DRAP Preparation Mock Exam 2

DRAP Mock Exam 2 (Forensic Pharmacy)

Subject: Forensic Pharmacy

- - - Questions Type: Multiple Choice Questions (MCQs)
    - Total number of questions: 80
    - Total number of pages: 2 (each contain 50 questions)
    - Total time: 1hr & 20min
    - 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:

The Drugs Licensing, Registration & Advertising Rules,1976

The Drugs (Appellate Board) Rules, 1976

The Drugs (Import & Export) Rules, 1976

The Drugs (Federal Inspectors, Federal Drug Laboratory and Federal Government Analysis) Rules, 1976

Drugs (Specifications) Rules, 1978

The Drug Research Rules, 1978

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Phone

What is the purpose of an "airlock" in pharmaceutical manufacturing?

It's a type of packaging material used for transporting drugs.

It's a defined quantity of starIng material in a single process.

It's an enclosed space with controlled airflow used to maintain cleanliness between rooms.

It's a type of sterilizaIon process used in drug manufacturing

What does the term "batch number (or lot number)" refer to?

The quanIty of finished products in a single container.

The unique idenIfication code for a specific manufacturing process.

The number of stages involved in the production of a pharmaceutical product

The defined quantity of starting material, packaging material, or finished product processed together.

Which term refers to the set of operations that establish the relationship between values indicated by an instrument and known reference standards?

Calibration

Validation

Compounding

Reconciliation

What are the types of licences to manufacture drugs under Drugs Licensing, Registering & Advertising rules 1976?

Licence to manufacture only by way of basic manufacture.

Licence to manufacture only by way of formulation.

Licence to manufacture by way of basic manufacture, semi-basic manufacture, formulation, repacking, and for experimental purposes.

Licence to manufacture only by way of repacking.

What is the maximum duration of a licence issued under Drugs Licensing, Registering & Advertising rules 1976?

1 year

2 years

3 years

5 years

What is the purpose of a separate application for manufacturing drugs on more than one set of premises?

To ensure different types of licences are issued.

To streamline the licensing process.

To ensure each set of premises complies with rules

To facilitate communication with the Central Licensing Board.

What form should be used for applying for the grant or renewal of a licence to manufacture drugs?

Form 2

Form 1 or l-A

Form 3

Form A-1

What condition must be met for an application for renewal of a licence to be entertained?

It must be submitted within thirty days after the expiry of the licence.

It must be submitted within ninety days after the expiry of the licence.

It must be submitted within sixty days after the expiry of the licence.

It must be submitted before the expiry of the licence.

Which authority is responsible for issuing licences to manufacture drugs by way of repacking under section 18 of ordinance in a province?

Central Licensing Board

Federal Government

Provincial Health Department

Central Board of Revenue

10.

What is the role of the Quality Control Department in the manufacturing process?

Oversee the financial aspects of manufacturing.

Monitor the licensing process for compliance.

Ensure proper waste disposal in the manufacturing premises.

Carry out tests of the strength, potency, quality, and purity of substances used in manufacturing

11.

What are the conditions that the Central Licensing Board must ensure are complied with before granting or renewing a licence to manufacture drugs by way of basic or semi-basic manufacture?

The applicant's financial standing and credit history.

The applicant's social connections and networking.

The suitability of the premises, adequate equipment, and competent technical staf

The applicant's prior experience in the pharmaceuIcal industry.

12.

In what type of premises should the manufacturing of drugs by way of basic or semi-basic manufacture take place?

Small and easily accessible locations.

Any area free from any source of light.

Locations with convenient access to main roads.

Suitable premises in size, construction, and free from contaminaIon sources.

13.

What degree qualifications are required for the competent technical staff involved in the manufacture of drugs by way of basic or semi-basic manufacture?

Any science-related degree.

A degree in medicine or veterinary sciences

A degree in business administraIon.

A degree in pharmacy, medicine, science with chemistry, or chemical engineering.

14.

What is the role of the Quality Control Department in the manufacturing process?

Ensuring that manufacturing premises are cluttered and untidy

Conducting marketing research for the manufactured drugs

Checking the packaging and labeling of drugs.

Carrying out tests of the strength, potency, quality, and purity of substances used in manufacturing.

15.

What is the purpose of the Central Research Fund mentioned in the Drugs Licensing, Registering & Advertising Rules 1976?

To fund adverIsing campaigns for pharmaceuIcal products.

To support research and development activities related to new drugs.

To provide financial support for the Central Licensing Board's operations.

To distribute profits among pharmaceutical companies.

16.

Under what conditions is contract manufacture permissible?

Only for pharmaceutical companies with a global presence.

Only for manufacturers with a history of successful contracts.

For manufacturers with valid drug manufacturing licenses and proper facilities

For manufacturers who have received approval from foreign regulatory authorities.

17.

What information should be included in the written contract between the contract giver and contract acceptor for contract manufacture?

An inventory of personal belongings of the employees.

Detailed personal information of the employees.

A clear description of their respective responsibilities and technical arrangements.

A list of suppliers of raw materials

18.

What is the purpose of the license to manufacture drugs for experimental purposes?

To manufacture drugs for regular commercial distribution.

To conduct marketing research for new drugs.

To test the safety and efficacy of drugs under controlled conditions.

To manufacture drugs for internaIonal distribution.

19.

What labeling requirements apply to drugs manufactured for experimental purposes?

No labeling is required for experimental drugs.

The labels must indicate the drug's generic name and commercial purpose.

The labels must contain only the name of the manufacturer

The labels must include the manufacturer's contact information

20.

What authority is responsible for inspecting and regulaying the manufacturing of drugs under 1976 rules?

The Federal Tax Authority

The Central Research Institute

The National Security Council.

The Central Licensing Board.

21.

What is the term of office for members of the Registration Board?

2 years

3 years

5 years

7 years

22.

In which situations may the Registration Board provisionally register a drug for a period of two years?

When the drug has already been registered in another country

When the drug is a new invention

When the drug is a life-saving medication

When the drug's efficacy is not yet established

23.

What is the fee for the renewal of registration of a new drug?

Rs. 1000

Rs. 2000

Rs. 3000

Rs. 5000

24.

What must be included in the labelling and promotion of a registered drug?

Details of the manufacturing process

Scientific research references

Dosage and side effects

Marketing slogans

25.

When can deviations be made from the information submitted during the registration of a drug?

Deviations are never allowed

Deviations are allowed only for imported drugs

Deviations can be made after obtaining prior approval from the Registration Board

Deviations can be made only for over-the-counter drugs

26.

Who is responsible for maintaining records of quarterly production and disposal of a drug?

Chairman of the Central Licensing Board

Secretary of the RegistraIon Board

Provincial Inspector

Chairman of the Registration Board

27.

In which circumstances may the Registration Board register a drug on its own motion?

When there is a shortage of that drug in the market

When the manufacturer insists on it

When there are multiple applications for the same drug

When it's necessary in the public interest

28.

What is the purpose of the Committee on Drugs Evaluation?

To conduct clinical trials of new drugs

To evaluate the efficacy of registered drugs

To inspect manufacturing facilities

To evaluate the expertise of registration applicants

29.

How often must records of quarterly production and disposal of a drug be supplied to the Chairman of the Registration Board?

Monthly

Annually

Every 6 month

Every quarter

30.

What ethical criteria should be followed for medical drug promotion?

As long as the drug is safe, any promotional methods are acceptable

Ethical criteria are not required for drug promotion

Ethical criteria are determined by the manufacturer

Follow the criteria given in Schedule G

31.

What is the maximum duration for which the approval of an advertisement under sub-rule (1) is valid?

1 year

3 years

2 years

5 years

32.

In what situations can a drug or substance be advertised to the medical, pharmaceutical, and allied professions without referring to the Federal Government?

Only through professional journals

Only through documentary films

Through press adverIsements

Through medical representatives or professional journals

33.

Which of the following statements about advertisement material is NOT true?

AdverIsement material should contain informaIon on side effects.

Advertisement material should present claims in accordance with those approved for registration.

Advertisement material should use superlatives to describe the product.

Advertisement material should avoid making exaggerated claims.

34.

What condition must be met for a drug or substance to be advertised through press without reference to the Federal Government?

The advertisement must be intended to inform the public about the availability of the drug.

The advertisement must mention the maximum retail price of the drug.

The advertisement must be limited to mentioning the drug's name and manufacturer.

The advertisement must be approved by the Drug Administration of the Health Division.

35.

What is the maximum allowable retailer's discount for drugs?

10%

20%

15%

36.

What is the definition of "promotion" for the purposes of Schedule G of 1976 Rules?

Inducing prescription, supply, purchase, and use of medicinal drugs

Exclusively providing information about medicinal drugs

Generating awareness about medicinal drugs in the general public

Advertising only to health care professionals

37.

Which of the following criteria should promotional claims about drugs adhere to?

Claims should be misleading, omissive, and exaggerated

Claims should not contain scientific data and should be vague

Claims should be reliable, accurate, truthful, and substantiated

Claims should be solely based on the manufacturer's opinion

38.

According to the Drug Licensing, Registering & Advertisement rules 1976, what type of information should advertisements to physicians and health-related professionals be consistent with?

Celebrity endorsements and testimonials

Claims that cannot be substantiated

Approved scientific data sheet or similar document

The manufacturer's creative vision

39.

Under what conditions are drug advertisements to the general public generally permitted?

To promote prescription drugs for serious condiIons treated by qualified health practioners

For over-the-counter drugs available without a prescription

Only for scheduled narcotic and psychotropic drugs

To encourage self-medication and drug dependency

40.

What is the purpose of the criteria regarding medical representatives?

To limit the number of representatives employed by pharmaceutical companies

To ensure that medical representatives have limited medical knowledge

To ensure that medical representatives provide biased information

To ensure that medical representaIves are knowledgeable, honest, and ethical

41.

What is the short title of the rules that govern the Drugs Appellate Board?

Drugs Regulatory Authority Rules, 1976

Drugs Appellate Board Act, 1976

Drugs (Appellate Board) Rules, 1976

Drugs Appeal and Review RegulaIons, 1976

42.

Who serves as the ex-officio Chairman of the Appellate Board?

Director Legal Affairs, Drug Regulatory Authority of Pakistan

Secretary of Health Department, Punjab

Chief Executive Officer of the Drug Regulatory Authority of Pakistan

One professor of medicine nominated by the Authority

43.

How long do members, other than ex-officio members, of the Appellate Board hold office for initially?

One year

Two years

Three years

Four years

44.

What is the maximum time limit for submieng an appeal to the Appellate Board after receiving a decision?

30 days

45 days

60 days

90 days

45.

What is the fee for submitting an appeal to the Appellate Board, as mentioned in the rules?

Rs. 25,000

Rs. 35,000

Rs. 50,000

Rs. 75,000

46.

In case of an appeal against the decision of the Registration Board rejecting an application for registration of a drug, what statement is required to be submitted?

Statement of financials

Statement of assets and liabilities

Statement of marketing strategy

Statement in form A or form B of the Schedule

47.

What is the Appellate Board's authority to call for the record of a case for review?

It can only call for the record if requested by the appellant

It can call for the record only if there is a legal dispute

It can call for the record at any Ime to satisfy itself about the correctness of an order

It can call for the record only in cases involving pricing matters

48.

What is the duration of a license to import drugs, unless suspended or canceled?

One year

Three years

Two years

Five years

49.

Under what condition can finished drugs be imported?

Only for personal use

By obtaining permission from the Federal Government

By obtaining permission from the Appellate Board

Without any conditions

50.

What is the maximum quantity of a single drug that can be imported for personal use without exceeding the limit?

Fifty average doses

One hundred average doses

Two hundred average doses

Three hundred average doses

51.

What is the purpose of Form 6?

Application for a license to import drugs other than finished drugs

Application for a license to import small quantities of drugs for clinical trial

Application for a duplicate copy of an import license

Application for permission to import drugs for personal use

52.

Who may physically inspect an imported consignment, draw samples, and order the importer not to sell or dispose of the drug for a specific period?

The manufacturer of the drug

A provincial inspector or a person authorized by the Federal Government

The importer of the drug

The licensing authority

53.

What is the consequence of violating the conditions of a license to import drugs or the provisions of the Act?

A warning letter from the licensing authority

A fine of fifty rupees

Suspension or cancellation of the license

An appeal to the Appellate Board

54.

What is the procedure for appealing the suspension or cancellation of a license under Drugs Import & Export Rules 1976?

An appeal can be made directly to the Drug Regulatory Authority of Pakistan

An appeal can be made to the Collector of Customs

An appeal can be made to the manufacturer of the drug

An appeal can be made to the Appellate Board within sixty days

55.

What is the duration of a license to export drugs?

One year

Three years

Two years

Five years

56.

Under what circumstance can an exporter withdraw a batch of drugs from export after being informed by the licensing authority?

If the batch is damaged during transport

If the batch fails to meet specifications

If the batch has expired

If the batch is in surplus

57.

What is the purpose of Form 10 in the export of drugs?

To apply for a license to export drugs

To report the export of drugs to customs

To track the movement of exported drugs

To record the sale of exported drugs

58.

Who has the authority to physically inspect consignments of exported drugs and draw samples for testing?

Customs officials

The licensing authority

The Federal Government

The Appellate Board

59.

What provision allows an exporter to recall issues already made from a batch of drugs that have been found to be in contravention of the Act or rules of 1976?

Clause (i)

Clause (iii)

Clause (iv)

Clause (v)

60.

In case an exporter's license is suspended or canceled, what recourse does the licensee have?

The licensee can reapply for a new license immediately.

The licensee can appeal to the Appellate Board within thirty days.

The licensee can apply for a refund of the license fee.

The licensee can conInue exporIng drugs despite the suspension or cancellaIon

61.

What is the commencement date for the Drugs (Specifications) Rules, 1978?

One month after publication

Six months after publication

One year after publication

At once

62.

According to the schedule in the Drugs (Specifications) Rules, what specifications should drugs bear that reference publications specified under sub-clause (ii) of clause (z) of Section 3?

Specifications given in the publication referred to on the labelling

Specifications approved by the Registration Board

Specifications provided by the World Health Organisation

Specifications from the United States Pharmacopoeia

63.

For veterinary drugs, what is the source of specifications if they are not approved by the Registration Board?

Current edition of the British Veterinary Codex

International Pharmacopoeia

European Pharmacopoeia

United States National Formulary

64.

What type of containers are ophthalmic solutions and suspensions required to be contained in?

Any glass containers

Neutral glass or soda glass treated with alkali

Plastic containers only

Opaque glass containers

65.

Which type of ophthalmic preparations is allowed to have a preservative?

Ophthalmic solutions for surgery

Ophthalmic ointments

Ophthalmic solutions and suspensions that need to be sterile

Ophthalmic preparaIons for veterinary use

66.

For drugs other than those falling under specific categories, whose approval is required for the specifications?

World Health Organisation

Drug manufacturer's approval

Registration Board's approval

Government Analyst's approval

67.

According to the Drugs (Specifications) Rules, 1978, what is the requirement for ophthalmic ointments?

They must be packed in plastic containers.

They must not contain any preservatives.

They must be free from foreign matter.

They must be in single-dose containers.

68.

What is the purpose of the Drugs (Research) Rules, 1978?

To regulate the manufacture and sale of drugs

To establish guidelines for importing drugs

To govern the research, development, and evaluation of drugs

To control the export of drugs

69.

Who is considered an "investigator" under the Drugs (Research) Rules?

A person who uses drugs for personal use

A person engaged in drug manufacturing

A person who conducts research on drugs

A person who distributes drugs to patients

70.

What is the meaning of "sponsor" in the context of the Drugs (Research) Rules?

A person who conducts clinical trials

A person who funds drug research

A person who manufactures drugs

A person who prescribes drugs

71.

Which type of research involves intervention, treatment, or medication programs using human subjects?

Clinical trials

Basic research

Operational research

Animal studies

72.

What is the primary purpose of the Committee of Experts on Drug Research?

To promote drug manufacturing

To oversee clinical trials

To provide scholarships for drug research

To advise on the uIlization of the research fund

73.

What stage of investigation on human beings involves determining safety, effectiveness, and common side effects of a drug?

Stage I

Stage II

Stage III

Stage IV

74.

Under what conditions can the aid from the research fund be withdrawn and a clinical trial terminated?

Evidence of significant hazard, convincing evidence of drug ineffectiveness, submission of false data

Failure to submit applications, failure to comply with legal requirements, commercialization of the drug

Lack of progress in research, failure to obtain paIent consent, misuse of research funds

Failure to report minor side effects, incomplete data submission, absence of written consent

75.

What is the primary focus of basic research in the context of the Drugs (Research) Rules?

Evaluating the effectiveness of existing drugs

Discovering and developing new drugs, including chemical synthesis and pre-clinical testing

Conducting clinical trials for drug approval

Monitoring the safety of drugs in the market

76.

What is the purpose of 'the Drugs (Federal Inspectors, Federal Drug Laboratory and Federal Government Analysts) Rules, 1976'?

To regulate the sale of drugs to the public

To establish a government pharmacy network

To set guidelines for the functioning of drug laboratories.

To define the qualifications of medical practitioners.

77.

Who qualifies as a Federal Inspector according to these rules?

Anyone with a degree in any field of science

A person with at least five years of practical experience in drug administration.

A person with a degree in Pharmacy and ten years' practical experience.

An officer of the medical department with a degree in Medicine.

78.

What is the main duty of a Federal Inspector?

To sell drugs to licensed premises

To test and analyze drugs in a government laboratory

To regulate the import and export of drugs

To perform routine inspections of drug premises.

79.

What is the primary function of the Federal Drug Laboratory as stated in the rules?

To test and analyze imported drugs only

To provide technical assistance to pharmaceutical industries

To evaluate the effectiveness of drugs for treatment.

To test and analyze samples of drugs sent to it.

80.

Which authority may authorize a Federal Inspector to disclose information acquired during official duties?

The President of Pakistan.

The Drug Court.

The Provincial Government.

The Federal Government

DRAP Preparation Mock Exam 2

DRAP Mock Exam 2 (Forensic Pharmacy)

Subject: Forensic Pharmacy

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