DRAP Preparation Mock Exam 1

DRAP Mock Exam (Forensic Pharmacy)

Subject: Forensic Pharmacy

- - Questions Type: Multiple Choice Questions (MCQs)
  - Total number of questions: 84
  - Total number of pages: 2 (each contain 50 questions)
  - Total time: 1hr & 24min
  - All questions carry equal marks.
  - There is no negative marking.
  - Result: After test submission you can see your score and the number of questions attempted and all the questions with their correct answers.

Syllabus:

– DRAP Act 2012
– Drugs Act 1976
– The ethical marketing to healthcare professionals rules 2021.

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Credit:

PEG (Pharmacy Exam Guide) Team

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Start DRAP Preparation Mock Exam 1

Name

Phone

What is the purpose of The Drug Regulatory Authority of Pakistan Act, 2012?

To provide for the establishment of the Drug Regulatory Authority of Pakistan

To regulate the import and export of therapeuMc goods

To establish a medical research center in Pakistan

To promote inter-provincial trade and commerce of pharmaceuMcal products

Which of the following is NOT considered as "Therapeutic goods" under the Act?

Drugs

Medical Devices

Alternative Medicine

Agricultural products

What is the role of the Appellate Board under The Drug Regulatory Authority of Pakistan Act, 2012?

To manufacture therapeuMc goods

To regulate the pricing of drugs

To handle appeals against decisions of the Licensing Board or the Registration Board or Pricing Commitee

To oversee inter-provincial trade and commerce of therapeutic goods

Who has the authority to establish the Drug Regulatory Authority of Pakistan?

Federal Government

Provincial Assemblies

Ministry of Health

World Health Organization

How many members does the Policy Board consist of?

10 members

12 members

15 members

18 members

Which Division is responsible for the evaluation, assessment, and registration of pharmaceutical drugs for human beings and animals?

Division of Drug Licensing

Division of Medical Devices and Medicated Cosmetics

Division of PharmaceuMcal Evaluations and Registration

Division of Biological Evaluation and Research

What is the age requirement for the Chief Executive Officer (CEO) of the Authority?

30 to 45 years

40 to 55 years

50 to 60 years

Not less than 45 years and not more than 56 years

What is the tenure of the CEO's appointment, and how many times can it be extended?

1 year, extendable for 1 more year

2 years, extendable for 2 more years

3 years, extendable for 1 more year

4 years, extendable for 2 more years

What is the purpose of the Drug Regulatory Authority of Pakistan Fund?

To invest in government schemes

To provide pensions to Authority employees

To meet expenses incurred in carrying out Authority functions

To finance the Central Research Fund

10.

Which of the following is NOT a source of financing the Drug Regulatory Authority Fund?

Grants and loans from national and international agencies

Charges and fees collected by the Authority

Proceeds from the sale of non-essential assets

Donations and endowments

11.

The Central Research Fund fee collected by the Authority will be utilized for:

Paying salaries to Authority employees

Investing in government schemes

Conducting research in the pharmaceutical industry

Funding pensions for retired employees

12.

The Authority shall levy and collect fees for its functions at rates determined by:

The Federal Government

The Policy Board with the approval of the Board

The CEO of the Authority

The Provincial Government

13.

The Authority may open its accounts with:

Any registered chartered accountant

Any scheduled Bank or financial institution within the prescribed rules

The Federal Government

Any financial institution

14.

Who is responsible for carrying out the audit of the Authority's accounts?

The Federal Government

The Authority's CEO

The Auditor General of Pakistan

One or more registered chartered accountants

15.

What action should the Authority take in response to objections raised by the Auditor-General?

Provide a copy of the audit report to the Federal Government

Seek approval from the Policy Board

Rectify the objections raised by the Auditor-General

Ignore the objections if they are not significant

16.

Who has the authority to make rules for carrying out the purposes of the DRAP Act 2012?

The Policy Board

The CEO of the Authority

The Federal Government with approval from the Authority

The Authority with the approval of the Federal Government

17.

Within what time frame should the Authority submit its annual report to the Federal Government?

One month

Three month

Six months

One year

18.

What is the penalty for a person who fails to provide information requested by the Authority?

Imprisonment for up to 6 months

A fine not exceeding one hundred thousand rupees

Suspension from the Authority

Termination from their job

19.

In case of inconsistency between the provisions of the DRAP Act and any other law, what takes precedence?

The other law

The recommendaMon of the Board

The DRAP Act

The President's approval

20.

What is the purpose of Schedule-III of the DRAP Act?

To specify penalties for contravention of provisions in Schedule-II

To list the offenses specified in the Act

To list drugs and substances regulated by the Authority

To provide information about the Board's decisions

21.

If any difficulty arises in giving effect to any provision of the DRAP Act, who has the authority to remove the difficulty?

The Authority's CEO

The Inspector

The Federal Government

The Policy Board

22.

Which of the following is NOT included in the definition of "Biologicals" under Schedule-I?

Blood products such as Plasma and Albumin

Anti-inflammatory drugs for topical use

Vaccines, including live and inactivated viral vaccines

Biotechnology products manufactured using recombinant DNA technology

23.

What is the definition of "Biological Drugs (Ready-to-fill form)" under Schedule-I?

Biological Drugs filled and labeled at one site

Biological Drugs stored as a Concentrated-Bulk at controlled temperatures

Biological Drugs that require standardization by biological assays

Biological Drugs manufactured at one site but filled and labeled at another site

24.

What is the meaning of "Reference Biotherapeutic Product (RBP)" under ScheduleI?

A biosimilar biological drug with relevant differences in quality, safety, and efficacy

A biological drug product stored in Concentrated-Bulk form

An originator biological drug licensed on the basis of a full registration dossier

A biological drug manufactured using recombinant RNA technology

25.

What substances are NOT included in the definition of "Drug" under Schedule-I?

Medicinal products prepared according to Ayurvedic system

Substances used for the destruction of vermin and insects

Medical devices for diagnosis and monitoring of diseases

Substance prepared according to Chinese system of treatment

26.

What are "Medical Devices" under Schedule-I?

Instruments used for cleaning and disinfection in residential areas

Any substances listed in the Pakistan Pharmacopoeia

Cosmetics containing drugs for beautifying and altering the appearance

Medical equipment intended for diagnosis, monitoring, and treatment of diseases

27.

What are "Medicated Cosmetics" under Schedule-I?

Cosmetics containing active drug ingredients for topical use

Articles intended for use as a component of medical devices

Articles containing active drug ingredients for oral administration

Articles intended for use in the treatment of diseases

28.

Which of the following substances would NOT be considered a "Medicated Cosmetic"?

Face cream containing an active drug ingredient for acne treatment

Body lotion containing a drug for skin irritation relief

Soap with moisturizing properties

Shampoo with added antifungal drug for scalp health

29.

Which of the following actions related to therapeutic goods is PROHIBITED under Schedule-II?

Selling therapeutic goods without a valid license

Advertising any substance used in the Ayurvedic system of treatment

Distributing therapeutic goods as samples without proper authorization

Importing therapeutic goods with the correct batch number

30.

What is the penalty for selling a drug in the finished form over and above the maximum retail price fixed by the Federal Government?

Suspension of the seller's business license

Confiscation of all the drugs in possession of the seller

Monetary fine as determined under the Drug Pricing Policy

Imprisonment for a period specified in the Act

31.

What does the term "Advertise" mean under Schedule-II?

Displaying sign boards for hospitals and clinics

Promoting the sale of therapeutic goods indirectly

Making any representation to promote a treatment for a disease

Distributing therapeutic goods for promotional purposes

32.

Under Schedule-II, what is allowed in terms of distributing therapeutic goods as samples?

Distribution of therapeutic goods as samples without any restrictions

Distribution of therapeutic goods as samples without a license

Distribution of therapeutic goods as samples in small quantities for personal use

Distribution of therapeutic goods as samples in accordance with prescribed conditions

33.

What is the condition under which printing of labeling for therapeutic goods is allowed under Schedule-II?

Printing labeling for any therapeutic good without a license

Printing labeling for therapeutic goods that are not registered under this Act

Printing labeling for therapeutic goods imported through an indenter

Printing labeling for any therapeutic good for personal use only

34.

What is the punishment for a person who exports, imports, manufactures for sale, or sells any spurious therapeutic good or any unregistered therapeutic good?

Imprisonment for a term between three to ten years and a fine of up to ten lakh rupees

Imprisonment for a term between one to five years and a fine of up to one lakh rupees

Imprisonment for a term between five to seven years and a fine of up to five lakh rupees

Imprisonment for a term up to one year and a fine of up to one lakh rupees

35.

What is the penalty for a person who obstructs an Inspector in the exercise of any power conferred upon him under the Act?

Imprisonment for a term between one to five years and a fine of up to one lakh rupees

Imprisonment for a term up to one year and a fine of up to one lakh rupees

Imprisonment for life or imprisonment between five to ten years and a fine of up to five hundred thousand rupees

Imprisonment for a term up to seven years and a fine of up to five lakh rupees

36.

What is the punishment for violating any prohibitions specified in Schedule-II of the DRAP Act?

Imprisonment for a term up to five years and a fine of up to five hundred thousand rupees

Imprisonment for life or imprisonment between five to ten years and a fine of up to five hundred thousand rupees

Imprisonment for a term between three to ten years and a fine of up to ten lakh rupees

Imprisonment for a term up to one year and a fine of up to one lakh rupees

37.

What is the penalty for a subsequent offense under Clause (1) of Schedule-III?

Imprisonment for life or imprisonment between five to ten years and a fine of up to five hundred thousand rupees

Imprisonment for a term between one to five years and a fine of up to one lakh rupees

Imprisonment for a term up to one year and a fine of up to one lakh rupees

Imprisonment for a term up to seven years and a fine of up to five lakh rupees

38.

What is the penalty for giving a false warranty in respect of any therapeutic good or applying a warranty given for another therapeutic good?

Imprisonment for life or imprisonment between five to ten years and a fine of up to five hundred thousand rupees

Imprisonment for a term between one to five years and a fine of up to one lakh rupees

Imprisonment for a term up to one year and a fine of up to one lakh rupees

Imprisonment for a term up to seven years and a fine of up to five lakh rupees

39.

Who has the power to institute a prosecution for a contravention of any provision of the DRAP Act, 2012, and The Drugs Act, 1976?

Drug Court

Licensing Board

Provincial Inspector

Federal Inspector

40.

Which of the following offenses punishable under Schedule-III is non-cognizable?

Offenses mentioned in Clause (1) of that Schedule

Offenses mentioned in Clause (2) of that Schedule

Offenses mentioned in Clause (3) of that Schedule

Offenses mentioned in Clause (4) of that Schedule

41.

Which court shall try an offense punishable under the DRAP Act, 2012, and The Drugs Act, 1976?

High Court

Provincial Court

Federal Court

Drug Court

42.

What does an Inspector require from a person during a search or seizure under Schedule-V?

Name and address

Witness statements

Information about other drugs

Signature on a receipt for the seized goods

43.

Which power of the Inspector requires specific authorization by the Government?

Inspection of premises

Seizing therapeutic goods and materials

Requiring persons to appear and give statements

Locking and sealing premises

44.

Where should one portion of a sample taken by an Inspector be sent for test and analysis?

To the Provincial Quality Control Board

To the Chairman, Licensing Board

To the Government Analyst concerned

To the Registration Board

45.

When an Inspector seizes a therapeutic good containing any filthy or putrid substance, vermin, worm, etc., what should he do with the seized therapeutic good?

Return it to the person from whom it was seized

Dispose of it within seven days

Send it to the Drug Court for further action

Send it to the Provincial Quality Control Board

46.

What is the maximum period for which an Inspector can forbid a person in charge of premises from removing or dispensing therapeutic goods?

Two weeks

One month

Three months

Six months

47.

When does an Inspector need to divide a sample into three portoons instead of four?

When the sample is taken from a registered manufacturer

When the sample is taken from premises where the drug is manufactured

When the sample is taken from a licensed retailer

When the sample is taken from premises where the drug is sold

48.

Who can revoke an order passed under Section 32 of the DRAP Act, 2012?

Provincial Quality Control Board

Licensing Board

Registration Board

Federal Inspector

49.

What should an Inspector do if he finds that the therapeutic good does not contravene any provisions of the Act?

Inform the Provincial Inspector

Inform the Board concerned and revoke the order

Inform the Federal Inspector

Seek further orders from the Drug Court

50.

When a Federal Inspector is not competent to take action under Schedule-IV, what should he do?

Seek approval from the Licensing Board

Seek approval from the Provincial Inspector

Seek approval from the Drug Court

Report the matter and hand over the case to the Provincial Inspector

51.

The Drugs Act, 1976 extends to which of the following areas?

Whole of Pakistan

Federal Government offices only

Provincial capitals only

Rural areas only

52.

What does the term "generic name" of a drug refer to?

Name given by the manufacturer

Non-proprietary, scientific, or official name approved by the Federal Government

Brand name given by the retailer

Name mentioned in the local pharmacy's inventory

53.

Which of the following is NOT included in the definition of a "drug" under the Act?

Pesticides causing health hazards

Medicines used exclusively in the ayurvedic system

Substances mentioned in pharmacopoeia or formulary

Surgical ligatures and sutures

54.

What is the primary purpose of the "expiry date" on the label of a drug?

To indicate the manufacturing date

To provide information about the drug's price

To identify the batch number

To indicate the expected loss of efficacy, safety, quality, or potency

55.

What is the consequence of selling a "spurious drug" as per the Drugs Act, 1976?

Suspension of business for one year

Fine imposed by the local authorities

Immediate shutdown of the pharmacy

Legal action including prosecution and imprisonment

56.

Who regulates the import and export of drugs according to the Drugs Act 1976?

Provincial Governments

Drug Manufacturers

Federal Government

Drug Retailers

57.

In which countries should drugs be on sale before being imported to Pakistan?

Western European countries

USA, Japan, and Australia

Any country specified by the Federal Government

All of the above

58.

Which board is responsible for regulating the grant of licenses to manufacture drugs?

Central Licensing Board

Provincial Quality Control Board

Registration Board

Appellate Board

59.

Which body is responsible for setting up the Pakistan National Formulary?

Central Licensing Board

Provincial Quality Control Board

Federal Government

Appellate Board

60.

What is the purpose of the Appellate Board mentioned in the Drugs Act 1976?

To regulate the sale of drugs

To register drugs in accordance with prescribed conditions

To dispose of appeals from persons aggrieved by decisions of certain boards

To fix maximum prices of drugs

61.

According to the Act, how many portions should a sample of a drug be divided into?

Three portions

Four portions

Five portions

Six portions

62.

Which authority can cancel or suspend the registration of a drug if certain conditions are met?

Provincial Quality Control Board

Central Licensing Board

Registration Board

Drug Court

63.

What is the maximum punishment for exporting, importing, manufacturing, or selling a spurious drug or an unregistered drug?

Imprisonment for a term of not less than one year and fine up to fifty thousand rupees

Imprisonment for a term of three to ten years and a fine up to one lakh rupees

Imprisonment for life or imprisonment of five years and a fine up to two lakh rupees

Imprisonment for a term of not less than two years and a fine up to fifty thousand rupees

64.

What does the term "advertise" mean in the context of the Drugs Act 1976?

To sell any drug through online platforms

To promote the sale or disposal of a drug directly or indirectly

To display sign boards for clinics or hospitals offering treatment

To manufacture any drug without a valid license

65.

Under which section of the Drugs Act 1976, the Drug Court may order the forfeiture of drugs or substances involved in an offense?

Section 27

Section 28

Section 29

Section 30

66.

In what circumstances shall a drug not be deemed misbranded or adulterated?

If it contains any innocuous substance or ingredient for increasing its bulk, weight, or measure

If it contains any harmless substance or ingredient for making the drug fit for carriage or consumption

If it contains any decomposed substance resulting from a natural process of decomposition

If it contains any substance for concealing its inferior quality

67.

Who shall not be liable for a contravention of Section 23 of the Drugs Act 1976?

A person who imports a drug without a proper license

A person who sells a drug without having a warranty in the prescribed form

A person who peddles, hawks, or offers for sale any drug in a public place

A person who acquires the drug from a duly licensed manufacturer or his authorized agent under a written warranty

68.

What kind of offense is non-cognizable under the Drugs Act 1976?

Offense mentioned in Section 27(1)

Offense mentioned in Section 27(2)

Offense mentioned in Section 27(3)

Offense mentioned in Section 27(4)

69.

Who may prefer an appeal to a Bench of the High Court against a decision of the Drug Court?

The accused person convicted under Section 27(1)

The Drug Court Chairman

The licensing authority

The Federal Government

70.

Which authority has the power to make rules for carrying out the purposes of the Drugs Act 1976?

The Central Licensing Board

The Provincial Government

The Federal Government

The Drug Court

71.

What is the purpose of prescribing the specifications of drugs in the rules?

To regulate the import and export of drugs

To control the manufacture and sale of drugs

To determine the prices of drugs in the market

To specify the quantity of drugs that can be sold to a patient

72.

Under the rules, what can the Federal Government do to secure and maintain supplies of drugs at reasonable prices?

Fix prices, commissions, and discounts of drugs

Impose additional taxes on drug manufacturers

Restrict the import and export of drugs

Prohibit the advertising of certain drugs

73.

Which power is given to the Provincial Government in making rules under the Drugs Act 1976?

Power to establish the Federal Drug Laboratory

Power to regulate the manufacture of drugs for export

Power to issue licenses for drug imports

Power to regulate the sale and distribution of drugs

74.

Which Acts or Ordinances are repealed by the Drugs Act 1976?

Drugs Act, 1940 and Drugs Ordinance, 1976

Drugs Act, 1940, Drugs (Generic Names) Act, 1972, and Drugs Ordinance, 1976

Drugs Act, 1940 and Drugs (Generic Names) Act, 1972

Drugs Act, 1940, and Drugs (Generic Names) Act, 1972, and Drugs Act, 1940

75.

What happens to the licenses issued under the Drugs Act, 1940, after the repeal of the Act?

All licenses become invalid immediately after the repeal.

Licenses for import or export will continue to be valid until new rules are framed under the Drugs Act 1976

Licenses for manufacture will be transferred to the Drug Court.

All licenses will be revalidated by the Central Licensing Board.

76.

What does "demonstration product" refer to in the rules?

Product provided for human use, either as free samples or loans

Product that healthcare professionals can prescribe, recommend, purchase, or supply

Product used for training healthcare professionals or patient education

Product used for conducting clinical trials

77.

What is the purpose of ethical interactions between companies and healthcare professionals, according to the rules?

To increase sales transacMons and revenue for companies

To provide extravagant gifts and entertainment to healthcare professionals

To ensure that medical decisions are made in the best interest of the patient

To promote innovation and development of medical technologies through unethical collaborations

78.

According to the rules, what is the key purpose of consulting arrangements between companies and healthcare professionals?

To provide financial support to healthcare professionals for personal expenses

To enhance the quality and efficacy of patient care through collaboration

To ensure healthcare professionals prescribe specific therapeutic goods

To influence the purchase of medical technologies

79.

Which type of conference can companies support through grants to conference organizers or institutions?

Business conferences for promoting company products

Recreational conferences for healthcare professionals

Educational conferences for promoMng scientific knowledge and medical advancement

Entertainment conferences for patients and healthcare professionals

80.

What conditions should be met for companies to provide medical technology for demonstration and evaluation purposes?

The product should be provided free of charge with no restrictions.

The evaluation product should be provided in large quantities to healthcare professionals.

Demonstration products should be provided in quantities that healthcare professionals can purchase.

Loaned product should be retrieved or returned if not purchased by the end of the evaluation period.

81.

What should companies do to ensure effective implementation of the Ethical Marketing to Healthcare Professionals Rules?

Hire external auditors to evaluate healthcare professionals' compliance.

Ensure that sales representatives control decision-making for grants and donations.

Encourage employees to report breaches of the rules but not provide any safe mechanisms for reporting.

Provide ongoing training and education on the code of conduct and company policies.

82.

How should companies handle consulting arrangements with healthcare professionals?

Healthcare professionals should be selected based on the volume of business generated by them.

Healthcare professionals should be reimbursed in advance for their services

Compensation to healthcare professional consultants should be paid only for the services actually performed.

Consulting arrangements should be made directly between the company and the healthcare professional's spouse.

83.

According to the rules, what is the acceptable mode of payment for grants and donations made by companies?

Cash payments

Electronic bank transfer or cross cheques

Gig cards

Direct reimbursement of expenses

84.

What is the punishment for contravening any provision of the Ethical Marketing to Healthcare Professionals Rules?

Warning and a fine

Suspension of business operations

Imprisonment

Monetary penalty as per the Act and Schedules made thereunder

DRAP Preparation Mock Exam 1

DRAP Mock Exam (Forensic Pharmacy)

Subject: Forensic Pharmacy

Syllabus:

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