1. The Drugs Act, 1976 extends to which of the following areas?
2. What condition must be met for an application for renewal of a licence to be entertained?
3. What is the fee for submitting an appeal to the Appellate Board, as mentioned in the rules?
4. Who qualifies as a Federal Inspector according to these rules?
5. According to the Drugs (Specifications) Rules, 1978, what is the requirement for ophthalmic ointments?
6. What is the purpose of the Central Research Fund mentioned in the Drugs Licensing, Registering & Advertising Rules 1976?
7. Which of the following is NOT included in the definition of "Biologicals" under Schedule-I?
8. What does an Inspector require from a person during a search or seizure under Schedule-V?
9. Who serves as the ex-officio Chairman of the Appellate Board?
10. Which power of the Inspector requires specific authorization by the Government?
11. 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?
12. What is the purpose of Form 6?
13. The Authority may open its accounts with:
14. What action should the Authority take in response to objections raised by the Auditor-General?
15. Under Schedule-II, what is allowed in terms of distributing therapeutic goods as samples?
16. What is the punishment for violating any prohibitions specified in Schedule-II of the DRAP Act?
17. What is the purpose of Schedule-III of the DRAP Act?
18. Which of the following is NOT included in the definition of "Biologicals" under Schedule-I?
19. What is the maximum quantity of a single drug that can be imported for personal use without exceeding the limit?
20. What is the meaning of "sponsor" in the context of the Drugs (Research) Rules?
21. Which of the following substances would NOT be considered a "Medicated Cosmetic"?
22. What is the procedure for appealing the suspension or cancellation of a license under Drugs Import & Export Rules 1976?
23. What is the role of the Quality Control Department in the manufacturing process?
24. What is the maximum allowable retailer's discount for drugs?
25. Which authority may authorize a Federal Inspector to disclose information acquired during official duties?
26. What is the penalty for giving a false warranty in respect of any therapeutic good or applying a warranty given for another therapeutic good?
27. What is the duration of a license to import drugs, unless suspended or canceled?
28. What is the tenure of the CEO's appointment, and how many times can it be extended?
29. Where should one portion of a sample taken by an Inspector be sent for test and analysis?
30. 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?
31. Which court shall try an offense punishable under the DRAP Act, 2012, and The Drugs Act, 1976?
32. According to the Drug Licensing, Registering & Advertisement rules 1976, what type of information should advertisements to physicians and health-related professionals be consistent with?
33. Which type of research involves intervention, treatment, or medication programs using human subjects?
34. Which of the following criteria should promotional claims about drugs adhere to?
35. Under Schedule-II, what is allowed in terms of distributing therapeutic goods as samples?
36. What is the fee for the renewal of registration of a new drug?
37. Within what time frame should the Authority submit its annual report to the Federal Government?
38. Within what time frame should the Authority submit its annual report to the Federal Government?
39. What are "Medicated Cosmetics" under Schedule-I?
40. 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?
41. Which of the following is NOT considered as "Therapeutic goods" under the Act?
42. Under what conditions is contract manufacture permissible?
43. What is the punishment for a person who exports, imports, manufactures for sale, or sells any spurious therapeutic good or any unregistered therapeutic good?
44. Which power of the Inspector requires specific authorization by the Government?
45. What is the purpose of the Drug Regulatory Authority of Pakistan Fund?
46. What is the consequence of violating the conditions of a license to import drugs or the provisions of the Act?
47. What is the primary purpose of the Committee of Experts on Drug Research?
48. What labeling requirements apply to drugs manufactured for experimental purposes?
49. What is the maximum duration for which the approval of an advertisement under sub-rule (1) is valid?
50. What are "Medicated Cosmetics" under Schedule-I?
51. What is the purpose of the criteria regarding medical representatives?
52. What does the term "Advertise" mean under Schedule-II?
53. Which of the following actions related to therapeutic goods is PROHIBITED under Schedule-II?
54. What is the Appellate Board's authority to call for the record of a case for review?
55. What degree qualifications are required for the competent technical staff involved in the manufacture of drugs by way of basic or semi-basic manufacture?
56. In case of inconsistency between the provisions of the DRAP Act and any other law, what takes precedence?
57. Which of the following offenses punishable under Schedule-III is non-cognizable?
58. Under what condition can finished drugs be imported?
59. What substances are NOT included in the definition of "Drug" under Schedule-I?
60. How often must records of quarterly production and disposal of a drug be supplied to the Chairman of the Registration Board?
61. What are the types of licences to manufacture drugs under Drugs Licensing, Registering & Advertising rules 1976?
62. Which Division is responsible for the evaluation, assessment, and registration of pharmaceutical drugs for human beings and animals?
63. What is the penalty for selling a drug in the finished form over and above the maximum retail price fixed by the Federal Government?
64. What is the penalty for a person who obstructs an Inspector in the exercise of any power conferred upon him under the Act?
65. Who has the power to institute a prosecution for a contravention of any provision of the DRAP Act, 2012, and The Drugs Act, 1976?
66. What kind of offense is non-cognizable under the Drugs Act 1976?
67. What condition must be met for a drug or substance to be advertised through press without reference to the Federal Government?
68. What does the term "Advertise" mean under Schedule-II?
69. What is the purpose of the Drug Regulatory Authority of Pakistan Fund?
70. For drugs other than those falling under specific categories, whose approval is required for the specifications?
71. What is the primary focus of basic research in the context of the Drugs (Research) Rules?
72. What is the purpose of an "airlock" in pharmaceutical manufacturing?
73. For veterinary drugs, what is the source of specifications if they are not approved by the Registration Board?
74. What is the duration of a license to export drugs?
75. When does an Inspector need to divide a sample into three portoons instead of four?
76. What is the penalty for a subsequent offense under Clause (1) of Schedule-III?
77. What is the penalty for a person who obstructs an Inspector in the exercise of any power conferred upon him under the Act?
78. Who is responsible for carrying out the audit of the Authority's accounts?
79. What is the commencement date for the Drugs (Specifications) Rules, 1978?
80. The Authority shall levy and collect fees for its functions at rates determined by:
81. What is the punishment for a person who exports, imports, manufactures for sale, or sells any spurious therapeutic good or any unregistered therapeutic good?
82. What type of containers are ophthalmic solutions and suspensions required to be contained in?
83. In case of inconsistency between the provisions of the DRAP Act and any other law, what takes precedence?
84. In case an exporter's license is suspended or canceled, what recourse does the licensee have?
85. Who has the authority to establish the Drug Regulatory Authority of Pakistan?
86. What is the primary function of the Federal Drug Laboratory as stated in the rules?
87. What is the meaning of "Reference Biotherapeutic Product (RBP)" under ScheduleI?
88. If any difficulty arises in giving effect to any provision of the DRAP Act, who has the authority to remove the difficulty?
89. What stage of investigation on human beings involves determining safety, effectiveness, and common side effects of a drug?
90. What must be included in the labelling and promotion of a registered drug?
91. What is the role of the Appellate Board under The Drug Regulatory Authority of Pakistan Act, 2012?
92. What are "Medical Devices" under Schedule-I?
93. What is the definition of "Biological Drugs (Ready-to-fill form)" under Schedule-I?
94. In which circumstances may the Registration Board register a drug on its own motion?
95. Which of the following statements about advertisement material is NOT true?
96. How long do members, other than ex-officio members, of the Appellate Board hold office for initially?
97. What is the main duty of a Federal Inspector?
98. What does an Inspector require from a person during a search or seizure under Schedule-V?
99. 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?
100. What is the definition of "promotion" for the purposes of Schedule G of 1976 Rules?
