Pharmacy Law and Ethics

Chapter Topics 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 test, examination and analysis, manufacture of new drug, loan license and repacking license.

Study of schedule 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 experiment, Records, Power to suspend or revoke 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 manufacture, 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. 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 manufacture and sale Assignments The students shall be asked to submit written assignments on the following topics (One assignment per student per sessional period. i.e., a minimum of THREE assignments per student)

1. Requirements for Ayurvedic, Homeopathic manufacturing, sale, and licensing requirements

2. Layout and contents of official websites of various agencies regulating the profession of pharmacy in India: e.g., CDSCO, SUGAM portal, PCI, etc.

3. Licenses required, application processes (online/offline), drug regulatory office website of the respective state

4. Case studies – actions taken on violation of any act / rule related to pharmacy

5. Schedule H1 drugs and its implementation in India

6. Counterfeit / Spurious medicines

7. Drug Testing Labs in India

8. Overview of Pharma marketing practices

9. Generic Medicines

9. Appendices No Appendix Document 1.

A typical format for the assessment of an Assignment 2.

A typical format for the assessment of a Field Visit Report 3.

List of instruments and equipment required for the conduct of D.Pharm program as per ER-2020 Appendix – 1 A typical format for the assessment of an Assignment Name of the College:

Name of the Student:

Academic Year of the Student:

Name of the Subject:

Title of the Assignment:

Date on which the Assignment was given:

Date on which the Assignment was submitted:

Name & Designation of the Evaluator:

Signature of the Evaluator with Date:

Directions: For evaluation, enter rating of the student utilizing the following scale:

5 – Excellent; 4 - Very Good; 3 – Good; 2 – Satisfactory; 1 - Poor Assessment Criteria Score Comments if any a. Relevance with the content b. Use of resource material c. Organization & mechanical accuracy d. Cohesion & coherence e. Language proficiency & Timely submission Total Score Signature of the Student with Date:

Note: Subject teacher should try to cover all assignments mentioned in the list for each practical subject by assigning the topics to the students. Students should be encouraged to submit an assignment (in a format decided by the Institute) and encouraged to present assignments (at least any one assignment per subject) in the class.

Appendix – 2 A typical format for the assessment of a Field Visit Report Name of the College:

Name of the Student:

Academic Year of the Student:

Name of the Subject:

Name & full address of the organization visited:

Date and Duration of Visit:

Name & Designation of the Evaluator:

Signature of the Evaluator with Date:

Objectives set for the field visit: (give 2 – 4 objectives one by one) Prior preparation of the student for the field visit: (minimum 100 words) Describe the general experiences during the field visit: (minimum 100 words) Learning points: Describe what theoretical concept that is correlated during the field visit: (minimum 300 words) Appendix – 3 List of Instruments and Equipment required for the Conduct of D.Pharm program as per ER-2020 As per ER 2020 regulation; At least four laboratories specified below should be provided for:

1. Pharmaceutics Lab.

2. Pharm. Chemistry Lab.

3. Physiology, Pharmacology and Pharmacognosy Lab.

4. Biochemistry, Clinical Pathology, Hospital and Clinical Pharmacy Lab.

The institutions shall provide “Model Pharmacy” as per following details Model Pharmacy No.

Area Essential:

Running Model Community Pharmacy Desirable:

Drug Model Store 80 Sq. Mts.

(Including 10 Sq. mt. for Drug Information Centre & 10 Sq.

mt. for Patient Counselling) NOTE: Wherever animal experimentations are prescribed in the curriculum, the required knowledge and skill should be imparted by using computer assisted modules. Animal hold area shall be as per the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) guidelines.

Practical of Social Pharmacy, Pharmacotherapeutics can be conducted in any one of the laboratories by making necessary provisions.

Department wise List of Minimum Equipment required for D.Pharm (For a practical batch of 20 students)

1. Physiology, Pharmacology and Pharmacognosy Lab.

S. No.

Name Minimum required Nos.

for DPharm 60 intake Microscopes Haemocytometer with Micropipettes Sahli’s haemoglobinometers Sphygmomanometers Stethoscopes Human Permanent Slides for various tissues One pair of each tissue Organs and endocrine glands Models for various organs One model of each organ system Specimen for various organs and systems One model for each organ system Human Skeleton and bones One set of skeleton and one spare bone Different Contraceptive Devices and Models One set of each device Digital Balance (10 mg Sensitivity) Computer with LCD Licensed Software packages for Physiological & Pharmacological experiment IR Thermometer Refrigerator First aid equipment Adequate number Stop watch Dummy Inhalers and Nebulizer Pharmacotherapeutic charts for various diseases & disorders Adequate number Surgical devices and Sutures Adequate number Digital BP Instrument Mercury Thermometer Digital Thermometer Pulse Oximeter ESR Apparatus (Westergren and Wintrobe) Peak Flow meter Stadiometer Adult Weighing Scale (150 kg) Glucometer Projection microscope Permanent slide set of plants and charts for Pharmacognosy Lab Adequate number Drug information resources Adequate number Various types of PPE Kits, Adequate number Charts /displays/ AVs on tobacco control, glycemic index of foods, nutrition, reproductive health Adequate number Menstrual hygiene products Adequate number Display for various disinfectants, mosquito repellents etc Adequate number Water Testing Kit Adequate number Permanent slide of different microbes Adequate number NOTE: Adequate number of glassware commonly used in the laboratory should be provided in each laboratory and department

2. Pharmaceutical Chemistry/ Biochemistry, Clinical Pathology S. No.

Name Minimum required Nos.

for DPharm 60 intake Hot plates Hot Air Oven Refrigerator Analytical Balances for demonstration Digital balance 10mg sensitivity Magnetic Stirrers with Thermostat Vacuum Pump Digital pH meter Wall Mounted Water Distillation Unit Nessler’s Cylinders Digital Melting Point Apparatus Thieles Tube Digital Colorimeter Thermostatic Water Bath NOTE: Adequate number of glassware commonly used in the laboratory should be provided in each laboratory and department

3. Pharmaceutics S. No.

Name Minimum required Nos.

for DPharm 60 intake Digital balance (10mg) Microscopes Autoclave Vacuum Pump Standard sieves, sieve no. 8, 10, 12,22,24, 44, 54, 60, 80, 85, 100, 120 10 sets Tablet dissolution test apparatus IP (Digital single/double Unit) Magnetic stirrer, 500ml and 1 litter capacity with speed control Digital pH meter Capsule Counter Hot Plate Distillation Unit Tablet counter – small size Hot air oven Electric water bath unit Stalagmometer Desiccator Buchner Funnels (Medium) Filtration assembly with Vacuum Pump Andreasen’s Pipette Ointment slab Ointment spatula Pestle and mortar porcelain Refrigerator Micrometre slide Eyepiece Micrometre slide Stage Viscometer Ostwald/Brookfield Stop watch Sintered glass filter with vacuum NOTE: Aseptic cabinet or area should be provided as per Appendix A of ER 2020 Adequate number of glassware commonly used in the laboratory should be provided in each laboratory and department Machine Room S. No.

Name Minimum required Nos.

for D.Pharm 60 intake Capsule filling machine Automated Single Station Tablet punching machine Tablet disintegration test apparatus IP (Digital Single/Double unit) Monsanto’s hardness tester Pfizer type hardness tester Friability test apparatus (Digital Single/Double unit) Sieve shaker with sieve set Ointment filling machine All-purpose equipment with all accessories Bottle washing Machine Bottle Sealing Machine Liquid Filling Machine Ampoule washing machine Ampoule filling and sealing machine (Jet Burner) Clarity test apparatus Collapsible tube – Filling and Sealing Liquid Mixer NOTE: Adequate number of glassware commonly used in the laboratory should be provided in each laboratory and department

4. Hospital and Clinical Pharmacy Lab S. No.

Name Minimum required Nos for D.Pharm 60 intake Orthopaedical & Surgical Aids such as knee cap, LS belts, abdominal belt, walker, walking sticks, etc Adequate Number Different Types of bandages such as sterile gauze, cotton, crepe bandages, roll bandage etc Adequate Number Mannequins for CPR-1 (with indication Signals) Mannequins for injection IV Arm Variety of Needles Variety of Syringes Variety of catheters IV set Urine Bag RYLE’s tube Urine pots Colostomy bags Oxygen masks Inventory Software for Retail Pharmacy NOTE: Adequate number of glassware commonly used in the laboratory should be provided in each laboratory and department

5. Model Pharmacy S. No.

Name Minimum required Nos.

for D.Pharm 60 intake ( • Empty cartons of variety medicines (across variety dosage forms) • Various name plates indicating different parts of Pharmacy, • Proper arrangement of medicines, shelves, racks, drawers • Box/area for expiry medicines, • Display windows, shelves • Computer • Refrigerator • Designated patient counselling area, • Patient Information .Leaflets/Cards • Patient waiting area, • Drug Information books • Health information display, • Various devices for screening services (B.P. monitor, glucometer etc) • Height and body weight chart • Dummy devices (eg. Inhalers) • Display of pharmacist registration, license and other licenses • Display of name of owner • Inspection book, • Lock and key arrangement for Schedule X and NDPS medicines, • Bill book (dummy) , Computer stationary for bill printing Adequate Computers:

hospital and community pharmacy management software APPENDIX 4 Subject wise list of Recommended Books (Latest Edition) Pharmaceutics

1. History of Pharmacy in India by Dr. Harikishan Singh

2. Indian Pharmacopoeia, Govt. of India Publication

3. A Text book of Pharmaceuticals Formulation by B.M. Mithal, Vallabh Prakashan.

4. Bentleys’ Text book of Pharmaceutics, Editor E.A. Rawlins, Elsevier Int.,

5. The Theory and Practice of Industrial Pharmacy. Leon Lachman, Herbert Lieberman and Joseph Kanig, Editors, Lea and Febiger, Philadelphia.

Varghese Publishing House

6. Responsible Use of Medicines: A Layman’s Handbook, www.ipapharma.org / publications Pharmaceutical Chemistry

1. Medicinal & Pharmaceutical chemistry by Harikishan Singh and VK Kapoor

2. Wilson and Griswold’s Text book of Organic Medicinal and pharmaceutical Chemistry

3. Practical Organic Chemistry by Mann and Saunders.

4. Practical Pharmaceutical Chemistry, Volume- I & II by Beckett and J. B.

Stenlake

5. Indian Pharmacopoeia

6. Vogel’s text book of Practical Organic Chemistry Pharmacognosy

1. Text book of Pharmacognosy by C. K. Kokate, S. B. Gokhale, A.P.

Purohit, Nirali Prakashan

2. Text book of Pharmacognosy by C.S. Shah and J. S. Qadry, CBS Publishers & Distributors Pvt. Ltd.

3. Text Book of Pharmacognosy by T. E. Wallis. CBS Publishers & Distributors Pvt. Ltd.

4. Study of crude drugs by M. A. Iyengar, Manipal Press Ltd, Manipal

5. Powder crude drugs by M. A. Iyengar, Manipal Press Ltd, Manipal

6. Anatomy of crude drugs by M. A. Iyengar, Manipal Press Ltd, Manipal

7. Augmented Text Book of Homeopathic Pharmacy by Dr. D D Banerjee, B Jain Publishers (P) Ltd Human Anatomy and Physiology

1. Human Physiology by C. C. Chatterjee

2. Human Anatomy and Physiology by S. Chaudhary and A. Chaudhary

3. Derasari and Gandhi’s elements of Human Anatomy, Physiology and Health Education

4. S.R. Kale and R.R. Kale, Textbook of Practical Anatomy and Physiology

5. Ross and Wilson Anatomy and Physiology in Health and illness

6. Human Anatomy and Physiology by Tortora Gerard J

7. Fundamentals of Medical Physiology by K. Sambulingam and P Sambulingam

8. Ranade V.G. Text Book of Practical Physiology

9. Goyal R.K., Natvar M.P. and Shah S.A., Practical Anatomy, Physiology and Biochemistry, Experimental Physiology Social Pharmacy

1. Social Pharmacy – Innovation and development. Geoff Harding, Sarah Nettleton and Kevin Taylor. The Pharmaceutical Press.

2. Text Book of Community Pharmacy Practice. RPSGB Publication

3. Community Pharmacy Handbook- Jonathan Waterfield

4. S Khurana, P Suresh and R Kalsi. Health Education & Community Pharmacy. S Vikas & Co

5. Social Pharmacy: Tayler, Geoffrey. Pharmaceutical Press. London.

6. Textbook by Dandiya PC, Zafer ZYK, Zafer A. Health education & Community Pharmacy. Vallabh Prakashan.

7. Websites of Ministry of Health and Family Welfare, National Health Portal

8. Pharmacists at the Frontlines: A Novel Approach at Combating TB www.ipapharma.org Visit Publications

9. Where There Is No Doctor: A Village Health Care Handbook by David Werner ,2015 updated version 10.Various WHO publications www.who.int Pharmacology

1. Pharma Satoskar, R.S.

and Bhandarkar, S.D.

Pharmacology and Pharmacotherapeutics

2. B. Suresh, A Text Book of Pharmacology

3. Derasari and Gandhi’s Elements of Pharmacology

4. S.K. Kulkarni, Practical Pharmacology and Clinical Pharmacy

5. H.K. Sharma. Principles of Pharmacology

6. Mary J. Mycek, Lippincott Williams and Wilkins. Lippincott’s illustrated Reviews: Pharmacology

7. Tripathi, K.D. Essentials of Medical Pharmacology.

8. Various Drug Information Books like British National Formulary, MIMS, CIMS, Drug Today etc., WHO, NIH Websites Community Pharmacy and Management

1. Health Education and Community Pharmacy by N.S. Parmar.

2. WHO consultative group report.

3. Drug store and Business management by Mohammed Ali and Jyoti.

4. Handbook of pharmacy – health care. Edt. Robin J Harman. The Pharmaceutical Press

5. Comprehensive Pharmacy Review – Edt. Leon Shargel. Lippincott Williams and Wilkins.

6. Good Pharmacy Practices Training Manual by IPA/CDSCO/WHO India

7. Training Module for Community Pharmacists in TB Care and Control/ by MoH/IPA

8. Hand Book of PharmaSoS, Drugs in Special population- Pregnancy and Lactation, Tobacco free future- Choice is yours: KSPC Publications.

9. Responsible Use of Medicines: A Layman’s Handbook, www.ipapharma.org /publications

10. Community Pharmacy Practice around the Globe:

Part One:

www.ipapharma.org /publications Biochemistry and Clinical Pathology

1. Essentials of Biochemistry by U. Satyanarayana, Books and Allied (P) Ltd.

2. A Textbook of Biochemistry by A.V.S.S. Rama Rao, UBS Publishers’ Distributors Pvt. Ltd.

3. Practical Biochemistry by R.C. Gupta and S. Bhargava.

4. Laboratory manual of Biochemistry by Pattabiraman and Sitaram Acharya Pharmacotherapeutics

1. Clinical Pharmacy and Therapeutics - Roger and Walker, Churchill Livingstone Publication

2. Clinical Pharmacy and Therapeutics - Eric T. Herfindal, Williams and Wilkins Publication

3. Applied Therapeutics: The clinical Use of Drugs. Lloyd Young and Koda-Kimble MA Lippincott, Williams and Wilkins Publication.

4. Pharmacotherapy: A Pathophysiologic approach - Joseph T. Dipiro et al.

Appleton and Lange Publication.

5. National Formulary of India, Indian Pharmacopoeia Commission, Ghaziabad.

Hospital and Clinical Pharmacy

1. A Textbook of Clinical Pharmacy Practice - Essential concepts and skills - Parthasarathi G, Karin Nyfort-Hansen and Milap Nahata. Orient Longman Pvt. Ltd.

Hyderabad.

2. Text Book of Hospital and Clinical Pharmacy by Dr. Pratibha Nand and Dr. Roop K Khar, Birla publications, New Delhi.

3. Gupta B.K and Gupta R.N., GPP in Hospital Pharmacy, Vallabh Prakashan.

4. Basic skills in interpreting laboratory data - Scott LT, American Society of Health System Pharmacists Inc.

5. Australian drug information- Procedure manual. The Society of Hospital Pharmacists of Australia.

Pharmacy Law and Ethics

1. Text book of Forensic Pharmacy by B.M. Mithal

2. Forensic Pharmacy by B. Suresh

3. Hand book of drug law-by M.L. Mehra

4. A text book of Forensic Pharmacy by N.K. Jain

5. Drugs and Cosmetics Act/Rules by Govt. of India publications.

6. Medicinal and Toilet preparations Act 1955 by Govt. of India publications.

7. Narcotic Drugs and Psychotropic Substances Act by Govt. of India publications

8. Drugs and Magic Remedies Act by Govt. of India publications.

9. CDSCO Website, NPPA Website

10. Books on Drugs and Cosmetic Act by Nilesh Gandhi and Sudhir Deshpande

11. Text Book of Forensic Pharmacy by Dr Guruprasad Mohanta