1. What is the purpose of The Drug Regulatory Authority of Pakistan Act, 2012?
2. Who has the authority to make rules for carrying out the purposes of the DRAP Act 2012?
3. What are "Medical Devices" under Schedule-I?
4. What does an Inspector require from a person during a search or seizure under Schedule-V?
5. According to the Drug Licensing, Registering & Advertisement rules 1976, what type of information should advertisements to physicians and health-related professionals be consistent with?
6. Which of the following statements about advertisement material is NOT true?
7. What degree qualifications are required for the competent technical staff involved in the manufacture of drugs by way of basic or semi-basic manufacture?
8. What is the tenure of the CEO's appointment, and how many times can it be extended?
9. Who has the power to institute a prosecution for a contravention of any provision of the DRAP Act, 2012, and The Drugs Act, 1976?
10. Where should one portion of a sample taken by an Inspector be sent for test and analysis?
11. Who has the authority to establish the Drug Regulatory Authority of Pakistan?
12. Which of the following is NOT included in the definition of "Biologicals" under Schedule-I?
13. What is the penalty for selling a drug in the finished form over and above the maximum retail price fixed by the Federal Government?
14. Which authority is responsible for issuing licences to manufacture drugs by way of repacking under section 18 of ordinance in a province?
15. What is the primary function of the Federal Drug Laboratory as stated in the rules?
16. What is the purpose of the license to manufacture drugs for experimental purposes?
17. Which type of research involves intervention, treatment, or medication programs using human subjects?
18. What form should be used for applying for the grant or renewal of a licence to manufacture drugs?
19. What type of containers are ophthalmic solutions and suspensions required to be contained in?
20. Under what conditions is contract manufacture permissible?
21. What condition must be met for an application for renewal of a licence to be entertained?
22. What kind of offense is non-cognizable under the Drugs Act 1976?
23. Who is responsible for maintaining records of quarterly production and disposal of a drug?
24. Which of the following actions related to therapeutic goods is PROHIBITED under Schedule-II?
25. What is the purpose of Form 6?
26. What is the purpose of 'the Drugs (Federal Inspectors, Federal Drug Laboratory and Federal Government Analysts) Rules, 1976'?
27. What is the purpose of the Committee on Drugs Evaluation?
28. What is the penalty for a person who fails to provide information requested by the Authority?
29. What is the penalty for a person who obstructs an Inspector in the exercise of any power conferred upon him under the Act?
30. What are the types of licences to manufacture drugs under Drugs Licensing, Registering & Advertising rules 1976?
31. What labeling requirements apply to drugs manufactured for experimental purposes?
32. What is the primary focus of basic research in the context of the Drugs (Research) Rules?
33. What is the meaning of "sponsor" in the context of the Drugs (Research) Rules?
34. What is the fee for submitting an appeal to the Appellate Board, as mentioned in the rules?
35. Which of the following is NOT considered as "Therapeutic goods" under the Act?
36. What is the punishment for violating any prohibitions specified in Schedule-II of the DRAP Act?
37. 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?
38. For veterinary drugs, what is the source of specifications if they are not approved by the Registration Board?
39. What action should the Authority take in response to objections raised by the Auditor-General?
40. If any difficulty arises in giving effect to any provision of the DRAP Act, who has the authority to remove the difficulty?
41. What is the maximum duration for which the approval of an advertisement under sub-rule (1) is valid?
42. What is the penalty for a person who obstructs an Inspector in the exercise of any power conferred upon him under the Act?
43. What is the consequence of violating the conditions of a license to import drugs or the provisions of the Act?
44. What is the purpose of The Drug Regulatory Authority of Pakistan Act, 2012?
45. In what circumstances shall a drug not be deemed misbranded or adulterated?
46. What is the purpose of an "airlock" in pharmaceutical manufacturing?
47. What are "Medicated Cosmetics" under Schedule-I?
48. What is the purpose of Schedule-III of the DRAP Act?
49. Under what circumstance can an exporter withdraw a batch of drugs from export after being informed by the licensing authority?
50. What is the maximum duration of a licence issued under Drugs Licensing, Registering & Advertising rules 1976?
51. Who has the authority to make rules for carrying out the purposes of the DRAP Act 2012?
52. Who is responsible for carrying out the audit of the Authority's accounts?
53. When does an Inspector need to divide a sample into three portoons instead of four?
54. What does an Inspector require from a person during a search or seizure under Schedule-V?
55. In which circumstances may the Registration Board register a drug on its own motion?
56. What is the definition of "promotion" for the purposes of Schedule G of 1976 Rules?
57. Under what conditions are drug advertisements to the general public generally permitted?
58. What is the role of the Quality Control Department in the manufacturing process?
59. If any difficulty arises in giving effect to any provision of the DRAP Act, who has the authority to remove the difficulty?
60. 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?
61. Which power of the Inspector requires specific authorization by the Government?
62. What is the duration of a license to import drugs, unless suspended or canceled?
63. What is the maximum allowable retailer's discount for drugs?
64. What is the definition of "Biological Drugs (Ready-to-fill form)" under Schedule-I?
65. What is the fee for the renewal of registration of a new drug?
66. How many members does the Policy Board consist of?
67. What is the punishment for a person who exports, imports, manufactures for sale, or sells any spurious therapeutic good or any unregistered therapeutic good?
68. What are "Medical Devices" under Schedule-I?
69. What authority is responsible for inspecting and regulaying the manufacturing of drugs under 1976 rules?
70. What must be included in the labelling and promotion of a registered drug?
71. Where should one portion of a sample taken by an Inspector be sent for test and analysis?
72. What is the role of the Appellate Board under The Drug Regulatory Authority of Pakistan Act, 2012?
73. What is the procedure for appealing the suspension or cancellation of a license under Drugs Import & Export Rules 1976?
74. Which type of ophthalmic preparations is allowed to have a preservative?
75. What substances are NOT included in the definition of "Drug" under Schedule-I?
76. Who has the authority to physically inspect consignments of exported drugs and draw samples for testing?
77. How long do members, other than ex-officio members, of the Appellate Board hold office for initially?
78. When does an Inspector need to divide a sample into three portoons instead of four?
79. Who qualifies as a Federal Inspector according to these rules?
80. What should an Inspector do if he finds that the therapeutic good does not contravene any provisions of the Act?
81. What is the purpose of a separate application for manufacturing drugs on more than one set of premises?
82. In what situations can a drug or substance be advertised to the medical, pharmaceutical, and allied professions without referring to the Federal Government?
83. What is the penalty for a person who fails to provide information requested by the Authority?
84. Which court shall try an offense punishable under the DRAP Act, 2012, and The Drugs Act, 1976?
85. What is the penalty for a subsequent offense under Clause (1) of Schedule-III?
86. Which of the following actions related to therapeutic goods is PROHIBITED under Schedule-II?
87. What is the purpose of the Drug Regulatory Authority of Pakistan Fund?
88. Who serves as the ex-officio Chairman of the Appellate Board?
89. What is the maximum period for which an Inspector can forbid a person in charge of premises from removing or dispensing therapeutic goods?
90. What is the duration of a license to export drugs?
91. The Authority may open its accounts with:
92. Which of the following substances would NOT be considered a "Medicated Cosmetic"?
93. What is the purpose of an "airlock" in pharmaceutical manufacturing?
94. Who shall not be liable for a contravention of Section 23 of the Drugs Act 1976?
95. What substances are NOT included in the definition of "Drug" under Schedule-I?
96. Under Schedule-II, what is allowed in terms of distributing therapeutic goods as samples?
97. What is the purpose of the Central Research Fund mentioned in the Drugs Licensing, Registering & Advertising Rules 1976?
98. What ethical criteria should be followed for medical drug promotion?
99. 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?
100. What does the term "Advertise" mean under Schedule-II?
