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23. |
Certificate of Diploma in Pharmacy: A certificate of Diploma in Pharmacy shall
be granted by the Examining Authority to a successful candidate on producing
certificate of having passed the Diploma in Pharmacy Part I and Part II and
satisfactory completion of practical training for Diploma in Pharmacy (Part -
III) |
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24. |
Miscellaneous: No course of training in pharmacy shall be considered for
approval under regulation 18 unless it satisfies all the conditions prescribed
under these regulations. |
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25. |
Repeal and Savings
(1) The Education Regulations, 1981 (hereinafter referred to as the said
regulations) published by the Pharmacy Council of India vide No. 14-55/79 Pt.
I/PCI/42353-4650 dated 8th July 1981 is hereby repealed.
(2) Notwithstanding such repeal, |
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(a) anything done or any action taken under the said
regulations shall be deemed to have been done or taken under the corresponding
provision of these regulations |
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(b) a person who was admitted as a student under the said regulation to the
course of training for Diploma in Pharmacy and who had not passed the
examination at the commencement of these regulations shall be required to pass
the examination in accordance with the provision of the said regulation as if
these regulations had not come into force: |
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Provided however, the Examining Authority in a particular State may fix a date
after
which the examinations under the said Regulations shall not be conducted. |
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Appendix - A
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Syllabus
Diploma in Pharmacy (Part - I)
1.1 Pharmaceutics – I
Theory (75 hours)
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1. |
Introduction of different dosage forms. Their classification with examples -
their relative applications. Familiarisation with new drug delivery systems. |
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2. |
Introduction to Pharmacopoeias with special reference to the Indian
Pharmacopoeia. |
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3. |
Metrology - Systems of weights and measures. Calculations including conversion
from one to another system. Percentage calculations and adjustments of
products. Use of alligation method in calculations, Isotonic solutions. |
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4. |
Packing of Pharmaceuticals - Desirable features of a container - types of
containers. Study of glass and plastics as materials for containers and rubber
as a material for closures - their merits and demerits. Introduction to aerosol
packaging. |
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5. |
Size reduction Objectives, and factors affecting size reduction, methods of size
reduction - Study of Hammer mill, Ball mill, Fluid Energy Mill and
Disintegrator. |
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6. |
Size separation - Size separation by sifting. Official Standard for powders.
Sedimentation methods of size separation. Construction and working of cyclone
separator. |
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7. |
Mixing and Homogenisation - Liquid mixing and powder mixing, Mixing of
semisolids, study of Silver son Mixer- Homogeniser, Planetary Mixer; Agitated
powder mixer; Triple Roller Mill; Propeller Mixer, Colloid Mill and Hand
Homogeniser. Double cone mixer. |
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8. |
Clarification and Filtration - Theory of filtration, Filter media; Filter aids
and selection of filters. Study of the following filtration equipments-Filter
Press, Sintered Filters, Filter Candles, Metafilter. |
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9. |
Extractions and Galenicals - (a) Study of percolation and maceration and their
modification, continuous hot extraction - Applications in the preparation of
tinctures and extracts. (b) Introduction to Ayurvedic dosage forms. |
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10. |
Heat processes Evaporation - Definition Factors affecting evaporation - Study of
evaporating still and Evaporating Pan. |
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11. |
Distillation - Simple distillation and Fractional distillation; Steam
distillation and vacuum distillation. Study of vacuum still, preparation of
Purified Water I.P and water for Injection I.P. Construction and working of the
still used for the same. |
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12 |
Introduction to drying processes - Study of Tray Dryers: Fluidized Bed Dryer,
Vacuum Dryer and Freeze Dryer. |
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13. |
Sterilization - Concept of sterilization and its differences from disinfection -
Thermal resistance of micro - organisms. Detailed study of the following
sterilization process. |
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a. |
Sterilization with moist heat, |
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b. |
Dry heat sterilization, |
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c. |
Sterilization by radiation, |
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d. |
Sterilization by filtration and |
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e. |
Gaseous sterilization |
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Aseptic techniques. Application of sterilization process in hospitals
particularly with reference to surgical dressings and intravenous fluids.
Precautions for safe and effective handling of sterilization equipment. |
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14. |
Processing of Tablets - Definition; Different types of compressed tablets and
their properties. Processes involved in the production of tablets; tablets
excipients; Defects in tablets. Evaluation of Tablets; Physical Standards
including Disintegration and Dissolution. Tablet coating - Sugar coating; film
coating, enteric coating and micro encapsulation (Tablet coating may be dealt in
an elementary manner.) |
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15. |
Processing of Capsules - Hard and soft gelating capsules; different sizes
capsules; filling of capsules; handling and storage of capsules, Special
applications of capsules. |
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16. |
Study of Immunological products like sera vaccines, toxoids & their
preparations. |
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Practical (100 hours) |
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Preparation (minimum number stated against each) of the following categories
illustrating different techniques involved. |
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a. |
a.
Aromatic Waters...................................................3 |
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b. |
Solutions..............................................................4 |
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c. |
Spirits..................................................................2 |
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d. |
Tinctures..............................................................4 |
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e. |
Extracts...............................................................2 |
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f. |
Creams...............................................................2 |
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g. |
Cosmetic Preparations..........................................3 |
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h. |
Capsules.............................................................2 |
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i. |
Tablets................................................................2 |
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j. |
Preparations involving sterilization.........................2 |
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k. |
Ophthalmic preparations.......................................2 |
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l. |
Preparations involving aseptic techniques...............2 |
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Books Recommended: (Latest editions) |
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1. |
Remington's Pharmaceutical Sciences. |
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2. |
The Extra Pharmacopoeia - Martindale. |
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1.2. Pharmaceutical Chemistry – I |
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Theory (75 hours) |
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1. |
General discussion on the following inorganic compounds including important
physical and chemical properties, medicinal and Pharmaceutical uses, storage
conditions and chemical incompatibility. |
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(A) Acids, bases and buffers Boric acid*, Hydrochloric acid, strong Ammonium
hydroxide, Calcium hydroxide, Sodium hydroxide and official buffers |
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(B) Antioxidants - Hypophosphorous acid, Sulphur dioxide, Sodium bisulphate,
Sodium metabisulphite, Sodium thiosulphate, Nitrogen and Sodium Nitrite. |
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(C) Gastrointestinal agents -
(i) Acidifying agents Dilute hydrochloric acid.
(ii) Antacids - Sodium bicarbonate, Aluminium hydroxide gel, Aluminium
Phosphate, Calcium carbonate,Magnesium trisilicate, Magnesium oxide,
Combinations of antacid preparations.
(iii) Protectives and Adsorbents - Bismuth sub carbonate and Kaolin.
(iv) Saline Cathartics - Sodium Potassium tartrate and Magnesium
sulphate. |
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(D) Topical Agents -
(i) Protectives-Talc, Zinc Oxide, Calamine, Zinc stearate, Titanium
dioxide, Silicon Polymers.
(ii) Antimicrobials and Astringents - Hydrogen peroxide*, Potassium
permanganate, Chlorinated lime, Iodine, Solutions of Iodine, Povidone - iodine,
Boric acid, Borax, Silver nitrate, Mild silver protein, Mercury, Yellow mercuric
oxide, Ammoniated mercury.
(iii) Sulphur and its compounds-Sublimed sulphur precipitated sulphur,
selenium sulphide.
(iv) Astringents: - Alum and Zine Suphate |
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(E) Dental Products-Sodium Fluoride, Stannous Fluoride, Calcium carbonate,
Sodium metaphosphate, Dicalcium phosphate, Strontium chloride, Zinc chloride. |
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(F) Inhalants - Oxygen, Carbon dioxide, Nitrous oxide. |
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(G) Respiratory stimulants - Ammonium Carbonate. |
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(H) Expectorants and Emetics - Ammonium Chloride*, Potassium iodide, Antimony
Potassium tartrate. |
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(I) Antidotes - Sodium nitrate. |
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2. |
Major Intra and Extra cellular electrolytes - |
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A) Electrolytes used for replacement therapy - Sodium chloride and its
preparations, Potassium
chloride and its preparations.
(B) Physiological acid - base balance and electrolytes used - Sodium acetate,
Potassium acetate, Sodium bicarbonate injection, Sodium citrate, Potassium
citrate, Sodium lactate injection, Ammonium chloride and its injection.
(C) Combination of oral electrolyte powders and solutions. |
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3. |
Inorganic Official compounds of Iron, Iodine and Calcium Ferrous Sulphate and
Calcium gluconate |
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4. |
Radio pharmaceuticals and Contrast media - Radio activity - Alpha, Beta and
Gamma Radiations, Biological effects of radiations, Measurement of radio
activity, G. M. Counter Radio isotopes their uses, storage and precautions with
special reference to the official preparations |
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Radio opaque Contrast media- Barium sulfate. |
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5. |
Quality control of Drugs and Pharmaceuticals. Importance of quality control,
significant errors, and methods used for quality control, sources of impurities
in Pharmaceuticals, Limit tests for Arsenic, Chloride, Sulphate, Iron and Heavy
metals. |
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6. |
Identification tests for cations and anions as per Indian Pharmacopoeia. |
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