UPSC DRUG Insppector Question Paper Aug 2023 Pharmapedia

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1. Which one of the following is not applicable to 4. Which of the following statemnents are not
non-linear pharmacokinetics ? of solid
(a) The elimination or absorption half-lives
correct regarding dissolution testing
change as doses are increased. dosage forms ?
(b) The area under the curve (AUC) 1. Dissolution tests are used to aid
increase in a proportional manner to the formulation development, check product
administered dose.
quality and performance and to assess
(c) The composition and/or ratio of the batch-to-batch uality of a drug with
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metabolites of a drug may be affected by
a change in the dose. respect to drug product specifications.
Elimination or absorption of drug does Dissolution test conditions are not
2.
not follow simple first-order kinetics. selected based on properties of the drug
and the type of drug form.
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2, Presystemic metabolism : 3. Dissolution is often the rate-limiting
Occurs in liver as first-pass metabolism. step in the absorption of drugs with poor
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- 1.
2 Occurs in intestine and its walls. water solubility.
3. Occurs when drug is administered 4 Dissolution cannot be correlated to oral
ed
transdermally or by inhalation. bioavailability whilst disintegration of
4. Results in d crease in bioavailability. dosage form is a strong indicator of oral
Select the correct answer using the code given bioavailability.
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below : Select the correct answer using the code given
1,2 and 4
below:
(a) 1 and 3 only
(b) 1,3 and 4
(b) 1and 2 only
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(c) 1,2 and 3

2 and 4 only
(d) 2, 3 and 4 1 and 4 only
(d)
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5. Which one of the following is not correct for

3. An IV dose of 500 mg is administered to a
patient. It was observed that 70% of the dose dosage forms prepared using protein based
Ph
was recovered unchanged in the urine. The drugs ?

AUC (area under the curve) was found to be
362 mg.hr/L. What will be the total clearance Trehalose and sucrose are ineffectivve in
råte (TCR), metabolic clearance rate (MCR) preventing protein denaturation
and renal clearance rate (RCR) ?
Low pH, i.e. pH 3 6 prevents chemical
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(b)
(a) TCR = 23 mL/min.; RCR
16-1 mmin.; MCR = 9-2 mL/min. degradation
(b) TCR = 63 mUmin.; RCR (c) Cyclization of proteins makes them less
susceptible to gut amino and carboxy
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44-1 mL/min.; MCR = 8-1 mL/min.

(c) TCR = 23 m/min.; RCR peptidases
16-1 mL/min.: MCR = 6-9 mL/min.
(d) Metal chelating agents can be used to
TCR 46 mL/min.; RCR
(d)
enhance the stability
=
32-2 mL/min.; MCR = 13-8 mLmin.
KLOS-F-PHRM (2-D)
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6. Which one of the following represents the 9. Which one of the following statements
correct sequential arrangement in regarding pharmaceutical powders is not
correct ?
transdermal patch (rate-limiting Hygroscopic powders absorb moisture
membrane-type) from top to bottom ? (a)
from the air.
(BL =.backing layer; DR = drug reservoir; (b) Deliquescent powders absorb moisture
AD = adhesive; RRL = removable release from the air and partially or wholly
liner; RLM = Rate-limiting membrane) liquefy.
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Efflorescent powders absorb moisture
a BL’ AD ’ DR’ RLM’ RRL from the air and form water molecules
(b) BL ’ RLM ’ AD ’DR’ RRL of hydration or crystallization.
(c) BL’ DR ’ RLM ’ AD ’ RRL (d) Eutectic powders, upon mixing, become
sticky or pasty or liquefy.
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(d) BL ’ RRL ’ DR ’ RLM ’ AD
10. Which one of the following vehicles cannot be
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7. Inbalation aerosols should have particles used for injection of drugs parenterally ?
which are: (a) Mineral oil
(a)
(b)
Porous with large physical diameter and
small aerodynamicdiameter
Porous with small physical diameter
ed (b)
d)
Corn oil
Sesame oil
Castor oil
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and large aerodynamic diameter
11. Capsules are available in various sizes
Non-porous with large physical
(c)
diameter and small aerodynamic (1, 2, 3, 4, 5, 000, 00E, 00, 0 and OE) for
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human administration. Which of the following

diameter
statements regarding capsule size is/are
Ya) Non-porous with small physical correct?
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diameter and large aerodynamic

diameter
P. "000 is the largest capsule size.
Q. 5" is the smallest capsule size.
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8. In 2015, the formulation "Spritam" approved

R. "0 is the smallest capsule size.
S. 5" is the largest capsule size.
by US FDA, is a :
"000" is the smallest capsule size.
he
T.
(a) 3D printed fast dissolving tablet
Select the correct answer using the code given
3D printed transdermal patch below :
S and T
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(a)
(c) 3D printed delayed release oral dosage
form b) P and Q
(c) R and S
(d) 3D printed repeat action oral dosage
(d) P and R
form
(3-D)
KLOS-F-PHRM
Medical Devices
12. 10 suppositories containing 300 mg| 16. Medical devices under the
acetaminophen have to be prepared using classified in which of
Rules, 2017 have been
cocoa butter. Average weight of the blank
cocoa butter suppository is 2g and the the following classes ?
average weight of medicated suppository is (a) Class 1, Class 2, Class 3, Class 4
18 g. What willbe the actual weight of cocoa
butter required to prepare the suppositories? (b) Class O, Class P, Class Q., Class R
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(a) 18-0 g (c) Class A, Class B,Class C, Class D
bl 150g
(c) 18-6 g (d) Class I, Class II, Class III, Class IV
(d) 15-6 g
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13. Microemulsions have droplets in the size Application for manufacture of cosmetics for
17.
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range of:
(a) 100 À to 5000 ¢ sale/distribution is required to be made to the
(b) 100 ¢ to 1000 ¢ State Licensing Authority in :
ed
1000 ¢ to 5000 Å
(a) Form COS-3
(d) 5000 ¢to 10000 ¢
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(b) Form COS-5
14. Which one of the following is the best
technique to sterilize thermolabile and (c) Form COS-6
moisture-sensitive materials ?
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(d) Form COS-7
(a) Filtration sterilization ~
Gas sterilization
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(c) Dry heat sterilization

18. The premises licensed for manufacturing
(d) Steam sterilization
cOsmetics shall be inspected by Inspector
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15. Diffusion is facilitated in suspensions via

Brownian movement when the suspensions appointed by the Central Government and
are : State Government to verify the conditions of
(a) Deflocculated with particle size in licence not less than :
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sub-micrometre range
(b) Deflocculated with particle size in Once in a year
macrometre range
(b) Once in two years
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(c) Flocculated with particle size in

sub-micrometre range (c) Once in three years
Flocculated with particle size in
macrometre range (d) Once in four years
KLOS-F-PHRM (4-D)
for offences committed without 21. An Indian pharmaceutical company wants to

19. Penalty market a fixed dose combination (FDC) of two
ohtaining a valid licence for manufacture and drugs for an indication for which those drugs
are already approved and given together not
sale of drugs under the Drugs and Cosmetics as an FDC, but individualy at same doses.
Rules shall be not less than: What will be the data requirement for
marketing permission ?
1. One year (a) Marketing data to be submitted will be
similar to data required for any new
Two years drug including clinical trials.
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2
(b) Chemical and pharmaceutical data as
3 Five years well as data on animal toxicology of new
combination will be required.
Three years Available data on pharmacological,
(c)
and fine which shall not be less than: toxicological, clinical data on the
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Z 50,000
individual ingredients along with
(i) animal toxicity and pharmacological
data of new combination should be
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(ii) T 2,00,000 submitted.
(d) Chemical and pharmaceutical data as
(iii) Z 1,00,000
ed
well as data showing the stability of the
should be
(iv) T 3,00,000 proposed dosage form
submitted.
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22. Which one of the following Schedules of Drugs
below :
and Cosmetic Rules, 1945 lists the
requirements for the functioning and
(a) 1, (ii)
operation of a blood bank and/or for
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Bl 2, (i) preparation of blood components ?

(a) Schedule D
(c) 3, (iv)
Schedule F
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(d) 4, (iii) (c) Schedule M
(d) Schedule R
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23. All of the following statements categorize the

20. To maintain perpetuity of a licence to drug to be spurious except :
application for its If it is manufactured under a name
manufacture drugs, (a)
which belongs to another drug.
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continuation is required to be made within :

(b) If it bears or contains, for the purpose of
(a) 3 years colouring only, a colour other than
which is prescribed.
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(b) 2 years If its label bears the name of a company

(c)
which does not exist.
5 years
d) If it is substituted in part by another
(d) 7 years drug.
(5-D)
KLOS-F-PHRM
of the following statements is
24. Which one of the following statemnents 28. Which one correlation in in vitro - in
regarding Phase II clinical trials is correct ? correct for Level B
(a) Phase II studies are called Pivotal vivo correlation (IVIVC) ?
Trials'. single point-to-point correlation
a It is a parameter such
(6) Phase II study is primarily done to between a dissolution
dissolved and percent
determine the toxicology and as percent drug
pharmacokinetics of the test drug. drug absorbed.
It involves convolution and
Phase II study is the first controlled (b)
clinical study done to determine efficacy deconvolution techniques.
and safety in patients. justify
Level B correlation alone can
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(c) and
(d) Phase II study begins with the formulation modification
submission of a New Drug Approval. manufacturing site change.
mean
25. Which one of the following procedures may be Le It is a comparison between and mean
in vitro dissolution time
preferred by FDA to speed up the drug in vivo
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residence time Or mean
development process for drugs that are used dissolution time as per the statistical
to treat both serious and less serious diseases
so that there are major advances in treatment moment theory.
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or provide a treatment where no adequate
therapy exists ?
29. Which one of the following properties is not
(a) Fast Track
(c)
(d)
Accelerated Approval
Priority Review
Breakthrough Therapy" designation
ed exhibited by Narrow Therapeutic Index (NTI)
drugs or critical dose drugs?
(a) Difference between the minimum toxic
plasma concentration and minimum
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26. Consider the following statements regarding effective dose concentration is very low.
active drug transport : (b) Require therapeutic monitoring based
i. Transport of drug depends On on pharmacokinetic or
pharmacodynamic measures.
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concentration gradient.
, 2. Transport requires energy. Possess very high within-subject
3. The process is capacity limited. variability.
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4. The rate is slower than passive transport.

(d) Sub-therapeutic concentrations lead to
serious therapeutic failure.
Which of the statements given above are
correct?
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a) 1,2 and3 30. Which one of the following is correct for drugs
(b) 2, 3 and 4 administered via extravascular route, at C.
'max
(c) 2 and 3 only (maximum plasma concentration) ?
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(d) 3 and 4 only Rate of drug absorption is equal to

the
rate of drug elimination
27. The increasing order of absorption from the
available dosage form are : (b) Rate of drug elimination is
higher than
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the rate of drug

Capsule, suspension, emulsion, solution absorption
(b) Suspension, capsule, emulsion, solution (c) Rate of drug absorption is
(c) Emulsion, suspension, capsule, solution the rate of drug higher than
elimination
Solution, capsule, emulsion, suspension (d) Rate of drug absorption is zero
KLOS-F-PHRM (6 D )
31. Separation of ions in Mass spectrometer is 37. Which one of the following materials is used
according to their: in construction of Attenuated Total
Charge to mass ratio Reflectance (ATR) cells ?
(a)
Mass to charge ratio (a) Germanium
(c) Electron to proton ratio (b) Sodium chloride
Proton to neutron ratio e) Potassium bromide
(d)
(d) Potassium chloride
32. which one of the following plants is the major
source for reserpine ? 38. Which one of the following is a reasonable
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internal reference standard for PMR
(a) Gelsemium sempervirens
spectroscopic studies of solutions in water of
(b) Catharanthus roseus
Colchicum autumnale
D,0?
(c)
T Rawolfia serpentina a Tetramethylsilane (TMS)
(b) Silicone grease
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Which one of the following chemicals is used (c) Silicon dioxide
33.
in the preparation of Dragendorff'sreagent ? (d) Sodium 2,2-dimethyl-2-silapentane-5
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(a) Picric acid sulphonate (DSS)
(b) Iodine in potassium iodide Mercaptoacetic acid in a solution buffered
39.
el Potassium bismuth iodide with ammonium citrate reacts to form a
34.
(d) Potassio-mercuric iodide
Precision of an analytical method for assay of

ed purple coloured complex with :
Arsenic
Lead
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drugs in formulation within laboratory
conditions like different days, different (c) Mercury
analysts, etc. is expressed as: (d) Iron
(a) Repeatability What will be the retention factor of an analyte
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40.
al Reproducibility analyzed by HPL, if its retention time is
(c) Robustness 8-0 minutes and retention time of unretained
Intermediate Precision peak is 2-0 minutes?
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(d)
(a) 2-0
is
35. Which one of the following detectors (b) 3-0
Commonly used in FT-IR spectrophotometry ?
Ph
(c) 6-0
(a) Thermocouple (d) 80
(b) Pyroelectric detector
will be the concentration of
(c) Golay-pneumatic detector 41. What
methyltestosterone solution in ethanol if its
ta) Photomultiplier tube
he
absorbance in 1 cm cell at 241 nm was found

to be 0:890 ?
36. The non-agueous solvent dimethyl formamide
(DMF) belongs to which one of the following (the A (1%, 1 cm) of methyltestosterone is
classes of solvents ? 540 at 241 nm)
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(a) Aprotic (a) 0-020 g/100 mL

(b) 0-010 g/100 mL
) Amphiprotic
(c) 0-001 g/100 mL
Protogenic
(d) 0-100 g/100 mL
(d) Protophilic
(7-D)
KLOS-F-PHRM
42. In an assay of ferrous sulphate by titration46. Which one of the following does not provide
against ceric sulphate using ferroin as an passive immunity ?
internal redox indicator, a red colour of (a) Inactivated micro-organisms
solution in titration vessel before end point is (bl Humanized monoclonal antibodies
due to: (c) Natural mother antibody transferred to
a l 1,10-phenanthroline ferric ion complex foetus
(d) Antitoxin
(b) 1,10-phenanthroline ferrous ion complex
47. Consider the following vaccines:
Oxidation product of ferrous sulphate
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(c)
1. DNAvaccine
(d) Reduction product of ceric sulphate 2. mRNA vaccine
3. Live attenuated vaccine
43. Head space gas chromatographic analysis is a 4. Inactivated vaccine
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very effective technique for the analysis of : The correct order of stability of vaccines given
above is :
(a) Non-volatile compounds
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(a) 1>3>4>2
Mixture of volatile compounds (b) 2> 4>3> 1
(c) Non-volatile compounds in presence of (c) 1>4>3> 2
ed
high proportion volatile compounds (d) 2>3>4>1
(d) Volatile compounds in presence of high
proportion non-volatile compounds
48. Which one of the following Human Leukocyte
Antigens (HLA) encodes for major
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histocompatibility complex-II?
(a) HLA-A
44. Iodine value of oils and fats is a measure of :
(b) HLA-B
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(a) Average molecular weight of fatty acids (c) HLA-C

a Degree of unsaturation present in fatty (d) HLA-D
acids
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49. Which one of the following clotting factors

(c) Free fatty acids does not require vitamin K during blood
(d) Unsaponifiable matter coagulation process ?
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(a) Factor IX
Factor V
45. In an assay of boric acid by aqueous acid-base (c) Factor VII
titration, glycerin is added :
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(d) Factor X
(a) To dissolve boric acid
50. Which one of the following proteins is
(b) To enhance the strength of boric acid
mainly
responsible for binding with drugs in plasma?
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(c) To suppress the ionization of boric acid

(a) Apolipoproteins
(b Albumin
d) To prevent precipitation of reaction (c) Transferrin
product of titration (d) Immunoglobulin G
KLOS-F-PHRM (8-D)
51. Which 0ne of the following methods is not 54. An applicant for grant of retail license in
used for the separation of plasma proteins ? Form 20 or Form 21 or both is required to
Flow cytometer provide the premises which are in area not
less than :
(b) Precipitation by salting out technique
(a) 8 m
(c) Ultracentrifugation
10 m2
(d) Electrophoresis
(c) 12 m2
52. Match the List I with List II and select the (d) 15 m2
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correct answer using the code given below the
lists : 55. The permitted synthetic organic/natural
organic colours used in the cosmetics shall
List I List II
not contain more than :
(Type of (Function)
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Globulin) Ta 1 ppm of arsenic, 10 ppm of lead and
A. High density 1. Carries triglycerols 50 ppm of heavy metals other than lead
from liver to 4 ppm of arsenic, 30 ppm of lead and
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lipoprotein (b)
adipose tissue 200 ppm of heavy metals other than
B. Low density 2. Collects cholesterol lead
ed
lipoprotein from body tissues
and brings it back (c) 2 ppm of arsenic, 20 ppm of lead and
to liver 100 ppm of heavy metals other than
C. Very low density 3. Involved in cell-cell lead
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lipoprotein interactions (d) 2ppm of arsenic, 25 ppm of lead and
D. Glycoproteins 4. Carries cholesterol 150 ppm of heavy metals other than
from liver to cells of lead
the body
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56. Toothpastes containing fluoride should not

Code :
contain fluoride more than:
A B D
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1
(a) 500 ppm
4
(b) 3 1 4 2 1000 ppm
(c) 2000 ppm
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(c) 2 1 4 3
(d) 3 4 1 2 (d) 3000ppm
53. The level of mercury as preservative in the 57. Application for licence to manufacture drugs
other than those specified in Schedules C and
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cOSmetics intended for use only in the area of

eye should not exceed : CI) shall be made to the Licensing Authority
of the State in :
(calculated as metal)
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(a) Form 24B

0-005%
Form 24
(b) 0-007%
(c) Form 24F
(c) 0-009%
(d) Form 24D
(d) 0-010%
KLOS-F-PHRM (9-D)
Láce r retal sabe of drugs e of the folowing is usei
ther than61. Which
Szele X re ise by the State
Licenaúng calibratáon of absortance scale of UW-V
Asuthrity in : htoseter ?
reguúre spets
serviees registered
pharmatiet Potassium chioride solution
Form 20, 21 b) Potassium chromate solutáon
(b) Porn 20B, 21B
Form 20F.20G Holmium perchirate solutin
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Forn 20A, 21A Potassium ichromate solution
The rugs pecifiei under which of the
frliewing chedules to the Drugs and
Cosmetács Rules, 1945 will not be sold by 82. Which one of the following is not an example
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retail exegt on and in accordance with the of utility software ?
prescriptin of Registered Medical a) Antivirus
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Practitámer :
1 Schedule U (b) WinZip
2 Schedule Y
o Google Chrome
ed
Schedule H
Schedule H1 Disk Defragmenter
Schedule X
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Selet the correst answer using the code given 63. Which one of the folowing programming
belorw
(a) 2and 4 only languages is used to develop an android
application for mobile device ?
m
3,4 and 5
(e) 1,2 and3 (a) Python
(d) 2,3, 4 nd 5 (b)
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The medical devicen shall conform to the Java

standarde laid down bythe:
(d) C++
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1 WHO
2 USFDA
Bureau of Indian Standards (BIS) 64. Which one of the following symbols
4 190/1ECPharmacopoeial standards the data flow in motion, represents
used in data flow
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where BIS standards are not available diagram (DFD) ?

Belet the orret answer using the code given (a) Open-ended box
below :
Square
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(a) 1and 2 only (b)

(b) 1,3 and4 (c) Circle
(e) 2 and 3 only
d Arrow
2and 4 only
KLOS-F-PHRM (10-D )
58.
Licenses for retail sale of drugs Which one of the following is
used for
Schedule X are issued by the Stateother than 61.
Licensing calibration of absorbance scale of
UV-Vis
Authority in : spectrophotometer ?
(which require services of registered
pharmacist) (a) Potassium chloride solution
a), Form 20, 21 Potassium chromate solution
(b) (b)
Form 20B, 21B
(c) Form 2OF, 20G (c) Holmium perchlorate solution
(d) Form 20A, 21A
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Potassium dichromate solution
59. The drugs specified under which of the
following schedules to the Drugs and
Cosmetics Rules, 1945 will not be sold by 62. Which one of the following is not an example
retail except on and in accordance with the
.c
of utility software ?
prescription of Registered Medical
Practitioner: (a) Antivirus
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1 Schedule U (b) WinZip
2. Schedule Y
o Google Chrome
Schedule H
Schedule H1
Schedule X ed (d) Disk Defragmenter
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Select the correct answer using the code
given63. Which one of the following
below :
programming
(a) 3 and 4 only languages is used to develop an android
application for mobile device ?
m
3, 4 and 5
(c) 1, 2 and 3 (a) Python
(d) 2, 3, 4 and 5
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(b)
60. The medical devices shall conform to the Java
standards laid down bythe:
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1. WHO (d) C++
2. US FDA
3. Bureau of Indian Standards (BIS) 64. Which one of the following
symbols represents
he
4.
ISO/IECPharmacopoeial standards
where BIS standards are not available
the data flow in
motion, used in data flow
diagram (DFD) ?
below : (a)
Open-ended box
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(a) 1 and 2 only (b) Square

(b) 1, 3 and 4
(c) Circle
(c) 2 and 3only
3 and 4 only d Arrow
KLOS-F-PHRM
(10 D)
Which one of the following is designed to 69. Which one of the following is the synonym of
65.
control the internal operations of the the word written in capitals in the sentence :
computer system ? The invaders who constantly raided India in
(a)
Antivirus the past and pillaged it were infamous for
their RAPACITY"?
() Application software
(a) Greed
(c)
Compiler
(b) Criminality
System software
(c) Exaggeration
om
Militancy
66. Which one of the following performs the 70. Which one of the following is the antonym of
matching of domain names to IP addresses in the wordwritten in capitals in the sentence :
the Internet services ? "The imnpoverished children in the charitable
school were treated to a SCRUMPTIOUS
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al HTTP administration
meal by the local On
(b) URL Independence Day"?
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a t Unpalatable
(c) DNS Appetizing
(b)
67.
(d)
Which
HTML
of the following statements|T1.

ed (c)
(d)
Hearty
Scanty
Consider the following jumbled words :

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one
/himself/ who / knows / succeeds / he/
regarding Anti-spyware software is correct ? A B D E
(a) It edits the files to become not readable. Which one of the following order of words
creates a meaningful sentence ?
m
traffic.
(b) It is used to analyse the network Ta BCEAD«
all files before they are (b) EACBD
(c) It
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ScanS
(c) DCABE
installed in the computer system. (d) EBCAD
programs
Nd) It detects and removes all the Consider the following jumbledwords:
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72.
installed illegally in the computer / perfection /manifestation of/ is the /
A B
system.
education / in man/
he
D E
not a threat to
68. Which one of the following is Which one of the following order of words
cyber security ? creates a meaningful sentence ?
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(a) Denial of service (a) CBDAE

(b) ACDEB
(b) Phishing
DCBAE
ol RSA (d) EDCBA
(d) Malware
(11-D)
KLOS-F-PHRM
73. Eriochrome Black T is :
Which one of the following parts of the 76.
a Natural indicator
sentence, It is widely acknowledged by a) Metallochrome indicator
Redox indicator
general census that whereas failure is the (c)
Acid-base indicator
(d)
stepping stone to succesSs, successive failures 77. Which one of the following is an example
of
are not successive stepping stones to success aminoglycoside antibiotic ?
has an error ? Streptomycin
(b) Clavulanic acid
Cefaclor
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(a) It is widely acknowledged by general (c)
(d) Azithromycin
census
78. Which one of the following is an example of
(b) that whereas failure is the stepping reverse transcriptase inhibitor ?
stone (a) Acyclovir
(b) Cytarabine
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tosuccess, successive failures are not (c) Idoxuridine
Zidovudine
(d) successive stepping stones to success
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79. Reactive intermediate in S,l reaction is :
(a) Carbene
(b) Carbanion
ed
74. Which one of the following parts of the Free radical
(d) Carbocation
sentence, "The visiting students who had just
80. Parameter that indicates polarity of a solvent
arrived in Srinagar decided that they would is:
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circumnavigate around the Dal Lake the (a) Dissociation constant
Dielectric constant
following day' has an error ?
(c) Boiling point
ta) The visiting students who had just (d) Freezing point
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arrived 81. Vitamin B consists of which one of the

following ring systems ?
(b) in Srinagar decided, that they would (a) Pyridine
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circumnavigate around the Dal Lake Piperidine

(c) (c) Pyrimidine
the following day (d) Pyridazine
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(d)
82. Nitric oxide is biosynthesized from:
tal L-Citrulline
75. Which one of the following is the most (b) L-Glycine
appropriate meaning of the idiom Break a
he
(c) L-Arginine
(d) L-Tyrosine
leg' ?
83. Chemical structure of Timolol has which of
(a) To playa practical joke the following heterocycles ?
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(b) To dance happily (a) Morpholine and Thiadiazole

(b) Morpholine and Triazole
a To be violent with someone e Piperidine and Imidazole
(d) To wish someone luck (d) Pyridine and Morpholine
KLOS-F-PHRM (12-D )
84. Phenobarbitone is the active metabolite of: 91. Which one of the following antiarrhythmic
(a) Phenytoin drugs produces brief therapeutic action and
(b) Primidone transient adverse effects ?
el Phenoxybenzamine
Diltiazem
(d) Phenylephrine
(b) Propafenone
85. Benzhydryl bromide is the starting material (c) Esmolol
for the synthesis of :
(a) Diphenhydramine (d) Adenosine
om
(b) Diclofenac
Diphenylhydantoin
Dipyridamole 92. Which one of the following statenments
(d)
regarding Succimer is most appropriate ?
86. Thyroxine can be synthesized from: (a) It produces less toxicity than
.c
(a) L-Tryptophan
Dimercaprol.
h L-Tyrosine
h It is ineffective orally.
ia
(c) L-Proline
(d) L-Phenylalanine (c) It is effective for treatment of iron
poisoning.
87. Rochelle salt is :
(b)
Potassium sodium tartrate
Silver nitrate
Sodium thiosulphate
ed (d) It is contraindicated for use in children.
ap
(c) 93. Which one of the following monoclonal
Potassium chloride
(d) antibodies is specific for RANKL and is
2,6-Xylidine is the reactant for the synthesis indicated for treatment of postmenopausal
88. women with osteoporosis ?
m
of:
a Benzocaine (a) Eculizumab
(b) Procaine
(b) Palivizumab
ar
(c) Lidocaine
(d) Cinchocaine e l Ranibizumab
can be calculated Denosumab
89. mav for conjugated dienes
(d)
Ph
? ruleslaw
by which one of the following
Woodward's rule
(a)
Beer-Lambert law 94. Which one of the following is the mechanism
(c) Saytzeffs rule of action of bisphosphonates in the treatment
of osteoporosis ?
he
(d) Markovnikov's rule
banned for its Increasing the osteoid formation

90. Thalidomide, previously
(a)
introduced in the
teratogenic activity is again the following Decreasing the osteoclast mediated bone
market for which one of
T
resorption
uses ?
(a) Sedative hypnotic (c) Increasing the mineralization of osteoid
(b) Anticonvulsant
el Lepra reactions (d) Decreasing the parathyroid hormone
secretion
(d) Antibiotic
(13-D )
KLOS-F-PHRM
95. Which one of the following99. Pegvisomant is used for treatment of which
one of the following clinical conditions ?
immunosuppressant agent does not cause
bone marrow suppression as one of its adverse (a) Infertility
effects ?
(b) Pituitary dwarfism
(a) Azathioprine
(b) Cyclosporine T) Acromegaly
(c) Sirolimus (d) Turner syndrome
om
Methotrexate
100. Which one of the following drugs is not

96. Which one of the following anti-diabetic commonly combined with Methotrexate for
drugs is mainly given to control postprandial the treatment of Rheumatoid Arthritis ?
.c
hyperglycemia in type 2 diabetics ?
(a) Sulfasalazine
(a) Metformin
ia
(b) Leflunomide
(b) Pioglitazone
(c) Nateglinide fc) Azathioprine
d Dapagliflozin
ed (d) Chloroquine
ap
97. Which one of the following anti-diabetic 101, All of the
following drugs can be used for
medicine undergoes metabolism by
diagnosis of Myasthenia gravis except :
Cytochrome P450 enzymnes and has drug
m
interactions with Rifampicin ? (a) Neostigmine

(a) Acarbose d-Tubocurarine
ar
(b) Metformin
(c) Edrophonium
(c) Pioglitazone
(d) Physostigmine
Ph
Sitagliptin
102. Which of the

98. All of the following drugs act by stimulating One
following types of
Glucagon-like peptide-1 (GLP-1) receptor and antagonism is observed between the actions of
he
are useful for treatment of type 2 diabetes nitrites and cyanides ?

except : (a) Physical antagonism
(a)
T
Exenatide
(b) Repaglinide
(b)
Physiological antagonism
(c) Liraglutide
(c)
Chemical antagonism
d Dulaglutide d) Competitive antagonism
KLOS-F-PHRM (14 D )
of the following
108 Which one of the following schedules in 106. Spironolactone has which one
Current Good Manufacturing Practice ring system ?
(CGMP) in India is used for Medical devices ? (a) y-Lactone
(a) M
B-Lactone
M-I
(c) B-Lactam
(b)
(d) y-Lactam
M-II
M-III 107. Paracetamol was detected as a metabolite of :
om
(a) Diclofenac
(b) Ibuprofen
104. In scale-up and post-approval changes, level 3 (c) Ketoprofen
changeindicates:
e Phenacetin
.c
(a) Changes that are unlikely to have any for which one
detectable impact on formulation 108. Gutzeit test apparatus is used
of the following limit tests ?
ia
quality and performance.
(a) Heavy metals
(b) Changes that could have a significant (b) Iron
ed
impact on formulation quality and Arsenic
performance and
usually require
dissolution profile comparisons in (d) Sulphate
multiple media.
ap
109. Benzyne formation takes place during:
Nucleophilic aromatic substitution
(c) Changes that could have a significant ad
impact on formulation quality and (b) Sl reaction
of
performance and require conduct
m
(c) Sy2 reaction

bioequivalence study. Electrophilic aromatic substitution
(d)
significant
ar
Changes that could have a Xylose yields :

(d)
formulation quality and 110. Ruff degradation of (+)
impact on the (a) (H Glucose
and lead to rejection of
performance
(+) Fructose
Ph
(b)
product.
(c) () Threose
(+) Glucose
self-inspection under
105. There is requirement of Formation of Acetyl-CoA is the link between
he
by the licensed 111.

GMP to be carried out which of the following ?
manufacturers of drugs. A complete
once in : (a) Glycolysis and Pentose shunt pathway
self-inspection should be carried out
T
(b) Glycolysis and Gluconeogenesis

(a) Two years
Glycolysis and Citric acid cycle
(b) Three years
Citric acid cycle and Electron transport
(c) A year chain
Six months
(15 D)
KLOS-F-PHRM
antagonist of which one
112. Indole is synthesized by : 117. Burimamide is a full
(a) Sandmeyer reaction of the following receptors ?
Tbl Beckmann rearrangement (a) H-receptor
(c) Skraup synthesis (b) D-receptor
(d) Fischer synthesis
(c) H,-receptor
113. Primaquine induces hemolysis in Some
African patients deficient in which one of the e D,-receptor
om
following enzymes?
a Glucose-6-phosphate dehydrogenase anaesthetic
118. The principal mechanism limiting
of sodium
(b) Carbonic anhydrase duration after single dose
.c
(c) Acetylcholinesterase thiopental includes :
(d) Chymotrypsin Hepatic metabolism
(a)
ia
114. Enalapril belongs to which one of the b Redistribution
following esters of enalaprilic acid ?
Metabolism by pseudocholinesterase
ed
(c)
(a) Methyl
Ethyl (d) Rapid clearance
(c) Benzyl
ap
(d) n-Propyl 119. Metoclopramide has the following actions on
gastrointestinal tract except :
115. Which one of the following is an example of
Increases tone ofpyloric sphincter
m
Angiotensin II blocker ? (a)
(a) Fosinopril (b) Increases tone of lower esophageal

sphincter
ar
(b) Clonidine
o Cosartan (c) Increases gastric peristalsis
Propranolol ae Increases intestinal peristalsis

Ph
(d)
116. The reaction between methylbromide and

120. The following antibiotics are commonly
hydroxide ion toyield methanol is a/an: employed for the treatment of Helicobacter
he
(a) S2 reaction pylori associated peptic ulcer except :

(a) Clarithromycin
(b) SEl reaction
(b) Ciprofloxacin
T
(c) E2 reaction od Amoxicillin

T E1 reaction (d) Tinidazole
KLOS-F-PHRM (16 D )
G P guidelines, all of the
121. According to GCP guidelines, the minimum 124. As per ICH E6
number of members required in guorum of
following should be complied except :
(a) Information recorded in the
Ethics Committee to review the protocol is : investigator's reports should be
(a) 5 complete, accurate and legible
(b) 6 b) Any missed study visits may not be
noted in the reports
7
(c) SubjectS who were dropped from or
(d) 9 failed to complete the study are noted in
om
the report with the reason adequately
122. According to GCP guidelines, which one of the explained
following statements does not hold true for (d) Informed consent should be adequately
Ethics Committee? documented
members serving in Ethics guidelines, whose
.c
125. As per ICH GCP
Committee that Oversees human
responsibility is it to ensure that investigators
research at an institution must be
are qualified by education and experience and
ia
employed by that institution. are trained on the conduct of the protocol ?
Ethics Committee should include at (a) FDA
(b)
least one member whose primary area of
(c)
interest is non-scientific.
Ethics Committee should
appropriate gender representation.
have ed (b)
(c)
Study sponsor
Investigator
Ethics Committee
126. The document retention period as required by

ap
(d) For review of each protocl the quorum FDA following the date of marketing
least
of Ethics Committee shall be at application approval or after the investigation
:
five members. is discontinued and the FDA notified, is
m
considered (a) One year

123. Which one of the following is not (b Two years
subject's
as the essential element in the study Three years
ar
to
informed consent documents according Five years
GCP guidelines ? Enzyme-Linked Immunosorbent
of the subËect's|127. In indirect
Ph
(a) Expected duration

Assay:
participation antibody is
(a) A standardized monoclonal
(b) An explanation about
whom to contact immobilized on the solid support for
for trial related queries, rights of detection.
he
subjects and in the event of an injury

(b) A standardized
polyclonal antibody is
a possibility of immobilized on the solid support for
(c) A statement that there is
failure of investigational product to detection.
is
therapeutic effects te Antigen-antibody complex
T
provide intended
that the particular
immobilized on the solid support for
A statement
(d) detection.
treatment or procedure may invoke
A standardized antigen is immobilized
risks to the subject, which are currently (d)
unforeseeable on the solid support for detection.
KLOS-F-PHRM (17-D )
is responsible for binding and
128, Which one of the following antibodies is 132. Ceruloplasmin
responsible for allergie reactions? transportatior of which one of the following
elements in the blood ?
(a IgE (a) Copper
(b) IgG (b) Iron
(c) Magnesium
(c) IgM
Zinc
om
(d) IgA
133. Erythropoiesis is the process of:
129. Which one of the following is not a bacterial Ta Development of red blood cells
vaccine?
(b) Development of thrombocytes
.c
(a) BCG vaccine (c) Development of white blood cells
(b) Pertussis vaccine (d) Development of monocytes
ia
(c) Meningococcal vaccine 134. Which one of the following statements
ed
regarding blood group "0" is correct ?
Measles vaccine
(a) It has agglutinogen A only on the RBCs.
130. Which one of the following (b) It has
statements agglutinogen B only on the RBCs.
ap
regarding adjuvants is not correct ? (c) It has agglutinogen A and B both, on
They increase the antigen specific the RBCs.
immune responses. ) It has agglutinin anti-A and anti-B
m
in
(b) They decrease the antigen specific the plasma.
immune responses. 135. Consider the
ar
vaccines:
following statements regarding
(c) They preserve antigen integrity,
(d) They produce high affinity immune
1
Polio-Salk is a live attenuated vaccine.
Ph
responses. 2
Polio-Sabin is an inactivated vaccine.
131. Which one of the following is the
3
Hepatitis A is an inactivated vaccine.
correct 4
Hepatitis B is
sequence of immunoglobulins on the basis of
he
a subunit vaccine
molecular weight (Dalton) ? (HBsAg).
(a) IgG > IgA > IgD> IgM > IgE Which of the
statements given above are
T
correct ?
IgM > IgE > IgG> IgD> IgA (a) 2and 4
(c) IgD > IgG> IgA >IgE > IgM (b) 2 and 3
(d) l and 3
IgM> IgE > IgD > IgA > IgG
(d) 3and 4
KLOS-F-PHRM
(18-D )
136.
Previous
WHO guidelines
Year Paper GPAT Pharmacist
on
stability Drud Inspector/DCO
studies Visit https://thepharmapedia.com/
recommend storage
of pharmaceutical
140. As per Indian Pharmacopeia, maximum
products
different temperatures and
at number of particles per mL allowed for the
relative humidity in different zones. The Larger Volume Parenteral (LVP), labelled as
temperature
Zone IVb are:
and humidity recommended for containing 100 mL or more of a single dose
large volume injection intended for
(a) 30°C/60% RH
(6) 30°C/65% RH administration by intravenous infusion with
30°C/70% RH particle size not exceeding 10 um is :
(d) 30°C/75% RH (a) 5 particles per mL
187. When there is change in the equipment of the (b) 25 particles per mL
om
process, there will be need for : (c) 50 particles per mL
(a) Retrospective validation (d) 10 particles per mL
Concurrent validation
(c) Prospectivevalidation 141. In India, IP Reference Substances (IPRS) are
.c
(d) Revalidation issued by the :
138. Which one of the following is not correctly
ia
(a) Central Drug Research Institute,
matched as per the classification of Clean Lucknow
rooms IS0-14644 ?
(b) Chemical Laboratory, Pune
(a)
(b)
Part l: Classification of air cleanliness
Part 3: Test methods
Part 4 : Design, construction and
start-up
ed Indian
Ghaziabad
Pharmacopoeia Commission,
ap
(d) Part 5 : Terms and definitions
(d) Indian Institute of Chemical Biology,
Kolkata
139. Which of the following are correctly matched

m
regarding registration of Pharmaceuticals for 142. Which one ofthe following classes of clean air
Human Use (ICH) ? is required for aseptic operation ?
ar
1. ICH guideline Q8 Pharmaceutical (a) Class 100

Development (b) Class 1,000
c Class 10,000
Ph
2. ICH guideline Q9 : Quality Risk

Management (d) Class 100,000
3. : Radio
ICH guideline Q10
pharmaceutical
he
guidelines 143. Which one of the following antioxidant

compounds is used in aqueous system
cosmetics ?
below :
T
(a) 1and 3 only Sodium bisulphite

(b) 1and 2 only (b) Hydroquinone
(c) 2 and 3 only (c) a-Tocopherol
d) 1, 2 and 3 (d) Propyl gallate
KLOS-F-PHRM (19-D )
L44. Which one of the following application forms 148. The expert committee shall examine the
is applicable in case of manufacture for sale of report of serious event of death and give its
Ayurveda, Siddha or Unani drugs ? recommendation to the licensing authority for
(a)
the purpose of arriving at the cause of the
Form 25-E adverse event within how many days of the
Form 24-D occurrence of the adverse event?
(c)
(a) 150 days
Form 26-D
(b) 30 days
om
(d) Form 25-D el 90 days
(d) 105 days
145. Which one of the
following guidelines are 149. According to New Drugs and Clinical Trials
followed for analytical method validation, if Rules, 2019, the sponsor is required to
the method of analysis is not
.c
official in any forward his report on serious adverse event of
pharmacopeia appear in other recognized
or death after due analysis to the licensing
references? authority and the head of the institution
ia
where the trial has been conducted within
(a) ICH guidelines
how many days of the occurrence of the
ed
(b) WHO guidelines event ?
(a) Within 1 day
GLP guidelines
Within 7 days
(d) HACCP guidelines
ap
(c) Within 14 days
146. Which one of the following (d) Within 30 days
sections represents
misbranded cosmetics under manufacture, 150. With regard to compensation in case of
m
sale and distribution of drugs and or death during injury

cosmetics ? clinical trial, all of the
following statements are true except :
Section 9A (a)
Financial
ar
(b) Section 9D
form of
compensation could be in the
payment for medical
management.
Section 17C Financial compensation is not provided
Ph
for a child injured in-utero

(d) Section 14
the because of
trial,participation of parent in clinical
147. Which one of the following (c) In case of death,
antimicrobials is give financial there a provision to
he
is
used in the preparation of deodorant soaps ?
(a) Bithionol (d) nominee(s) of the compensation
trial
to the
subject.
Fnancial compensation shall be
provided if injury or death occurs
T
(b) Propylene glycol due to

failure of
Trichlorocarbanilide investigational product to
provide intended
(d) Titanium dioxide
where, the standard therapeutic
care,
effect
available, was though
subject as per the not provided to the
clinical trial
KLOS-F-PHRM protocol.
(20 -D)

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Previous Year Paper GPAT Pharmacist Drud Inspector/DCO Visit https://thepharmapedia.

(c) 1,2 and 3

5. Which one of the following is not correct for

was recovered unchanged in the urine. The drugs ?

44-1 mL/min.; MCR = 8-1 mL/min.

32-2 mL/min.; MCR = 13-8 mLmin.

human administration. Which of the following

diameter and large aerodynamic

8. In 2015, the formulation "Spritam" approved

(c) Dry heat sterilization

15. Diffusion is facilitated in suspensions via

(c) Flocculated with particle size in

for offences committed without 21. An Indian pharmaceutical company wants to

Bl 2, (i) preparation of blood components ?

(d) 4, (iii) (c) Schedule M

23. All of the following statements categorize the

continuation is required to be made within :

(b) 2 years If its label bears the name of a company

4. The rate is slower than passive transport.

(d) 3 and 4 only Rate of drug absorption is equal to

the rate of drug

Precision of an analytical method for assay of

absorbance in 1 cm cell at 241 nm was found

(a) Aprotic (a) 0-020 g/100 mL

(a) Average molecular weight of fatty acids (c) HLA-C

49. Which one of the following clotting factors

(c) To suppress the ionization of boric acid

56. Toothpastes containing fluoride should not

cOSmetics intended for use only in the area of

(a) Form 24B

The medical devicen shall conform to the Java

where BIS standards are not available diagram (DFD) ?

(a) 1and 2 only (b)

1. WHO (d) C++

(a) 1 and 2 only (b) Square

(b) URL Independence Day"?

of the following statements|T1.

Consider the following jumbled words :

(a) Denial of service (a) CBDAE

arrived 81. Vitamin B consists of which one of the

circumnavigate around the Dal Lake Piperidine

(b) To dance happily (a) Morpholine and Thiadiazole

(d) Markovnikov's rule

banned for its Increasing the osteoid formation

100. Which one of the following drugs is not

interactions with Rifampicin ? (a) Neostigmine

102. Which of the

are useful for treatment of type 2 diabetes nitrites and cyanides ?

(c) Sy2 reaction

Changes that could have a Xylose yields :

by the licensed 111.

(b) Glycolysis and Gluconeogenesis

Angiotensin II blocker ? (a)

(a) Fosinopril (b) Increases tone of lower esophageal

o Cosartan (c) Increases gastric peristalsis

Propranolol ae Increases intestinal peristalsis

116. The reaction between methylbromide and

(a) S2 reaction pylori associated peptic ulcer except :

(c) E2 reaction od Amoxicillin

126. The document retention period as required by

considered (a) One year

(a) Expected duration

subjects and in the event of an injury