What are requirement of DRAP for exporting medicines for sale in other countries ?

📦Exporting medicines to other countries involves adherence to various regulatory requirements to ensure the safety, efficacy, and quality of pharmaceutical products. The specific requirements can vary depending on the destination country, as each country has its own regulatory framework. However, some common requirements and considerations for exporting medicines include:

1.Registration and Licensing:

➺Ensure that the pharmaceutical company is registered and holds the necessary licenses to manufacture and export medicines.

2.Good Manufacturing Practices (GMP):

➺Comply with international GMP standards to ensure that the manufacturing facilities meet the required quality and safety standards.

3.Product Registration:

➺Register the medicines with the regulatory authorities in the destination country. This often involves submitting detailed information about the product, including its composition, manufacturing process, and clinical data.

4.Labeling and Packaging:

➺Ensure that the labeling and packaging meet the requirements of the destination country. This includes providing information in the local language, adhering to specific format requirements, and including necessary warnings and instructions.

5.Quality Control and Testing:

➺Conduct thorough quality control and testing of the medicines to ensure they meet the specifications and standards set by the destination country.

6.Documentation:

➺Prepare and submit the required documentation, including a Certificate of Analysis, Certificate of Origin, and other relevant certificates as per the regulations of the importing country.

7.Import/Export Permits:

➺Obtain the necessary import and export permits from both the exporting and importing countries.

8.Pharmacovigilance:

➺Implement a pharmacovigilance system to monitor and report any adverse reactions or quality issues associated with the exported medicines.

9.Cold Chain Compliance:

➺If applicable, ensure that the transportation and storage of medicines comply with cold chain requirements, especially for products that require specific temperature conditions.

10.Customs Compliance:

➺Comply with customs regulations of both the exporting and importing countries, including proper documentation and adherence to import/export restrictions.

11.Compliance with International Standards:

➺Ensure that the manufacturing and quality control processes comply with relevant international standards, such as those set by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

12.Intellectual Property Protection:

➺Consider intellectual property issues, such as patents and trademarks, to avoid infringement during the export process.

📍It's crucial to engage with regulatory experts and legal professionals familiar with the pharmaceutical industry and the specific regulations of the target markets to navigate the complex requirements successfully. Additionally, staying updated on changes in regulations is essential, as they may evolve over time.

📑MCQS From Past Papers of Hospital Pharmacist 👨‍⚕️ 01-100

 

MCQS From Past Papers of Hospital Pharmacist 👨‍⚕️ 

1.Which of the following Cephalosporins may precipitate disulfiram-like reaction when used concomitantly with ethanol?

a.Cefazolin

b.Cefoperazone

c.Cefepime

d.Cefotaxime

Ans: [B]
Note: Cefamandole & Moxalactam may also precipitate this reaction.

2.Choose an example of organized crude drugs?

a.Digitalis

b.Belladonna

c.Aloe

d.Ginger 

Ans: [C]

3.Test for identification of Anthraquinones is?

a.Dragendorff's Test

b.Borntrager's Test

c.Mayer's Test

d.Wagner's Test

Ans: [B]

Note: Others are identification tests of alkaloids.

4.Solvents that can actas both electron donor & electron acceptor are called?

a.Amphiprotic solvents

b.Diprotic solvents

c.Amphiphilic solvents

d.Organic solvents

Ans: [A]

5.In phenols & phenolic compounds, which compound " is directly attached to hydrocarbon ring?

a.Sulfhydryl

b.Hydroxyi

c.Aromatic amine

d.Carbonyl group

Ans: [B]

6.Codeine is chemically?

a.Methyl Morphine

b.Diacetyl Morphine

c.Monoacetyl Morphine

d.Dimethyl Morphine

Ans: [A]

7.Ocusert, an ophthalmic insert, is inserted in cul-de-sac for treatment of?

a.Inflammation of eyes

b.Irritation of eyes

c.Dryness of eyes

d.Glaucoma

Ans: [D]
Note: Ocusert contains pilocarpine.

8.Ability of buffer to resist change in pH on addition of acid or base Is called?

a.Buffer resistance

b.Buffer efficiency

c.Buffer capacity

d.Neutralizing capacity

Ans: [C]

 9.All parts of following plants are useful as crude drugs EXCEPT?

a.Belladonna

b. Digitalis c. Clove

d. Aloe 

Ans: [D]

10.Building blocks of proteins are?

a.Monosaccharides

b.Amino acids

c.Polypeptides

d.Fatty acid

Ans: [B]

11.Most abundant biomolecule on earth is?

a.Carbohydrates

b.Proteins

c.Lipids

d.Nucleic acids 

Ans: [A]

Note: Cellulose is most abundant biomolecule on earth.

12. Occurrence of carbohydrates is?

a.50% in plants, 50% in animals

b.50% in plants, 30% in animals 

c. 30% in plants, 10% In animals

d. 30% in plants, 1% in animals
Ans: [D] 

13.If pH-pKa = 2, what is the percentage of ionized drug?

a.99%

b.90%

c.10%
d.1%

Ans: [A]
Note: When pH-pKa = 0 (50%), 1 (90%), 2 (99%), 3 (99.9%).

 

14.Polysaccharides which are consumed to give energy?

a) Starch & Glycogen
b) Starch & Chitin
Glycogen & Cellulose
Starch & Glucose

 Ans: [A]

15.Carbohydrates are chemically?

a.Polyhydroxy ethers & ketones
b.Polyhydroxy ketones & carboxylic acids
c.Polyhydroxy aldehydes &
ketones
d) Polyhydroxy alcohols & aldehydes
Ans:[C]

16.Lipids for medicinal use are extracted by using which technique?

a.Cold extraction
b.Solvent extraction
c.Heating with water
d.Heating with organic solvent
Ans: [A]

17.The process of calcination is carried out commercially in ?

a.Furnaces or reactors

b.Steam jacket

c.Water bath

d.Sand bath

Ans: [A]

Note: Calcination refers to heating the solids to high temperatures in the absence of oxygen.

18. Alkalolds are extracted as mineral salts from plants by?

a.Agitation with aqueous acidic

b.solution

c.Agitation with water & organic

d.solvent

e.Heating with mineral acid & organic solvent

f.Heating with potassium hydroxide & lead acetate

Ans: [A]

19. Galenical preparations of cinchona bark are used as?

a.Bitter tonic

b.Astringent

c.Laxative

d.Analgesic 

Ans: [A] 

20. Saponins are therapeutically used as?

a.Laxative

b.Carminative

c.Antipyretic

d.Emollient

Ans: [D]

21.In fusion method of making suppositories, which order of melting is correct? (Melting point of bees wax Is 65?c and hard paraffin is 45?c).

a.Bees wax is melted first

b.Hard paraffin is melted first

c.Both are melted at the same time

d.Any of the two can be melted first
Ans: [A]

22.Isoprenoid Is?

a.Precursor of alkaloids

b.Precursor of volatile oils

c.Degradation product of tannins

d.Used to make resins

Ans: [B]

23. One liter is equal to how many pints?

a.1.5

b.2.1

c.2.7

d.3.1

Ans: [B]

24. Volatile oils consist of?

a.Sesquiterpenes & polyterpenolds

b.Sesquiterpenes & lactones

c.Polyterpenolds & anthracene

d.Dianthrone & saponins

Ans: [A]

25. Carboxylic group of one amino acid is linked to the amino group of other amino acid by which linkage?

a.Glycosidic linkage

b.Peptide bond

c.Hydrogen bond

d.Covalent bond
Ans: [B]

26. According to USP-NF, dissolution testing of extended release tablets is carried out using which apparatus?

a.Paddle Method

b.Reciprocating Cylinder

c.Flow Through Cell

d.Paddle Over Disk

Ans: [B] 

27. Antidepressant that inhibits reuptake of serotonin & norepinephrine? 

a.Fluoxetine

b.Paroxetine

c.Venlafexine

d.Fluvoxamine

Ans: [C]

28. A point at which all three phases of a substance i.e. solid, liquid and vapor coexist in equilibrium with each other, is called? 

a.Critical point

b.Triple point

c.Isoelectric point

d.Boiling point

Ans: [B]

29. A cross sectional study is also known as?

a.Cohort study

b.Case control study

c.Epidemiological study

d.Follow-up study

Ans: [C]
Note: Cohort, cross sectional & case control are collectively called epidemiological studies.

30. Pharmaceutical care consists of how many components?

a) 2
b) 3
c) 4
d) 5
Ans: [B]

31. All statements about protein bound drugs are true EXCEPT:

a.It cannot be eliminated

b.It cannot be metabolized

c.It cannot leave vascular compartment

d.It is pharmacologically active

Ans: [D] 

32.A weakly acidic drug is best soluble in?

a.Acidic environment

b.Basic environment

c.Neutral environment

d.Buffer solutions

Ans: [B]

33. Responsible provision of drug therapy for the purpose of achieving definite outcomes that Improve patient's quality of life is called?

a)Clinical Pharmacy
b)Pharmaceutical care

c)Pharmacy practice

d)Clinical pharmacology

Ans: [B]

34. If manufactured tablets have more thickness than normal, It can affect?

a.Counting & Storage

b.Packaging & Transportation

c.Storage & Transportation

d.Counting & Packaging

Ans: [D]

35. Which of the following is NOT a part of pharmaceutical care?

a.Subjective Information
b.Care plan
c.Evaluation
d.Follow up
Ans: All are included in pharmaceutical care.

36.Traffic control during manufacturing of sterile preparations Includes?

a.Pharmacist

b.Technician

c.Labor

d.All of the above

Ans: [D]

37. Crude drug having emetic properties among the following?

a.Senna
b.Ipecac
c.Ergot
d.Colchicum
Ans: [B]

38.Medication errors can be avoided by ?

a.Research

b.Experiment

c.Observation

d.All of the above

Ans:[D]

39. Crude drug having bronchodilator properties among the following?

a.Glycyrrhiza
b.Cascara
c.Tea
d.Quassia
Ans: [C]

40.Which of the following represents milli-moles (mmol) of solute per liter of solvent?

a.Molarity

b.Molality

c.Normality

d.Osmolarity

Ans: [A]

41. Which of the following is NOT an example of medication error?

a.Wrong dose error

b.Omission error

c.Formulation error

d.Authorization error

Ans: [D]

42. Oral hypoglycemic having no systemic side effect?

a.Miglitol

b.Metformin

c.Gliclazide

d.Ploglitazone

Ans: [A]

43. Absorption of moisture by a drug on exposure with air Is called?

a.Efflorescence

b.Deliquescence

c.Hygroscopicity

d.Vaporization

Ans:[C]
Note: Hygroscopic drugs absorb moisture, Deliquescent drugs absorb so much water that these are converted to liquid.

44. Metabolism of phenytoin is increased by?

a.Cimetidine

b.Carbamazepine

c.Chloramphenicol

d.Glucagon

Ans: [B]

45. Two drugs having same pharmacological action when given together, produce?

a.Additive effect

b.Synergistic effect

c.Agonism

d.Antagonism

Ans: [A]

46. Transport across membranes along the concentration gradient with the help of macromolecules without the expense of energy Is called?

a.Active transport

b.Facilitated diffusion

c.Simple diffusion

d.Vesicular transport

Ans: [B]

47. Which of the following Is an example of unsaturated fatty acid?

a.Oleic acid

b.Omega-3

c.Arachidonic acid 

d.All of the above

Ans: [D]

48. Crude drug that is used as a bitter tonic among the following?

a.Eugenol

b.Quassia

c.Cinchona

d.Glycyrrhiza

Ans: Both Quassia [B] wood & Cinchona [C] bark are used as bitter tonic.

49. Nialamide Is pharmacologically classified as?

a.Selective Serotonin Reuptake
Inhibitor (SSRI)
b.Serotonin Norepinephrine Reuptake Inhibitor (SNRI)
c.Serotonin Dopamine Reuptake Inhibitor (SDRI)
d.Monoamine Oxidase Inhibitor (MAOI)
Ans: [D]

50. Most abundant neurotransmitter in ANS & CNS is?

a. Acetylcholine

b. Norepinephrine

c. Dopamine

d. Serotonin 

Ans: [A]

51. Atropine is a?

a.Strong Electrolyte

b.Weak Electrolyte

c.Non-Electrolyte

d.All of the above

Ans: [B]

52. Which of the following is responsible for patient's drug related needs? 

a.Clinical Pharmacist

b.Physician

c.Dietician

d.Nurse

Ans: [A]

53. Concept of optimizing patient care and consulting with other healthcare professionals is called?

a.Pharmacology

b.Clinical Pharmacy

c.Pharmaceutical Care

d.Clinical Pharmacokinetics 

Ans:[C]

54. Branch of pharmacy that deals with direct patient care by pharmacist is called?

a.Clinical Pharmacy
b.Pharmacoepidemiology 
c.Rheumatology
d.Biopharmaceutics
Ans: [A]

55. Benzoin is used as?

a.Purgative

b.Analgesic

c.Carminative

d.Anthelmintic

Ans: [B]

56. In 1900, Russian scientist Mikhail Tsvet Invented?

a.Chromatography

b.Spectrometry

c.Analytical Chemistry

d.Pharmacognosy

Ans: [A]

57. Peppermint Is an example of?

a.Phenolic Ether Volatile Oil

b.Aldehyde Volatile Oil

c.Ketonic Volatile Oil
d.Alcoholic Volatile Oil 

Ans: [D]

58. Cinchona is an example of?

a.Quinoline Alkaloids

b.Iso-Quinolone Alkaloids

c.Pyridine-Piperidine Alkaloids

d.Tropane Alkaloids

Ans: [A]

59. Storax is?

a.Viscid

b.Liquid

c.White

d.All of these 

Ans: [D]

60. Podophyllum is classified as?

a.Laxative

b.Emetic

c.Anticancer

d.Stimulant

Ans: [A] 

61. Concentration of drug fluctuates between maximum or peak concentration and lowest or trough concentration; is called?

a.Therapeutic Window

b.Duration of Action

c.Steady State

d.Half-Life 

Ans: [A]

62 . Therapeutic Index is also known as?

I. Therapeutic Ratio

II. Therapeutic Window 

III. Safety Window

a. I only

b. ll only

c. I & lll only

d. l, ll & III

Ans: [D]

63. As compared to large molecules, small molecules move across cell membranes ?

a.With mild ease
b.With more ease
c.With more difficulty
d.With equal difficulty

Ans: [B]

64.Autacoids act in the body?

I. Near the site of production
Il. By travelling through blood
III. In similar fashion to hormones
a.I only
b.ll only
c.I & III only
d.l, 11 & III

Ans: [A]
Note: Autacolds are also called local hormones.

65.Based on thermodynamics, how many isomers does a molecule have?

a.2

b.3

c.4

d.5

Ans:[A]

66.Maltose consists of?

a.Glucose + Galactose

b.Glucose + Fructose

c.Glucose + Glucose

d.Fructose + Fructoze

Ans: [C]

67.All of the following are true about peptones EXCEPT?

a.Insoluble in water

b.Not precipitated by heat

c.Not precipitated by ammonium chloride

d.Precipitated by phosphotungustic acid

Ans:[A]

68. Alkaloids are in nature? 

a.Acidic

b.Basic

c.Neutral

d.Highly Acidic

Ans:[B]

69. Hydrolysis of glycosides yield?

a.Glycone

b.Aglycone 
c.Resins
d.Tannins
Ans: Hydrolysis of glycosides gives both glycone & aglycone.

70. Phase O Clinical Trials are?

a.1st in human trials

b.2nd in human trials

c.3rd in human trials

d.4th in human trials

Ans: [A)
Note: Also known as "Human Micro dosing Trials"

71.Study and monitoring of side effects of drugs Is called?

a.Pharmacovigilance

b.Pharmacogenetics

c.Pharmacoeconomics

d.Drug Utilization Review

Ans: [A]

72.RLD in context of pharmacy stands for?

a.Relative Lethal Dose

b.Reference Listed Drug Products

c.Receptor-Ligand Drug Complex
d.Right Left Drug System
Ans: [B] 

73. Botanical family of Glycyrrhiza is?

a.Liliaceae

b.Leguminosae

c.Papaveraceae

d.Scrophulariaceae

Ans: [B]

74. Most widely used alkaloid of opium (poppy) is? 

a.Codeine

b.Heroin
c.Morphine
d.Thebaine 

Ans:[C]

75. Tertiary alcohols are oxidized to compounds with?

a.Same molecular mass

b.Higher molecular mass

c.Lower molecular mass

d.Half molecular mass

Ans: Tertiary alcohols are resistant to oxidation.

76.Boiling points of alcohol's in descending order?

a.Tertiary, Secondary, Primary

b.Primary, Secondary, Tertiary

c.Tertiary, Primary, Secondary

d.Primary, Tertiary, Secondary

Ans: [B] 

77. Paints are?

a.Liquid

b.Solid

c.Semi Solid

d.Gaseous

Ans: [A]

78. Turpentine oil is an example of?

a.Phenolic ether volatile oils

b.Hydrocarbon volatile oils

c.Aldehydic volatile oils

d) Ketonic volatile oils

Ans: [B]

79. Vegetable oils and pectin are obtained from?

a.Plants only

b.Animals only

c.Plants & animals

d.Birds only

Ans: [A]

80. Deoxy sugars have?

a.Less oxygen

b.No oxygen

c.More oxygen

d.Abundant oxygen

Ans: [B]

81. Which of the following is a ketose sugar?

a.Dihydroxyacetone

b.Glycolaldehyde

c.Ribose

d.Xylose

Ans: [A]
Note: Dihydroxyacetone is triose ketose sugar. 

82. Which of the following is NOT a ketose sugar?a.Ribulose

b.Erythrulose

c.Glucose

d.Sorbose

Ans: [C]
Note: Erythrulose (tetrose), Ribulose
(pentose), Sorbose (hexose) ketose.

83.Which of the following property determines whether a given formulation is accepted or rejected?

a.Stability

b.Solubility

c.Dissolution

d.Disintegration

Ans: [C]

84. Urea is classified as?

a.Thiazide diuretic

b.Loop diuretic

c.Osmotic diuretic

d) Carbonic anhydrase inhibitor

Ans: [C]

85. Time period during which drug concentration is above Minimum Effective Concentration (MEC) but below Minimum Toxic Concentration (MTC) is called?

a.Onset time

b.Offset time

c.Half-life

d.Duration of action 

Ans: [D]

86.Ephedrine is classified as?

a.Proto-alkaloid

b.True alkaloid

c.Pseudo-alkaloid

d.Glycoside

Ans: [C]

87. Morphine is classified as?

a.Proto-alkaloid

b.True alkaloid
c.Pseudo-alkaloid
d.Glycoside
Ans: [B] 

88.In solanaceous alkaloids, which bond is hydrolysable?

a.Hydroxyl

b.Ester

c.Carbonyl
d) Ether
Ans: [B]

89. Belladonna belongs to which class of alkaloids ?

a.Purine

b.Indole

c.Tropane

d.Quinoline

Ans: [C]

90.Urginea maritima is the biological name of?

a.Cascara

b.White squill

c.White onion

e.Red onion

Ans: [B]

91.Gums are made up of?a.Sugar + Citric Acid

b.Sugar + Benzoic Acid

c.Glucose + Citric Acid

d.Glucose + Tannic Acid

Ans: [A]

92. Barbaloin is obtained from which crude drug?

a.Aloe

b.Rhubarb

c.Quassia

d.Senna 

Ans: [A]

93. Table sugar is?

a.Glucose

b.Fructose

c.Sucrose

d.Maltose 

Ans:[C]

94. Aloe belongs to which botanical family?

a.Liliaceae
b.Leguminosae
c.Apocynacae
d.Scrophulariacae 

Ans: [A]

95. Botanical source of senna is?

a.Cassia fistula
b.Cassia angustifolia
c.Prunus serotina
d.Brassica nigra
Ans: [B]

96. Carbohydrate consumed to give energy is?

a.Starch
b.Cellulose
c.Glucose
d.Fructose
Ans: [C]

97. Most widely used root & rhizome drugs are obtained from plants?

a.Monocotyledonous

b.Dicotyledonous

c.Both a & b

d.None of these

Ans: [B]

98.Extraction from soft crude drugs is done by?

a.Infusion

b.Decoction

c.Double maceration

d.Reserved percolation 

Ans: [A]

99. Chromatography is a ___ of HPLC?

a.Part

b.Stage

c.Component

d.Segment

Ans: [A]

Note: Actually HPLC is a type of chromatography. Question statement is wrong.

100.Official Compendia are of types?

a.2

b.3

c.4

d.5

Ans: [2]
Note: Pharmacopoeia & National Formulary.

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