Diploma pharmacy syllabus, Study Guides, Projects, Research of Pharmacy

Download Diploma pharmacy syllabus and more Study Guides, Projects, Research Pharmacy in PDF only on Docsity!

Pharmacy Council of India

New Delhi

“Syllabus framed under Regulation 7,

List of prescribed equipments and

apparatus under Appendix-A of

The Education Regulations, 2020

For Diploma Course in Pharmacy”

CONTENTS

S. No. Contents Page No.

1. Preamble 1 - 2

2. Competencies for the Indian

D.Pharm Holders

3. Competency Mapping with the

Courses (Part I, II & III) of Education

Regulations 2020

4. ER-2020 D.Pharm Syllabus – An

Overview

5. Guidelines for the conduct of theory

examinations

6. Guidelines for the conduct of

practical examinations

7. ER-2020 D.Pharm Syllabus – Part I 12 - 35

8. ER-2020 D.Pharm Syllabus – Part II 36 - 64

9. Appendices 65 - 77

1. Preamble

“Revamping the curriculum, pedagogy, assessment, and student support” is one of the vision statements and recommendations of the National Education Policy (NEP) of Govt. of India for attaining enhanced learning experiences by the students. In light of this, Pharmacy Council of India, the apex body regulating the pharmacy education in the country, committed to revise the education regulations of Diploma in Pharmacy (D.Pharm) program and thus, the ‘Education Regulations 2020’ (ER-2020) has been notified in the Gazette of India in October 2020. This new regulation has given due consideration for the fact that, universally the role of pharmacist has undergone continuous evolution from ‘dispenser of medicines’ to ‘medicine expert’ in the multidisciplinary health care team. Accordingly, the courses (course means the subject) of the existing education regulations (ER-91) have been revisited, compared with the present and future needs of the society, expectations of the healthcare team and other stakeholders from the pharmacists were assessed, feedback from the experts in the pharmacy and other healthcare professions were sought. Thus, the course of study prescribed in ER-2020 is an amalgamation of all such exercises to arrive at a curriculum structure for D.Pharm that is more relevant to the current practice standards, dynamic to accommodate and address the upcoming changes. Though the total number of courses across the program remain 21 as that of ER-91, the number of theory courses is reduced from 12 to 11 in the new regulation, while the number of practical courses is increased from 9 to 10. Further, the theory teaching hours across the program have been reduced from 850 to 825, while the practical hours have been increased from 750 to 800 in the new regulation. Three practical courses have been introduced for the first time in ER-2020. Further, about 275 hours have been assigned for the first time in D.Pharm curriculum for ‘Tutorial’ activities. All such changes explicitly reveal that the ER-2020 is intended to provide a little edge to the experiential learning through the practical courses and encourages the small group teaching-learning, self-directed learning, etc. in the tutorial hours. Introduction of ‘Pharmacotherapeutics’ courses (theory and practical) is one of the revolutionary changes in the new curriculum, that will help the students to hone their knowledge and skills in the area of pharmaceutical care services which will certainly redefine the roles of the D.Pharm qualified pharmacists in both community and hospital settings. Also, the introduction of ‘Social Pharmacy’ courses (theory and practical) will provide insights about the primary and preventive healthcare concepts in the country and the potential roles of pharmacists in such healthcare segments. In this backdrop, the Council has formulated a Committee which comprised of 16 Members who have rich experiences in various domains such as education, hospital

2. Competencies for the Indian D.Pharm Holders

Competency is defined as “A distinct composite of knowledge, skill, attitude and value that is essential to the practice of the profession in real life contexts”. The candidates who successfully complete the Diploma in Pharmacy (D.Pharm) program of Education Regulations 2020 (ER-2020), from the institutions approved by the Pharmacy Council of India are expected to attain the following professional competencies.

1. Review Prescriptions
2. Dispense Prescription / Non-Prescription Medicines
3. Provide Patient Counselling / Education
4. Hospital and Community Pharmacy Management
5. Expertise on Medications
6. Proficiency on drugs / pharmaceuticals
7. Entrepreneurship and Leadership
8. Deliver Primary and Preventive Healthcare
9. Professional, Ethical and Legal Practice
10. Continuing Professional Development
11. Review Prescriptions: The student should receive and handle prescriptions in a professional manner and be able to check for their completeness and correctness. Also, the prescribers should be contacted for any clarifications and corrections in the prescriptions with suggestions if any.
12. Dispense Prescription / Non-Prescription Medicines: The student should be able to dispense the various scheduled drugs / medicines as per the implications of the Drug & Cosmetics Act and Rules thereunder. Also, the non-prescription medicines (over-the-counter drugs) should be dispensed judicially to the patients as required.
13. Provide Patient Counselling / Education: The student should be able to effectively counsel / educate the patients / caretakers about the prescription / non- prescription medicines and other health related issues. Effective communication includes using both oral and written communication skills and various communication techniques.
14. Hospital and Community Pharmacy Management: The student should be able to manage the drug distribution system as per the policies and guidelines of the hospital pharmacy, good community pharmacy practice and the recommendations of regulatory agencies. Also, be able to manage the procurement, inventory, and distribution of medicines in hospital / community pharmacy settings.

5. Expertise on Medications: The student should be able to provide an expert opinion on medications to health care professionals on safe and effective medication-use, relevant policies and procedures based on available evidences.
6. Proficiency on Pharmaceutical Formulations: The student should be able to describe the chemistry, characteristics, types, merits and demerits of both drugs and excipients used in pharmaceutical formulations based on her/his knowledge and scientific resources.
7. Entrepreneurship and Leadership: The student should be able to acquire the entrepreneurial skills in the dynamic professional environments. Also, be able to achieve leadership skills through teamwork and sound decision- making skills.
8. Deliver Primary and Preventive Healthcare: The student should be able to contribute to various healthcare programs of the nation including disease prevention initiatives to improve public health. Also contribute to the promotion of national health policies.
9. Professional, Ethical and Legal Practice: The student should be able to deliver professional services in accordance with legal, ethical, and professional guidelines with integrity.
10. Continuing Professional Development: The student should be able to recognize the gaps in the knowledge and skills in the effective delivery of professional services from time to time and be self-motivated to bridge such gaps by attending continuing professional development programs.

4. ER-2020 D.Pharm Syllabus – An Overview

The ER-2020 D.Pharm Syllabus has the following structure in every course. Though the theory and practical courses are not mutually exclusive, as per the Regulations, the theory and practical are to be considered as individual courses. Scope: These are broader statements on the purpose of the course in the curriculum, key contents of the course that will contribute to the specific knowledge and or skill developments. The teacher is expected to orient the students about the scope of the particular course at the beginning and intermittently. Course Objectives: The course objectives describe the key topics that are intended by the teacher to be covered in the course. In general, these are more specific than the scope and broader than the course outcomes. The teacher is expected to discuss the objectives of the course with the students and break-down the course objectives into micro levels as objectives of a specific topic / objectives of a specific lecture, etc. Such an exercise shall make the students to understand the significance of the course / topic / lecture and enhance their attention on the course / topic / lecture. Course Outcomes: The course outcomes are more specific than the course objectives describe that describe the abilities of the students to perform/act, upon successful completion of the course. Hence, conventionally the course outcomes are described with verbs that are measurable or observable actions. The teacher is expected to describe the desired outcomes of the particular course, so that the students shall understand the various assessment criteria, modalities, and parameters. This also serves as a broader guideline for the teachers for preparing the assessment plan. A well-structured assessment plan associated with the course outcomes shall enable to mapping with the professional competencies and their attainment levels that are attributed to the program outcomes. Theory Courses: The theory courses basically provide concepts and explain the relationships between the concepts. Understanding of the theoretical courses enable the students to identify the problems in real life situation and make a plan for addressing such problems. Also, the theory course helps to understand what is not known and thus is the tool for accumulation of knowledge. The syllabus of the theory courses has been systematically and logically described as different chapters and the minimum number of hours to be spent on teaching are mentioned chapter wise and course wise. The teachers shall further distribute the total hours of any given chapter among the sub-topics as required by the subject matter.

Practical Courses: The practical courses are designed for applying the theoretical knowledge in the given experimental / simulated conditions. The practical courses deepen the understanding of theories, develop the skills, hone professional competencies, provide opportunities to observe, think and analyse problem solving methods. Further, they help to gain experience with the real things in practice. The teachers shall train the students in actual / simulated practical conditions. Tutorials: The purpose of the tutorial hour is typically to engage the students in smaller groups in order to pay a closer attention on their learning process. This is an opportunity for the students to complete their assignments, develop specific skills, discuss any problems in the study topics in a less formal way. During the tutorial hour, the students shall exchange their ideas within the small group, and learn to accept constructive criticism and listen to others. Also, the tutorial hour enables the teachers to closely monitor the progress of the individual student and provide additional academic support to individuals, if necessary. Assignments: The purpose the assignments are to encourage the students for self- directed learning. Further, the assignments will provoke critical thinking, enhance the skills such as literature search, data mining, data interpretation, report formatting, time-management, and written communication. This is also a mode of self- assessment for the student about the level of understanding of the concepts of a particular course. The teachers shall apply their knowledge and wisdom in choosing the assignment topics at a micro level in alignment with the topics given in the syllabus. The assignments shall be evaluated against a set of criteria. A typical format for the assessment of an assignment is given in Appendix -1. Field Visits: The purpose of field visits is to provide a real-world experience to the students. The field visits will help them to realize that what they learn within the walls of the classroom / laboratory can help them solve the problems they see in the world around them. Also, this is helpful to the teachers to widen their horizons of knowledge and broadening the scope of the syllabus. Every student shall submit a report describing their objectives, experience, learning points, etc. pertaining to the field trip, in the typical format given in Appendix-2. Recommended Books: For each course, a list of recommended books is given in the syllabus. The list shall be considered as an important and common resource for the teaching-learning process, but not the complete list. It is always encouraged to use the latest edition of the books specified. Further, the teachers and students are encouraged to explore more primary, secondary, and tertiary resources as required.

5. Guidelines for the conduct of theory examinations

Sessional Examinations There shall be two or more periodic sessional (internal assessment) examinations during each academic year. The duration of the sessional exam shall be 90 minutes. The highest aggregate of any two performances shall form the basis of calculating the sessional marks. The scheme of the question paper for theory sessional examinations shall be as given below. I. Long Answers (Answer 3 out of 4) 3 x 5 = 15 II. Short Answers (Answer 5 out of 6) 5 x 3 = 15 III.Objective type Answers (Answer all 10 out of 10) 10 x 1 = (Multiple Choice Questions / Fill-in the Blanks / One word OR one Sentence questions)

---

Total = 40 marks

Internal assessment: The marks secured by the students out of the total 40 shall be reduced to 20 in each sessional, and then the internal assessment shall be calculated based on the best two averages for 20 marks. Final Board / University Examinations The scheme of the question paper for the theory examinations conducted by the examining authority (Board / University) shall be as given below. The duration of the final examination shall be 3 hours. I. Long Answers (Answer 6 out of 7) = 6 x 5 = 30 II. Short Answers (Answer 10 out of 11) = 10 x 3 = 30 III. Objective type Answers (Answer all 20) = 20 x 1 = 20 (Multiple Choice Questions / Fill-in the Blanks / One word OR one Sentence questions)

---

Total = 80 marks

6. Guidelines for the conduct of practical examinations

Sessional Examinations There shall be two or more periodic sessional (internal assessment) practical examinations during each academic year. The duration of the sessional exam shall be three hours. The highest aggregate of any two performances shall form the basis of calculating the sessional marks. The scheme of the question paper for practical sessional examinations shall be as given below. I. Synopsis = 10 II. Experiments = 50* III. Viva voce = 10 IV. Practical Record Maintenance = 10

---

Total = 80 marks

• The marks for the experiments shall be divided into various categories, viz. major experiment, minor experiment, spotters, etc. as per the requirement of the course. Internal assessment: The marks secured by the students out of the total of 80 shall be reduced to 10 in each sessional, and then the internal assessment shall be calculated based on the best two averages for 10 marks from the sessional and other 10 marks shall be awarded as per the details given below. Actual performance in the sessional examination = 10 marks Assignment marks (Average of three) = 5 marks* Field Visit Report marks (Average for the reports) = 5 marks $

---

Total = 20 marks

*, $ Only for the courses given with both assignments and field visit/s Note:

1. For the courses having either assignments or field visit/s, the assessments of assignments or field visit/s shall be done directly for 10 marks and added to the sessional marks.
2. For the courses not having both assignment and field visit, the whole 20 marks shall be calculated from the sessional marks.

7. ER-2020 D.Pharm Syllabus – Part I

S.

No. Course Code Name of the Course Total Theory / Practical Hours Total Tutorial Hours Theory / Practical Hours per Week Tutorial Hours per Week

1. ER20-11T Pharmaceutics – Theory

2. ER20-11P Pharmaceutics – Practical

3. ER20-12T Pharmaceutical Chemistry – Theory

4. ER20-12P Pharmaceutical Chemistry – Practical

5. ER20-13T Pharmacognosy – Theory

6. ER20-13P Pharmacognosy – Practical

7. ER20-14T Human Anatomy & Physiology – Theory

8. ER20-14P Human Anatomy & Physiology – Practical

9. ER20-15T Social Pharmacy – Theory

10. ER20-15P Social Pharmacy – Practical

PHARMACEUTICS – THEORY

Course Code: ER20-11T 75 Hours (3 Hours/week) Scope: This course is designed to impart basic knowledge and skills on the art and science of formulating and dispensing different pharmaceutical dosage forms. Course Objectives: This course will discuss the following aspects of pharmaceutical dosage forms

1. Basic concepts, types and need
2. Advantages and disadvantages, methods of preparation / formulation
3. Packaging and labelling requirements
4. Basic quality control tests, concepts of quality assurance and good manufacturing practices Course Outcomes: Upon successful completion of this course, the students will be able to
5. Describe about the different dosage forms and their formulation aspects
6. Explain the advantages, disadvantages, and quality control tests of different dosage forms
7. Discuss the importance of quality assurance and good manufacturing practices Chapter Topics Hours (^1)  History of the profession of Pharmacy in India in relation to Pharmacy education, industry, pharmacy practice, and various professional associations.  Pharmacy as a career  Pharmacopoeia: Introduction to IP, BP, USP, NF and Extra Pharmacopoeia. Salient features of Indian Pharmacopoeia

2 Packaging materials: Types, selection criteria, advantages and disadvantages of glass, plastic, metal, rubber as packaging materials

3 Pharmaceutical aids: Organoleptic (Colouring, flavouring, and sweetening) agents Preservatives: Definition, types with examples and uses

4 Unit operations: Definition, objectives/applications, principles, construction, and workings of:

Size reduction: hammer mill and ball mill Size separation: Classification of powders according to IP, Cyclone separator, Sieves and standards of sieves

2. Formulation of dosage forms based on working formula
3. Appropriate Packaging and labelling requirements
4. Methods of basic quality control tests Course Outcomes: Upon successful completion of this course, the students will be able to
5. Calculate the working formula from the given master formula
6. Formulate the dosage form and dispense in an appropriate container
7. Design the label with the necessary product and patient information
8. Perform the basic quality control tests for the common dosage forms Practicals
9. Handling and referring the official references: Pharmacopoeias, Formularies, etc. for retrieving formulas, procedures, etc.
10. Formulation of the following dosage forms as per monograph standards and dispensing with appropriate packaging and labelling  Liquid Oral: Simple syrup, Piperazine citrate elixir, Aqueous Iodine solution  Emulsion: Castor oil emulsion, Cod liver oil emulsion  Suspension: Calamine lotion, Magnesium hydroxide mixture  Ointment: Simple ointment base, Sulphur ointment  Cream: Cetrimide cream  Gel: Sodium alginate gel  Liniment: Turpentine liniment, White liniment BPC  Dry powder: Effervescent powder granules, Dusting powder  Sterile Injection: Normal Saline, Calcium gluconate Injection  Hard Gelatine Capsule: Tetracycline capsules  Tablet: Paracetamol tablets
11. Formulation of at least five commonly used cosmetic preparations – e.g. cold cream, shampoo, lotion, toothpaste etc
12. Demonstration on various stages of tablet manufacturing processes
13. Appropriate methods of usage and storage of all dosage forms including special dosage such as different types of inhalers, spacers, insulin pens
14. Demonstration of quality control tests and evaluation of common dosage forms viz. tablets, capsules, emulsion, sterile injections as per the monographs

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. Various systems of measures commonly used in prescribing, compounding and dispensing practices
2. Market preparations (including Fixed Dose Combinations) of each type of dosage forms, their generic name, minimum three brand names and label contents of the dosage forms mentioned in theory/practical
3. Overview of various machines / equipments / instruments involved in the formulation and quality control of various dosage forms / pharmaceutical formulations.
4. Overview of extemporaneous preparations at community / hospital pharmacy vs. manufacturing of dosage forms at industrial level
5. Basic pharmaceutical calculations: ratios, conversion to percentage fraction, alligation, proof spirit, isotonicity Field Visit The students shall be taken for an industrial visit to pharmaceutical industries to witness and understand the various processes of manufacturing of any of the common dosage forms viz. tablets, capsules, liquid orals, injectables, etc. Individual reports from each student on their learning experience from the field visit shall be submitted.