2nd | Revision | |
| 3rd | Revision | |
| 38th | 1st | Revision |
| 2nd | Revision | |
| 3rd | Revision | |
| 39th | 1st | Revision |
| 2nd | Revision | |
| 3rd | Revision | |
| 40th | 1st | Revision |
| 2nd | Revision | |
| 3rd | Revision | |
| 41th | 1st | Revision |
| 2nd | Revision | |
| 3rd | Revision | |