VELLALAR COLLEGE OF PHARMACY

GPAT EXAMINATION
SUBJECT: PHARMACEUTICAL JURISPRUDENCE
TOPIC : UNIT 1 & 2 DRUG AND COSMETIC ACT
1. No colour is permitted to be used in drugs except mentioned in the D & C rules,1945
under
a. Rule 126
b. Rule 127
c. Rule 128
d. Rule 129
2. A licensee shall maintain an inspection book in which of the following forms under the
D&C act 1940,
a. Form 35
b. Form 36
c. Form 37
d. Form 38
3. Schedule R of D&C act word apply to
a. Standards for mechanical contraceptive
b. Standards for medical device
c. Standards for cosmetics
d. Standards for surgical dressing
4. Which of the following diseases is not covered under schedule J
a. Diabetes
b. Obesity
c. Hypertension
d. Parkinsonism
5. Which of the following drugs are prohibited to be imported
a. Spurious drugs
b. Toilet preparation
c. Schedule H
d. All the above
6. Every drug manufacturer shall maintain manufacturing and analytical record to the D&C
rules,
a. Schedule M
b. Schedule U
c. Schedule V
d. Schedule T
7. Chlorpropamide and Dexamphetamine drugs belong to
a. Schedule G & X
b. Schedule X & H
c. Schedule H & Q
d. Schedule Q & M
8. Cosmetics means any article intended to
a. Affect the structure of the human body
b. Destruct vermin of insects
c. Alter the appearance of human body
d. All the above
9. Standards for surgical dressing was given in
a. Schedule F3
b. Schedule F2
c. Schedule F1
d. Schedule FF
10. The first schedule of the drug and cosmetic act 1940 prescribes.
a. Standard for cosmetics
b. Standards for medical devices
c. Authoritative books of ayurvedic system standards of drugs to be complied with
by importer drugs
d. Standards for contraceptives
11. Standards of quality for the drugs are prescribed in
a. First schedule
b. Second schedule
c. Schedule J
d. Schedule D
12. In pharmacy the term cool place means
a. Temperature not exceeding 8° C
b. Temperature between 8° C and 25° C
c. Temperature between 25 and 30° C
d. None of the above
13. Application for permission to import or manufacture new drug to undertake clinical trial
should be made in
a. Form 21
b. Form 44
c. Form 11
d. Form 12A
14. Clinical trial is related to which schedule?
a. Schedule Y
b. Schedule C
c. Schedule M
d. Schedule D
15. Which of the following drug not come under the prohibition of manufacture of drugs?
a. Manufacturer of sale of any drug without a valid license
b. Manufacture for the sale of any misbranded drug
c. Manufacture of drug for the purpose of examination test or the analysis
d. Manufacturer of sale of spurious drugs
16. Life periods of drugs belong to which schedule
a. Schedule P
 b. Schedule S
c. Schedule X
d. Schedule Q
17. The warning to be sold by retail on the prescription of a register medical practitioner only
shall appear on the label of
a. Schedule H drugs
b. Schedule X drugs
c. Schedule g drugs
d. Schedule H and X
18. Which of the following drugs is a scheduled bulk drug
a. Alprazolam
b. Codeine
c. Salbutamol
d. Amikacin
19. Specific requirements for the manufacturing of sterile product and parental preparations
are prescribed in which of the following parts of the schedule M
a. Part 1A
b. Part 1B
c. Part 1C
d. Part 1D
20. Forms used to send a memorandum to government analyzed under the schedule. A is
done in
a. Form 14- A
b. Form 18, 18-A
c. Form 15
d. Form 19
21. Example of schedule C drug is
a. Fish liver oil
b. Insulin
c. Ergot
d. Barbital
22. Patient concern from participation in a phase 1 clinical trial was given in appendix
a. I
b. II
c. IV
d. V
23. Which one of the following will be termed as manufactured drug
a. Aspirin tablet
b. Paracetamol
c. Caffeine
d. Morphine
24. Schedule F to the drug and cosmetic rules 1945 prescribes
a. The requirement for the functioning and operation of your blood bank
 b. Standards for surgical dressing.
c. List of drugs to be prescribed
d. Standard for disinfectant fluid
25. Drug inspector shall be deemed to be public servant under section
a. 12of LPC
b. 21 of LPC
c. 42 of LPC
d. 48 of LPC
26. Power of the inspectors appointed under drug and cosmetic act 1940 are mentioned under
which of the following section of the act
a. 20
b. 21
c. 22
d. 23
27. Schedule FF to the drug and cosmetic rules 1945 contains
a. The list of drug which can be marked under generic name only
b. Drugs which are habit forming
c. Standard for ophthalmic preparation
d. Drug which are exempted from certain provision applicable to the manufacturing
28. As per the definition of D and C Act, Gudakhu (rubbed against human teeth) is
considered
a. Drug
b. Cosmetic
c. Food
d. Sweetening gum
29. Schedule 'C and Schedule 'N' as per the Drugs and Cosmetics Act deal with the following
a. Standards for cosmetics
b. Biological and special products
c. Life period of drugs
d. List of minimum equipment's for the efficient running of a pharmacy
Identify the correct statements

(a) [A] [B] (b) [B], [D] (c) [C], [B] (d) [D]. [B]
30. Secobarbital is a,
a. Schedule G
b. Schedule H
c. Q
d. X
31. For the manufacture of cosmetics license is granted in
a. Form 25C
b. Form 20D
c. Form 24
d. Form 32
32. A drug consist, in full or in whole or in part of any filthy putrid or decomposed substance
 a. Adultered drug
b. Spurious drug
c. Misbranded drug
d. Patent drug
33. The schedule for: Good manufacturing practices and requirements of factory premises for
the manufacture of belongs to.
a. Schedule X
b. Schedule W
c. Schedule L
d. Schedule M
34. The Drugs and Cosmetic Act was passed in
a. 1940
b. 1945
c. 1947
d. 1946
35. The main aim of The Drugs and Cosmetics Act, 1940 and Rules 1945 is to maintain
a. Excise duties on drugs and cosmetics
b. Import, manufacture, distribution, and sale of drugs and cosmetics
c. Imposition of narcotic drugs
d. Medical treatment standards only.
36. According to the Act, 'drug' includes
a. All food substances intended for internal use
b. All medicines for internal or external use of human beings or animals
c. Only substances used for the treatment of diseases in humans
d. Only preparations applied on the human body
37. The import of any drug which claims to cure a disease specified in which schedule is
prohibited?
a. Schedule C.
b. Schedule H.
c. Schedule J13
d. Schedule M
38. Import licenses are granted by
a. The Central Government
b. The State Government
c. The licensing authority
d. The Customs Collector
39. A separate import license is required from
a. Consignment of drugs
b. Retailer of drugs
c. Manufacturer, in respect of drugs
d. Importer of drugs.
40. A false warranty by a manufacturer to a purchaser can lead to
a. Imprisonment of 5 years
b. Fine up to ₹ 10,000
 c. Imprisonment or fine up to ₹ 500 or both
d. Cancellation of the manufacturing license.
41. The penalty for manufacturing adulterated or spurious drugs that may not cause death or
serious body hurt is imprisonment
a. Up to 6 months and/or fine.
b. 1-3 years and fine of not less than ₹ 5,000
c. 5 years and fine.
d. 7 years and fine.
42. The application for manufacturing a new drug should be supplemented with the data
mentioned in
a. Schedule C
b. Schedule H.
c. Schedule M.
d. Schedule Y
43. For manufacturing drugs other than Schedules C, C1, and X, one of the technical staff
should be a graduate in science (with chemistry as principal subject) with an experience
of at least
a. 6 months in drug manufacture.
b. 1 year in drug testing.
c. 3 years in the manufacture of drugs
d. 18 months in pharmaceutical sales
44. Schedule C and C1 drugs are manufactured under a license obtained after paying the
prescribed fee to the
a. Central Government.
b. State Government.
c. Licensing Authority
d. Drugs Technical Advisory Board.
45. For the import of drugs for personal use, the quantity of a single drug should generally
not be more than
a. 50 average doses.
b. 100 average doses
c. 200 average doses.
d. 500 average doses.
46. The manufacture of drugs is a
a. Fully liberalized process.
b. Regulated process
c. Prohibited process.
d. Process overseen by the Customs Department.
47. Which schedule to the Drugs and Cosmetics Rules lists the standards to be complied with
by drugs imported and manufactured for sale?
a. First Schedule
b. Second Schedule
c. Schedule M4
d. Schedule H4
48. Schedule D of the Drugs and Cosmetics Rules pertains to
a. List of prescription drugs
b. List of drugs exempted from the provisions of import of drugs
c. Good Manufacturing Practices (GMP) requirements
d. Standards for patent or proprietary medicines6
49. An import license for drugs, if not suspended or cancelled, remains valid until
a. The date specified on the license
b. One year from the date of issue.
c. 31st December of the year it was granted
d. It needs to be renewed every six months.
50. Import of drugs for personal use, not part of a passenger's luggage, may be allowed if an
application is made in
a. Form 9
b. Form 11
c. Form 12A
d. Form 12B
51. In what year were Schedules M and Y established?
a. 1985
b. 1988
c. 1990
d. 1995
52. What does the caution label on Schedule G medicines state?
a. Use with caution.
b. Keep away from children.
c. It is dangerous to take this preparation except under medical supervision.
d. For external use only.
53. Which of the following is NOT listed as an example of a Schedule G drug?
a. Insulin
b. Aminopterin
c. Aspirin
d. Metformin
54. What does Schedule H primarily contain?
a. Over-the-counter drugs
b. Prescription drugs only
c. Controlled substances only
d. Herbal remedies
55. Which symbol is used on drugs under Schedule H that fall under the Narcotic Drugs and
Psychotropic Substances Act, 1985?
a. Rx
b. NRx
c. Cx
d. Px
56. How many drugs are listed in Schedule H?
a. 250
 b. 300
c. 536
d. 750
57. When was Schedule H1 introduced?
a. 2010
b. 2011
c. 2013
d. 2015
58. What types of drugs does Schedule H1 specifically regulate?
a. Pain relievers
b. Antibiotics
c. Antidepressants
d. Antipyretics
59. What is the main purpose of Schedule H1 regulations?
a. To promote prescription drugs
b. To control the sale of antibiotics and monitor their use and abuse
c. To eliminate over-the-counter medications
d. To restrict access to all medications
60. Schedule M deals with
a. Good Manufacturing Practices for Ayurvedic Medicines
b. Requirements for the Sale of Drugs
c. Good Manufacturing Practices and Requirements of Plant Equipment for Allopathic
Drugs
d. Standards for Cosmetics
61. What type of room should be used for manufacturing and filling antibiotic-containing
preparations?
a. Room with natural ventilation
b. Air-conditioned and dehumidified room
c. A slightly humid room
d. An open-air facility
62. Which of the following materials is specified for mixing tanks used in manufacturing
ointments and lotions?
a. Plastic
b. Glass
c. Stainless steel or other suitable materials
d. Wood
63. The building used for manufacturing drugs should meet the conditions given in the2
a. Pharmacy Act, 1948
b. Drugs and Cosmetics Act, 1940
c. Factories Act, 1948
d. Medical Council Act, 1956
64. Medical inspection of the workers should be conducted
a. Once every three years
b. Twice a year
 c. At least once a year
d. Whenever a worker feels unwell
65. What equipment is essential during the filler and sealing processes for parenteral
preparations?
a. Laboratory coats
b. Dust-proof storage cabinets and filling units
c. Normal tables and chairs
d. Basic kitchen equipment
66. Schedule X lists
a. Drugs that can be sold without a prescription
b. Drugs for veterinary use only
c. List of Narcotic Drugs and Psychotropic Substances
d. Drugs requiring refrigeration
67. For liquid oral dosage forms under Schedule V, the alcohol content of pharmaceutical
products should be between
a. 50-60% of the labelled contents
b. 90-110% of the labelled contents
c. 20-30% of the labelled contents
d. 120-130% of the labelled contents
68. Schedule V deals with
a. Standards for patent or proprietary medicines
b. List of narcotic and psychotropic substances
c. Standards for Patent or Proprietary Medicines
d. List of poisonous substances
69. Schedule U specifies the
a. List of drugs that can be sold over the counter
b. Standards for surgical dressings
c. Particulars to be Shown in Manufacturing Records
d. Requirements for the import of drugs
70. What is the minimum area required for basic installations for manufacturing ointments,
emulsions, or lotions as per Schedule M?
a. 20 square meters
b. 30 square meters
c. 40 square meters
d. 50 square meters
71. As per Schedule N, the premises of a pharmacy should have a minimum height
a. 2 meters
b. 2.5 meters
c. 3 meters
d. 3.5 meters
72. As per Schedule P, the life period for Adramycin is listed as:
a. 24 months
b. 30 months
c. 36 months
 d. 48 months
73. According to Schedule T, the manufacturing plant for Ayurvedic, Siddha, and Unani
medicines should have adequate space for:
a. Only receiving and storing raw material
b. Only manufacturing process areas
c. Only quality control section
d. Receiving and storing raw material, manufacturing process areas, quality control
section, finished goods store, office, and rejected goods/drugs store
74. According to Schedule U, manufacturing records should include details of:
a. Only the name of the product
b. Only the batch number
c. Serial number, name of the product, reference of Master Formula Records,
Lot/Batch size
d. Only the date of manufacturing
75. Schedule V deals with:
a. Standards for veterinary medicines
b. Standards for Patent or Proprietary Medicines
c. List of over-the-counter drugs
d. Requirements for drug testing laboratories
76. As per Schedule V, tablets should fulfill the needs for:
a. Only disintegration and dissolution
b. Only uniformity of weight
c. Disintegration, dissolution, and other physical defects such as leakage from joints,
pinholes or cracks
d. Only the nature of coating
77. Schedule X lists:
a. Drugs requiring refrigeration
b. Drugs liable to cause addiction
c. List of Narcotic Drugs and Psychotropic Substances
d. Drugs for export only
78. Schedule Y deals with the:
a. Standards for disinfectants
b. Guidelines for import of cosmetics
c. Requirements and Guidelines for Permission to Import and/or Manufacture of New
Drugs for Sale or to Undertake Clinical Trials
d. List of coloring agents permitted in drugs
79. Schedule F - Part XII B deals with the requirements for the functioning and operation of a
a. Pharmacy store
b. Drug testing laboratory
c. Blood Bank and/or for Preparation of Blood Components
d. Cosmetic manufacturing unit
80. As per Schedule F - Part XII B, a blood bank should have a minimum room area of:
a. 50 sq meters
b. 100 sq meters
 c. 150 sq meters
d. 200 sq meters
81. According to Schedule F - Part XII B, blood should not be collected from a donor if the
haemoglobin is less than:
a. 10.5 gm%
b. 12.5 gm%
c. 13.5 gm%
d. 14.5 gm%
82. What is prohibited under the Classes of Drugs whose Sale is Prohibited?
a. Sale of Schedule H drugs without prescription
b. Sale of drugs with minor labeling defects
c. Misbranded, spurious, adulterated, and non-standard quality drugs
d. Sale of drugs after the expiry date with a special permission
83. Which of the following bodies advises the Central and State Governments on technical
matters arising out of the operation of the Drugs and Cosmetics Act?
a. Drugs Technical Advisory Board (DTAB)
b. Central Drugs Standard Control Organization (CDSCO)
c. Drugs Consultative Committee
d. Licensing Authority
84. What is the primary function of the Central Drugs Laboratory?
a. To grant licenses for manufacturing drugs
b. To inspect premises where drugs are sold
c. To analyse or test the drug or cosmetic samples sent by the customs collectors or
courts
d. To regulate the prices of essential drugs
85. The Drugs Consultative Committee advises:
a. Only the Central Government on matters related to drug policy
b. Only the State Governments on uniform implementation of the Act
c. The Central Government, the State Governments, and the Drugs Technical
Advisory Board on any matter tending to secure uniformity throughout India in the
administration of this Act
d. The pharmaceutical industry on quality control standards
86. Government Drug Analysts are primarily responsible for:
a. Issuing drug licenses b) Inspecting manufacturing units
b. Analysing and testing drug and cosmetic samples and providing reports to the
Government
c. Prosecuting offenders under the Drugs and Cosmetics Act
87. Who is empowered to inspect premises licensed for the manufacture or sale of drugs?
a. Government Analyst
b. Licensing Authority
c. Drug Inspector
d. Drugs Consultative Committee
88. The qualifications for appointment as a Drug Inspector include:
a. Only a degree in pharmacy
 b. Only experience in the pharmaceutical industry
c. A degree in pharmacy or pharmaceutical chemistry or medicine with specialisation
in clinical pharmacology or microbiology, and experience of at least one year in the
manufacture or testing of drugs
d. Any science degree with three years of experience in a related field
89. Under the procedure of inspection by a Drug Inspector, if any drug appears to be adulterated
or misbranded, the inspector shall:
a. Immediately seize all stocks and initiate prosecution
b. Issue a warning to the licensee and allow them to rectify the issue
c. Take a sample of such drug and send it for test or analysis to the Government
Analyst
d. Destroy the suspected drugs on the premises
90. The containers of Schedule H and G drugs are required to have labels with red coloured
letters. What is the primary reason for this specific color requirement?
a. To indicate that the drug is manufactured under strict quality control
b. To differentiate between prescription and over-the-counter drugs
c. To make the caution statements clearly visible
d. To comply with international pharmaceutical labelling standards
91. According to Schedule P, the label provides the names of drugs along with their dosage
form and pack sizes. What other crucial information regarding the stability of the drug is
specified under Schedule P?
a. The optimal temperature for storage
b. Whether it requires refrigeration
c. The life period of the drugs in months and the recommended storage conditions
d. The maximum retail price inclusive of all taxes
92. Separate licences are needed for wholesale of drugs under:
a. Schedule C and C1 only
b. Schedule X only
c. Other than Schedule C and C1 only
d. Schedule C and C1 and other than Schedule C and C12
93. For the sale of restricted drugs specified in Schedule C, C1 and X, but not in Schedule H,
a restricted licence is issued in Form:
a. 20
b. 20A
c. 21
d. 21A
94. For the sale of Schedule X and Schedule H drugs on a Registered Medical Practitioner's
prescription, the dispensing should not be done more than:
a. Once for any prescription
b. Twice for any prescription within the validity period
c. The number of times specified in the prescription
d. Three times within one month
95. The sale of a drug after its expiry date is:
a. Permitted if the quality is maintained
 b. Permitted with special permission from authorities
c. Prohibited
d. Permitted if it is a non-prescription drug
96. What is the penalty for the first conviction of sale, stocking, or exhibition for sale of drugs
deemed to be spurious?
a. Imprisonment for 1-3 years and fine up to ₹ 5,000
b. Imprisonment for 3 - 5 years and fine up to ₹ 10,000
c. Imprisonment for 5 years to life and fine not less than ₹ 10,000
d. Only a monetary fine
97. Failure to keep records or disclose required information related to drug sales attracts a
penalty of:
a. Only a warning
b. Imprisonment for 1 year
c. Fine up to ₹ 1,000
d. Imprisonment for 1 year and/or fine up to ₹ 1,000
98. Schedule U of the Drugs and Cosmetics Rules, 1945 specifies the particulars to be shown
in manufacturing records for:
a. Patent and proprietary medicines
b. Drugs intended for import
c. Substances Other than Parenteral Preparations in General
d. Parenteral Preparations
99. According to Schedule V, the patent or proprietary medicines should fulfill the following
requirements for tablets:
a. They should be chewable.
b. The nature of coating and the permitted colours should be added on the label.
c. They should be blister packed.
d. They should be scored for easy breaking.
100. According to Schedule P, the life period of Adrenaline is specified as:
a. 12 months
b. 30 months with storage in a cool place
c. 24 months
d. 36 months in a cool place