Q. 1
Pharmacy
Difficulty: Easy
(1 Mark)
The Drug Regulatory Authority of Pakistan (DRAP) was officially established under which legislative Act?
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Step-by-Step Explanation & Concept Rationale
DRAP was established under the Drug Regulatory Authority of Pakistan Act, 2012 (Act No. XXI of 2012) following the 18th Constitutional Amendment to regulate manufacture, import, export, and registration of therapeutic goods.
Q. 2
Pharmacy
Difficulty: Medium
(1 Mark)
Under the Drugs Act 1976, a drug which is manufactured under a name which belongs to another drug or imitates another drug is defined as a:
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Step-by-Step Explanation & Concept Rationale
Section 3(zb) of Drugs Act 1976 defines a 'spurious drug' as one which is an imitation of, or substitute for, another drug, or bears the name or trade mark of another product or manufacturer without authorization.
Q. 3
Pharmacy
Difficulty: Medium
(1 Mark)
Under Section 3(a) of the Drugs Act 1976, a drug containing decomposed or putrid substance, or packed under insanitary conditions is categorized as:
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Step-by-Step Explanation & Concept Rationale
An 'adulterated drug' consists in whole or in part of any filthy, putrid or decomposed substance, or has been prepared, packed or held under insanitary conditions whereby it may have been contaminated.
Q. 4
Pharmacy
Difficulty: Easy
(1 Mark)
When a Drug Inspector takes a sample of a drug from a retail pharmacy for analysis under the Drugs Act 1976, into how many portions must the sample be divided?
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Step-by-Step Explanation & Concept Rationale
Under Section 19(3) of Drugs Act 1976, the Inspector must divide the sample into four portions: 1 for the person sampled, 1 for the Government Analyst, 1 for production before the Drug Court, and 1 for warrantor/manufacturer.
Q. 5
Pharmacy
Difficulty: Medium
(1 Mark)
Which official statutory form is issued by a Drug Inspector when tendering payment and taking a drug sample for analysis?
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Step-by-Step Explanation & Concept Rationale
Under the Drugs (Federal Inspectors, Federal Drug Laboratory and Federal Government Analyst) Rules, Form 5 is the official receipt granted by the Inspector when taking a sample, while Form 4 is used for orders seizing stocks.
Q. 6
Pharmacy
Difficulty: Medium
(1 Mark)
The report or certificate issued by the Government Analyst regarding the test or analysis of a drug sample is provided on:
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Step-by-Step Explanation & Concept Rationale
Form 6 is the statutory certificate of test or analysis issued by the Government Analyst declaring whether a tested sample conforms to pharmacopoeial specifications.
Q. 7
Pharmacy
Difficulty: Medium
(1 Mark)
What is the maximum statutory time period granted to the Government Analyst to submit the test report of a sampled drug from the date of receipt?
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Step-by-Step Explanation & Concept Rationale
Under Section 19(5) of the Drugs Act 1976, the Government Analyst must deliver the report in Form 6 within 60 days of receiving the sample, unless an extension is permitted by the board.
Q. 8
Pharmacy
Difficulty: Easy
(1 Mark)
Offenses under the Drugs Act 1976 are tried by which judicial body?
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Step-by-Step Explanation & Concept Rationale
Section 31 of the Drugs Act 1976 provides for the constitution of Drug Courts, comprising a Chairman who is qualified to be a Judge of a High Court and two members who are experts in the medical or pharmaceutical field.
Q. 9
Pharmacy
Difficulty: Hard
(1 Mark)
Under Section 27 of the Drugs Act 1976, what is the maximum punishment for manufacturing or selling a spurious or adulterated drug?
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Step-by-Step Explanation & Concept Rationale
Section 27 provides severe penalties for spurious drugs, including imprisonment for a term which may extend to life (minimum 3 to 7 years in provincial amendments) and heavy monetary fines.
Q. 10
Pharmacy
Difficulty: Medium
(1 Mark)
Which statutory board in Pakistan is responsible for granting licenses to manufacture drugs by way of formulation or basic synthesis?
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Step-by-Step Explanation & Concept Rationale
The Central Licensing Board (CLB) constituted under the Drugs (Licensing, Registering & Advertising) Rules 1976 approves and grants Drug Manufacturing Licenses (DML) for pharmaceutical plants.
Q. 11
Pharmacy
Difficulty: Easy
(1 Mark)
Which statutory body at the provincial level reviews drug inspection reports and accords sanction for prosecuting violators in the Drug Court?
💡
Step-by-Step Explanation & Concept Rationale
The Provincial Quality Control Board (PQCB) investigates drug quality reports, hears explanations from manufacturers/chemists, and decides whether to refer cases to the Drug Court for formal prosecution.
Q. 12
Pharmacy
Difficulty: Easy
(1 Mark)
Under the Pharmacy Act 1967, which register maintained by the Provincial Pharmacy Council contains the names of qualified registered graduate pharmacists (Pharm.D / B.Pharm)?
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Step-by-Step Explanation & Concept Rationale
Section 24 of Pharmacy Act 1967 mandates Register A for graduate pharmacists holding a recognized university degree in pharmacy (Pharm.D/B.Pharm), while Register B is for pharmacy technicians/assistant pharmacists.
Q. 13
Pharmacy
Difficulty: Medium
(1 Mark)
Under the DRAP Act 2012, therapeutic goods include which of the following categories?
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Step-by-Step Explanation & Concept Rationale
The DRAP Act 2012 expanded the scope beyond allopathic drugs to include medical devices, biologicals, alternative medicines (herbal, homeopathic, unani), and health/nutraceutical products under the umbrella of 'Therapeutic Goods'.
Q. 14
Pharmacy
Difficulty: Hard
(1 Mark)
Which schedule of the Drugs (Licensing, Registering & Advertising) Rules specifies Good Manufacturing Practice (GMP) requirements for premises and equipment?
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Step-by-Step Explanation & Concept Rationale
Schedule B of the Drug Rules 1976 sets out standard conditions for manufacturing premises, personnel, sanitation, quality control, and machinery (cGMP requirements).
Q. 15
Pharmacy
Difficulty: Hard
(1 Mark)
A Drug Inspector cannot inspect or take samples without a warrant under which circumstance?
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Step-by-Step Explanation & Concept Rationale
Under Section 18 of the Drugs Act 1976, an Inspector may enter and search any premises where drugs are manufactured or sold, but entry into a private dwelling house requires a warrant from a Magistrate.
Q. 16
Pharmacy
Difficulty: Easy
(1 Mark)
Under the Drug Rules, a drug formulation must NOT be sold after its expiry date because:
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Step-by-Step Explanation & Concept Rationale
Post-expiry, the active pharmaceutical ingredient degrades below official pharmacopoeial potency (typically < 90-95%), and toxic degradation products (e.g., epitetracycline) can accumulate.
Q. 17
Pharmacy
Difficulty: Medium
(1 Mark)
Who serves as the ex-officio Chairman of the Policy Board of the Drug Regulatory Authority of Pakistan (DRAP)?
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Step-by-Step Explanation & Concept Rationale
Under the DRAP Act 2012, the Federal Minister or Minister of State for National Health Services serves as the ex-officio Chairman of the overarching DRAP Policy Board.
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