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”  

COMMITTEE MEMBERS

CONTENTS

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 pharmacy practice, community pharmacy practice, clinical pharmacy practice, administrative and regulatory affairs to design the syllabus for the individual theory and practical courses as per the curriculum framework defined in ER-2020. The Committee with its clear understanding about the philosophy and objectives of the ER-2020, drafted the syllabus for individual theory and practical courses with utmost care to avoid repetitions, redundancy, over/under utilization of hours, etc. Every course is defined with scope, set of course objectives and course outcomes which will help to understand the significance and the expectations of the course from both teachers and students. Lots of scope has been given in the syllabus for the active learning by the students through the assignment topics and field visit activities which will enhance their critical thinking, searching scientific literatures, interpretational skills and communication skills. 

According to the ER-2020 curriculum framework, the students do not earn any credits based on the academic hours they spend. However, as per the conventional methodology of credit calculations, the curriculum of ER-2020 shall be deemed equivalent to 80 credits that shall be used for the administrative purposes, wherever necessary.

Further, the ‘Competencies for the Indian D.Pharm Holders’ based on the knowledge, skill, attitude and value that are essential for the successful practice of the profession have been derived. These competencies have also been mapped with the individual courses of the curriculum based on the expected outcomes of the individual course. Thus, the courses and the competencies are interlaced in such a way that multiple courses contribute to build one competency and one course contributes to build more than one competency, which reveal the strength of the competency mapping. 

The Council strongly believes that the ER-2020 regulations, curriculum and syllabus will uplift the knowledge and skills of the students on par with the contemporary and future professional demands and enable them to be a successful practitioner in the chosen field of pharmacy. 

By considering the substantial changes and inclusion of advanced and current subject matters in the new syllabus, the Council shall conduct series of meetings, seminars, conferences, workshops, and webinars for the faculty members handling D.Pharm courses and equip them to deliver such new courses / topics more effectively and efficiently. 

The Council appreciate all the efforts of the Members for successfully bringing out the Education Regulations 2020, curriculum and syllabus. Also, profound gratitude to all the stakeholders who contributed directly or indirectly in completing this task.

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

1. 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.

2. 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.

3. Provide Patient Counselling / Education: The student should be able to effectively counsel / educate the patients / caretakers about the prescription / nonprescription medicines and other health related issues. Effective communication includes using both oral and written communication skills and various communication techniques.

4. 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. 

3. Competency Mapping with the Courses (Part I, II & III) of  Education Regulations 2020

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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 selfdirected 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 selfassessment 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.

Practical Training: The goal of the practical training for the students is to provide a real-time, supervised experience on the professional tasks emphasised in their course of study. Further, it helps them to apply their acquired knowledge and skills in the professional working environment. The practical training intensively prepares the students with adequate competencies and qualifications required for the career opportunity in the future.  

Thus, the ER 2020 D.Pharm syllabus is designed to nurture the students in all the three domains of Bloom’s Taxonomy viz. cognitive (knowledge), affective (attitude) and psychomotor (skills). Further, it also provides ample of scope to the students for different learning styles viz. visual, auditory and kinaesthetic, i.e., ‘see, hear and do’. 

The summary of the curriculum, courses and other activities and their metrics across the ER-2020 D.Pharm program (Part I, II & III) are given here. 

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. 

1. 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 =10

                    (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.

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. 

1. Synopsis                                                             =         10
2. Experiments                                                 =           50*

• Viva voce                                                             =           10

1. 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.

Final Board / University Examinations

The scheme of the question paper for the practical examinations conducted by the examining authority (Board / University) shall be as given below. The duration of the final examination shall be 3 hours.

1. Synopsis                                                             =         10
2. Experiments                                                 =           60*

• Viva voce                                                =           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. 

7. ER-2020 D.Pharm Syllabus – Part I

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

1. Describe about the different dosage forms and their formulation aspects
2. Explain the advantages, disadvantages, and quality control tests of different dosage forms
3. Discuss the importance of quality assurance and good manufacturing practices

PHARMACEUTICS – PRACTICAL

Course Code: ER20-11P                                                    75 Hours (3 Hours/week)

Scope: This course is designed to train the students in formulating and dispensing common pharmaceutical dosage forms.

Course Objectives: This course will discuss and train the following aspects of preparing and dispensing various pharmaceutical dosage forms

1. Calculation of working formula from the official master formula
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

1. Calculate the working formula from the given master formula
2. Formulate the dosage form and dispense in an appropriate container
3. Design the label with the necessary product and patient information
4. Perform the basic quality control tests for the common dosage forms

Practicals

1. Handling and referring the official references: Pharmacopoeias, Formularies, etc.

for retrieving formulas, procedures, etc.  

2. 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
3. Formulation of at least five commonly used cosmetic preparations – e.g. cold cream, shampoo, lotion, toothpaste etc

4. Demonstration on various stages of tablet manufacturing processes

5. Appropriate methods of usage and storage of all dosage forms including special dosage such as different types of inhalers, spacers, insulin pens  
6. 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.

PHARMACEUTICAL CHEMISTRY – THEORY

Course Code: ER20-12T                                                    75 Hours (3 Hours/week)

Scope: This course is designed to impart basic knowledge on the chemical structure, storage conditions and medicinal uses of organic and inorganic chemical substances used as drugs and pharmaceuticals.  Also, this course discusses the impurities, quality control aspects of chemical substances used in pharmaceuticals.

Course Objectives: This course will discuss the following aspects of the chemical substances used as drugs and pharmaceuticals for various disease conditions

1. Chemical classification, chemical name, chemical structure
2. Pharmacological uses, doses, stability and storage conditions
3. Different types of formulations / dosage form available and their brand names 4. Impurity testing and basic quality control tests

Course Outcomes: Upon successful completion of this course, the students will be able to

1. Describe the chemical class, structure and chemical name of the commonly used drugs and pharmaceuticals of both organic and inorganic nature
2. Discuss the pharmacological uses, dosage regimen, stability issues and storage conditions of all such chemical substances commonly used as drugs
3. Describe the quantitative and qualitative analysis, impurity testing of the chemical substances given in the official monographs
4. Identify the dosage form & the brand names of the drugs and pharmaceuticals popular in the marketplace

PHARMACEUTICAL CHEMISTRY – PRACTICAL

Course Code: ER20-12P                                                  75 Hours (3 Hours/week)

Scope: This course is designed to impart basic training and hands-on experiences to synthesis chemical substances used as drugs and pharmaceuticals.  Also, to perform the quality control tests, impurity testing, test for purity and systematic qualitative analysis of chemical substances used as drugs and pharmaceuticals.

Course Objectives: This course will provide the hands-on experience on the following aspects of chemical substances used as drugs and pharmaceuticals 

1. Limit tests and assays of selected chemical substances as per the monograph
2. Volumetric analysis of the chemical substances
3. Basics of preparatory chemistry and their analysis
4. Systematic qualitative analysis for the identification of the chemical drugs

Course Outcomes: Upon successful completion of this course, the students will be able to

1. Perform the limit tests for various inorganic elements and report
2. Prepare standard solutions using the principles of volumetric analysis
3. Test the purity of the selected inorganic and organic compounds against the monograph standards
4. Synthesize the selected chemical substances as per the standard synthetic scheme
5. Perform qualitative tests to systematically identify the unknown chemical substances

Practicals

Assignments

The students shall be asked to submit the written assignments on the following topics (One assignment per student per sessional period. i.e., a minimum of THREE assignments per student)

1. Different monographs and formularies available and their major contents
2. Significance of quality control and quality assurance in pharmaceutical industries
3. Overview on Green Chemistry
4. Various software programs available for computer aided drug discovery
5. Various instrumentations used for characterization and quantification of drug

PHARMACOGNOSY – THEORY

Course Code: ER20-13T                                                    75 Hours (3 Hours/week)

Scope: This course is designed to impart knowledge on the medicinal uses of various drugs of natural origin. Also, the course emphasizes the fundamental concepts in the evaluation of crude drugs, alternative systems of medicine, nutraceuticals, and herbal cosmetics.

Course Objectives: This course will discuss the following aspects of drug substances derived from natural resources.

1. Occurrence, distribution,     isolation,         identification tests     of         common phytoconstituents
2. Therapeutic activity and pharmaceutical applications of various natural drug substances and phytoconstituents
3. Biological source, chemical constituents of selected crude drugs and their therapeutic efficacy in common diseases and ailments
4. Basic concepts in quality control of crude drugs and various system of medicines
5. Applications of herbs in health foods and cosmetics

Course Outcomes: Upon successful completion of this course, the students will be able to

1. Identify the important/common crude drugs of natural origin
2. Describe the uses of herbs in nutraceuticals and cosmeceuticals
3. Discuss the principles of alternative system of medicines
4. Describe the importance of quality control of drugs of natural origin

PHARMACOGNOSY – PRACTICAL

Course Code: ER20-13P                                                    75 Hours (3 Hours/week)

Scope: This course is designed to train the students in physical identification, morphological characterization, physical and chemical characterization, and evaluation of commonly used herbal drugs. 

Course Objectives: This course will provide hands-on experiences to the students in 

1. Identification of the crude drugs based on their morphological characteristics
2. Various characteristic anatomical characteristics of the herbal drugs studied through transverse section
3. Physical and chemical tests to evaluate the crude drugs

Course Outcomes: Upon successful completion of this course, the students will be able to

1. Identify the given crude drugs based on the morphological characteristics
2. Take a transverse section of the given crude drugs
3. Describe the anatomical characteristics of the given crude drug under microscopical conditions
4. Carry out the physical and chemical tests to evaluate the given crude drugs Practicals

1. Morphological Identification of the following drugs:

Ispaghula, Senna, Coriander, Fennel, Cardamom, Ginger, Nutmeg, Black Pepper, Cinnamon, Clove, Ephedra, Rauwolfia, Gokhru, Punarnava, Cinchona, Agar.

2. Gross anatomical studies (Transverse Section) of the following drugs:

Ajwain, Datura, Cinnamon, Cinchona, Coriander, Ashwagandha, Liquorice, Clove, Curcuma, Nux vomica, Vasaka

3. Physical and chemical tests for evaluation of any FIVE of the following drugs:

Asafoetida, Benzoin, Pale catechu, Black catechu, Castor oil, Acacia, Tragacanth, Agar, Guar gum, Gelatine.

Assignments

The students shall be asked to submit the written assignments on the following topics (One assignment per student per sessional period. i.e., a minimum of THREE assignments per student)

1. Market preparations of various dosage forms of Ayurvedic, Unani, Siddha, Homeopathic (Classical and Proprietary), indications, and their labelling requirements
2. Market preparations of various herbal formulations and herbal cosmetics, indications, and their labelling requirements
3. Herb-Drug interactions documented in the literature and their clinical significances

Field Visit

The students shall be taken in groups to a medicinal garden to witness and understand the nature of various medicinal plants discussed in theory and practical courses. Additionally, they shall be taken in groups to the pharmacies of traditional systems of medicines to understand the availability of various dosage forms and their labelling requirements. Individual reports from each student on their learning experience from the field visit shall be submitted.

HUMAN ANATOMY AND PHYSIOLOGY – THEORY

Course Code: ER20-14T                                                    75 Hours (3 Hours/week)

Scope: This course is designed to impart basic knowledge on the structure and functions of the human body. It helps in understanding both homeostasis mechanisms and homeostatic imbalances of various systems of the human body.

Course Objectives: This course will discuss the following: 

1. Structure and functions of the various organ systems and organs of the human body
2. Homeostatic mechanisms and their imbalances in the human body
3. 
   Various vital physiological parameters of the human body and their significances

Course Outcomes: Upon successful completion of this course, the students will be able to

1. Describe the various organ systems of the human body
2. Discuss the anatomical features of the important human organs and tissues
3. Explain the homeostatic mechanisms regulating the normal physiology in the human system
4. Discuss the significance of various vital physiological parameters of the human body

HUMAN ANATOMY AND PHYSIOLOGY – PRACTICAL

Course Code: ER20-14P                                                    75 Hours (3 Hours/week)

Scope: This course is designed to train the students and instil the skills for carrying out basic physiological monitoring of various systems and functions.  

Course Objectives: This course will provide hands-on experience in the following: 

1. General blood collection techniques and carrying out various haematological assessments and interpreting the results
2. Recording and monitoring the vital physiological parameters in human subjects and the basic interpretations of the results
3. Microscopic examinations of the various tissues permanently mounted in glass slides
4. Discuss the anatomical and physiological characteristics of various organ systems of the body using models, charts, and other teaching aids

Course Outcomes: Upon successful completion of this course, the students will be able to

1. Perform the haematological tests in human subjects and interpret the results
2. Record, monitor and document the vital physiological parameters of human subjects and interpret the results
3. Describe the anatomical features of the important human tissues under the microscopical conditions
4. Discuss the significance of various anatomical and physiological characteristics of the human body

Practicals

1. Study of compound microscope
2. General techniques for the collection of blood
3. Microscopic examination of Epithelial tissue, Cardiac muscle, Smooth muscle, Skeletal muscle, Connective tissue, and Nervous tissue of ready / pre-prepared slides.
4. Study of Human Skeleton-Axial skeleton and appendicular skeleton
5. Determination of
   1. Blood group
   2. ESR
   3. Haemoglobin content of blood
   4. Bleeding time and Clotting time
6. Determination of WBC count of blood
7. Determination of RBC count of blood
8. Determination of Differential count of blood
9. Recording of Blood Pressure in various postures, different arms, before and after exertion and interpreting the results
10. Recording of Body temperature (using mercury, digital and IR thermometers at various locations), Pulse rate/ Heart rate (at various locations in the body, before and after exertion), Respiratory Rate
11. Recording Pulse Oxygen (before and after exertion)
12. Recording force of air expelled using Peak Flow Meter
13. Measurement of height, weight, and BMI
14. Study of various systems and organs with the help of chart, models, and specimens
    1. Cardiovascular system
    2. Respiratory system
    3. Digestive system
    4. Urinary system
    5. Endocrine system
    6. Reproductive system
    7. Nervous system
    8. Eye
    9. Ear
    10. Skin

SOCIAL PHARMACY – THEORY

Course Code: ER20-15T                                                    75 Hours (3 Hours/week)

Scope: This course is designed to impart basic knowledge on public health, epidemiology, preventive care, and other social health related concepts. Also, to emphasize the roles of pharmacists in the public health programs.

Course Objectives: This course will discuss about basic concepts of

1. Public health and national health programs
2. Preventive healthcare
3. Food and nutrition related health issues
4. Health education and health promotion
5. General roles and responsibilities of pharmacists in public health

Course Outcomes: Upon successful completion of this course, the students will be able to

1. Discuss about roles of pharmacists in the various national health programs
2. Describe various sources of health hazards and disease preventive measures
3. Discuss the healthcare issues associated with food and nutritional substances
4. Describe the general roles and responsibilities of pharmacists in public health

SOCIAL PHARMACY – PRACTICAL

Course Code: ER20-15P                                                    75 Hours (3 Hours/week)

Scope: This course is designed to provide simulated experience in various public health and social pharmacy activities. 

Course Objectives: This course will train the students on various roles of pharmacists in public health and social pharmacy activities in the following areas:

1. National immunization programs
2. Reproductive and child health programs
3. Food and nutrition related health programs
4. Health education and promotion
5. General roles and responsibilities of the pharmacists in public health
6. First Aid for various emergency conditions including basic life support and cardiopulmonary resuscitation

Course Outcomes: Upon successful completion of this course, the students will be able to 

1. Describe the roles and responsibilities of pharmacists in various National health programs
2. Design promotional materials for public health awareness
3. Describe various health hazards including microbial sources
4. Advice on preventive measures for various diseases
5. Provide first aid for various emergency conditions

Note: Demonstration / Hands-on experience / preparation of charts / models / promotional materials / role plays / enacting / e-brochures / e-flyers / podcasts / video podcasts / any other innovative activities to understand the concept of various elements of social pharmacy listed here. (At least one activity to be carried out for each one of the following):

Practicals

1. National immunization schedule for children, adult vaccine schedule, Vaccines which are not included in the National Immunization Program.
2. RCH – reproductive and child health – nutritional aspects, relevant national health programmes.
3. Family planning devices
4. Microscopical observation of different microbes (readymade slides)
5. Oral Health and Hygiene
6. Personal hygiene and etiquettes – hand washing techniques, Cough and sneeze etiquettes.
7. Various types of masks, PPE gear, wearing/using them, and disposal.
8. Menstrual hygiene, products used
9. First Aid – Theory, basics, demonstration, hands on training, audio-visuals, and practice, BSL (Basic Life Support) Systems [SCA – Sudden Cardiac Arrest, FBAO – Foreign Body Airway Obstruction, CPR, Defibrillation (using AED) (Includes CPR techniques, First Responder).
10. Emergency treatment for all medical emergency cases viz. snake bite, dog bite, insecticide poisoning, fractures, burns, epilepsy etc.
11. Role of Pharmacist in Disaster Management.
12. Marketed preparations of disinfectants, antiseptics, fumigating agents, antilarval agents, mosquito repellents, etc.
13. Health Communication: Audio / Video podcasts, Images, Power Point Slides, Short Films, etc. in regional language(s) for mass communication / education / Awareness on 5 different communicable diseases, their signs and symptoms, and prevention.
14. Water purification techniques, use of water testing kit, calculation of Content/percentage of KMnO4, bleaching powder to be used for wells/tanks
15. Counselling children on junk foods, balanced diets – using Information, Education and Communication (IEC), counselling, etc. (Simulation  Experiments).
16. Preparation of various charts on nutrition, sources of various nutrients from Locally available foods, calculation of caloric needs of different groups (e.g.

child, mother, sedentary lifestyle, etc.). Chart of glycemic index of foods.

17. Tobacco cessation, counselling, identifying various tobacco containing products through charts/pictures

Assignment

The students shall be asked to submit the written assignments on the following topics (One assignment per student per sessional period. i.e., a minimum of THREE assignments per student)

1. An overview of Women’s Health Issues
2. Study the labels of various packed foods to understand their nutritional contents
3. Breastfeeding counselling, guidance – using Information, Education and Communication (IEC)
4. Information about the organizations working on de-addiction services in the region (city / district, etc.)
5. Role of a pharmacist in disaster management – A case study
6. Overview on the National Tuberculosis Elimination Programme (NTEP)
7. Drug disposal systems in the country, at industry level and citizen level
8. Various Prebiotics or Probiotics (dietary and market products)
9. Emergency preparedness: Study of local Government structure with respect to Fire, Police departments, health department
10. Prepare poster/presentation for general public on any one of the Health Days. e.g. Day, AIDS Day, Handwashing Day, ORS day, World Diabetes Day, World Heart Day, etc.
11. List of home medicines, their storage, safe handling, and disposal of unused medicines
12. Responsible Use of Medicines: From Purchase to Disposal
13. Collection of newspaper clips (minimum 5) relevant to any one topic and its submission in an organized form with collective summary based on the news items
14. Read a minimum of one article relevant to any theory topic, from Pharma

/Science/ or other Periodicals and prepare summary of it for submission 15. Potential roles of pharmacists in rural India  

Field Visits

The students shall be taken in groups to visit any THREE of the following facilities to witness and understand the activities of such centres/facilities from the perspectives of the topics discussed in theory and/or practical courses. Individual reports from each student on their learning experience from the field visits shall be submitted.

1. Garbage Treatment Plant
2. Sewage Treatment Plant
3. Bio-medical Waste Treatment Plant
4. Effluent Treatment Plant
5. Water purification plant
6. Orphanage / Elderly-Care-Home / School and or Hostel/Home for persons with disabilities
7. Primary health care centre

8. ER-2020 D.Pharm Syllabus – Part II

PHARMACOLOGY – THEORY

Course Code: ER20-21T                                                    75 Hours (3 Hours/week)

Scope: This course provides basic knowledge about different classes of drugs available for the pharmacotherapy of common diseases. The indications for use, dosage regimen, routes of administration, pharmacokinetics, pharmacodynamics, and contraindications of the drugs discussed in this course are vital for successful professional practice.

Course Objectives: This course will discuss the following: 

1. General concepts of pharmacology including pharmacokinetics, pharmacodynamics, routes of administration, etc.
2. Pharmacological classification and indications of drugs
3. Dosage regimen, mechanisms of action, contraindications of drugs 4. Common adverse effects of drugs

Course Outcomes: Upon successful completion of this course, the students will be able to

1. Describe the basic concepts of pharmacokinetics and pharmacodynamics2. Enlist the various classes and drugs of choices for any given disease condition
2. Advice the dosage regimen, route of administration and contraindications for a given drug
3. Describe the common adverse drug reactions

PHARMACOLOGY – PRACTICAL

Course Code: ER20-21P                                                    50 Hours (2 Hours/week)

Scope: This course provides the basic understanding about the uses, mechanisms of actions, dose dependent responses of drugs in simulated virtual animal models and experimental conditions. 

Course Objectives: This course will demonstrate / provide hands-on experience in the virtual platform using appropriate software on the following 

1. Study of pharmacological effects of drugs like local anaesthetics, mydriatic and mitotic on rabbit eye
2. Screening the effects of various drugs acting in the central nervous system
3. Study of drug effects on isolated organs / tissues
4. Study of pyrogen testing on rabbit

Course Outcomes: Upon successful completion of this course, the students will be able to 

1. Study and report the local anaesthetic, mydriatic and mitotic effects of the given drug on the rabbit eye
2. Choose appropriate animal experiment model to study the effects of the given drugs acting on the central nervous system and submit the report
3. Perform the effects of given tissues (simulated) on isolated organs / tissues and interpret the results
4. Interpret the dose dependent responses of drugs in various animal experiment models

Practicals

Introduction to the following topics pertaining to the experimental pharmacology have to be discussed and documented in the practical manuals.

1. Introduction to experimental pharmacology
2. Study of laboratory animals

                        (a) Mice; (b) Rats; (c) Guinea pigs; (d) Rabbits

3. Commonly used instruments in experimental pharmacology
4. Different routes of administration of drugs in animals
5. Types of pre-clinical experiments: In-Vivo, In-Vitro, Ex-Vivo, etc. Techniques of blood collection from animals

Experiments

Note: Animals shall not be used for doing / demonstrating any of the experiments given. The given experiments shall be carried– out / demonstrated as the case may be, ONLY with the use of software program(s) such as ‘Ex Pharm’ or any other suitable software 

1. Study of local anaesthetics on rabbit eye
2. Study of Mydriatic effect on rabbit eye
3. Study of Miotic effect on rabbit eye
4. Effect of analgesics using Analgesiometer
5. Study of analgesic activity by writhing test
6. Screening of anti-convulsant using Electro Convulsiometer
7. Screening of Muscle relaxants using Rota-Rod apparatus
8. Screening of CNS stimulants and depressants using Actophotometer
9. Study of anxiolytic activity using elevated plus maze method
10. Study of effect of drugs (any 2) on isolated heart
11. Effect of drugs on ciliary motility on frog’s buccal cavity
12. Pyrogen testing by rabbit method

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. Introduction to Allergy Testing
2. Introduction to Toxicity Studies
3. Drug Facts Labels of US FDA
4. Pre-clinical studies in new drug development Medicines and meals: Before or After food
5. Pre-clinical studies in new drug development
6. Drugs available as paediatric formulations
7. Drug information apps

COMMUNITY PHARMACY AND MANAGEMENT – THEORY

Course Code: ER20-22T                                                    75 Hours (3 Hours/week)

Scope: The course is designed to impart basic knowledge and skills to provide various pharmaceutical care services to patients and general practitioners in the community setup.

Course Objectives: This course will discuss the following: 

1. Establishing and running a community pharmacy and its legal requirements
2. Professional aspects of handling and filling prescriptions
3. Patient counselling on diseases, prescription and or non-prescription medicines
4. Scope for performing basic health screening in community pharmacy settings

Course Outcomes: Upon successful completion of this course, the students will be able to 

1. Describe the establishment, legal requirements, and effective administration of a community pharmacy
2. Professionally handle prescriptions and dispense medications
3. Counsel patients about the disease, prescription and or non-prescription medicines
4. Perform basic health screening on patients and interpret the reports in the community pharmacy settings

COMMUNITY PHARMACY AND MANAGEMENT – PRACTICAL

Course Code: ER20-22P                                                    75 Hours (3 Hours/week)

Scope: The course is designed to train the students and improve professional skills to provide various pharmaceutical care services in community pharmacy.

Course Objectives: This course will train the students in the following 

1. Professional handling and filling prescriptions
2. Patient counselling on diseases and minor ailments
3. Patient counselling on prescription and / or non-prescription medicines
4. Preparation of counselling materials such as patient information leaflets 5. Performing basic health screening tests

Course Outcomes: Upon successful completion of this course, the students will be able to 

1. Handle and fill prescriptions in a professional manner
2. Counsel patients on various diseases and minor ailments
3. Counsel patients on prescription and or non-prescription medicines
4. Design and prepare patient information leaflets
5. Perform basic health screening tests

Practicals

Note: The following practicals shall be carried out in the model community pharmacy with appropriate simulated scenarios and materials. Students shall be trained through role plays wherever necessary. The activities of the students shall be assessed / evaluated using a structured objective assessment form. 

1. Handling of prescriptions with professional standards, reviewing prescriptions, checking for legal compliance and completeness (minimum 5)
2. Identification of drug-drug interactions in the prescription and follow-up actions (minimum 2)
3. Preparation of dispensing labels and auxiliary labels for the prescribed medications (minimum 5)
4. Providing the following health screening services for monitoring patients / detecting new patients (one experiment for each activity)

Blood Pressure Recording, Capillary Blood Glucose Monitoring, Lung function assessment using Peak Flow Meter and incentive spirometer, recording capillary oxygen level using Pulse Oximeter, BMI measurement

5. Providing counselling to simulated patients for the following chronic diseases / disorders including education on the use of devices such as insulin pen, inhalers, spacers, nebulizers, etc. where appropriate (one experiment for each disease)

                             Type      2      Diabetes      Mellitus,      Primary                  Hypertension,       Asthma,

Hyperlipidaemia, Rheumatoid Arthritis 

6. Providing counselling to simulated patients for the following minor ailments (any three)

Headache, GI disturbances (Nausea, Vomiting, Dyspepsia, diarrhoea, constipation), Worm infestations, Pyrexia, Upper Respiratory Tract infections, Skin infections, Oral and dental disorders.

• Appropriate handling of dummy dosage forms with correct administration techniques – oral liquids with measuring cup/cap/dropper, Eye Drops, Inhalers, Nasal drops, Insulin pen, nebulizers, different types of tablets, patches, enemas, suppositories
• Use of Community Pharmacy Software and digital health tools

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. SOPs for various activities in Community Pharmacy (as discussed in Theory and Practical)
2. List out the various abbreviations, short forms used in prescriptions and their interpretation
3. Patient Information Leaflet for a given chronic disease / disorder
4. Patient Information Leaflet for prescription / non-prescription medicines
5. Preparation of window / shelf display materials for the model community pharmacy
6. Overview of Software available for retail pharmacy management including billing, inventory, etc.
7. Dosage / Medication Reminder Aids
8. Overview on the operations and marketing strategies of various online pharmacies
9. Overview on the common fixed dose combinations
10. Overview on the medications requiring special storage conditions
11. Role of Community Pharmacists in preventing Antimicrobial Resistance
12. Jan Aushadhi and other Generic Medicine initiatives in India
13. Global Overview of Online Pharmacies
14. Community Pharmacy Practice Standards: Global Vs. Indian Scenario 15. Overview of pharmacy associations in India

Field Visit

The students shall be taken in groups to visit community pharmacies and medicine distributors to understand and witness the professional activities of the community pharmacists, and supply chain logistics. Individual reports from each student on their learning experience from the field visit shall be submitted.

BIOCHEMISTRY & CLINICAL PATHOLOGY – THEORY

Course Code: ER20-23T                                                    75 Hours (3 Hours/week)

Scope: This course is designed to impart basic knowledge on the study of structure and functions of biomolecules and the chemical processes associated with living cells in normal and abnormal states.  The course also emphasizes on the clinical pathology of blood and urine.

Course Objectives: This course will discuss the following at the fundamental level 

1. Structure and functions of biomolecules
2. Catalytic activity, diagnostic and therapeutic importance of enzymes
3. Metabolic pathways of biomolecules in health and illness (metabolic disorders)
4. 
   Biochemical principles of organ function tests and their clinical significance
5. Qualitative and quantitative determination of biomolecules / metabolites in the biological sample
6. Clinical pathology of blood and urine

Course Outcomes: Upon successful completion of this course, the students will be able to 

1. Describe the functions of biomolecules
2. Discuss the various functions of enzymes in the human system
3. Explain the metabolic pathways of biomolecules in both physiological and pathological conditions
4. Describe the principles of organ function tests and their clinical significances
5. Determine the biomolecules / metabolites in the given biological samples, both qualitatively and quantitatively
6. Describe the clinical pathology of blood and urine

BIOCHEMISTRY & CLINICAL PATHOLOGY – PRACTICAL

Course Code: ER20-23P                                                    50 Hours (2 Hours/week)

Scope: This course is designed to train the students in the qualitative testing of various biomolecules and testing of biological samples for determination of normal and abnormal constituents 

Course Objectives: This course will train and provide hands-on experiences on the following

1. Qualitative determination of biomolecules / metabolites in simulated biological samples
2. Determination of normal and abnormal constituents of simulated blood and urine samples

Course Outcomes: Upon successful completion of this course, the students will be able to 

1. Qualitatively determine the biomolecules / metabolites in the given biological samples
2. Determine the normal and abnormal constituents in blood and urine samples and interpret the results of such testing

Practicals

1. Qualitative analysis of carbohydrates (4 experiments)
2. Qualitative analysis of Proteins and amino acids (4 experiments)
3. Qualitative analysis of lipids (2 experiments)
4. Qualitative analysis of urine for normal and abnormal constituents (4 experiments)
5. Determination of constituents of urine (glucose, creatinine, chlorides)  (2 experiments)

6. Determination of constituents of blood/serum (simulated) (Creatine, glucose, cholesterol, Calcium, Urea, SGOT/SGPT) (5 experiments)
7. Study the hydrolysis of starch from acid and salivary amylase enzyme (1 experiment)

Assignments 

The students shall be asked to submit written assignments on Various Pathology Lab Reports (One assignment per student per sessional period. i.e., a minimum of THREE assignments per student)

PHARMACOTHERAPEUTICS – THEORY

Course Code: ER20-24T                                                    75 Hours (3 Hours/week)

Scope: This course is designed to impart basic knowledge on etiopathogenesis of common diseases and their management along with quality use of medicines.  

Course Objectives: This course will discuss about 

1. Etiopathogenesis of selected common diseases and evidence-based medicine therapy
2. 
   Importance of individualized therapeutic plans based on diagnosis
3. Basic methods for assessing the clinical outcomes of drug therapy

Course Outcomes: Upon successful completion of this course, the students will be able to 

1. Help assessing the subjective and objective parameters of patients in common disease conditions
2. Assist other healthcare providers to analyse drug related problems and provide therapeutic interventions
3. Participate in planning the rational medicine therapy for common diseases 4. Design and deliver discharge counselling for patients

PHARMACOTHERAPEUTICS – PRACTICAL

Course Code: ER20-24P                                                    25 Hours (1 Hour/week)

Scope: This course is designed to train the students in the basic skills required to support the pharmaceutical care services for selected common disease conditions.   

Course Objectives: This course will train the students on

1. How to prepare a SOAP (Subjective, Objective, Assessment and Plan) note for clinical cases of selected common diseases
2. Patient counselling techniques/methods for common disease conditions

Course Outcomes: Upon successful completion of this course, the students will be able to 

1. Write SOAP (Subjective, Objective, Assessment and Plan) notes for the given clinical cases of selected common diseases
2. Counsel the patients about the disease conditions, uses of drugs, methods of handling and administration of drugs, life-style modifications, and monitoring parameters.

Practicals

1. Preparation and discussion of SOAP (Subjective, Objective, Assessment and Plan) notes for at least SIX clinical cases (real / hypothetical) of the following disease conditions.
   1. Hypertension
   2. Angina Pectoris
   3. Myocardial Infarction
   4. Hyperlipidaemia
   5. Rheumatoid arthritis
   6. Asthma
   7. COPD
   8. Diabetes
   9. Epilepsy
   10. Stroke
   11. Depression
   12. Tuberculosis
   13. Anaemia (any one type as covered in theory)
   14. Viral infection (any one type as covered in theory)
   15. Dermatological conditions (any one condition as covered in theory)

1. Patient counselling exercises using role plays based on the real / hypothetical clinical case scenarios. The students are expected to provide counselling on disease condition, medications, life-style modifications, monitoring parameters, etc. and the same shall be documented. (Minimum 5 cases)

• Simulated cases to enable dose calculation of selected drugs in paediatrics, and geriatrics under various pathological conditions. (Minimum 4 cases)

HOSPITAL AND CLINICAL PHARMACY – THEORY

Course Code: ER20-25T                                                    75 Hours (3 Hours/week)

Scope: This course is designed to impart fundamental knowledge and professional skills required for facilitating various hospital and clinical pharmacy services. 

Course Objectives: This course will discuss and train the students in the following 

1. Hospital and Hospital Pharmacy organization and set-ups
2. Basics of hospital pharmacy services including the procurement, supply chain, storage of medicines and medical supplies
3. 
   Basics of clinical pharmacy including introduction to comprehensive pharmaceutical care services
4. Basic interpretations of common laboratory results used in clinical diagnosis towards optimizing the drug therapy

Course Outcomes: Upon successful completion of this course, the students will be able to

1. Explain about the basic concepts of hospital pharmacy administration
2. Manage the supply chain and distribution of medicines within the hospital settings
3. Assist the other healthcare providers in monitoring drug therapy and address drug related problems
4. Interpret common lab investigation reports for optimizing drug therapy

HOSPITAL AND CLINICAL PHARMACY – PRACTICAL

Course Code: ER20-25P                                                       25 Hours (1 Hour / Week)

Scope: This course is designed to train the students to assist other healthcare providers in the basic services of hospital and clinical pharmacy. 

Course Objectives: This course will train the students with hands-on experiences, simulated clinical case studies in the following: 

1. Methods to systematically approach and respond to drug information queries
2. How to interpret common laboratory reports to understand the need for optimizing  dosage regimens 
3. How to report suspected adverse drug reactions to the concerned authorities
4. Uses and methods of handling various medical/surgical aids and devices How to interpret drug-drug interactions in the treatment of common diseases. 

Course Outcomes: Upon completion of the course, the students will be able to

1. Professionally handle and answer the drug information queries
2. Interpret the common laboratory reports
3. Report suspected adverse drug reactions using standard procedures
4. Understand the uses and methods of handling various medical/surgical aids and devices
5. Interpret and report the drug-drug interactions in common diseases for optimizing the drug therapy

Note: Few of the experiments of Hospital and Clinical Pharmacy practical course listed here require adequate numbers of desktop computers with internet connectivity, adequate drug information resources including reference books, different types of surgical dressings and other medical devices and accessories. Various charts, models, exhibits pertaining to the experiments shall also be displayed in the laboratory.

Practicals

1. Systematic approach to drug information queries using primary / secondary / tertiary resources of information (2 cases)
2. Interpretation of laboratory reports to optimize the drug therapy in a given clinical case (2 cases)
3. Filling up IPC’s ADR Reporting Form and perform causality assessments using various scales (2 cases)
4. Demonstration / simulated / hands-on experience on the identification, types, use / application /administration of
   • Orthopaedic and Surgical Aids such as knee cap, LS belts, abdominal belt, walker, walking sticks, etc.
   • Different types of bandages such as sterile gauze, cotton, crepe bandages, etc.
   • Needles, syringes, catheters, IV set, urine bag, RYLE’s tube, urine pots, colostomy bags, oxygen masks, etc.
5. Case studies on drug-drug interactions (any 2 cases)
6. Wound dressing (simulated cases and role play –minimum 2 cases)
7. Vaccination and injection techniques (IV, IM, SC) using mannequins (5 activities) Use of Hospital Pharmacy Software and various digital health tools  

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. Typical profile of a drug to be included in the hospital formulary
2. Brief layout and various services of the Central Sterile Supplies Department (CSSD)
3. Various types of sterilizers and sterilization techniques used in hospitals
4. Fumigation and pesticide control in hospitals
5. Role of Pharmacists in Transition of Care: Discharge cards, post hospitalization care, medicine reconciliation activities in developed countries
6. Total parenteral nutrition and IV admixtures and their compatibility issues
7. Concept of electronic health records
8. Invasive and Non-invasive diagnostic tests – HRCT, MRI, Sonography, 2D ECHO, X-rays, Mammography, ECG, EMG, EEG
9. Home Diagnostic Kits – Pregnancy Test, COVID testing etc
10. Measures to be taken in hospitals to minimize Antimicrobial Resistance
11. Role and responsibilities of a pharmacist in public hospital in rural parts of the country
12. Safe waste disposal of hospital waste

Field Visit

The students shall be taken in groups to visit a Government / private healthcare facility to understand and witness the various hospital and clinical pharmacy services provided. Individual reports from each student on their learning experience from the field visit shall be submitted.

PHARMACY LAW AND ETHICS – THEORY

Course Code: ER20-26T                                                 75 Hours (3 Hours/week)

Scope: This course is designed to impart basic knowledge on several important legislations related to the profession of pharmacy in India

Course Objectives: This course will discuss the following 

1. General perspectives, history, evolution of pharmacy law in India
2. Act and Rules regulating the profession and practice of pharmacy in India
3. Important code of ethical guidelines pertaining to various practice standards 4. Brief introduction to the patent laws and their applications in pharmacy

Course Outcomes: Upon successful completion of this course, the students will be able to

1. Describe the history and evolution of pharmacy law in India
2. Interpret the act and rules regulating the profession and practice of pharmacy in India
3. Discuss the various codes of ethics related to practice standards in pharmacy
4. Interpret the fundamentals of patent laws from the perspectives of pharmacy

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

Appendix – 1

A typical format for the assessment of an Assignment

Name of the College:

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

5 – Excellent; 4 – Very Good; 3 – Good; 2 – Satisfactory; 1 – Poor

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:

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. 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

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.

NOTE: Adequate number of glassware commonly used in the laboratory should be provided in each laboratory and department

2. Pharmaceutical Chemistry/ Biochemistry, Clinical Pathology

NOTE: Adequate number of glassware commonly used in the laboratory should be provided in each laboratory and department

3. Pharmaceutics

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

NOTE: Adequate number of glassware commonly used in the laboratory should be provided in each laboratory and department

4. Hospital and Clinical Pharmacy Lab

NOTE: Adequate number of glassware commonly used in the laboratory should be provided in each laboratory and department

5. Model Pharmacy

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                   
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. 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 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,         S.     and      Bhandarkar, S.D.     Pharmacology             and Pharmacotherapeutics
2. Suresh, A Text Book of Pharmacology
3. Derasari and Gandhi’s Elements of Pharmacology
4. K. Kulkarni, Practical Pharmacology and Clinical Pharmacy
5. 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, ipapharma.org

/publications

10. Community Pharmacy Practice around the Globe: Part One: 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