Schedules from D & C Act, 1940 and MCQs for
RRB Pharmacist Recruitment Exam
KGMU Pharmacist Recruitment Exam
KSSSCI Pharmacist Recruitment Exam
MPESB Pharmacist Recruitment Exam
Drugs Inspector Exams
Drugs Controller Exams
GPAT
DPEE
D.Pharm, B.Pharm, and Pharm.D.
Schedules and Description
J: List of diseases and ailments which a drug may not purport to prevent or cure or make claims to prevent or cure. E.g., AIDS, Appendicitis, Bronchial Asthma, Cataract, Paralysis, etc.
K: Classes of drugs which are exempted from certain provisions applicable to manufacture and sale of drugs.
M: GMP was first incorporated in Schedule M of the Drugs and Cosmetics Rules, 1945 in the year 1988
Good manufacturing practices and requirements of premises, plant and equipment for pharmaceutical products:
Part 1 : Good manufacturing practices for premises and materials.
Part 1A : Specific requirements for manufacture of sterile products, parenteral preparations (small volume injectables and large volume parenterals) and sterile ophthalmic preparations.
Part 1B : Specific requirements for manufacture of oral solid dosage forms (tablets and capsules).
Part 1C : Specific requirements for manufacture of oral liquids (syrups, elixirs, emulsions and suspensions).
Part 1D : Specific requirements for manufacture of topical products, i.e. external preparations (creams, ointments, pastes, emulsions, lotions, solutions, dusting powders and identical products).
Part 1E : Specific requirements for manufacture of metered-dose-inhalers (MDI).
Part 1F : Specific requirements of premises, plant and materials for manufacture of active pharmaceutical ingredients (bulk drugs).
Part 2 : Requirements of plant and equipment.
M-I: Good manufacturing practices and requirements of premises, plant and equipment for homeopathic medicines.
M-II: Requirements of factory premises for manufacture of cosmetics.
M-III: Quality management system for notified medical devices and in-vitro diagnostics.
N: List of minimum equipment for the efficient running of a pharmacy.
O: Standard for disinfectant fluids.
Part 1 : Provision applicable to black fluids and white fluids.
Part 2 : Provisions applicable to other disinfectant fluids.
P: Life period of drugs.
Condition of storage:
1. The term “cold place” means a place having a temperature not exceeding 8oC.
2. The term “cool place” means a place having a temperature between 10oC and 25oC.
3. Capsules should be kept in a well-closed container at temperature not exceeding 30oC.
4. Wherever condition of storage is not specified, it may be stored under normal room temperature.
P1: Pack sizes of drugs.
Q:
Part 1 : List of dyes, colours and pigments permitted to be used in cosmetics and soaps.
Part 2 : List of colours permitted to be used in soaps.
R: Standards for condoms made of rubber latex intended for single use and other mechanical contraceptives.
R1: Standards for medical devices. The medical devices conform to the Indian Standards laid down from time to time by the Bureau of Indian Standards.
S: Standards for cosmetics in finished form.
T: Good manufacturing practices for Ayurvedic, Siddha and Unani medicines.
U: Particulars to be shown in manufacturing and analytical records. Records of raw materials.
U(I): Particulars to be shown in the manufacturing records and records of raw materials of cosmetics.
V: Standards for patent or proprietary medicines.
X: List of psychotropic substances.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
E.g. Amphetamine, etc.
Y: Requirements and guidelines for permission to import and / or manufacture of new drugs for sale or to undertake clinical trials.
MCQs
1. GMP requirement of factory premises, plants and equipment ______.
(a) Schedule - M
(b) Schedule - P
(c) Schedule - Q
(d) Schedule – S
2. Requirements for efficient running of pharmacy prescribed under which Schedule?
(a) Sch. M
(b) Sch. N
(c) Sch. H
(d) Sch. W
3. Given the following are schedule X drugs, except ______.
(a) Amobarbital
(b) Amphetamine
(c) Glutethimide
(d) Phenformin
4. Sch. R(1) Stands for ______.
(a) Standards for mechanical contraceptives
(b) Standards for medical devices.
(c) Standards for ophthalmic preparations.
(d) Standards for cosmetic
5. Schedule ‘C’ and Schedule ‘N’ as per the Drugs and Cosmetics Act deal with the following:
(P) Standards for cosmetics
(Q) Biological and special products
(R) Life period of drugs
(S) List of minimum equipments for the efficient running of a pharmacy
Identify the correct statements.
(a) P, Q
(b) Q, S
(c) R, S
(d) P, R
6. List of diseases and ailments which a drug may not purport to prevent or cure or make claims to prevent or cure under the Drugs and Cosmetics Rule 1945 is given under ______.
(a) Schedule J
(b) Schedule K
(c) Schedule M
(d) Schedule P
7. Standards for condoms made of rubber latex intended for single use and other mechanical contraceptives are provided in ______.
(a) Schedule F
(b) Schedule G
(c) Schedule P
(d) Schedule R
8. As per schedule P Carbenicillin Sodium Powder should be stored in/at ______.
(a) A cool place
(b) A cold place
(c) Temperature not exceeding 5°C
(d) Well closed container, protect from light, in cool place, protect from light
Check your answers below:
Recommended book for the preparation of GPAT and Drugs Inspector Exams, ESSENTIAL PHARMACY REVIEW FOR DRUGS INSPECTOR EXAMS, NIRALI PRAKASHAN, PUNE
To know more about the book:
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Recommended book for the preparation of Pharmacist Exams, PHARMACIST RECRUITMENT EXAM, NIRALI PRAKASHAN, PUNE
To know more about the book:
Click here
Check your Answers:
1. (a)
2. (b)
3. (d)
4. (b)
5. (b)
6. (a)
7. (d)
8. (c)
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