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HomeChapter VI

EDUCATIONAL REGULATIONS


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PHARMACOLOGY
Practical (50 hours)


The first six of the following experiments will be done by the students while the remaining will be demonstrated by the teacher.

1.  Effect of K+, Ca+, acetycholine and adrenaline on frog's heart.
2.  Effect of acetylcholine on rectus abdominis muscle of Frog and guinea pig ileum.
3.  Effect of spasmogens and relaxants on rabbits intestine.
4.  Effect of local anaesthetics on rabbit cornea.
5.  Effect of mydriatics and miotics on rabbits eye.
6.  To study the action of strychnine on frog.
7.  Effect of digitalis on frog's heart.
8.  Effect of hypnotics in mice.
9.  Effect of convulsants and anti convulsant in mice or rats.
10.  Test for pyrogen.
11.  Taming and hypnosis potentiating effect of chlorpromazine in mice / rates.
12.  Effect of diphenhydramine in experimentally produced asthma in guinea pigs.
   
  2.3.  Pharmaceuticals Jurisprudence
Theory (50 hours)
1. Origin and nature of Pharmaceutical legislation in India, its scope and objectives. Evolution of the “Concept of Pharmacy” as an integral part of the Health Care System.
2. Principles and significance of Professional Ethics. Critical study of the code of Pharmaceutical Ethics drafted by Pharmacy Council in India.
3. Pharmacy Act, 1948 - The General study of the Pharmsacy act with special reference to Education Regulations, working of State and Central Councils, constitution of these councils and functions, Registration procedures under the Act.
4. The Drugs and Cosmetics Act, 1940 - General study of the Drugs and Cosmetics Act and the Rules there under. Definitions and salient features related to retail and wholesale distribution of drugs.  The powers of Inspectors, the sampling procedures and the procedure and formalities in obtaining licenses under the rule.  Facilities to be provided for running a Pharmacy effectively.  General study of the Schedules with special reference of schedules C, C1, F, G, J, H and P and X and salient features of labeling and storage condition of drugs.
5. The Drugs and Magic Remedies (Objectionable Advertisement) act, 1954 - General study of the Act Objectives, special reference to be laid on Advertisements. Magic remedies and objectionable and permitted advertisements - disease which cannot be claimed to be cured
6. Narcotic Drugs and Psychotropic Substances Act, 1985 - A brief study of the act with special reference to its objectives, offences and punishments.
7.

Brief introduction to the study of the following acts.  

8.

Surgical dressing like cotton, gauze, bandages and adhesive tapes including their pharmacopoeial tests for quality.  Other hospital supply e.g. I.V. sets B. G. sets, Ryals tubes, Catheters, Syringes etc.

9. Application of computer in maintenance of records, inventory control, medication monitoring, drug information and data storage and retrieval in hospital and retail pharmacy establishments.
   
 

Part - II :  Clinical Pharmacy

1.

Introduction to Clinical Pharmacy Practice - Definition, scope.

2. Modern dispensing aspects - Pharmacist and Patient counselling and advice for the use of common drugs, medication history.
3. Common daily terminology used in the Practice of Medicine.
4. Disease, manifestation and pathophysiology including salient symptoms to understand the disease like Tuberculosis, Hepatitis, Rheumatoid Arthritis, Cardiovascular diseases, Epilepsy, Diabetes, Peptic Ulcer, Hypertension.
5.

Physiological parameters with their significance.

6. Drug Interactions:
 

(a) Definition and Introduction.

(b) Mechanism of Drug Interaction.

(c) Drug - drug interaction with reference to analgesics, diuretics, cardiovascular drugs, Gastro - intestinal agents, Vitamins and Hypoglycemic agents.

(d) Drug - food interaction.

7.

Adverse Drug Reactions:

 

(a) Definition and Significance.

(b) Drug - induced diseases and Teratogenicity.

8.

Drugs in Clinical Toxicity - Introduction, general treatment of poisoning, systematic antidotes. Treatment of insecticides poisoning, heavy metal poison, Narcotic drugs, Barbiturate, Organophosphorus poisons.

9. Drug dependences, Drug abuse, addictive drugs and their treatment, complications.
10. Bio-availability of drugs, including factors affecting it.
 

Books recommended (latest editors)  

1.     Remington's Pharmaceutical Sciences.

2.     Martindale The Extra Pharmacopoeia.

Practical (50 hours)  

1.     Preparation of transfusion fluids.

2.     Testing of raw materials used in (1)

3.     Evaluation of surgical dressings.

4.     Sterilization of surgical instruments, glassware and other hospital supplies.

5.     Handling and use of data processing equipments.

   
 

Appendix - B
(See Regulation - 9)
Conditions to be fulfilled by the Academic Training Institution

  Any authority in India applying to the Pharmacy Council of India for approval of courses study for Pharmacists under sub-section (1) of section 12 of the Pharmacy Act, 1948 shall provide.
  (A) Accommodation

Suitable and sufficient accommodation with adequate ventilation lighting and other hygienic conditions should be provided to the rooms for Principal / Head of the department, office, class rooms, library, staff, staff common room, students common room, museum, stores etc.
 

At least four laboratories specified below should be provided for:

1. Pharmaceutics Lab

2. Pharm. Chemistry Lab.

3. Physiology, Pharmacology and Pharmacognosy Lab.

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

  In addition to the laboratories, balance room, aseptic room or cabinet, animal house, a machine room  is also to be provided for.
  Floor area of the laboratory should not be less than 30 square feet per students required to work in the laboratory at any given time subject to a minimum of 500 square feet.
  Laboratories should be fitted and constructed in a manner that these can be kept reasonably clean.  Gas and water fittings, shelves, fume cupboards be provided wherever necessary.
 
(B) Staff
Principal / Director / Head of the department may be engaged in teaching up to Eight hours a week, and the work load of other teaching staff should not be more than 16 hours per week.
Staff student ratio should not exceed 1: 60 in theory classes and 1: 20 in practical classes.  There should be two teachers for a batch of 30 students in practicals.
According to the above norms, the following staff is required for an intake of 60 students:
Professor / Reader – One (Professor may also work as Principal or Head of the department, as the case may be)
Senior Lecturers / Lecturers -  Seven
The minimum qualifications of The Principal / Director / Head of the Institution / Department and the teachers be as given below:
 

Principal / Director / Head of  Institution / Department (Professor / Reader) -  Basic Degree in pharmacy and Post - Graduate in any discipline of Pharmaceutical Sciences with not less than 5 years experience in teaching.
  Lecturer -  M.Pharm or B.Pharm with 3 years teaching / Professional experience.5[Lecturer (1) Anatomy & Physiology (2) Biochemistry & Clinical pathology M.Pharm or B.Pharm with 3 years teaching / professional experience or M.B.B.S.

The pay scale of teaching staff shall be as prescribed by the All India Council for Technical Education for teaching staff of Polytechnics fro m time to time.”  

Provided that the above qualifications shall not apply to the incumbents appointed under the repealed Education Regulations.  

Non - Teaching Staff

List of Non - Teaching staff for the D. Pharm course  

 

1

Laboratory Technician (Qualification-Diploma in Pharmacy)

2

2

Laboratory Attendant

4

3

Office Superintendent

 

4

Clerk - cum – Accountant

1

5

Store – Keeper

1

6

Typist

1

7

Assistant Librarian

1

8

Peons

2

9

Cleaners / Sweepers

4

10

Gardener

1

1. List of Equipment for pharmaceutics Laboratory
 

A.  Special equipment and instruments

No. required for 60 students

No.  required for 120 students

1

2

3

1. Continuous hot extraction equipment

5

10

2. Conical percolators

20

40

3. Tincture Press

1

1

4. Hand grinding mill

5

5

Disintegrator

1

1

6. Ball mill

1

1

7. Hand operated tablet machines

3

3

8. Tablet coating pan unit with hot air blower laboratory size

1

1

9. Polishing Pan Laboratory size

1

1

10. Tablet Hardness Tester
(Monsanto Type)

3

3

11. Tablet Hardness tester (Pfizer type)

3

3

12. Disintegration Test Unit

2

2

13. Dissolution Rate Test apparatus

1

1

14. Granulating sieve sets

20

40

15. Tablet counter small size

5

5

16. Friability Tester

1

1

17. Collapsible Tube filling and sealing equipments

2

2

18. Capsule filling machine (Laboratory size)

2

2

19. Prescription balance

40

60

20. Balance Torsion type with removable glass pan sensitivity, 30 mgm

5

5

21. Distillation equipment for distilled water

2

2

22. Water deionization Unit

1

2

23. All glass distillation Unit for making for injection

2

4

24. Ampoule washing machine

1

1

25. Ampoule filling and sealing machine

1

1

26. Sintered glass filters for (4 different grades) Bacteria proof filtration

20 each grades

20 each grades

27. Millipore filters 3 grades

2 each grades

2 each grades

28. Autoclaves

2

2

29. Pressure cookers

5

10

30. Hot Air sterilizer

2

3

31. Incubators

2

2

32. Aseptic cabinet

2

3

33. Rabbit cages and holders

10

10

34. Ampoule clarity Test equipments

2

2

35. Blender

2

3

36. Sieves Set (Pharmacopoeial standard)

10

10

37. Laboratory centrifuge

2

3

38. Ointment slabs

40

40

39. Ointment spatulas

40

40

40. Pestle and mortar (Porcelain)

40

40

41. Pestle and mortar (glass)

10

10

42. Suppository moulds of 3 size

20 each

30 each

43. Refrigerator

1

1

B. General glassware

Adequate

Adequate

C. Chemicals, appliances and laboratory facilities

Adequate

Adequate

2.

List of equipment for Pharmaceutical Chemistry Laboratory. 

 

A.  Special equipment and instruments

No. required for 60 students

No. required for 120 students

 

1

2

3

1

Refractometer

1

1

2

Polarimeter

1

1

3

Photo electric Colorimeter

1

1

4

PH meter

2

2

5

Atomic model sets

10

10

6

Analytical balances and weight box sets

10

15

7

Physical balances & weight box sets

5

5

8

Platform balance

2

2

9

Periodic Table chart

2

2

 

B.  General Glassware

Adequate

Adequate

 

C.  Miscellaneous appliances, chemicals and laboratory facilities

Adequate

Adequate

3.

List of Equipment for physiology / Pharmacology Laboratory

 

A.  Special Equipment and Instruments

Nos. required for 60 students

Nos. required for 120 students

 

1

2

3

1

Haemoglobinometer

20

30

2

Haemocytometer

10

20

3

Student's Organ bath

5

10

4

Sherrington rotating drum

5

10

5

Frog Boards

10

20

6

Trays (dissecting)

10

20

7

Frontal writing levers

15

30

8

Aeration Tube

20

40

9

Tele thermometer

1

2

10

Pole Climbing apparatus

1

2

11

Histamine chamber

1

2

12

Simple levers

15

30

13

Starling heart levers

10

20

14

ECG machine

-

-

15

Aerators

5

10

16

Histological slides

25

25

17

Sphygmomanometer (B. P. apparatus)

5

5

18

Stethoscope

5

5

19

First aid equipments

5 sets

5 sets

20

Contraceptive

5 sets

5 sets

21

Dissecting (Surgical) instruments

20 sets

30 sets

22

Operation table (small)

2

2

23

Balance for weighing small animals

1

2

24

Kymograph paper

Adequate

Adequate

25

Activity cage (actophotometer)

1

1

26

Analgesiometer

1

1

27

Thermometers

20

20

28

Distilled water stills

2

2

29

Plastic animal cages

10

10

30

Double unit organ bath with thermostat

1

1

31

Refrigerator

1

1

32

Single pan balance

1

1

33

Charts

Adequate

Adequate

34

Human Skeleton

1

1

35

Anatomical Specimen (Heart, brain, eye, ear, reproductive system etc.)

1 set

1 set

36

Electro - convulsometer

1

1

37

Stop watches

10

10

38

Clamp, Bo ssheads, screw clips

Adequate

Adequate

39

Symes' Cannula

20

40

 

B. General Glassware

Adequate

Adequate

 

C. Chemical and Misc. Laboratory apparatus and appliances(needles, thread, Plasticin, tubing, burners, polythene tubes, syringes etc)

Adequate

Adequate

4.

List of Equipment for Biochemistry and clinical Pathology Laboratory

 

A.  Special Equipment and Instruments

Nos. required for 60 students

Nos. required for 120 students

 

1

2

3

1

Colorimeter

2

2

2

Microscopes

20

20

3

Permanent slides (Skin, Kidney, Pancreas, Smooth - muscle, Liver etc.)

Adequate

Adequate

4

Watch glasses

25

50

5

Centrifuge

1

1

6

Microscope with oil immersion

5

5

 

B.  General Glassware

Adequate

Adequate

 

C.  Biochemical reagents for analysis of normal and pathological constituents of urine and blood and facilities.

Adequate

Adequate

5. List of Equipment for Pharmacognosy Laboratory .
 
 

A.  Special Equipment and Instruments

Nos. required for 60 students

Nos. required for 120 students

 

1

2

3

1

Dissecting Microscope

20

20

2

Charts (different types)

100

100

3

Models (Different types)

50

50

4

Permanent Slides

100

100

5

Slides and cover slips

Adequate

Adequate

 

B.  General glassware

Adequate

Adequate

 

C.  Miscellaneous appliances, Chemicals and laboratory facilities

Adequate

Adequate

6. List of Equipments for Hospital and Clinical Pharmacy Practicals
 
    Quantity

1

Water Still

1

2

Mixing Vat with stirrer

2

3

Filtration equipment

2

4

Filling Machine

1

5

Sealing machine

1

6

Autoclave sterilizer

1

7

Membrane filter

1 Unit

8

Sintered glass funnel with complete filtering assembly

10 Units

9

Small disposable membrane filters for IV admixture filtration

Adequate

10

Laminar air flow bench

1

11

Vacuum pump

1

12

Ovens

2

13

Surgical dressing

2

14

Incubator

1

15

Karl Fischer apparatus for moisture content determination

1

16

Flame photometer

1

17

PH meter

1

18

Dissolution apparatus

1

19

Disintegration test apparatus

1

20

Hardness tester

1

21

Centrifuge

1

22

Magnetic stirrer

1

23

Thermostatic bath

1

24

Experimental Animals

Adequate

 
 

7.General List of Equipment

Nos. required for 60 students

Nos. required for 120 students

 

1

2

3

1

Distilled water still

2

2

2

Vacuum pump

2

3

3

Refrigerator

1

2

4

General filling equipment for the museum

Adequate

Adequate

5

Compound microscopes

20

20

6

Oil immersion microscope

1

2

7

Over head projector

1

1

8

Slide cum strip projector

1

1

9

Projection screen

1

1

 
Museum

Every institution shall maintain a museum of crude drugs, harbarium sheets, botanical specimens of the drugs and plants mentioned in the course.  In addition, the following are recommended:-

1.   Coloured slides of medicinal plants:

2.   Display of popular patent medicines; and

3.   Containers of common usage in medicines.  

 
Library 

Every institution shall maintain a library which should contain books mentioned in the syllabus and also the current pharmaceutical journal.  There should be adequate place in the library for students and staff to refer books

  Note:  The above requirements are the minimum requirements and the Institutes and the Institute is free to provide more - physical and Teaching facility.
   
 

Appendix - C
(See regulation 18)

Conditions to be fulfilled by the Examining Authority

1.

The Examining Authority shall be either a statutory Indian University or a body constituted by the Central or State Government.  It shall ensure that discipline and decorum at the examination centres.

2. It shall permit the Inspector or Inspectors of the Pharmacy Council of India to visit and inspect the examinations.
3. It shall provide:-
 
      • (a)    adequate rooms with necessary furniture for holding written examinations;
      • (b)    well-equipped laboratories for holding practical examinations;
      • (c)    an adequate number of qualified and responsible examiners and staff to conduct and invigilate the examination; and
      • (d)    such other facilities as may be necessary for efficient and proper conduct of  examinations.
4. It shall, if so required by a candidate, furnish the statement of marks secured by a candidate in the examinations after payment of prescribed fee, if any, to the Examining Authority.
5. It shall appoint examiners whose qualifications should be similar to those of the teachers in the respective subjects as shown in Appendix-B.
6. In pursuance of sub - section (3) of section 12 of the Pharmacy Act, 1948, the Examining  
   Authority shall communicate to the Secretary, Pharmacy Council of India not less than six
   weeks in advance the dates fixed for examinations, the time - table for such examinations, so
   as to enable the Council to arrange for inspection of the examinations.
7. The Chairman and at least one expert member of Examining Committee of the Examining
  authority concerned with appointment of examiners and conduct of pharmacy examinations
  should be persons possessing Persons possessing Pharmacy qualifications.
 

Appendix - D
[See regulations 20 (3)]  

Conditions to be fulfilled by the Institution to be recognized for 
giving Practical Training

1. The Institution, where practical training is given to student pharmacists, shall from time to time, if required, furnish such information as may be needed by the Pharmacy Council of India about the staff, accommodation and equipment of the institution concerned and its working.  
2. The Institution shall permit the Inspectors of the Pharmacy Council of India to inspect the premises at any reasonable time while the work is proceeding therein.
3. The Institution shall entrust some member or members of its staff, who shall be registered pharmacist (s), to look after the student pharmacists.  Such members of the staff shall be responsible in this behalf to the Head of the Institution concerned. 
4. The Institution shall provide such opportunity, accommodation, apparatus, materials and books of reference as may be required to enable the student pharmacists to undergo the practical training properly.
5. The number of student pharmacists that may be taken in any hospital, pharmacy and chemist and druggist and a drugs manufacturer licensed under the Drugs and Cosmetics Rules, 1945 made under the Drug and Cosmetics Act 1940 shall not exceed two where there is one registered pharmacist engaged in the working in which the student pharmacist is undergoing practical training; where there is more than one registered pharmacist similarly engaged, the number shall not exceed one for each additional such registered pharmacist.
6.

The Institution wishing to be recognized under regulation 20 shall apply in writing to the Secretary, Pharmacy Council of India stating its desire, to be so recognized.

7.

Having satisfied that the institution shall follow the conditions laid down in these rules, the Pharmacy Council of India shall grant such recognition.

8. In the event of any question arising as to the interpretation or observance of these conditions the decision of the Pharmacy Council of India shall be final.
 

Appendix - E

[See regulations 21 (1)]
Practical Training Contract form for Pharmacists.

 
 

Section I

This form has been issued to -------------------(Name of the student pharmacist) son of / daughter of ------------------, residing at ------------------------, who has produced evidence before me that he / she is entitled to receive the Practical Training as set out in the Education Regulations framed under section 10 of the Pharmacy Act, 1948.

Date:                                                    The Head of the Academic Training

                                                                 Institution

Section II

I ---------------- accept (Name of the Student Pharmacist) ------------------(Name of the Apprentice Master) of------------------------(Name of the Institution)  

(Hospital or Pharmacy) as my Apprentice Master for the above training and agree to obey and respect him / her during the entire period of my training

                                                            ------------------ (Student Pharmacist)

Section III

I, ----------------------(Name of the Apprentice Master) accept--------------------- (Name of the student pharmacist) as a trainee and I agree to give him / her training facilities in my organization so that during his / her training he / she may acquire: -

1.   Working knowledge of keeping of records required by the various Acts affecting the profession of pharmacy; and

2.    Practical experience in -  

(a) the manipulation of pharmaceutical apparatus in common use;

(b) the reading, translation and copying of prescriptions including the checking of doses;

(c) the dispensing of prescriptions illustrating the commoner methods of administering medicaments; and

(d) the storage of drugs and medicinal preparations.  

I also agree that a Registered Pharmacist shall be assigned for his / her guidance.  

                                                                        (Apprentice Master)

                                                            (Name & address of the Institution)

Section IV

I certify that ---------------------- (Name of student pharmacists) has undergone -------------hours training spread over --------------- months in accordance with the details enumerated in Section III.

                                                                        --------------------------------------
                                    (Head of the Organization or Pharmaceutical Division.)

Section V

I certify that ------------------------(Name of student pharmacist) has completed in all respect his practical training under regulation 20 of the Education Regulations framed under section 10 of the Pharmacy Act, 1948.  He had his practical training in an Institution approved the Pharmacy Council of India.

Date:                                                                            --------------------
                                                                        (Head of the Academic Institution)

PHARMACY COUNCIL OF INDIA

New Delhi-110002, the 13th February 1996

No. [4-55/93/ (Part-I)/ PCI/9137-9652-In exercise of the powers conferred by Section 10 of the Pharmacy Act, 1948 ( 8 of 1948), the Pharmacy Council of India, with the approval of the Central Government, hereby makes the following regulations further to amend the Education Regulations,1991, namely:-

  1. (i) These regulations may be called the Education (Amendment) Regulations, 1996.

  (ii) They shall come into force on the date of their publication in the Official Gazzette.

  1. In the Education Regulations, 1991 (hereinafter referred to as the said regulations), in regulation 13 for sub-regulation (2), the following shall be substituted, namely:-

       “(2) A candidate who fails in theory or practical examination, shall reappear in such theory or
            practical paper(s) as the case may be “;  

  1. In the said regulations, in regulation 15, for the figures “50%”, wherever they occur, the figures “40%” shall be substituted.
  2. In the said regulations, in regulation 20,-
    1. (i)      in sub-regulation (1), item (iii) shall be omitted;
    2. (ii)     in sub-regulation (2) the words “ and Drugs manufacturing unit “ shall be omitted.
  1. In the said regulations, in Appendix-D, in paragraph 5, the words “and drugs manufacturer” shall be omitted.  

                                                                                                              R. S. THAKUR

                                                                                                                Acting Secy.


Chapter I  |  Chapter II  |  Chapter III  |  Chapter IV  |  Chapter V  |  Chapter VI